消费性电子产品验厂文件.doc

FACTORY QUALITY SYSTEM AUDIT REPORTReport #:Page: 17 of 17Factory Name:Factory Address:Telephone #:Fax:Email:Factory Established on:Auditor(s):Type of Audit:Initial AuditPrevious Report#: Follow-up AuditRe-AuditOther(please specify):SECTION:Critical Issue Major IssuePOINTSRATINGACHIEVED(A)POSSIBLE (P)(A/PX100)AQuality management system56%BPre-production36%CPurchasing and incoming inspection control60%DManufacturing and in-process inspection control88%EFinal inspection44%FQuality information and customer communication28%GReliability test28%HHazardous substances control32%IESD control28%Total:400% Category AScore = 85% -100%Re-audit within 2 years Category BScore = 70% to 84.9%Re-audit within 1 years Category CScore = 60% to 69.9%Re-audit within 6 months Category DScore 60%Critical Issue: Issues lead to quality system, major quality activity, product safety and function failure systematically or out of control.Major Issue: Issues lead to quality system, major quality activity, product quality failure partiallyFor NEW FACTORY, all critical/major issues must be rectified before approval;For EXISTING FACTORY, all critical/major issues must be rectified and validated onsite if necessary.Audit Result Pass Score 70% for Surge/Power Score 65% for Electric & Electronic Product Score 60% for Other Product Fail Score 70% for Surge/Power Score 65% for Electric & Electronic Product Score 60% for Other Product Other (please specify)Audit HistoryNo.Audit DateAudit TypeScoreResultRemark12345Audit Findings SummaryNo.IssueCriticalMajorMinor123456789101112131415161718192021222324252627282930Auditor Comments:COMPANY ORGANIZATIONNAMEMET DURING AUDITGeneral Manager Yes NoSales Manager/Marketing Manager Yes NoPlant Manager Yes NoQC/QA Supervisor Yes NoProduction Manager Yes NoName and title of person interviewed:GENERAL INFORMATION:Major Customers:Monthly Production Capacity:General Leadtime:Main Products Manufactured:Total Area (Sq.Meter):No. of Back Up Power Generator:Certification:Main production processesSTAFFSStaffFull TimePart Time1.No. of employees2.Supervisor3.R & D4.Quality5.ProductionA: QUALITY MANAGEMENT SYSTEMNo systemSignificant deficiencyNeed improvementSatisfactoryOutstandingScoreNo.Description012341Does factory establish a formal documented quality management system based on international standards (such as ISO9001, TS16949, etc.) and certified by recognized certification organization? 2Are quality policy, objectives and responsibility clearly stated, widely distributed, and understood through the company?3Does the quality management system was audited periodically by qualified internal employees on schedule and the result be used to improve the quality management? 4Does the company management review the quality management system periodically and use the result to improve the system? 5Does the factory designate an independent department with adequate personnel responsible for quality control?6Is there a documented procedure for document control and followed effectively? 7Is there a documented procedure for records control and be implemented effectively? 8Are all quality control personnel trained and qualified adequately before they were allowed to perform their jobs? 9Is there an adequate annual training plan established and implemented well?10Is there a procedure available for the control of test and measure equipment?11Is there a list for all test and measure equipments?12Is there a calibration schedule for all test and measure equipments?13Are calibration and maintenance personnel fully qualified and in sufficient quantity? 14Is the standard calibration equipment adequate and calibrated by certified organizations?Total Points:0Available Points:56Item #:Remarks:CriticalMajorMinor0000000000B: PRE-PRODUCTIONNo systemSignificant deficiencyNeed improvementSatisfactoryOutstandingScoreNo.Description012341Is there a design and development procedure exist and followed well? 2Are samples of design inspected, measured and tested carefully and adequately?3Are pilot run carried out effectively? 4Are pilot runs reviewed carefully by all relevant departments?5Are products tested in reliability adequately before mass production?6Are there clear specifications, drawings, BOM and work instruction available for all products?7Are incoming orders reviewed by all relevant departments or personnel? 8Are inspection and test plans established for all products?9Are statistical techniques (such as FMEA) used to reduce variation before the start of mass production? Total Points:0Available Points:36Item #:Remarks:CriticalMajorMinor0000000000C: PURCHASING AND INCOMING INSPECTIONNo systemSignificant deficiencyNeed improvementSatisfactoryOutstandingScoreNo.Description012341Is there a documented procedure established for new supplier selecting and qualifying?2Are all suppliers evaluated properly before approval and a controlled AVL updated timely?3Are suppliers performances in quality, delivery, price and services evaluated periodically? (monthly or quarterly)4Are there clear specification and drawings was available for raw materials?5Is there a clear procedure/instruction provided to IQC to conduct incoming inspection? 6Are incoming inspection facilities and equipment adequate, sufficient, in good condition and calibrated? 7Are adequate inspection standards established for all materials needed inspection? 8Is the inspection sampling plan adequate and can the quality of the product be guaranteed with confidence? 9Are incoming inspection samples used and controlled well? 10Are IQC personnel trained well and understand the relevant procedure, instruction and standards well?11Are all materials inspected properly, correctly and adequately?12Are incoming inspection results used for corrective and preventive action?13Are all materials identified, stored and protected properly?14Are non-conforming materials identified, segregated and treated properly?15Are all raw materials re-inspected periodically according to the storage period? Total Points:0Available Points:60Item #:Remarks:CriticalMajorMinor0000000000D: MANUFACTURING AND IN-PROCESS QUALITY CONTROLNo systemSignificant deficiencyNeed improvementSatisfactoryOutstandingScoreNo.Description012341Are control charts and other process controls properly implemented?2Are process capabilities (CPK) established and monitored on all major processes? 3Are there adequate work instructions available in work area as guideline for worker operation? 4Are all operators trained well and qualified if necessary?5Are all critical and major process parameters specified and monitored continuously?6Is there sufficient and adequate production equipment for intent products?7Is preventative maintenance performed on the equipment and facilities?8Are there adequate approved samples available in all work area as guideline to worker and inspectors? 9Is there a procedure to ensure only correct and acceptable products would be packed with correct packages in proper manner?10Is there a procedure/process to ensure packing quantity accurate? 11Is there adequate actions to ensure only clean products will be packed into retail package? 12Is there a sufficient label, code or mark to trace the production and quality of products? 13Are the production lines checked by QC (or by other means) to ensure compliance with all relevant requirements?14Are there adequate inspection procedure/instructions available for inspectors and followed well? 15Are there adequate inspection standards available for inspectors and followed well? 16Are in-process inspection facilities and equipment adequate, sufficient, in good condition and calibrated?17Are in-process inspector trained well and implemented inspection adequately and effectively?18Are non-conforming in-process products identified, segregated, and treated properly? 19Are the results of in-process inspections used in the promotion of effective corrective and preventative action? 20Is there a procedure to allow authorized personnel to require stop production if serious problems found? 21Are inspection defects charted and analyzed; and corresponding corrective and preventive actions taken to improve product quality? 22Are in-process materials/components/products identified, stored and protected properly?Total Points:0Available Points:88Item #:Remarks:CriticalMajorMinor0000000000E: FINAL INSPECTIONNo systemSignificant deficiencyNeed improvementSatisfactoryOutstandingScoreNo.Description012341Is there a documented procedure/instruction for final inspection? 2Are final inspection standards adequate and sufficient? 3Are sampling plan for final inspection adequate and sufficient? 4Are final inspection facilities and equipment adequate, calibrated and in good condition? 5Are final inspector trained well and understand the relevant procedure, instruction and standards properly?6Are product drawings/specifications and/or samples as well as packing instruction available for the inspector from the QC or the engineering department?7Are all products inspected properly and correctly?8Are non-conforming products identified, treated and re-inspected properly? 9Is there a procedure require acceptable inspection report to authorize product shipments?10Are final acceptance inspection results used for corrective and preventative action?11Are all finished products identified, stored and protected properly?Total Points:0Available Points:44Item #:Remarks:CriticalMajorMinor0000000000F: QUALITY INFORMATION & CUSTOMER COMMUNICATIONNo systemSignificant deficiencyNeed improvementSatisfactoryOutstandingScoreNo.Description012341Is there a documented Quality Information system which addresses the collection, reporting, and analysis of data covering (a) performance of supplied materials, (b) performance of processes, (c) performance of product and (d) Field/Customer feedback?2Is all important quality data treated and analyzed appropriately and sufficiently?3Is the quality information analysis result used for the improvement of products, processes, and services effectively?4Does the factory notify their clients immediately to advise and discuss any failures on their projects?5Is there a formal procedure to handle customer complaints? 6Are all customer complaints analyzed the root causes and adequate corrective and preventive actions were taken? 7Are the corrective and preventive actions properly conducted and monitored to show effectiveness? Total Points:0Available Points:28Item #:Remarks:CriticalMajorMinor0000000000G: RELIABILITY TESTNo systemSignificant deficiencyNeed improvementSatisfactoryOutstandingScoreNo.Description012341Is there a documented procedure/instruction for raw materials and finished products regular reliability test?2Are there adequate procedure/instruction and criteria established for all reliability test items?3Are reliability test facilities and equipment adequate, calibrated and in good condition?4Are reliability test operator trained and qualified adequately?5Is there a plan/schedule available for raw materials/finished products reliability test?6Are all necessary items tested on schedule properly and correctly?7Is there proper action taken for reliability test failure?Total Points:0Available Points:28Item #:Remarks:CriticalMajorMinor0000000000H: HAZARDOUS SUBSTANCES CONTROL No systemSignificant deficiencyNeed improvementSatisfactoryOutstandingScoreNo.Description012341Is there a documented procedure/instruction for hazardous substance control?2Is there a clear test standard established for hazardous substances control?3Are hazardous substances test facility and equipment adequate, calibrated and in good condition?4Are hazardous substances test ope