【正文】
c) initiation of preventive action and application of controls to ensure that it is effective。 andd) application of controls to ensure that corrective action is taken and that it is effective.Corrective actions have been pleted in accordance with the procedures. Preventive actionThe procedures for preventive action include:a) the use of appropriate sources of information such as processes and work operations which affect product quality, concessions, audit results, quality records, service reports and customer plaints to detect, analyze and eliminate potential causes on nonconformities。b) investigation of the cause of nonconformities relating to product, process and quality system, and recording the results of the investigation。b) accepted with or without repair by concession。h) ensure that the handling, preservation and storage of inspection, measuring and test equipment is such that the accuracy and fitness for use are maintained。f) assesse and document the validity of previous inspection and test results when inspection, measuring or test equipment is found to be out of calibration。d) identify inspection, measuring and test equipment with a suitable indicator or approved identification record to show the calibration status。b) identify all inspection, measuring and test equipment that can affect product quality, and calibrated/adjusted them at prescribed intervals, or prior to use, against certified equipment having a known valid relationship to internationally or nationally recognized standards.Where no such standards exist, the basis used for calibration is documented。 andg) suitable maintenance of equipment to ensure continuing process capability.Where the results of processes cannot be fully verified by subsequent inspection and testing of the product and where, for example, processing deficiencies may bee apparent only after the product is in use, the processes are carried out by qualified operators and/or require continuous monitoring and control of process parameters to ensure that the specified requirements are met.The requirements for any qualification of process operations, including associated equipment and personnel, are specified.Records are maintained for qualified processes, equipment and personnel, as appropriate. Inspection and testing GeneralThe supplier shall establish and maintained documented procedures for inspection and testing activities in order to verify that specified requirements for the product are met.The required inspection and testing, and the records to be established, are be detailed in the quality plan or documented procedures. Receiving inspection and testingThe supplier ensures that ining product is not used or processed (except in ) until it has been inspected or otherwise verified as conforming to specified requirements.Verification of conformance to the specified requirements is in accordance with the quality plan and/or documented procedures.In determining the amount and nature of receiving inspection, consideration shall be given to the amount of control exercised at the subcontractor’s premises and the recorded evidence of conformance provided.Where ining product is released for urgent production purposes prior to verification, it is positively identified and recorded (see ) in order to permit immediate recall and replacement in the event of nonconformity to specified requirements. Inprocess inspection and testingThe supplier:a) inspects and tests the product as required by the quality plan and/or documented procedures。e) the approval of processes and equipment, as appropriate。c) pliance with reference standards/codes, quality plans and/or documented procedures。c) the title, number and issue of the quality system standard to be applied.The supplier reviews and approves purchasing documents for adequacy of the specified requirements prior to release. Verification of purchased product Supplier verification at subcontractor’s premisesWhen the supplier verifies purchased product at the subcontractors premises, verification arrangements and the method of product release are specified in the purchasing documents. Customer verification of subcontracted productWhere specified in the contract, the supplier’s customer of the customer’s representative is afforded the right to verify at the subcontractor’s premises and the supplier’s premises that subcontracted product conforms to specified requirements.Such verification is not used by the supplier as evidence of effective control of quality by the subcontractor.Verification by the customer does not absolve the supplier of the responsibility to provide acceptable product, nor does it preclude subsequent rejection by the customer. Control of customersupplied productThe supplier shall establish and maintain documented procedures for the control of verification, storage and maintenance of customersupplied product provided for incorporation into the supplies or for related activities.Any such product that is lost, damaged or is otherwise unsuitable for use is recorded and reported to the customer.Verification by the supplier does not absolve the customer of the responsibility to provide acceptable product.Customer supplied product is controlled in accordance with the procedure. Product identification and traceabilityWhere appropriate, the supplier shall establish and maintain documented procedures for identifying the product by suitable means from receipt and during all stages of production, delivery and installation.Product is identified in accordance with the procedures.Where and to the extent that traceability is a specified requirement, the supplier shall establish and maintain documented procedures for unique identification of individual product or batches.This identification shall be recorded.Product traceability is maintained in accordance with the procedures. Process controlThe suppli