【正文】 Control of Nonconforming ProductsStatistical TechniquesStatistical techniques are used for the following activities:167。 monitor the performance of key manufacturing facilities, utilities, and processes, 167。 to monitor product characteristics on a lot to lot basis, 167。 in qualifications and validations of facilities, manufacturing processes, and test methods, and 167。 in development of product/process specifications. Electronic databases are maintained to facilitate the review of environmental monitoring and of quality characteristics for water used in production. Electronic databases are also maintained for key raw materials, subassemblies, and final product to facilitate review of processes and product performance over time.Statistically based sampling plans, process controls, and process capability studies will be incorporated into appropriate aspects of inspection and testing, as well as manufacturing processes and related validations. The methods and tools that will be used for this process are based on techniques described in ISO TR 8550 and ISO 28591.References:167。 090074SOP, QC Sampling Techniques 167。 090189SOP, Master Sampling Plan 167。 ISO 9001, , Statistical Techniques 167。 ISO TR 8550, Guide for the Selection of an Acceptance Sampling System, Scheme or Plan for Inspection of Discrete Items in Lots 167。 ISO 28591, Sampling Schemes Indexed by Acceptance Quality Limit (AQL) for Lotbylot InspectionQUALITY VERIFICATIONInspection and TestingAll ining parts and materials used in manufacturing steps are inspected or verified to established requirements prior to use. Purchasing efforts are directed at establishing successful partnerships with suppliers to assure that all ining parts and materials meet specifications. Final product is not released for use until it is verified to be in conformance with the specifications.Inprocess inspection is carried out as stated in Manufacturing Batch Records and Part Number Specification documents. If a part is needed for further manufacturing prior to the pletion of inspection and testing, approval by appropriate management personnel is obtained via a Discrepancy Report.Final inspection and testing is performed before release of the product for shipment. The final product release review procedure includes a verification that all acceptance data is present and that all specifications were met.Each step of inspection and testing activities is controlled and results are recorded to provide evidence that each stage is pleted. Records are maintained to show the pass or fail status of the test/inspection pared to specified acceptance criteria. The records also identify the QA/QC Department Head responsible for the release of the product.References:167。 060001SOP, Packaging and Inspection of Final Assemblies 167。 090003SOP, Raw Material Quality Assurance Procedure 167。 090004SOP, Discrepancy Report Procedure 167。 090006SOP, Device History Record 167。 090041SOP, Manufactured Material Quality Assurance Procedure 167。 090074SOP, QC Sampling Techniques 167。 090084SOP, QC Test Failure, Repetition and Investigation Rules 167。 090088SOP, Retention Sample Requirements 167。 120072SOP, Inspection and Test General Requirements 167。 ISO 9001, , Product Inspection and TestingInspection, Measuring, and Test EquipmentEquipment used for inspection and testing is selected based on applicability and sensitivity of measurement for the particular product attribute being evaluated. Test equipment is controlled through periodic calibration and maintenance activities to ensure the integrity of the equipment. The calibration status for each piece of test equipment is indicated on the equipment. When equipment found to be out of calibration is used to test product and parts, a product impact assessment is performed and, where appropriate, those products and parts are retested before release. Calibration and maintenance activities are recorded and accessible to personnel using the equipment and/or involved with the calibration and maintenance activities.Test equipment is stored and maintained in the appropriate environment to achieve the limits for accuracy and precision. Test hardware and software is verified according to documented procedures and schedules.References:167。 110033SOP, Instrument Calibration Program 167。 110061SOP, Preventive Maintenance Program 167。 110079SOP, General Calibration Protocol 167。 110080SOP, Vendor Calibration 167。 120026SOP, Master Equipment Files 167。 ISO 9001, , Control of Inspection EquipmentInspection and Test StatusThe inspection/test status of all raw materials, ponents, and finished products is identified by labeling, segregating, and recording at all phases of production, testing, installation, servicing, and warehousing. Inspection and test results are documented as the material/product progresses through the production process. The inspection/test status identifies the material status and those items which do not conform to specifications.References:167。 090003SOP, Raw Material Quality Assurance Program 167。 090041SOP, Manufactured Material Quality Assurance Procedure 167。 100002SOP, Materials Control Raw Materials 167。 100003SOP, Materials Control Finished Product 167。 100008SOP, Materials Control Work in Process (WIP) 167。 ISO 9001, , Inspection and Test Status of ProductsQUALITY IMPROVEMENTCorrective and Preventative ActionCorrective action is a documented activity used to stimulate continuous improvement to quality problems. Corrective action includes: 1) identification of the nonconforming material, process, facility, and/or equipment, 2) identification of deviations from established procedures/processes or specifications, 3) identification of the cause for nonconformities or deviations, 4) implementing activities designed to stimulate improvement, and 5) assessing and verifying the effectiveness of the corrective action. The corrective action systems respond