1.1.The quality system is documented, controlled, and maintained to clearly describe current practice. Documented procedures required. Records Quality manual and all QS procedures show revision control (sign-offs & dates), history of changes, quality organization's responsibilities 1.2.Quality reports, trend charts and data analysis identify areas of opportunity and are used by management on a routine basis. Records required. Product quality yield data, top problems and corresponding improvement actions, status of preventive/corrective actions taken, internal audit results 1.3.Quality performance targets are clearly defined, included in the business plan and monitored for improvements. Strategic and tactical objectives, goals, action plans, etc. 1.4.Executive management participates in periodic quality system reviews that address quality related feedback from customers and internal quality metrics. Records required. Analysis of field failures, inspection yields, resource needs, internal audit results, corrective action status, etc. 2.1.Preventive actions are taken based on the analysis of significant business trends, design reviews, customer satisfaction surveys or other meaningful inputs. Documented procedures required. Records required. Management review meetings, goal setting, performance measurement, internal audits, action plans, customer surveys 2.2.A formal approach is used to actively pursue cost containment and other continual improvement activities throughout the organization. Documented procedures required. Records required. Employee involvement / recognition program, Lean, Six Sigma, kaizen, SPC, 5-S, cost reduction program, preventive actions 2.3.A corrective action system is in place that provides root cause analysis and takes timely and effective action to prevent recurrence. Documented procedures required. Records required. Corrective action records, trend charts, meeting minutes, nonconformance frequency & cost analysis. Does CA system cover customer, internal & supplier issues? 3.1.The skill and education level required for each job is documented and appropriate training / re-training is provided. Records required. Job descriptions, job skills assessment, training records, training manuals. Look for use of training aids & work instructions at work stations. 3.2.Inspected material is adequately identified as to acceptance or rejection and traceable to receiving inspection report. Records required. Qualification records, certification history, etc. 3.3.Suitable methods are used to verify training effectiveness. Records required. Records of student testing, production quality records, audit records, interview workers to validate training records. Look for use of training aids & work instructions at work stations. 4.1.Customer needs and requirements are incorporated into product designs and/or manufacturing processes. Critical-to- Quality (CTQ) characteristics are identified and understood. Records required. Market studies, customer/end-user surveys, technical design reviews, mfg process capability studies, formal process qualification plan, manufacturing verification tests, pilot runs, etc. 4.2.Product specifications and drawings are generated, controlled and maintained for new or changed product designs. Records required. Complete product characteristics, application requirements, and other information essential for its safe and proper use and eventual disposal, etc. 4 . D E S I G N D E V E L O P M E N T &
S U P P O R T Responsibility Status ROOT CAUSE & Scope of Problem Including Other Areas REMEDIAL ACTION Immediate Actions Taken to Address Issue / Finding Supplier CA-PA Req'd? (Y / N) CORRECTIVE ACTION Taken to Address Root Cause & Prevent Recurrence PREVENTIVE ACTION Actions Taken to Prevent Similar Issues in Other Areas Completion Date (mm/dd/yy) O b j e c t i v e
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N o t A p p l i c a b l e Audit Score SUPPLIER AUDIT CHECKLIST 2 . 0 . C O N T I N U A L I M P R O V E M E N T 3 . T R A I N I N G A N D M O T I V A T I O N 1 . 0 Q U A L I T Y M A N A G E M E N T SUPPLIER NAME ADRESS Requirements Typical Objective Evidence Responsibility Status ROOT CAUSE & Scope of Problem Including Other Areas REMEDIAL ACTION Immediate Actions Taken to Address Issue / Finding Supplier CA-PA Req'd? (Y / N) CORRECTIVE ACTION Taken to Address Root Cause & Prevent Recurrence PREVENTIVE ACTION Actions Taken to Prevent Similar Issues in Other Areas Completion Date (mm/dd/yy) O b j e c t i v e
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N o t A p p l i c a b l e Audit Score SUPPLIER AUDIT CHECKLIST 4.3.Design validation is an integral part of the design process and occurs prior to production release. Records required. Design results, manufacturability, productivity and cost studies, confirmation that product fulfills its specified requirements or intended use or applications, design-FMEA, etc. 4.4.Human and technical resources are adequate to meet STI SANOH requirements for design collaboration, tooling design and electronic drawing and data exchange. Qualification of technical staff. Equipment/software capabilities; CAD, PRO-E, etc. 5.1.Production samples are inspected and provided to customers upon request. Records required. Completed PPAP or similar forms, inspection reports, availability of qualified resources 5.2.Customer production requirements and quality specifications are reviewed to ensure they can be met on a consistent basis. Records required. Procedures, design / process review minutes, FMEA's, mfg capacity plans, resource plans that address all product test, storage, packaging and shipment requirements 6.1.New and revised customer specifications are reviewed and implemented in a timely manner. Documented procedures required. Technical review of methods to be used, capability studies on similar parts, documented review procedure, ie., APQP, PPAP. 6.2.Current process control documents are in place and used for production start-up and continuing production. Documented procedures required. Customer specifications, engineering drawings, change notices, work instructions and specifications as applicable. 6.3.Customer notification / approval occurs for changes to Control Plans, manufacturing site, product transfers, raw material or product obsolescence. Records required. Customer notification procedure on major changes & compliance to Jedec standards JESD 46 and JESD 48 (or equivalent, if app.). Signed material / process change requests. Customers are notified of RoHS compliance status change. 6.4.Quality records are maintained. A record control system is in place for the identification, storage, protection, retrieval, retention time, and disposition of quality records. Procedures, list of records to be kept with retention periods specified 7.1.A formal process is used for the selection, qualification and re- qualification of suppliers. Records required. Supplier quality system audits and related corrective actions, engineering testing and approval records, plant production trials 7.2.Purchases from unapproved suppliers are prevented by a properly controlled and available Approved Supplier List (ASL). Records required. ASL, procedures for control and use of ASL, production material receipt records 7.3.Preventive actions are taken to continuously improve performance of the supplier base. Records required. Supplier quality performance analysis, performance trends, supplier audit reports, Inflation Model, documented goals regarding raw material cost containment 7.4.A supplier quality assurance system ensures that all purchased product or material conforms to defined specifications and applicable regulatory or customer requirements. Records required. Receiving inspection, supplier audits, source inspection, qualification testing, Certificate of Compliance (COC), component marking, labeling, etc. 4 . D E S I G N D E V E L O P M E N T &
S U P P O R T 6 . D R A W I N G S A N D S P E C I F I C A T I O N S 5 . Q U A L I T Y P L A N N I N G 7 . P R O C U R E M E N T SUPPLIER NAME ADRESS Requirements Typical Objective Evidence Responsibility Status ROOT CAUSE & Scope of Problem Including Other Areas REMEDIAL ACTION Immediate Actions Taken to Address Issue / Finding Supplier CA-PA Req'd? (Y / N) CORRECTIVE ACTION Taken to Address Root Cause & Prevent Recurrence PREVENTIVE ACTION Actions Taken to Prevent Similar Issues in Other Areas Completion Date (mm/dd/yy) O b j e c t i v e
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N o t A p p l i c a b l e Audit Score SUPPLIER AUDIT CHECKLIST 7.5.A system exists for the identification, verification and protection of customer supplied product that includes notifying the customer if product is damaged or lost. Records required. Procedures, segregation during storage, limited and controlled access to stored inventories 7 . P R O C U R E M E N T SUPPLIER NAME ADRESS Requirements Typical Objective Evidence Responsibility Status ROOT CAUSE & Scope of Problem Including Other Areas REMEDIAL ACTION Immediate Actions Taken to Address Issue / Finding Supplier CA-PA Req'd? (Y / N) CORRECTIVE ACTION Taken to Address Root Cause & Prevent Recurrence PREVENTIVE ACTION Actions Taken to Prevent Similar Issues in Other Areas Completion Date (mm/dd/yy) O b j e c t i v e
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N o t A p p l i c a b l e Audit Score SUPPLIER AUDIT CHECKLIST 8.1.Receiving inspection is performed per documented procedures and detailed work instructions. Records required. Procedures, inspection instructions resources (manpower and equipment) allocated for incoming inspection 8.2.Inspected material is adequately identified as to acceptance or rejection and traceable to receiving inspection report. Records required. Quality Control label, marking or use of designated hold area as indicated in the procedure 8.3.Supplier corrective action requests require root cause investigation and records show responses are analyzed. Documented procedures required. Records required. Availability of written procedure, standardized Corrective Action form, analysis of corrective action cycle time and closure measurements 9.1.There is a formal method used to qualify new or rebuilt production equipment prior to production use. Qualification plan that includes established goals for process yields/up- time, etc. and record of process capability, review and approval, etc. 9.2.Control Plans are used to plan and deploy inspection and test functions throughout the production process. Process flow diagram, statistical tools to be used, key inspection points, inspection frequency, records, control responsibility, inspection/test method, gaging used, acceptable yield rates 9.3.Appropriate work instructions are available where needed that accurately describe all work methods including inspections and tests to be done during production. Sample size, frequency, method, document control dates/revision level, etc. Handling procedures for Electro- Static Discharge (ESD), RoHS compliant materials & other process conditions. 9.4.Appropriate inspections, tests and process adjustments are made per applicable work instructions to verify conformance at key points throughout the process and prior to shipment. Records required. Records of inspections performed at incoming, first piece, in-process and/or final inspection or test. Capability study, material test, RoHS and other regulatory tests, etc. 9.5.The inspection and process status of product is identified and maintained throughout the production process. Records required. Batch records, travelers, tags, labels, product markings or use of designated & identified areas. 10.1.Process capability is measured and actions are taken to maintain established minimum Cpk/Ppk targets. Documented process capability studies and results (actual vs target Cpk/Ppk) 10.2.Out of control conditions are noted on charts and documented corrective action is taken to bring the process back into control. Documented procedures required. Records required. Control charts 11.1Nonconforming materials, parts and assemblies are segregated (where practical) and identified to prevent unapproved use. Documented procedures required. Records required. Tags, marking, controlled staging areas, etc. Look for mixing of RoHS compliant & non-compliant materials. 11.2.Reworked material, parts and assemblies are re-inspected or re- tested to confirm compliance to requirements. Records required. Inspection record, tag, stamp, etc. 11.3.Use of nonconforming material is documented under a formal waiver or concession system. Records required. Written procedure, waiver or concession records 1 1 . N O N C O N F O R M A N C E H A N D L I N G 8 . I N C O M I N G M A T E R A I L 9 . M A N U F A C T U R I N G Q U A L I T Y 1 0 . P R O C E S S C O N T R O L SUPPLIER NAME ADRESS Requirements Typical Objective Evidence Responsibility Status ROOT CAUSE & Scope of Problem Including Other Areas REMEDIAL ACTION Immediate Actions Taken to Address Issue / Finding Supplier CA-PA Req'd? (Y / N) CORRECTIVE ACTION Taken to Address Root Cause & Prevent Recurrence PREVENTIVE ACTION Actions Taken to Prevent Similar Issues in Other Areas Completion Date (mm/dd/yy) O b j e c t i v e
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N o t A p p l i c a b l e Audit Score SUPPLIER AUDIT CHECKLIST 11.4.Product traceability is maintained (to the extent required by STI Sanoh) to facilitate problem evaluation and corrective action. Documented procedures required. Records required. Serial number records, lot number, date of manufacture, labeling and marking of containers or product, etc. Look for mixing of RoHS compliant & non- compliant materials. 11.5.Resolving customer complaints through systematic approach and closure based on effectiveness monitoring Customer complaint register and 8D reports 11.6.There is a positive recall system to notify customers of nonconforming product that has already been shipped. Records required. Documented procedure and review of system 12.1.Gage Repeatability & Reproducibility studies are conducted to verify suitability of measuring devices for their use in checking product quality or control of processes. Records required. GR&R studies, reports 12.2.Measuring devices, gaging and test equipment are routinely calibrated and controlled per documented procedures. Records required. Gage calibration stickers, calibration records, positive identification or segregation of out-of-calibration devices, and inventory, location & status records, etc. 12.3.Gages and test equipment are calibrated against standards traceable to a recognized regulatory body or agency. Records required. Calibration procedures, and calibration stickers and other records. 12.4.Assessments are made to check the validity of previous measurements done on products where out-of-calibration measuring devices were used. Records required. Assessment records, corrective actions, etc. 13.1.A formal Preventive Maintenance system exists for production equipment, tools and Review of system, PM plans, PM schedule and compliance results 13.2.Preventive Maintenance schedule is followed. Product cannot be made with tools that are outside of maintenance period. Performance is audited No equipment, tools, or fixtures are in use that are outside TPM schedule, or have unclear status
14.1.Areas around the facility are clean and orderly. Tools and equipment are properly stored and readily available for use. Lighting and air quality are adequate. Observe production, office & product storage areas for use of 5S/6S principles (Sort, Set-in-order, Shine, Standardize, Sustain + Safety) 14.2.Proper equipment and methods are used to prevent product damage or loss in all phases of the material handling process. Observe handling and transit of raw material, work-in-process, and finished goods. 14.3.Documented procedures are followed to ensure proper control and preservation of handling, storage (FIFO), packaging, and delivery of product. FIFO practices are defined, packaging specifications, test results, handling and storage procedures. 14.4.Suitability of product packaging is reviewed and any concerns are communicated to the customer prior to initial production shipment. Packaging tests if required. Records required. Technical review, packaging/shipping tests, packaging work instructions, carton strength tests 1 1 . N O N C O N F O R M A N C E H A N D L I N G 1 2 . M E A S U R I N G E Q U I P M E M T 1 3 . P R E V E N T I V E
M A I N T E N A N C E 1 4 . S T O R A G E & P A C K I N G SUPPLIER NAME ADRESS Requirements Typical Objective Evidence Responsibility Status ROOT CAUSE & Scope of Problem Including Other Areas REMEDIAL ACTION Immediate Actions Taken to Address Issue / Finding Supplier CA-PA Req'd? (Y / N) CORRECTIVE ACTION Taken to Address Root Cause & Prevent Recurrence PREVENTIVE ACTION Actions Taken to Prevent Similar Issues in Other Areas Completion Date (mm/dd/yy) O b j e c t i v e
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N o t A p p l i c a b l e Audit Score SUPPLIER AUDIT CHECKLIST 14.5.Contingency plans have been developed that describe actions to be taken in the event of a major interruption of the manufacturing process. Process covering utility interruptions, labor shortages, key equipment failures, major production issues. 1 4 . S T O R A G E & P A C K I N G SUPPLIER NAME ADRESS Requirements Typical Objective Evidence Responsibility Status ROOT CAUSE & Scope of Problem Including Other Areas REMEDIAL ACTION Immediate Actions Taken to Address Issue / Finding Supplier CA-PA Req'd? (Y / N) CORRECTIVE ACTION Taken to Address Root Cause & Prevent Recurrence PREVENTIVE ACTION Actions Taken to Prevent Similar Issues in Other Areas Completion Date (mm/dd/yy) O b j e c t i v e
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N o t A p p l i c a b l e Audit Score SUPPLIER AUDIT CHECKLIST TOTAL SCORES FOR THIS CHECKLIST ONLY N o t A p p l i c a b l e On-Site Audit Std Chklst SCORE Maximum Total Score Available: 0 208 Actual Score: DATE OF AUDIT: SUPPLIER NAME: STI SANOH AUDITOR NAME: SUPPLIER AUDITEE NAME: SIGN: SIGN: Doc.no:FM:QA:37:00 AUDIT RESULT EVALUATION METHOD MINIMUM REQUIREMENT SCORING GUIDELINES D-Poor.If the audit score is <60,Reaudit required after improvement C-Average.If the audit score is>=60,CA required B-Good.If the audit score is>=70,CA required A-Excellent .If the audit score is >=90, No CA required 1 = RARELY COMPLIES; Corrective actions planned or in-progress 0 = REQUIREMENT NOT ADDRESSED ((AUDIT SCORE)/208-(POINTS NA *4))*100 B EVALUATION RATING 4= NO NON-COMPLIANCES; Exceeds Minimum Requirement / No CA required 3 = NO NON-COMPLIANCES; Meets Minimum Requirement / No CA required 2 = SOME NON-COMPLIANCES; Corrective actions planned or in-progress