Manufacturing process audits are a type of quality assurance that is performed to ensure that manufacturing processes conform to the company’s quality standards. A manufacturing process audit is a systematic examination and evaluation of a company’s manufacturing processes to ensure they adhere to established standards, procedures, and best practices. The primary goal of a process audit is to identify any potential deviations, inefficiencies, or non-compliance issues in the production process. In addition, these audits aim to identify non-conformances and correct them before they cause problems downstream. Process audits can assess any type of manufacturing process, from simple assembly line processes to complex multi-step processes. This type of audit usually focuses on one specific process at a time but can also assess the entire manufacturing operation. Process audits come in various forms, from completing simple checklists to deeper and broader processes into specific manufacturing operations. During a process audit, the auditor records, aggregates, and categorizes potential non-conformances. Afterward, the operations staff will then perform corrective actions based on the audit findings. Process audits are a critical part of ensuring that lines are working properly and enforcing quality and safety. It also helps pinpoint non-conformances at the source. They help ensure that products are manufactured according to its quality standards. These audits can also help identify potential problems with the manufacturing process to be corrected before they cause defects in the finished product. They help to ensure that manufacturing processes are running smoothly and efficiently. By identifying bottlenecks and inefficiencies in the manufacturing process, process audits can help improve overall productivity. They can help to ensure compliance with regulatory requirements. By auditing the manufacturing process, companies can identify areas where they may be out of compliance and take corrective actions to fix the issue. Process audits offer several benefits to manufacturing companies. By conducting these audits, companies can assess the effectiveness and efficiency of their manufacturing processes, identify areas for improvement, and ensure the consistent production of high-quality products.Key aspects of a manufacturing process audit may include:
- Documentation review: The auditor examines process documentation, including standard operating procedures (SOPs), work instructions, process flowcharts, and other relevant documents to ensure they are accurate, up-to-date, and being followed.
- Observation: The auditor directly observes the manufacturing process in action, looking for deviations from established procedures, potential bottlenecks, and areas where improvements can be made.
- Data analysis: The auditor may analyze production data, quality control records, and other performance metrics to identify trends, patterns, and possible issues affecting the manufacturing process.
- Compliance check: The auditor verifies whether the manufacturing process complies with relevant industry standards, safety regulations, and any applicable legal requirements.
- Root cause analysis: If any issues or non-conformities are identified during the audit, the auditor may conduct a root cause analysis to determine the underlying reasons for the problems and recommend corrective actions.
- Continuous improvement: A key objective of the audit is to identify opportunities for process improvement. The auditor may suggest changes or enhancements to the manufacturing process to increase efficiency, reduce waste, and enhance product quality.
Manufacturing process audits can be conducted by internal auditors from the same organization or by external auditors who are independent of the manufacturing process being assessed. These audits play a vital role in maintaining product quality, ensuring consistency, and enhancing overall manufacturing performance. They also contribute to building trust with customers and stakeholders by demonstrating a commitment to delivering high-quality products.Some of the most important benefits are the following:
- Helps ensure that products are manufactured according to company quality standards
- Helps identify potential problems with the manufacturing process so they can have corrective action before they cause defects in the finished product
- It Helps ensure that manufacturing processes are running smoothly and efficiently
- Helps ensure compliance with regulatory requirements
- Helps improve overall productivity
9.2.2.3 Manufacturing process audit
The organization has to 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, the organization must determine the approach to be used. Within each individual audit plan, each manufacturing process has to be 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.
The organization has to audit all manufacturing processes over each three-year calendar period to determine their effectiveness and efficiency. Conducting manufacturing process audits over a three-year calendar period helps to assess the effectiveness and efficiency of their production processes. This periodic audit approach allows the organization to gather sufficient data and make meaningful evaluations without being too burdensome on resources. .At the beginning of the three-year period, the organization should establish an audit plan. This plan outlines the schedule, scope, and objectives of the audits to be conducted during the period. It may identify the manufacturing processes that will be audited, the frequency of audits, and the resources required. The organization will decide which manufacturing processes will be audited based on their significance, risk level, impact on product quality, customer requirements, and any other relevant criteria. During the three-year period, individual audits are conducted based on the schedule outlined in the audit plan. The audits are typically carried out by internal or external auditors who have expertise in process evaluation and compliance. The auditors will gather relevant data during the audit process. This may include reviewing documentation, observing the manufacturing processes, interviewing personnel, and analyzing performance metrics. The auditors will assess the effectiveness and efficiency of the manufacturing processes based on predetermined criteria, such as adherence to standards, compliance with procedures, productivity levels, and quality output. Reporting: After each audit is completed, a comprehensive report is generated. The report includes findings, areas for improvement, non-conformities, and recommendations for corrective actions. Based on the audit findings, the organization will implement corrective actions to address identified issues and improve the manufacturing processes. Throughout the three-year period, the organization will continuously monitor the effectiveness of implemented corrective actions and make adjustments as needed. This process fosters a culture of continuous improvement within the organization. In some cases, follow-up audits may be conducted to verify that corrective actions have been effectively implemented and to ensure sustained improvements. By auditing all manufacturing processes over a three-year period, the organization can gain valuable insights into its overall manufacturing performance and identify trends or patterns that might not be apparent through more frequent but narrowly focused audits. It also allows them to allocate resources effectively and proactively address potential issues, resulting in enhanced product quality, increased efficiency, and improved customer satisfaction.
Customer-specific required approaches
When an organization is required to audit all its manufacturing processes using customer-specific approaches for process audits, it means that each customer may have their own unique set of requirements and expectations for how the audits should be conducted. These requirements could include specific audit criteria, evaluation methods, documentation, and reporting formats. Additionally, some customers might not provide explicit guidelines for the audit process, leaving the organization to decide on the appropriate approach.In such cases, the organization must follow these steps to ensure successful process audits. The first step is to thoroughly understand the specific requirements and expectations of each customer regarding process audits. This may involve reviewing contracts, quality agreements, specifications, and any other relevant documents provided by the customers. Based on the customer’s requirements and any industry standards or best practices, the organization should create tailored audit plans for each manufacturing process. These plans should outline the scope, objectives, audit criteria, methods, and resources to be used in the audits. Ensure that the internal or external auditors who will conduct the audits are well-trained and competent in using the customer-specific approach. They should be familiar with the audit criteria and methodologies required by each customer. During the audit, the organization must strictly adhere to the customer’s prescribed audit standards and procedures. The auditors should apply the specified evaluation methods and collect the required data accordingly. For customers who do not provide explicit audit requirements, the organization must be flexible and adaptable in determining the approach to be used. It may involve aligning with recognized industry standards or adopting best practices to ensure thorough and effective audits. After each audit, the organization should create comprehensive audit reports that align with the customer’s reporting format and include all the relevant findings, non-conformities, and corrective action recommendations. Open and transparent communication with customers is crucial throughout the audit process. The organization should share the audit results, address any customer concerns, and collaborate on implementing corrective actions when necessary. The organization should use the audit findings to drive continuous improvement efforts in their manufacturing processes. By addressing issues and making necessary enhancements, they can meet or exceed customer expectations. In summary, when faced with customer-specific approaches for process audits, the organization must carefully understand and comply with the unique requirements of each customer. By developing effective audit plans, using competent auditors, and maintaining open communication, the organization can demonstrate its commitment to quality and customer satisfaction.
Shift considerations
Auditing each manufacturing process on all shifts, including the appropriate sampling of shift handovers, is a comprehensive approach to ensure a thorough assessment of the process’s performance and consistency across different work shifts. Here’s how the organization can execute this process: For each manufacturing process, create a detailed audit plan that outlines the scope, objectives, and specific audit criteria to be evaluated during the audit. Determine the frequency of audits, ensuring that each shift is covered within the designated audit period. Identify all the shifts during which the manufacturing process occurs. This may include day shifts, night shifts, and any other shift patterns applicable to the organization’s production schedule. Determine the appropriate sampling size for each shift. The sample should be representative of the production activities and should provide sufficient data to assess the process’s effectiveness and compliance with standards. Pay special attention to shift handovers, where one shift’s team hands over responsibilities to the incoming shift. These handovers are critical points where communication and information transfer are crucial for maintaining process continuity and quality. During each shift, auditors should collect relevant data and observe the manufacturing process in action. This may include checking process parameters, equipment settings, quality control measures, and other critical factors. Engage with employees working on each shift to gain insights into their specific experiences and challenges during the production process. Effective communication with shift workers can provide valuable information about potential issues or opportunities for improvement. Assess whether the manufacturing process is being executed consistently across all shifts. Look for variations or deviations that may occur during different shifts and determine if there are any patterns or trends affecting process performance. Examine the shift handover procedures to ensure that critical information, including any ongoing process issues, quality concerns, and special instructions, are effectively communicated between shifts. After completing the audit for each shift, compile the findings into comprehensive reports. Compare the results between shifts and analyze any differences or trends observed. If any non-conformities or opportunities for improvement are identified during the audits, work with the relevant teams to implement corrective actions promptly. Use the audit findings and corrective actions to drive continuous improvement efforts across all shifts and manufacturing processes. By auditing each manufacturing process on all shifts, including sampling shift handovers, the organization can ensure that process effectiveness and efficiency are consistently monitored and improved. This approach also fosters a culture of accountability, encourages process standardization, and helps maintain a high level of product quality across all shifts.
Effective Implementation
Conducting an audit of the effective implementation of the process risk analysis, control plan, and associated documents is a critical aspect of ensuring the reliability, safety, and quality of the manufacturing processes. Here’s how the organization can carry out this audit:
- Audit Scope and Objectives: Define the scope and objectives of the audit, focusing on the examination of the process risk analysis (e.g., Process Failure Mode and Effects Analysis – PFMEA), control plan, and other related documents.
- Document Review: Gather and review all relevant documents, including the PFMEA, control plan, process flowcharts, work instructions, and any other documentation associated with the manufacturing process. Ensure these documents are up-to-date, accurate, and properly linked.
- Risk Analysis Assessment: Evaluate the effectiveness of the process risk analysis (PFMEA) by examining how well potential failure modes, their effects, and mitigation measures are identified and documented. Verify whether risk rankings are appropriately assigned and whether the documented actions are relevant and actionable.
- Control Plan Evaluation: Assess the control plan to determine if it adequately addresses the identified risks and ensures that appropriate control measures are in place to prevent or detect potential failures. Verify that the control plan aligns with the risk analysis and that it is followed consistently in the manufacturing process.
- Compliance Check: Verify whether the documented risk analysis and control plan comply with the organization’s internal standards, industry best practices, and any customer-specific requirements.
- Effectiveness Verification: Review records and data related to the process to assess the effectiveness of the implemented control measures in mitigating identified risks and preventing process deviations or defects.
- Associated Documents Audit: Ensure that all associated documents, such as standard operating procedures (SOPs), work instructions, training materials, and change management records, are consistent with the risk analysis and control plan.
- Process Operator Interviews: Interview the process operators and personnel involved in executing the manufacturing process to understand their awareness of risk analysis and control measures. Verify if they follow the prescribed procedures and if they have adequate training to handle potential risks effectively.
- Gap Identification: Identify any gaps or deviations between the documented risk analysis, control plan, and their actual implementation in the manufacturing process.
- Reporting and Corrective Actions: Compile the audit findings into a comprehensive report. Include any non-compliances, deviations, and improvement opportunities. Recommend corrective actions to address identified issues and enhance the effectiveness of the risk analysis and control plan implementation.
- Continuous Improvement: Use the audit results to drive continuous improvement efforts in the manufacturing processes. Implement corrective actions promptly and monitor their effectiveness over time.
By conducting audits that focus on the effective implementation of the process risk analysis, control plan, and associated documents, the organization can strengthen its risk management practices, improve product quality, and enhance overall process performance. These audits also contribute to maintaining compliance with quality standards and regulatory requirements.
