IATF 16949:2016 Clause 8.7.1.5 Control of repaired product

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

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.