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。不合格控制规范 1目的 规定不合格的控制以及不合格处置的有关职责和权限确保不符合要求的输出得到识别和控制防止非预期的使用或交付。 2范围 适用于原辅材料、半成品、成品检验中和顾客抱怨的不合格及可疑产品的控制。 3定义 31 合格品:完全达到标准要求的产品。 32 不合格品:产品的质量特性不符合规
Nonconformance Control Specification
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Purpose This specification establishes the responsibilities and authorities for controlling nonconformance and its disposal, ensuring the identification and control of outputs that do not meet requirements, and preventing unintended use or delivery.
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Scope This specification applies to the control of nonconforming and suspect products in the inspection of raw materials, semi-finished products, finished products, and customer complaints.
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Definitions 3.1 Conforming Product: A product that fully meets the specified requirements. 3.2 Nonconforming Product: A product whose quality characteristics do not meet the specified requirements. 3.3 Rework (Correction): Measures taken to make nonconforming products meet the requirements. The result of rework is a conforming product. 3.4 Repair: Measures taken to make nonconforming products suitable for their intended use. The result of repair remains a nonconforming product. 3.5 Emergency Release (Special Acceptance): Nonconforming materials or products that, due to urgent production requirements, are accepted and used without rework/sorting or after reconditioning/sorting. 3.6 Scrap: Products that cannot meet the basic requirements of use or have safety defects. 3.7 Outsourced Component: Parts provided by the company's suppliers, processed by the supplier; parts provided entirely by the supplier according to the company's requirements. 3.8 Corrective Measures: Measures taken to correct identified nonconforming products, defects, or other undesired situations and eliminate their causes.
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Responsibilities 4.1 The Quality Department is responsible for identifying nonconforming products according to relevant standards (or specifications) and implementing labeling. The Quality Department is responsible for organizing analysis and review of nonconforming products and providing handling recommendations. The Quality Department is responsible for tracking and verifying corrective and preventive actions for nonconforming products. 4.2 The Production Department is responsible for isolating nonconforming products in the manufacturing process. 4.3 The Responsible Department is responsible for analyzing, correcting, and implementing preventive measures for process nonconforming products. 4.4 The Technical Department is responsible for assisting in the handling of nonconforming products (root cause analysis and technical support). 4.5 The Warehouse is responsible for isolating nonconforming raw/auxiliary materials, finished products, and outsourced components. 4.6 The Purchasing and Production Departments are responsible for cooperating in implementing corrective and preventive measures for nonconforming raw/auxiliary materials and outsourced components.
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Work Content 5.1 Nonconforming products from incoming materials, in-process, finished products, purchased parts, and customer returns should be determined by inspectors. 5.2 Nonconforming Product Review and Disposal a) Corrective action b) Isolation, containment, return, or suspension of product and service provision c) Notification to customers d) Obtaining authorization for concession acceptance e) Sorting 5.2.1 When incoming inspection products are nonconforming, the quality personnel shall stamp them as nonconforming. For raw materials needed for production, if they can be sorted without affecting the product quality, the quality personnel shall confirm and agree, fill out the "Nonconforming Product Report Handling Form," arrange warehouse personnel to select qualified raw materials, and the quality personnel shall reinspect them before they can be put into storage. Nonconforming products shall be placed in the nonconforming product area, labeled, isolated, and recorded in the "Nonconforming Product Ledger," or sent back to the supplier. If necessary, the inspector shall fill out the "Nonconforming Product Report Handling Form," propose disposal actions, and submit them to the purchasing department along with the incoming inspection records, and the purchasing department shall fill out the "Supplier Quality Information Feedback Form" and email it to the supplier. The supplier shall provide the reasons for the occurrence of defects and corrective measures to prevent recurrence. 5.2.2 In the event of nonconforming first article during the process, if immediate improvement is not possible, the quality engineer shall notify the production line to immediately stop production and hand over the defective samples to the manufacturing unit for analysis and resolution. If necessary, the quality engineer and production supervisor shall review the issue together until it is resolved. Nonconforming products detected by the production unit during the production process need to be classified, isolated, and stored separately. For appearance nonconforming products, the disposition shall be determined based on the "Appearance Inspection Standard." When appearance defects or dimension defects occur, the inspector shall put them in the red nonconforming product box at the rework station for "isolation" processing. The nonconforming product statistics form should indicate the product name, quantity, reason for nonconformance, the name of the person isolating the product, and the date to facilitate tracking. If necessary, the inspector shall conduct a preliminary analysis of the causes of defects, fill out the "Nonconforming Product Report Handling Form," and submit it to the responsible unit or convene relevant departments for joint review, countermeasures, implementation, and follow-up. 5.2.3 Finished Products (inbound, outbound, returns, etc.) 5.2.3.1 When finished products fail the inspection, the QC personnel shall be responsible and fill out the "Nonconforming Product Handling Form." The Quality Department shall organize relevant departments to review and make disposition conclusions, which shall be recorded on the "Nonconforming Report Handling Form" and finally confirmed by the Quality Department. 5.2.3.2 For nonconforming products that cannot be reworked according to the review, the QC personnel shall fill out the "Nonconforming Product Report Handling Form," and the warehouse shall handle them as scrap. 5.2.3.3 For customer returns (and/or customer feedback), if requested by the customer and/or required by the agreement, follow the customer's and agreement's requirements. An analysis must be conducted within the specified time, and corresponding measures must be formulated. If necessary, the "Nonconformance Corrective Measures Control Specification" shall be followed. 5.2.3.4 Nonconforming products during warehousing/handling: When packaging damage or other defects occur during warehousing/handling, the warehouse personnel should promptly notify the inspector for confirmation and handling. Only after the defects are improved and inspected by the inspector can the product proceed to the next process. Based on different defect situations, the inspection and warehouse units should evaluate and improve the storage environment, packaging quality, etc., to prevent the occurrence of nonconforming products during warehousing/handling. Old products or discontinued products stored for more than two years must undergo reinspection to determine whether they should be scrapped, reworked, or shipped.
5.3 Suspect Material/Product Review and Disposal 5.3.1 When suspect materials/semi-finished products/finished products are found, the inspector shall treat them as nonconforming products, attach the corresponding nonconforming product label, and have the Technical Department, Quality Department, and other relevant departments conduct a review and make disposition conclusions. 5.3.2 If they are confirmed as conforming products, attach the conforming product label. If they require rework, perform the rework. After rework, self-inspection and testing are required. If they cannot be reworked, handle them as returns or scrap. 5.3.3 Suspect products leaving the factory: When suspect products leaving the factory are found during production inspection or customer feedback, first notify the customer to stop using the suspect products, recover the products in transit, and isolate the inventory until the cause is identified before further handling. If they are nonconforming, dispose of them on-site and negotiate follow-up measures with the customer. If repair or sorting is possible and with customer consent, handle them on-site or return them for repair
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