In the automotive industry, statistical tools and concepts are widely used to ensure product quality, process control, and continuous improvement. Various clauses o IATF 16949 arequire the application of these tools to achieve compliance and meet customer requirements. Here are some key statistical tools and concepts commonly used in the automotive industry, along with their application:

1. Control Charts (Clause 9.1.3.3 – IATF 16949): Control charts are fundamental tools for monitoring process stability and variation. They help identify special cause variation and prevent over-adjustment. Control charts are applied to various process parameters in the automotive industry to ensure that critical characteristics remain within specified control limits.
2. Process Capability Analysis (Clause 8.5.1.1 – IATF 16949): Process capability indices (e.g., Cp, Cpk) are used to assess the capability of manufacturing processes to meet customer specifications. This analysis ensures that the process is capable of consistently producing products within defined tolerances.
3. Design of Experiments (DOE) (Clause 8.5.1.2 – IATF 16949): DOE is applied during product and process design to optimize parameters and identify critical factors affecting product performance. It helps understand the relationships between process inputs and outputs.
4. Failure Mode and Effects Analysis (FMEA) (Clause 8.5.3.1 – IATF 16949): FMEA is used to analyze potential failure modes and their consequences on product performance. It aids in prioritizing risks and implementing appropriate preventive measures.
5. Statistical Process Control (SPC) (Clause 8.4.1.2 – IATF 16949): SPC involves using statistical techniques to monitor process performance and identify trends or deviations. Control charts, histograms, and other SPC tools are employed to keep processes in control and detect any signs of nonconformity.
6. Measurement System Analysis (MSA) (Clause 7.1.5.1 – IATF 16949): MSA assesses the accuracy, precision, and repeatability of measurement systems. This ensures that measurement data is reliable and trustworthy.
7. Sampling Plans (Clause 7.5.1.1 – IATF 16949): Sampling plans are applied during inspection and testing to determine the sample size and acceptance criteria. They help ensure representative data while reducing inspection costs.
8. Process Audits (Clause 9.2.2 – IATF 16949): Statistical concepts are used in process audits to assess process capability, stability, and adherence to defined control limits.
9. Continuous Improvement (Clause 10.2.1 – IATF 16949): Statistical tools and concepts underpin continuous improvement initiatives in the automotive industry. Analysis of historical data and performance metrics guides improvement efforts.

The automotive industry relies heavily on statistical tools and concepts to achieve consistent product quality, meet regulatory requirements, and drive process excellence. The effective application of these tools helps automotive companies deliver safe, reliable, and high-quality vehicles to customers worldwide.

You must plan and implement processes that measure, analyze and improve the health of your QMS. The focus of these processes must be on product and process conformity and improving QMS effectiveness. Consider using a variety of methods including statistical techniques. In planning what to track and measure, we should review the quality objectives we established and the performance indicators we established for our QMS processes and activities. You have to be careful not to overwhelm your organization with objectives as this may cause more frustration than positive results. Prioritize objectives and performance indicators to focus on meeting customer requirements and key or risk prone processes. Planning of measurement and data analyses processes must consider the methods and resources (time, manpower, computer, software, statistical tool, etc) needed to collect, organize and analyze product and QMS performance data. Use your APQP reference manual to determine what statistical methods to use for products and QMS processes and to what extent to use them. Include these methods in your control plan. Statistical methods for product development may include – variation analysis; regression analysis; dependability analysis; and prediction. Statistical methods for purchased product may include – histograms and stratification; Pareto fault analysis; sampling plans; criteria for acceptance statistics. Statistical methods to verify product characteristics and process parameters include – process capability studies; control charts; Pareto analysis; variation analysis (special cause, common cause). Statistical methods for field analysis include – dependability assessment; Pareto analysis; traceability analysis; Shainin techniques. Statistical methods for monitoring and measuring devices – refer to various techniques in your customer reference manuals – e.g. Measurement Systems Analysis (MSA) reference manual. Define and implement appropriate training and competency requirements for all personnel using statistical methods, tools and analysis.

9.1.1.2    Identification of statistical tools

The organization must decide on the suitable application of statistical tools. It should ensure that relevant statistical tools are integrated into the advanced product quality planning process or its equivalent, and are incorporated into the design risk analysis, such as DFMEA where applicable, the process risk analysis, such as PFMEA, and the control plan.

The standard require statistical tools to be identified for each process during the advanced quality planning phase and included in the control plan. Within your process you will therefore need a means of determining when statistical techniques will be needed to determine product characteristics and process capability. One way of doing this is to use checklists when preparing customer specifications, design specifications, and verification specifications and procedures. These checklists need to prompt the user to state whether the product characteristics or process
capability will be determined using statistical techniques and if so which techniques are to be used.Techniques for establishing and controlling process capability are essentially the same -the difference lies in what you do with the results. Firstly you need to know if you can make the product or deliver the service in compliance with the agreed specification. For this you need to know if the process is capable of yielding conforming product. Statistical Process Control techniques (SPC) will give you this information. Secondly you need to know if the product or service produced by the process actually meets the requirements. SPC will also provide this information. However, having obtained the results you need the ability to change the process in order that all product or service remains within specified limits and this requires either real-time or off-line process monitoring to detect and correct variance. To verify process capability you rerun the analysis periodically using sampling techniques by measuring output product characteristics and establishing that the results demonstrate that the process remains capable. There are many uses for statistical techniques in establishing and controlling product characteristics.

• Receipt inspection – a technique for verifying product characteristics where sampling can be used on large quantities to reduce inspection costs and improve throughput.
• SPC – a technique for controlling product characteristics as well as controlling processes.
• Reliability prediction – a technique for establishing product characteristics where the reliability targets cannot be measured without testing many hundreds of products over many thousands of hours. (On long production runs of low value items, reliability testing is possible but with one-off systems of high value it is not cost effective; hence reliability has to be predicted using statistical techniques.)
• Market analysis – a technique for establishing product characteristics where the customer requirements are revealed by market survey and determined by statistical techniques for inclusion in specifications.
• Design by experiment – a technique where product characteristics are established by conducting experiments on samples or by mathematical modeling to simulate the effects of certain characteristics and hence determine suitable parameters and limits.

When carrying out quality planning you will be examining intended product characteristics and it is at this stage that you will need to consider how achievement is to be measured and what tool or technique is to be used to perform the measurement. When you have chosen the tool, you need to describe its use in the control plan. Statistical tools are powerful techniques that aid in analyzing data, identifying patterns, and making informed decisions in manufacturing and other processes. The organization must assess when and how to use these tools effectively to improve process understanding, control, and performance. Here are some key considerations for determining the appropriate use of statistical tools:

Process Complexity: Consider the complexity of the manufacturing process. Statistical tools are particularly useful when dealing with complex processes with multiple variables and interactions. Simpler processes may not require extensive statistical analysis.

1. Data Availability: Statistical tools require sufficient data for meaningful analysis. Evaluate whether enough data is available to support the use of statistical methods.
2. Process Stability: Determine if the process is stable before applying statistical tools. It’s essential to have a stable process to get accurate and reliable results from statistical analysis.
3. Process Capability: Assess if the process is capable of meeting the desired specifications. Statistical tools, like process capability analysis, help evaluate whether the process is capable of producing within specified tolerances.
4. Variability: Identify sources of variability in the process and determine if statistical tools can help understand and reduce this variability.
5. Root Cause Analysis: Statistical tools can aid in root cause analysis by identifying factors contributing to non-conformances or inefficiencies in the process.
6. Continuous Improvement: Statistical tools play a crucial role in continuous improvement initiatives, helping monitor process performance and identify opportunities for enhancement.
7. Understanding and Expertise: Evaluate the organization’s level of understanding and expertise in using statistical tools. Proper training and knowledge are essential for applying statistical methods accurately.
8. Resource Availability: Consider the availability of skilled personnel and resources to conduct statistical analysis effectively. Regulatory and Customer Requirements: Determine if statistical analysis is mandated by regulatory bodies or required by customers for certain processes or products.
9. Risk Assessment: Conduct a risk assessment to determine if the potential benefits of using statistical tools outweigh the associated costs and efforts.

Some commonly used statistical tools in manufacturing processes include control charts, process capability analysis, hypothesis testing, design of experiments (DOE), regression analysis, and Pareto analysis, among others. By carefully assessing the appropriateness of statistical tools, organizations can make data-driven decisions, optimize processes, and continuously improve product quality, thus enhancing overall performance and customer satisfaction.

The standard emphasizes the importance of including appropriate statistical tools in various phases of the quality planning process, such as Advanced Product Quality Planning (APQP) or its equivalent. These statistical tools are instrumental in conducting design and process risk analysis, as well as developing control plans to ensure product quality. Here’s how statistical tools are integrated into different aspects of the quality planning process:

1. Advanced Product Quality Planning (APQP): APQP is a structured approach used in the automotive industry (and other sectors) to ensure that products meet customer requirements and are launched successfully. Statistical tools are essential components of APQP to support data-driven decision-making and risk management.
2. Design Risk Analysis (DFMEA – Design Failure Mode and Effects Analysis): DFMEA is a method used during the design phase to identify potential failure modes and their effects on the product’s performance. Appropriate statistical tools can be applied in DFMEA to assess the severity, occurrence, and detection ratings of failure modes, helping prioritize and address critical risks.
3. Process Risk Analysis (PFMEA – Process Failure Mode and Effects Analysis): PFMEA is used to assess potential failure modes in the manufacturing process and their impacts on product quality. Statistical tools can assist in analyzing historical process data, identifying key process parameters, and quantifying the potential risks associated with failure modes.
4. Control Plan: The Control Plan outlines the specific control measures and activities to ensure that the manufacturing process remains in control and capable of meeting quality requirements. Statistical tools play a vital role in developing control plans by defining appropriate control limits, inspection frequencies, and acceptance criteria based on data analysis.

Examples of statistical tools commonly used in quality planning include:

• Control Charts: For monitoring process stability and identifying trends or deviations.
• Process Capability Analysis: To assess the capability of a process to meet specified tolerances.
• Design of Experiments (DOE): To optimize process parameters and identify significant factors affecting product quality.
• Pareto Analysis: To prioritize issues based on their frequency and impact.
• Failure Mode and Effects Analysis (FMEA): For risk assessment and mitigation.

By incorporating appropriate statistical tools throughout the quality planning process, organizations can ensure a systematic and data-driven approach to managing risks, enhancing product quality, and meeting customer expectations. These tools help organizations make informed decisions, continuously improve processes, and deliver products that consistently meet high-quality standards.

9.1.1.3    Application of statistical concepts

Employees involved in collecting, analyzing, and managing statistical data must comprehend and utilize statistical concepts such as variation, control (stability), process capability, and the impacts of over-adjustment.

The organization is to establish and maintain process to implement and control the application of statistical techniques. Where statistical techniques are used for establishing, controlling, and verifying process capability and product characteristics, procedures need to be produced for each application. You might for instance need a Processes for Process Control , Process Capability Analysis , Receipt Inspection , Reliability Prediction , Market Analysis , etc. The process need to specify when and under what circumstances the techniques should be used and provide detailed instruction on the sample size, collection, sorting, and validation of input data, the plotting of results and application of limits. Guidance will also need to be provided to enable staff to analyze
and interpret data, convert data, and plot the relevant charts as well as make the correct decisions from the evidence they have acquired. Where computer programs are employed, they will need to be validated to demonstrate that the results being plotted are accurate. You may be relying on what the computer tells you rather than on any direct measurement of the product.

The standard emphasizes the importance of employees understanding and using key statistical concepts in the context of data collection, analysis, and management. Statistical concepts are essential tools for ensuring quality, process control, and continuous improvement in various industries. Here are the key statistical concepts that employees involved in statistical data should understand and use:

1. Variation: Variation refers to the natural differences or fluctuations that exist in any process or data. Understanding variation is crucial because it helps identify the normal range of performance and distinguish between common cause variation (inherent to the process) and special cause variation (due to specific factors).
2. Control (Stability): Process control, also known as stability, refers to the state when a process is consistent and predictable over time. Control charts are commonly used to monitor process stability and detect any unusual patterns or trends that might indicate a process going out of control.
3. Process Capability: Process capability analysis assesses a process’s ability to produce output within specified tolerances. Employees should understand how to calculate and interpret process capability indices like Cp, Cpk, Pp, and Ppk, which provide insights into process performance and its ability to meet customer requirements.
4. Over-Adjustment (Tampering): Over-adjustment, also known as tampering, occurs when personnel intervene in a stable process in response to random variation. This can lead to increased variability and poorer process performance. Employees should be aware of the consequences of over-adjustment and the importance of letting a stable process remain in control.
5. Data Collection and Sampling: Understanding proper data collection methods and sampling techniques is crucial to ensure that the data collected accurately represents the process or population being studied.
6. Statistical Analysis Techniques: Employees should be familiar with various statistical analysis techniques, such as hypothesis testing, regression analysis, design of experiments (DOE), and analysis of variance (ANOVA). These tools help extract insights from data and make informed decisions.
7. Interpreting Graphs and Charts: The ability to interpret graphs and control charts is essential for understanding process performance and identifying trends or anomalies in the data.
8. Statistical Software: Proficiency in using statistical software, such as Microsoft Excel, Minitab, or other specialized tools, can facilitate data analysis and reporting.

Having a workforce that understands these statistical concepts enables organizations to make data-driven decisions, identify process improvements, and implement effective quality management practices. It fosters a culture of continuous improvement and empowers employees to play an active role in ensuring the overall quality and efficiency of the organization’s processes. It is not sufficient to train staff solely in the techniques they need to use – a wider appreciation of the concepts will facilitate improved application. The staff assigned to quality planning need an even wider appreciation of statistical concepts and it is probably useful to have an expert in your company upon whom staff can call from time to time. If the primary technique is SPC then you should appoint an SPC coordinator who can act as mentor and coach to the other operators of SPC techniques. All managers need a basic appreciation but those in production ought to be able to apply the techniques their staff use in order to be able to detect when they are not being applied correctly. Auditors need to be able to determine whether the right techniques are being applied and whether the techniques are being applied as directed.

Monitoring and measurement of manufacturing processes refer to the systematic and ongoing activities of collecting data and evaluating the performance of various aspects of the production process to ensure its efficiency, effectiveness, and quality. The goal is to continuously assess and control the manufacturing processes to meet the desired product specifications, maintain consistent product quality, and identify opportunities for improvement. The process involves gathering relevant data from various stages and elements of the manufacturing process. This data can include process parameters, operating conditions, material properties, machine settings, and other relevant variables. In many cases, monitoring involves real-time observation of the manufacturing process as it happens. This can be done using sensors, gauges, cameras, or other devices that provide live data on process conditions. Once the data is collected, it is analyzed to identify patterns, trends, and variations. Statistical analysis and process control techniques are often used to gain insights into the process performance. Monitoring and measurement are essential components of quality control. By continuously measuring critical parameters, manufacturers can identify deviations from the desired quality standards and take corrective actions promptly. Monitoring helps assess the stability and capability of the manufacturing processes. Stable processes show consistent performance over time, while capable processes are those that produce products within specified tolerances. Through monitoring and measurement, manufacturers can identify inefficiencies or bottlenecks in the process and optimize it to improve productivity and reduce waste. Monitoring is essential to ensure compliance with industry standards, regulations, and customer requirements. By measuring key parameters, manufacturers can verify that they are meeting the necessary standards. Regular monitoring and measurement provide valuable data for continuous improvement initiatives. By analyzing the data and identifying areas for enhancement, manufacturers can implement changes to optimize their processes. Preventive Maintenance: Monitoring equipment and machines can help detect early signs of potential issues, allowing for timely preventive maintenance to prevent costly breakdowns and downtime. Monitoring and measurement activities also contribute to product traceability, as data records can be used to track and verify the history of products throughout the manufacturing process. In summary, monitoring and measurement of manufacturing processes are crucial for maintaining product quality, process efficiency, and compliance with standards. By continuously collecting and analyzing data, manufacturers can make informed decisions, implement improvements, and ensure that their production processes consistently meet the desired specifications and objectives.

Clause 9.1.1.1 Monitoring and measurement of manufacturing processes

The organization is required to conduct process studies for all new manufacturing processes, including assembly or sequencing, to confirm process capability and provide input for process control, particularly for special characteristics. They must uphold manufacturing process capability or performance results as specified by the customer’s part approval process requirements. Additionally, the organization must ensure implementation of the process flow diagram, PFMEA, and control plan, including adherence to measurement techniques, sampling plans, acceptance criteria, and recording of actual measurement values or test results for variable data. Significant process events like tool changes or machine repairs should be documented and retained. In instances where characteristics are either statistically incapable or unstable, the organization must enact reaction plans outlined in the control plan, which may involve product containment and 100 percent inspection as needed. Furthermore, corrective action plans should be devised and executed to stabilize the process and achieve statistical capability, detailing specific actions, timelines, and assigned responsibilities. These plans may require customer approval. The organization should maintain records of process change effective dates. In cases where demonstrating product compliance through process capability is challenging for certain manufacturing processes, alternative methods such as batch conformance to specification may be considered.

You must establish methods and indicators to monitor and measure your manufacturing processes to demonstrate process capability to achieve planned results and identify opportunities to improve the process. Use your organizations cross-functional knowledge of customer requirements, product, technology, manufacturing processes, etc, to determine process monitoring and measuring indicators and controls. Monitoring and measurement may be done manually or by automated means. One way to identify useful measuring and monitoring methods is to review what problems could occur or have occurred within a particular process. Monitor and measure these occurrences and develop process controls (methods) to reduce or eliminate them. Problems (risks) can occur with any of the variables in a process – e.g. – materials, equipment, facility, methods, technology, personnel, computer hardware or software etc. By using fishbone analysis or similar tools, you can develop very useful monitoring and measuring methods and process performance indicators.  Correction refers to action taken to eliminate a detected nonconformity . You must monitor your manufacturing QMS processes, first to determine and establish capability of new processes to conform to requirements and secondly, to monitor these processes over time to verify ongoing stability and capability to meet requirements and thirdly to determine and achieve levels of continual improvement. Use your APQP, FMEA, MSA and PPAP reference manuals for guidance in determining process monitoring and measuring indicators and controls. The output of your manufacturing process design process must specify the manufacturing process capability, reliability, maintainability & availability indicators, as well as process approval acceptance criteria. Your manufacturing process capability performance must conform to the capability documented in your PPAP submission or agreed with your customer in writing. You must keep records of this ongoing conformance to your customer requirements and use this information to identify opportunities to improve the process. The measurement techniques, sampling plans, acceptance criteria and reaction plans must be documented or referenced in your control plan. Managers responsible for corrective action must be promptly informed of product and process nonconformities . Where the customer is significantly affected by a process nonconformity or change, they must be notified. Corrective action plans as well as resulting updated/changed PPAP’s must be reviewed and approved by the customer, when so required. If in doubt, get clarification from the customer.
Use your manufacturing design process and change control process to manage manufacturing process changes. Performance indicators are not needed for this clause as it provides direction for the application of monitoring and measurement performance indicators for all processes. However the output of monitoring and measurement methods used within each process provides useful performance indicators for determining the effective implementation and maintenance of processes. Review the performance indicators within each process covered this far. Performance indicators to measure process effectiveness and efficiency include – productivity; reduction of cycle time, waste, errors, omissions and failures; asset utilization rates (downtime, turnover), etc. Don’t overlook performance indicators to measure compliance with process related regulatory requirements – e.g., reduction in health and safety incident/violation rates; reduction in regulatory reporting violations, etc.

When a new manufacturing process is introduced or significantly modified, it is crucial to conduct process studies. These studies involve the systematic examination and evaluation of the process to understand its characteristics, potential risks, and performance capabilities.Process capability refers to the ability of a manufacturing process to produce products that consistently meet the desired specifications. By performing process studies, the organization can assess whether the new process is capable of meeting the required quality standards. Process control involves managing and regulating the manufacturing process to ensure it operates within defined parameters and produces products of consistent quality. The data and insights obtained from process studies play a significant role in establishing effective process control measures. In the automotive industry and other sectors with critical product requirements, certain product characteristics are designated as “special characteristics.” These are features that have a significant impact on product performance, safety, or regulatory compliance. Process studies help identify and control these special characteristics to prevent defects and ensure product integrity. The information gathered through process studies serves as valuable input for developing control plans, setting process parameters, and implementing control measures. It helps establish a clear understanding of the critical process parameters and how to monitor and control them effectively.Overall, conducting process studies for new manufacturing processes is essential for ensuring that the organization can produce products that consistently meet customer requirements and adhere to industry standards. It supports the establishment of robust process control measures and plays a key role in identifying and managing special characteristics, leading to improved product quality and customer satisfaction.The object of a process control system is to make economic and sound decisions about the actions affecting the process. Data concerning the variations in process performance are collected and analyzed and decisions taken as to whether action on the process is or is not necessary to maintain production of conforming product . However, process control and process capability are not one and the same. A process is in control when the average spread of variation coincides with the nominal specification for a parameter. The range of variation may extend outside the upper and lower limits but the proportion of parts within the limits can be predicted. This situation will remain as long as the process remains in statistical control. A process is in statistical control when the source of inherent variation is from common causes only: i.e. a source of variation that affects all the individual values of the process output and appears random. Common cause variation results in a stable and repeatable distribution of results over time. When the source of variation causes the location, spread, and shape of the distribution to change, the process is not in statistical control. These sources of variation are due to special or assignable causes and must be eliminated before commencing with process capability studies. It is only when the performance of a process is predictable that its capability to meet customer expectations can be assessed. Process capability studies are studies conducted to obtain information about the inherent variation present in processes that are under statistical control, in order to reduce the spread of variation to less than the tolerances specified in the product specification. Preliminary process capability studies are those based on measurements collected from one operating run to establish that the process is in statistical control and hence no special causes are present. Studies of unpredictable processes and the determination of associated capability indices have little value. Preliminary studies should show acceptable results for special characteristics before production approval can be given. These studies and associated indices only apply to the measurement of variables and not to attributes Several measures of process capability have evolved and are presented as indices C_p, C_pk, and P_pk. Acceptable processes are those with a P_pk value greater than 1.67. Those with P_pk between 1.33 and 1.67 may not meet customer requirements but approval may be granted. If the P_pk is less than 1.33, the process is not acceptable. The object of the studies is to compute the indices and then take action to reduce common cause variation by preventive maintenance, mistake-proofing, operator training, revision to procedures and instructions, etc. The inherent limitations of attribute data prevent their use for preliminary statistical studies since specification values are not measured. Attribute data have only two values (conforming/nonconforming, pass/fail, go/no-go, present/absent) but they can be counted, analyzed, and the results plotted to show variation. Measurement can be based on the fraction defective, such as parts per million (PPM). While variables data follows a distribution curve, attribute data varies in steps since you can’t count a fraction. There will either be zero errors or a finite number of errors. Following production launch, process capability and performance should be measured continually in order to demonstrate that your processes remain capable and the capability index continues to rise. Appropriate action should be taken on characteristics that are either unstable or non-capable. Action plans should be implemented to contain process output and continually improve performance.

Customer’s part approval process requirements

The organization must maintain manufacturing process capability or performance results in line with customer requirements, specifically related to the part approval process. Process capability is the ability of a manufacturing process to consistently produce products that meet the desired specifications. It indicates how well the process can control its variation and produce products within the specified tolerances. Maintaining process capability is crucial for ensuring consistent product quality. Performance results is the data and metrics obtained from monitoring and measuring the manufacturing process. This data provides insights into how well the process is performing and whether it meets the required performance standards. The Part Approval Process (PPAP) is a standardized method used in the automotive industry and other sectors to ensure that the manufacturing process is capable of consistently producing parts that meet customer specifications. The customer may have specific requirements for process capability and performance that the organization must adhere to. The organization is responsible for continuously monitoring and measuring the manufacturing process and ensuring that it remains capable and performs as required by the customer’s PPAP requirements. This involves regular data collection, analysis, and process control activities. The organization must communicate the process capability or performance results to the customer as part of the PPAP submission. This ensures that the customer has confidence in the organization’s ability to deliver products that meet their quality expectations. In cases where the process capability or performance does not meet customer requirements, the organization should take corrective actions and implement improvements to bring the process back into compliance. Maintaining manufacturing process capability and performance results as specified by the customer’s PPAP requirements is essential for achieving customer satisfaction, meeting contractual obligations, and demonstrating the organization’s commitment to delivering high-quality products. It involves proactive monitoring, data-driven decision-making, and a continuous improvement mindset to ensure that the manufacturing process remains capable and consistently meets customer expectations.

Verification of process flow diagram, PFMEA and control plan

It is the organization’s responsibility to verify the implementation of essential documents such as the process flow diagram, Process Failure Mode and Effects Analysis (PFMEA), and control plan. This verification process involves ensuring adherence to various aspects related to measurement techniques, sampling plans, acceptance criteria, record-keeping, and reaction plans when acceptance criteria are not met. Let’s break down the key points in the statement:

1. Process Flow Diagram: The process flow diagram provides a visual representation of the sequence of steps in the manufacturing process. The organization must verify that the process flow diagram accurately reflects the actual process and that all process steps are implemented as specified.
2. Process Failure Mode and Effects Analysis (PFMEA): PFMEA is a risk assessment tool used to identify potential failure modes, their effects on the product, and the actions needed to prevent or mitigate those failures. The organization must ensure that the PFMEA is appropriately implemented, and the identified risk mitigation measures are put into practice.
3. Control Plan: The control plan outlines the specific control measures and activities to ensure that the manufacturing process remains in control and capable of meeting quality requirements. The organization must verify that the control plan is followed and that all identified controls are effectively implemented.
4. Adherence to Measurement Techniques: The organization should verify that the specified measurement techniques for monitoring process parameters and product characteristics are being followed correctly. This may involve using specific instruments, calibration procedures, and data collection methods.
5. Sampling Plans: Sampling plans determine how samples are taken from a production lot for inspection and testing. The organization must ensure that the correct sampling plans are used and that they align with the relevant standards or customer requirements.
6. Acceptance Criteria: Acceptance criteria define the quality standards that products must meet to be accepted. The organization must verify that these criteria are clearly defined, communicated, and adhered to during inspection and testing activities.
7. Records of Measurement Values and Test Results: The organization should maintain records of actual measurement values and test results for variable data. These records provide evidence of product conformity and are essential for traceability and process improvement.
8. Reaction Plans and Escalation Process: The organization must have documented reaction plans in place to address situations where acceptance criteria are not met. These plans should outline the steps to be taken to investigate the root cause, implement corrective actions, and prevent recurrence. Additionally, there should be an escalation process to notify relevant stakeholders if critical quality issues arise.

Verification of these elements ensures that the manufacturing process is well-controlled, capable, and consistently producing products that meet the required quality standards. It supports the organization’s commitment to quality and customer satisfaction by addressing potential risks, preventing defects, and providing a structured approach for addressing nonconformities.

Reaction Plan

The standard emphasizes the organization’s responsibility to initiate a reaction plan when characteristics of a manufacturing process are either not statistically capable or are unstable. The reaction plan, as indicated on the control plan, should be implemented to evaluate the impact on compliance to specifications. In situations where the process is not capable or stable, the reaction plan may include containment actions and 100 percent inspection, as appropriate. A statistically not capable characteristic is one where the manufacturing process does not have the ability to produce the characteristic within the desired specifications consistently. An unstable characteristic is one where the process exhibits excessive variability over time. The control plan outlines the control measures and activities to ensure that the manufacturing process is in control and capable of meeting quality requirements. Within the control plan, a reaction plan should be specified for addressing situations where characteristics are not statistically capable or are unstable. When the process exhibits characteristics that are not statistically capable or unstable, the organization must initiate the predefined reaction plan promptly. This ensures that appropriate actions are taken to address the issue and prevent nonconforming products from reaching the customer. The reaction plan should include an evaluation of the impact on compliance to product specifications. This involves assessing how the unstable or not capable characteristic affects the final product’s quality and performance. Containment actions are taken to prevent nonconforming products from reaching the customer. This may involve segregating and holding suspect products until the root cause of the issue is identified and corrective actions are implemented. In some cases, 100 percent inspection of products may be necessary to ensure that each item meets the required specifications. This level of inspection is often used when the process is not capable or stable, and the risk of nonconformities is high.The purpose of the reaction plan is to address quality issues proactively and prevent nonconforming products from reaching the customer. By evaluating the impact on compliance to specifications and taking appropriate containment and inspection measures, the organization can mitigate risks associated with unstable or not statistically capable characteristics. The goal is to identify the root causes of the issues and implement corrective actions to improve process capability and stability, thus ensuring consistent product quality and customer satisfaction.

Corrective action plan

It states the requirement for the organization to develop and implement a corrective action plan when the manufacturing process is not stable and statistically capable. The corrective action plan should outline specific actions, timelines, and assigned responsibilities to address the issues and improve process stability and capability. Additionally, the plan may require review and approval by the customer, depending on the circumstances. The organization must first identify that the manufacturing process is not stable or statistically capable. This may be determined through process monitoring, data analysis, or other quality control methods. Once the process instability or lack of capability is identified, the organization must develop a corrective action plan. This plan outlines the steps that will be taken to address the root causes of the issues and improve process performance. The corrective action plan should clearly define specific actions that need to be taken to address the identified problems. These actions may include process adjustments, changes to process parameters, equipment calibration, training, or other measures. The plan should include timelines for implementing each action. Timelines help ensure that the corrective actions are executed promptly and efficiently. The plan should clearly specify who is responsible for each action. Assigning responsibilities ensures accountability and facilitates effective execution of the corrective measures. In some cases, depending on the severity of the issues and customer requirements, the corrective action plan may need to be reviewed and approved by the customer. This ensures that the customer is aware of the actions being taken to address the issues and that the proposed solutions align with their expectations. Implementation: Once the corrective action plan is developed and approved (if required), the organization must implement the identified actions as per the specified timelines and responsibilities. Monitoring and Verification: The effectiveness of the corrective actions should be monitored and verified to ensure that the process becomes stable and statistically capable as intended. This may involve ongoing data analysis and process performance evaluation. By developing and implementing a well-structured corrective action plan, the organization can address process instability and lack of capability effectively. The plan helps in resolving quality issues, improving process performance, and ultimately enhancing product quality and customer satisfaction.

Maintaining records of effective dates of process changes

Maintaining records of significant process events, such as tool changes or machine repairs, is a crucial requirement in quality management to ensure traceability and process control. Additionally, the organization is responsible for keeping records of the effective dates of process changes. These records are vital for quality assurance, process improvement, and compliance with quality management standards .

1. Significant Process Events: Significant process events refer to any critical activities or changes in the manufacturing process that may impact product quality, process capability, or compliance with standards. Examples include tool changes, machine repairs, equipment adjustments, or process parameter modifications.
2. Recording of Significant Process Events: When such events occur, the organization must document them in a systematic manner. This documentation should include details such as the event’s nature, date and time, reasons for the event, personnel involved, and any specific actions taken.
3. Retention of Records: The organization must retain these records for a specified period, as required by relevant quality management standards or customer requirements. Retention periods can vary depending on industry regulations and organizational policies.
4. Traceability and Root Cause Analysis: By recording significant process events, the organization ensures that there is traceability of actions taken in the event of any issues or non-conformances. These records also facilitate root cause analysis, helping identify the cause of any problems and implementing corrective and preventive actions.
5. Maintaining Effective Dates of Process Changes: In addition to recording the occurrence of process events, the organization must also keep track of the effective dates of process changes. This information allows the organization to assess the impact of process modifications on product quality and performance over time.
6. Process Control and Improvement: By maintaining a comprehensive record of significant process events and changes, the organization can effectively manage its processes, monitor trends, and implement continuous improvement initiatives.
7. Audit and Compliance: Records of significant process events and process changes play a vital role during internal and external audits. They demonstrate the organization’s commitment to process control and compliance with quality standards.

Overall, recording and maintaining records of significant process events and effective dates of process changes are essential practices to ensure transparency, process control, and continuous improvement in the manufacturing environment. These records provide valuable insights for decision-making, risk management, and enhancing the overall efficiency and effectiveness of the organization’s quality management system.

Alternative methods

In certain manufacturing processes, it may not be feasible or practical to demonstrate product compliance through traditional process capability analysis, especially when the process is complex or produces unique products. In such cases, alternative methods can be used to assess and demonstrate product compliance, and one such method is “batch conformance to specification.”Batch conformance to specification involves evaluating product quality by inspecting and testing specific batches of products to ensure they meet the required specifications and quality standards. Instead of relying solely on process capability metrics, this method focuses on verifying the compliance of individual batches of products.Here’s how batch conformance to specification works:

1. Batch Sampling: In this method, specific batches of products are selected for inspection and testing. The size and frequency of batch sampling depend on the product complexity, the criticality of the characteristics being evaluated, and the level of confidence required.
2. Inspection and Testing: During the batch sampling, products are inspected and tested against the defined specifications and acceptance criteria. This can involve various quality control techniques, including visual inspections, dimensional measurements, functional testing, and material analysis.
3. Acceptance Criteria: The acceptance criteria for each batch are typically based on customer requirements, industry standards, or internal quality specifications. Products within the batch must meet these criteria to be considered compliant.
4. Recording Results: The results of the inspection and testing are recorded, and the compliance of each batch is documented. This data serves as evidence of product quality and can be used for traceability and reporting purposes.
5. Continuous Improvement: The organization can analyze the data from batch conformance to specification to identify trends, potential issues, or areas for improvement. This information can guide efforts to enhance process performance and product quality.

While batch conformance to specification provides an alternative method for demonstrating product compliance, it is essential to recognize that this approach does not guarantee the stability and capability of the entire manufacturing process. It focuses on assessing the quality of individual batches rather than the overall process performance.Organizations adopting this method should carefully consider its suitability for their specific manufacturing processes and product requirements. In some cases, combining batch conformance to specification with other quality control methods, such as statistical process control and continuous improvement initiatives, can provide a more comprehensive approach to ensuring product compliance and process stability.

The definition of nonconformity states that it is the nonfulfillment of specified requirements; therefore a nonconforming product is one that does not conform to the specified requirements. Specified requirements are either requirements prescribed by the customer and agreed by the organization in a contract for products or services, or are requirements prescribed by the organization which are perceived as satisfying a market need & statutory and regulatory requirements This requirements applies to products, processes, and services and not to activities, quality system elements, or procedures. Any product may be considers as non conforming product which does not :

• Satisfy the specified requirements
• Satisfy intended usage requirements
• Satisfy stated or implied needs
• Satisfy your own requirements
• Satisfy customer expectations

You should classify all failures to meet these requirements as non- conformities and then assign classification so as to treat each according to its merits.

Clause 8.7.1.3 Control of suspect product

The organization is responsible for categorizing and managing products with unidentified or suspicious status as nonconforming items. Additionally, the organization must ensure that all relevant manufacturing personnel receive training on how to handle and contain suspect and nonconforming products.

The standard indicates that these requirements are to apply to product that is suspected of being nonconforming -which might be the case with a batch of product that has failed the sampling inspection. Only the samples checked are definitely nonconforming-the others in the batch are only suspected as being nonconforming. You should therefore look further than the product that has been found to be nonconforming and seek out other products which may possess the same characteristics as those found to be nonconforming. These other products may have already been released to customers. This latter situation can arise if you discover the measuring or processing equipment to be inaccurate or malfunctioning. Any product that has passed through that process since it was last confirmed as serviceable is now suspect. Seeking suspect product should also be a factor to be considered when determining corrective action. Another example of suspect product is when product is mishandled but shows no obvious signs of damage. This may arise when product is dropped or not handled in the stipulated clean conditions or in accordance with electrostatic safe-handling procedures. Suspect product should be treated in the same manner as nonconforming product and quarantined until dispositioned. However, until a nonconformity can be proven, the documentation of the nonconformity merely reveals the reason for the product being suspect.

Classifying nonconformities
Although the standard does not explicitly classify nonconformities, the practical application of nonconformity controls requires controls to be balanced with the severity Of the nonconformity. It is not necessary to seek concessions from a customer against requirements that have not been specified, or seek design authority approval for workmanship imperfections. The definition of the term defect , and the fact that there are many requirements other than those specified in a contract or needed to satisfy market needs, demands that it is sensible to classify nonconformities into three categories:

• Critical Nonconformity: a departure from the specified requirements which renders the product or service unfit for use
• Major Nonconformity: a departure from the specified requirements included in the contract or market specification
• Minor Nonconformity: a departure from the supplier’s requirements not included in the contract or market specification

it is crucial for the organization to classify and control products with an unidentified or suspect status as nonconforming. When there is uncertainty about the status of a product, treating it as nonconforming helps prevent potential risks and ensures that proper control measures are implemented to manage its disposition effectively. Products with an unidentified or suspect status may pose risks to quality, safety, or compliance. Treating them as nonconforming ensures that they are properly assessed and managed to avoid any adverse impact. Treating products with uncertain status as nonconforming prevents their accidental use or distribution, reducing the likelihood of customer complaints or safety incidents. Classifying products as nonconforming creates a clear record of their status, ensuring traceability and enabling accountability for managing the situation. Taking prompt action and controlling products with an unidentified status demonstrates the organization’s commitment to maintaining quality standards, which helps build customer confidence.

Segregation of nonconforming product
The standard requires the supplier to provide for the segregation of nonconforming product and that quarantine areas have visual identification. Segregating a nonconforming product (or separating good from bad) places it in an area with restricted access. Such areas are called quarantine areas. Products should remain in quarantine until disposal instructions have been issued. The area should be clearly marked and a register maintained of all items that enter and exit the area. Without a register you won’t be able to account for the items in the area, check whether any are missing, or track their movements. The quarantine store may be contained within another area, providing there is adequate separation that prevents mixing of conforming and nonconforming articles. Where items are too large to be moved into a quarantine area, measures should be taken to signal to others that the item is not available for use and this can be achieved by cordons or floor markings. With services the simplest method is to render the service unavailable or inaccessible.

Review of nonconforming product
The organization is to review nonconforming product in accordance with documented procedures and advises that it may be:

1. Reworked to meet the specified requirements, or
2. Accepted with or without repair by concession, or
3. Regraded for alternative applications, or d) Rejected or scrapped.

If you choose to accept a nonconforming item as is without rework, repair, etc., you are in effect granting a concession or waiving the requirement only for that particular item. If the requirements cannot be achieved at all, this is not a situation for a concession but a case for a change in requirement. If you know in advance of producing the product or service that it will not conform with the requirements, you can then request a deviation from the requirements. This is often referred to as a production permit. Concessions apply after the product has been produced, production permits apply before it has been produced and both are requests that should be made to the acceptance authority for the product. In some cases products and services are offered in several models, types, or other designations but are basically of the same design. Those which meet the higher specification are graded as such and those which fail may meet a lower specification and can be regraded. The grading should be reflected in the product identity so that there is no confusion. The inclusion of the term rejected is not a disposition because all nonconforming items are initially rejected. Items may be rejected and then returned to their supplier for action but all other rejections should be subject to one of the other dispositions. Scrapping an item should not be taken lightly — it could be an item of high value. Scrapping may be an economical decision with low cost items, whereas the scrapping of high value items may require prior authorization as salvage action may provide a possibility of yielding spares for alternative applications. The list in the standard omits two other possibilities, those of modification and completion. A product that is nonconforming may be so due to errors in the specification and can be eliminated by a modification to the design. The product may meet the specified requirement but be unfit for use, in which case this is a major modification. Alternatively, the product may meet the supplier’s specifications but not meet the customer or market specified requirements; this calls for a minor modification. Some modifications may be necessary only for certain batches due to variations in material or component tolerances. Modifications may be necessary to overcome component obsolescence or changes in bought-in parts that were not covered by the procurement specification. Completion of product is different to rework as “rework” implies that something was carried out incorrectly whereas “returning product for completion” implies that something was not done at all. To meet this requirement your documented procedures should specify the authorities who make the disposition, where it is to be recorded, and what information should be provided in order that it can be implemented and verified as having been implemented. In order to implement these requirements your nonconformity control procedures should include the following actions:

• Specify how product should be scrapped or recycled, the forms to be used, the authorizations to be obtained.
• Specify the various repair procedures, how they should be produced, selected, and implemented.
• Specify how modifications should be defined, identified, and implemented.
• Specify how production permits (deviations) and concessions (waivers) should be requested, evaluated, and approved or rejected.
• Specify how product should be returned to its supplier, the forms to be completed, and any identification requirements in order that you can detect product on its return.
• Specify how regrading product is to be carried out, the product markings, prior authorization, and acceptance criteria.

When making the disposition your remedial action needs to address:

• Action on the nonconforming item to remove the nonconformity
• A search for other similar items which may be nonconforming (i.e. suspect product)
• Action to recall product containing suspect nonconforming product

If you need to recall product that is suspected as being defective you will need to devise a recall plan, specify responsibilities and time-scales, and put the plan into effect. Product recall is a remedial action not a corrective action, as it does not prevent a recurrence of the initial problem. An auditor would expect to find staff consulting the rework instructions when carrying out rework. However, information in documents can be memorized or become habit through familiarity with the process. Rework instructions are often unique to the non-conformity and therefore personnel cannot rely on prior knowledge. When deciding on repair or rework action, you may need to consider whether the result will be visible to the customer on the exterior of the product. Rework or repairs that may not be visible when a part is fitted into the final assembly might be visible when these same parts are sold as service spares. To prevent on-the-spot decisions being at variance each time, you could:

1. Identify in the drawings, plans, etc. those products which are supplied for service applications: i.e. for servicing, maintenance, and repair.
2. Provide the means for making rework invisible where there are cost savings over scrapping the item.
3. Stipulate on the drawings etc. the approved rework techniques.

Use of nonconforming product
The standard requires that where required by the contract, the proposed use or repair of product which does not conform to specified requirements shall be reported for concession to the customer or customer’s representative. The supplementary requirement requires customers to be informed promptly in the event that nonconforming product is shipped. The IATF 16949 requirement define two situations: one where you know in advance that the product is nonconforming and you want permission for its shipment, the other where at the time of shipment you did not know it was nonconforming and only found out subsequently. The only cases where you need to request concession from your customer are when you have deviated from one of the customer requirements and cannot make the product conform. Even when you repair a product, providing it meets all of the customer requirements, there is generally no need to seek a concession from your customer. While it is generally believed that nonconformities indicate an out-of-control situation, providing you detect and rectify them before release of the product, you have qualify under control, and have no need to report nonconformities to your customer.

Training of personnel

Providing training to all appropriate manufacturing personnel for the containment of suspect and nonconforming product is essential for effective quality management and product control. Proper training ensures that employees understand the importance of handling nonconformities and are equipped with the knowledge and skills to take appropriate actions when dealing with suspect or nonconforming products. Training ensures that manufacturing personnel are familiar with the organization’s documented processes for identifying, segregating, and containing suspect and nonconforming products. This helps ensure consistency and adherence to established procedures. Trained personnel are more likely to detect suspect or nonconforming products early in the manufacturing process. Timely detection allows for quick containment and minimizes the chances of the products progressing further in the production line. Proper training helps employees understand the potential risks associated with suspect or nonconforming products. This knowledge enables them to take appropriate precautionary measures and prevent further issues.Training emphasizes the importance of segregating nonconforming products from conforming ones to prevent accidental mixing or use, which could lead to quality problems or safety hazards. Properly trained personnel can effectively manage suspect or nonconforming products, reducing the likelihood of delivering defective products to customers and thereby enhancing customer satisfaction. To ensure effective training for containment of suspect and nonconforming product, the organization should consider the following: The training should cover the identification of suspect or nonconforming products, the organization’s procedures for containment, the importance of segregation, and reporting mechanisms. Regular training sessions and refresher courses should be provided to keep manufacturing personnel up to date with the latest processes and requirements. Maintain records of the training sessions conducted and the attendance of employees. This documentation helps in tracking compliance and identifying any gaps in training coverage. Encourage feedback from manufacturing personnel regarding the training and containment processes. Use this feedback to make improvements and enhance the effectiveness of the training program. Consider providing cross-functional training to employees involved in different stages of the manufacturing process. This helps in fostering collaboration and a unified approach to containment. By investing in proper training, the organization can empower its manufacturing personnel to play an active role in managing nonconformities effectively. Training contributes to the overall quality culture within the organization and reinforces the commitment to delivering high-quality products while meeting customer requirements and industry standards.

The standard requires the supplier to provide for the disposition of nonconforming product and for notification to the functions concerned. Disposition means to dispose of or decide what to do with the nonconforming item, whether to use it, repair it, scrap it, etc. The disposition of nonconforming product refers to the decision-making process and actions taken by an organization when dealing with products or materials that do not meet specified requirements or quality standards. Disposition involves determining what to do with the nonconforming items to ensure they are appropriately handled and do not compromise the organization’s commitment to producing high-quality products or services. By providing for the disposition of product you need to determine the action to take and notify those who are to carry it out. You cannot merely accumulate nonconforming items in a quarantine area. Apart from anything else they occupy valuable space and could present a hazard as they deteriorate. To implement this requirement you will need a form or other such document in which to record the decision and to assign the responsibility for the remedial action. The disposition process typically involves several options for managing nonconforming products, and the appropriate action depends on the severity of the nonconformity, the potential impact on product safety or performance, and any applicable regulatory or customer requirements. Here are some common disposition options:

1. Scrap or Reject: Nonconforming products that cannot be salvaged or repaired are usually scrapped or rejected. This means the items are removed from further processing or distribution to prevent them from reaching the customer.
2. Rework or Repair: For nonconforming products with minor issues or defects that can be corrected, rework or repair may be a suitable disposition. The organization will perform necessary corrective actions to bring the product into compliance with the required standards.
3. Use as Is with Customer Concession: In some cases, nonconforming products may still be usable or safe with certain deviations from the requirements. If the customer agrees, a concession is obtained, allowing the product to be used as is with specific conditions.
4. Return to Supplier: If the nonconformity is due to supplier-related issues, the organization may return the nonconforming products to the supplier for resolution or replacement.
5. Segregation or Quarantine: Nonconforming products may be placed in a segregated or quarantined area to prevent accidental use or distribution until a disposition decision is made.
6. Analysis and Investigation: For significant or recurring nonconformities, the organization may conduct a thorough analysis and investigation to identify root causes and implement corrective and preventive actions.

The disposition process is a critical part of the organization’s quality management system. It ensures that nonconforming products are managed appropriately, preventing the delivery of defective items to customers and protecting the organization’s reputation for delivering quality products or services. The process often involves collaboration among different departments, such as quality assurance, production, and supply chain, to make well-informed decisions and take appropriate actions.

Clause 8.7.1.1 Nonconforming product disposition

The organization needs to establish a documented process for handling nonconforming products that are not eligible for rework or repair. If a product fails to meet requirements, the organization must ensure that any scrapped product is made unusable before disposal. It’s imperative that the organization does not repurpose nonconforming products for service or other purposes without obtaining prior approval from the customer.

When nonconforming products are not suitable for rework or repair, it is essential for the organization to have a documented process for their disposition. This documented process outlines the steps, responsibilities, and actions to be taken when dealing with nonconforming products that cannot be brought into compliance with the required standards. Here are the key elements that should be included in the documented process for the disposition of nonconforming product not subject to rework or repair:

1. Identification and Segregation: The process should outline how nonconforming products are identified, and the steps to segregate them from conforming products. Proper identification and segregation prevent accidental use or distribution of nonconforming items.
2. Assessment and Classification: The process should specify the criteria for assessing the severity and impact of nonconformities. This assessment helps in classifying nonconforming products into different categories based on their significance.
3. Disposal Methods: The documented process should list the available methods for disposing of nonconforming products that are not subject to rework or repair. Common disposal methods include scrapping, destruction, or returning the items to the supplier.
4. Decision-Making Authority: The process should clearly define the roles and responsibilities of individuals or teams involved in making disposition decisions. This ensures accountability and consistency in the decision-making process.
5. Customer Communication: If the nonconforming products affect customer requirements, the process should outline how the organization communicates with the customer about the disposition decisions and any potential impacts on their operations.
6. Documentation and Records: The process should require the proper documentation of disposition decisions, including the rationale behind the chosen method. Maintaining accurate records is essential for traceability and auditing purposes.
7. Escalation Procedures: The process should include escalation procedures for exceptional cases or situations where nonconforming products have significant consequences. This ensures that critical decisions receive appropriate attention and consideration.
8. Continuous Improvement: The documented process should also include a mechanism for continuous improvement. This involves analyzing the disposition data and feedback to identify opportunities for enhancing the nonconforming product management process.

Having a well-documented process for the disposition of nonconforming products not subject to rework or repair ensures that these items are handled in a systematic and controlled manner. It helps the organization prevent the unintended use of nonconforming products, protect customer satisfaction, and maintain compliance with quality standards and regulations. Additionally, the process supports the organization’s commitment to delivering high-quality products and services to its customers.

Defining disposition responsibility

The organization are to define the responsibility for review and authority for the disposition of nonconforming product. The decision on product acceptance is a relatively simple one because there is a specification against which to judge conformance. When product is found to be nonconforming there are three decisions you need to make based on the following questions:

• Can the product be made to conform?
• If the product cannot be made to conform, is it fit for use?
• If the product is not fit for use, can it be made fit for use?

The authority for making these decisions will vary depending on the answer to the first question. If, regardless of the severity of the nonconformity, the product can be made to conform simply by rework or completing operations, these decisions can be taken by operators or inspectors, providing rework is economical. Decisions on scrap, rework, and completion would be made by the fund-providing authority rather than the design authority. If the product cannot be made to conform by using existing specifications, decisions requiring a change or a waiver of a specification should be made by the authority responsible for drawing up or selecting the specification. It may be sensible to engage investigators or quality engineers to review the options to be considered and propose remedial actions for the authorities to consider. In your procedures or the quality plan you should identify the various bodies that need to be consulted for each type of specification. Departures from customer requirements will require customer approval; departures from design requirements will require design approval; departures from process requirements will require process engineering approval, etc. The key lies in identifying who devised or selected the requirement in the first place. All specifications are but a substitute for knowledge of fitness for use-any departure from such specification must be referred back to the specification authors for a judgement.

Scrapping of Non conforming products

Ensuring that nonconforming products are rendered unusable before disposal is an essential practice in quality management. Properly scrapping and rendering nonconforming products unusable prevent any unintentional use or distribution, which could lead to potential safety hazards, customer dissatisfaction, or regulatory non-compliance.By rendering nonconforming products unusable, the organization eliminates the risk of these items mistakenly finding their way back into the production or distribution process, where they could cause issues or compromise product quality. Disposing of nonconforming products properly ensures that customers receive only products that meet the required quality standards. This helps maintain customer satisfaction and confidence in the organization’s products. In certain industries, there may be specific regulations regarding the disposal of nonconforming products. Ensuring proper disposal practices helps the organization comply with applicable regulations. In cases where nonconforming products contain proprietary or sensitive information, proper disposal ensures that such information is not accessible to unauthorized parties. Proper disposal practices may involve recycling or environmentally responsible methods, which contribute to the organization’s commitment to sustainability and environmental stewardship.

To ensure that nonconforming products are made unusable before disposal, the organization should consider implementing the following measures. Physically destroy the nonconforming products to render them unusable. This could involve cutting, crushing, shredding, or other methods that irreversibly alter the product’s form. Clearly mark or tag the nonconforming products as “Scrap” or “Unusable” to prevent accidental use. Store the nonconforming products in a secure area designated for scrap materials until they can be disposed of properly. Maintain records or documentation to verify that the nonconforming products have been made unusable before disposal. This documentation serves as evidence of proper handling and disposal practices.By following these practices, the organization can demonstrate its commitment to responsible product management and reinforce its dedication to quality, safety, and environmental responsibility.

Customer approval to divert nonconforming product to service or other use

The organization should not divert nonconforming products to service or any other use without prior customer approval. Nonconforming products are those that do not meet specified requirements or quality standards, and their use may pose risks to customer satisfaction, safety, and compliance. Prior customer approval ensures that the customer is fully aware of any nonconforming products that may be used in service or other applications. This allows the customer to make informed decisions based on their own risk assessments and requirements. Many customer agreements or contracts specify that only conforming products meeting the specified requirements should be used. Diverting nonconforming products without approval may breach contractual obligations. Nonconforming products may not perform as expected or meet safety standards. Using them in service or other applications without approval could lead to failures, accidents, or subpar performance. In some industries, there may be legal or regulatory requirements governing the use of nonconforming products. Diverting them without approval may lead to non-compliance with relevant regulations. Using nonconforming products without approval can damage the organization’s reputation and erode customer trust in their ability to deliver high-quality products or services.

To ensure proper handling of nonconforming products, the organization should follow these best practices:

1. Segregation: Properly segregate nonconforming products from conforming ones to prevent accidental use or mixing.
2. Disposition Process: Establish a documented process for the disposition of nonconforming products, including obtaining customer approval when necessary.
3. Customer Communication: Clearly communicate with the customer about any identified nonconformities and seek their approval for concession or deviation if required.
4. Rework and Repair: For nonconforming products that can be reworked or repaired to meet specifications, implement appropriate corrective actions and seek customer approval if needed.
5. Proper Disposal: For nonconforming products that cannot be reworked or repaired, ensure proper disposal according to environmental regulations and organizational policies.

By adhering to these practices, the organization can effectively manage nonconforming products and maintain their commitment to quality, customer satisfaction, and compliance. It also fosters a strong relationship with customers, based on trust and transparency in product handling and decision-making.

Nonconforming product is defined as product that does not conform to customer requirements, applicable regulatory requirements or your own organization requirements. The definition may also apply to nonconforming processes and services. Nonconformities may relate to suppliers and outsourced work, your own organizational activities or product shipped to customers. Your documented process for nonconforming product must include controls and responsibilities to identify, contain it,(i.e. prevent further processing or use), keep records of the nature and other details of the nonconformity, notify appropriate personnel and customers, where appropriate, evaluate what disposition action needs to be taken, carry out timely disposition, determine policies for release for further processing or shipment to the customer, obtain customer concessions and deviation permits, rework and re-verification, waivers and approvals of supplier materials, etc. Product or material found with no identification or its quality status is not known, must be treated as nonconforming product and controlled by the above procedure. If you find that nonconforming product has been shipped, without a customer concession, notify the customer immediately and use your procedure, to effectively contain and resolve the situation to your customer’s satisfaction. Where required, use the customer prescribed form for recording and controlling nonconforming product. An authorization refers to written permission (number or code) to ship or manufacture nonconforming product. The permission is usually very specific about product, quantity and time frame during which nonconforming product can be shipped. The authorization number or code must identify each container shipped under the authorization. A concession authorization allows you to ship nonconforming product, under controlled conditions. A deviation authorization allows you to manufacture product different from the original specification, under controlled conditions.

In the case of nonconforming products identified during manufacturing, obtaining customer authorization for concession becomes crucial. Customer authorization for concession is required when an organization wishes to proceed with the manufacturing or delivery of nonconforming products with the explicit approval of the customer. This approval allows the organization to deviate from the agreed-upon product specifications, standards, or contractual requirements. Nonconforming products may be identified during the manufacturing process through various quality control measures such as inspections, testing, or process monitoring. The organization must evaluate the nonconforming products to understand the nature and severity of the nonconformity. This evaluation will help determine whether the nonconforming product poses a risk to the product’s performance or safety. If the nonconformity is deemed significant, and the organization believes the product can still be used or delivered with some agreed-upon deviation, they will initiate a concession request. The concession request should include details about the nonconformity, its potential impact on the product, the proposed deviation or actions to address the nonconformity, and the rationale for seeking customer authorization. The organization will contact the customer to explain the situation, the identified nonconformity, and the proposed actions to address it. They will request the customer’s approval for the concession. The customer will evaluate the concession request and consider various factors such as the criticality of the nonconformity, the potential impact on their operations or end-users, and their contractual agreements with the organization. Based on the evaluation, the customer will decide whether to grant authorization for the concession or not. The decision may involve some negotiation or discussions between the organization and the customer to reach an agreement. If the customer approves the concession, the organization should document the customer’s decision, including the agreed-upon deviation or actions. This documentation serves as evidence of the customer’s approval. With the customer’s approval in hand, the organization can proceed with the agreed-upon actions, such as continuing manufacturing, making necessary adjustments, or providing additional testing or validation. It’s essential for organizations to have a well-defined process for managing nonconforming products and seeking customer authorization for concession when needed. This ensures that potential risks are appropriately communicated and addressed, and customer expectations are met, maintaining a strong relationship with the customer and adherence to quality standards.

Clause 8.7.1.1 Customer authorization for concession

The organization must obtain permission from the customer before further processing nonconforming products for “use as is” or for rework, especially when there are differences from the current approved product or manufacturing process. If any sub-components from nonconforming products are reused in manufacturing, this reuse must be clearly communicated to the customer in the permission obtained. The organization needs to keep a record of the expiration date or quantity authorized under this permission. Also, when the authorization expires, the organization ensures compliance with the original or updated specifications and requirements. Any material shipped under such permission must be clearly labeled on each shipping container. This requirement also extends to purchased products, for which the organization must approve any requests from suppliers before they are submitted to the customer.

The organization must have prior written customer authorization whenever the product or process is different from that currently approved. This may seem a very onerous requirement since it stops you changing almost anything without customer approval. In the context of nonconforming product, it applies to any action you take to eliminate the nonconformity other than scrapping and regrading the item, if permitted. Any rework and repair procedure has to be approved in the product approval submission. Obviously to improve performance continuously you must change something, but not the product’s physical and functional characteristics, the key process parameters, or the dimensions and tolerances of the tools and gages used. The requirement also applies to your supplier. Therefore you will need a product approval submission from each of your subcontractors and will need to put in place procedures to regulate deviations from the approved standard. An example where this may be quite common is where specified materials become unobtainable and alternatives need to be selected, or where there is a slight change in the material specification. IATF 16949 allows for such a situation but you must seek prior authorization. It means that before you deviate from approved specifications for production items you must obtain authorization to apply the process. You will need a process for conveying the information to the customer, obtaining approval, and keeping records of the expiration date or quantity authorized. Concessions or waivers are issued only on specific quantities or for a specific duration, therefore cannot be open-ended. You also need a system of identifying the concessed product up to shipment in order that the shipping staff can apply the same identity to the shipping containers.

Customer concession or deviation permits

Obtaining customer concession or deviation permits is critical when dealing with nonconforming products, especially in cases where the product or manufacturing process differs from the approved specifications. This process ensures that any deviations from the agreed-upon requirements are formally communicated, evaluated, and approved by the customer before proceeding with further processing. The goal is to maintain transparency and alignment with customer expectations while addressing nonconformities appropriately.Here are the key steps involved in obtaining customer concession or deviation permits for “use as is” and rework dispositions of nonconforming products:

1. Identification of Nonconforming Product: Nonconforming products are identified through various quality control measures during the manufacturing process, such as inspections, testing, or process monitoring.
2. Assessment of Nonconformity: The organization evaluates the nonconforming products to understand the nature and severity of the nonconformity, along with potential impacts on the product’s performance or safety.
3. Concession or Deviation Request: If the nonconformity is significant, and the organization believes the product can still be used or reworked to meet requirements with some deviation, they initiate a concession or deviation request.
4. Concession or Deviation Request Content: The request includes detailed information about the nonconformity, its potential impact, the proposed deviation or rework actions, and the rationale for seeking customer approval.
5. Communication with the Customer: The organization communicates with the customer, presenting the nonconformity situation, the identified deviation or rework actions, and any potential risks or implications for the customer’s use of the product.
6. Customer Evaluation: The customer evaluates the concession or deviation request and considers factors such as the criticality of the nonconformity, potential impact on their operations or end-users, and contractual agreements.
7. Customer Concession or Deviation Permit: Based on the evaluation, the customer decides whether to grant a concession or deviation permit. The decision may involve negotiation or discussions to reach an agreement.
8. Documenting the Customer Concession or Deviation: If the customer approves the request, the organization documents the customer’s decision, including the agreed-upon deviation or rework actions. This documentation serves as evidence of the customer’s approval.
9. Implementation of Approved Actions: With the customer’s permit in hand, the organization proceeds with the approved actions, such as reworking the product or making necessary adjustments to meet the agreed-upon requirements.

By following this process, organizations ensure that deviations from approved specifications are properly addressed and customer approval is obtained before further processing, thus maintaining product quality, customer satisfaction, and compliance with contractual agreements. Additionally, maintaining clear documentation throughout the process is essential for traceability and auditing purposes.

Reuse of sub-components in the manufacturing process

when sub-components from nonconforming products are reused in the manufacturing process, it is crucial to communicate this reuse explicitly to the customer in the concession or deviation permit. Transparency and clear communication with the customer are essential to ensure they are fully aware of any deviations or potential risks associated with the nonconforming sub-components.Here’s why clear communication is important and how it can be achieved:

Importance of Clear Communication: By communicating the reuse of nonconforming sub-components, the customer becomes aware of the situation and can make informed decisions about the acceptability of the final product. The customer needs to understand any potential risks or implications that may arise from reusing nonconforming sub-components. This allows them to assess the impact on their processes, products, or end-users. If the customer’s agreement or contract requires adherence to specific quality standards or requirements, clear communication ensures compliance and avoids misunderstandings.

Achieving Clear Communication: The concession or deviation request should explicitly mention the reuse of nonconforming sub-components. Provide details about the sub-components, the reason for reuse, and the actions taken to mitigate any risks associated with the reuse. Avoid technical jargon or ambiguous terms in the concession or deviation permit. Use clear and easily understandable language to describe the situation and actions taken. Include any relevant documentation, such as inspection reports, testing results, or quality assurance records, to support the communication and provide evidence of the steps taken to address the nonconformities. Request the customer to acknowledge receipt and understanding of the concession or deviation permit. This acknowledgment can be in the form of a signed document or written confirmation. Offer contact information for a designated person within the organization who can address any questions or concerns the customer may have regarding the reuse of nonconforming sub-components.

By adhering to these practices, organizations can maintain transparency and build trust with their customers. It also helps in ensuring that customers can make informed decisions about accepting products that contain reused nonconforming sub-components, and it demonstrates the organization’s commitment to managing nonconformities responsibly.

Expiration date

When obtaining customer authorization for concession on nonconforming products, the organization must keep a record of the expiration date or the quantity authorized under the concession. This information is crucial for tracking and managing the use of nonconforming products and ensuring that the approved deviation is not exceeded. When the customer grants authorization for the concession on nonconforming products, the organization documents the specific details of the concession, including the expiration date of the authorization or the quantity of nonconforming products allowed to be used or processed. During the period covered by the concession, the organization carefully tracks and monitors the usage of the nonconforming products. This is to ensure that they do not exceed the approved quantity or continue using the concession after the expiration date. While utilizing the customer-authorized concession, the organization ensures that they comply with the original or superseding specifications and requirements provided by the customer. This means adhering to any specific conditions or constraints outlined in the concession permit. When the concession’s expiration date approaches, the organization plans to discontinue the use of nonconforming products after the authorized period. They should be prepared to return to the standard manufacturing process or seek alternative solutions that meet the original specifications. If there are any issues or changes affecting the concession, the organization communicates promptly with the customer. This includes situations where the authorized quantity has been used up or if there is a need for an extension of the concession period. If there is a need to continue using nonconforming products beyond the initial concession period, the organization seeks the customer’s approval for renewal or obtains a new authorization as appropriate. By diligently adhering to these steps, organizations demonstrate their commitment to maintaining compliance with customer requirements and handling nonconforming products responsibly. Keeping accurate records of customer authorizations and ensuring compliance with concession conditions helps maintain trust and strengthen the relationship between the organization and its customers.

Identifying materials shipped under concession

Properly identifying materials shipped under concession is essential for maintaining transparency and traceability throughout the supply chain. When nonconforming products are shipped to the customer with their explicit approval (concession), clear identification on each shipping container becomes crucial. This ensures that the customer is aware of the nonconforming nature of the products and can handle them appropriately upon receipt. Clear identification informs the customer that the materials being shipped are nonconforming products authorized for use under concession. This awareness allows the customer to take necessary actions based on their own procedures for handling nonconforming materials. Proper identification aids in tracking nonconforming products throughout the supply chain. It helps the customer and the organization to know which containers contain concessioned materials, making it easier to manage and control these products. Clear identification prevents unintended use or mixing of nonconforming products with conforming ones. It helps avoid confusion during the receiving and inspection process, ensuring that concessioned materials are treated differently from regular inventory. Properly labeled shipping containers provide documented evidence that the nonconforming products were shipped with customer approval. This documentation can be vital during audits or quality assessments. To achieve proper identification, the shipping containers can be labeled or marked in a way that clearly indicates the presence of concessioned materials. This might include using stickers, tags, or specific markings that differentiate the nonconforming products from regular shipments. The labeling should be easily visible and ideally include information such as “Concessioned Material – For Approved Use Only.” Furthermore, organizations should communicate with their customers regarding the proper handling and storage of concessioned materials. Providing clear instructions and guidelines ensures that the customer is aware of any specific requirements related to the use of nonconforming products authorized under concession. By implementing these measures, organizations can enhance their customer relationships, maintain product quality, and demonstrate their commitment to responsible nonconforming product management.

Supplier non conforming products

When dealing with nonconforming products or materials from suppliers, the organization must have a clear process in place to handle these situations effectively. As part of this process, any requests for concessions or deviations from suppliers should be carefully reviewed and approved by the organization before submission to the customer. By having a central approval process within the organization, they can ensure consistency in handling nonconforming products from different suppliers. This control helps in maintaining uniformity in the evaluation and resolution of nonconformities. The organization needs to assess the risks associated with using nonconforming products from suppliers. By reviewing and approving the supplier’s request for concession, the organization can ensure that any potential risks are adequately evaluated and managed. The organization needs to communicate effectively with the customer about any nonconforming materials received from suppliers. By reviewing the requests before submission, the organization can provide the customer with accurate and relevant information about the nonconformities and the actions taken to address them. In some industries, there may be specific regulations or standards governing the use of nonconforming products. By obtaining internal approval, the organization can ensure that they are complying with applicable regulations before seeking customer concessions. The approval process allows the organization to maintain strict control over the acceptance or rejection of nonconforming products. This ensures that only authorized nonconforming materials are used or processed as per the agreed-upon deviations. The organization’s internal approval process should involve relevant stakeholders, such as quality control personnel, procurement teams, and possibly representatives from engineering or production departments. It’s essential to thoroughly review the supplier’s request, assess the impact of the nonconformity, and determine the best course of action before submitting the concession request to the customer. By following this approach, the organization can demonstrate their commitment to maintaining quality standards and customer satisfaction while effectively managing nonconforming products received from suppliers. Additionally, it helps in maintaining clear documentation of the decisions made during the approval process, which is valuable for internal audits and compliance purposes.

Nonconforming products are items or products that do not meet specified requirements or standards set by the organization or its customers. These products may have defects, deficiencies, or deviations from the intended design, quality, or performance criteria. Nonconforming products can arise at various stages of the production process, from raw materials and components to finished goods.Here are some examples of nonconforming products:

1. Manufacturing Defects: Products with manufacturing defects that occurred during the production process. These defects can include issues with dimensions, material properties, or assembly errors.
2. Design Deviations: Products that deviate from the intended design specifications due to design errors, changes, or misinterpretations.
3. Incorrect Labeling or Packaging: Products that have incorrect or inadequate labeling, packaging, or instructions.
4. Out-of-Specification Items: Products that do not meet the required quality standards, such as those with measurements or performance that fall outside specified tolerances.
5. Expired or Obsolete Products: Products that have passed their expiration date or are no longer valid due to changes in regulations or technology.
6. Damaged Products: Items that have been physically damaged during production, handling, or transportation, rendering them unfit for use.
7. Customer Returns: Products returned by customers due to defects or dissatisfaction.
8. Recalled Products: Items that have been recalled due to safety or quality concerns.

It’s essential for organizations to have a systematic approach to identify, segregate, and manage nonconforming products. Proper handling of nonconforming products is critical to prevent their unintended use, avoid customer complaints, and ensure compliance with regulatory requirements and customer expectations. Effective management of nonconforming products involves initiating corrective actions, investigating the root causes, and taking preventive measures to minimize future occurrences

8.7.1.2 Control of nonconforming product — customer-specified process

The organization must adhere to the nonconforming product controls specified by the customer.

The statement “The organization shall comply with applicable customer-specified controls for nonconforming product” implies that an organization is required to adhere to the specific requirements set forth by its customers concerning how to handle nonconforming products. Let’s break down this statement:

1. “The organization shall comply”: This means the organization must follow or adhere to certain guidelines or requirements.
2. “Applicable customer-specified controls”: These are specific instructions or controls related to handling nonconforming products that are provided by the organization’s customers.
3. “Nonconforming product”: This refers to products that do not meet the specified requirements or standards and have been deemed unsatisfactory in some way.

In essence, this statement means that if a customer has outlined particular rules or protocols regarding what should be done with nonconforming products, the organization must follow those guidelines. These controls may cover various aspects, such as how to identify, segregate, document, report, and disposition nonconforming products.Following customer-specified controls is essential for maintaining a good relationship with customers, meeting their specific expectations, and ensuring the quality of products delivered to them. Noncompliance with these controls could result in customer dissatisfaction, potential contract violations, or even loss of business opportunities. Therefore, it is crucial for the organization to understand and adhere to the customer’s requirements regarding nonconforming products.

Ensuring compliance with applicable customer-specified controls for nonconforming products requires a systematic approach and effective quality management practices. Here are some steps an organization can take to achieve this:

1. Communication and Understanding: The organization must communicate with its customers to clearly understand their specific requirements and controls for handling nonconforming products. This can be achieved through regular meetings, written documentation, and open dialogue to address any potential ambiguities.
2. Documentation and Review: The organization should maintain detailed records of customer-specified controls for nonconforming products. These documents should be reviewed regularly to ensure that the latest requirements are being followed and any updates are implemented promptly.
3. Quality Management System (QMS): Implement a robust QMS that incorporates the customer-specified controls. This system should include standard operating procedures (SOPs) that outline how to handle nonconforming products as per customer requirements.
4. Training and Awareness: Train employees on the customer-specified controls and their importance in maintaining customer satisfaction. Employees at all levels should be aware of these controls and understand their roles in complying with them.
5. Inspection and Testing: Develop a thorough inspection and testing process to identify nonconforming products accurately. This will help in segregating such products and initiating appropriate actions as per customer requirements.
6. Segregation and Labeling: Nonconforming products should be clearly segregated from conforming ones to prevent their unintended use or shipment. Proper labeling and identification of nonconforming products are essential to avoid mix-ups.
7. Reporting and Corrective Actions: Establish a reporting mechanism for nonconforming products. Any instances of nonconformity should trigger immediate corrective actions as per customer requirements.
8. Supplier Management: If the organization relies on suppliers for materials or components, it should ensure that these suppliers also adhere to the customer-specified controls. Regular audits and performance evaluations can help ensure supplier compliance.
9. Customer Feedback and Satisfaction: Continuously seek feedback from customers to assess their satisfaction with how nonconforming products are handled. This feedback can be valuable in making improvements and adjustments to the process.
10. Internal Audits: Conduct internal audits to assess compliance with customer-specified controls. Regular audits help identify areas for improvement and demonstrate the organization’s commitment to meeting customer requirements.

By following these steps and maintaining a strong focus on customer requirements, an organization can enhance its capability to comply with applicable customer-specified controls for nonconforming products, leading to improved customer satisfaction and business success.

Clause 8.7.1.6 Customer notification

The organization is required to promptly inform the customer if any nonconforming product has been shipped. This initial notification should be followed by comprehensive documentation of the incident.

The statement “The organization must immediately notify the customer in the event that nonconforming product has been shipped” emphasizes the importance of promptly informing the customer when a nonconforming product has been sent or delivered to them. This notification is critical for ensuring transparency, customer trust, and the opportunity for the customer to take appropriate actions to address the nonconformity. Here are some key aspects of this requirement:

1. Timely Communication: The organization should have processes in place to identify nonconforming products before or during shipment. Once a nonconforming product is detected, immediate action is necessary to notify the customer as soon as possible.
2. Clear Notification: The notification to the customer should be clear and concise, indicating that a nonconforming product has been shipped. It should also provide relevant details, such as the nature of the nonconformity and any potential risks or impact on the customer’s operations.
3. Communication Channels: The organization should use appropriate communication channels to reach the customer quickly. This may include emails, phone calls, official letters, or any other agreed-upon means of communication.
4. Customer Support: After notifying the customer, the organization should be prepared to provide adequate customer support to address any concerns or questions that arise from the nonconforming product.
5. Corrective Actions: Along with the notification, the organization should outline the actions it plans to take to rectify the situation. This may involve offering replacements, refunds, or taking other corrective measures as agreed upon with the customer.
6. Preventive Measures: The organization should also investigate the root cause of the nonconforming product and implement appropriate corrective and preventive actions to avoid similar occurrences in the future.
7. Continuous Improvement: The incident should be treated as a learning opportunity for the organization to improve its quality management system, production processes, and overall customer satisfaction.

Notifying the customer about nonconforming products is an essential part of maintaining a strong customer-supplier relationship and demonstrating a commitment to delivering quality products and services. By promptly informing the customer and taking appropriate actions, the organization can minimize the impact of nonconformities and build trust and credibility with its customers.

Following the initial communication to the customer about the shipment of a nonconforming product, it is crucial to provide detailed documentation of the event. This documentation serves several essential purposes:

1. Transparency and Traceability: Detailed documentation ensures transparency and traceability of the nonconforming product incident. It provides a clear record of what happened, when it happened, and the specific nature of the nonconformity.
2. Evidence for Investigation: The documentation serves as evidence for any internal investigations into the root cause of the nonconforming product. This information is vital for understanding why the nonconformity occurred and for implementing appropriate corrective and preventive actions.
3. Compliance and Reporting: In certain industries or for specific customers, there may be regulatory requirements or contractual obligations to report incidents of nonconforming products. The detailed documentation helps fulfill these obligations accurately and efficiently.
4. Customer Records: Detailed documentation ensures that the customer also has a comprehensive record of the incident. This helps the customer understand the situation better and allows them to evaluate the impact on their operations.
5. Risk Assessment and Mitigation: The documentation allows the organization and the customer to assess the risks associated with the nonconforming product. This assessment helps in making informed decisions on how to mitigate the risks and prevent similar incidents in the future.
6. Legal and Liability Considerations: In some cases, nonconforming products may lead to legal implications or potential liabilities. Proper documentation becomes crucial in such situations to protect the interests of all parties involved.

The documentation should include relevant details such as:

• Date and time of the shipment.
• Description of the nonconforming product and the specific nonconformity.
• Quantity of nonconforming products shipped.
• How the nonconforming product was detected.
• Actions taken to notify the customer.
• Any initial responses or feedback from the customer.
• Investigation findings and root cause analysis (if available).
• Corrective and preventive actions proposed or implemented.
• Follow-up actions and their status.

It is essential to maintain accurate and well-organized records to ensure effective communication, problem-solving, and continuous improvement. Detailed documentation helps create a culture of accountability, learning, and quality improvement within the organization.

In the context of IATF 16949, which is the International Automotive Quality Management System standard, both repair and rework are relevant concepts in managing non-conforming products. IATF 16949 places a strong emphasis on preventing and addressing non-conformities to ensure the delivery of high-quality products in the automotive industry. Rework in IATF 16949 refers to the action taken to correct a non-conformity or defect found during the production process. When a non-conforming product is identified, the organization takes appropriate measures to bring it back to the required specifications and quality standards. Rework is typically performed within the controlled production environment before the product is released to the customer.The standard requires organizations to have effective processes in place for identifying, documenting, and managing non-conformities, including procedures for rework. The organization must ensure that the reworked product meets all necessary requirements and is fit for its intended purpose. Repair in IATF 16949 refers to the action taken to correct a non-conformity or defect that is discovered after the product has been delivered to the customer or is in use. It involves restoring the product to its desired functionality or performance level to meet customer requirements. The standard also emphasizes the importance of addressing customer complaints and conducting effective root cause analysis to prevent similar issues from occurring in the future. Repair processes must be well-defined, documented, and monitored to ensure effective resolution of customer complaints and continuous improvement in product quality.In summary, both rework and repair are essential elements of non-conformance management in IATF 16949. Rework addresses non-conformities during the production process, while repair deals with non-conformities discovered after the product has been delivered to the customer. Organizations following IATF 16949 are expected to have robust systems in place for managing non-conforming products, including well-defined procedures for rework and repair to ensure the delivery of high-quality automotive products to customers.

Clause 8.7.1.5 Control of repaired product

The organization needs to establish a documented procedure for confirming repairs in line with the control plan or other relevant documented instructions. Before initiating the repair process, a risk analysis such as FMEA must be conducted to assess potential risks. Approval from the customer is required before commencing repairs. Additionally, documented customer authorization for concessions for repair of the product must be obtained. Work instructions for disassembly or repair, including re-inspection and traceability requirements, must be accessible to and followed by the relevant personnel. Furthermore, records detailing the disposition of repaired products, including quantity, disposition, disposition date, and relevant traceability information, must be maintained.

A documented process for repair confirmation is essential for quality management in the automotive industry. This process ensures that repairs made by suppliers align with the control plan and other relevant documented information, maintaining the required standards and specifications. Here are the key steps involved in a typical repair confirmation process:

1. Defining Repair Requirements: The control plan or relevant documented information should outline the specific requirements for repairs, including the criteria for identifying defects, the acceptable repair methods, and any quality standards that must be met.
2. Identifying Repairs: When a defect or non-conformance is detected in the supplied components, the issue must be identified and documented, indicating the nature of the repair required.
3. Communication with the Supplier: The OEM needs to communicate with the supplier to notify them of the identified defects and request necessary repairs. Clear communication is essential to ensure the supplier understands the issues and the required corrective actions.
4. Repair Method Determination: Based on the control plan or other documented information, the appropriate repair method should be determined. The repair method should adhere to the specified guidelines and must ensure that the component meets all required quality standards after repair.
5. Repair Validation: Before implementing the repair on a larger scale, a validation process is often necessary. The validation may involve testing and inspection of the repaired components to verify that the repairs meet the required specifications and quality standards.
6. Documenting Repairs: All repair activities should be thoroughly documented, including details of the defects, the repair methods used, and any testing or inspection results. This documentation is essential for traceability and future reference.
7. Review and Approval: The repair confirmation process might involve review and approval steps to ensure that the repairs were conducted correctly and met the required criteria.
8. Implementation of Repairs: After successful repair validation and approval, the supplier can proceed with implementing the repairs on the affected components.
9. Post-Repair Inspection: In some cases, a post-repair inspection may be conducted to verify that the repairs were successfully implemented and that the components meet the necessary quality standards.
10. Monitoring and Continuous Improvement: The repair confirmation process should be continuously monitored, and any issues or improvements identified should be addressed to prevent recurrence of defects and enhance the overall repair process.

Having a well-documented and controlled repair confirmation process ensures consistency and reliability in the repair activities conducted by the suppliers. It also helps maintain product quality and customer satisfaction in the automotive industry.

Risk analysis

Conducting risk analysis, such as Failure Mode and Effects Analysis (FMEA), before repairing products is a crucial step in the quality management process. FMEA is a systematic method used to identify potential failure modes, their causes, and the effects of those failures on the product or process. By performing FMEA before repair activities, the organization can proactively assess and mitigate risks, leading to more effective and reliable repairs. The first step is to identify all possible failure modes that could occur during the repair process. These could include issues like incorrect repairs, incomplete repairs, or introducing new defects during the repair. For each identified failure mode, assess the severity of its potential consequences. Consider how severe the impact would be if the failure occurred and was not detected. Determine the potential causes of each failure mode. This involves identifying factors that could lead to the failure, such as lack of technical expertise, inadequate tools, or poor repair procedures. For each failure mode, analyze the detection methods in place. Consider how likely it is that the failure will be detected before it reaches the customer or causes further issues. The RPN is a numerical value obtained by multiplying the severity, occurrence, and detection rankings. This number helps prioritize which failure modes require immediate attention. Based on the RPN values, prioritize the failure modes that pose the highest risk. Develop and implement mitigation strategies to reduce the likelihood of these failures occurring or improve detection methods. Continuously review and update the FMEA as necessary. As the repair process evolves or new risks emerge, the FMEA should be revisited to ensure ongoing effectiveness. Maintain clear documentation of the FMEA, including the identified failure modes, risk assessments, mitigation strategies, and any changes or improvements made over time. By conducting FMEA, the organization can be better prepared to handle potential risks in the repair process, leading to improved repair outcomes, reduced defects, and enhanced customer satisfaction. It also demonstrates a commitment to quality and proactive problem-solving, contributing to a strong quality management system in the automotive industry.

Customer’s approval and Concession

Obtaining customer approval and documented authorization for concessions is a critical step before commencing repairs on a product, especially in the automotive industry where quality and safety are paramount. A concession is an agreement between the supplier and the customer to allow the repair of a product that deviates from the original specifications. Here’s the typical process for obtaining customer authorization for concessions:

1. Defect Identification: When a product is found to have a non-conformance or defect that requires repair, the organization should thoroughly identify and document the issue.
2. Concession Request: The organization should prepare a concession request, outlining the specific details of the defect, the proposed repair process, and the potential impact on the product’s performance and quality. This request should be clear, concise, and supported by relevant data or evidence.
3. Concession Submission to Customer: The concession request is then submitted to the customer. This can be done through official communication channels, such as a formal letter or electronic documentation.
4. Customer Evaluation: The customer evaluates the concession request to understand the nature of the defect, the proposed repair, and the implications on the product’s performance, safety, and warranty.
5. Customer Approval or Rejection: Based on their evaluation, the customer either approves or rejects the concession request. If approved, the customer will provide written authorization for the repair to proceed.
6. Documented Authorization: The customer’s approval for the concession repair must be documented. This document should include details such as the concession reference number, the scope of repair, the agreed-upon repair method, and any additional conditions or requirements specified by the customer.
7. Proceed with Repair: With the customer’s documented authorization in hand, the organization can proceed with the approved repair process.
8. Record Keeping: All correspondence, including the concession request, customer authorization, and any communication related to the repair, should be accurately recorded and retained for future reference and audit purposes.

Obtaining customer authorization for concessions ensures transparency, accountability, and alignment with the customer’s requirements. It also helps to prevent unauthorized repairs, which could potentially lead to legal or contractual issues. By following this process, the organization demonstrates a commitment to quality and customer satisfaction while adhering to agreed-upon standards and contractual obligations in the automotive industry.

Work Instruction

Having clear and accessible work instructions for disassembly or repair is crucial for ensuring consistency, quality, and traceability in the repair process. These instructions provide detailed step-by-step guidance to the appropriate personnel, ensuring that repairs are carried out correctly and in compliance with the required standards. Here’s what should be included in the work instructions:

1. Scope and Purpose: Clearly define the scope and purpose of the work instructions. Specify the type of disassembly or repair tasks covered and the specific products or components involved.
2. Safety Precautions: Begin with safety precautions and any personal protective equipment (PPE) requirements that must be followed during the repair process to ensure the well-being of the personnel involved.
3. Disassembly Procedures: Provide detailed step-by-step instructions for the disassembly process, including specific tools, equipment, and techniques to be used. This section should cover the order of disassembly and any critical points that need special attention.
4. Inspection Requirements: Outline the inspection criteria and methods to assess the condition of the components during the disassembly process. This is essential to identify any additional repair needs or to validate the repair work later.
5. Repair Procedures: If repairs are required, provide detailed procedures on how to perform them. Include information on recommended repair techniques, permissible tolerances, and any additional testing or verification required.
6. Re-inspection and Quality Checks: Detail the re-inspection steps after the repair has been completed. This is to ensure that the repaired components meet the required quality standards and are free from any defects.
7. Traceability Requirements: Emphasize the importance of maintaining traceability throughout the repair process. Document the serial numbers, batch numbers, or other identifiers that link the repaired components to their original source.
8. Photographs or Illustrations: Incorporate photographs or illustrations to support the written instructions. Visual aids can help clarify complex steps and reduce the risk of errors.
9. Acceptance Criteria: Clearly define the acceptance criteria for completed repairs. Outline what constitutes an acceptable repair and what actions should be taken if a repair does not meet the required standards.
10. Revision Control: Ensure that the work instructions have version control and are regularly updated to reflect any changes or improvements in the repair process.
11. Accessibility: Make the work instructions easily accessible to the appropriate personnel involved in the repair process. This can be in the form of printed documents, digital manuals, or accessible online resources.

Having well-documented and accessible work instructions for disassembly and repair ensures consistency, reduces the risk of errors, and helps maintain the desired level of quality and traceability in the automotive industry. It also fosters a culture of continuous improvement, allowing the organization to refine its repair processes over time.

Records

Maintaining records on the disposition of repaired products is crucial for quality control, traceability, and compliance purposes in the automotive industry. These records provide a comprehensive history of the repaired products, ensuring transparency and accountability throughout the repair process. The key information that should be included in the records includes:

1. Quantity: The number of units or components that underwent the repair process. This helps track the volume of repairs and can be valuable for trend analysis.
2. Disposition: The specific disposition of each repaired product, indicating what action was taken after repair. Common dispositions may include “Accepted,” “Rejected,” “Reworked,” “Scrapped,” or “Returned to Stock.”
3. Disposition Date: The date when the final disposition decision was made. This is crucial for tracking the timeline of the repair process and for maintaining accurate historical records.
4. Traceability Information: Relevant traceability information that links the repaired product back to its original source. This information typically includes unique identifiers like serial numbers, batch numbers, or part numbers, which facilitate product traceability and recall management.
5. Repair Details: Specific details about the repair process, including any issues identified during disassembly or inspection, the repair methods employed, and any validation or testing performed post-repair.
6. Inspection and Verification Results: Documentation of the results of the re-inspection and verification process after the repair, confirming whether the product meets the required quality standards and acceptance criteria.
7. Responsible Personnel: The names or identification of the personnel involved in the repair process, including those responsible for conducting the repair, inspection, and final disposition.
8. Records Maintenance: The location and duration of record retention should be specified, ensuring that the records are properly stored and available for auditing or reference purposes.
9. Non-Conformance Reports (NCRs): If any non-conformances are discovered during the repair process, the corresponding NCRs should be attached or referenced in the disposition records.
10. Customer Authorization: If the repair required customer authorization, documentation of the customer’s approval or concession should be included in the records.

Having comprehensive and well-maintained records on the disposition of repaired products allows the organization to demonstrate compliance with quality standards, maintain traceability, and provide evidence of proper repair procedures. It also facilitates root cause analysis in case of recurring issues, helping the organization identify opportunities for process improvement and enhancing customer satisfaction in the automotive industry.

Rework and repair are two terms used in the context of fixing defects or non-conformities in products or processes. While both involve correcting issues, there are some key differences between rework and repair. Rework refers to the process of correcting defects or non-conformities found in a product or process during the production or manufacturing stage. It involves reprocessing the item to bring it back to the required specifications or quality standards. Rework typically occurs before the product is released to the customer. Repair, on the other hand, is the process of fixing defects or non-conformities found in a product after it has been delivered to the customer or is in use. It involves restoring the product to its desired functionality or performance level. Rework is done during the production process, before the product is considered complete or ready for delivery. It takes place when defects are identified in the initial inspection or quality control stages. Repair takes place after the product has been delivered to the customer or is already in use. It addresses defects that were not detected or could not be corrected during the production process. Rework is typically applied to the entire product or batch to correct a systemic issue or non-conformity affecting the entire lot. Repair is generally focused on individual products that have specific defects or failures.Rework is usually less costly and easier to implement than repair because it is done within the controlled production environment, and the defective items are still in the organization’s possession. Repair can be more expensive and time-consuming as it may require retrieving the defective products from customers, diagnosing the issues, and addressing them. Rework is generally done before the product reaches the customer, so it has less direct impact on customer satisfaction. Repair involves addressing issues experienced by the customer, and its effectiveness can significantly impact customer satisfaction and loyalty.In summary, rework is the correction of defects during the production process, while repair is the correction of defects after the product has been delivered to the customer. Both rework and repair are essential in quality management to ensure that products meet the required standards and customer expectations. Ideally, organizations strive to minimize the need for both rework and repair by implementing robust quality control measures and continuous improvement practices.

8.7.1.4 Control of reworked product

The organization needs to establish a documented procedure for rework confirmation, aligning with the control plan or other relevant documented guidelines to ensure compliance with original specifications. Before initiating any rework on the product, the organization must conduct a risk analysis, such as FMEA, to assess potential risks in the rework process. If the customer mandates, the organization must seek approval from the customer before proceeding with the rework. Additionally, the organization must provide work instructions for disassembly or rework, which include re-inspection and traceability requirements, accessible to and followed by the relevant personnel. Moreover, the organization must maintain records detailing the disposition of reworked products, including quantity, disposition, disposition date, and relevant traceability information.

The organization must have a documented process for rework confirmation. This process is established to ensure that any non-conforming products or components that have undergone rework are brought back into compliance with the original specifications and requirements. The rework confirmation process is an essential part of the control plan and other relevant documented information that outlines the organization’s quality control measures.The rework confirmation process typically involves the following steps:

1. Identification of Non-Conformities: Non-conformities or defects are identified during the production process through inspections, testing, or other quality control measures.
2. Authorization for Rework: The identified non-conformities are assessed to determine whether rework is an appropriate corrective action. The decision to proceed with rework is based on established criteria and is documented for traceability purposes.
3. Rework Procedures: The organization follows defined rework procedures that outline how to correct the non-conformities and bring the product back to compliance with the original specifications. These procedures may include step-by-step instructions, rework techniques, and any specific requirements for the reworked product.
4. Rework Inspection: After the rework is completed, the reworked product is subjected to inspections or testing to verify that the non-conformities have been effectively addressed. This may involve dimensional checks, visual inspections, functional testing, or other relevant evaluations.
5. Compliance Verification: The rework confirmation process ensures that the reworked product complies with the original specifications, as defined in the control plan or other relevant documented information. Any deviations or variations from the original requirements are documented and addressed as necessary.
6. Documentation and Traceability: All aspects of the rework confirmation process are documented to provide a record of the rework activities, the compliance verification, and any associated findings. This documentation facilitates traceability and supports quality audits.
7. Control Plan Updates: The control plan or other relevant documented information may be updated to reflect the rework actions taken and any necessary adjustments to the production process or inspection procedures.
8. Customer Communication: If the non-conforming product has already been shipped to the customer, the organization may communicate with the customer regarding the rework action taken and obtain approval if necessary.

The rework confirmation process ensures that non-conforming products are appropriately corrected, preventing the release of defective items to customers. By having a well-documented and systematic approach to rework, organizations can maintain product quality, meet customer requirements, and demonstrate compliance with IATF 16949 and other quality standards.

Conducting Risk analysis

The organization must conduct risk analysis, such as Failure Mode and Effects Analysis (FMEA), before proceeding with the rework process. Risk analysis helps to identify potential failure modes, assess their severity, occurrence, and detection, and prioritize actions to mitigate the risks effectively. This analysis is crucial to ensure that the rework process is well-controlled, effective, and does not introduce new risks or problems. FMEA is a systematic approach used to identify potential failure modes, understand their effects, and prioritize actions to reduce or eliminate risks. It involves cross-functional teams reviewing the rework process step by step to identify potential issues. The team identifies all potential failure modes or issues that could occur during the rework process. These could include incorrect rework procedures, inadequate inspections, or failure to restore the product to its original specifications. The team assesses the severity of each identified failure mode. Severity indicates the potential impact on the product’s performance, safety, or customer satisfaction if the failure mode occurs. The team evaluates the likelihood of each failure mode occurring during the rework process. Occurrence is a measure of how frequently the failure mode might happen. The team assesses the likelihood of detecting each failure mode before it reaches the customer. Detection evaluates the effectiveness of current controls in detecting or preventing the failure mode. The FMEA team calculates the Risk Priority Number (RPN) for each failure mode by multiplying the Severity, Occurrence, and Detection ratings. This helps prioritize which failure modes require immediate attention. Based on the RPN and criticality of each failure mode, the team formulates action plans to mitigate the risks. These actions could include improving rework procedures, enhancing inspections, providing additional training, or implementing redundancy measures. The organization should continuously monitor the effectiveness of the risk mitigation actions and make improvements as needed to further reduce risks in the rework process. By conducting risk analysis, particularly FMEA, organizations can proactively identify and address potential risks in the rework process. This approach enhances the effectiveness of the rework process, minimizes the chances of introducing new defects, and ensures the reworked products meet the required quality standards. The application of risk analysis aligns with the principles of IATF 16949 and supports the organization’s commitment to delivering high-quality products in the automotive industry.

Customer’s approval

Organizations must obtain approval from the customer before commencing rework of the product. This approval process ensures that the customer is aware of the non-conformity or defect found in the product, is informed about the proposed corrective action (rework), and agrees to proceed with the rework process. Customer approval fosters transparency and communication between the organization and the customer. It ensures that both parties are on the same page regarding the non-conformity, its impact on the product, and the proposed corrective action. Seeking approval demonstrates that the organization values customer input and is committed to meeting customer requirements and expectations. It reinforces customer confidence in the organization’s ability to handle quality issues professionally. By obtaining customer approval, the organization ensures that the customer is aware of any potential risks associated with the rework process. It establishes shared responsibility and mitigates any potential liability concerns. Some customers may have specific procedures or approval processes for handling non-conforming products. Adhering to these customer-specific requirements is essential for maintaining a positive customer-supplier relationship. Customer approval helps prevent unauthorized changes to the product or process. This ensures that the organization does not take any corrective action that the customer has not agreed upon. Reworking products can be costly for both the organization and the customer. Customer approval helps ensure that both parties are aligned on the costs associated with the rework process. The process of obtaining customer approval for rework typically involves communicating the non-conformity to the customer, providing details about the proposed corrective action (rework), and seeking explicit approval through formal channels such as written correspondence, change orders, or customer-specific approval processes. It is essential for the organization to document the customer’s approval as evidence of their agreement to proceed with the rework. This documentation ensures that there is a clear record of customer consent and supports traceability during quality audits or customer inquiries. By adhering to the requirement of obtaining customer approval for rework, organizations demonstrate their commitment to customer satisfaction, adherence to quality standards, and the principles of IATF 16949.

Work Instruction

the organization must have work instructions for disassembly or rework processes. These instructions should provide clear guidance on how to perform disassembly or rework activities to correct non-conformities and bring the product back into compliance with the required specifications and quality standards. The work instructions should cover all necessary steps, including re-inspection and traceability requirements, and be readily accessible to and utilized by the appropriate personnel involved in the rework process.Here are the key aspects that should be addressed in the work instructions for disassembly or rework:

1. Detailed Procedure: The work instructions should outline a step-by-step procedure for disassembly or rework. It should include information on how to identify the non-conformities, the sequence of actions to be taken during the rework, and the tools and equipment required.
2. Quality Criteria: Specify the acceptance criteria and quality standards that the reworked product must meet. This ensures that the rework is carried out effectively and the product meets the original specifications.
3. Re-inspection Requirements: Describe the re-inspection process to verify that the rework has been performed correctly and that the non-conformities have been effectively addressed. This may involve conducting dimensional checks, visual inspections, or functional tests.
4. Traceability: Include traceability requirements to ensure that the rework process can be traced back to the specific product or batch. This is essential for recording and tracking rework activities and is particularly important for audit purposes.
5. Personnel Competence: Specify the qualifications and competencies required for personnel involved in the rework process. Training and experience are vital to ensure that the rework is performed accurately and efficiently.
6. Safety Considerations: Address any safety requirements or precautions that personnel must follow during disassembly or rework activities. Safety is critical in any manufacturing process, and rework is no exception.
7. Documentation and Record Keeping: Instruct personnel to document all rework activities, including any changes made, re-inspection results, and any necessary adjustments to the original work instructions.
8. Access and Utilization: Ensure that the work instructions are readily accessible to the appropriate personnel involved in the rework process. Effective utilization of the work instructions helps ensure consistent and standardized rework practices.

By having well-documented work instructions for disassembly or rework, organizations can achieve consistent and effective rework processes. This contributes to product quality, customer satisfaction, and compliance with IATF 16949 requirements. Moreover, accessible and utilized work instructions support the organization in maintaining process control, enabling personnel to consistently perform rework tasks to the required quality standards.

Records

The organization must maintain records on the disposition of reworked products. These records should provide details about the reworked product, including the quantity of reworked items, the disposition of each reworked item, the date of disposition, and relevant traceability information.The disposition of reworked product refers to the final decision made regarding the reworked items after they have undergone the rework process. There are several possible dispositions for reworked products, and the organization must document the outcome for each item. Common dispositions include:

1. Accepted: The reworked product meets all the required specifications and quality standards and is accepted for use or delivery to the customer.
2. Rejected: The reworked product does not meet the required specifications even after rework and is rejected as non-conforming.
3. Scrap: In some cases, the reworked product may not meet the desired quality standards even after rework, and it is deemed unusable. Such items are often designated for scrap or disposal.
4. Reworked Again: In some instances, the rework process may not completely address all the non-conformities. In such cases, the product may be sent for rework again to address the remaining issues.

The records on the disposition of reworked product should be comprehensive and include:

• Quantity: The number of reworked items should be documented to track the extent of rework activities.
• Disposition: The disposition status of each reworked item (Accepted, Rejected, Scrap, Reworked Again, etc.) should be clearly recorded.
• Disposition Date: The date when the disposition decision was made should be recorded to maintain a timeline of events.
• Traceability Information: Relevant traceability information, such as product batch or serial numbers, should be recorded to link the reworked product to its original source and manufacturing process.

By maintaining records on the disposition of reworked product, the organization can demonstrate compliance with IATF 16949 requirements and establish a traceable record of all rework activities. These records are essential for quality audits, process improvement, and ensuring that reworked products meet the necessary quality standards before release to the customer. Effective record-keeping also supports traceability throughout the rework process and helps the organization maintain transparency and accountability in their quality management practices.

Acceptance criteria refer to the defined conditions or specifications that a product, process, or service must meet to be considered acceptable. These criteria are established to ensure that automotive manufacturers and their suppliers consistently deliver high-quality products and services that meet customer requirements. The acceptance criteria in IATF 16949 cover various aspects of the automotive industry, including design, production, and service processes. Specifications for appearance items, parts, and components, such as dimensions, material properties, surface finish, color, gloss, and texture, are defined as acceptance criteria. These criteria ensure that the appearance items meet the required quality standards. The acceptance criteria for dimensions are specified based on the product design and engineering drawings. They ensure that appearance items and components are manufactured within the allowable tolerances.If appearance items have specific performance requirements, such as load-bearing capacities, mechanical properties, or durability, these are defined as acceptance criteria.Acceptance criteria may include requirements for the material properties of appearance items, such as hardness, tensile strength, or chemical resistance.The standard may include criteria for visual inspection, such as allowable surface defects or imperfections, to ensure the appearance items meet the required aesthetic standards. The acceptance criteria for manufacturing processes are defined based on the process capability indices (Cp and Cpk) to ensure that the processes are capable of consistently producing appearance items within the specified tolerances.The results of inspections, testing, and measurement processes are compared against predefined acceptance criteria to determine whether the appearance items conform to the required quality standards. The acceptance criteria also include compliance with applicable statutory, regulatory, and customer-specific requirements relevant to the automotive industry and appearance items.The standard may set targets for continuous improvement in quality metrics, such as defect rates or customer satisfaction scores, as part of the acceptance criteria.The acceptance criteria may define the expectations for implementing corrective actions in case of non-conformance to ensure that appearance items meet the required quality standards.It is essential for organizations in the automotive industry to adhere to the acceptance criteria specified in IATF 16949 to achieve consistent product quality, customer satisfaction, and compliance with industry standards. These criteria help organizations establish and maintain a robust quality management system to meet the demanding requirements of the automotive industry.

Clause 8.6.6 Acceptance criteria

The organization must establish acceptance criteria, which may need approval from the customer when deemed necessary or appropriate. When employing attribute data sampling, the acceptance standard should be zero defects.

Acceptance criteria are the requirements which, if met, will deem the product acceptable. Every requirement should be stated in such a way that it can be verified. Characteristics should be specified in measurable terms with tolerances or min/max limits. These limits should be such that will ensure that all production versions will perform to the product specification and that such limits are well within the limits to which the design has been tested . Where there are common standards for certain features, these may be contained in a standards manual. Where this method is used it is still necessary to reference the standards in the particular specifications to ensure that the producers are always given full instructions. Some organizations omit common standards from their specifications. This makes it difficult to specify different standards or to subcontract the manufacture of the product without handing over proprietary information. In determining your inspection and test requirements it is necessary not only to specify what inspections and tests are required and when, but also to define the acceptance criteria and the frequency of inspection and test. Are the acceptance criteria those defined in the product specification or are the limits to be closed to gain better control over the process? Is every product to be inspected or are the quantities so large that it would be economically nonviable? If sampling is to be performed what are the acceptance criteria? Answers to these and other questions need to be provided by your inspection and testing process requirements. The organization is responsible for establishing specific criteria that products, processes, or services must meet to be considered acceptable and in compliance with the quality requirements.When defining acceptance criteria, the organization must consider various factors, including customer requirements, industry standards, regulatory requirements, and internal quality objectives. The acceptance criteria should be clear, measurable, and aligned with the organization’s overall quality policy and objectives.Here are some key considerations when defining acceptance criteria:

1. Customer Requirements: Ensure that the acceptance criteria reflect the specific requirements and expectations of the customers. This may include appearance standards, performance specifications, and any unique features requested by the customers.
2. Industry Standards: Incorporate relevant industry standards, , into the acceptance criteria. Adhering to these standards helps ensure compliance with recognized best practices.
3. Regulatory Requirements: Consider applicable statutory and regulatory requirements that affect the appearance items and the organization’s processes. Compliance with relevant regulations is critical for the automotive industry.
4. Product and Process Specifications: Base the acceptance criteria on detailed product specifications, engineering drawings, and process control plans. These specifications should define the required dimensions, materials, tolerances, and other critical characteristics.
5. Performance Metrics: Define measurable performance metrics that align with the organization’s quality objectives. These metrics may include defect rates, on-time delivery, customer satisfaction scores, and other key performance indicators.
6. Process Capability: Establish criteria that reflect the process capability needed to consistently produce appearance items that meet the specified requirements.
7. Inspection and Testing Methods: Identify the specific inspection and testing methods to be used to evaluate appearance items against the acceptance criteria.
8. Continuous Improvement: Set targets for continuous improvement to drive the organization to higher levels of quality and customer satisfaction.
9. Review and Approval: Ensure that the defined acceptance criteria are reviewed and approved by relevant stakeholders, including customers, suppliers, and internal quality personnel.

By defining their own acceptance criteria, organizations can tailor the quality requirements to their specific products and processes while ensuring alignment with customer expectations and industry standards. Having well-defined acceptance criteria facilitates effective quality control, reduces variability, and helps the organization deliver appearance items that consistently meet high-quality standards.

Acceptance criteria for attribute data

The standard requires the acceptance criteria for attribute data sampling plans to be zero defects. Attribute data refers to data that can be categorized into discrete categories or attributes, such as “defective” or “non-defective,” “pass” or “fail,” or “conforming” or “non-conforming.”When the acceptance level is set at zero defects, it means that the organization or quality control process will not accept any defective units or items during the sampling inspection. If any defects are found during the sampling process, the entire lot or batch may be rejected, and corrective actions may be initiated to address the root causes of the defects.Setting the acceptance level at zero defects is common in industries where product quality is critical, such as the automotive industry, where safety and reliability are paramount. Appearance items and other critical components are subject to strict quality requirements, and any defects can have significant implications for performance, safety, and customer satisfaction. With attribute data the product either has or has not the ascribed attribute — it can there fore either pass or fail the test. There are no gray areas. Attributes are measured on a go or no-go basis. With variables, the product can be evaluated on a scale of measurement. However, with inspection by attributes we sometimes use an acceptable quality level (AQL) that allows us to ship a certain percent defective in a large batch of product -probably no more than 10 in 1,000 — but to the automobile industry that is not good enough. The standard imposes a strict requirement on characteristics that are measured by attributes. There shall be no AQL, there shall be zero percent defective in the sample selected for inspection, otherwise the batch shall be rejected. This is what it implies, as your customer does not want to be supplied any defective products. For inspection by variables the acceptance criteria have to be specified and the place to specify it is the control plan, which is submitted to your customer for approval.To achieve a zero-defect acceptance level, organizations must implement robust quality management systems, effective inspection processes, and continuous improvement initiatives. This involves:

1. Establishing Clear Quality Standards: Clearly defining the quality standards and acceptance criteria for appearance items, ensuring that they align with customer requirements and industry standards.
2. Implementing Robust Inspection Procedures: Developing rigorous inspection procedures and quality control measures to identify any defects or non-conformities during the sampling process.
3. Training Personnel: Providing training to personnel involved in inspection and quality control to ensure they can accurately identify defects and assess conformity.
4. Using Statistical Process Control (SPC): Implementing statistical process control methods to monitor the manufacturing process and detect potential defects early on.
5. Continuous Improvement: Regularly reviewing inspection results and performance data to identify trends and opportunities for process improvement.
6. Collaboration with Suppliers: Collaborating with suppliers to ensure they also adhere to zero-defect quality standards for externally provided processes, products, and services.
7. Root Cause Analysis and Corrective Actions: Conducting root cause analysis for any identified defects and implementing corrective actions to prevent recurrence.

Achieving a zero-defect acceptance level requires a commitment to quality and a culture of continuous improvement throughout the organization. While it may be challenging, it is a critical goal for industries like automotive, where safety, reliability, and customer satisfaction are paramount.

Customer’s approval

Getting approval from the customer for acceptance criteria involves effective communication, collaboration, and documentation. Thoroughly understand the customer’s requirements and expectations for the appearance items. This may involve reviewing contracts, specifications, engineering drawings, and any other relevant documents. Based on the customer’s requirements and internal quality objectives, develop a set of proposed acceptance criteria for the appearance items. Ensure that these criteria are clear, measurable, and aligned with the customer’s needs. Initiate communication with the customer to present the proposed acceptance criteria. This can be done through meetings, video conferences, email exchanges, or other preferred communication channels. Provide a detailed explanation of the proposed acceptance criteria, including how they align with the appearance items’ specifications and how they ensure quality and performance. Listen to the customer’s feedback, questions, and concerns regarding the proposed acceptance criteria. Be open to making necessary revisions based on the customer’s input. Collaborate with the customer to review the acceptance criteria together. This interactive approach helps in gaining a shared understanding and fosters a collaborative relationship. If the customer requests changes or adjustments to the acceptance criteria, incorporate those revisions and provide updated documents for their review. Once the acceptance criteria have been reviewed and revised as necessary, formally request approval from the customer. This request can be made in writing, such as through a formal letter or email. Request the customer to provide written confirmation of their approval for the acceptance criteria. This confirmation serves as documented evidence of the customer’s agreement. Keep records of all communication with the customer, including meeting minutes, emails, and any exchanged documents. Maintain a record of the customer’s written approval for future reference and audits. Maintain open lines of communication with the customer throughout the production process. If there are any changes or updates to the acceptance criteria during production, seek customer approval for those changes as well. By following these steps, organizations can effectively obtain customer approval for acceptance criteria, ensuring that appearance items meet customer requirements and expectations. Clear communication, collaboration, and proper documentation are key to obtaining and maintaining customer satisfaction in the automotive industry.