5.4 Once non-conforming or suspicious materials are found during the inspection of each production line, they should be immediately isolated and labeled, and must not be mixed or circulated. The relevant departments should promptly handle and resolve the issue without delay. If it cannot be resolved in a timely manner, it should be reported to the superior.

5.5 Rework of non-conforming products 5.5.1 When non-conforming products can be reworked, the rework should fully meet the specified requirements. When non-conforming products can be repaired, the repair should only be limited to general minor non-conforming products that do not affect safety regulations or key characteristics. 5.5.2 For all rework, there must be a rework plan that should be placed in a location easily accessible by the operator. 5.5.3 Rework/repair products should be appropriately labeled, and the inspector should indicate "rework/repair" in the inspection record. 5.5.4 After rework/repair, the product must undergo inspection. Products that pass the inspection are considered qualified products and do not require additional labeling.

5.6 The quality department should conduct monthly statistics and analysis of the product quality during the production process, and organize relevant departments for discussion. Priority improvement plans should be implemented, and risk response measures should be updated regularly to reduce the RPN value and adjust the inspection frequency. For serious non-conforming products and recurring non-conforming products, the "8D report" should be adopted to analyze the causes and take corrective actions. The quality department is responsible for tracking and verifying the implementation results of the measures.

5.7 The organization should take appropriate measures based on the nature of the non-conformities and their impact on the conformity of products and services. This also applies to non-conforming products and services discovered after product delivery or during or after service provision, and should be handled in accordance with the "Non-conforming Corrective Measures Control Specification".

5.8 Special approval: If the inspection of raw materials or semi-finished products does not comply with the regulations but does not affect the characteristics of the finished product, it should be approved by the inspection manager. If it affects the characteristics of the finished product, the business and customer should be contacted to apply for special approval. If the finished product inspection does not comply with the regulations, it must be contacted by the business and customer. After obtaining customer confirmation, the inspection should fill in the "special approval" label and record the special approval number and customer confirmation in the "special approval application form". Special approved raw materials and products must not violate safety, pollution, and important quality functional requirements.

5.9 For customer concession, the quantity and time of the customer's concession should be clearly defined and documented.

5.10 If suspicious products or non-conforming products have already been shipped, the customer should be notified promptly and the "emergency plan" should be followed.

  1. Related documents 6.1 QD8.5.2-2021 "Traceability Control Specification" 6.2 QD8.6.1-2021 "Product and Service Release Control Specification" 6.3 QD10.2.1-2021 "Non-conforming Corrective Measures Control Specification"

  2. Related records 7.1 QR8.7-01 "Non-conforming Registration Ledger" 7.2 QR8.7-02 "Non-conforming Label" 7.3 QR8.7-03 "Non-conforming Product Report Handling Form" 7.4 QR8.7-04 "Customer Concession Authorization-Notification Form" 7.5 QR8.7-05 "Return Analysis Handling Form"

Attachment 1: Non-conforming Product Control Process Flowchart Flow Responsibility Department/Person Task Non-conforming product information Identify non-conforming reasons Label Isolate Review Implement continuous improvement process Corrective action Scrap, return, concession acceptance, downgrade segregation, labeling Approval Revalidation Identification evaluation Simple Complex Progress tracking Rework, repair Record Discovering department/person Inspector Inspector Quality department and other relevant department personnel Technical personnel, etc. Inspector Material control personnel Quality inspector Responsible department Quality inspector Quality department Fill in non-conforming product inspection record, non-conforming product labeling Inspection, determination Fill in "Non-conforming Product Report Handling Form" Reason analysis, measure requirements/formulation Develop "rework plan" if necessary Processing progress tracking Execute according to the disposal conclusion Rework verification, measure verification Collect and save record

你是翻译公司的一名译者现在请你翻译一下公司文件请使用正确和正式的英语表达并按照原文格式进行排版。54 各生产线检验时一旦发现不合格品或可疑物料时应立即予以隔离并标识不得混淆和流转。 相关部门应及时处理解决不得推迟拖延。 如不能及时解决的应向上级报告。 55 不合格品的返工 551 不合格品可返工时返工应能完全达到规定的要求;不合格品可返修时返修后需以不影响安全法规、关键特性为限只可对一般的次要

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