【正文】 , 1996 Chrysler Corporation, Ford Motor Company, and General Motors Corporation 59 Product Process Management ? Element Control of Inspection, Measuring, and Test Equipment (cont.) ? Additional: ? Include in calibration records: ? Revisions following engineering changes ? Gage conditions and actual readings as received for calibration ? Notification to customer if suspect material shipped ? Analyze variation of measurement and test equipment with statistical studies Copyright 169。 , 1996 Chrysler Corporation, Ford Motor Company, and General Motors Corporation 55 Product Process Management ? Element Inspection and Testing ? Requirements: ? Verify ining product before use according to plan ? In determining the approach, consider: ? Amount of control at subcontractor ? Recorded evidence of conformance provided ? If product is released prior to verification: ? Positively identify and record ? Recall or replace if found nonconforming ? Inspect and test inprocess product according to plan ? Hold product until verification is pleted Copyright 169。 , 1996 Chrysler Corporation, Ford Motor Company, and General Motors Corporation 51 Product Process Management ? Element Product Identification and Traceability ? Requirements: ? Where appropriate, identify product by suitable means from receipt and during all stages of production and delivery ? Where traceability is a specified requirement, provide for unique identification of product and record identification Copyright 169。 track to monitor timely pletion and conformance to requirements ? Have written customer approval or waiver on design changes ? Have customer review proprietary design changes Copyright 169。 , 1996 Chrysler Corporation, Ford Motor Company, and General Motors Corporation 44 Product Process Management ? Element Design Control (applies to design responsible suppliers only) ? Requirements: ? Identify activities, resources, responsibilities, and technical interfaces (use qualified personnel with adequate resources) ? Identify design input requirements ? Include statutory/regulatory requirements ? Resolve unclear requirements ? Consider results of contract reviews Copyright 169。 , 1996 Chrysler Corporation, Ford Motor Company, and General Motors Corporation 40 Quality System Structure Control ? Element Internal Quality Audits ? Requirements: ? Plan and implement internal quality audits: ? Verify that activities ply with the quality plan ? Determine the effectiveness of the quality system ? Base the schedule on status/importance of the activity ? Done by independent personnel ? Record and report results to the audited department ? Take timely corrective action ? Verify the effectiveness of the corrective action with followup audits ? Additional: ? Include suitable work environment as part of the internal audit process Copyright 169。 , 1996 Chrysler Corporation, Ford Motor Company, and General Motors Corporation 36 Quality System Structure Control ? Element Document and Data Control ? Requirements: ? Ensure that: ? Documents and data are reviewed and approved for use ? Changes to the documents are reviewed, approved, and controlled ? Control external documents (., customer drawings) ? Additional: ? Have current releases of referenced documents available ? Identify special characteristics on documents ? Timely review, distribution, and implementation of customer specifications and standards ? Keep records of the implementation date Copyright 169。 , 1996 Chrysler Corporation, Ford Motor Company, and General Motors Corporation 32 Quality System Structure Control ? Provides the framework for and control of the quality system: ? Requires a documented quality system be established and maintained ? Provides controls for documents and data ? Requires investigation and corrective action of nonconformances ? Provides controls for quality records ? Requires audits of the quality system Copyright 169。 , 1996 Chrysler Corporation, Ford Motor Company, and General Motors Corporation 28 Quality Management Leadership ? Provides requirements for the effective management of the quality system: ? Outlines management’ s responsibility, involvement, and support of the quality system ? Provides anizational structure requirements for the support of quality functions ? Emphasizes training of personnel affecting quality Copyright 169。s quality policy X Supplier39。 , 1996 Chrysler Corporation, Ford Motor Company, and General Motors Corporation 22 QS9000 Overview ? Quality system documentation ? Suppliers must establish, document, and implement effective quality systems based on QS9000 ? All requirements of QS9000 must be incorporated into the supplier’ s quality system (see quality system documentation progression) Copyright 169。 , 1996 Chrysler Corporation, Ford Motor Company, and General Motors Corporation 18 MODULE 2 QS9000 Overview Copyright 169。 , 1996 Chrysler Corporation, Ford Motor Company, and General Motors Corporation 14 Variables Affecting Quality ? Accuracy in identifying customer requirements and expectations ? Adequacy of raw materials ? Adequacy of product design ? Competency of personnel ? Variances in process equipment ? Adequacy of measures taken to prevent damage to the product after production Copyright 169。 , 1996 Chrysler Corporation, Ford Motor Company, and General Motors Corporation 10 Definitions of Quality ? Juran Fitness for use