Preventive action is an essential component of IATF 16949, the automotive quality management standard. It focuses on proactively identifying and addressing potential issues to prevent their occurrence or recurrence. Preventive actions aim to minimize risks, improve process performance, and enhance product quality. Here are key aspects of preventive action in IATF 16949:

1. Risk Assessment and Analysis: Preventive actions begin with a thorough risk assessment and analysis. Organizations identify potential risks and analyze their likelihood, severity, and potential impacts on product quality and customer satisfaction. This analysis helps prioritize risks and determine appropriate preventive actions.
2. Proactive Approach: IATF 16949 promotes a proactive approach to preventive action. Organizations are expected to identify and address potential issues before they result in non-conformities or quality problems. Proactive measures help prevent problems from occurring, reducing the need for corrective actions and minimizing the associated costs and disruptions.
3. Root Cause Analysis: Preventive actions involve conducting root cause analysis to identify the underlying causes of potential issues or risks. Organizations investigate the factors that could lead to non-conformities, defects, or quality issues. By addressing the root causes, organizations can implement targeted actions that prevent the recurrence of similar problems.
4. Process Improvement: Preventive actions often focus on improving processes to minimize the occurrence of potential issues. Organizations identify areas for process enhancement, such as optimizing process parameters, implementing error-proofing techniques (poka-yoke), or upgrading equipment. Process improvements aim to eliminate or reduce the factors that could contribute to problems.
5. Training and Competence Development: Preventive action includes providing training and competence development programs for employees. Organizations ensure that employees possess the necessary skills and knowledge to perform their tasks effectively. Training programs address potential gaps, enhance employee capabilities, and promote a culture of continuous improvement and proactive problem-solving.
6. Change Management: Preventive action is closely linked to change management processes. Organizations assess the potential risks associated with changes in products, processes, or the quality management system. This assessment helps identify preventive actions that need to be implemented alongside the changes to mitigate or eliminate associated risks.
7. Monitoring and Measurement: Organizations establish systems to monitor and measure key process indicators and performance metrics. By regularly monitoring and analyzing data, organizations can identify trends, deviations, or early warning signs of potential issues. This proactive monitoring enables timely implementation of preventive actions to avoid non-conformities and quality problems.
8. Documentation and Record-Keeping: Organizations maintain documentation of preventive actions taken. This documentation includes the identification of potential issues, the corresponding preventive measures implemented, and the evaluation of their effectiveness. By documenting preventive actions, organizations can track their implementation, monitor outcomes, and demonstrate compliance with IATF 16949 requirements.
9. Continuous Improvement: Preventive action is an integral part of the culture of continuous improvement promoted by IATF 16949. Organizations continually evaluate the effectiveness of preventive actions, learn from experiences, and refine their preventive action processes. Lessons learned from preventive actions feed into ongoing improvement initiatives, contributing to enhanced product quality and customer satisfaction.

By integrating preventive actions into their quality management systems, organizations can reduce risks, enhance process performance, and prevent quality problems. Implementing a proactive approach, conducting root cause analysis, improving processes, providing appropriate training, and continuously monitoring performance contribute to effective preventive action in compliance with IATF 16949.

IATF 16949:2016 Clause 6.1.2.2 Preventive action

The organization needs to figure out the action it need to take to eliminate the causes of potential nonconformity before they happen. That should match the severity of the potential problems could be. They need to set up processes to reduce how much damage might happen due to the negative effect of risks. This means figuring out potential non-conformities and causes, deciding if they need to do something to stop occurrence of nonconformities, determining what actions are needed , implement those actions, Document those actions, reviewing the effectiveness of the actions taken. Leaning for those actions to stop to to occur to similar processes.

Corrective action is action taken to eliminate the cause of a detected nonconformity to prevent recurrence, whereas preventive action is action taken to eliminate the cause of a potential nonconformity or other undesirable situation, to prevent occurrence.  Sources of information for finding potential QMS nonconformities include – analyses of data (see clause 8.4); audit results; cost of quality reports; quality records; service reports; supplier performance; customer satisfaction feedback; FMEA’s; management review records; lessons learned from past experience; SPC charts and analyses. You must have a documented procedure for your preventive action process which must address basically all of the explanation points and tips covered under the corrective action process.    While preventing potential QMS nonconformities is our focus for ISO 9001 and IATF 16949, it might be very useful to think of preventive action in a wider context, i.e. the entire business. Think in terms of actions needed to prevent – loss of market share; loss of product profitability; loss due to lack of product diversity; loss of business opportunities due to lack of capacity, inadequate or older facilities, production equipment, technology or information systems; loss of key or competent personnel; inadequate business financing; inadequate staffing, etc. These issues may have far more serious consequences than QMS issues. Consider a process that involves developing a business plan covering these issues, based on – gathering relevant research data on these issues; use of appropriate risk evaluation and management methods; developing proactive strategies and action; monitoring and reviewing performance against the business plan. This would constitute the ultimate preventive action process. Consider using a Pareto analysis to organize and rank the dollar value impact of the data on the issues listed above in order to: Determine the magnitude of risks and effects on the organization and Prioritize preventive on these issues as they are all important and may need significant amounts of resources to address them. Performance indicators to measure the effectiveness of the preventive action process may include – reduction in cycle time for preventive actions, problem re-occurrence, open preventive actions, costs; and improvement in QMS productivity.  

Some examples of preventive actions commonly implemented in the automotive industry to prevent quality issues and improve overall performance:

Design for Manufacturability (DFM) Analysis: Conducting DFM analysis during the product design phase to identify and address potential manufacturing challenges and issues upfront. This helps prevent design-related problems and ensures smooth production processes.

Robust Incoming Material Inspection: Implementing thorough inspection and testing procedures for incoming materials and components to identify any quality issues or deviations early on. This prevents the use of defective or substandard materials in the manufacturing process.

Regular Equipment Maintenance and Calibration: Establishing a proactive equipment maintenance schedule to ensure machinery and tools are operating optimally. Conducting regular calibrations and preventive maintenance helps prevent equipment failures, reduce downtime, and maintain consistent quality.

Statistical Process Control (SPC): Utilizing statistical process control techniques to monitor critical process parameters and detect any variations or trends that may impact product quality. Implementing SPC allows for early identification of potential issues and enables corrective actions to be taken promptly.

Supplier Quality Management: Implementing robust supplier quality management processes to ensure that suppliers meet specified quality requirements. This includes conducting audits, performance evaluations, and regular communication to address any potential quality issues proactively.

Employee Training and Competence Development: Providing comprehensive training programs for employees to enhance their skills and knowledge. This includes training on quality standards, work instructions, and process controls, ensuring that employees understand and adhere to quality requirements.

Failure Mode and Effects Analysis (FMEA): Conducting FMEA to identify potential failure modes and their potential effects on product quality, reliability, and safety. Taking preventive actions based on FMEA findings helps eliminate or minimize potential risks and improves overall product quality.

Continuous Improvement Initiatives: Encouraging a culture of continuous improvement throughout the organization. Implementing methodologies such as Kaizen, Lean Manufacturing, and Six Sigma helps identify areas for improvement and facilitates preventive actions to enhance processes and product quality.

Customer Feedback Analysis: Actively gathering and analyzing customer feedback, including complaints and warranty claims. This enables organizations to identify recurring issues, take preventive actions, and make necessary improvements to products and services.

Early Warning Systems: Implementing systems to capture and analyze real-time data from production processes and product performance. Early warning systems help detect anomalies, deviations, or potential failures, allowing for prompt corrective and preventive actions.

Remember that these examples are not exhaustive, and the specific preventive actions implemented in the automotive industry may vary depending on the organization, its products, and its quality management approach. Regenerate response

When implementing preventive actions in the automotive industry, organizations typically follow a systematic approach. Here are the general steps involved:

1. Identify Potential Risks: Conduct a comprehensive risk assessment to identify potential risks, issues, and failure modes that could affect product quality, safety, or customer satisfaction. This involves analyzing historical data, conducting FMEA, or utilizing other risk assessment tools.
2. Prioritize Risks: Prioritize the identified risks based on their severity, probability of occurrence, and detectability. This helps allocate resources effectively and focus on the most critical risks that require immediate attention.
3. Develop Preventive Measures: Once the high-priority risks are identified, develop preventive measures or actions to eliminate or reduce the likelihood of those risks occurring. This may involve implementing process controls, improving design features, enhancing supplier quality management, or implementing new technologies.
4. Document Preventive Actions: Document the preventive actions in a formal manner, ensuring clear descriptions of the actions, responsibilities, timelines, and success criteria. This documentation helps in effective implementation, tracking progress, and measuring the effectiveness of the preventive actions.
5. Implementation and Communication: Execute the preventive actions according to the documented plan. Communicate the preventive actions to relevant stakeholders, including employees, suppliers, and customers, as necessary. Ensure that everyone involved understands their roles and responsibilities.
6. Monitoring and Measurement: Establish monitoring mechanisms to track the implementation of preventive actions and measure their effectiveness. This may involve conducting audits, inspections, or utilizing performance indicators to assess progress and ensure the preventive actions are achieving the desired outcomes.
7. Review and Continuous Improvement: Regularly review the effectiveness of the preventive actions through performance evaluations, customer feedback, and internal audits. Identify areas for improvement and make necessary adjustments to the preventive actions, processes, or procedures to enhance their effectiveness continually.
8. Documentation and Records: Maintain appropriate documentation and records of the preventive actions taken, including any changes made, results achieved, and lessons learned. This documentation serves as evidence of compliance and helps in future decision-making and improvement initiatives.
9. Training and Competence: Provide necessary training and education to employees involved in implementing preventive actions. Ensure they have the required knowledge and skills to execute the actions effectively and contribute to a culture of prevention within the organization.
10. Management Review: Periodically review the effectiveness of the preventive actions during management reviews. This provides an opportunity to assess overall performance, review risk assessment results, and make strategic decisions to further enhance preventive measures.

It’s important to note that the specific steps and processes may vary between organizations and depend on the context, size, and complexity of the automotive industry operations. Following these steps helps organizations systematically address potential risks and take proactive measures to prevent quality issues, improve performance, and enhance customer satisfaction.

The procedure for implementing preventive actions typically involves the following steps:

1. Identify the Need for Preventive Action: Identify the need for preventive action based on various inputs such as risk assessments, analysis of historical data, customer feedback, internal audits, or performance indicators. This step helps identify areas where proactive measures can be taken to prevent potential issues or risks.
2. Define the Objectives and Scope: Clearly define the objectives and scope of the preventive action. Identify the specific outcome or improvement expected from the preventive action and ensure that it aligns with the organization’s overall goals and quality management system.
3. Establish Responsibility and Resources: Assign responsibility for implementing the preventive action to individuals or teams within the organization. Provide them with the necessary resources, authority, and support to effectively execute the action.
4. Plan the Preventive Action: Develop a detailed plan for implementing the preventive action. This plan should outline the specific tasks, timelines, milestones, and deliverables associated with the action. It should also identify any required resources, such as personnel, tools, equipment, or training.
5. Implementation of the Preventive Action: Execute the preventive action according to the plan. This may involve implementing process changes, updating procedures, conducting training sessions, or introducing new control measures. Ensure that all relevant stakeholders are informed and involved in the implementation process.
6. Monitor and Measure the Results: Establish monitoring and measurement mechanisms to track the effectiveness and progress of the preventive action. This may involve collecting data, conducting audits, or using performance indicators to assess the impact of the action on preventing potential issues or risks.
7. Evaluate and Analyze the Results: Evaluate the data and results obtained from the monitoring and measurement activities. Analyze the effectiveness of the preventive action in achieving the desired objectives and identify any deviations or areas for improvement.
8. Take Corrective Actions: If any deviations or non-conformities are identified during the evaluation, take appropriate corrective actions to address them. This may involve modifying the preventive action plan, adjusting processes, or implementing additional control measures to ensure the desired outcomes are achieved.
9. Review and Documentation: Review and document the results, lessons learned, and any modifications made during the preventive action process. Maintain records of the entire procedure, including the initial identification of the need for preventive action, the plan, implementation details, monitoring results, and any corrective actions taken.
10. Review and Continual Improvement: Periodically review the effectiveness of the preventive action during management reviews or quality management system reviews. Assess the overall performance, analyze the trends, and identify opportunities for further improvement. Use this feedback to drive continuous improvement initiatives within the organization.

It’s important to adapt the preventive action procedure to the specific requirements and context of your organization. The procedure should align with your quality management system and any relevant industry standards or regulations applicable to your business.

The readers are advised to read the following three articles before reading this article to have a better understanding of this article

1. Risk based thinking
2. Quality Risk Management
3. ISO 31001:2018 Risk Management Guidelines

In the context of the automotive industry, IATF 16949 is a globally recognized quality management standard specifically developed for automotive suppliers. Risk analysis plays a crucial role within IATF 16949 to ensure that potential risks are identified and managed effectively. The standard emphasizes the need for organizations to establish a systematic approach to risk assessment and mitigation throughout their operations. Here’s how risk analysis is incorporated within IATF 16949: Risk-Based Thinking: IATF 16949 promotes a risk-based thinking approach, which requires organizations to consider risks and opportunities in their quality management system (QMS) processes. This means identifying and addressing risks that could impact the ability to achieve quality objectives, meet customer requirements, and maintain product and process conformity. Risk Assessment: Organizations are expected to conduct risk assessments to identify and prioritize potential risks related to their processes, products, and services. This includes analyzing risks associated with the automotive supply chain, manufacturing processes, product design, and customer requirements. The risk assessment helps in determining the severity, likelihood, and detection controls for identified risks. Control Plan: The IATF 16949 standard requires the development and implementation of control plans. Control plans document the key characteristics of products or processes that are critical for meeting customer requirements. As part of the control plan, organizations are expected to assess and mitigate risks associated with these key characteristics to ensure their consistent control and conformity. Failure Mode and Effects Analysis (FMEA): FMEA is a widely used risk analysis tool in the automotive industry. IATF 16949 emphasizes the use of FMEA as a proactive risk assessment technique. Organizations are required to perform FMEA on their products and processes to identify and evaluate potential failure modes, their causes, and the effects on customers. FMEA helps in prioritizing risks and developing appropriate preventive and corrective actions. Risk Mitigation and Prevention: IATF 16949 emphasizes the implementation of preventive and corrective actions to mitigate identified risks. This includes establishing controls, implementing process improvements, providing training and awareness programs, and continuously monitoring and measuring risks. The standard encourages organizations to adopt a proactive approach to risk management to prevent non-conformities and ensure customer satisfaction. Continual Improvement: Risk analysis and management are integral to the continual improvement process in IATF 16949. Organizations are expected to regularly review and update their risk assessments, control plans, and FMEAs to reflect changes in processes, products, customer requirements, and the external risk landscape. This helps in identifying emerging risks and taking proactive measures to address them. By incorporating risk analysis within the framework of IATF 16949, automotive suppliers can identify potential risks, implement effective controls, and continuously improve their quality management systems. This contributes to enhanced product quality, customer satisfaction, and overall business performance in the automotive industry.

Risk analysis is a systematic process of identifying, assessing, and prioritizing potential risks or uncertainties that may impact a project, organization, or any other endeavor. It involves evaluating the likelihood and potential impact of each identified risk and determining appropriate measures to mitigate or manage them effectively. Risk analysis is an essential component of risk management, as it helps stakeholders make informed decisions and develop strategies to minimize or avoid potential negative consequences.Here’s a breakdown of the key steps involved in risk analysis:

1. Risk Identification: The first step is to identify potential risks. This can be done through various techniques such as brainstorming, checklists, historical data analysis, expert judgment, and documentation review. The goal is to capture all possible risks that could affect the project or organization.
2. Risk Assessment: Once the risks are identified, they need to be assessed to understand their potential impact and likelihood of occurrence. This step involves analyzing each risk in terms of its severity or impact on objectives and the probability of its occurrence. Various qualitative and quantitative methods can be used for assessment, such as risk matrices, risk scoring, probability analysis, and statistical modeling.
3. Risk Prioritization: After assessing the risks, they need to be prioritized based on their significance. Risks can be ranked according to their severity, probability, or a combination of both. This prioritization helps in focusing resources and attention on the most critical risks that require immediate attention.
4. Risk Mitigation or Response Planning: Once the risks are prioritized, appropriate risk mitigation or response strategies are developed. These strategies aim to reduce the probability and/or impact of the identified risks. They can include risk avoidance, risk transfer, risk reduction, risk acceptance, or a combination of these approaches. The goal is to develop actionable plans to address each significant risk.
5. Risk Monitoring and Review: Risk analysis is an ongoing process, and risks need to be monitored continuously throughout the project or organizational lifecycle. Regular reviews and updates are essential to identify new risks, assess the effectiveness of mitigation measures, and make necessary adjustments. Monitoring allows for timely identification and response to changes in the risk landscape.
6. Documentation and Communication: Effective risk analysis involves documenting the identified risks, assessment results, mitigation strategies, and monitoring activities. Clear and concise communication of risks and their potential impacts to stakeholders is crucial for informed decision-making and maintaining awareness of the risk landscape.

By conducting risk analysis, organizations can proactively identify and address potential risks, make informed decisions, allocate resources effectively, and enhance overall project or organizational resilience. It is a fundamental process in risk management, helping to minimize the negative impact of uncertainties and improve the likelihood of successful outcomes.

IATF 16949:2016 6.1.2.1 Risk analysis

In addition to the requirement given in ISO 9001:2015 Clause 6.1 Action to address risk and opportunities, in Clause 6.1.2.1 Risk analysis of IATF 16949:2016, Additional requirements for risks analysis now involve, at the very least, taking into account what we’ve learned from product recalls, product audits, field returns and repairs, complaints, scrap, and rework. The records of the results of risk analysis must be kept as an evidence.

please click here for ISO 9001:2015 clause 6.1 Action to address risk and opportunities.

The organization shall include in its risk analysis, at a minimum, lessons learned from product recalls, product audits, field returns and repairs, complaints, scrap, and rework. The organization shall retain. documented information as evidence of the results of risk analysis. This clause is meant to capture risks rising not detected earlier. Some of the areas/events where risk are found at: Product recalls, product audits, field returns and repairs, complaints, scrap, and rework etc are events that risks can be found; and therefore must be prevented. Retain records on such risk studies, This is a second net to catch risks which may have escaped from the ‘context analyses’. This is activated after each failure. Risks associated with the failure shall be analysed and actions taken. Once a risk is resolved, lessons learned can be updated to the FMEA, control plan and other lesser documents down the line to prevent recurrence.

1) Lessons learnt from Product recalls

Product recalls can have significant consequences for companies, including financial losses, damage to reputation, and potential harm to customers. Here are some key lessons that can be learned from product recalls:

1. Quality Assurance and Testing: Product recalls often highlight the importance of rigorous quality assurance processes and thorough product testing. Ensuring that products undergo comprehensive testing, both during development and before they reach the market, can help identify potential issues early on and prevent recalls.
2. Supply Chain Management: Product recalls can expose vulnerabilities in the supply chain. It is crucial to have effective supplier management processes in place, including supplier qualification, monitoring, and auditing, to ensure that all components or materials meet the required standards and specifications.
3. Transparent Communication: Open and transparent communication is vital during a product recall. Companies should promptly and clearly communicate with affected customers, regulators, and the public, providing accurate information about the issue, potential risks, and the steps being taken to address the problem. Honest and transparent communication helps maintain trust and credibility.
4. Robust Traceability Systems: Having robust traceability systems in place can significantly aid in managing product recalls. Being able to quickly identify affected products, trace their distribution channels, and notify customers is crucial for an efficient recall process. Implementing technologies such as serial numbers, barcodes, or RFID tags can enhance traceability capabilities.
5. Effective Recall Plan: Having a well-prepared recall plan in advance can streamline the recall process and minimize the impact on customers and the company. The plan should outline the roles and responsibilities of key personnel, provide clear procedures for communication, identify necessary resources, and establish a system for monitoring and evaluating the recall progress.
6. Continuous Improvement: Product recalls should be seen as learning opportunities. Companies should conduct thorough investigations to determine the root causes of the issue and take appropriate corrective and preventive actions. Regularly reviewing and updating quality management systems, processes, and testing protocols based on lessons learned from recalls can help prevent similar issues in the future.
7. Regulatory Compliance: Compliance with applicable regulations and standards is essential for product safety. Understanding and adhering to regulatory requirements, conducting regular audits, and staying updated on industry standards can help minimize the risk of non-compliance issues that may lead to recalls.
8. Customer Focus: Putting the customer at the center is crucial. Companies should prioritize customer safety and satisfaction when responding to a product recall. Promptly addressing customer concerns, providing adequate support, and offering appropriate remedies can help maintain customer loyalty and minimize reputational damage.
9. Post-Recall Analysis: After a recall, conducting a comprehensive analysis of the entire recall process is essential. This analysis should evaluate the effectiveness of the recall plan, communication strategies, and corrective actions taken. Identifying areas for improvement can help strengthen the company’s recall management capabilities.

By internalizing these lessons, companies can strengthen their product quality, supply chain resilience, and customer relationships, reducing the likelihood of future product recalls and mitigating the impact if they do occur. Product recalls within the framework of IATF 16949, the automotive quality management standard, provide specific lessons that can help companies improve their processes and prevent future recalls. Here are some key lessons learned from product recalls in the context of IATF 16949:

Robust Change Management: Product recalls often occur due to changes in processes, materials, or designs that were not properly evaluated or controlled. It is crucial to have a robust change management process in place that includes comprehensive risk assessments, validation activities, and effective communication with all relevant stakeholders.

Effective Supplier Management: The automotive industry relies on complex supply chains, and product recalls can be triggered by non-conforming components or materials supplied by external parties. Implementing robust supplier management processes, including strict qualification criteria, regular audits, and ongoing monitoring, is essential to ensure the quality and reliability of supplied components.

Preventive Maintenance and Calibration: Equipment and tools used in automotive manufacturing processes need to be regularly maintained and calibrated to ensure accuracy and reliability. Neglecting proper maintenance and calibration can lead to defects and quality issues that may result in recalls. Implementing preventive maintenance programs and adhering to calibration schedules are crucial to minimize such risks.

Process Validation: Inadequate process validation can lead to product recalls. It is important to conduct thorough process validation activities, such as process capability studies and production part approval processes (PPAP), to ensure that manufacturing processes are capable of consistently producing products that meet customer requirements.

Effective Non-Conformity Management: Non-conformities identified during internal audits, customer complaints, or other quality management activities should be promptly and effectively addressed. Robust non-conformity management processes, including investigation, root cause analysis, corrective actions, and verification of effectiveness, are essential to prevent recurring issues that may lead to recalls.

Continuous Training and Competence Development: Adequate training and competence development programs for employees are critical to ensure that they possess the necessary skills and knowledge to perform their tasks effectively. By investing in ongoing training, employees are better equipped to identify potential quality issues, adhere to processes, and take appropriate corrective actions.

Robust Measurement Systems: Accurate and reliable measurement systems are crucial in the automotive industry to ensure the conformity of products. Implementing robust measurement system analysis (MSA) techniques and calibration processes helps maintain the accuracy of measurement equipment and ensures reliable measurement data for decision-making.

Post-Market Surveillance: Effective post-market surveillance processes help monitor the performance and safety of products in the field. Companies should establish mechanisms to gather and analyze post-market data, including customer complaints, warranty claims, and field performance feedback. This information can help identify emerging issues and trigger proactive measures to address them before they escalate into larger problems.

Culture of Quality and Continuous Improvement: Building a culture of quality and continuous improvement is essential in preventing product recalls. This involves fostering a mindset of accountability, attention to detail, and a commitment to identifying and addressing potential risks. Encouraging employees to participate in problem-solving activities, providing avenues for feedback, and recognizing and rewarding contributions to quality improvement can help create a strong quality culture.

By incorporating these lessons into their quality management systems, companies operating under IATF 16949 can enhance their processes, reduce the risk of recalls, and ensure the production of high-quality automotive products that meet customer expectations.

2) Lessons learnt from Product audits

Product audits, also known as product inspections or quality audits, are conducted to evaluate the conformity of products with established standards, specifications, and customer requirements. These audits provide valuable insights into the quality of the products and highlight areas for improvement. By applying these lessons from product audits, organizations can enhance their quality management systems, improve product quality, and achieve higher customer satisfaction levels. Continuously integrating these lessons into operations can lead to ongoing process improvement and the delivery of consistently high-quality products. Product audits within the framework of IATF 16949, the automotive quality management standard, provide specific lessons that can help companies operating in the automotive industry improve their processes and product quality. Here are some key lessons learned from product audits in the context of IATF 16949:

1. Adherence to IATF 16949 Requirements: Product audits assess the extent to which organizations comply with the requirements of IATF 16949. Lessons learned emphasize the importance of thoroughly understanding the standard and ensuring that all processes, documentation, and practices align with its requirements.
2. Product Conformity: Product audits focus on verifying the conformity of products with established specifications and customer requirements. Lessons learned highlight the significance of consistently meeting these requirements throughout the manufacturing process, including design, production, and final inspection stages.
3. Control Plans and Process Monitoring: Product audits assess the effectiveness of control plans and the monitoring of key characteristics during production. Lessons learned emphasize the importance of implementing robust control plans, conducting thorough process monitoring, and addressing any deviations promptly to ensure product quality and conformity.
4. Supplier Quality Management: Product audits may reveal issues with suppliers and the components or materials they provide. Lessons learned stress the need for strong supplier quality management processes, including supplier qualification, ongoing evaluation, and monitoring. Effective collaboration and communication with suppliers are crucial to ensure the delivery of high-quality components.
5. Non-Conformity Management and Corrective Actions: Product audits often identify non-conformities or deviations from specifications. Lessons learned highlight the importance of promptly addressing non-conformities through robust non-conformity management processes. This includes conducting root cause analysis, implementing corrective actions, and verifying their effectiveness to prevent similar issues from recurring.
6. Process Capability and Variation Reduction: Product audits assess the capability of manufacturing processes to consistently produce products that meet specifications. Lessons learned emphasize the importance of conducting process capability studies, statistical process control, and variation reduction initiatives to improve process stability, reduce defects, and enhance overall product quality.
7. Documented Evidence and Record-Keeping: Product audits evaluate the adequacy and accuracy of documentation and record-keeping practices. Lessons learned emphasize the importance of maintaining comprehensive and up-to-date records, including process documentation, inspection reports, and corrective action records. Accurate documentation provides evidence of adherence to requirements and aids in traceability.
8. Continuous Improvement: Product audits provide valuable insights for continuous improvement. Lessons learned stress the importance of using audit findings as opportunities to identify areas for improvement, implement corrective actions, and drive ongoing process enhancements. Regular review and analysis of audit results contribute to the continual improvement of product quality and organizational performance.
9. Training and Competence Development: Product audits may reveal gaps in employee skills and knowledge. Lessons learned highlight the significance of providing adequate training and competency development programs to enhance employee capabilities. Ensuring that employees possess the necessary skills and knowledge contributes to improved product quality and process performance.

By incorporating these lessons from product audits into their quality management systems, organizations can enhance their processes, optimize product quality, and align with the requirements of IATF 16949. This fosters a culture of continuous improvement and drives the delivery of high-quality products in the automotive industry.

3) Lessons learnt from field returns and repairs

Field returns and repairs refer to situations where products are returned by customers due to defects or issues and require repair or replacement. Handling field returns and repairs effectively is crucial for organizations operating under IATF 16949, the automotive quality management standard. Here are some key lessons learned from field returns and repairs in the context of IATF 16949:

1. Root Cause Analysis: Field returns and repairs provide an opportunity to identify the root causes of defects or issues. Lessons learned highlight the importance of conducting thorough root cause analysis to understand the underlying reasons for the problems. This analysis helps in implementing effective corrective actions to prevent similar issues from recurring in the future.
2. Customer Feedback and Communication: Field returns and repairs offer valuable feedback from customers about product performance and quality. Lessons learned emphasize the significance of actively collecting and analyzing customer feedback. Effective communication with customers during the return and repair process is crucial to address their concerns, manage expectations, and maintain customer satisfaction.
3. Corrective and Preventive Actions: Lessons learned from field returns and repairs emphasize the importance of implementing robust corrective and preventive actions. Corrective actions address the immediate issue, while preventive actions aim to prevent similar issues from occurring in the future. These actions should be carefully documented, implemented, and verified for effectiveness.
4. Supplier Collaboration: Field returns and repairs may reveal issues with components or materials supplied by external parties. Lessons learned highlight the need for close collaboration with suppliers to address these issues. Establishing effective communication channels, conducting supplier audits, and working together to implement corrective actions can improve the quality of supplied components and prevent future problems.
5. Field Failure Analysis: Field returns and repairs provide an opportunity for field failure analysis. This analysis involves evaluating the failed product or component to identify the mode of failure, root causes, and potential design or manufacturing improvements. Lessons learned emphasize the value of field failure analysis in enhancing product reliability and durability.
6. Continuous Improvement: Field returns and repairs serve as sources of valuable data and insights for continuous improvement. Lessons learned stress the importance of analyzing trends and patterns in field returns, identifying common issues, and implementing process improvements to prevent recurrence. Regularly reviewing and analyzing field return data contribute to ongoing improvement efforts.
7. Training and Skill Development: Field returns and repairs can highlight the need for additional employee training and skill development. Lessons learned emphasize the importance of providing training programs to enhance the knowledge and skills of employees involved in repair and quality control activities. Well-trained employees are better equipped to handle repairs effectively and ensure product quality.
8. Documentation and Reporting: Lessons learned from field returns and repairs emphasize the importance of comprehensive documentation and reporting. Accurate documentation of return and repair processes, including detailed records of issues, actions taken, and outcomes, is essential for traceability, analysis, and auditing purposes.
9. Warranty and Claims Management: Field returns and repairs often involve warranty claims and management. Lessons learned stress the importance of effectively managing warranty claims, including timely resolution, accurate record-keeping, and thorough analysis of warranty data. This helps in identifying recurring issues and taking appropriate actions to improve product quality and reduce warranty costs.

By incorporating these lessons learned from field returns and repairs into their quality management systems, organizations can enhance their product quality, customer satisfaction, and overall performance. Implementing effective corrective and preventive actions, conducting root cause analysis, and fostering a culture of continuous improvement contribute to reducing field returns, improving product reliability, and strengthening customer relationships.

4) Lessons learnt from complaint

Complaints play a significant role in identifying customer dissatisfaction and areas for improvement within the framework of IATF 16949, the automotive quality management standard. Handling complaints effectively is crucial for organizations to enhance customer satisfaction and meet their quality objectives. Here are some key lessons learned from complaints in the context of IATF 16949:

1. Customer Focus: Lessons learned from complaints highlight the importance of placing the customer at the center of operations. Organizations should actively listen to customer complaints, treat them as valuable feedback, and prioritize their resolution. Fostering a customer-centric culture helps identify opportunities for improvement and build stronger customer relationships.
2. Complaint Handling Process: Establishing a well-defined and structured complaint handling process is essential. Lessons learned emphasize the need to document, track, and analyze complaints systematically. Implementing clear procedures, roles, and responsibilities for complaint handling ensures timely and consistent resolution, enhances customer satisfaction, and facilitates continuous improvement.
3. Root Cause Analysis: Complaints provide insights into the underlying root causes of customer dissatisfaction. Lessons learned stress the importance of conducting thorough root cause analysis to identify the reasons behind complaints. This analysis helps organizations implement effective corrective actions that address the root causes, prevent recurrence, and improve overall product and service quality.
4. Communication and Response: Effective communication with customers is crucial during the complaint handling process. Lessons learned highlight the significance of prompt and transparent communication with customers, acknowledging their concerns, and providing updates on the progress of complaint resolution. Responsive and proactive communication helps build trust and demonstrates commitment to addressing customer issues.
5. Corrective and Preventive Actions: Lessons learned from complaints emphasize the need for robust corrective and preventive actions. Corrective actions focus on resolving the specific complaint and preventing its recurrence. Preventive actions aim to identify and address potential issues to prevent similar complaints from arising in the future. Implementing these actions helps improve overall quality and customer satisfaction.
6. Continuous Improvement: Complaints offer opportunities for continuous improvement. Lessons learned stress the importance of analyzing complaint data, identifying trends, and using this information to drive process improvements. Regularly reviewing and analyzing complaint data helps organizations address systemic issues, enhance product quality, and exceed customer expectations.
7. Employee Training and Empowerment: Lessons learned highlight the significance of providing appropriate training and empowering employees to handle complaints effectively. Equipping employees with customer service skills, complaint resolution techniques, and problem-solving capabilities enables them to address complaints in a professional and customer-centric manner.
8. Documentation and Reporting: Thorough documentation and reporting of complaints are essential. Lessons learned stress the importance of accurately recording complaint details, actions taken, and resolutions achieved. Comprehensive documentation supports traceability, analysis, and monitoring of complaint trends and outcomes.
9. Supplier Collaboration: Complaints may reveal issues with supplied components or materials. Lessons learned emphasize the importance of collaborating with suppliers to address complaints and prevent their recurrence. Engaging in open dialogue, implementing corrective actions, and improving supplier quality management processes enhance the overall quality of supplied components.

By incorporating these lessons learned from complaints into their quality management systems, organizations can effectively address customer concerns, improve product quality, and enhance overall customer satisfaction. Emphasizing a customer-centric approach, implementing robust complaint handling processes, and driving continuous improvement contribute to organizational success within the framework of IATF 16949.

5 Lessons learnt from Scrap and Reword

Scrap and rework are significant quality issues that organizations strive to minimize within the framework of IATF 16949, the automotive quality management standard. Effectively managing scrap and rework is crucial for improving efficiency, reducing costs, and maintaining product quality. Here are some key lessons learned from scrap and rework in the context of IATF 16949:

1. Root Cause Analysis: Scrap and rework often indicate underlying process or design issues. Lessons learned emphasize the importance of conducting thorough root cause analysis to identify the reasons behind scrap and rework. This analysis helps organizations implement targeted corrective actions that address the root causes and prevent recurrence.
2. Process Control and Monitoring: Lessons learned stress the significance of effective process control and monitoring to minimize scrap and rework. Implementing robust control plans, process monitoring techniques, and statistical process control (SPC) helps ensure process stability, identify deviations early, and take corrective action promptly.
3. Supplier Quality Management: Scrap and rework may result from issues with supplied components or materials. Lessons learned highlight the importance of robust supplier quality management processes, including supplier qualification, ongoing monitoring, and supplier performance evaluation. Collaborating with suppliers to address quality issues helps reduce the likelihood of scrap and rework due to external factors.
4. Employee Training and Competence: Lessons learned emphasize the significance of providing adequate training and competence development programs for employees. Well-trained employees are better equipped to perform their tasks effectively, adhere to standard processes, and minimize errors leading to scrap and rework. Training programs should focus on enhancing technical skills, process knowledge, and problem-solving abilities.
5. Process Improvement: Scrap and rework provide opportunities for process improvement. Lessons learned stress the importance of analyzing scrap and rework data, identifying trends, and implementing process improvements based on this analysis. Continuous improvement efforts help reduce waste, enhance process efficiency, and improve overall product quality.
6. Documentation and Reporting: Comprehensive documentation and reporting of scrap and rework instances are essential. Lessons learned highlight the significance of accurately recording scrap and rework details, including root causes, actions taken, and resolutions achieved. Detailed documentation supports analysis, reporting, and identification of areas for improvement.
7. Prevention over Inspection: Lessons learned emphasize the importance of focusing on prevention rather than relying solely on inspection. Instead of identifying defects through inspection and rework, organizations should prioritize proactive measures to prevent defects from occurring in the first place. Implementing robust quality planning, process control, and training programs can help prevent scrap and rework.
8. Continuous Communication and Feedback: Effective communication and feedback channels are essential in reducing scrap and rework. Lessons learned stress the importance of promoting open communication among employees, encouraging them to report potential quality issues, and providing feedback loops for continuous improvement. Encouraging suggestions for improvement and fostering a culture of collaboration can help identify and address quality issues promptly.
9. Metrics and Performance Monitoring: Lessons learned highlight the value of establishing metrics and performance indicators related to scrap and rework. Monitoring and analyzing these metrics help organizations track their progress, identify areas for improvement, and set targets for reducing scrap and rework over time. Regular performance reviews and data analysis facilitate data-driven decision-making.

By incorporating these lessons learned from scrap and rework into their quality management systems, organizations can reduce waste, improve process efficiency, and enhance overall product quality within the framework of IATF 16949. Focusing on root cause analysis, process control, employee training, and continuous improvement efforts contribute to minimizing scrap and rework and achieving higher levels of operational excellence.

6) Some of the methods used in IATF 16949:2016

IATF 16949, the automotive quality management standard, does not prescribe specific methods or techniques for risk analysis. However, organizations implementing IATF 16949 can choose from a range of risk analysis methods based on their specific needs and requirements. Here are some commonly used risk analysis methods in the context of IATF 16949:

1. Failure Mode and Effects Analysis (FMEA): FMEA is a widely used risk analysis method in the automotive industry. It is a systematic approach for identifying and evaluating potential failure modes, their causes, and the effects on product performance. FMEA helps organizations prioritize risks, develop appropriate controls, and implement preventive actions to improve product quality and reliability.
2. Control Plan: Control plans, which are an integral part of IATF 16949, involve risk analysis. Control plans document critical product and process characteristics, associated risks, and control measures to ensure their consistent control and conformity. Risk analysis is performed to identify potential risks and determine appropriate controls and actions to manage them effectively.
3. Hazard Analysis and Critical Control Points (HACCP): HACCP is a risk analysis method commonly used in the food industry, but it can also be applied in automotive manufacturing. HACCP involves identifying and analyzing potential hazards and critical control points throughout the manufacturing process to prevent or reduce risks related to product safety, quality, and regulatory compliance.
4. Statistical Process Control (SPC): SPC is a method used to monitor and control process variability. It involves statistical analysis of process data to identify trends, patterns, and abnormal variations. By analyzing process control charts and other statistical tools, organizations can identify potential risks and take appropriate actions to reduce process variability and improve product quality.
5. 5 Whys Analysis: The 5 Whys technique is a simple but effective method for identifying root causes of problems or risks. It involves asking “why” repeatedly to drill down to the fundamental cause of an issue. By analyzing the root causes, organizations can develop targeted actions to address the underlying risks and prevent their recurrence.
6. Risk Matrices: Risk matrices are visual tools used to assess and prioritize risks based on their severity and likelihood. They involve assigning scores or levels to risks based on predefined criteria. Risk matrices help organizations identify high-priority risks that require immediate attention and allocate appropriate resources for risk mitigation.
7. SWOT Analysis: SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis is a widely used strategic planning tool. While it is not specifically a risk analysis method, it helps organizations identify and analyze internal and external factors that may pose risks or opportunities. SWOT analysis can be used to identify risks related to market conditions, competition, technological advancements, or organizational capabilities.

It’s important to note that the selection of risk analysis methods should be based on the specific needs and context of the organization. Organizations implementing IATF 16949 can choose one or a combination of these methods to perform risk analysis and effectively manage risks within their quality management systems.

Documented information, such as records, plays a vital role in providing evidence of the results of risk analysis in IATF 16949. It helps demonstrate that risk analysis activities have been conducted, risks have been identified and evaluated, and appropriate actions have been taken to manage those risks. Here are some examples of documented information that serve as evidence of the results of risk analysis:

1. Risk Assessment Reports: Risk assessment reports document the process, findings, and outcomes of risk analysis activities. They provide a comprehensive overview of the identified risks, their potential impacts, the likelihood of occurrence, and the controls or actions recommended to mitigate or manage those risks. Risk assessment reports serve as key evidence of the risk analysis process and its outcomes.
2. Risk Registers or Logs: Risk registers or logs capture and maintain a record of identified risks, their descriptions, risk levels, and associated mitigation measures. These documents help in tracking and monitoring risks over time, evaluating their effectiveness, and making informed decisions regarding risk management strategies. Risk registers or logs provide tangible evidence of the risks identified and the corresponding actions taken.
3. FMEA Reports: If organizations employ Failure Mode and Effects Analysis (FMEA), the resulting reports serve as evidence of the risk analysis process. FMEA reports detail the identified failure modes, their potential effects, causes, and recommended actions to prevent or mitigate them. These reports demonstrate the organization’s proactive approach to risk analysis and the measures taken to address potential failures.
4. Control Plans: Control plans, as required by IATF 16949, outline the key product and process characteristics, associated risks, and the control measures implemented to ensure their consistent control and conformity. These plans document the analysis of risks and the prescribed actions to manage those risks effectively. Control plans provide tangible evidence of the organization’s risk analysis efforts and risk management strategies.
5. Corrective and Preventive Action Reports: When risks identified through analysis result in non-conformities or issues, organizations undertake corrective and preventive actions. Reports documenting these actions serve as evidence of the identified risks, the actions taken to address them, and the evaluation of their effectiveness. These reports demonstrate the organization’s commitment to managing risks and continuous improvement.
6. Change Management Records: Risk analysis is an essential component of change management processes. Documentation related to changes, including change requests, impact assessments, and risk evaluations, provide evidence of the consideration of risks during the change management process. These records demonstrate how risks associated with changes were assessed and managed appropriately.
7. Audit Reports: Internal and external audit reports often include findings related to risk analysis and risk management. These reports document the audit observations, including the identification and evaluation of risks, adherence to risk management processes, and the effectiveness of risk controls. Audit reports serve as independent evidence of the organization’s risk analysis practices and their compliance with IATF 16949 requirements.

The documentation of risk analysis activities and their outcomes is crucial for demonstrating compliance with IATF 16949 and for providing a historical record of risk management efforts. These documented records serve as tangible evidence that the organization has conducted risk analysis, identified risks, implemented controls or actions, and continuously monitored and improved its risk management practices.

Process :         Management Representative
Name Of Auditors :		Date :
Name Of Audittees :		Time :
CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
5.3	Do they aware about Company Quality Policy, Vision & Mission.
5.5	Check whether the departmental objectives are identified on the basis of Quality Policy.
5.5	Does he know his responsibility & authority for achieving the departmental objectives? Check the availability of Organisation Chart
5.5	Check whether they have made any road map or action plan to achieve the dept. objectives and are they following the same or not.
4.2.3	Check on random basis that the document distribution with current revision and issue date are being maintained.
4.2.3	Check whether the Master Files for the Process Approaches and Relevant Document are being maintained.
4.2.3	Check & Verify that the acknowledgement taken from the concerned dept. for the documents mentioned in the document distribution record.

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
5.6 /8.2.2	Do they have Annual Plan for Internal Quality Audits and Management Review Meeting  & the same plan is being followed or not.
8.2.2	Check the availability of  Department & Month -wise trend graphs made for audit non- conformances for comparison.
8.2.2	Review the action taken by the dept. to close the non-conformance are implemented effectively and also review the verification results. (Verify Non Conformity Report with the help of evidences)
8.2.2	Are they using proper check list for Internal Audit covering all the requirement of ISO/TS- 16949: 2002.
5.6	Check whether all the clauses of ISO/TS are being discussed during management review meeting.( Key Performance Indicators must be reviewed in MRM )
5.6	Check whether the periodic follow-up being done with the concerned HOD’s for the points raised during management review meeting. (Verify the current status of the Minutes of Management Review Meeting report )
5.6.2	Check whether the Overall Cost of Quality for the Organization are being calculated.
5.6.2	Check whether the Action Plan is being taken from the concerned dept. for reducing cost of quality.
5.1.1	Check whether the Effectiveness Indicators are identified by the department and trend graphs for the same is made. i.e.K.P.I. Trends

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
5.1.1	Do they have done analysis and make any action plan for achieving their Effectiveness and Efficiency target and are they following the same.
5.5.3	Check whether the Inter-relation Matrix of the department is displayed at appropriate place and do they aware about the inter- relations with the other department
4.2.4	Check whether the Record Matrix for all the Quality System Documents made and displayed at appropriate place. Also verify that, the documents are located as mentioned in the record matrix.
5.5.3	Review the Communication Matrix of the department, is there any communication missing which is provided by the department and check is it displayed at appropriate place.
6.4	Check the condition of 5S.
Signature of Auditors                                                                        Signature of Audittees

Process :       Engineering
Name Of Auditors :		Date :
Name Of Audittees :		Time :
CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
5.3	Are they aware about Company Quality Policy, Vision & Mission.
5.5	Check whether the departmental objectives are identified on the basis of Quality Policy.
5.5	Do they know their responsibility & authority for achieving the departmental objectives? Check the availability of Organisation Chart
4.2.1	Do they have Procedures & Formats of APQP, New Parts Development , Handling ECN, Supplier Selection , Resource Management, Initial Supply Control, in line with TS Standards. ( Verify the effectivness of the procedures )
5.5	Check whether they have made any road map or action plan to achieve the dept. objectives and are they following the same or not.
4.2.3	Check whether the distribution records are being maintained whenever new or revised documents issued.
4.2.3	Check whether the List and Distribution records are being maintained for external origin documents.

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
4.2.3.1	Check whether the engg. Drawings and all relevant documents are being revised in case of ECN received from customer. (i.e. find out any of the engineering change made in process and review the PPAP file revised accordingly and document issue record.)
7.1	Check whether the APQP study are being carried for all the new components parallel with Time Planning Chart. (Find out any component being developed in Tool Room and co-relate the same with APQP stages).
7.3.6	Check whether the PPAP files are being made during Pilot Lot Production of the new components and submitted to customer. (i.e. Find out any component for           which Pilot Lot being manufactured and co- relate the same with PPAP file.)
7.3.6	Check whether the PPAP files for existing components are being made . (Verify any one of the existing part and relevant PPAP documents)
7.3	Check whether APQP & PPAP files consist all the documents as per Check List for APQP & PPAP.
7.3.6	Check whether the Mistake Proofing, Productivity and Cost Saving concept are being considered during tool designing.
7.3.2.2	Check and co-relate the Process Control Sheet with relevant Control Plan.
7.3.6	Check whether the Action Plans are being made on the basis of feedback received from customer for new components.

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
7.3.2	Check whether the Bench Marks during APQP are decided on the basis of competitor data or data of similar products.
7.5.1.5	Check whether the Tool Progress Chart are being made & followed in case Tools are fabricated from outside agency.
7.5.1.1	Check whether the Control Plan Compatible with FMEA.
4.2.3	Date of implementation of engineering change is being maintained ( ECN Records ).
5.5.3	Review the Communication Matrix of the department, is there any communication missing which is provided by the department and check is it displayed at appropriate place. (Verify the list of documents handed over during transfer of part for production )
6.3 / 6.4	Do they have List of Infrastructure & Work Environment and actions have been taken where available infrastructure is not good.
8.5	Do they have identified the continuous improvement projects to achieve the departmental objectives and improvements in Audit Results, Conformity to Product Requirement?
5.1.1	Check whether the Effectiveness Indicators are identified by the department and trend graphs for the same made. i.e. On Time Submission of PPAP.

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
5.1.1	Do they have done analysis and make any action plan for achieving their Effectiveness and Efficiency target and are they following the same.
5.5.3	Check whether the Inter-relation Matrix of the department is displayed at appropriate place and do they aware about the inter- relation with the other department
4.2.4	Check whether the Record Matrix for all the Quality System Documents made and displayed at appropriate place. Also verify that, the documents are located as mentioned in the record matrix.
6.4	Check the condition of 5S.
Signature of Auditors                                                  Signature of Audittees

Process:      Plant Maintenance
Name Of Auditors :		Date :
Name Of Audittees :		Time :
CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT  OBSERVATIONS
5.3	Do they aware about Company Quality Policy, Vision & Mission.
5.5	Check whether the departmental objectives are identified on the basis of Quality Policy.
5.5	Do they know their responsibility & authority for achieving the departmental objectives? Check the availability of Organisation Chart
4.2.1	Do they have Procedures & Formats defined for executing the work.
5.5	Check whether they have made any road map or action plan to achieve the dept. objectives and are they following the same or not.
7.5.1.4	Verify & co-relate the Breakdown Maintenance Report & Preventive Maintenance Schedule with History Cards. ( Check for availability of P.M.Plan Vs Actual status)

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT  OBSERVATIONS
8.2.3	Review the History Card, if any problem repeated for any critical machine then proper analysis is being done.( Verify the action plan for Improvement )
7.5.1.4	What is their system of Predictive Maintenance and are they using proper checklist for the same.
7.5.1.4	On the basis of history card , do they prepare predictive maintenance plan & follow the same.
5.1.1	Check whether the Effectiveness Indicators are identified by the department and trend graphs for the same made. i.e. Key Performance Indicators.
5.1.1	Do they have done analysis and make any action plan for achieving their Effectiveness and Efficiency target and are they following the same.
7.5.1.4	Are they maintaining Pending Job Register for pending jobs related with maintenance?
8.5.2.2	Review the process and Check that Preventive actions are being implemented where any problem likely to occur and review also Effectiveness & Efficiency parameter for the same..
7.6.2.	Check whether all the measuring devices are properly calibrated & identified i.e. Pressure Gauges, Welding Machine Instruments, Tachometer or speedometer.

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT  OBSERVATIONS
5.5.3	Review the Communication Matrix of the department, is there any communication missing which is provided by the department and check is it displayed at appropriate place.
6.3	Do they have List of Infrastructure & Work Environment and actions have been taken where available infrastructure is not good.Check for availability of contingency plan.
8.5	Do they have identified the continuous improvement projects to achieve the departmental objectives and improvements in Audit Results, Conformity to Product Requirement?
6.4	Whether the safety devices are effectively implemented in shop floor. Check the condition of 5S.
Signature of Auditors                                               Signature of Audittees

Process :          Stores & Despatch
Name Of Auditors :		Date :
Name Of Audittees :		Time :
CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
5.3	Do they aware about Company Quality Policy, Vision & Mission.
5.5	Check whether the departmental objectives are identified on the basis of Quality Policy.
5.5	Do they know their responsibility & authority  for achieving the departmental objectives? Check the availability of Organisation Chart .
4.2.1	Do they have Procedures & Formats defined for executing the work.
5.5	Check whether they have made any road map or action plan to achieve the dept. objectives and are they following the same or not.
8.5.2.2	Review the process and Check that Preventive actions are being implemented where any problem likely to occur and review also Effectiveness & Efficiency parameter for the same, are they  are likely to fail from target.

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
7.4.3.2	Do they have List of Direct on Line Items and are they updating the same periodically.
7.4.1	Do they have list of Process Consumables and Machine Spares indicating the sources.
7.5.5	Check and co-relate whether the material is being issued on the line as per the requirement  of Bop /raw material given by In-charge Planning.
7.5.5	Check & Physically verify that proper monitoring of KANBAN system is being done as per the norms decided. ( Verify the availability of Inventory Norms ).
7.5.5	Check whether the material lying at Receipt Store indicating the Inspection and Test Status of the goods.
7.5.5	Check & Co-relate that the Weekly Plan for PPC made on the basis of stock statement & Customer requirement.
7.5.5	Are they maintaining the extra freight paid record and are they taking action to avoid the extra freight in future.
7.5.5	Check whether the corrective actions are being taken and recorded in case of Delivery Performance Rating is less that 100%.

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
7.5.5	Do they intimate their Out-station Customer (Distance>200 Kms.) Through Advance Shipment notification at the time of dispatch.
7.5.5	Do they have packing instructions for all the finished goods to be dispatched? And also verify that material is being packed as per the Packing Instructions.
7.4.3.2	Check whether the DOL items are being received along with DOL Stickers.
7.5.5.1	Check whether the stock of the material at incoming stages are being maintained as per Inventory Norms.
7.5.5.1	Check what is the criteria or basis for deciding Inventory Norms .
7.5.5.1	Are they calculating the Inventory Turnover Ratio and what is their target. Verify the Trend of inventory turnover ratio.
7.5.5.1	Do they have any action plan for reducing inventory.
7.4.1	Are they maintaining the List of Minimum Spares / Consumables required.

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
7.5.5.1	Do they have any disposal system for slow moving or obsolete material lying at store and are they making action plan for disposal.
5.1.1	Check whether the Effectiveness Indicators are identified by the department and  trend graphs for the same made .
5.1.1	Do they have done analysis and make any action plan for achieving their Effectiveness and Efficiency target and are they following the same.
5.5.3	Review the Communication Matrix of the department, is there any communication missing which is provided by the department and check is it displayed at appropriate place.
8.5	Do they have identified the continuous improvement projects to achieve the departmental objectives and improvements in Audit Results, Conformity to Product Requirement.
6.4	Check the condition of 5S.
Signature of Auditors                                                 Signature of Audittees

Process :         Purchase
Date :		Name Of Auditors :
Time :		Name Of Audittees :
CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT  OBSERVATIONS
5.3	Do they aware about Company Quality Policy, Vision & Mission.
5.5	Check whether the departmental objectives are identified on the basis of Quality Policy.
5.5	Do they know their responsibility & authority for achieving the departmental objectives? Check the availability of Organisation Chart .
4.2.1	Do they have Procedures & Formats defined for executing the work. (Purchasing, Supplier Selection & evaluation, Supplier Development etc.)
5.5	Check whether they have made any road map or action plan to achieve the dept. objectives and are they following the same or not.
7.4.3	Check whether the Vendor Capability Assessment is being carried out before selecting the vendor.
7.3.6	Are they receiving all the applicable PPAP documents from the supplier during new sample submission? (Verify the List of PPAP Documents )
7.4.1	Do they have List of Approved Vendors for Job Work Material, BOP,. Raw Material Process Consumables and Machine Spares.

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT  OBSERVATIONS
7.4.1.2	Are the entire supplier certified to ISO-9000 or they have plan to get certification and also verify the progress being done by supplier for getting ISO-9000  certification.
7.4.1.2	Check whether the System Audit of ISO-9002 supplier are being carried out as per ISO/TS- 16949:2002 Check Sheet. ( Verify the Supplier Audit Check sheet )
7.4.3.2	Do they have any documented criteria for declaring any item as Dol or Non-DOL. Also verify that that criteria is being followed.
7.4.3.2	Do they have DOL items Audit Plan for verifying the Quality Status of the lots of the DOL items.
7.4.1.2	Check whether the Follow-up audit is being carried out after target dates for verification of the corrective actions against supplier audit.
7.4.3.2	Are they considering the Extra Freight and Line Stoppage factors during calculation of Vendor Performance  Rating.
7.4.3.2	Do they receive Corrective Action Report in case Vendor Delivery Rating observed less than100%.
7.4.3.2	Do they receive Corrective Action Report in case of Quality Problems (QPCR).
7.4.3.2	Check whether the Purchase Order indicating the 100% On-time delivery requirement and Inspection Criteria. (Packing instructions & mode of transports / special requirements)

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT  OBSERVATIONS
7.4.1	Check whether they are dispatching vendor delivery schedule letters on time.
7.4.1	Check whether the Schedule vs. Supply statement are being made and
7.4.3.2	Are they maintaining the extra freight paid record which is paid due to vendor mistake and are they taking action to avoid the extra freight in future.
7.4.3.2	Do they have List of DOL Items and are they updating the same periodically.
7.4.1	Do they have list of Process Consumables and Machine Spares indicating the sources.
7.4.1	Check whether the amendment in BOP/RM requirement given by In-charge- Planning is incorporated in the Vendor Schedules.
7.4.1	Are they maintaining the Pending Purchase Order File for follow-up with vendors.
5.1.1	Do they monitor & make any action plan for achieving their Effectiveness and Efficiency target and are they following the same.
5.5.3	Review the Communication Matrix of the department, is there any communication missing which is provided by the department and check is it displayed at appropriate place.
8.5	Do they have identified the continuous improvement projects to achieve the departmental objectives and improvements in Audit Results, Conformity to Product Requirement.

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT  OBSERVATIONS
7.4.1.3	Check the criteria of Vendor selection in line with Procedures. Verify at random the evaluation  sheet of any of the running vendor.
7.4.2	Do they inform the Vendor Rating to concerned vendors for improvement
7.4.3.2	Do they have any action plan for Vendor Upgradation.
6.4	Check the condition of 5S.
Signature of Auditors                                                                          Signature of Audittees

Process :     PPC
Name Of Auditors :		Date :
Name Of Audittees :		Time :
CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
5.3	Do they aware about Company Quality Policy, Vision & Mission .
5.5	Check whether the departmental objectives are identified on the basis of Quality Policy.
5.5	Do they know their responsibility & authority for achieving the departmental objectives? Check the availability of Organisation Chart .
4.2.1	Do they have Procedures & Formats defined for executing the work. Is it effectively implemented ?
5.5	Check whether they have made any road map or action plan to achieve the dept. objectives  and are they following the same or not.
7.5.1.6	Check & Co-relate that the Weekly Schedule for Production Dept. is being made on the basis of Inventory Status and Dispatch Schedule received from Dispatch Section.
7.5.1.6	Do they prepare the Weekly Production Plan for each section and send to the respective  section In- charge.
7.5.1.6	Do they submit the weekly Raw Material /BOP requirement to Purchase Deptt.
7.5.1.6	Check whether they revise the production plan and send to the concerned  section incharge ,in case of amendment in schedule received from Mktg.

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
7.5.1.6	Do they make Shop-wise Monthly trend graph (Actual Production Vs Production Planned.)
6.4.4	Check whether the Shop-wise OEE trend Graphs are being made and action are being  taken where OEE observed less.
7.5.16	Are they getting Countermeasure Report from concerned section in case of production failure.
5.5.3	Review the Communication Matrix of the department, is there any communication missing which is provided by the department and check is it displayed at appropriate place.
6.3 / 6.4	Do they have List of Infrastructure & Work Environment and actions have been taken where available infrastructure is not good.
8.5	Do they have identified the continuous improvement projects to achieve the departmental objectives and improvements in Audit Results, Conformity to Product Requirement.
8.4.1	Do they monitor their Key Performance Indicator & Analyse for Failures. Do they take preventive measures to eliminate such  failures.
7.2.2.2 &	Do they Maintain :
7.2.3	a) Master List of Products – Customer & Model
	Wise.
	b) List Of Machines & equipments with capacity.
	c) Partwise No. of Tools & respective machine
	capacity requirement.
	d) Annual & Monthly Delivery Requiremets –
	Customerwise.
	e) Cycle time for all the operations.

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
6.3.2	Do they know the contingency plan to meet Customer’s Requirements
6.4	Check the condition of 5S.
Signature of Auditors                                                 Signature of Audittees

Process:  PRODUCTION
Name Of Auditors :		Date :
Name Of Audittees :		Time :
CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
5.3	Do they aware about Company Quality Policy, Vision & Mission .
5.5	Check whether the departmental objectives are identified on the basis of Quality Policy.
5.5	Do they know their responsibility & authority for achieving the departmental objectives? Check the availability of Organisation Chart .
4.2.1	Do they have Procedures & Formats defined for executing the work. Is it effectively implemented ?
5.5	Check whether they have made any road map or action plan to achieve the dept. objectives and are they following the same or not.
7.5.1.6	Are they following Monthly / Weekly Production Plan and correlate the same with daily loading plan for critical machine.
8.2.3	Check whether all the relevant Process Sheets/Work Instructions are displayed on the machine for all the components while in operation. Are they properly controlled & Legible.

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
7.3.2.2	Review the fitment/critical function of the products being manufactured and check the fitment/critical dimensions are highlighted in process sheet as Ma/Cr.
7.5.2	Check whether Process Qualification of all the components have been made and co-relate the Parameter finalized with the parameter monitored on machine and mentioned in process sheet.
8.2.3.1	Check and Co-relate the Process Sheets with Relevant control Plan for the dimensions.
6.3.2	Do they have Contingency Plan for the Critical eventualities (I.e. Critical Machines, Tools ,Machines, Tools, Jig& fixtures) and do they made any action plan whenever there is non availability of source for the same.
4.2.3	Check whether the Uncontrolled copy of the Work Instruction/Procedures or photocopy of the control stamped W.I./Procedures are being used.
7.5.2	Check whether the machine parameters of special processes are being monitored and recorded. ( PPM ,FEED,Pressure, Shut Height etc.)
7.5.1.6	Check whether the Daily Production Records are being maintained.
8.3.2	Review the Rework & Rejection status of the shop and verify that re-inspection of the reworked pieces & proper disposal of scrapped parts.

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
8.1.2	Are they conducting SPC (Attribute/Variable) for Cr/Ma Characteristics and action plans are being followed where Cp/Cpk value found less than 1.33.
6.4.2	Check whether the 5-S & Safety Instructions are displayed at the appropriate places and being effectively implemented.
8.3.4	Review the Inspection records , if production is carried out under any deviation then, under deviation note approved from Head-QA. (Verify Deviation Notes ).
7.5.3.1	Check whether the Inspection & test Status of the Products In-process is being maintained as per the Prescribed Procedure.
8.2.3.1	Do they have identified & displayed any reaction plan for taking action immediately on the Process Non-conformances.
7.5.3.1	Check whether the Product Identification and Traceability is being maintained. Verify the identification of Master samples & Limit samples .
7.5.2	Check & Co-relate the Process parameters mentioned in process Sheets with the parameters finalized in Process Qualification Records.
8.3.2	Check whether Rework Are has been identified & Rework Instructions Displayed at appropriate place.
8.5.2.	Check whether the daily non-conformances register is being maintained & co-relate the same with the rejection lying at shop floor.

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
8.5.2	Are they making summary of the non-conformances observed on daily basis and are they taking corrective action for the same.
5.1.1	Check whether the Effectiveness Indicators are identified by the department and trend graphs for the same made . i.e. Rejection, Rework, Plan Vs Produced etc.
5.1.1	Do they have done analysis and make any action plan for achieving their Effectiveness and Efficiency target and are they following the same.
8.5	Are they maintaining the Before and After Status for the Projects where Mistake Proofing done.(This may be recorded in the format of Kaizen Projects)
8.2.3	Check whether the machine -wise OEE trend Graphs made and analysis done where OEE found Less.
5.5.3	Review the Communication Matrix of the department, is there any communication missing which is provided by the department and check is it displayed at appropriate place.
7.5.2	Check whether the Operators are adequately qualified for operation . ( Verify the Skill Matrix ).
8.5.2.2	Review the process and Check that Preventive actions are being implemented where any problem likely to occur and review also Effectiveness & Efficiency parameter for the same, are likely to fail from target.

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
7.5.5	Check whether the Packing Instructions displayed if On-line packing is being done.
8.5	Do they have identified the continuous improvement projects to achieve the departmental objectives and improvements in Audit Results, Conformity to Product Requirement.
8.2.4	Do they carry out the inspection of the first of Pieces processed at the time of setting. (FOP -First of Production Approval).
8.2.4	Check whether the Recording of the FOP and Patrol inspection is being carried out.
7.5.1.3	How do they inform the Maintenance department regarding Die Repair ? Do they verify & record the inspection results whenever there is loading of Die after maintainence or repair ?
8.2.4	Do they have the Inspection Reports for the Product found non-conforming during Patrol Inspection being carried out.
8.2.4	Check whether the Final Inspection is being carried out for the components, which are directly submitted to the dispatch section after completion of the process.(Final Inspection of the Components arenot being done by the QA Dept.)

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
8.2.4	Do they have Final Inspection Standards or customer Specified Standard for the components being processed.
6.2.2.2	Do they have identified Training needs for their operator’s Skill Upgradation.? Is there any annual Training plan / Schedule ?
Signature of Auditors                                                Signature of Audittees

Process :     HR
Name Of Auditors :		Date :
Name Of Audittees :		Time :
CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
5.3	Do they aware about Company Quality Policy, Vision & Mission .
5.5	Check whether the departmental objectives are identified on the basis of Quality Policy.
5.5	Do they know their responsibility & authority for achieving the departmental objectives? Check the availability of Organisation Chart .
4.2.1	Do they have Procedures & Formats defined for executing the work. Is it effectively implemented ?
5.5	Check whether they have made any road map or action plan to achieve the dept. objectives  and are they following the same or not.
6.2.2	Check whether the Training Programmes are being held as per the Monthly/Annually Schedule.
6.2.2	Check whether the Induction Trainings are being Provided to New Entrant and Records are being maintained.

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
6.2.2	Check whether the Monthly Schedule consist On The Job Training requirements.
6.2.2	Are they getting feedback from the participants after completion of training programme.
6.2.2	Check whether the Training Effectiveness assessment frequency  is defined & being carried out as per plan.
6.2.2	In case Skill Improvement is not found during Effectiveness Assessment , Verify the Action Plan made for improvement in future.
6.2.2.4	Check whether the Job Description Manual Updated whenever new designation  introduced in the organization.
6.2.2	Check Competency Norms and Matrix for all the Critical Stages in the Departments  have been made.
6.2.2	Are they identifying the training needs before imparting trainings.
6.2.2	Check whether Attendance Records for the Training Programmes are being maintained.
6.2.2	Do they have Plan Vs Actual Trend Graphs for the Training Programmes.
6.2.2.4	Check whether the suggestions are being received.

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
6.2.2.4	Check whether the assessment of the valid suggestions are being carried out properly by section in charge(s).
6.2.2.4	Do they have any Evaluation criteria for deciding Prize for the  valid suggestions  received.
6.2.2.4	Do they have decided the schedule for Empowerment Assessment of the Employees and the same is being followed.
6.2.2.4	Check whether the Action Plan made where discrepancies found during empowerment assessment.
6.2.2.4	Do they have Monthly Trend Graphs for No. of Suggestions  Received. and no. of suggestions implemented.
5.1.1	Check whether the Effectiveness Indicators are identified by the department and trend   graphs for the same made . i.e. Training Scheduled Vs Actual, No. of Suggestions Received Vs No. of Valid Suggestions,  Down Time due to Manpower, Employee Turnover Ratio, Skill Enhanced Trend Through Training etc.
5.1.1	Do they have done analysis and make any action plan for achieving their Effectiveness  and Efficiency target and are they following the same.
5.5.3	Review the Communication Matrix of the department, is there any communication  missing which is provided by the department and check is it displayed at appropriate place.
6.3.2	Do you have contingency plan for Resource related eventualities.

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
6.3 / 6.4	Do they have List of Infrastructure & Work Environment and actions have been taken where available infrastructure is not good.
8.5	Do they have identified the continuous improvement projects to achieve the departmental objectives and improvements.
6.4	Check the condition of 5S.
Signature of Auditors                                                  Signature of Audittees

Process :    Unit Head
Date :		Name Of Auditors :
Time :		Name Of Audittees :
CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
5.3	Does he aware about Company Quality Policy, Vision & Mission
5.5	Check whether the company objectives (Business Plan) are identified on the basis of Quality Policy.
5.5	Does he knows his responsibilities & authorities for achieving the departmental objectives. Check the availability of organisation chart.
4.2.1	Does he have Procedures & Formats defined for executing the work. Is it effectively implemented ?
5.5	Check whether he has made any road map or action plan to achieve the company objectives .
5.4.1	Check whether the monitoring of Business Parameters are being done.
5.1.1	Does he have trend graph for the objectives defined in Business Plan.

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
5.1.1	Check and review the Monitoring of individual departmental performance is being done as per plan. ( MRM Report )
8.5	Check whether the Review of Kaizen Projects are being done . Check whether the Continuous Improvement Projects are being identified on the basis of Business Parameters.
6.4	Check the condition of 5S.
Signature of Auditors                                                 Signature of Audittees

Process:      Tool Management
Date :		Name Of Auditors :
Time :		Name Of Audittees :
CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
5.3	Do they aware about Company Quality Policy, Vision & Mission .
5.5	Check whether the departmental objectives are identified on the basis of Quality Policy.
5.5	Do they know their responsibility & authority for achieving the departmental objectives? Check the availability of Organisation Chart .
4.2.1	Do they have Procedures & Formats defined for executing the work. Is it effectively implemented ?
5.5	Check whether they have made any road map or action plan to achieve the dept. objectives and are they following the same or not.
7.5.1.5	Do they have  Master list of Tooling  and are they updating the same whenever new tool received .
7.5.1.5	Check & verify physically that, Breakdown reports are being received for the tools lying at Tool Maintenance dept.

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
7.5.1.5	Are they up-dating the Tool Breakdown History in Tool Histoy card.
7.5.1.5	Do they have any Preventive maintenance schedule for Press Tools and verify that the schedule is being followed.
7.5.1.5	Are they getting comments of the Shift Supervisor after repairing and trial of the tool.
7.5.4.1	Check whether the Identification of Customer Supplied Product Tools are being done properly for ownership.
7.5.1.5	Check whether Tool Status cum Rectification Reports are being maintained during loading and unloading of the tool for recovery.
7.5.1.5	Do they receive the Tool Breakdown report from concerned Shift Incharge or observation from std room during validation for repairing the jig/fixtures
7.5.1.5	Are they up-dating the Tool Breakdown History Card after trial of the repaired tool
7.5.1.5	Check and Co-relate the Tool History Record and Tool Breakdown Reports.

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
7.5.1.5	Whether the product is inspected after tool repair & recorded in Inspection Sheet. Verify the records. Does any procedue exists for the same. ( Verify QA / Prod. Approval after repair)
5.1.1	Check whether the Effectiveness Indicators are identified by the department and  trend graphs for the same made . i.e. B.D. Hrs Trend Graph
5.1.1	Do they have done analysis and make any action plan for achieving their Effectiveness and Efficiency target and are they following the same.
5.5.3	Review the Communication Matrix of the department, is there any communication missing which is provided by the department and check is it displayed at appropriate place.
8.5	Do they have identified the continuous improvement projects to achieve the departmental objectives and improvements in Audit Results, Conformity to Product Requirement.
8.5.2.2	Review the process and Check that Preventive actions are being implemented where any problem or customer complaint likely to occur and review also Effectiveness & Efficiency parameter for the same, are they  are likely to fail from target.
7.5.2	Check whether the Operators are adequately qualified for Tool Repair . ( Verify the Skill Matrix )
6.4	Whether the safety devices are effectively implemented in shop floor. Check the condition of 5S.
Signature of Auditors                                             Signature of Audittees

Process :         Quality Assurance
Date :		Name Of Auditors :
Time :		Name Of Audittees :
CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT  OBSERVATIONS
5.3	Do they aware about Company Quality Policy, Vision & Mission.
5.5	Check whether the departmental objectives are identified on the basis of Quality Policy.
5.5	Do they know their responsibility & authority for achieving the departmental objectives. Verify the Organisation  Chart.
5.5	Check whether they have made any road map or action plan to achieve the dept. objectives and are they following the same or not.
5.5.3	Review the Communication Matrix of the department, is there any communication missing which is provided by the department and check is it displayed at appropriate place.
8.5	Do they have identified the continuous improvement projects to achieve the departmental objectives and improvements in Audit Results, Conformity to Product Requirement.
6.4	Whether the safety devices are effectively implemented in shop floor. Check the condition of 5S.

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT  OBSERVATIONS
Receiving Inspection
4.2.1	Do they have Procedures & Formats defined for executing the work. Is it effectively implemented ?
7.4.3	Do they have any list of Inspection Quality Standards for all the items. (BOP, Raw Material, Job Work Items) and are they updating the same whenever new item added ? Whether DOL items are identified & approved supplier list maintained ?
7.4.3.1	Check whether the verification of the each lot of Non- DOL Items is being done and recorded. (BOP, Raw Material, Job Work Items).
7.4.3.2	Do they receive the Dimensional Report with each lot of the DOL/Non DOL from the vendors.
7.4.3.2	Check & verify that, material test report of the material is being received from the vendors with every lot. Are they verifying the major characteristics (e.g. Hardness , Penetrations etc.)
7.4.3.2	Have they maintained a list of Inhouse inspection & test instruments for carrying out Inspection & testing activities.
7.4.3.2	Do they have any plan for Third part inspection/test of Incoming parts & whether the frequency have been defined.
8.2.4	Check whether the Quality of the Product being monitored in case of any BOP/Raw material issued due to urgent production requirement.
7.1.2	Do they refer Zero Defect Sampling Plan for selecting the sample size during inspection. If no, Which sampling method they follow & is it effectively implemented.
7.4.3	Do they get Under Deviation Note approved from Head- QA whenever there is urgent requirement and part is not conforming the requirements. (Verify Deviation Records)

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT  OBSERVATIONS
5.5.1.1	Do they raise & receive Quality Problem   Countermeasure Report from the vendors in case of   non- conformances observed in Non-DOL / DOL Items ( NCs from Internal/Inhouse Customers & from the External Customers ).
8.5.2 , 8.5.3	Do they verify the effectiveness of Corrective & Preventive actions furnished by vendors in case of NCs. How they Close the QPCR.
8.4, 8.5	Are they carrying out Supplier Quality Rating. What are the criteria for Rating. How do they Inform the same to the vendors. Is there any vendor upgradation plan for improvement in their quality.
7.4.3.2	Do they examine and give their remarks on the test report received from vendor for DOL  items.
7.4.3.2	Do they have any DOL item Audit Plan for verification of the Quality Status of the DOL items periodically and are they following the same plan.
7.4.3.2	What is the criteria for declaring any item as a DOL Item and are they conducting Audit of the items to be declared for DOL Supplies.
5.1.1	Check whether the Effectiveness Indicators are identified by the department and trend graphs for the same made .
5.1.1	Do they record the COPQ due to BOP items ?
5.1.1 , 8.4	Do they have done analysis and make any action plan for achieving their target and are they following the same ?

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT  OBSERVATIONS
Product Audit
4.2.1	Do they have Procedures & Formats defined for executing the work. Is it effectively implemented ?
8.2.2.3	Check whether they have made any schedule for product audit and that is being followed.
8.2.2.3	Do they have audit check list for all product being manufactured  considering  customer  specific requirement,drawings,packing & product data & audit is being done as per check list ?
8.2.2.3	Do the have a list of qualified auditors & and audit is being done by qualified auditors ?
8.2.2.3	Check whether corrective & preventive action is being taken for any non-conformity observed & effectiveness of action taken is also being measured.
5.1.1 , 8.4	Check whether the Effectiveness Indicators are identified by the department and trend graphs for the same made.

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT  OBSERVATIONS
Final Inspection
4.2.1	Do they have Procedures & Formats defined for executing the work. Is it effectively implemented ?
8.2.4	Do they have Component Wise Matrix Chart indicating the responsibilities for final inspection of the finished goods being manufactured in the different shops.
8.2.4	Do they have concession records for the material dispatched under deviation after getting approval from customer.(I.e. Co-relate & Verify the same with the Under Deviation Note approved for in-house production of any component.)
8.2.4	Do they have Final Inspection Standards/Customer Specified Standards/ Visual Aids for all the components.
7.1.2	Do they refer Zero Defect Sampling Plan or sampling plan specfd. By customer for selecting the sample size during inspection.(Review the No. of Samples mentioned in Inspection Report)
8.2.4	Check whether the recording of the final inspection is being done.
8.2.2.3	Check whether the Dock Audit of the material lying at dispatch store is being conducted and recording is being done.
8.2.2.3	Do they have relevant checkpoints to be verified during Dock Audit.

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT  OBSERVATIONS
7.5.2	Check whether the Inspectors are adequately qualified for Inspection. ( Verify the Skill Matrix ).
6.2.2.2	Do they have identified Training needs for their inspector’s Skill Upgradation.? Is there any annual Training plan / Schedule ?
7.5.5	Do they have packing instructions for all the finished goods to be dispatched? And also verify that material is being packed as per the Packing Instructions.
7.5.5	Check whether the material lying at dispatch store indicating the inspection & test status.
8.4	Are Reaction Plan for Various types of Defects Displayed in concerned shop for containment actions ?
8.4	Do they maintain segregation/rework records ?
5.1.1	Check whether the Effectiveness Indicators are identified by the department and trend graphs for the same made .
5.1.1 , 8.4	Do they have done analysis and make any action plan for achieving their target and are they following the same ?

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT  OBSERVATIONS
Control Of Non Conforming Products
4.2.1	Do they have Procedures & Formats defined for executing the work. Is it effectively implemented ?
8.3	Are the responsibilities and authorities for dealing with non-conforming product defined in the procedure?
8.3	Do the procedure address identification and control of non-conforming products to prevent unintended use or delivery?
8.3	Do the procedure address the ways of disposition of the non-conforming product in form of rework, use-as it is, alternate use?
8.3	Are records & nature of non-conformities maintained?
8.3	Is re-verification carried out for the corrected product?
8.3	Are appropriate actions taken in case of a non- conformity detected after delivery of the product, after analyzing the effects of non-conformity?
8.3.1	What is the criteria of considering suspected products as non-conforming materials (e.g. Lost Test Status, materials tested with instrument out of calibration and obsolete materials )?
8.3.2	Do   work   instructions   for   re-inspection   of   re-work products for the type of defects exist?
8.3.3	How do they inform the Non Conformity to their immediate customer ?

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT  OBSERVATIONS
8.3.4	Do they maintain Deviation Records ?
8.4	Do they analyse the Non Conformity on Daily & Monthly Basis?
8.4	Do they initiate CAPA for eliminating / Reducing the Non Conformities ?
8.4	Are Reaction Plan for Various types of Defects Displayed in concerned shop for containment actions ?
8.4	Do they maintain segregation/rework records ?
8.4	Do they update / revise the Control Plan / FMEA/PFC/Inspection Standards etc. as a result of CAPA ?
5.1.1	Check whether the Effectiveness Indicators are identified by the department and  trend graphs for the same made .
5.1.1	Do they record the COPQ due to NC items ?
5.1.1 , 8.4	Do they have done analysis and make any action plan for achieving their target and are they following the same ?

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT  OBSERVATIONS
Callibration
4.2.1	Do they have Procedures & Formats defined for executing the work. Is it effectively implemented ?
7.6.2	Do they have Master list of Instruments & gauges & their Locations
7.6.2	Do they maintain callibration schedule for every equipments & gauges.
7.6.2	Do they have a list of Accredited External laboratories for carrying out Callibration.
7.6.2	Do they update the History card of individual instruments
7.6.2	Are all the gauges/instruments are traceable (whether callibrated or not & due dates of callibration etc.)
7.6.2	Check whether the records for the rejected and deviated instruments are being maintained and status is mentioned on the instruments in case being used for inspection.
7.6.2	How do you communicate in case the lot shipped is suspected being made as per rejected gauge/instrument
5.1.1	Check whether the Effectiveness Indicators are identified by the department and trend graphs for the same made .
5.1.1 , 8.4	Do they have done analysis and make any action plan for achieving their target and are they following the same ?

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT  OBSERVATIONS
Callibration
4.2.1	Do they have Procedures & Formats defined for executing the work. Is it effectively implemented ?
7.6.1	Do they have schedule for conducting Measurement System Analysis of all the equipments identified from Control Plans.
7.6.1	Do they have any action Plan, in case of  R & R found Unsatisfactory.
5.1.1	Check whether the Effectiveness Indicators are identified by the department and trend graphs for the same made .
5.1.1 , 8.4	Do they have done analysis and make any action plan for achieving their target and are they following the same ?
Lab Management
4.2.1	Do they have Procedures & Formats defined for executing the work. Is it effectively implemented ?
7.6.3.2	Do they have a list of Internal Lab scope & External Lab scope.
7.6.3	Check whether the environmental parameters are being monitoring and recorded.
5.1.1	Check whether the Effectiveness Indicators are identified by the department and trend graphs for the same made .
5.1.1 , 8.4	Do they have done analysis and make any action plan for achieving their target and are they following the same ?

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT  OBSERVATIONS
Layout Inspection
4.2.1	Do they have Procedures & Formats defined for executing the work. Is it effectively implemented ?
8.2.4.1	Do they have Master list of products.
8.2.4.1	Do they have Layout Inspection Schedule for all regular items processed in the plant (Review the same, is it covering all the items)
8.2.4.1	Check whether the Layout Inspection of the components are being done as per the schedule and recorded.
8.2.4.1	Check & verify that are they taking corrective action whenever any non-conformance observed during Layout Inspection.
5.1.1	Check whether the Effectiveness Indicators are identified by the department and trend graphs for the same made .
5.1.1 , 8.4	Do they have done analysis and make any action plan for achieving their target and are they following the same ?

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT  OBSERVATIONS
Process Audit
4.2.1	Do they have Procedures & Formats defined for executing the work. Is it effectively implemented ?
8.2.2.3	Do they have audit check list for all product being manufactured considering customer specific requirement,drawings,packing & product data & audit is being done as per check list ?
8.2.2.2 /8.5.2/8.5.3	Check whether the Process Audits are being carried as per schedule and Corrective Action being taken where non-conformances  observed.
5.1.1	Check whether the Effectiveness Indicators are identified by the department and trend graphs for the same made .
5.1.1 , 8.4	Do they have done analysis and make any action plan for achieving their target and are they following the same ?
Validation
4.2.1	Do they have Procedures / work Instructions & Formats defined for executing the work. Is it effectively implemented ?
7.6.2	Do you have a plan for Validation of Jigs & Fixture / Panel Checkers.
7.6.2	Are the plan being effectively adhered.
7.6.2	Check & verify that, all the parameters are being checked as per drawing / check list during validation and being recorded.
7.5.2	Do you have a plan for process validation & is it effectively adhered.

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT  OBSERVATIONS
5.1.1	Check whether the Effectiveness Indicators are identified by the department and trend graphs for the same made .
5.1.1 , 8.4	Do they have done analysis and make any action plan for achieving their target and are they following the same ?
Control of Dawing & ECN
4.2.1	Do they have Procedures / work Instructions & Formats defined for executing the work. Is it effectively implemented  ?
4.2.3.1	Do they maintain drawing control register ?
4.2.3.1	Do they maintain ECN register. (Verify any of the ECN being effectively implemented )?
Handling of Customer Complaints
4.2.1	Do they have Procedures / work Instructions & Formats defined for executing the work. Is it effectively implemented  ?
5.5.3	How do they Communicate the Customer Complaints to the concerned department as well as the top management ?

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT  OBSERVATIONS
7.2.3 ,	How do you communicate the CAPA and NC part being
8.3.3	shipped to the customers. Do they have any Time Frame
	decided for Customer Complaint Handling (e.g. Time for
	Containment action, Corrective action, Preventive action
	etc.)
8.5.2 , 8.5.3	Do they determine the causes of non-conformity & accordingly initiate CAPA ?
8.5.2,   8.5.3	Do they review the Customer complaint status (e.g. Monthwise, shopwise, modelwise,4M distribution, pareto analysis, Cause & effect Diagram etc. )
8.5.2,   8.5.3	Is there any criteria for closing the QPCR against Customer Complaints ?
8.5.2,	Do they maintain the record of Segregartion / Repair
8.5.3	done as containment action against customer complaints.
8.5.2.2	Do they use error proofing techniques as CAPA? Verify the Records.
8.5.2.3	Do they apply to other similar processes & products the CAPA & Controls implemented to eliminate the cause of non-conformity.                         ( Horizontal deployment )
8.5	Do they update & record the Non conformity & CAPA details in relevant documents ( e.g. FMEA , Control Plan , Process Flow Diagram , Check sheets, Inspection standards , Visual Aids , Process Control sheets , Product history sheets etc. )

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT  OBSERVATIONS
5.1.1	Check whether the Effectiveness Indicators are identified by the department and trend graphs for the same made .
5.1.1 , 8.4	Do they have done analysis and make any action plan for achieving their target and are they following the same ?
Signature of Auditors                                                                              Signature of Audittees

Process :         Marketing / Business Development
Date :		Name Of Auditors :
Time :		Name Of Audittees :
CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
5.3	Do they aware about Company Quality Policy, Vision & Mission.
4.2.1	Do they have Procedures & Formats defined for executing the work. Is it effectively implemented ?
5.4.1	Are   the   Quality   Objectives   deployed   in   the   marketing department?     i.e. Same Objectives as determined along with Quality Policy or Supporting Departmental Objectives.
5.5	Do they know their responsibility & authority  for achieving the departmental objectives. Verify the Organisation Chart.
5.5	Check whether they have made any road map or action plan to achieve the dept. objectives  and are they following the same or not.
5.5.3	Review the Communication Matrix of the department, is there any communication missing which is provided by the department and check is it displayed at appropriate place.
8.3	How customer is informed promptly, when non-conforming products have  been  dispatched to  them?  (If not  covered by QC )

CLAUSE NO.	ITEMS TO BE AUDITED OR GUIDELINES FOR AUDIT	AUDIT OBSERVATIONS
8.2.1	Is method of measurement of customer satisfaction / perception determined?   i.e. customer feedback, customer audits, customer survey, feedback to obtain product image in the market, handling customer complaints, increased market share, repeat orders, cost effectiveness, enhance met in product properties, product development and innovations, etc.
8.2.1	Verify the Corrective & preventive actions in case the Request For Quotations  ( RFQs) are rejected.
7.2.2	Is the output from the marketing department communicated to the relevant departments? Verify.
6.2	Is  the  competence  defined  for  the  personnel  performing marketing process?
6.2	Are these competence requirements complied with?
5.1.1	Check whether the Effectiveness Indicators are identified by the department and  trend graphs for the same made .
5.1.1 , 8.4	Do they have done analysis and make any action plan for achieving their target and are they following the same ?
Signature of Auditors                                                                           Signature of Audittees

MANUFACTURING PROCESS AUDIT CHECKLIST
Product Under Manufacture (Description & No.).:						Auditor (Name):
Date of audit (DD/MM/YYYY):						Auditee (Name):
Department:                                                                                Machine No.						Process No. as per Process Flowchart:
Sl. No.	Check Point Question	Element	Sl. No.	Sub-Element	CP No.	Actual Observation at time of audit	NCR No.
1	Is material identification provided for input material?	Material	1.1	Input Material	1.1.1
	Is the input material inspected and approved for this process?				1.1.2
	Is the input material of the correct grade and size required for the product?				1.1.3
	Are the input material containers / crates / trolleys as per defined standard?				1.1.4
	Is the material container clean and suitable for protecting the material?				1.1.5
	Is the storage condition of input material satisfactory (free from dirt, dust, fibres, foreign materials, burrs, etc.)?				1.1.6
	Does the material require any specific humidity and temperature controls?				1.1.7
	If yes, are the required storage and preservation conditions provided?				1.1.8
	Does the material have any limited shelf life / expiry date?				1.1.9
	If the material has any expiry date, are expired materials used in production?				1.1.10
	Is FIFO (First-In-First-Out) system followed in issuing/consuming the input materials?				1.1.11
	Is Raw Material / Input Material traceability required?				1.1.12
	If traceability is required, are traceability records maintained legibly?				1.1.13
	Does the material require any pre-conditioning / pre-treatment before the process? (Ex. Sieving, pre-heating, cleaning, oiling, etc.).				1.1.14
	If yes, is the required pre-conditioning done before use?				1.1.15
	Does the material require any specific handling equipments? If yes, are they available in good condition and required quantities? (Ex. Sleeves on trolleys, resting pad condition, etc.).				1.1.16
	Are the required quantities of the material available for the process? (This is to prevent having to wait for materials in-between the process).				1.1.17
	Is the material usage rate as per norms? (Ex. Yield, output-input ratio etc.) (Write Target Vs. Actual Value in Observation box)				1.1.18
	Is material identification provided for the consumables / packing materials?		1.2	Process Consumables and interim / primary / secondary packing materials	1.2.1
	Are the consumables / packing materials inspected and approved for this process?				1.2.2
	Is the material container clean and suitable for protecting the items?				1.2.3
	Is the storage condition of consumables and packing materials satisfactory (free from dirt, dust, foreign materials, burrs, damage, deterioration etc.)?				1.2.4
	Do the consumables require any specific humidity and temperature controls?				1.2.5
	If yes, are the required storage and preservation conditions provided?				1.2.6
	Does the material have any limited shelf life / expiry date?				1.2.7
	If the material has any expiry date, are expired materials used in production?				1.2.8
	Is FIFO (First-In-First-Out) system followed in issuing/consuming the consumable and packing materials?				1.2.9
	Is Raw Material / Input Material traceability required? If yes are they provided?				1.2.10
	Are the required quantities of all consumables / packing items available?				1.2.11
	Are suitable containers / chutes available for keeping output materials?		1.3	Output materials	1.3.1
	Are the output material containers / crates / trolleys as per defined standard?				1.3.2
	Are the containers clean, free of burr, dust, fibres, damages, etc?				1.3.3
	Are the parts touching each other / rubbing on containers when stored?				1.3.4
	Is the storage location suitable to protect the output material from damage, environmental conditions, etc.?				1.3.5
	Are suitable identification (and traceability if applicable) provided on outputs?				1.3.6
	Are proper storage bins available for NC, Obsolete & Suspect Materials?		1.4	Control of NC, Obsolete and Suspect Materials	1.4.1
	Are proper identification provided for NC, Obsolete & Suspect Materials?				1.4.2
	Are NC, Obsolete & Suspect materials kept segregated from good material?				1.4.3
	Are records kept for the NC, Obsolete & Suspect Materials?				1.4.4
	Are NC, Obsolete & Suspect Materials disposed off regularly?				1.4.5

Sl. No.	Check Point Question	Element	Sl. No.	Sub-Element	CP No.	Actual Observation at time of audit	NCR No.
2	Is the Machine and Tools used same as that specified in Control Plan / WI?	Machines, Fixtures and Tools, Work Environment, Facilities	2.1	Machine Condition	2.1.1
	Is the Machine / Work Station under Preventive Maintenance (PM or TBM)?				2.1.2
	Has scheduled PM / TBM been carried out on the Machine?				2.1.3
	Is the Machine / Work Station under Predictive Maintenance (CBM)?				2.1.4
	Is the Machine covered under periodic geometric accuracy checks?				2.1.5
	Has scheduled CBM / Accuracy Checks been carried out on the Machine?				2.1.6
	Are all the required spare parts replaced on time?				2.1.7
	Has JH been carried out on the machine / work station as per Checklist?				2.1.8
	Are the specified Poka-yokes provided and installed as per Control Plan?				2.1.9
	Are all Poka-yokes provided on the machine / work station working satisfactorily?				2.1.10
	Are all safety features of the Machine / work station working satisfactorily?				2.1.11
	Has machine capability (Cm / Cmk) studies been conducted on the machine?				2.1.12
	If yes, is the Cm / Cmk ≥ 2.00, or in worst case, not lesser than 1.67?				2.1.13
	Is the machine and set up clean?				2.1.14
	Is the machine and set up really ready for production?				2.1.15
	Are the tool materials / inserts used of the correct specification / grade?		2.2	Fixture & Tool Condition	2.2.1
	Are the fixtures and tools covered under periodic pro-active verification plan?				2.2.2
	Are tool life monitoring charts being maintained?				2.2.3
	Are the fixtures and tools periodically verified as per plan and records available?				2.2.4
	Are the wear parts of the fixtures / worn tools replaced on time?				2.2.5
	Are torque wrenches (if used) calibrated?				2.2.6
	Are torque wrenches (if used) set for correct value?				2.2.7
	Are the automatic tool change programmes working satisfactorily?				2.2.8
	Are any special accessories / supporting devices required for the machine / tool operation?				2.2.9
	If yes, are they provided and also adequate?				2.2.10
	Are work environment requirements (lighting, dust control, air flow, humidity, temperature, noise level, electrostatic protection, earthing, vibration levels, etc.) documented?		2.3	Work Environment	2.3.1
	Are the work environment conditions monitored regularly? At what frequency?				2.3.2
	Is each of the work environment conditions within specifications given in the documentation?				2.3.3
	Is the work environment clean and free of obstructions for effective operations? (Ex. Ergonomics, ease of operation, part and operator travel).				2.3.4
	Are corrections and corrective actions evident when the work environment is found unsatisfactory?				2.3.5
	Are the quality of services (compressed air, water, electricity, coolant contamination levels, coolant flow, etc.) defined?		2.4	Services	2.4.1
	Are the quality of services being monitored?				2.4.2
	Are the quality of services maintained and available as required for the process?				2.4.3
	Is 3-R and 5-S maintained in the work area? Is it satisfactory?				2.4.4
	Is separate area ear-marked and provided for rework / rectification?				2.4.5
	Is there a potential for mix-up of NC material with conforming material?				2.4.6
	Are the required process control instruments available as per Control Plan?		2.5	Measurement Systems (Instruments, Test Equipment, Gauges, etc.)	2.5.1
	Are the process control instruments and gauges under calibration control and calibrated?				2.5.2
	Are the required product checking instruments available exactly as specified in Control Plan (both variable gauges and attribute gauges)?				2.5.3
	Are the product checking gauges / instruments under calibration control and calibrated?				2.5.4
	Are proper storage arrangements made for the instruments and gauges so that they are protected from burr, dust, damage, etc.				2.5.5
	Are required part holding devices available for inspection activities?				2.5.6
	Has relevant MSA studies (Bias, Linearity, Stability, Variable R&R, Attribute R&R) been conducted for the relevant measurement systems?				2.5.7
	Are the MSA study reports showing that the measurement systems are capable for the measurements to be made? (See Point No. 3.2.9 also).				2.5.8

Sl. No.	Check Point Question	Element	Sl. No.	Sub-Element	CP No.	Actual Observation at time of audit	NCR No.
3	Is the operator fully aware of the requirements of the Control Plan, WI’s, etc.?	Man	3.1	Awareness	3.1.1
	Is the operator aware of special characteristic symbols and their significance?				3.1.2
	Is the operator aware of his roles and responsibilities?				3.1.3
	Is the operator aware of the customer needs & expectations?				3.1.4
	Is the operator aware of customer complaints and actions taken on them?				3.1.5
	Is the operator aware of Quality Alerts for rejections / customer complaints?				3.1.6
	Is the operator aware of how to plot Control Charts, if applicable for the process?				3.1.7
	Is the operator aware of safety precautions to be taken?				3.1.8
	Is there a skill card available for the operator?		3.2	Skill & Competence	3.2.1
	Does the skill card indicate that the operator is fully qualified for this process?				3.2.2
	Is the operator qualified to independently carry out the process?				3.2.3
	Does the operator take the specified reaction plans for NC products?				3.2.4
	Does the operator take the specified reaction plans for NC processes?				3.2.5
	Does the operator plot, and correctly plot control charts, if applicable?				3.2.6
	Does the operator know how to identify process instability from control charts and how to interpret the control charts?				3.2.7
	Is the operator using the instrument / gauges correctly?				3.2.8
	Is the operator handling and storing the measuring devices with due care in order to protect them from damage and deterioration?				3.2.9
	Has the operator’s vision been tested by a qualified doctor and found fit for the process / inspection?				3.2.10
	Is the operator wearing the specified spectacles / contact lenses / vision correction devices if applicable while carrying out the process?				3.2.11
	Has MSA studies been conducted and operator’s capability to use the instruments, gauges etc. and / or visual inspection been established?				3.2.12
	Is the operator punctual in process monitoring?		3.3	Motivation	3.3.1
	Is the operator punctual in checking product characteristics?				3.3.2
	Does the operator follow all the specified safety precautions, including wearing / use of Personal Protective Equipment?				3.3.3
	Does the operator inform the supervisor of process abnormalities?				3.3.4
	Does the operator make entries in all records legibly?				3.3.5
	Does the operator make entries in all records immediately after checks?				3.3.6
	Is the required number of operators for the process defined?		3.4	Manpower Availability	3.4.1
	Are the required number of operators with required competence provided for the process?				3.4.2

Sl. No.	Check Point Question	Element	Sl. No.	Sub-Element	CP No.	Actual Observation at time of audit	NCR No.
4	Are all required documents (Drawings, Process Flowcharts, Control Plans, WI, Checklists, Formats, etc.) available at the Machine / Workstation?	Methods	4.1	Availability of Documentatio n	4.1.1
	Are there any obsolete documents and / or obsolete formats in use?				4.1.2
	Are the available documents legible, clear and easily readable and understandable?				4.1.3
	Are there any un-approved corrections in any of these documents?				4.1.4
	Are these documents displayed / stored at places where the operator can easily see them and read / refer to them without straining himself / herself?				4.1.5
	If the process is a special process, has it been qualified? Are process qualification records available?				4.1.6
	Are the process parameters defined in the Control Plan / WI exactly what is qualified for the special process?				4.1.7
	Has the special process been re-qualified for changes if any made?				4.1.8
	In case of changes in line balance, has the relevant work instructions been revised and approved?				4.1.9
	Is each of the process parameters set on the machine / programme / workstation exactly as specified in Control Plans / Work Instructions?		4.2	Adherence to documentatio n	4.2.1
	Is the operator following the process sequence exactly as specified in CP / WI?				4.2.2
	Is the operator finding it difficult to carry out any process?				4.2.3
	Are there any process changes implemented which have not been validated yet?				4.2.4
	Are there any product changes implemented which have not been validated yet?				4.2.5
5	Is set-up verification carried out for new set-ups and when set-up is changed? (Note: Set-up verification need be done and approved before allowing production to start for all new set-ups and whenever set up is changed for any reason. Ex. Machine breakdown, tool change, process parameter change, etc.).	Monitoring & Measurement	5.1	Set-up Verification	5.1.1
	Are set-up verification records available and authorised by competent person?				5.1.2
	Are process parameters monitored at intervals specified in Control Plans?		5.2	Process Monitoring	5.2.1
	Are the process parameter monitoring records legibly maintained?				5.2.2
	Are deviations if any approved by specified competent personnel?				5.2.3
	Are reaction plans implemented when the process become unstable/non-capable?				5.2.4
	Are the reaction plans effective? That is, has the problem been resolved with the implementation of the specified reaction plan?				5.2.5
	Are significant process events recorded in Control Charts / other records? (Ex. Material batch changes, machine breakdowns, tool changes, shift changes, etc.).				5.2.6
	Is 1st Piece Inspection / Testing carried out and records maintained? (Note: 1st piece inspection here does not mean inspection of just one piece, but inspection of whatever quantity is specified in Control Plan for approval before allowing full scale regular production).		5.3	Product Monitoring	5.3.1
	Does the 1st Piece inspection record show that all characteristics are met?				5.3.2
	Are in-process inspections carried out on the products as specified in Control Plan?				5.3.3
	Are in-process inspection records legibly maintained?				5.3.4
	Does the in-process inspection record show that all characteristics are met?				5.3.5
	Are final inspections carried out on the products as specified in Control Plan?				5.3.6
	Are final inspection records legibly maintained?				5.3.7
	Does the final inspection record show that all characteristics are met?				5.3.8
	Are deviations if any approved by specified competent personnel?				5.3.9
	Are Control Charts plotted as per specified in Control Plan?				5.3.10
	Does the Control Chart show that the process is stable and capable?				5.3.11

Sl. No.	Check Point Question	Element	Sl. No.	Sub-Element	CP No.	Actual Observation at time of audit	NCR No.
6	Is rejection and rework in the process tracked?	Process Effectiveness & Efficiency	6.1	Process Effectiveness	6.1.1
	Are the rejection values within targets over last 3 months? (Write Target Value Vs. Average Value for 3 months in Observation box).				6.1.2
	Are the rework values within targets over last 3 months? (Write Target Value Vs. Average Value for 3 months in Observation box).				6.1.3
	Is process performance (Ppk) higher than 1.67 for special characteristics?				6.1.4
	Is process performance (Ppk) higher than 1.33 for other characteristics?				6.1.5
	Are root cause analysis and corrective actions evident for rejections, rework and low process capability?				6.1.6
	Are there any unresolved customer complaints / complaints from next process?				6.1.7
	Is productivity / cycle time monitored?		6.2	Process Efficiency	6.2.1
	Is the productivity / cycle time maintained as per process design targets?				6.2.2
	Is line balance maintained based on cycle times?				6.2.3
	Are there any recent safety incidents at the machine / work station?				6.2.4
	Are there any potential for safety incidents at the machine / work station?				6.2.5
			6.3.	Any other Observation	6.3.1
					6.3.2
					6.3.3
Signature of Auditor: Signature of Auditee: Date:

1. OBJECTIVE
1.1. This Policy governs the code of conduct to be followed by the employees and describes the actions and follow-ups to be taken by the organization in case of any violations arising if any.
2. ELIGIBILITY & APPLICABILITY
2.1. All Employees on regular rolls, contractual rolls and other outside agency people works under the premises of XXX
3.0 Responsible: Individual
4. POLICY & PROCEDURE
4.1. Code of Conduct needs to be accepted by the employee at joining the same should be filed in their personal file by HR
4.2. In case of violations of the code the violations will be categorized as shown below

Violation Category	Nature of Violations	Actions to be taken by HR
Minor	In Consequential	Notice / Warning
	Financial	Termination
	Work environment	Notice / Warning
	Endangering fellow employee/security	Notice / Warning
	Endangering Company property/security	Notice / Warning
Major	Financial	Termination
	Legal	Termination
	Work environment	Termination
	Endangering fellow employee/security	Termination
	Endangering Company property/security	Termination

Employee Code of Conduct

This code of conduct has been drawn up to imbibe in all XXX employees, certain basic norms of behavior, business dealing, work ethics and values which the organization firmly believes in.

Employees of Company shall:-

• Be punctual and regular in their attendance.
• Refrain from wearing casual or flashy dress or accessories while at work. Only wear the Company Uniform when in company representing at any platform i.e. Customer, Seminar, Outside Trainings etc.
• Refrain from smoking or chewing tobacco in the office premises and outside when on duty.
• Never report to work under the influence of alcohol or prohibited drugs.
• Act both with loyalty and with honesty in carrying out the policy and instructions of the organization and not undermine its image or reputation.
• Use organizational resources available to them like internet, internal network, phones, mobiles, and any other office equipment, cost effectively with a view to optimize their use in attaining objectives of the organization.
• Pay proper regard to the safety and protection of equipment, sample, material and processes committed to their charge. Unless permission has been granted by the management, resources are not to be used for personal purposes.
• Fully observe the confidentiality of information which comes to them in the course of their duties and not use the information for personal gain or in a manner which may be detrimental to the organization.
• Take all reasonable precautions including password maintenance and file protection measures to prevent unauthorized access in order to maintain the security and confidentiality of the system.
• Adhere to proper record management practice and filing procedures and not damage, dispose of, or in any other manner interfere with official documents or files.
• Not engage directly or indirectly with the media and express their opinion about the organization without prior knowledge and authorization of the management.
• Keep reasonable distance in relationships with the suppliers to ensure that it does not influence any business dealings, which may happen subconsciously.
• Not accept any gratification, gifts or commissions from any business associate/supplier. If ever a gift is received, it should be handed over to the human resource department.
• Not undertake any other employment, work or service of profit without previous written permission from the management.
• Act with honesty and integrity while giving any personal information to the company or making any claims. It includes personal information, previous employment details, details of any expense incurred while carrying out the duty or any other information that is required by the management.
• Actively participate in all training and development programs conducted by the organization.
• Treat all members of the organization equally and not harass or discriminate based on gender, nationality, ethnic origin, race, colour and political or religious beliefs.
• Treat all members of the organization with due respect and not indulge in any form of sexual harassment or pass derogatory remark, which affects the dignity of any employee.
• Promote a healthy, safe and nice work environment by keeping the office premises and workstations clean and organized.
• Speak softly and politely to colleagues and on phone in order to maintain an atmosphere of silence.
• Not threaten, intimidate, use abusive language or do bodily harm to other colleagues.
• Refrain from theft, fraud or misappropriation of company’s funds or theft of property of ather employee.
• Conduct ourselves as good citizens in the society we associate with and in the country.

Signature………………………..…………
Name………………….…………..…………
Date………………….…………..………….
Employee Code No………..…………

1. OBJECTIVE

1.1 XXX is committed to the prevention, deterrence and detection of fraud, bribery and all other corrupt business practices. It is Anti Bribery and Anti-Corruption Policy to conduct all of its business activities with honesty, integrity and the highest possible ethical standards and vigorously enforce its business practice, wherever it operates.

2.0 ELIGIBILITY & APPLICABILITY

2.1. This Anti-bribery and Anti-corruption Policy (this “Policy”) applies to all individuals at all levels and grades, including Directors, Senior Management, Office Staff, Officers, employees (whether permanent, fixed-term or temporary), consultants, contractors, trainees, seconded staff, casual workers, volunteers, interns, agents, or any other person associated with Company (collectively referred to as “You” or “you” in this Policy).

2.2. In this Policy, “Third Party(ies)” means any individual or organization, who / which come into contact with Company or transact with Company and also includes actual and potential clients, suppliers, business contacts, consultants, intermediaries, representatives, subcontractors, agents, advisers, joint ventures and government & public bodies (including their advisers, representatives and officials, politicians and political parties).

3.0 Responsible: Individual.

4.0 POLICY & PROCEDURE

4.1. General

A bribe is an inducement, payment, reward or advantage offered, promised or provided to any person in order to gain any commercial, contractual, regulatory or personal advantage. It is illegal to directly or indirectly offer a bribe or receive a bribe. It is also a separate offence to bribe a government / public official. “Government/ public official” includes officials, whether elected or appointed, who hold a legislative, administrative or judicial position of any kind in the country.

A bribe may be anything of value and not just money — gifts, inside information, sexual or other favors, corporate hospitality or entertainment, offering employment to a relative, payment or reimbursement of travel expenses, charitable donation or social contribution,
abuse of function — and can pass directly or through a third party. Corruption includes wrong doing on the part of an authority or those in power through means that are illegitimate, immoral or incompatible with ethical standards. Corruption often results from patronage and is associated with bribery.

4.2. Examples of bribery:

• Offering a bribe - Mohan, an employee of (Company Name) , offers a potential client, tickets to a major sporting event, but only if they agree to do business with Company Company. This would be an offence as Mohan is making an offer to gain a commercial advantage. It may also be an offence for the potential client to accept Mohan’s offer. Providing clients with hospitality is acceptable, provided the requirements, set out in section titled “Gifts and hospitality” are followed. 
• Receiving a bribe – Arjun works in the Supply Chain Management Department. A regular supplier offers a job for Arjun’s cousin, but makes it clear, that in return they expect Arjun to use his influence to ensure company continue to do business with the supplier. 
• Bribing a government official – Imran is asked to arrange for the record payment to be made to a customs official to speed up the administrative process of clearing our goods through customs. 

4.3. Gifts and hospitality

• Employees or members of their immediate families (spouse, mother, father, son, daughter, brother, sister or any of these step- or in-law relationships, whether established by blood or marriage including common law marriage) should not provide, solicit or accept cash or its equivalent, entertainment, favors, gifts or anything of substance to or from competitors, vendors, suppliers, customers or others that do business or are trying to do business with Company. Loans from any persons or companies having or seeking business with Company, except recognized financial institutions, should not be accepted. All relationships with those who Company deals with should be cordial, but must be on an arm’s length basis. Nothing should be accepted, nor should the employee have any outside involvement, that could impair, or give the appearance of impairing, an employee’s ability to perform his/her duties or to exercise business judgment in a fair and unbiased manner.
• This Policy does not prohibit normal and appropriate gifts, hospitality, entertainment and promotional or other similar business expenditure, such as calendars, diaries, pens, meals and invitations to theatre and sporting events (given and received), to or from Third Parties. However, the key determining factor for appropriateness of the gift or hospitality and/or its value would be based on facts and circumstances under which such gift or hospitality is provided.
• The practice of giving gifts and hospitality is recognized as an established and important part of doing business. However, it is prohibited when they are used as bribes. To avoid committing a bribery offence, the gift or hospitality must be: a. Reasonable and justifiable in all the circumstances b. Intended to improve the image of Company, better present its products and services or establish cordial relations

The giving or receiving gifts or hospitality is acceptable under this Policy if all the following requirements are met:
a. It is not made with the intention of influencing a Third Party to obtain/ retain business or a business advantage or to reward the provision or retention of business or a business advantage or in explicit or implicit exchange for favors/ benefits or for any other corrupt purpose
b. It complies with the laws and customs
c. It does not include cash or a cash equivalent (such as gift certificates or vouchers)
d. It is appropriate in the circumstances. For example, in India. it is customary for small gifts to be given at Diwali time
e. Taking into account the reason for the gift or hospitality, it is of an appropriate type and value and given at an appropriate time
f. It is given openly, not secretly and in a manner that avoids the appearance of impropriety

Examples of Token Gifts: Corporate calendar, pens, mugs, books, T-shirts, wine bottles, bouquet of flowers or a pack of sweets or dry fruits.

If the gifts or hospitality given or received is more than a token gift or modest meal/ entertainment in the ordinary course of business, you must obtain prior written approval from your vertical head and must notify the Whistleblower Committee for recording in the gift and hospitality register.

The Whistleblower Committee will maintain a gift and hospitality register as a written record, setting out full details of the gift or hospitality given or received including the approximate value, the purpose or intention of the gift or hospitality, the name of the recipient and provider of the gift or hospitality and their relationship.

Examples of hospitality:

(i) Abhishek, a customer relationship manager, invites an important existing client to attend a fine dining or a football match as part of a public relations exercise designed to cement good relations and enhance the client’s knowledge of our services. Is this acceptable? 

Yes. This hospitality seems to be reasonable and justifiable in all the circumstances and the intention is to improve Company image, better present our products and services and improve cordial relations.

(ii) Samantha invites a potential client to watch Wimbledon a week before the deadline for RFP opening for a large IT deal, which she hopes to secure in order to persuade them to accept her company’s RFP. Is this acceptable? 

No. This hospitality would constitute bribery as it would be made with the intention of influencing the potential client to obtain business. The timing of this hospitality is important. If there was no RFP deadline you may be able to entertain the potential clients without breaching the law. This is because the intention of the hospitality would be then to improve the Company’s image, better present the products and services and establish cordial relations with the potential client.

(iii) Employees of Company company are invited to be a guest of an outside company or person at meetings, trips, etc, usually overnight, that have an emphasis on recreation of some type. Is it ok for you to participate? 

The employee participation in such events should be limited only to those, where a benefit to Company Company is expected and as much of the employee expenses, as is possible and practical, should be paid by Company Company. The sponsor of the event should be in good standing with Company Company based on past performance.

(iv) A vendor offers a five-star, seven-day holiday package to Hawaii or Singapore to Aman, a Sales Manager at Company Company and his family as a token of his appreciation for a contract awarded to the Vendor. Can you go? 

No. Taking into account the reason for the gift, the value of the holiday is excessive and
unreasonable in the circumstances. Aman should politely decline the gift and explain that you cannot accept such an offer.

(v) A potential sub-contractor delivers a case of expensive wine to the office of Radheshyam, a week before Radheshyam has to make an purchase decision of the services or goods. Can Radheshyam accept the gift? 

No. The gift appears to have been made with the clear intention of influencing Radheshyam to award the contract to the sub-contractor. Radheshyam should return the case of wine explaining that he cannot accept the gift and Radheshyam should assess the quote for the supply of services impartially with quotes Radheshyam has obtained from other sub-contractors.

4.4. What is not acceptable?

It is not acceptable for any employee of Company (or someone on his / her behalf) to:

a. Accept an offer of a gift of any size from any Third Party which is in negotiation with, or is submitting a proposal with Company.
b. Give, promise to give or offer, any payment, gift, hospitality or advantage with the expectation or hope that a business advantage will be given or received or to reward a business advantage already given
c. Give, promise to give or offer, any payment, gift or hospitality to a government official, agent or representative to “facilitate” or expedite a routine procedure
d. Accept or solicit any payment, advantage, gift or hospitality from a Third Party that you know or suspect is being offered with the expectation that it will obtain a business advantage for them
e. Threaten or retaliate against, another employee who has refused to commit a bribery offence or who has raised concerns under this Policy
f. Engage in any activity that might lead to a breach of this Policy

The points stated above are illustrative in nature and in no way intend to limit the applicability of this Policy.

4.5 Willful blindness

If an employee willfully ignores or turns a blind eye to any evidence of corruption or bribery within his / her department and/or around him / her, it will also be taken against the employee. Although such conduct may be “passive”, i.e. the employee may not have directly participated in or may not have directly benefited from the corruption or bribery concerned, the willful blindness to the same can, depending upon the circumstances, carry the same disciplinary action as an intentional act.

4.6 Facilitation payments and kickbacks

Neither an employee of Company nor any person acting on behalf of Company shall make and shall not accept facilitation payments or “kickbacks” of any kind. “Facilitation Payments” are typically small, unofficial payments (sometimes known as “grease payments”) made to secure or expedite a routine government action by a government official. “Kickbacks” are typically payments made to commercial organizations in return for a business favor/ advantage, such as a payment made to secure the award of a contract. You must avoid any activity that might lead to or suggest that a Facilitation Payment or Kickback will be made or accepted by Company.

4.6.1 Guidance on how to avoid making Facilitation Payments

Corrupt government officials demanding payments to perform routine government actions may often put people acting on behalf of Company in very difficult positions. Therefore, there is no easy solution to the problem. However, the following steps may help:

• Insist on official receipts for any payments you make
• Report suspicions, concerns, queries and demands for Facilitation Payments to the higher ups and to local enforcement authorities and refuse to make such payments

4.7 Blackmail / Extortions

We remain committed to our policy of not making Facilitation Payments. The only limited exception to this is in circumstances where you or the Third Parties are left with no alternative but to make payments in order to protect against loss of life, limb or liberty. In such circumstances, you make the payment and it is your immediate responsibility to contact your Manager as soon as possible after the event, so that the incident can be properly recorded, reviewed and accounted for with the authorities.

4.8 Charitable Donations

As part of its corporate citizenship activities, Company may support local charities or provide sponsorship, for example, to sporting or cultural events. We only make charitable donations that are legal and ethical under local laws and practices and also within the corporate governance framework of the organization.

4.9 Political Activities

We are apolitical, advocate government policies on sustainability and do not contribute financial or in- kind to political parties, politicians and related institutions.
We do not make contributions to political parties, political party officials or candidates for political office. Payment or use of corporate assets of any type as payment, directly or indirectly to any person, business, political organization or public official for any unlawful or unauthorized purpose is prohibited. You should not make any political contribution on behalf of Company use any Company resources to assist a candidate or elected official in any campaign or coerce or direct another employee to vote a certain way. You should never attempt to offer any incentives to public officials in the hopes of influencing the decision of that individual.

4.10 Business relationships

Company expects all Third Parties doing business with Company to approach issues of bribery and corruption in a manner that is consistent with the principles set out in this Policy. Company requires all Third Parties to cooperate and ensure compliance with these standards, to continue the business relationship.

In order to maintain the highest standards of integrity, with respect to any dealings with a Third Party, you must ensure that:

a) Employees and associates shall conduct due diligence enquiries to review the integrity records of any Third Party before entering a commercial relationship with them
b) Employees and associates shall fully document the engagement process and the final approval of the selection of any Third Party
c) Employees and associates shall implement a program to provide appropriate information on this Policy to all Third Parties engaged in business relationship with Company
d) Employees and associates shall ensure that:

• Each Third Party within your work area are fully briefed on this Policy and have made a formal commitment in writing to abide by it
• Fees and commissions agreed will be appropriate and justifiable remuneration for legitimate services rendered
• Contractual agreements will include appropriate wording making it possible to withdraw from the relationship if any of the Third Parties fail to abide by this Policy

In the event of any doubt on the integrity of a Third Party, it is the employee’s responsibility to contact his / her Manager as soon as possible.

4.11 What we expect of our Employees

Employees are the pillars of this organization and are behind each Company success story. Every employee must ensure that he / she shall read, understand and comply with this Policy. If any employee has doubts or concerns, he / she should contact his / her Manager.

The prevention, detection and reporting of bribery and other forms of corruption are the responsibility of all those working for Company or under Company control. Employees are required to avoid any activity that might lead to or suggest a breach of this Policy.

Employees must notify his/her Manager the Whistleblower Committee via whistleblower@indoautotech.com as soon as possible if you believe or suspect that a breach of or conflict with this Policy has occurred or may occur in the future.

Any employee who breaches this Policy will face disciplinary action, which could result in dismissal. We reserve our right to terminate our contractual relationship with you if you breach this Policy. Any breach of this Policy would also result in imposition of large fines/ imprisonment on the individual/ the Company as the case may be or termination of contract with a Third Party.

4.12 Record-keeping

Employees must ensure all expenses claims relating to hospitality, gifts or expenses incurred to Third Parties are submitted in accordance with our expenses policy and specifically record the reason for the expenditure.

All accounts, invoices, memoranda and other documents and records relating to dealings with third parties, such as clients, suppliers and business contacts, should be prepared and maintained with strict accuracy and completeness. No accounts will be kept “off-book” to facilitate or conceal improper payments and the same is ensured through effective monitoring and auditing mechanisms in place.

Employees must follow all the procedures laid out in other policies (available in the respective intranet portal) which help in anti-bribery and corruption due diligence on suppliers, potential joint venture parties, clients and other Third Parties.

4.13 How to raise a concern

Every person, to whom this policy applies too, is encouraged to raise their concerns about any bribery issue or suspicion of malpractice at the earliest possible stage. If he / she is unsure whether a particular act constitutes bribery or corruption or if he / she has any other queries, these should be raised with their respective Manager

4.14 What to do if you are a victim of bribery and corruption?

It is his / her responsibility to inform / report it to their respective Managers and the Whistleblower Committee via whistleblower@xxx.com as soon as possible if you are offered a bribe by a third party, you are asked to make one, suspect that this may happen in the future or believe that you are a victim of another form of corruption or other unlawful activity. You must refuse to accept or make the payment from or to a third party, explain our policy against accepting or making such payment and make it clear that the refusal is final and non-negotiable because of this Policy. If you encounter any difficulty making this refusal, you should seek assistance from your Manager.

4.15 Protection

Those who refuse to accept or offer a bribe or those who raise concerns or report another’s wrong- doing, are sometimes worried about possible repercussions. We encourage openness and will support anyone who raises genuine concerns in good faith under this Policy, even if they turn out to be mistaken. We are committed to ensuring that no one suffers any detrimental treatment as a result of refusing to take part in bribery or corrupt activities or because of reporting their suspicion in good faith that an actual or potential bribery or other corruption offence has taken place or may take place in the future. If any employee believes that he / she has suffered any such treatment, he / she should inform your Manager

4.16 Who is responsible for the Policy?

The Chief Executive Officer has overall responsibility for ensuring that this Policy complies with our legal and ethical obligations and that all those under our control comply with it. Managers at all levels are responsible for ensuring that those reporting to them are made aware of and understand this Policy, undertake training on how to implement and adhere to it and also monitor compliance of it. The Compliance/ HR team is responsible for this Policy and for monitoring its use and effectiveness (and dealing with any queries on its interpretation). Management at all levels is responsible for ensuring that those reporting to them are made aware of and understand this Policy and attend regular training on how to implement and adhere to it. Every person to whom this policy applies is responsible for the success of this Policy and should ensure that he / she should use it to disclose any suspected activity or wrong-doing.

4.17 Waiver and amendment of the policy

We are committed to continuously reviewing and updating our policies and procedures based on the learning. This is so even when Company enters new market/ sector/ country, which may pose a risk under this Policy. The Compliance/ HR team will monitor the effectiveness and review the implementation of this Policy, regularly considering its suitability, adequacy and effectiveness. Any improvements identified will be made as soon as possible. Therefore, this document is subject to modification. Any amendment or waiver of any provision of this Policy must be approved in writing by DEO. The Policy will be reviewed and audited from time to time, which requires cooperation from all concerned.

1.0 Introduction

We are a customer centric organization, and our high quality standards and emphasis on excellence, allows us to take pride in our work at every step of every production process. We are a team of talented people practicing continuous improvements as a way of working in our organization, willing to go the extra mile for achieving and delivering results. The diverse needs of our valued customers, both domestic and overseas, are carefully addressed by our commitment to the following:

Quality : Continuous Improvement to meet and exceed customer expectations

Cost: Competitiveness with value added products

Delivery: Deliver products at right time.

By adhering to the quality standards, our mission is to be a leading company in our field of activity, service & excellence, through total customer satisfaction and thereby developing a nationwide market of our present and future products.

1.1 Infrastructure Available

1. Design : Auto CAD & 3D Modeling, Solid Edge
2. Manufacturing:
   • Press Shop: Presses ranging from 2T-400T (Mechanical, Hydraulic and Hydro Pneumatic)
   • Tool Room: Lathe, Milling Machines, Radial Drilling, Cylindrical Grinders, Surface Grinders
   • Machine Shop: Special Purpose Blank Turning, Multi Spindle Drilling, Hobbing, Thread Rolling, Centre Less Grinder, Deburring, Window Grinding, Automats, Riveting, Tube Cutting & Chamfering, Tapping, Induction Hardening & Tempering.
3. Welding and CNC Equipment: CNC Turning Machine, CNC Tube Bending, Robotic MIG welders, MIG/TIG welding, Projection welding and Spot welding.
4. Testing & Quality: Measuring & Testing Equipment Such as Profile Projector, Hardness Tester, Salt Spray Chamber, Spring Load Testing, Plating Thickness Tester, Height Gauges, Micrometers, Calipers. Digital Micro Hardness Tester , Micro Scope for Cut Etching Testing, Crack Detector Machine
5. AT EMS:- Hardness tester, Plating Thickness tester, Height Gauges, Micrometers, Calipers.

2.0 References and Standards

The List of References which include Standards, Manuals, Processes and applicable product Regulatory Requirements used in developing and implementing the systems is given below:

Our Quality Management System makes reference to the following standards

a)	ISO 9000:2015:	QMS Fundamental and Vocabulary
b)	ISO 9001:2015	:QMS Requirements
c)	ISO 9004:2009	:QMS guidelines for performance improvement
d)	IATF 16949:2016	:   Quality    management   system    requirements    for                    automotive production and relevant service parts organizations
e)	ISO190011:2011	Guidelines for quality and/or Environmental management System Audit
f)	ISO / IEC 17025	General requirement  for the competence of testing & calibration laboratories

3.0 Terms, Definition & Abbreviations

In this Quality System Manual and related procedures / instructions, following terms / definitions and abbreviations have been used

1. Interested Parties:Person or organization that can affect, be affected by, or perceive itself to be affected by a decision or activity
2. Risk: Effect of uncertainty
3. Competency: Ability to apply knowledge and skill to achieve intended results
4. Documented Information:Information required to be controlled and maintained by the an Organization and the medium on which it is contained
5. Requirement :Need or expectation that is stated, generally implied or obligatory
6. Management System: Set of interrelated or interacting elements of an organization to establish policies and objectives and process to achieve those objectives
7. Top Management: Person of group of people who direct and control an organization at the height level
8. Effectiveness: Extent to which planned activities are realized and planned results achieved
9. Policy: Intentions and direction of an organization, as formally expressed by its top management
10. Objective: Result to be achieved
11. Process: Set of interrelated or interacting activities, which transfer input into output.
12. Outsource: Make an arrangement where an external organization performs part of an organization’s function or process
13. Monitoring :  determining the status of a system, a process or an activity
14. Measurement  : process or determine a value.
15. Audit  : Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled
16. Conformity  :  Fulfillment of a requirement
17. Non-conformity : Non fulfillment of a requirement
18. APQP  : Support development of a product/service that will satisfy customer requirements
19. After Market :Not procured or released by an OEM for service parts application
20. Challenge (Master) parts :  Use to validate the functionality of the error-proofing device or check fixtures
21. Design for assembly (DFA)    Process by which product are designed with ease of assembly consideration
22. Design for manufacturing (DFM): Integration of product design & process planning to design a product that is easily & economically manufactured
23. Design for six sigma (DFSS): Systematic methodology, tools & technique with the aim of being a robust design of product or process that meets customer expectations & can be produced at six-sigma quality level
24. Design for manufacturingand assembly (DFMA) : combination of two methodologies: Design for Manufacture (DFM), which is the process of optimizing the design to be easier to produce, have higher throughput, and improved quality; and Design for Assembly (DFA), which is the optimization of the design to reduce risk of error, lowering costs, and making it easier to assemble design for six sigma (DFSS) systematic methodology, tools, and techniques with the aim of being a robust design of products or processes that meets customer expectations and can be produced at a six sigma quality level
25. Escalation process: Process used to highlight or flag certain issues with an organization so that the appropriate personnel can respond to these situations and monitor resolutions
26. Fault tree analysis (FTA)   Maps the relationship between faults, subsystem and redundant design elements by creating a logic diagram of the overall system
27. No trouble found (NTF): Parts replace during a service events that, when analyzed, Meets all the requirements of good parts
28. Preventive maintenance  :Planned activities at regular intervals (time-based, periodic inspection, and overhaul) to eliminate causes of equipment failure and unscheduled interruptions to production, as an output of the manufacturing process design.
29. Periodic overhaul :To prevent a major unplanned breakdown where, based on faults or interruption history, a piece of equipment, or subsystem of the equipment, is proactively taken out of service
30. Predictive maintenance: Set of technique to evaluate the condition of in service equipment by performing periodic or continuous monitoring of equipment conditions, in order to predict when maintenance should be performed
31. Product safety: Standard relating to the design & manufacturing of product to ensure they do not represent harm or hazards to customer
32. Production shutdown: Manufacturing processes are idle; item span may be few hours to few months
33. Total productive :Maintaining& improving the integrity of the production and quality
34. Maintenance  : system through machines, equipment, processes and employee that add value to the organization
35. Trade off curves : Tool to understand and communicates the relationship of various design characteristics of a product to each other
36. Trade off processes  :Methodology of developing & using trade off curves
37. Premium freight : Extra costs or charges incurred additional to contracted delivery (This can be caused by method, quantity, unscheduled or late deliveries, etc)
38. Remote location :Location that supports sites and at which noon-production processes occur
39. Special characteristic :Product characteristic or manufacturing process parameter which can affect safety or compliance with regulations, fit, function, performance or subsequent processing of product
40. Verification: Conformation through the provision of objective evidence, that specified requirement have been fulfilled.
41. Validation :Conformation through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.
42. Corrective action : action to eliminate the cause of nonconformity and to prevent re-occurrence.
43. Continual Improvement: recurring activity to enhance performance
44. accessory part: customer-specified additional component(s) that are either mechanically or electronically connected to the vehicle or power train before (or after) delivery to the final customer (e.g., custom floor mats, truck bed liners, wheel covers, sound system enhancements, sunroofs, spoilers, super-chargers, etc.)
45. Advanced product quality: Product quality planning process that supports development of a planning (APQP) product or service that will satisfy customer requirements; APQP serves as a guide in the development process and also a standard way to share results between organizations and their customers; APQP covers design robustness, design testing and specification compliance, production process design, quality inspection standards, process capability, production capacity, product packaging, product testing and operator training plan among other items
46. Aftermarket part :Replacement part(s) not procured or released by an OEM for service part applications, which may or may not be produced to original equipment specifications    
47. Authorization  :documented permission for a person(s) specifying rights and responsibilities relate to giving or denying permissions or sanctions within an organization
48. challenge (master) part : part(s) of known specification, calibrated and traceable to standards,  with expected results (pass or fail) that are used to validate the   functionality of an error-proofing device or check fixtures (e.g., go /   no-go gauging)
49. Control plan : Documented description of the systems and processes required for controlling the manufacturing of product
50. Customer requirements: All requirements specified by the customer (e.g., technical, commercial, product and manufacturing process-related requirements, general terms and conditions, customer specific requirements, etc.).  Where the audited organization is a vehicle manufacturer, vehicle manufacturer subsidiary, or joint venture with a vehicle manufacturer, the relevant customer is specified by the vehicle manufacturer, their  subsidiaries, or joint ventures.
51. customer-specific requirements (CSRs): Interpretations of or supplemental requirements linked to a specific  clause(s) of this Automotive QMS Standard.
52. Design-responsible organization:  Organization with authority to establish a new, or change an existing product specification. NOTE : This responsibility includes testing and verification of design’s performance within the customer’s specified application.
53. Error proofing :product and manufacturing process design and development to prevent manufacture of nonconforming products
54. Escalation process  : Process used to highlight or flag certain issues within an organization that the appropriate personnel can respond to these situations and monitor the resolutions
55. Laboratory : Facility for inspection, test, or calibration that may include but is not / limited to the following: chemical, metallurgical, dimensional, physic electrical, or reliability testing
56. Laboratory scope :Controlled document containing specific tests, evaluations, and calibrations that a laboratory qualified to perform; a list of the equipment that the laboratory uses to perform the above; And list of methods and standards to which the laboratory performs the above
57. Manufacturing : Process of making or fabricating production materials; production parts or service parts; assemblies; or heat treating, welding, painting, plating, or other finishing services.
58. Manufacturing feasibility : An analysis and evaluation of a proposed project to determine if it is technically feasible to manufacture the product to meet customer requirements. This includes but is not limited to the following (as applicable): within the estimated costs, and if the necessary resources, facilities, tooling, capacity, software, and personnel with required skills, including support functions, are or are planned to be available
59. Manufacturing services : companies that test, manufacture, distribute, and provide repair services for components and assemblies
60. Multi-disciplinary approach :  Method to capture input from all interested parties who may influence how a process is administered by a team whose members include personnel from the organization and may include customer and supplier representatives; team members may be internal or external to the organization; either existing teams or ad hoc teams may be used as circumstances warrant; input to the team may include both organization and customer inputs
61. Outsourced process : Portion of an organization’s function (or processes) that is performed by an external organization      
62. Product :Applies to any intended output resulting from the product realization process.
63. Reaction plan  : Action or series of steps prescribed in a control plan in the event abnormal or nonconforming events are detected
64. Service part :Replacement part(s) manufactured to OEM specifications that are procured or released by the OEM for service part applications, including remanufactured parts site
65. Site : Location at which value-added manufacturing processes occur
66. Special status :Notification of a customer-identified classification assigned to an organization where one or more customer requirements are not being satisfied due to a significant quality or delivery issue
67. Support function : Non-production activity (conducted on site or at a remote location) that supports one (or more) manufacturing sites of the same organization
68. Embedded software : Embedded software is a specialized programme stored in an automotive component (typically computer chip or other non- volatile memory storage) specified by the customer, or as part of the system design, to control its function(s). To be relevant in the scope of IATF 16949 certification, the part that is controlled by embedded software must be developed for an automotive application (i.e., passenger cars, light commercial vehicles, heavy trucks, buses, and motorcycles; ). NOTE: Software to control any aspect of the manufacturing process (e.g., machine to manufacture a component or material) is not included in the definition of embedded software.

4  Context of the organization

4.1  Understanding the organization and its context

XXX conducts SWOT Analysis for identification of internal & external issues for every process; these issues are considered while caring out the risk analysis. Action plan is prepared for mitigating the risk & also for improvement considering the strength & opportunities. Issues & Requirements monitoring sheet- Annexure- 05

4.2 Understanding the needs and expectations of interested parties

XXX has identified relevant interested parties having effect or potential effect on the organization’s ability to supply products & services that meet customer & applicable statutory and regulatory requirements. Needs & expectation of these interested parties are considered while doing risk and opportunity analysis & while establishing quality management system

Issues & Requirements monitoring sheet- Annexure- 05

4.3 Determining the scope of the quality management system

XXX has considered the internal & external issues, need & expectations of relevant interested parties while establishing the Quality Management Systems.

4.3.1 Supplemental

Permitted exclusions with justification for XXX defined in scope

Scope                           Manufacture of Tubular, Sheet Metal and Machined Components and Sub Assemblies

Manufacturing            Machining, Sheet Metal Press shop, Pipe binding, Induction

Processes                     hardening, Welding, Assemblies , Shot Blasting and plasma Cutting.

Manufacturing            CNC Turning, Hobbing, Drilling, Sheet Metal Press shop,

Processes                     Induction hardening, Assembly, Broaching, Tapping.

Products-                    Rear Sprocket, Drum sprocket assembly, Shafts and shafts assembly, Sheet Metal components and Engine Sprockets.

Remote location                   Nil

Exclusion                    8.3.3.1,8.3.2.3, 8.3.5.1- Product design & development

Justification                   Products are manufactured as per customer drawings

Unit:                                        XXXXXX       

4.3.2 Customer-specific requirements

CSR Matrix-Annexure-8

4.4 Quality management system and its processes

4.4.1 XXX has established, documented, implemented and is maintaining the QMS and improving its effectiveness continually in accordance with the requirements of IATF16949:2016

S.No.	Process	Requirements
1.	Top Management (Policy making, Business planning, Continual improvement, Management review)	4.1, 4.2, 5.1.1, 5.1.2, 5.2.1, 5.2.2, 5.3, 9.3.1, 9.3.2, 9.3.3
2	Marketing	4.1, 4.2, 4.4.1, 4.4.2, 6.1, 6.2, 7.1.6,
	(Contract review, Customer feed back/ satisfaction assessment, enquiry handling, Schedule planning, production & dispatch)	7.2, 7.3, 7.5.3, 8.2.1, 8.2.2, 8.2.3, 8.2.4, 8.5.3, 8.5.5, 9.1.2, 9.1.3, 10.2
3	Purchase (Supplier selection, Supplier Evaluation and monitoring, Procurement of material, Supplier audit, Supplier system development, control over outsourced process)	4.1, 4.2, 6.1, 6.2, 7.1.6, 7.2, 7.3, 7.5.3, 8.4.1, 8.4.2, 8.4.3, 8.5.2, 8.5.3, 8.5.4, 8.7, 9.1.3, 10.2
4	Production (Machining, Sheet Metal, Pipe binding, Welding, Induction Hardening)	4.1, 4.2, 6.1, 6.2, 7.1.2, 7.1.3, 7.1.4, 7.1.5, 7.1.6, 7.2, 7.3, 7.5.3, 8.1, 8.5.1, 8.5.2, 8.5.3, 8.5.4, 8.5.5, 8.5.6, 8.7,
5	Quality& Lab (Control of monitoring & measuring resources, MSA, SPC, Incoming, In-process, Final, Layout/Dock inspection, Control over NC products, Customer complaints, Analysis & Corrective action)	4.1, 4.2, 6.1, 6.2, 7.1.3, 7.1.4, 7.1.5.1, 7.1.5.2, 7.1.6, 7.2, 7.3, 7.5.3, 8.5.2, 8.5.6, 8.6, 8.7, 9.1.1, 9.1.3, 10.2
6	Human resource (Training, Motivation activities, Manpower recruitment)	4.1, 4.2, 6.1, 6.2, 7.1.6, 7.2, 7.3, 7.5.3, 9.1.3, 10.2
7	Information technology (Hardware & software provision and updation, control to access the application system & Data integrity)	4.1, 4.2, 6.1, 6.2, 7.1.3, 7.5
8	Quality Management System (Control of documents, Control of records, Corrective & Preventive action, Control of NC products, Internal quality audit, Management review meeting, Continual improvement process)	4.1, 4.2, 6.1, 6.2, 7.1.6, 7.2, 7.5.3, 8.5.2, 8.5.3,8.7, 9.1.3, 10.2
9	Store &Dispatch (Handling, storage, Preservation, Issue of material, Packing, Dispatch planning & Transportation)	4.1, 4.2, 6.1, 6.2, 7.1.6, 7.2, 7.5.3, 8.5.2, 8.5.3, 8.5.4, 8.7, 9.1.3, 10.2
10	Maintenance (Preventive, Predictive, Breakdown Maintenance and Periodic overhauling)	4.1, 4.2, 6.1, 6.2, 7.1.3, 7.1.6, 7.2, 7.3, 7.5.3, 9.1.3, 10.2
11	Tool Room (Tool design, Tool Manufacturing & Tool Maintenance)	4.1, 4.2, 6.1, 6.2, 7.1.3, 7.1.6, 7.2, 7.3, 7.5.3, 9.1.3, 10.2
12	Engineering (ECN/ECR (External), PCN (Internal), APQP, PPAP)	4.1, 4.2, 6.1, 6.2, 7.1.6, 7.2,7.3,8.3,8.7,8.5.3, 10.2

1. Input required & output expected for all processes-Turtle Annexure-06 of Q.M
2. Sequences & Interaction of the above processes – Annexure-04 of Q.M
3. Performance indicators have been determined for the above processes-
4. Resources has been determined for the above processes & availability has been ensured
5. Responsibilities & authorities have been assigned –Annexure-02 of Q.M
6. Risk & opportunities have been addressed-Annexure-03 of Q.M
7.  Processes are evaluated & implemented any change if required to ensure the achievement of indented results
8. Improvement is done in the processes & QMS- Ref. Kaizen sheet

4.4.1.1 Conformance of products and processes

Customer, statutory & regulatory requirements are identified for all products & processes and conformance for the same are ensured during process design & development, Manufacturing & Procurement. XXX ensures conformance of all products and processes and those that are outsourced, to all applicable customer, statutory, and regulatory requirements.

XXX do not produce any service parts for any of the customer.

4.4.1.2 Product safety

XXX has documented process for the management of product-safety related products and manufacturing processes, which shall include but not be limited to the following, where applicable:

1. identification by the organization of statutory and regulatory product safety requirements;
2. customer notification of requirements in item a);
3. special approvals for design FMEA;
4. identification of product safety-related characteristics;
5. identification and controls of safety-related characteristics of product and at the point of manufacture;
6. special approval of control plans and process FMEA;
7. reaction plans
8. defined responsibilities, definition of escalation process and flow of information, including top management, and customer notification;
9. training identified by the organization or customer for personnel involved in product-safety related products and associated manufacturing processes;
10. changes of product or process are approved prior to implementation, including evaluation of potential effects on product safety from process and product changes
11. transfer of requirements with regard to product safety throughout the supply chain, including customer-designated sources
12. product traceability by manufactured lot (at a minimum) throughout the supply chain
13. lessons learned for new product introduction.

Note: Special approval is an additional approval by the function (typically the customer) that is responsible to approve such documents with safety-related content.

Ref- Documented process product safety

4.4.2    XXX:
a) maintains documented information to support the operation of its processes;
b) retains documented information to have confidence that the processes are being carried out as planned.

Ref-List of records with retention period

5.0 Leadership

5.1 Leadership and commitment

5.1.1 General

1. Director is accountable for the effectiveness of the quality management system
2. Quality Policy, Objectives/KPI with action plan are established
3. QMS requirements are integrated into the business process &addressed in the documented process of the related business processes. (Marketing,Purchase, Production, Quality, Maintenance, Tool Room, Store, Dispatch, Top Management, Engineering, Quality management system, Human resource, Information technology)
4. PFMEA is done for manufacturing process & risk assessment is done for all business process & action is taken for improvement where ever is required
5. Resources needed for the QMS are identified during management review and fulfilled by the management
6. Training is imparted on the requirements of QMS and related documented processes for effective implementation of QMS throughout the organization
7. Internal audit is done at planned intervals to ensure the QMS achieves its indented results
8. Kaizens/suggestion schemes are promoted through out the organization to promote improvements
9. Support the lower management & workers to contribute the effectiveness of the quality management system

5.1.1.1 Corporate responsibility

XXX has defined and implemented corporate responsibility policies, including at a minimum

1. Anti bribery policy

XXX is committed to the prevention and detection of fraud, bribery and all other corrupt business practices. It is XXX’s policy to conduct all of its business activities with honesty, integrity and the highest possible ethical standards and actively enforce its business practice, wherever it operates throughout the world, of not engaging in bribery or corruption.

2. Employee code of conduct

We promote freedom of expression and open communication. But we expect all employees to follow our code of conduct. They should avoid offending, participating in serious disputes and disrupting our workplace. We also expect them to promote a well-organized, respectful and collaborative environment.

3. Compliance with law

All employees must protect our company’s legality. They should comply with all environmental, safety and fair dealing laws. We expect employees to be ethical and responsible when dealing with our company’s finances, products, partnerships and public image.

4. Respect in the workplace

All employees should respect their colleagues. We won’t allow any kind of discriminatory behavior, harassment or victimization. Employees should conform with our equal opportunity policy in all aspects of their work, from recruitment and performance evaluation to interpersonal relations.

5. Protection of Company Property

All employees should treat our company’s property, whether material or intangible, with respect and care. Employees:

• Shouldn’t misuse company equipment or use it frivolously.
• Should respect all kinds of incorporeal property. This includes trademarks, copyright and other property (information, reports etc.) Employees should use them only to complete their job duties.
• Employees should protect company facilities and other material property (e.g. company cars) from damage and vandalism, whenever possible.

6) Whistle Blowing Policy

a) Objective & Scope

• To provide a framework to employees to report in good faith, in case they observe unethical & improper practices or any alleged wrongful conduct in the organization & to protect employees who raise such concerns about serious irregularities in the organization

• Scope: All employees of XXXX

b) Policy guidelines

• Protected discloser
• Subject
• Whistle blower
• HOD H.R email xx@xx.xx

c) Procedure & Discloser

• Any employee observed him self/her self any unethical & improper practices or alleged wrong full conduct shall make a discloser to the HOD H.R in writing or email asap and later then 30 days of occurrence of the incidents
• All discloser through email/mobile no.
• Anonymous discloser will be entertained

d) Enquiry

• HOD H.R will forward the complaint to the Director
• Designation of committee by Director to investigate preferably from plant representative
• External agency may be involved depending on the severity of the complaints if initial investigation reveals no basis / warrants, no further investigation the complaint will be dropped
• In case initial enquiry reveals further investigation any information and document can be called as deemed appropriate by the committee
• No attempt to conceal evidence
• Report on completion of investigation to be made to Director
• Next cores of action to be determined and may order for remedies

e) Disqualifications

• No protection in this policy against bogus complaints
• Whistle blowers to make protected discloser which have subsequently found to be malafide frivolous and malicious shall be liable to the prosecuted under company code of conduct

f) Secrecy/ confidentiality

The whistle blower the subject and every one involve in the process shall: –

• Maintain complete confidentiality /secrecy of the matter
• No discuss in meetings/informal gatherings/social get-together. Discuss only to the extent or with the person required for the purpose of completing the process & investigation
• No keep any papers unattended anywhere at any time
• Keep electronic mails/files under password

If any one is found not compliance with the above he/she can be held liable for such disciplinary action as dimmed fit

g) Protection

• Designated authority will ensure that no adverse personal action shall be taken or recommended against an employee in retaliation to his /her discloser in good faith of any unethical and improper practices alleged wrongful conduct
• No protection against adverse action which occur due to poor job performance or any other discloser made pursuant to this policy etc. depended of his discloser of unethical & improper practices or alleged wrongful conduct

h) Reporting

• Quarterly report with the number of complaints received under the policy & their outcome shall be placed to the Director by the HOD H.R

5.1.1.2 Process effectiveness and efficiency

Performance indicators are made for product realization processes & support processes. Monthly review is done to evaluate & improve their effectiveness & efficiency and output is reviewed in Management review . Top management reviews the product realization processes and support processes to evaluate and improve their effectiveness and efficiency. The results of the process review activities are included as input to the management review. Top Management reviews the Production Realization Processes and support processes to assure the effectiveness and efficiency of the QMS through:

• the results of Manufacturing Process Audits,
• the Goals and Objectives Matrix ,
• general Quality Issues,
• Customer Complaints

These reviews are formally conducted during Management Review Meetings, but may also be addressed as part of the day-to-day business activities to assure the effectiveness and efficiency of our processes.

5.1.1.3 Process owners

Process owners are identified for all processes. Roles, responsibility & authorities are assigned and communicated

Ref- Organization chart

5.1.2 Customer focus

Top Management ensures that customer requirements are determined and are met with the aim of enhancing customer satisfaction. Customer Requirements may be determined through Quotations, Purchase Orders, Specifications; Customer provided Supplier Quality Manuals, as well as Customer Satisfaction and Dis-satisfaction data. To ensure that the defined customer requirements are being met, Top Management will rely on data from the Goals and Objectives Matrix and customer feedback (i.e. Customer Report Cards, and general customer communications). Top management demonstrates leadership and commitment with respect to customer focus by ensuring that:

1. Customer, statutory & regulatory requirements are identified for all products & processes and conformance for the same are ensured during process design & development, Manufacturing & Procurement
2. PFMEA is done for manufacturing process & risk assessment is done for all business process & action is taken for improvement where ever is required
3. Customer satisfaction/customer score card is monitored & action is taken to enhance satisfaction level

Actions will be taken as necessary to ensure that customer requirements are continually met and enhanced

5.2 Policy

5.2.1 Establishing the quality policy

Top management has established, implemented and maintained a quality policy that:

1. is appropriate to the purpose and context of the xxx and supports its strategic direction;
2. provides a framework for setting quality objectives;
3. includes a commitment to satisfy applicable requirements;
4. includes a commitment to continual improvement of the quality management system.

The quality policy is

“To meet or exceed customer expectation by supplying quality products at competitive   prices    &   on-time   deliveries     by   complying    with   all    applicable requirements and through continual improvement of QMS”

Date-xx.xx.xxxx                                                                                             Sd-Director Operation

5.2.2 Communicating the quality policy

The quality policy is:

1. available and maintained as documented information ;
2. communicated by displaying at appropriate locations & understood by discussing policy commitments in meeting, via training and applied within the organization. Policy is communicated through display boards in English, Hindi.
3. Training is given to the employee time to time for the same to enhance understanding & effective implementation
4. available relevant interested parties by publishing on Web site.

5.3 Organizational roles, responsibilities and authorities

Responsibility & Authority are assigned, communicated & understood within the organization. Chief Manager System has the responsibility & authority for the followings

• To conduct internal audits as per plant & ensure that the quality management system conforms to the requirements of this International Standard;
• Review the Key performance indicators monthly to ensure that the processes are delivering their intended outputs;
• Reporting on the performance of the quality management system and on opportunities for improvement in particular to Director as and when required & during Management review
• Communicate the CSR within the organization to ensure the promotion of customer focus throughout the organization;
• Review the Document change note for any change in the documents & engineering change note for any change in the product /process w.r.t the QMS requirements to ensure the integrity of the quality management system is maintained.

5.3.1 Organizational roles, responsibilities, and authorities -supplemental

Top management assigned personnel with the responsibility and authority to ensure that customer requirements are met. These assignments are documented. This includes but is not limited to the
a) selection of special characteristics,
b) setting quality objectives and related training,
c) corrective and preventive actions,
d) product design and development,
e) capacity analysis,
f) logistics information,
g) customer scorecards, and customer portals

HOD Engineering is responsible to ensure the fulfillment of customer requirements. Responsibility & authority has been defined, communicated & understood to HOD Engineering

5.3.2 Responsibility and authority for product requirements and corrective actions

Top management ensures that personnel responsible for conformity to product requirements have the authority to stop shipment and stop production to correct quality problems. Personnel with authority and responsibility for corrective action are promptly informed of products or processes that do not conform to requirements to ensure that nonconforming product is not shipped to the customer and that all potential nonconforming product is identified and contained. Production operations across all shifts are staffed with personnel in charge of, or delegated responsibility for, ensuring conformity to product requirements.

• HOD Quality has the authority to stop shipment and stop production to correct quality problems.
• If any non-conformity occurred in the products or process then line in-charge/ Engineer QA/ inspector informs to Plant Head.
• Plant Head with the help of Director takes the decision on the Nonconforming products & identified NC products are contained and prevent to ship to the customer
• Night shift supervisor/Line in charge is responsible to ensue conformity to product requirements

6 Planning

6.1 Actions to address risks and opportunities

6.1.1 When planning for the quality management system, xxx consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to:
a) give assurance that the quality management system can achieve its intended result(s);
b) enhance desirable effects;
c) prevent, or reduce, undesired effects;
d) achieve improvements.

Risk & Opportunities have been determined for the following processes

(Marketing, Purchase, Production, Quality, Maintenance, Tool Room, Store, Dispatch, Top Management, Engineering, Quality management system, Human resource, Information technology)

6.1.2 XXX plan:

1. actions to address these risks and opportunities;
2. how to:
   • integrate and implement the actions into its quality management system processes
   • evaluate the effectiveness of these actions.

Actions taken to address risks and opportunities are proportionate to the potential impact on the conformity of products and services. Action has been initiated to Mitigate the risk & planning has been done in case of contingency. All actions have been integrated and implemented in the related documented processes and actions are evaluated monthly for the effectiveness

Ref-Risk assessment sheet

6.1.2.1 Risk analysis

XXX include in its risk analysis, at a minimum, lessons learned from product recalls, product audits, field returns and repairs, complaints, scrap, and rework. PFMEA is done for all manufacturing processes considering lesson learned from product recalls, product audits, filed returns & repairs, complaints, scrap & rework. XXX retain documented information as evidence of the results of risk analysis.

Ref- AIAG Manual PFMEA

6.1.2.2 Preventive action

XXX determines and implement action(s) to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions are appropriate to the severity of the potential issues. XXX has established a process to lessen the impact of negative effects of risk including the following:

• Potential non-conformities are identified during Risk analysis/PFMEA
• Recommended actions are decided based on severity of the risk / potential issues
• Root cause analysis is done for the potential Risk/issues/Nonconformity
• Determine & implement the action needed to prevent nonconformity
• evaluating the need for action lo prevent occurrence of nonconformities:
• determining and implementing action needed;
• documented information of action taken;
• reviewing the effectiveness of the preventive action taken;
• utilizing lessons learned to prevent recurrence in similar processes
• Review the effectiveness of the action taken
• Horizontal deployment in the similar processes

Ref- Documented process of Corrective &Preventive action

6.1.2.3 Contingency plans

Contingency plans made for continuity of supply in the event of any of the following:

• key equipment failures interruption from externally provided products,processes, and services;
• recurring natural disasters;
• fire;
• utility interruptions;
• cyber-attacks on information technology systems;
• labour shortages;
• infrastructure disruptions;

Periodic test is done for all contingencies as per frequency given in contingency plan. Contingency plan is reviewed once in a year& update if required. Manager systems is authorized to change the contingency plan. Product Validation is done after emergency shutdown. For computers data backup and for emails auto back up done on NAS drive. Seqrite antivirus end point security admin console software available at XXXX to outcome Cyber attacks.

Ref- Contingency Plan(Annexure -09)

6.2 Quality objectives and planning to achieve them

6.2.1 Xxx has established quality objectives at relevant functions, levels and processes needed for the quality management system. The quality objectives shall:

1. be consistent with the quality policy;
2. be measurable;
3. take into account applicable requirements;
4. be relevant to conformity of products and services and to enhancement of customer satisfaction;
5. be monitored;
6. be communicated;
7. be updated as appropriate.

Quality objectives are established for the following processes

• Marketing & Sales
• Purchase
• Production
• Quality
• Machine Maintenance
• Tool Management, Storage
• Packing & Dispatch
• Top Management
• New product development
• Internal audit & control of documented information
• Human resource development
• Information technology)

XXX maintains documented information on the quality objectives.

Ref- Management policy deployment & objectives- F-02

6.2.2 Planning is done for all objectives. When planning how to achieve its quality objectives, the organization shall determine:

1. what will be done;
2. what resources will be required;
3. who will be responsible;
4. when it will be completed;
5. how the results will be evaluated

Ref- Management policy deployment & objectives- F-02

6.2.2.1 Quality objectives and planning to achieve them — supplemental

Top management ensures that quality objectives to meet customer requirements are defined, established, and maintained for relevant functions, processes, and levels throughout the organization. The results of the organization’s review regarding interested parties and their relevant requirements is considered when establishing its annual (at a minimum) quality objectives and related performance targets (internal and external).

Ref- Management policy deployment & objectives- F-02

6.3       Planning of changes

When XXX determines the need for changes to the quality management system, the changes are carried out in a planned manner. XXX consider:

1. the purpose of the changes and their potential consequences;
2. the integrity of the quality management system;
3. the availability of resources;
4. the allocation or reallocation of responsibilities and authorities.

For changes following documented processes are referred

For engineering/process change – Documented process to control of drawing & ECN  

Form change in documents- Documented process for control of documents

7.0 Support

7.1 Resources

7.1.1 General

Top Management provides sufficient resources for the effect implementation of QMS. Resource requirements have been defined as equipment, manpower, and training needs. Resource requirements are formally addressed during Management Review Meetings but may be identified and provided for during normal day-to-day operations. Any associate may request additional resources while the Department Managers/Supervisors, and other members of Top Management have the defined responsibility and authority to determine if the need for the resource(s) is valid, required and feasible. When determining these resources, consideration will be given to:

• Current business opportunities and constraints;
• Mechanisms that will encourage innovative continual improvement;
• Methods to enhance existing competency; and
• Future resource requirements.

Requested resources may be needed

1. to implement and maintain the quality management system and continually improve its effectiveness
2. to enhance customer satisfaction by meeting customer requirements

• Ref- List of machines
• Ref- List of Monitoring & Measuring Equipment
• Ref- List of Supplier (BOP, Outsourced processes& services (Calibration, Trainings, Transportations)
• Ref- Skill Matrix & Competency Matrix
• Capacity analysis is done as per the customer requirements and if required procurement is done for the required resources or arranged from external providers/suppliers

7.1.2 People

XXX determines and provide the persons necessary for the effective implementation of quality management system for the operation and control of it’s processes. Sufficient personnel are available for the effective implementation of QMS & for the operation & control of the processes

Ref- Skill Matrix & Competency Matrix with Education, skill& experience

7.1.3 Infrastructure

DAG determines, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services. Infrastructure includes:
a) buildings and associated utilities;
b) equipment, including hardware and software;
c) transportation resources;
d) information and communication technology

Necessary infrastructure is determined, provided & maintained for the operation of its processes and to achieve conformity of products and services

• Building 5000 sq. Yards
• List of machines
• List of Monitoring & Measuring equipment
• List of Supplier (transporters/ Internal transport facilities)
• Internal communication through mail & intercom
• Soft data backup is taken on Server/external hard disc as per plan
• Data Backup plan, License renewal plan, List of Service providers (Hardware & software)

7.1.3.1 Plant, facility, and equipment planning

XXX use a multidisciplinary approach including risk identification and risk mitigation methods for developing and improving plant, facility, and equipment plans. In designing plant layouts, the XXX :
a) optimize material flow, material handling, and value-added use of floor space including control of nonconforming product, and
b) facilitate synchronous material flow, as applicable.

Methods are developed and implemented to evaluate manufacturing feasibility for new product or new operations. Manufacturing feasibility assessments include capacity planning. These methods are also applicable for evaluating proposed changes to existing operations. XXX maintain process effectiveness, including periodic re-evaluation relative to risk, to incorporate any changes made during process approval, control plan maintenance and verification of job set-ups. Assessments of manufacturing feasibility and evaluation of capacity planning are inputs to management reviews. Plant layout is design as per process flow of the product to optimize the material flow. Racks & Bins are provided for material handling & value added use of floor space. Manufacturing feasibility is reviewed for new product as well as change in the existing product. Assessment of manufacturing feasibility &evaluation capacity planning is reviewed in Management review (Once in six months). Cyber protection also provided to equipment and systems supporting manufacturing.

• Ref- Plant layout
• Ref- Process for APQP

7.1.4 Environment for the operation of processes

XXX determines, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services. Suitable environment can be a combination of human and physical factors, such as:

1. social (e.g. non-discriminatory, calm, non-confrontational);
2. psychological (e.g. stress-reducing, burnout prevention, emotionally protective);
3. physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise).

XXX has ensured that :

• Sufficient exhaust systems are provided for air flow at work place
• PPE’s are provided wherever is noise level is grater than permissible limit
• Sufficient fans, collars are provided at the work place to reduce the effect of increase in the temperature in summer season
• Insulation is done under shed, to resist the heat at work place
• Equal distribution of the work is ensured to prevent the stress building
• Timely breaks are given to prevent burnout prevention such as lunch break, tea break

7.1.4.1 Environment for the operation of processes — supplemental

XXX maintain its premises in a state of order, cleanliness, and repair that is consistent with the product and manufacturing process needs. Floor are maintained & repaired at regular intervals for smooth material flow in the work place. Daily cleaning is done to maintain dust free environment

7.1.5 Monitoring and measuring resources

7.1.5.1 General

XXX determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. XXX ensures that the resources provided:

• Necessary monitoring & measurement resources are provided as per control plan, to ensure valid & reliable results.
• Calibration/Verification is done at regular intervals to ensure their continuing fitness for their purpose
• Equipment/Gauge history card is maintained

XXX retains appropriate documented information as evidence of fitness for purpose of the monitoring and measuring resources

Ref- List of Monitoring & Measuring equipment

7.1.5.1.1 Measurement systems analysis

Statistical studies are conducted to analyse the variation present in the results of each type of inspection, measurement, and test equipment system identified in the control plan. The analytical methods and acceptance criteria used shall conform to those in reference manuals on measurement systems analysis. Other analytical methods and acceptance criteria may be used if approved by the customer. Records of customer acceptance of alternative methods are retained along with results from alternative measurement systems analysis

Prioritization of MSA studies focus on critical or special product or process characteristics.

• MSA is planned for all type of inspection, measurement, and test equipment system as identified in the control plan
• MSA plan is made for variable & attribute data

R&R study is conducted for variable data & kappa is for attribute data

• MSA is conducted as per AIAG reference manual
• MSA is planned once in a year & prioritization is done considering the special product or process characteristics

Ref- Documented process Management system analysis

7.1.5.2 Measurement traceability

When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment are:
a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification is retained as documented information;
b) identified in order to determine their status;
c) safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results.
XXX determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary. XXX ensures that:

• Calibration/Verification of the Monitoring & Measuring resources are done as per plan
• All calibration is traceable to NPL (National physical laboratory)
• MME are identified after calibration with sticker
• All MME are safeguarded from adjustments, damage or deterioration
• Previous measuring results are validate if equipment found unfit after calibration

Ref- Documented process for control of monitoring & measuring resources

7.1.5.2.1 Calibration/verification records

XXX have a documented process for managing calibration/verification records.
Record of the calibration/verification activity for all gauges and measuring and test equipment (including employee-owned equipment relevant for measuring, customer-owned equipment, or on-site supplier-owned equipment) needed to provide evidence of conformity to internal requirements, legislative and regulatory requirements, and customer-defined requirements are retained. XXX ensure that calibration/verification activities and records include the following details:
a) revisions following engineering changes that impact measurement systems;
b) any out-of-specification readings as received for calibration/verification;
c) an assessment of the risk of the intended use of the product caused by the out of-specification condition;

d) when a piece of inspection measurement and test equipment is found to be out of calibration or defective during its planned verification or calibration or during its use, documented information on the validity of previous measurement results obtained with this piece of inspection measurement and test equipment are retained, including the associated standard’s last calibration date and the next due date on the calibration report;
e) notification to the customer if suspect product or material has been shipped;
f) statements of conformity to specification after calibration/verification;
g) verification that the software version used for product and process control is as specified;
h) records of the calibration and maintenance activities for all gauging (including employee-owned equipment, customer-owned equipment, or on-site supplier-owned equipment);
i) production-related software verification used for product and process control (including software installed on employee-owned equipment, customer-owned equipment, or on-site supplier-owned equipment).

Ref- Documented process for control of monitoring & measuring resources

7.1.5.3 Laboratory requirements

7.1.5.3.1 Internal laboratory

At present XXX’s do not have internal laboratory for Inspection, testing and calibration

7.1.5.3.2 External laboratory

External/commercial/independent laboratory facilities used for inspection, test, or calibration services by XXX have a defined laboratory scope that includes the capability to perform the required inspection, test, or calibration, and either -the laboratory is accredited to ISO / IEC 17025or national equivalent and include the relevant inspection, test, calibration service in the scope of the accreditation (certificate); the certificate of calibration or test report shall include the mark of a national accreditation body; or -XXX uses external laboratory which is acceptable to the customer. XXX uses Material testing & calibration services from form outside NABL certified Lab / equipment manufacturer when a qualified laboratory is not available.

External lab are selected on the basis of NABL accreditation — where an accredited laboratory is not available (e.g., for specialist or integrated equipment, or for parameters with no international traceable standard reference), XXXX ensure that there is evidence that the laboratory has been evaluated and meets the requirements of ISO / IEC 17025

Ref- Master List of approved supplier (NABL accredited lab)

7.1.6 Organizational knowledge

XXX determines the knowledge necessary for the operation of its processes and to achieve conformity of products and services. This knowledge is maintained and be made available to the extent necessary. When addressing changing needs and trends, XXX consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates. Organizational knowledge is knowledge specific to the organization; it is generally gained by experience. It is information that is used and shared to achieve the organization’s objectives. Organizational knowledge can be based on:
a) internal sources (e.g. intellectual property; knowledge gained from experience; lessons learned from failures and successful projects; capturing and sharing undocumented knowledge and experience; the results of improvements in processes, products and services);
b) external sources (e.g. standards; academia; conferences; gathering knowledge from customers or external providers)

Ref- Knowledge matrix

7.2 Competence

Personnel performing work affecting conformity to product requirements will display competence to perform tasks based on appropriate education, training, skills and experience. Competence has been defined as the demonstrated ability to apply knowledge and skills, while skills have been identified as proficiency and dexterity in performing tasks.Competency Norms is made for all designation as per organization chart with required qualification, training, skill & experience Skill matrix/Competency matrix is made with actual qualification, skill & experience.

• Training is provided where ever is required to acquire the necessary competency
• Training record is maintained for the same

7.2.1 Competence — supplemental

The Department Managers/Supervisors, with assistance from Top Management, will

1. define the necessary competence for personnel performing work affecting conformity to product requirements via Job Descriptions. The Job Descriptions will include recommended minimum qualifications (such as education, experience and skills) to enter a position. Additional training will assist in providing the necessary knowledge and skills needed for an employee to be considered competent in their respective job task.
2. identify and provide training to support initial qualifications, promote and achieve employee competencies and promote employee development
3. evaluate the effectiveness of the training provided
4. ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives. This may be accomplished through any of the following methods:
   • Training (including Orientation and/or other training programs)
   • A variety of Quality and/or Safety Meetings
   • Internal Audit Activities
5. maintain appropriate records of education, training, skills and experience

Ref- Documented process for Training

7.2.2 Competence — on-the-job training

XXX provides on-the-iob training (which shall include customer requirements training) for personnel in any new or modified responsibilities affecting conformity to quality requirements, internal requirements, regulatory or legislative requirements; this includes contract or agency personnel. The level of detail required for on job training subject to the level of education, the personnel possess and the complexity of tasks they are required to perform for their daily work. Persons whose work can affect quality is informed about the consequences of nonconformity to customer requirements. On job training is provided to the concerned personnel (Operators, Inspectors & supervisors, Contractual workers etc.) involved in new or modified responsibilities affecting conformity to quality requirements, internal requirements, regulatory or legislative requirements; SOP, Instrument reading, Machine setting, Limit samples, Safety, Attribute inspection (Gauges/Visuals), Instruments readings etc. are covered during on job training.Operators, Inspectors & supervisors, Contractual workers etc are well aware about the consequences of nonconformity to customer requirements

7.2.3 Internal auditor competency

XXX documented process(es) to verify that internal auditors are competent, taking into account any customer-specific requirements. XXX maintain a list of qualified internal auditors. Quality management system auditors, manufacturing process auditors, and product auditors are competent to demonstrate the following minimum competencies:

1. understanding of the automotive process approach for auditing, including risk-based thinking;
2. understanding of applicable customer-specific requirements;
3. understanding of applicable ISO 9001 and IATF 16949 requirements related to the scope of the audit;
4. understanding of applicable core tool requirements related to the scope of the audit;
5. understanding how to plan, conduct, report, and close out audit findings. Additionally, manufacturing process auditors shall demonstrate technical understanding of the relevant manufacturing process(es) to be audited, including process risk analysis (such as FMEA) and control plan.
6. Product auditors shall demonstrate competence in understanding product requirements and use of relevant measuring and test equipment to verify product conformity where training is provided to achieve competency, documented information is retained to demonstrate the trainer’s competency with the above requirements.
7. Maintenance of and improvement in internal auditor competence is demonstrated through:
   1. executing a minimum number of audits per year, as defined by the organization; and
   2. maintaining knowledge of relevant requirements based on internal changes (e.g., process technology, product technology) and external changes (e.g., lso 9001, IATF 16949, core tools, and customer specific requirements).

Ref- Documented process Internal audit

7.2.4 Second-party auditor competency

Second party auditor(s) are competent. Second party auditor is also gone through the same training process as an Internal auditor. Second party auditor(s) are trained through competent person minimum two days internal auditor training program. Trainer competency record is maintained. Second party auditor(s) are able to demonstrate the minimum following core competencies, including understanding of

1. The automotive process approach to auditing, including risk based thinking;
2. Applicable customer and organization specific requirements;
3. Applicable ISO 9001 and IATF 16949 requirements related to the scope of the audit;
4. Applicable manufacturing process (es) to be audited, including PFMEA and control plan;
5. Applicable core tool requirements related to the scope of the audit;
6. How to plan, conduct, prepare audit reports, and close out audit findings.

Manufacturing process auditors have technical understanding of the relevant manufacturing process(es) to be audited, including process risk analysis (such as PFMEA) and control plan. Product auditors have competence in understanding product requirements and use of relevant measuring and test equipment to verify product conformity. Trainings are provided to Internal auditors to achieve required competence.

Reference Documented process-Supplier QMS development

7.3 Awareness

Persons doing work under the organization’s control are aware of:

1. The quality policy;
2. Relevant quality objectives
3. Their contribution to the effectiveness of the quality management system, including the benefits of improved performance;
4. The implications of not conforming to the quality management system requirements.

7.3.1 Awareness — supplemental

XXX maintain documented information that demonstrates that all employees are aware of their impact on product quality and the importance of their activities in achieving, maintaining, and improving quality, including customer requirements and the risks involved for the customer with nonconforming product. Training Plans, records & effectiveness evaluation records are maintained to demonstrates that all employees are aware of their impact on product quality and the importance of their activities in achieving, maintaining, and improving quality, including customer requirements and the risks involved for the customer with non-conforming product.

7.3.2 Employee motivation and empowerment

XXX maintain a documented process to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment that promotes innovation. The process includes the promotion of quality and technological awareness throughout the whole organization.

Ref-Documented process for employee’s motivation

7.4 Communication

XXX determine the internal and external communications relevant to the quality management system, including:
a. on what it will communicate;
b. when to communicate;
c. with whom to communicate;
d. how to communicate

Ref- Communication Matrix

7.4  Documented information

7.5.1 General

XXX’s quality management system include:

1. documented information required by this International Standard;
2. documented information determined by the XXX as being necessary for the effectiveness

Ref-List of Internal documents

7.1.5.1 Quality management system documentation

Quality Management system is documented & includes the Quality Manual , Issue No.00, and dated xx.xx.xxxx. Compliance with requirements of this International standard are addressed in this quality manual. Quality manual includes the followings

1. Scope of the QMS with justification for exclusion – Ref 4.3 & 4.3.2
2. List of documented processes- Ref- Annexure No.07
3. Process sequence & interaction- Ref- Annexure No.04
4. Type and extent of control of any outsourced processesRef- 8.1
5. Customer specific requirement ( i.e Table or a matrix) –Ref- CSR Matrix-Annexure-08

7.5.2 Creating and updating

When creating and updating documented information, ,XXX ensure appropriate:

1. identification and description (e.g. a title, date, author, or reference number);
2. format (e.g. language, software version, graphics) and
3. media (e.g. paper, electronic);

Ref-Documented process control of documents& records

7.5.3 Control of documented information

7.5.3.1 Documented information required by the quality management system and by this International Standard is controlled to ensure:

1. it is available and suitable for use, where and when it is needed;
2. it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).

7.5.3.2 For the control of documented information, XXX address the following activities, as applicable:

1. distribution, access, retrieval and use;
2. storage and preservation, including preservation of legibility;
3. control of changes (e.g. version control);
4. retention and disposition.
5. Documented information of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified as appropriate, and be controlled. Documented information retained as evidence of conformity is protected from unintended alterations.

Ref-Documented process control of documents& records

7.5.3.2.1 Record retention

XXX define, document, and implement a record retention policy. The control of records satisfy statutory, regulatory, organizational, and customer requirements. Production part approvals, tooling records (including maintenance and ownership), product and process design records, purchase orders (if applicable), or contracts and amendments are retained for the length of time that the product is active for production and service requirements, plus one calendar year, unless otherwise specified by the customer or regulatory agency. XXX ensures:

1. All records are retained as per the retention period defined in List of Internal documents
2. Retention periods after considering the statutory, regulatory, Organization & customer requirements
3. PPAP, Tooling, APQP, Contracts/Purchase orders/Amendments are retained for the length of time that the product is active for production and service requirements, plus one calendar year

Ref-List of Internal documents

7.5.3.2.2 Engineering specifications

XXX have a documented process describing the review, distribution, and implementation of all customer engineering standards/specifications and related revisions based on customer schedules, as required. XXX retain a record of the date on which each change is implemented in production implementation includes updated documents. Review should be completed within 10 working days of receipt of notification of engineering standards/specifications changes. A change in these standards/specifications may require an updated record of customer production part approval when these specifications are referenced on the design record or if they affect documents of the production part approval process, such as control plan, risk analysis (such as FMEAs), etc.

Ref-Documented process for control of drawing & ECN

8.0 Operation

8.1 Operational planning and control

XXX ensures

1. Requirements of the products are determined during Drawing study, Feasibility review & Advance product quality planning
2. Control plans /SOPs are made for the Product & Processes and criteria for the acceptance is established for the same
3. Resources such as Machines, Monitoring & measuring equipment, Tools/jig/fixtures are determined during Drawing study, Feasibility review & Advance product quality planning to achieve conformity to the product and service requirements
4. Incoming, In-process & Final inspection are carried out to demonstrate the conformity of products and services to their requirements
5. Planned changes are controlled and consequences of unintended changes are reviewed
6. Actions are taken to mitigate any adverse effects, as necessary
7. Outsourced processes are controlled as follows

S.No.	Out sourced process	Control
1	Plating, Rough Machining, Heat Treatment& Sheet Metal job work	Supplier system audit, Incoming inspection, Process audit, Product audit
3	Calibration& Testing	NABL accredited lab
4	AMC for CNC, VMC, DG Set , Plasma Cutting Machine & Compressors	Review the service report, Plan compliance & monitor the MTBF

8.1.1 Operational planning and control — supplemental

When planning for product realization, the following topics have been included:

1. Customer’s supplied drawings/specifications
2. Packing specifications/requirements
3. Manufacturing feasibility review
4. APQP
5. Acceptance criteria for the product
6. customer product requirements and technical specifications;
7. logistics requirements;
8. manufacturing feasibility:
9. project planning
10. The resources identified refer to the required verification, validation,monitoring, measurement, inspection, and test activities specific to the product and the criteria for product acceptance.

8.1.2 Confidentiality

XXX ensure the confidentiality of customer-contracted products and projects under development, including related product information. Confidentiality of customer-contracted products and projects under development, including related product information are maintained by the organization as follows

1. Controlling the distribution of the drawings/specification
2. Distribution of all drawings/specification (if required) is done after removing the customer name from drawings
3. Issue record is maintained by the Manager system
4. No drawings/specification is issued without written approval of the Director

8.2 Requirements for products and services

8.2.1 Customer communication

Communication with the customer are done for product, processes, enquiries, contracts/amendments, feed back, customer property & contingency actions as per communication matrix as mentioned in competency matrix.

Communication with customers include:

1. providing information relating to products and services;
2. handling enquiries, contracts or orders, including changes;
3. obtaining customer feedback relating to products and services, including customer complaints;
4. handling or controlling customer property;
5. establishing specific requirements for contingency actions, when relevant

8.2.1.1  Customer communication — supplemental

Written or verbal communication is in the language agreed with the customer. XXX have the ability to communicate necessary information, including data in a customer-specified Computer language and format (e.g.,computer-aided design data, electronic data interchange)’Written or verbal communication is done with the customer in English/local language. Necessary information is communicated through PDF, Microsoft office, CAD, Solidworks etc.

8.2.2 Determining the requirements for products and services

After receiving the enquiry for product, the followings requirements are determined during drawing study/feasibility review

1. List of Applicable statutory and regulatory requirements related to product.
2. List of applicable National/International/Customer’s specified standards.
3. List of special/safety characteristics.
4. List of manufacturing processes.
5. List of necessary resources (Machine, Tool/Jig/fixtures, Monitoring & measuring equipment).
6. List of Raw material/B.O.P/Outsourced processes

Ref- Team feasibility commitment

8.2.2.1 Determining the requirements for products and services — supplemental

These requirements include recycling, environmental impact, and characteristics identified as a result of the organization’s knowledge of the product and manufacturing processes includes but not be limited to the following:

1. all applicable government,
2. safety, and environmental regulations related to acquisition,
3. storage, handling, recycling, elimination, or disposal of material.
4. Environment impact of the manufacturing processes
5. Compliance to all applicable government, safety & environment regulations related to acquisition, storage, handling, recycling, elimination, or disposal of material

Ref- Legal Register

8.2.3 Review of the requirements for products and services

8,2,3,1 Contract review is carried out before committing to supply product to a customer for the followings

• Applicable statutory and regulatory requirements related to product
• Any applicable country specific requirements
• Packing specifications & logistic requirements
• Cost, Delivery & Volume
• Includes the amendment if any

Contract review record is maintained for the same

Ref- Contract review checklist

8.2.3.1.1 Review of the requirements for products and services — supplemental

If customer gives the waiver for formal contract review then documented information is maintained for the same

8.2.3.1.2 Customer-designated special characteristics

Customer requirements are conformed for designation, approval documentation, and control of special characteristics through mail of feasibility conformation

8.2.3.1.3 Organization manufacturing feasibility

XXX utilizes a multidisciplinary approach to conduct an analysis to determine if it is feasible that the organization’s manufacturing processes are capable of consistently producing product that meets all of the engineering and capacity requirements specified by the customer. XXX conducts this feasibility analysis for any manufacturing or product technology new to the organization and for any changed manufacturing process or product design. Additionally, XXX validate through production runs, benchmarking studies, or other appropriate methods, their ability to make product to specifications at the required rate. Cross-functional team does the manufacturing feasibility for new/ modified product/ manufacturing process for the followings

1. Whether machines/processes are capable to meet the desired specification
2. Whether special characteristics can meet the desired process capability index (Cpk>=1.33)
3. Whether sufficient resources (Tools, Instruments, Machines) are available to produce the product with in desired specification
4. Whether any outsourced process is required for the product

Validation is done through production trial run to make product to specifications at the required rate

8.2.3.2 The organization shall retain documented information, as applicable: Contact review record & any new requirements for the products and services is retained

8.2.4 Changes to requirements for products and services

XXX ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and services are changed. When the requirements for products and services are changed, revised work order/schedule is issued to the Production, QA, Purchase, Packing & dispatch,

Ref- Documented process of customer enquiry & order processing

8.3 Design and development of products and services

8.3.1 General

Manufacturing Process design & development has been established to ensure the subsequent provision of products & processes

8.3.1.1:Design and development of products and services — supplemental

Manufacturing process design and development is focused on error prevention rather than detection.XXX document the design and development process.

8.3.2 Design and development planning

APQP time line chart is made for the manufacturing process design & development planning, considering the followings

1. Design & development phase- Four phases
   • Planning & defining: The initial step of the product quality planning process is to ensure that customer needs and expectations are clearly understood
   • Process design & development: This step is designed to ensure the comprehensive development of an effective manufacturing system. The manufacturing system must assure that customer requirements, needs and expectations are met
   • Process Validation: Validating the manufacturing process through an evaluation of a significant production run. During a significant production run, the Development team validate that the control plan and process flow chart are being followed and the products meet customer requirements. Additional concerns are identified for investigation and resolution prior to regular production runs.
   • Feedback, Assessment & Corrective action: Quality planning does not end with process validation and installation. It is the component manufacturing stage where output is evaluated when all special and common causes of variation are present. This is also the time to evaluate the effectiveness of the product quality Planning effort. The production control plan is the basis for evaluating product or service at this stage. Variable and attribute data are evaluated. Appropriate actions are taken.
2. Responsibilities and authorities involved in the design and development process are Defined in project organization chart/APQP time line chart
3. Required resources are determined & planned for product/process
4. Review meeting is carried out at planned intervals and if required customers and supplier are called for the meeting

8.3.2.1 Design and development planning — supplemental

Cross-functional team is responsible for design & development planning & includes the following members

Internal; Marketing, Purchase, Process design & development, Production, Q.A, Tool room

External (if required): Customer, Supplier

Cross-functional team involves in the following activates

• Advance product quality planning
• Manufacturing process design activities
• Development & review of Process flow diagram
• Development & review of Failure mode & effect analysis
• Development & review of Control plan & SOP
• Correction & corrective action against customer feed back

Ref-Documented process for Advance product quality planning

8.3.2.2 Product design skills

XXX ensure that personnel with product design responsibility are competent to achieve design requirements and are skilled in applicable product design tools and techniques. Applicable tools and techniques are identified by XXX.

Manufacturing Process design skills

• Solid Works, Auto CAD and 3D Printing

Ref- List of Competent personnel to operate the above Software

8.3.2.3 Development of products with embedded software

At present no product is developed with embedded software

8.3.3 Design and development inputs

Essential requirements are determined for the product to be develop considering the follows

1. Functional and performance requirements as mentioned in the drawings
2. Information derived from previous similar design and development activities;
3. Statutory and regulatory requirements;
4. Standards or codes of practice that the organization has committed to implement;
5. Potential consequences of failure due to the nature of the products.

If there is any conflict/clarity required regarding inputs, then Project Head, resolved it after discussion with the customer. Inputs records are maintained & retained in APQP file

8.3.3.1 Product design input

XXX manufacture products as per customer requirements so requirements of this clause are not applicable.

8.3.3.2 Manufacturing process design input

Manufacturing process design input requirements includes the following

1. Engineering drawing / specification provided by customer
2. Special characteristics determined by the customer
3. Target productivity, Time, process capability & cost
4. Any alternate manufacturing method-if any
5. Customer specific requirements- if nay
6. Experience from previous development
7. New material
8. Material handling & ergonomics requirements in production
9. Design for manufacturing and design for assembly
10. Use of error proofing methods wherever feasible

8.3.3.3 Special characteristics

Multidisciplinary Approach used to identifying the special characteristics including those

• Determined by the customer (Ref-Product Drawing) and Risk Analysis ( PFMEA) performed by CFT
• Special characteristics includes in the followings documents PFMEA, Control plan, SOP/W.I
• Define the control & monitoring strategies for special characteristics in the PFMEA, Control plan, SOP/W.I
• Take the approval from the customer for defined controls if required
• Use the customer specified definitions &symbol
• At present there is no equivalent symbol is used by Tech Auto, if used in future then symbol conversion table will be made &submit to the customer-if required

8.3.4 Design and development controls

Followings controls are applied to control the design & development process

1. the results to be achieved are defined
2. Timely review the status of all stages as defined in APQP time line chart
3. Incoming, in process & Layout inspection of the product
4. verification activities are conducted to ensure that the design and development outputs meet the input requirements;
5. Validation of the manufacturing processes & product- where ever is feasible
6. Take correction & corrective action against the observed nonconformities
7. Documented information of these activities is retained

8.3.4.1 Monitoring

Measurements at specified stages during the design and development of products and processes shall e defined, analyzed, and reported with summary results as an input to management review. When required by the customer, measurements of the product and process development activity is reported to the customer at stages specified, or agreed to, by the customer. When appropriate, these measurements may include quality risks, costs, lead times, critical paths, and other measurements. Measurement stages are defined, analyzed & reported with APQP time line chart and related annexures as an input of the Management review. When required by the customer, status of APQP time line chart is shared with the customer

Ref-APQP time line chart

8.3.4.2 Design and development validation

Validation of the manufacturing process is done in house for new product. Product is developed as per customer drawing and samples are submitted to the customer. The customer does validation for the same and results are communicated to us through mail / inspection report

8.3.4.3 Prototype programme

At present there is no requirement of prototype programme & control plan by the customer.

8.3.4.4 Product approval process

• PPAP documents as per AIAG ref PPAP Manual is submitted to the customer. Default submission level is III unless otherwise specified by the customer.
• Externally provided products & processes are approved as per the requirements addressed in Section 8.4.3
• PFD, PFMEA,Control plan &PSWare taken from the supplier for PPAP approval
• The organization shall obtain documented product approval is obtained by the customer prior to shipment, if required
• Records of such approval is retained

Ref-Documented process for Production part approval process

8.3.5 Design and development outputs

C.F.T ensure that the design and development outputs:

1. Meet the input requirements;
2. Are adequate for the subsequent processes for the provision of products and services;
3. Include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria;
4. Specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision.

HOD NPD retains documented information on design and development outputs.

8.3.5.1 Design and development outputs — supplemental

XXX  manufacture products as per customer requirements so requirements of this clause are not applicable.

8.3.5.2 Manufacturing process design output

Manufacturing process design output includes the followings

1. Engineering specifications/Drawings
2. Special characteristics for product and manufacturing process
3. Tools/Dies for production
4. Monitoring & Measurement equipment
5. Process Flow Diagram
6. Floor plan layout
7. Capacity analysis
8. PFMEA
9. Control plan including error proofing methods,SOP/W.I
10. Results of Initial process capability & Measurement system analysis
11. Packing specification

8.3.6 Design and development changes

Engineering identify, review & control changes made during or subsequent to, the design and development of products. Documented information is retained for the followings

1. Engineering change note for design & development changes & results of review
2. HOD Engg. is authorized to change after consulting with the customer
3. Correction/corrective action report to prevent adverse impacts.

8.3.6.1 Design and development changes — supplemental

C.F.T evaluate all changes (for potential impact on fit, form, function, performance, and/or durability) after initial product approval, including those proposed by the organization and Suppliers. All changes are validated against customer requirements & approved by Director or by the customer (if required) prior to the implementation in production

Ref-Documented process for ECN

8.4 Control of externally provided processes, products and services

8.4.1 General

XXX ensure that externally provided processes, products and services conform to requirements. XXX determine the controls to be applied to externally provided processes, products and services when:
a) products and services from external providers are intended for incorporation into XXX’s own products and services;
b) products and services are provided directly to the customer(s) by external providers on behalf of XXX;
c) a process, or part of a process, is provided by an external provider as a result of a decision by XXX. XXX determine and apply criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide

S.No.	Externally provided Processes/product	Controls
		External providers	Products (Output)
1	BOP	System audit	Incoming Inspection, Product audit
2	Raw Material	System audit	Incoming inspection
3	Outsourced process (Plating, Machining, sheet metal job work &Heat-Treatment)	Process audit	Incoming Inspection
4	Heat Treatment of tools/ dies	Supplier assessment	Verification of Supplier Test certificates

Criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements has been determined. Documented information of these activities and any necessary actions arising from the evaluations is retained

Ref-List of outsource process & control

8.4.1.1. General — supplemental

XXX include all products and services that affect customer requirements such as sub assembly, sequencing, sorting, rework, and calibration services in the scope of their definition of externally provided products, processes, and services.

S.No.	Externally provided processes/product	Controls
1	Calibration services	NABL accreditation lab & traceability with N.P.L

8.4.1.2 Supplier selection process

XXX have a documented supplier selection process. The selection process shall include:

1. an assessment of the selected supplier’s risk to product conformity and uninterrupted supply of XXX’s product to their customers;
2. relevant quality and delivery performance:
3. an evalualion of the supplier’s quality management system;
4. multidisciplinary decision making; and
5. an assessment of software development capabilities, if applicable.

Other supplier selection criteria that should be considered include the following:

• volume of automotive business (absolute and as a percentage of total business);
• financial stability;
• purchased product, material, or service complexity;
• required technology (product or process);
• adequacy of available resources (e.g., people, infrastructure);
• design and development capabilities (including project management);
• manufacturing capability;
• change management process;
• business continuity planning (e.g., disaster preparedness, contingency planning); logistics process;
• customer service.

Ref-Documented process – Supplier selection

8.4.1.3 Customer-directed sources (also known as “Directed–Buy”)

Products, Material & processes are purchase from customer directed sources if specified by the customer &it mentioned in the list of approved supplier. Supplier selection process requirements are skipped for the customer directed sources

8.4.2 Type and extent of control

XXX ensure that externally provided processes, products and services do not adversely affect XXX’s ability to consistently deliver conforming products and services to its customers. XXX:

1. ensure that externally provided processes remain within the control of its quality management system;
2. define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output;
3. take into consideration:
   • the potential impact of the externally provided processes, products and services on XXX’s ability to consistently meet customer and applicable statutory and regulatory requirements;
   • the effectiveness of the controls applied by the external provider; d) determine the verification, or other activities, necessary

S.No.	Externally provided Processes/product	Controls
		External providers	Products (Output)
1	BOP	System audit	Incoming Inspection, Product audit
2	Raw Material	System audit	Incoming inspection
3	Outsourced process (Plating, Machining, sheet metal job work & Heat-Treatment)	Process audit	Incoming Inspection
4	Heat Treatment of tools/ dies	Supplier assessment	Verification of Supplier Test certificates

8.4.2.1 Type and extent of control — supplemental

XXX have a documented process to identify outsourced processes and to select the types and extent of controls used to verify conformity of externally provided products, processes, and services to internal (organizational) and external customer requirements. The process shall include the criteria and actions to escalate or reduce the types and extent of controls and development activities based on supplier performance and assessment of product, material, or service risks.

Ref-Documented process – Purchase and List of outsource process & control

8.4.2.2 Statutory and regulatory requirements

• Applicable Statutory & regulatory requirements are determined & recorded in the list of Parts
• Applicable Statutory & regulatory requirements are communicated to the supplier through Purchase order
• Compliance with the applicable Statutory & regulatory requirements/customer defines special controls for certain products are verified during system audit, product audit & incoming inspection

8.4.2.3 Supplier quality management system development

Supplier quality management system is developed through the following sequence. Unless otherwise authorized by the customer a QMS certified to ISO 9001 is the initial minimum acceptable level of development. Based on current performance and the potential risk to the customer, the objective is to move suppliers through the following QMS development progression:

1. Certification to ISO 9001:2015 through accredited certification body (accreditation mark of a recognized IAF MLA member and where the accreditation body’s main scope includes management system certification to ISO/IEC 17021)
2. Compliance to customer specific requirements (if applicable)
3. Compliance to IATF 16949 requirements through second party audit
4. Certification to IATF 16949 through third party audits (valid third-party certification of the supplier to IATF 16949 by an IATF-recognized certification body).
5. If supplier is not ISO 9001 certified then customer authorization is taken along with the development plan (Suppliers like Transporters and Logistic Support will be added in Development Plan)

8.4.2.3.1 Automotive product-related software or automotive products with embedded Software

XXX do not manufacturer automotive products related software or automotive product with embedded software.

8.4.2.4 Supplier monitoring

XXX have a documented process and criteria to evaluate supplier performance in order to ensure conformity of externally provided products, processes, and services to internal and external customer requirements. At a minimum, the following supplier performance indicators are monitored:

1. delivered product conformity to requirements;
2. customer disruptions at the receiving plant, including yard holds and stop ships;
3. delivery schedule performance;
4. number of occurrences of premium freight.

lf provided by the customer, XXX shall also include the following, as appropriate, in their supplier performance monitoring:

• special status customer notifications related to quality or delivery issues;
• dealer returns, warranty, field actions, and recalls.

Ref-Documented process – Supplier evaluation & monitoring

8.4.2.4.1 Second-party audits

Competent auditors do the Second part audit for Raw Material, BOP & Outsourced providers related to product at planned intervals for the followings

1. Supplier QMS development
2. Product audit
3. Process audit
4. Compliance with CSR (if any)

Audit frequency& scope are determined as follows

S.No.	Parameter	Frequency	Scope of audit
1	High risk/Safety product/Low performance / Not certified	12 Months	System, Product, Process & CSR (if any)
2	Medium performance / ISO 9001:2015 certified	15 Months	System, Product, Process & CSR (if any) and Third party audit report with Corrective action (annually)
3	Excellent performance & /ISO 9001:2015 certified	18 Months	System, Product, Process & CSR (if any) and Third party audit report with Corrective action (annually)
4	Excellent performance &IATF certified	24 Months	Product, Process & CSR (if any) and Third party audit report with Corrective action (annually)

8.4.2.5 Supplier development

• Supplier development priority is determined as follows

S.No.	Parameter	Priority
1	High risk/Safety product/Low performance / Not certified	First
2	Medium performance / ISO 9001:2015 certified	Second
3	Excellent performance &ISO 9001:2015 certified	Third
4	Excellent performance & IATF certified	Least / Not required

• Correction/Corrective actions are taken to resolve open (unsatisfactory) performance issues and pursue opportunities for continual improvement

Ref-Documented process – Supplier QMS development

8.4.3 Information for external providers

Following requirements are communicated to the external providers through Purchase orders

1. Drawing Number, Revision Number on Purchase order for B.O.P along with drawing
2. Material specification (Size & grade) for raw material
3. Product specification for outsourced processes
4. Validation of the special process (Plating)
5. Competency of the personnel involve in special process
6. Commercial terms & conditions
7. Statutory/regulatory requirements and special characteristics related to product/process- if any
8. Customer defines special controls for certain products – if any
9. Material test certificate along with material (Raw material)
10. PDI report for B.O.P & Outsourced processes
11. Verification or validation activities that the organization, or its customer, intends to perform at the external providers’ premises
12. Performance are communicated to the supplier through mail if requested by the supplier
13. Plant head &HOD purchase review the requirements for adequacy prior to communication with supplier

8.4.3.1 Information for external providers — supplemental

1. All applicable statutory and regulatory requirements and special product and process characteristics are communicated to the supplier through purchase orders
2. Above requirements are communicated to the down line at the point of Manufacture by the suppler
3. Effective communication& compliance of the above requirements are verified during second party audit

8.5 Production and service provision

8.5.1 Control of production and service provision

Production/ Manufacturing of the product is done under controlled condition, which includes the followings

• Control plan that defines the characteristics of the products & processes
• Availability of monitoring & measuring equipment for product & process as per control plan
• Incoming inspection, In-process inspection & Final inspection are carried out to verify the compliance with control plan
• Use of Machines, Tools/Dies/Jig/fixtures are per control plan
• Appointment of competent person as per skill matrix/competency norms
• Validation of the process is done as per plan
• Revalidation at least once in a year or any change in the process parameter/product parameter/Material
• Error proofing method where ever is necessary
• Packing is done as per the packing specification sheet
• PDI/Final inspection is carried out before dispatch

8.5.1.1 Control plan

Control plan has been developed for pre-launch & production for all Products including Raw material, BOP & Outsourced processes and shows linkage and incorporates information from PFD & PFMEA.

Prelaunch: A description of the dimensional measurements, material, and performance tests that occur after prototype and before full production. Pre- launch is defined as a production phase in the process of product realization that may be required after prototype build.

Production: Documentation of product/process characteristics, process controls, tests, and measurement systems that occur during mass production.

Control plan includes the followings

1. General data
   • Control plan number
   • issue date and revision date, if any
   • customer information (see customer requirements)
   • organization’s name/site designation
   • part number(s)
   • part name/description
   • engineering change level
   • phase covered (prototype, pre-launch, production)
   • key contact
   • part/process step number
   • process name/operation description
   • functional group/area responsible.
2. Product control
   • Product-related special characteristics;
   • other characteristics for control (number, product or process)
   • specification/tolerance;
3. Process control
   • Process parameters (including process settings and tolerances);
   • process-related special characteristics;
   • machines, jigs, fixtures, tools for manufacturing (including identifiers, as appropriate);
4. Methods
   • Evaluation measurement technique;
   • error-proofing
   • sample size and frequency
   • control method
5. Customer specific requirements-If any
6. Specified reaction plan; when nonconforming product is detected, the process becomes statistically unstable or not statistically capable
7. Control plan is reviewed & updated for any of the followings
   • If non conforming parts shipped to the customer
   • Any change occurs affecting product, manufacturing process, measurement, logistics, supply sources, production volume changes, or risk analysis (FMEA)
   • After a customer complaint and implementation of the associated corrective action, when applicable;
   • After one year
   • If required customer approval is taken after review or revision of the control plan

8.5.1.2 Standardized work — operator instructions and visual standards

XXX ensure that :

• Standardized operating procedures/Instructions are communicated to the employee & training has been given to all SOP to enhance their understanding
• SOP are printed in readable Font size & fax printing boards are displayed for general instructions
• Instructions are presented in Hindi/English/sketch form, which are understood by the responsible personnel
• SOP/Instructions are displayed at the work place
• Safety boards are displayed on the shop floor

8.5.1.3 Verification of job set-ups

Verification of job setup/First off is done for the followings:

• Initial run of the job
• Material change over
• Every morning at the time of start the machine
• Start the machine after un planned breakdown of the machine
• Start the production after planned / un planned plant shutdown
• First piece approval record is retained

8.5.1.4 Verification after shutdown

Verification of job setup/First off is done to ensure product compliance with requirements after planned / Unplanned plant shutdown

Reference- Documented process for validation of process

8.5.1.5 Total productive maintenance

Total predictive maintenance includes the followings

1. List of necessary machines is made to produce conforming product at the required volume
2. Minimum stock level of Critical spares are maintained for key machines
3. Hand grinders, Lathe Machines & Welding sets are available for maintenance
4. Tooling/gauges are preserved & stored in racks & almirah
5. Customer specific requirements –if any
6. Maintenance objectives- Machine maintenance hours, MTTR,MTBF& OEE
7. Performance of the Maintenance objectives are reviewed in management review
8. Monitoring of the P.M plan & objectives are done on monthly basis and corrective actions are initiated where objectives are not achieved
9. Preventive maintenance of every machine is carried out as per plan
10. Predictive maintenance is done by periodic or continuous monitoring of the equipment condition through hearing, touching, smelling and observing, in order to predict when maintenance is required
11. Periodic overhaul is done based on fault or interruption history, machine is proactively taken out of service and disassembled, repaired, parts replaced, reassembled, and then returned to service

Reference- Documented process for maintenance

8.5.1.6 Management of production tooling and manufacturing, test, inspection tooling and equipment

XXX provide resources for tool and gauge design, fabrication, and verification activities for production and service materials and for bulk materials, as applicable. XXX establish and implement a system for production tooling management, whether owned by XXX or the customer, including:
a) maintenance and repair facilities and personnel;
b) storage and recovery;
c) setup;
d) tool-change programmes for perishable tools;
e) tool design modification documentation, including engineering change level of the product;

f) tool modification and revision to documentation;
g) tool identification, such as serial or asset number; the status, such as production, repair or disposal; ownership; and location.
XXX verify that customer-owned tools, manufacturing equipment, and test inspection equipment are permanently marked in a visible location so that the ownership and application of each item can be determined. XXX implement a system to monitor these activities if any work is outsourced.

• Solid Works, Auto CAD and 3D Printing for Tool design & calculating the weight & detail work
• VMC,Lathe, shaper, Milling, Grinders, & Drill machines are provided for fabrication the tools
• Production tooling management includes the followings
  • Lathe, shaper, Milling, Grinders & Drill machines are used for maintenance & repair of tools
  • Responsibility of the tool design & maintenance are covered in responsibility & authority matrix-Annexure-02
  • Storage of the tools are stored in racks
  • First pcs are inspected for dies at the time of setup
  • Tool change programme for perishable tools (punches) as mentioned in control plan
  • Tool change modification is done if required against Engineering change/Process change & same is mentioned in the Engineering change/Process change note
  • Tool history card is updated after amendment in tools
  • Tool identification is done through serial number and list of dies is maintained for the same
• Customer-owned tools, manufacturing equipment, and test/inspection equipment are permanently marked (if provided)
• At present Heat Treatment of the tools are done outsourced and above mentioned activities are monitored through supplier visit&verifying the supplier’s test certificate.

Reference- Documented process for Tool Room

8.5.1.7 Production scheduling

XXX ensure that production is scheduled in order to meet customer orders/demands such as Just- ln-Time (JlT) and is supported by an information system that permits access to production information at key stages of the process and is order driven. XXX include relevant planning information during production scheduling, e.g., customer orders, supplier on time delivery performance, capacity, shared loading (multi-part station), lead time, inventory level, preventive maintenance, and calibration. XXX ensure

• Product schedule is done as per the customer’s order
• Work order is issued to the HOD production in line with the customer’s schedule
• HOD production plans the production as per availability of the machine, manpower & tools
• Daily production report is maintained, that permits access to production information at key stages of the process and is order driven
• Following information includes during production schedule
  • Customer’s required delivery date
  • Availability of the raw material & supplier delivery performance
  • Availability of machine & Capacity
  • Lead time/cycle time
  • Inventory level
  • Preventive maintenance plan & calibration plan

Reference- Documented process for Production

8.5.2 Identification and traceability

XXX. has identified all products by suitable means (i.e. tags, markings, labels, supplier/customer markings) throughout the product realization process. XXX identifies the product status with respect to monitoring and measurement requirements via labels, tags, inspection stamps, and/or associated quality records. Products whose identification and inspection status cannot be verified will be handled in accordance with the Control of Nonconforming Product .When traceability is a specified customer and/or industry requirement, XXX will control the unique identification of the product and maintain records (i.e. traceability via the Lot Numbers documented on the labels for each product).

8.5.2.1 Identification and traceability — supplemental

The purpose of traceability is to support identification of clear start and stop points for product received by the customer or in the field that may contain quality and/or safety-related nonconformities. Therefore, XXX shall implement identification and traceability processes as described below. XXX conduct an analysis of internal, customer, and regulatory traceability requirements for all automotive products, including developing and documenting traceability plans, based on the levels of risk or failure severity for employees, customers, and consumers. These plans shall define the appropriate traceability systems, processes, and methods by product, process, and manufacturing location that:

a) enable XXX to identify nonconforming and/or suspect product;
b) enable XXX to segregate nonconforming and/or suspect product;
c) ensure the ability to meet the customer and/or regulatory response time requirements;
d) ensure documented information is retained in the format (electronic, hardcopy, archive) that enables XXX to meet the response time requirements;
e) ensure serialized identification of individual products, if specified by the customer or regulatory standards;
f) ensure the identification and traceability requirements are extended to externally provided products with safety/regulatory characteristics.

Reference- Documented process for identification & traceability

8.5.3 Property belonging to customers or external providers

Specific requirements for communicating customer property issues will be established at the Quotation Phase and conveyed to the Quality and Manufacturing Departments, as applicable. While under XXX’s control, the customer property will be identified, verified, protected and safeguarded as if it were actually owned by XXX

Property belongs to customer or external providers are as follows

S.No.	Property belonging to	Property	Controls
1	Customer	Drawings& Samples	Identified though External document stampStored in filesList of drawing is made.Distributions      of      drawing                          are controlled, protected and safeguard
4	External Providers	Nil	NA

Customer owned packaging, dies, fixtures and/or equipment provided by the customer will be permanently marked so that the ownership of each item is visible and apparent. When the property is lost, damaged or otherwise found to be unsuitable for use, the organization reports this to concern personal through mail and retain this information

8.5.4 Preservation

XXX will preserve the product during internal processing and delivery to intended destination in order to maintain conformity to requirements. As applicable, preservation will include identification, handling, packaging, storage and protection. Preservation will also be applied to constituent parts of the product. Unless specified by contract, XXX’s policy is that the protection of the quality of the product ceases once the product is loaded onto the delivery vehicle and signed for by the transportation service . If required by customer, the responsibility for the quality of product may be extended to include delivery to destination. As business practices dictate, XXX will assist in the investigation of any customer claims resulting from possible subcontractor transit damage. XXX ensure that

• Products are stored in racks/Bins & movement is done through trollies
• Rustproof oil is applied on the material where ever is required by the customer to preserve the material
• Identification of the material is done though tags (Green, Yellow & Red)
• Packing is done in corrugated box/Jute bags/Plastic bags are the customer’s requirements

8.5.4.1 Preservation — supplemental

Preservation apply to materials and components from external and/or internal providers from receipt through processing, including shipment and until delivery to acceptance by the customer’ in order to detect deterioration, XXX assess at appropriate planned intervals the condition of product in stock, the place/type of storage container, and the storage environment. XXX use an inventory management system to optimize inventory turns over time and ensure stock rotation, such as “first-in-first-out’ (FIFO). XXX ensure that obsolete product is controlled in a manner similar to that of nonconforming product. Organizations shall comply with preservation, packaging, shipping, and labeling requirements as provided by their customers. XXX ensures that

• Stock is assess once in a year in the month of March to detect the deterioration
• FIFO is maintained through date of receiving & heat number. FIFO board is displayed & maintained to monitor the stock rotation for raw material
• Obsoleted products are identified with red tags & stored separately
• Labeling contains the following information- Customer’s Name, Part Name, Drawing Number, Number of pcs

Reference- Documented process for Handling, storage, preservation & issue of material

8.5.5 Post-delivery activities

Products are replaced/reworked free of cost, if found any manufacturing defects at the time of receiving inspection at customer end.

8.5.5.1 Feedback of information from service

Communication is done through email for any customer concerns related to manufacturing, material handling and logistics. If any product is found defective at customer end due to manufacturing/handling then minor rework is done at the customer end otherwise material is returned back by the customer & rework is done in house

8.5.5.2 Service agreement with customer

At present there is no service agreement with the customer. However, in future if there is any, the same will be considered accordingly.

8.5.6 Control of changes

Xxx reviews and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements. Xxx is to retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review

8.5.6.1 Control of changes — supplemental

XXX have a documented process to control and react to changes that impact product realization. The effects of any change. including those changes caused by XXX, the customer, or any supplier, are assessed.
XXX:
a) define verification and validation activities to ensure compliance with customer requirements;
b) validate changes before implementation;
c) document the evidence of related risk analysis;
d) retain records of verification and validation.
Changes, including those made at suppliers, should require a production trial run for verification of changes (such as changes to part design, manufacturing location, or manufacturing process) to validate the impact of any changes on the manufacturing process. When required by the customer, XXX shall:
e) notify the customer of any planned product realization changes after the most recent product approval;
f) obtain documented approval, prior to implementation of the change;
g) complete additional verification or identification requirements, such as production trial run and new product validation.

Ref-Documented process of ECN

8.5.6.1 Temporary change of process controls

XXX identify, document, and maintain a list of the process controls, including inspection, measuring, test, and error-proofing devices, that includes the primary process control and the approved back-up or alternate methods. XXX document the process that manages the use of alternate control methods. XXX include in this process, based on risk analysis (such as FMEA), severity, and the internal approvals to be obtained prior to production implementation of the alternate control method.
Before shipping product that was inspected or tested using the alternate method, if required, XXX shall obtain approval from the customer(s). XXX maintain and periodically review a list of approved alternate process control methods that are referenced in the control plan. Standard work instructions are available for each alternate process control method. XXX review the operation of alternate process controls on a daily basis, at a minimum, to verify implementation of standard work with the goal to return to the standard process as defined by the control plan as soon as possible. Example methods include but are not limited to the following:
a) daily quality focused audits (e.g., layered process audits, as applicable);
b) daily leadership meetings.
Restart verification is documented for a defined period based on severity and confirmation that all features of the error-proofing device or process are effectively reinstated.
XXX implement traceability of all product produced while any alternate process control devices or processes are being used (e.9., verification and retention of first piece and last piece from every shift).

Ref-Documented process – manages the use of alternate control methods

8.6 Release of products and services

Incoming, In-process and Final inspection is carried out to verify that the product and services requirements have been met. Release of product does not proceed to the customer until satisfactory completion of final inspection, unless otherwise approved by Director or customer. The organization retains the Final Inspection report on the release of products. Final inspection report includes

1. Evidence of conformity with the control plan / customer’s drawing/specification
2. HOD QA is authorized to release the product

Ref-Documented process in process & Final inspection report

8.6.1 Release of products and services — supplemental

XXX ensure that the planned arrangements to verify that the product and service requirements have been met encompass the control plan and are documented as specified in the control plan. XXX ensure that the planned arrangements for initial release of products and services encompass product or service approval. XXX ensure that product or service approval is accomplished after changes following initial release. NPD ensures that all product & process requirements for new product as well as changes have been incorporated & documented in the control plan through checking & reviewing by the competent person. Initial release of product is done through first piece approval

Ref-Documented process in process & Final inspection report

8.6.2 Layout inspection and functional testing

• A layout inspection is carrying out once in three months/unless otherwise specified by customer for complete measurement of all product as per customer supplied drawing.
• If any dimension couldn’t check in house such as thread load test & parameters related to CMM are checked by outside NABL accredited lab.
• Layout inspection records are available for customer review

Ref-Documented process Layout inspection

8.6.3 Appearance items

For organizations manufacturing parts designated by the customer as “appearance items,” XXX shall provide the following:

1. appropriate resources, including lighting, for evaluation.Sufficient lights, limit samples are provided to verify the following appearance parameters as mentioned in the drawings.
2. masters for colour, grain, gloss, metallic brilliance, texture, distinctness of image (DOl)’ and
3. maintenance and control of appearance masters and evaluation equipment.
4. verification that personnel making appearance evaluations are competent and qualified to do so.
5. Scratches, cracks, dents, burrs, un-filling, blowholes, finish etc. Limit samples / photographs are displayed at the work place.
6. Competency & Qualification of the personnel making appearance evaluation is verified through visual inspection test

Ref- Attribute MSA

8.6.4 Verification and acceptance of conformity of externally provided products and services

Following methods are used to ensure the quality of externally provided processes/product Review of pre-dispatch inspection report/ Material test report provided by the supplier

• Receiving inspection as per control plan
• Testing of the material through outside accredited lab
• Product/Process audit at supplier site

8.6.5 Statutory and regulatory conformity

Prior to release of externally provided products into its production flow, XXX confirms and provides evidence that externally provided processes, products, and services conform to the latest applicable statutory, regulatory, and other requirements in the countries where they are manufactured and in the customer-identified countries of destination, if provided. Followings requirements are verified for Statutory & regulatory compliance,prior to release the externally provided product in to the production flow

• Material test certificate for ROHS compliance – if required by customer
• MSDS for hazardous & toxic chemicals used in testing/production- if any

8.6.6 Acceptance criteria

Acceptance criteria are defined in the control plan and submitted to the customer for approval during PPAP approval. Acceptance level is zero defects for attribute data sampling.

8.7 Control of nonconforming outputs

Nonconforming products are identified through Red tags and kept separate to prevent unintended use or delivery. Following actions are taken care based on the nature of nonconformity and its effect on the conformity of product

• Segregation of the product
• Return to supplier for rework (if BOP/Outsourced)
• Alteration for in house defects
• Inform to the customer if non conforming products are detected after the delivery
• Obtaining authorization for acceptance under concession by the Director if required
• Re verification of the requirements after correcting the non conformities

Ref-Documented Process for Control of Non conforming Product

8.7.1.1 Customer authorization for concession

Director obtains the customer concession or deviation prior to further processing for “use as is” & for repair of nonconforming product/subcomponents, which is different from the currently approved. HOD Q.A maintains the record of expiry date for authorized quantity. HOD Q.A ensures compliance with the original or superseding specifications when the authorization expires. Material dispatched under concession is promptly identified on each packing box and informed to the customer through mail. The above requirements are also applicable to the purchased product.

8.7.1.2 Control of nonconforming product — customer-specified process

HOD QA ensures the compliance with Customer specific controls for nonconforming product(s).

8.7.1.3 Control of suspect product

Product with unidentified or suspect status is classified as a nonconforming product. Training for containment of suspect and non-conforming product is provided to the concerned personal

8.7.1.4 Control of reworked product

XXX utilize risk analysis (such as FMEA) methodology to assess risks in the rework process prior to a decision to rework the product. lf required by the customer, XXX shall obtain approval from the customer prior to commencing rework of the product. XXX have a documented process for rework confirmation in accordance with the control plan or other relevant documented information to verify compliance to original specifications. instructions for disassembly or rework, including re-inspection and traceability requirements, are accessible to and utilized by the appropriate personnel. XXX retain documented information on the disposition of reworked product including quantity, disposition, disposition date, and applicable traceability information.

Ref-Documented Process for Control of Non conforming Product

8.7.1.5 Control of repaired product

XXX utilize risk analysis (such as FMEA) methodology to assess risks in the repair process prior to a decision to repair the product. XXX obtain approval from the customer before commencing repair of the product. XXX have a documented process for repair confirmation in accordance with the control plan or other relevant documented information. Instructions for disassembly or repair, including re-inspection and traceability requirements, is accessible to and utilized by the appropriate personnel. XXX obtain a documented customer authorization for concession for the product to be repaired. XXX retain documented information on the disposition of repaired product including quantity, disposition, disposition date, and applicable traceability information.

Ref-Documented Process for Control of Non conforming Product

8.7.1.6 Customer notification

• Customer is informed immediately by phone/email in the event that nonconforming product is shipped
• Internal communication is done through meeting and raised internal NC & initiate corrective action for the same

8.7.1.7 Nonconforming product disposition

Non-conforming, Deviation & corrective action report is retained for rejection & rework that describes the below points

Daily/Monthly Non-conforming report

• Part Name & Process Name
• Qty inspected /produced
• Rejection & Rework quantity
• Nature& Qty of defects

Deviation report

• Part Name & Process Name
• Defect observed
• Description of the concession
• Authorized Qty /time period
• Authorized person

Corrective action report

• Part Name & Process Name
• Nature of defects
• Correction, Root cause & Corrective action
• HOD Q.A with the help of CFT decides the action for non-conforming products

Ref-Documented Process for Control of Non conforming Product

9   Performance evaluation

9.1 Monitoring, measurement, analysis and evaluation

9.1.1 General

S.No.	What to be Monitored & measured	Method of Monitoring, measurement, analysis & evaluation	Frequency of Monitoring & measurement,	Analysis & evaluation frequency	Documented information
1	Customer satisfaction	Customer satisfaction survey	Once in a year	Six Months during management review	Customer satisfaction assessment form & Minutes of management
2	Rejection in products	Variable & Attribute inspection through out the product realization	When ever occurred	Monthly	Rejection report
3	Rework in products	Variable & Attribute inspection through out the product realization	When ever occurred	Monthly	Rework report
4	Performance of external providers	Performance monitoring through quality & delivery marks	Monthly	Six Months during management review	External provider performance monitoring sheet
5	Machine Breakdown	Monitor the start time & end time of breakdown, spares used, correction, root cause & corrective action	When ever occurred	Monthly	Breakdown Maintenance record
6	Customer complaints	Receive the complaints through email/verbal mode and analysis the problem through root cause analysis and take correction & corrective action for the same	When ever occurred	Monthly	Customer complaint record sheet
7	Performance & effectiveness of the QMS	Achievement of the objectives (sale target, COPQ, Rejection, Rework, Productivity, MTTR, MTBF, Quenching oil consumption, Delivery etc.	Monthly	Six Months during management review	Objective sheet
8	Effectiveness of action taken to address risk & opportunity	Process wise monitoring of Risk, Probability, impact, exposure, mitigation & contingency	Yearly	Six Months during management review	Internal, External issues & Risk assessment sheet

9.1.1.1 Monitoring and measurement of manufacturing processes

Initial process study is carried out on all new manufacturing process to verify process capability and to provide additional input for process control for special characteristics. Manufacturing process capability are carried out as per AIAG reference manual or specified by customer (if any). Process audit & product audit is carried out to verify the followings:

• PFD, PFMEA & Control plans are implemented
• Adherence to the measurement techniques
• Adherence to the sampling plan
• Adherence to the acceptance criteria
• In-process inspection as per plan
• Adherence to reaction plan and escalation process when acceptance criteria are not met

Significant process events, such as tool change or machine repair are recorded in the run chart/in-process inspection report. Reaction plan includes the 100% inspection for characteristics that are either not statistically capable or are unstable. Corrective action is developed & implemented to ensure that the process becomes stable and statistically capable. Plans is reviewed with and approved by the customer, when required. Effective dates of process changes are maintained in the process change record sheet

9.1.1.2 Identification of statistical tools

XXX determine the appropriate use of statistical tools. XXX verify that appropriate statistical tools are included as part of the advanced product quality planning (or equivalent) process and included in the design risk analysis (such as DFMEA) (where applicable), the process risk analysis (such as PFMEA), and the control plan. Statistical tools such as Control charts (X-bar & R chart), Run chart,Cp/Cpk, Pp/Ppk are determined and includes as part of APQP and includes in the PFMEA & Control plan

9.1.1.3 Application of statistical concepts

Statistical concepts, such as variation, control (stability), process capability, and the consequences of over-adjustment, is understood and used by employees involved in the collection, analysis, and management of statistical data. Basic statistical concept such as Control charts (X-bar & R chart), Run chart, Cp/Cpk, Pp/Ppk, R&R &Kappa are understood and implemented through out the organization by trained personnel such as Engineer Quality/ Production.

9.1.2 Customer satisfaction

Xxx is to monitor customers’ perceptions of the degree to which their needs and expectations have been fulfilled. Xxx is determined the methods for obtaining, monitoring, and reviewing this information. The Quality In Charge has primary responsibility for Customer Satisfaction as one of the measurements of the Quality Management System and as to whether the organization has met customer requirements. Customer satisfaction shall include the collection of authentic data, frequency, and validity of the analysis. The trend and major elements affecting customer satisfaction and key indicators of customer dissatisfaction will be monitored supported by objective evidence. Wherever data available, the level of customer satisfaction will be compared with those of our competitors & a relevant action plan will be evolved. A customer satisfaction analysis survey will be conducted ONCE IN A 12 MONTHS Review of customer satisfaction will be taken by top management during Management Review Meeting as described in Procedure.

9.1.2.1 Customer satisfaction — supplemental

Following methods are used to monitor& review the Customer’s satisfaction

• Customer satisfaction survey once in a year for the followings- Delivery, Quality, Response of enquiries & complaints, Efforts for new product development, line stoppage, field returns, warranty failures.
• Customer’s score card/rating available on the portal or mailed by the customer (if provided)
• Followings Internal & external performance indicators based on objective evidences
  • Delivered part quality performance
  • Customer disruptions
  • Field returns, recalls, and warranty (where applicable)
  • Delivery schedule performance (including incidents of premium freight);
  • Customer notifications related to quality or delivery issues, including special status.

Reference- Documented process for monitoring customer satisfaction

9.1.3 Analysis and evaluation

HOD Q.A & Manager system analyzes and evaluates data and information arising from monitoring and measurement and result of analysis is used to evaluate the followings

• Customer satisfaction.
• In house rejection/rework
• Poor quality cost
• Productivity
• Customer returns
• Breakdown Hours
• Customer complaint
• On time dispatch
• External provider delivery/ quality performance
• Effectiveness of action taken to address risk & opportunity
• Performance, effectiveness & need for improvement to the QMS

9.1.3.1  Prioritization

Trends in quality and operational performance are compared with progress toward objectives and lead to action to support prioritization of actions for improving customer satisfaction.

9.2       Internal audit

Procedures are established for a system of planned and documented internal quality audits to verify that the Quality Management System conforms to the planned arrangements as per           IIATF 16949:2016 requirements and effectively implemented and maintained.

The MR is responsible for:

• Planning and organizing audits at works depending on the importance and the extent of the activity concerned and the results of the previous audits. The internal quality system audits as per schedule are to be carried out at least once in SIX Months period and at least 02 times during a year.
• MR also ensures that the trained auditors are involved in quality system audit to ensure the objectivity of the auditing processes and are not directly responsible for the area under audit. The results of the audit are documented in the specified format to record non-conformances in product/process and work practices and brought to the notice of the person responsible for the area audited, who in turn shall take appropriate corrective actions within the agreed time limit and ensure removal of deficiencies observed. Follow up on the effectiveness of the corrective action taken.
• The effectiveness of identified corrective action against any such internal audit findings is verified by the MR prior to subsequent management review meetings and recorded.
• MR is responsible for ensuring that non-conformances observed during IA are closed by appropriate corrective action implementation in a defined period.MR identifies and marks the corrective actions needing confirmation for their effective implementation and also arranges for the verification in subsequent audits or follow-up audits will be planned.
• MR maintains appropriate records of implementation & effectiveness in the form of internal audit reports. The details of the audit team, schedule, preparation of non-conformances reports,
• The follow up on the corrective actions is detailed in the procedure for corrective action
• The nonconformance identified during third-party audits or by external agencies is handled in the same manner. The non-conformances of IA remaining open due to a delay in the implementation of corrective action along with major non-conformances recorded will be reviewed during management review meetings.

9.2.2.1 internal audit programme

XXX have a documented internal audit process. The process includes the development and implementation of an internal audit programme that covers the entire quality management system including quality management system audits, manufacturing process audits, and product audits. The audit programme is prioritized based upon risk, internal and external performance trends, and criticality of the process(es). Where XXX is responsible for software development, XXX include software development capability assessments in their internal audit programme. The frequency of audits is reviewed and, where appropriate, adjusted based on occurrence of process changes, internal and external nonconformities, and/or customer complaints. The effectiveness of the audit programme is reviewed as a part of management review.

9.2.2.2 Quality management system audit

XXX audit all quality management system processes over each three-year calendar period, according to an annual programme, using the process approach to verify compliance with this Automotive QMS Standard. integrated with these audits, XXX sample customer-specific quality management system requirements for effective implementation.

9.2.2.3 Manufacturing process audit

XXX audit all manufacturing processes over each three-year calendar period to determine their effectiveness and efficiency using customer-specific required approaches for process audits. Where not defined by the customer, XXX shall determine the approach to be used. Within each individual audit plan, each manufacturing process is audited on all shifts where it occurs, including the appropriate sampling of the shift handover. The manufacturing process audit shall include an audit of the effective implementation of the process risk analysis (such as PFMEA), control plan, and associated documents.

9.2.2.4 Product audit

XXX audit products using customer-specific required approaches at appropriate stages of production and delivery to verify conformity to specified requirements. Where not defined by the customer, XXX shall define the approach to be used.

Ref-Documented Process Internal audit

9.3 Management review

9.3.1 General

QMS is reviewed once in six months to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization.Top management of Xxx is reviewing the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization. Management review will be conducted and chaired by MD  once in SIX Months to ensure continuing suitability & effectiveness in satisfying the requirements of   IATF 16949:2016 and the stated quality policy and objectives. The Management Review will include all elements of the entire quality system as detailed in the procedure and schedule for the Management Review. Records of Management Review Meetings shall be maintained by MR. The Director during review shall assess opportunities for improvement and the need for changes in the Quality Management System, including the Quality Policy and Quality Objectives.

9.3.1.1 Management review — supplemental

Top management review the organization’s QMS once in six months.The frequency of management review(s) is increased based on risk to compliance with customer requirements resulting from internal or external changes impacting the quality management system and performance-related issues.

9.3.2 Management review inputs & 9.3.2.1

The management review is planned and carried out taking into consideration

1. The status of actions from previous management reviews
2. Changes in external and internal issues that are relevant to the quality management system;
3. Information on the performance and effectiveness of the quality management system, including trends in:
   • customer satisfaction and feedback from relevant interested parties;
   • the extent to which quality objectives have been met;
   • process performance and conformity of products and services;
   • nonconformities and corrective actions;
   • monitoring and measurement results;
   • audit results;
   • the performance of external providers
4. The adequacy of resources;
5. The effectiveness of actions taken to address risks and opportunities;
6. Opportunities for improvement

9.3.2-1 Management review inputs – supplemental

The management review is planned & carried out taking into consideration

• Cost of poor quality
• Process effectiveness & efficiency for product realization processes,
• Product conformance
• Assessment of manufacturing feasibility made for changes to existing operations & for new facilities or new products
• Review of performance against maintenance objectives
• Review of customer scorecard
• Identification of potential field failure
• Actual field failure & their impact on safety/environment.
• Summary results of measurements at specified stages during the design and development of products and processes. (Measurements may consider, for example: timing, costs, or feasibility)

9.3.3 Management review outputs

The outputs of the management review includes decisions and actions related to

1. Opportunity for improvement
2. Any need for changes to the quality management system
3. Resources needs
4. Action plan when customer performance targets are not met.

9.3.3.1 Management review outputs – supplemental

Top management shall document and implement an action plan when customer performance targets are not met.

Ref-Documented Process Internal audit

10. Improvement

10.1 General

Once the processes are capable and stable then CFT determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction that includes the followings

1. Improvement in products and processes to meet requirements as well as to address future needs and expectations;
2. Correcting, preventing or reducing undesired effects such as Rejection/ Rework / COPQ /Complaints/Unplanned breakdowns etc.
3. Improving the performance and effectiveness of the quality management system through using the following tools
   • Cause & effect diagram
   • Flow chart
   • Histogram
   • Control charts
   • Check sheets
   • Internal audits
   • Management review outputs

10.2 Nonconformity and corrective action

10.2.1 The functional head collects the information related to the nonconformity from the followings

1. Customer complaint/ return/ feedback
2. In house rejection/rework
3. Internal audit non conformities
4. External audit (third party) non conformities
5. Customer’s audit non conformities
6. Supplier’s rejection

When above non-conformities occurs, the followings actions are taken

• Nonconformities related to customer complaint/ return logged in customer complaint register, in house rejection/rework in nonconformity register, internal/external/customer audit finding in corrective action request form.
• Functional head review the nature of nonconformity, identify the correction, consequences & root cause with the help of cause and effect diagram, why-why analysis and suggest the corrective action to eliminate the cause of detected nonconformity.
• Functional head ensures that corrective action gets implemented in the affected area.
• Director reviews and verifies the effectiveness of the corrective action taken.
• Corrective action & its effectiveness is recorded in the corrective action report or incase of customer complaint in the customer prescribed format if any and made available upon request to customer.
• Update risk & opportunities determined during planning as necessary
• Make changes to the QMS- such as PFD, PFEA, CP, QM, SOP etc. if necessary
• If corrective action effectively implemented then HOD Q.A apply it to the similar processes.

10.2.2 Corrective action report is retained which contains the followings

1. Nature of non conformities
2. Correction
3. Root cause
4. Corrective action
5. Horizontal deployment
6. Change in the QMS
7. Effectiveness of the corrective action

10.2.3 Problem solving

XXX have a documented process(es) for problem solving including:
a)defined approaches for various types and scale of problems (e.g., new product development, current manufacturing issues, field failures, audit findings);
b) containment, interim actions, and related activities necessary for control of nonconforming outputs
c) root cause analysis, methodology used, analysis, and results;
d) implementation of systemic corrective actions, including consideration of the impact on similar processes and products:
e) verification of the effectiveness of implemented corrective actions;
f) reviewing and, where necessary, updating the appropriate documented information (e.g., PFMEA, control plan). where the customer has specific prescribed processes, tools, or systems for problem solving, XXX uses those processes, tools, or systems unless otherwise approved by the-customer.

Ref-Documented Process for corrective action (Problem solving)

10.2.4 Error-proofing

XXX have a documented process to determine the use of appropriate error-proofing methodologies. Details of the method used is documented in the process risk analysis is such as PFMEA) and test frequencies are documented in the control plan. The process shall include the testing of error-proofing devices for failure or simulated failure. Records are maintained. Challenge parts, when used, is identified, controlled, verified, and calibrated where feasible. Error-proofing device failures shall have a reaction plan.

Ref-Documented Process corrective action (Error proofing)

10.2.5 Warranty management systems

When XXX is required to provide warranty for their product(s), XXX shall implement a warranty management process. XXX include in the process a method for warranty part analysis, including NTF (no trouble found). When specified by the customer, XXX shall implement the required warranty management process.

Reference- Documented process for Warranty Management

10.2.6 Customer complaints and field failure test analysis

CFT performs analysis on the parts rejected/complaints received from customer and initiate problem solving & corrective action with in target time given by customer.Records of this analysis is maintained and results are communicated to the customer & with in the organization. XXX perform analysis on customer complaints and field failures, including any returned parts, and initiate problem solving and corrective action to prevent recurrence. Where requested by the customer, this shall include analysis of the interaction of embedded software of XXX’s product within the system of the final customers product. XXX communicate the results of testing/analysis to the customer and also within XXX.

Reference- Documented process for customer complaint handling

10.3 Continual improvement

XXX continually improved the suitability, adequacy, and effectiveness of the quality management system. XXX considers the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that shall be addressed as part of the continual improvement

10.3.1 Continual improvement – supplemental

XXX have a documented process for continual improvement. XXX include in this process the following:

1. identification of the methodology used, objectives, measurement, effectiveness, and documented information;
2. a manufacturing process improvement action plan with emphasis on the reduction of process variation and waste:
3. risk analysis (such as FMEA).

Ref-Documented Process Continual Improvement

Customer Specific Requirements							Annexure-07 Rev 01   dated -01.12.2020
IATF Requirements	Customer specific additional Requirements for TVS Motor  ( ref. SQAM Supplier Quality Assurance Manual )	Customer specific additional Requirements for Multimatic	Customer specific additional Requirements for Jay Industries	Customer specific additional Requirements for Lander Automotives	Customer specific additional Requirements for Jost	Customer specific additional Requirements for Rockman Industries	Customer specific additional Requirements for Diado India	Process Name  (Where this requirement is applicable)
4.1	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
4.2	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
4.3	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
4.4	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
5.1	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
5.2	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
5.3 Organizational roles, responsibilities and authorities	The supplier shall submit an organisation chart including the roles and responsibilities of each function and number of persons (Manager, Executives, and Inspectors) along with the contact information.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	HR
	The supplier shall notify TVSM of any changes in their contact information as and when they are made. Revised forms shall be sent within 7 days of such changes.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
6.1	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
6.2	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
6.3	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
7.1.5.1.1 Measurement systems analysis	Supplier shall use MSA reference manual latest edition of AIAG for all attribute and variable gauge studies.	Supplier shall use MSA reference manual latest edition of AIAG for all attribute and variable gauge studies.	Supplier shall use MSA reference manual latest edition of AIAG for all attribute and variable gauge studies.	Supplier shall use MSA reference manual latest edition of AIAG for all attribute and variable gauge studies.	Supplier shall use MSA reference manual latest edition of AIAG for all attribute and variable gauge studies.	Supplier shall use MSA reference manual latest edition of AIAG for all attribute and variable gauge studies.	Supplier shall use MSA reference manual latest edition of AIAG for all attribute and variable gauge studies.	Quality
	On an on going basis, the supplier shall conduct Gauge R&R (variable and attribute studies) on all types of measurement systems at least once in a year
	The types of measurement system shall be identified / grouped based on instrument type, instrument range and resolution, part characteristics, operating environment and skills / competences of personnel using the instrument.
7.2	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
7.3	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
7.4	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
7.5 Documented information	Retention period- 2 Years Inspection Standards, Inspection Reports, Tooling Maintenance Reports, Control Chart, Material Test Reports, Performance Test Reports, Calibration Records, Machine Capability Study Reports, Audit Reports, QUALITY DEVIATION HIGHLIGHTS, Action Plans, Kaizens, QC Story	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Control of documented information
	Retention period- Life of the product Drawings, APQP Documents and Master Samples	Retention period- Life of the product Drawings, APQP Documents and Master Samples	Retention period- Life of the product Drawings, APQP Documents and Master Samples	Retention period- Life of the product Drawings, APQP Documents and Master Samples	Retention period- Life of the product Drawings, APQP Documents and Master Samples	Retention period- Life of the product Drawings, APQP Documents and Master Samples	Retention period- Life of the product Drawings, APQP Documents and Master Samples
8.1	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
8.2.3.1.3 Organization manufacturing feasibility	Prepare Manufacturing Feasibility and Risk Analysis format QSF PUR SQAM 002,003 and drawing feedback & agreement form QSF PRG 02 01 018 and feedback / suggestions for QCD improvements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Marketing & Sale and New Product Development
	manufacturing feasibility as per checklist QSF PUR SQAM 003	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
	Supplier shall use TVSM format QSF QAD 10 11 05 for preparation of AOI	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
8.3.2 Design and development planning	Readiness Review– This is done by reviewing product and process design documents as per checklist CL QAD 10 11 001	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	New Product Development
	IPTR (Initial Production Trial Run)– typically 50 nos. and reviewing the results as per checklist CL QAD 10 11 002	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
	SPTR (Significant Production Trial Run)– (8 hours Production or 300 nos ) at planned run-at-rate and reviewing the results as per checklist CL QAD 10 11 003	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
8.3.3.3 Special characteristics	Safety / Statutory / regulatory- severity = 9 or 10.  Minimum Process Performance index / process capability levels for variable characteristics 1.0 for geometric & 1.67 others	Follow as per Drawing	Follow as per Drawing	Follow as per Drawing	Follow as per Drawing	Follow as per Drawing	Follow as per Drawing	New Product Development
	Fit / Function – Critical- severity = 7 or 8. Minimum Process Performance index / process capability levels for variable characteristics 1.0 for geometric & 1.67 others
	Fit / Function – major- severity = 5 or 6. Minimum Process Performance index / process capability levels for variable characteristics 1.0 for geometric & 1.33 others
	Supplier shall send the of process capability reports on monthly basis for special characteristics, controlled through X-bar, R chart. Action plan to be submitted to improve the process capability, if Cpk is below the norms specified in the manual.							Quality & Production
8.3.4.4 Product approval process	Submit the PPAP documents through Collaboration Folder link available on http://www.tradewithtvs.com and Table 1 shows the 19 requirements for the PPAP submission	Pilot Lot of 300 nos along with PPAP Documents Material reports to be uploaded on IMDS If required	Intial 10 nos  nos along with PPAP Documents	Intial 5 nos  nos along with PPAP Documents Material reports to be uploaded on IMDS if required	Intial 05 nos  nos along with PPAP Documents	Intial 10 nos  nos along with PPAP Documents	Intial 10 nos  nos along with PPAP Documents	New Product Development
8.3.5.2 Manufacturing process design output	FMEA shall follow the latest edition of FMEA reference manual published by AIAG	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	New Product Development
	High risk in FMEA is defined where severity is high and / or RPN is high for a failure mode / cause. High Severity ³ 7 or High RPN ³ 63 ( action plan required to reduce severity or RPN ).	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
	special attention to be given for high severity rankings even if RPN is low. Whenever severity is 9 or 10 and no actions are possible to reduce severity ranking, efforts shall be taken to minimize occurrence and detection ranking.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
8.4 Control of externally provided processes, products and services	Maintain master list of all the T2 suppliers with clear details of the operations carried out and provide a copy to TVSM along with PPAP.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Purchase & Quality
	Carry out special processes like heat treatment, plating, painting, powder coating etc only at the mutually approved sources.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
	TVSM may review the PFD, PFMEA & Control Plan of the Tier 2 supplier during part development if required.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
8.4.2.4.1 Second Party Audit	Supplier shall make a plan for Tier 2 audit covering all Tier2 suppliers.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Purchase, G.M Systems & Quality
	Supplier shall verify following areas – Availability of latest revision of drawing and inspection standard – Adherence to Control Plan – Condition & Calibration of Gauges / Instruments / Tool / Equipments – Part parameter audit – Condition of jig / fixture / tools / gauges & history maintenance. – NC products identification and handling – Deployment of certified operators and inspectors in critical processes – If a special process is done by Tier 2, then the special process qualification to be verified and approval by TVSM. – Layout inspection, product audits. – Supplier may cover additional areas as required	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
8.5.1 Control of production and service provision	Process Qualification Supplier shall identify the special processes ie (Heat treatment, Plating, Painting, Powder Coating, Welding, etc) and make a plan for conducting the process qualification, including Tier 2.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Quality, Production & Purchase
	The process shall be set at minimum condition for all process parameters as per the Control Plan and produce the product as per the normal batch size. (E.g. Temp: 160 ~ 200 deg Time: 5minutes ~ 8 minutes in a plating process then produce the batch by setting temp at 160 deg and time 5 minutes for minimum condition)	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
8.5.2.1 Identification & Traceability	Batch Number Supplier Identification LH / RH designation Date of manufacture, Month, Year Cavity no, Mould no, Die no, Date Code / Heat Code	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Production, New Product Development & Tool Management
8.5.1.6 Management of production tooling and manufacturing, test, inspection tooling and equipment	Issue Tool Ownership Certificate (QSF PUR SQAM 017) to TVSM, once the tools are proved.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Tool Management
	Review the condition of tool when quantity produced reaches 75 % of the agreed life. Thereafter, review the tool condition at incremental 10% production of the agreed tool life quantity	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
8.5.6.1 Control of changes	Supplier shall submit request for engineering changes – format no. QSF PUR SQAM 014, process changes format no, QSF PUR SQAM 013 and obtain necessary clearance from TVSM for going ahead with the change implementation.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NPD
8.6	No additional requirements	Material TC and Inspection report with each every dispatch	Material TC and Inspection report with each every dispatch	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
8.7.1.1 Customer authorization for concession	Non-conformance of Minor in nature If the non conformance is minor in nature and if the supplier feels that it will not affect either the subsequent process at TVSM or the intended functional requirements at TVSM customer’s end, then they shall request TVSM for clearance thro, Deviation Approval Request format (QSF PUR SQAM 007) immediately and explain the non conformance nature.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Quality
	The suppliers are notified through Quality Deviation Highlights (QDH) on Web http://www.tradewithtvs.com, the supplier shall ensure corrective actions on receipt of QDH and communicate the causes of failure. QDH raised for non-conformance shall be replied within 24 hours through E-Mail, Fax, Courier, or in person.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
8.7.1.6 Customer notification	Non-conforming parts shipped to TVSM and suppler end Supplier shall send Notification of Suspected Shipment of Non-confirming Product format (QSF PUR SQAM 006) to TVSM Purchase / Quality	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Quality
9.1.1.1 Monitoring and measurement of manufacturing processes	SPC shall be in line with latest edition of AIAG manual	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Quality & Production
	Process capability studies shall be carried out over a sample size of minimum 100 nos. (25 subgroups of 4 samples each or 20 subgroups of 5 samples each)	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
	If the process becomes unstable or non-capable (as per table), supplier shall introduce 100% inspection for the parameter, till the Corrective Action is taken and normalcy restored.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
	Supplier shall send the of process capability reports on monthly basis for special characteristics, controlled through X-bar, R chart. Action plan to be submitted to improve the process capability, if Cpk is below the norms specified in the manual.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements
9.1.2.1 Customer satisfaction	Quality performance report for each supplier is published on the website http://www.tradewithtvs.com. Quality rating is arrived based on the quality performance covering lot, line rejections, and warranty returns including spare parts supply. If rating is less than 90%, supplier shall forward the action plans proposed / planned along with the time frame to meet the target, the progress of which shall be reviewed by the supplier management on monthly basis and to be presented to TVSM on demand.	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Quality, Marketing & Sale
9.2.2.4 Product Audit	Supplier shall perform product audit for ready for despatch parts, to confirm dimensions against standard, Functionality, Packaging, Labeling, etc	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Purchase & Quality
9.3	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
10.1	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA
10.2.5 Warranty management systems	Analyze the failure, using warranty analysis guidelines and warranty analysis summary format QSF PUR SQAM 010 & QSF PUR SQAM 011. It is recommended to check 50 – 100 nos of failed parts randomly and verify the following observations. – Phenomena of failure, kms etc – Location of failure – Bench mark study to identify the improvements – Simulation of field failure in lab – Identify the root cause of failure – Identify the counter measure – Compare the improvement in lab testing (before & after) – Implement the action with time plan format – Monitor the results	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Quality, Marketing & Sale
	The implemented corrective action score shall be minimum 4 Detection type Poka Yoke • Design improvement (Sev 5 to 7) • Process improvement (Cpk 1.33 to1.67) • 100% additional test station • Automation of tool change frequency – visual control	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Quality
10.2.6 Customer complaints and field failure test analysis	Upon the receipt of complaint (Email / Fax / Quality Deviation Highlights), supplier representative shall visit TVSM to understand the problem within 24 hours.	Corrective action required to submit on DMN Portal	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	Quality
	M1 action – Immediate action to be taken on stocks at TVSM- Quarantining / segregation / 100% inspection etc. Target lead time for completion of M1 action -Within 24 hrs
	M2 action -Temporary action to be taken at all stages of manufacturing, transit and storage through out the supply chain. to prevent the defect reaching TVSM.Example of means used –100% inspection / switch over from sampling to 100% inspection / Gauge introduction, etc Target lead-time for completion of M2 action – Within 48 hrs
	M3 action – Corrective action through problem solving approach (QC Story/Kaizen sheet/8D- report ) Target lead-time for( i) Submission of corrective action reports –within 7 days (ii) completion of M3 action – Within 15 days (according to the nature of problem and resolution)
10.3	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	No additional requirements	NA

KPI  of All DEPARTMENT
Dept Name	Indicator(s)								Units	Target	Monthly Observation  ( July 22 to March 23)									Average
											Jul-22	Aug-22	Sep-22	Oct-22	Nov-22	Dec-22	Jan-23	Feb-23	Mar-23
Dispatch	Dispatch Planned Vs Actual								%	100%	76	85	90	70	89	90	88	85	97	86
	Delivery Performances								%	100%	76	85	93	83	82	88	88	93	98	87
Engg	Timely development of new product as per Timing plan /Target given by the Customer								%	100	100	100	100	100	100	100	100	100	100	100
	First Time Approval								100%	100	100	100		99	99			99		99
	Discrepancy in PPAP Documents								Not Allowed	0	0	0	0	0	0	0	0	0	0	0
	Timely implementation of engineering change								Days	5	5	5	0	5	5	0	5	5	0	3
	No.of Customer complaints against PFMEA								Nos	0	0	0	0	0	0	0	0	0	0	0
	Modification of documents (PFMEA,CONTROL PLAN,WI,IS, O.S. etc).								Days
	Number of Projects Completed as plan								%
	Increase in Productivity								%
	Reduction in process Cost								Rs
	Reduction in Cycle Time Through reduced Material Movement								Sec
	Nos of Alternative method use								Nos
	CPK >1.67								Nos
HR	No. of Training programmes planned Vs Actually conducted								%	100	100	100	100	100	100	100	100	100	100	100
	Evaluation of Training Effectiveness								%	100	100	100	100	100	100	100	100	100	100	100
	Absenteeism Rate								%	10%	10	9	8	9	9	8	8	9	8	9
	One Suggestion/kaizen per employee								Nos
	Employee turnover ratio								%
LAB	No. of times discrepancy observed in test results								Nos	0	0	0	0	0	0	0	0	0	0	0
	Planned schedule Vs Actual calibration								%	100	100	100	100	100	100	100	100	100	100	100
	No. of times uncalibrated instruments found during the audits								Nos	0	0	0	0	0	0	0	0	0	0	0
	Layout Inspection Planned Vs Actual								%	100	100	100	100	100	100	100	100	100	100	100
	No. of parts inspected Vs parts accepted								%	100	100	100	100	100	100	100	100	100	100	100
	Required Testing time Carried Out								Hour
MAINT	Machine down Time due to Breakdown								Hrs	1000	841.7	277.4	216	249	236.28	224.5	204	205	204.83	295
	Mean time to repair (MTTR)								Hours	10	14.51	5.67	3.3	7.7	11.58	9.25	6.1	7.39	3.06	8
	Cost of Break Down								Rs	50000	343666	113595	187258	328264	144744	293877	294608	407476	318210	270189
	Mean Time Between Failure (MTBF)								Hours	10	12	15	18.0	10.0	12.0	17	12.0	15	16	14
	Preventive Maint.Planned vs Achievement								%
MS	No of repetitive NC								Nos	0	14	0	0	7	0	0	0	17	0	4
	No. of times wrong / manipulated records found during internal /External Quality Audit								Nos	0	0	0	0	0	0	0	0	0	0	0
	No of problem received Vs CAPA Implemented /Month								%	100	100	100	100	100	100	100	100	100	100	100
	Uncontrolled copies of documents found during audit								Nos	0	0	0	0	0	0	0	0	0	0	0
	Obsolete Documents found during audit								Nos	0	0	0	0	0	0	0	0	0	0	0
	Audit Planned Vs Actual								%	100	100	100	100	100	100	100	100	100	100	100
	Projects taken Vs implemented								Nos
	No of Improvements /Quarter								Nos
Prod	Production Plan Vs Achieved								%	100	76	85	90	70	89	90	88	85	97	86
	Cost of Poor Quality								RS	50000	33313	48149	41836	41918	41399	56499	24109	13402	12600	34803
	Rejection PPM								PPM	1000	1992	1997	2034	1559	1637	513	814	926	848	1369
	Rework PPM								PPM	1000	5785	4578	5581	6320	6215	8772	11111	4868	6580	6646
	OEE								%
QUALITY	No. of customer complaints received in accepted lots (including customer returns)								Nos	0	1	1	3	1	1	3	1	2	2	2
	Rejection PPM								PPM	1000	1992	1997	2034	1559	1637	513	814	926	848	1369
	MSA Planned Vs Actual								%	100	100	100	100	100	100	100	100	100	100	100
	No of Shop Floor Complaints on Accepted material								NO	0	0	1	1	1	1	2	1	1	1	1
	Clearence of MRN as per schedule								%	100	100	100	100	100	100	100	100	100	100	100
	Timely Validation (Planned Vs Actual)								%	100	100	100	100	100	100	100	100	100	100	100
Tool Room	Cycle time of Die Development Plan Vs Ach								%	100	868	1127	1545	2164	976	2311	1357	1658	1246	1472
	Die Development Cost Plan/Ach.								Rs	As per Plan	211092	237240	479109	520029	390258	1039305	341777	693939	739041	516866
	Tool Breakdown Hour								Hour	100	151	225	216	249	236.25	224.5	204	205	204.83	213
	Tool Breakdown Frequency								Nos	30	39	64	78	78	76	56	75	85	80	70
	First Time tool Trial accepted  ( Nos Of Tool  Tried out Vs first time Accepted								%	100	93	78	80	87	91	89	87	77	79.5	85
	Average Die Life								Nos of Strokes
	Preventive Maint Planned  Vs Achieved								%
	Ratio of cost of repairs vs. actual cost of die.								%
MARKETING	Number of New products Added								Nos.	13	0	0	3	4	0	2	6	1	9	3
	Enhanced Sales per Annum								%	1200	610.47	827.41	850.00	745.00	748.00	915.39	981.18	1049.45	1048.75	864
	No. of Enquiries handled Vs matured								Nos.	20	4	4	4	5	6	5	4	5	4	5
	Average time taken for closure of customer complaint								Days	7	7	7	3	1	1	3	1	4	4	3
	Number of customer complaints received per month.								Nos	0	1	1	3	1	1	3	1	2	2	2
	Customer Satisfaction Index								%	100	94.6	92.8	94.8	94.0	96.7	94.7	96.9	97.8	97.7	96
	VAPCO								%	6	1.57	2.47	2.58	2.7	3	3.5	3	3.25	3.3	3
	Number of improvements made in the products based on customer feedback.								Nos
PURCHASE	Supplier Performance Rating								%	100	91	92	94	92	93	94	92	94	90	92
	No. of suppliers upgraded to ISO System Every Year								Nos.	1	0	0	0	1	1	0	0	0	0	0
	No. of improvements made at supplier’s end								Nos.	5	2	1	1	1	2	1	1	1	1	1
	Execution of P.O as per schedule								%	100	88	89	88	89	87	88	89	87	88	88
	Production loss due to material non availability								Nos	0	2	2	2	3	2	1	2	2	2	2
	No. of time raw material rejected								Nos	0	1	1	1	1	1	2	1	1	1	1
STORE	No of. complaints related to transit & damage								Nos	0	0	1	1	2	1	2	1	1	2	1
	Matching of physical stock vs. recorded as per ERP								%	100	83	78	82	84	82	86	80	82	84	82
	Inventory Turn Over Ratio								%	25	10.5	12.84	15.64	12.75	14.75	15.72	16	15.75	16.25	14