IATF 16949:2016 Clause 8.7.1.4 Control of reworked product

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 must have a documented process for rework confirmation in accordance with the control plan or other relevant documented information to verify compliance to original specifications. The organization must conduct risk analysis (such as FMEA) to assess risks in the rework process prior to rework the product. If required by the customer, the organization must obtain approval from the customer prior to commencing rework of the product. The organization must have work Instructions for disassembly or rework, 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 reworked product including quantity, disposition, disposition date, and applicable 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.

Leave a Reply