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QS-9000 FORMS 1 WORKBOOK V2.0a Copyright 1998,1999, 2000 March Quality Services Part Name NAME Part Number NUMBER Engineering Change Level ECL Engineering Change Level Date ECL DATE Supplier Name SUPPLIER Supplier Code CODE Street Address ADDRESS City CITY State STATE Zip ZIP Phone Number 555-555-5555 Customer Name GM Division DIVISION Application APPLICATION File Name FILE.XLS For sales and technical support contact Carwin Ltd Tel: (44) 01708 861333/or Fax 867941 T r a n s la t io n E n g lis h G e r m a n THE FOLLOWING LEVELS OF DOCUMENTS WERE USED TO PREPARE THIS WORKBOOK. DOCUMENT EDITION PRINTING ADVANCED PRODUCT QUALITY PLANNING AND CONTROL PLAN REFERENCE MANUAL First Feb-95 MEASUREMENT SYSTEM ANALYSIS Second Jun-98 POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS Second Feb-95 PRODUCTION PART APPROVAL Third Feb-00 Page 4 of 85 A-1 DESIGN FMEA CHECKLIST Customer or Internal Part No. NUMBER Question Yes No Comment / Action Required PersonResponsible DueDate 1 Was the SFMEA and/or DFMEA prepared using the DaimlerChrysler, Ford, and General Motors Potential Failure Mode and Effects Analysis (FMEA) reference manual? 2 Have historical campaign and warranty data been reviewed? 3 Have similar part DFMEAs been considered? 4 Does the SFMEA and/or DFMEA identify Special Characteristics? 5 Have design characteristics that affect high risk priority failure modes been identified? 6 Have appropriate corrective actions been assigned to high risk priority numbers? 7 Have appropriate corrective actions been assigned to high severity numbers? 8 Have risk priorities been revised when corrective actions have been completed and verified? Revision Date: Prepared By: Page 5 of 85 A-2 DESIGN INFORMATION CHECKLIST Customer or Internal Part No. NUMBER Question Yes No Comment / Action Required PersonResponsible DueDate A. General Does the design require: 1 - New materials? 2 - Special tooling? 3 Has assembly build variation analysis been considered? 4 Has Design of Experiments been considered? 5 Is there a plan for prototypes in place? 6 Has a DFMEA been completed? 7 Has a DFMA been completed? 8 Have service and maintenance issues been considered? 9 Has the Design Verification Plan been considered? 10 If yes, was it completed by a cross functional team? 11 Are all specified tests, methods, equipment and acceptance criteria clearly defined and understood? 12 Have Special Characteristics been selected? 13 Is bill of material complete? 14 Are Special Characteristics properly documented? B. Engineering Drawings 15 Have dimensions that affect fit, function and durability been identified? 16 Are reference dimensions identified to minimize inspection layout time? Page 6 of 85 A-2 DESIGN INFORMATION CHECKLIST Customer or Internal Part No. NUMBER Question Yes No Comment / Action Required PersonResponsible DueDate 17 Are sufficient control points and datum surfaces identified to design functional gages? 18 Are tolerances compatible with accepted manufacturing standards? 19 Are there any requirements specified that cannot be evaluated using known inspection techniques? C. Engineering Performance Specifications 20 Have all special characteristics been identified? 21 Is test loading sufficient to provide all conditions, i.e., production validation and end use? 22 Have parts manufactured at minimum and maximum specifications been tested? 23 Can additional samples be tested when a reaction plan requires it, and still conduct regularly scheduled in-process tests? 24 Will all product testing be done in-house? 25 If not, is it done by an approved subcontractor? 26 Is the specified test sampling size and/or frequency feasible? 27 If required, has customer approval been obtained for test equipment? D. Material Specification 28 Are special material characteristics identified? 29 Are specified materials, heat treat and surface treatments compatible with the durability requirements in the identified environment? Page 7 of 85 A-2 DESIGN INFORMATION CHECKLIST Customer or Internal Part No. NUMBER Question Yes No Comment / Action Required PersonResponsible DueDate 30 Are the intended material suppliers on the customer approved list? 31 Will material suppliers be required to provide certification with each shipment? 32 Have Material characteristics requiring inspection been identified? If so, 33 - Will characteristics be checked in-house? 34 - Is test equipment available? 35 - Will training be required to assure accurate test results? 36 Will outside laboratories be used? 37 Are all laboratories used accredited (if required)? Have the following material requirements been considered: 38 - Handling? 39 - Storage? 40 - Environmental? Revision Date: Prepared By: Page 8 of 85 A-3 NEW EQUIPMENT, TOOLING, AND TEST EQUIPMENT CHECKLIST Customer or Internal Part No. NUMBER Question Yes No Comment / Action Required PersonResponsible DueDate Does the design require: 1 - New materials? 2 - Quick change? 3 - Volume fluctuations? 4 - Mistake proofing? Have lists been prepared identifying: 5 - New equipment? 6 - New tooling? 7 - New test equipment? Has acceptance criteria been agreed upon for: 8 - New equipment? 9 - New tooling? 10 - New test equipment? 11 Will a preliminary capability study be conducted at the tooling and/or equipment manufacturer? 12 Has test equipment feasibility and accuracy been established? 13 Is a preventive maintenance plan complete for equipment and tooling? 14 Are setup instructions for new equipment and tooling complete and understandable? 15 Will capable gages be available to run preliminary process capability studies at the equipment suppliers facility? 16 Will preliminary process capability studies be run at the processing plant? 17 Have process characteristics that affect special product characteristics been identified? Page 9 of 85 A-3 NEW EQUIPMENT, TOOLING, AND TEST EQUIPMENT CHECKLIST Customer or Internal Part No. NUMBER Question Yes No Comment / Action Required PersonResponsible DueDate 18 Were special product characteristics used in determining acceptance criteria? 19 Does the manufacturing equipment have sufficient capacity to handle forecasted production and service volumes? 20 Is testing capacity sufficient to provide adequate testing? Revision Date: Prepared By: THIS CHECKLIST IS NOT INTENDED TO REPLACE THE CHRYSLER, FORD, AND GENERAL MOTORS QUALITY SYSTEM ASSESSMENT. Page 10 of 85 A-4 PRODUCT/PROCESS QUALITY CHECKLIST Customer or Internal Part No. NUMBER Question Yes No Comment / Action Required PersonResponsible DueDate 1 Is the assistance of the customers quality assurance or product engineering activity needed to develop or concur to the control plan? 2 Has the supplier identified who will be the quality liaison with the customer? 3 Has the supplier identified who will be the quality liaison with its suppliers? 4 Has the quality assurance system been reviewed using the Chrysler, Ford, and General Motors Quality System Assessment? Are there sufficient personnel identified to cover: 5 - Control plan requirements? 6 - Layout inspection? 7 - Engineering performance testing? 8 - Problem resolution analysis? Is there a documented training program that: 9 - Includes all employees? 10 - Lists whose been trained? 11 - Provides a training schedule? Has training been completed for: 12 - Statistical process control? 13 - Capability studies? 14 - Problem solving? 15 - Mistake proofing? 16 - Other topics as identified? 17 Is each operation provided with process instructions that are keyed to the control plan? 18 Are standard operator instructions available at each operation? 19 Were operator/team leaders involved in developing standard operator instructions? THIS CHECKLIST IS NOT INTENDED TO REPLACE THE CHRYSLER, FORD, AND GENERAL MOTORS QUALITY SYSTEM ASSESSMENT. Page 11 of 85 A-4 PRODUCT/PROCESS QUALITY CHECKLIST Customer or Internal Part No. NUMBER Question Yes No Comment / Action Required PersonResponsible DueDate Do inspection instructions include: 20 - Easily understood engineering performance specifications? 21 - Test frequencies? 22 - Sample sizes? 23 - Reaction plans? 24 - Documentation? Are visual aids: 25 - Easily understood? 26 - Available? 27 - Accessible? 28 - Approved? 29 - Dated and current? 30 Is there a procedure to implement, maintain, and establish reaction plans for statistical control charts? 31 Is there an effective root cause analysis system in place? 32 Have provisions been made to place the latest drawings and specifications at the point of the inspection? 33 Are forms/logs available for appropriate personnel to record inspection results? Have provisions been made to place the following at the monitored operation: 34 - Inspection gages? 35 - Gage instructions? 36 - Reference samples? 37 - Inspection logs? 38 Have provisions been made to certify and routinely calibrate gages and test equipment? Have required measurement system capability studies been: THIS CHECKLIST IS NOT INTENDED TO REPLACE THE CHRYSLER, FORD, AND GENERAL MOTORS QUALITY SYSTEM ASSESSMENT. Page 12 of 85 A-4 PRODUCT/PROCESS QUALITY CHECKLIST Customer or Internal Part No. NUMBER Question Yes No Comment / Action Required PersonResponsible DueDate 39 - Completed ? 40 - Acceptable? 41 Are layout inspection equipment and facilities adequate to provide initial and ongoing layout of all details and components? Is there a procedure for controlling incoming product that identifies: 42 - Characteristics to be inspected? 43 - Frequency of inspection? 44 - Sample size? 45 - Designated location for approved product? 46 - Disposition of nonconforming products? 47 Is there a procedure to identify, segregate, and control nonconforming products to prevent shipment? 48 Are rework/repair procedures available? 49 Is there a procedure to requalify repaired/reworked material? 50 Is there an appropriate lot traceability procedure? 51 Are periodic audits of outgoing products planned and implemented? 52 Are periodic surveys of the quality system planned and implemented? 53 Has the customer approved the packaging specification? Revision Date: Prepared By: Page 13 of 85 A-5 FLOOR PLAN CHECKLIST Customer or Internal Part No. NUMBER Question Yes No Comment / Action Required PersonResponsible DueDate 1 Does the floor plan identify all required process and inspection points? 2 Have clearly marked areas for all material, tools, and equipment at each operation been considered? 3 Has sufficient space been allocated for all equipment? Are process and inspection areas: 4 - Of adequate size? 5 - Properly lighted? 6 Do inspection areas contain necessary equipment and files? Are there adequate: 7 - Staging areas? 8 - Impound areas? 9 Are inspection points logically located to prevent shipment of nonconforming products? 10 Have controls been established to eliminate the potential for an operation, including outside processing, to contaminate or mix similar products? 11 Is material protected from overhead or air handling systems contamination? 12 Have final audit facilities been provided? 13 Are controls adequate to prevent movement of nonconforming incoming material to storage or point of use? Page 14 of 85 A-5 FLOOR PLAN CHECKLIST Customer or Internal Part No. NUMBER Question Yes No Comment / Action Required PersonResponsible DueDate Revision Date: Prepared By: Page 15 of 85 A-6 PROCESS FLOW CHART CHECKLIST Customer or Internal Part No. NUMBER Question Yes No Comment / Action Required PersonResponsible DueDate 1 Does the flow chart illustrate the sequence of production and inspection stations? 2 Were all appropriate FMEAs (SFMEA, DFMEA) available and used as aids to develop the process flow chart? 3 Is the flow chart keyed to product and process checks in the control plan? 4 Does the flow chart describe how the product will move, i.e., roller conveyor, slide containers, etc.? 5 Has the pull system/optimization been considered for this process? 6 Have provisions been made to identify and inspect reworked product before being used? 7 Have potential quality problems due to handling and outside processing been identified and corrected? Revision Date: Prepared By: Page 16 of 85 A-7 PROCESS FMEA CHECKLIST Customer or Internal Part No. NUMBER Question Yes No Comment / Action Required PersonResponsible DueDate 1 Was the Process FMEA prepared using the Chrysler, Ford, and General Motors guidelines? 2 Have all operations affecting fit, function, durability, governmental regulations and safety been identified and listed sequentially? 3 Were similar part FMEAs considered? 4 Have historical campaign and warranty data been reviewed? 5 Have appropriate corrective actions been planned or taken for high risk priority items? 6 Have appropriate corrective actions been planned or taken for high severity numbers? 7 Were risk priorities numbers revised when corrective action was completed? 8 Were high severity numbers revised when a design change was completed? 9 Do the effects consider the customer in terms of the subsequent operation, assembly, and product? 10 Was warranty information used as an aid in developing the Process FMEA? 11 Were customer plant problems used as an aid in developing the Process FMEA? 12 Have the causes been described in terms of something that can be fixed or controlled? 13 Where detection is the major factor, have provisions been made to control the cause prior to the next operation? Revision Date: Page 17 of 85 A-7 PROCESS FMEA CHECKLIST Customer or Internal Part No. NUMBER Question Yes No Comment / Action Required PersonResponsible DueDate Prepared By: Page 18 of 85 A-8 CONTROL PLAN CHECKLIST Customer or Internal Part No. NUMBER Question Yes No Comment / Action Required PersonResponsible DueDate 1 Was the control plan methodology referenced in Section 6 used in preparing the control plan? 2 Have all known customer complaints been identified to facilitate the selection of special product/process characteristics? 3 Are all special product/process characteristics included in the control plan? 4 Were SFMEA, DFMEA, and PFMEA used to prepare the control plan? 5 Are material specifications requiring inspection identified? 6 Does the control pan address incoming (material/components) through processing/assembly including packaging? 7 Are engineering performance testing requirements identified? 8 Are gages and test equipment available as required by the control plan? 9 If required, has the customer approved the control plan? 10 Are gage methods compatible between supplier and customer? Revision Date: Prepared By: TEAM FEASIBILITY COMMITMENT Customer: GM Date: Part Number: NUMBER Part Name: NAME Feasibility Considerations Our product quality planning team has considered the following questions, not intended to be all-inclusive in performing a feasibility evaluation. The drawings and/or specifications provided have been used as a basis for analyzing the ability to meet all specified requirements. All no answers are supported with attached comments identifying our concerns and/or proposed changes to enable us to meet the specified requirements. YES NO CONSIDERATION Is product adequately defined (application requirements, etc. to enable feasibility evaluation? Can Engineering Performance Specifications be met as written? Can product be manufactured to tolerances specified on drawing? Can product be manufactured with Cpks that meet requirements? Is there adequate capacity to produce product? Does the design allow the use of efficient material handling techniques? Can the product be manufactured without incurring any unusual: - Costs for capital equipment? - Costs for tooling? - Alternative manufacturing methods? Is statistical process control required on the product? Is statistical process control presently used on similar products? Where statistical process control is used on similar products: - Are the processes in control and stable? - Are Cpks greater than 1.33? Conclusion Feasible Product can be produced as specified with no revisions. Feasible Changes recommended (see attached). Not Feasible Design revision required to produce product within the specified requirements. Sign-Off Team Member/Title/Date Team Member/Title/Date Team Member/Title/Date Team Member/Title/Date Team Member/Title/Date Team Member/Title/Date PSSP0005;REV 7 - INITIAL RISK EVALUATION FORMS PAGE 20 OF 20 REVIEW DATE MODEL YEAR SUPPLIER SUPPLIER VEHICLE LINE PART NUMBER NUMBER SUPPLIER CODE CODE PART NAME NAME Initial Risk Evaluation Checklist Item Levels of Concern No. Questions Low Med. High Comments DESIGN CATEGORY 1 - New Commodity For Selected Supplier? (RISK DRIVER*) * 2 - New Materials or Technology? (RISK DRIVER*) * 3 - New/Different Application of a Carry-Over Part? (RISK DRIVER*) * 4 - New Design Concept? 5 - Are there Safety/Emissions/Noise Requirements? 6 - Offshore Engineering Site? 7 - Will Design Need To Be Coordinated With Mating Parts For Fit, Function, or Appearance? 8 - Are There Other Car Line Applications Planned? 9 - Any Historic Quality/Warranty Issues? 10 - Is Program Timing An Issue? 11 - Are Sample Submission Dates Too Late for MTSs? MANUFACTURING CATEGORY 12 - New Manufacturing Facility? (RISK DRIVER*) * 13 - Is This a New Manufacturing Process? (RISK DRIVER*) * 14 - A Part or System With Historical Launch Problems? (RISK DRIVER*) * 15 - Offshore Manufacturing Site? 16 - Will Supplier Need Source Evaluation? 17 - Is New Production Equipment Required? 18 - Are Special Tools or Tooling Fixtures Required? 19 - Are Gages or Check Fixtures Required to Ensure Dimensional Integrity? 20 - Any Potential Handling or Shipping Issues? 21 - Will Parts Ever Be Shipped From a Location Other Than The Primary Source (i.e. Warehouse, Offshore, etc.) 22 - Will Returnable Packaging Be Required? 23 - Is JIT Delivery or Sequenced Part Delivery Required? ASSEMBLY CATEGORY 24 - Is Part Installation an Issue? 25 - Are Special Tools/Fixtures Required to Install Part in Vehicle? SERVICE CATEGORY 26 - Is Part Serviceability a Problem? 27 - Are Special Tools/Fixtures Required? OTHER CATEGORY 28 - Other? 29 - Other? NOTE: * INDICATES RISK DRIVER - PROCESS SPECIALIST ASSISTANCE MAY BE REQUIRED PSSP0005;REV 7 - INITIAL RISK EVALUATION FORMS PAGE 21 OF 21 REVIEW DATE MODEL YEAR SUPPLIER SUPPLIER VEHICLE LINE PART NUMBER NUMBER SUPPLIER CODE CODE PART NAME NAME Initial Risk Evaluation Summary INITIAL RISK EVALUATION RATING (Select One Below) (Refer to Initial Risk Evaluation Checklist) LOW LEVEL OF CONCERN INITIAL RISK EVALUATION TEAM INDICATES A LOW LEVEL OF CONCERN REGARDING THE SUCCESS OF SUPPLYING THIS PRODUCT. MEDIUM LEVEL OF CONCERN INITIAL RISK EVALUATION TEAM INDICATES THAT THERE IS A MEDIUM LEVEL OF CONCERN REGARDING ONE OR MORE CATEGORIES ASSURING THE SUCCESS OF SUPPLYING THIS PRODUCT. HIGH LEVEL OF CONCERN INITIAL RISK EVALUATION TEAM INDICATES THAT THERE IS A HIGH LEVEL OF CONCERN REGARDING ONE OR MORE CATEGORIES, (OR ONE OR MORE RISK DRIVERS) ASSURING THE SUCCESS OF SUPPLYING THIS PRODUCT. LIST HIGH CONCERN ITEMS LIST MEDIUM CONCERN ITEMS SIGNATURE DATE TEAM MEMBERS ENGINEERING SUPPLIER QUALITY SUPPLIER MANAGEMENT ADVANCED MFG. SUPPLIER SERVICE PRODUCT QUALITY PLANNING SUMMARY AND SIGN-OFF DATE: PRODUCT NAME: NAME PART NUMBER: NUMBER CUSTOMER: GM MANUFACTURING PLANT: CITY 1. PRELIMINARY PROCESS CAPABILITY STUDY QUANTITY REQUIRED ACCEPTABLE PENDING* Ppk - SPECIAL CHARACTERISTICS 2. CONTROL PLAN APPROVAL APPROVED: YES / NO* DATE APPROVED (If Required) 3. INITIAL PRODUCTION SAMPLES CHARACTERISTIC CATEGORY QUANTITY CHARACTERISTICS SAMPLES PER SAMPLE ACCEPTABLE PENDING* DIMENSIONAL VISUAL LABORATORY PERFORMANCE 4. GAGE AND TEST EQUIPMENT MEASUREMENT SYSTEM ANALYSIS QUANTITY REQUIRED ACCEPTABLE PENDING* SPECIAL CHARACTERISTIC 5. PROCESS MONITORING QUANTITY REQUIRED ACCEPTABLE PENDING* PROCESS MONITORING INSTRUCTIONS PROCESS SHEETS VISUAL AIDS 6. PACKAGING/SHIPPING QUANTITY REQUIRED ACCEPTABLE PENDING* PACKAGING APPROVAL SHIPPING TRIALS 7. SIGN-OF
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