Professional Documents
Culture Documents
Contents
i. Introduction / Sumitomo Business Principles ii. Approval / Revision Record
I.
Supplier Documentation and Quality Audits A. B. Quality and Enviromental Requirements Notice of Responsible Person of Quality Audits 1. Supplier Commitment Form Quality Systems Audits 1. Full System Audits 2. Mass Production Audit 3. Pre-production Audit 4. Countermeasure Audit 5. Quality Assurance Confirmation Audit 6. N+3 Audit
C.
II.
Part / Product Documentation A. PPAP 1. Advanced Notification of Initial Production Plan 2. PPAP Checklist 3. Initial Sample Inspection Report (ISIR) 4. Evaluation Form (reporting functional data) 5. Inspection Tools and Test Equipment 6. Shipping Id & Packaging Standards 7. Dimensional Requirements 8. CPK Requirements 9. Annual Requirements Tool Transfer Approvals / Localizations 1 Design Assembly Review Sheet Initial Production Parts 1. Initial Production Parts Mass Production Parts 1. Lot Retention 2. CPK Requirements Deviations for Non-Conforming Parts 1. Deviations Request
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B.
C.
D.
E.
B.
C.
B.
V.
Purchase Order
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It's evident in everything we do at Sumitomo Electric Wiring Systems, as a leading supplier of wiring harnesses, functional components, electronic control units and connecting components to the automobile industry, Sumitomo Electric Wiring Systems, Inc. prides itself in showing the utmost quality and professionalism to achieve the desired end result. The automotive industry is a dynamic world filled with constant changes as new technology emerges and consumer tastes evolve with the growing number of choices available.
Some of the biggest advances have been made in the field of automotive electronics distribution systems technology. Consequently, the automotive wiring harness has become the lifeblood of the modern automobile. Wiring harnesses produced by Sumitomo Electric Wiring Systems not only act as a power conductor for basic functions, but also for a whole range of new and exciting safety and convenience features. Wiring harnesses, functional components and electronic control units are composed of many component parts; therefore, quality control of components is essential to assuring superior quality. PERFORMANCE STANDARD- The basic standard of performance SEWS expects of our suppliers is the same as we demand of ourselves that is to strive toward zero defects. This must be the goal of each of us to effectively compete in the world market.
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SEWS "CONNECT WITH THE BEST" QUALITY SYSTEM- SEWS expects our suppliers to join us in becoming prevention oriented, using the necessary quality control / quality assurance activities to produce acceptable quality on a continuing basis. SEWS will audit our suppliers for compliance to SEWS Quality system requirements. SEWS has implemented a standard for Minimum Process Requirements (MPR). SEWS expects our suppliers to maintain standards to achieve these requirements. The MPR should be documented within the Supplier's control plans and operation standards. This standard is applicable to any supplier that produces parts that SEWS will use on product that has an application to Honda. DELIVERY SYSTEM- SEWS expects our suppliers to maintain 100% on-time delivery performance. Delivery performance will be monitored and will be a part of SEWS evaluation program. SEWS objective is to define the quality requirements to develop long term relationships with suppliers who are committed to never ending improvement in quality, delivery, and productivity which will mutually benefit the relationship. This manual outlines the general requirements for SEWS suppliers concerning the basic quality system used to assure the quality of products supplied to SEWS.
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David Anderson 10/15/08 Richard Whitaker 10/3/08 Gil Albee 10/3/08 Debbie Gillenwater 1/22/09 Terutsugu Fujimoto 2/4/09 Ken Woosley 11/3/08 Takashi Ichino 1/16/09 Steve Akin 1/19/09 Tom Minton 10/3/08 Omar Gutierrez 1/23/09 Barry Brown 10/3/08 Yoshio Pierce 1/15/09
Date: Actions: 08/21/1995 Previous Revisions 04/28/1997 Re-issue of complete manual. Suppliers to destroy old version. Addition of Delivery Standard. Addition of System Audit. Addition of Pre Production Audit. Revised Supplier Rating System to include delivery rating. Addition of revision record. 07/01/2000 07/31/2002 01/10/2003 10/30/2003 Revision of PIR procedure Re-issue of manual Addition of requirements (per end customer ) for IMDS Format and Grammar. Revised PIR procedure. Revised Sort and Rework requirements. Revised PPAP expectations. Revised General Procedures. Revised Registration Requirements. Added organizational chart. Added SEWS Business Principles. Revised audit guidelines and procedures. 12/15/2005 Revised monetary values. Revised organization chart. Added requirements for IPP Tag. Updated PPAP requirements. Updated Mass Production requirements. Updated IMDS requirements. Added bar code requirements. Added tool transfer requirements. Updated PPAP requirements. Added confirmation audit. Updated supplier rating for quality. 03/05/2007 Revised Supplier Rating and monthly scoring 09/29/2008 Addition of MP Audit checksheet, Addition of N+3 audit checksheet, addition of MPR requirements, Addition of W/H PIR process flow, revised Quality and Envirnmental requirements, Revised PPAP requirements, Deleted Org chart, Deleted general tooling guidelines
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I. A.
Unless otherwise specified, suppliers shall be third party registered to ISO 9001: 2000 or TS-16949 by an accredited thirdparty certification body. Suppliers must notify SEWS immediately upon loss of certification. In addition to ISO and TS regulations, suppliers shall conform to the requirements of the International Material Data Systems (IMDS) and submit information about their raw material usage as requested. Suppliers must also monitor and control their processes to assure that there are no sources of contamination that would cause the product sold to SEWS to exceed any of the SoC/ELV elements as indicated in the GADSL regulations, this includes all sub materials that pertain to the product such as inks, markers, additives, etc. SEWS environmental guidelines can be accessed at www.sewsus.com
B.
It is the responsibility of the Supplier to report to SEWS the names of key individuals who are responsible for delivering a quality product to SEWS. Suppliers shall use the registration sheet to register the persons with responsibility for SEWS products. There must be someone available with authority to make necessary decisions. These contacts shall include both on and off shifts. The responsible person(s) shall review SEWS Supplier Quality Assurance Manual and sign the registration form acknowledging compliance with these documents. Any change in this responsibility shall be reported to SEWS immediately.
C.
SEWS Supplier Quality and the OEM may complete various audits during the life of the contract. SEWS encourages our suppliers to strive for continuous improvements in their quality systems through the use of quality audits, with thorough followup in areas of concern. When any non-conformance is found during an audit, an improvement plan and implementation status must be submitted along with countermeasures to the auditor. Suppliers should fully understand the audit purpose and contents beforehand, and be prepared for the audit. It is the responsibility of the supplier to perform a pre-audit to confirm compliance to SEWS procedures. The supplier shall make their facilities available to SEWS and SEWS OEM customers as needed for auditing purposes. All audit forms are attached to this manual and are available at SEWS website, www.sewsus.com. 1. QAV or Full Systems Audit Upon submission of a new supplier, SEWS SQA and Purchasing may perform a full systems quality audit at the suppliers facility prior to acceptance. Suppliers with ISO 9001:2000 or TS-16949 registration and in good standing may have this requirement waived with the submission of most recent audit results and the approval of SEWS SQA and Purchasing. Suppliers must have an overall score of 70% on the audit with a minimum of 70% for each section. Any section that has a score of less than 70% must be addressed by the supplier and a written countermeasure plan must be submitted to SEWS for evaluation. 2. Mass Production Audit SEWS SQA may use the Mass Production Audit form to audit potential new suppliers. SEWS SQA will audit the suppliers quality systems, verifying the control plans and standards for a part that the supplier has in current mass production. The supplier must attain an overall score of at least 70% , with no individual question rated below 3 points. In the case that the supplier scores above 70% , but there are individual scores less 3 points, the supplier will be required to submit corrective actions with evidence of the improvements. SEWS SQA will decide whether to accept the improvement documentation to close the audit or to schedule a follow-up audit for verification.
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SEWS "CONNECT WITH THE BEST" 3. Pre-productioin Audit Once a supplier is ready for production, a Pre-Production Audit may be performed to validate the processes and quality systems. The Pre-Production Audit is designed to assure all requirements for the start up of new or changed processes are met. This audit should be performed by SQA and Purchasing from SEWS. The Pre-Production Audit may be performed by the supplier and results submitted to Supplier Quality at the discretion of SQA and Purchasing. More information pertaining to the Pre-production audit can be found with the attached forms. Pre-production Audit Guidelines and Checklist Criteria for conducting a Pre-production audit include, but are Start-up of a new component, including localization Significant process changes, material changes or manpower SEWS customer requests Tool repair, location change Ongoing problems with quality, deliver, etc. 4. Countermeasure Audit A countermeasure audit may be required in the event of the necessity to confirm the suppliers response and action after defective product has been observed and a claim is issued. 5. Quality Assurance Confirmation Audit Periodic or quality assurance confirmation audits may be performed as a proactive measure in assuring realization of quality, delivery, and program growth expectations. This audit will be similar to the QAV audit with focus on change points and technical and process improvements. The PK Audit may also be used. 6. N+3 Audit SEWS SQA may audit the suppliers based on the N+3 audit criteria. The N+3 audit is an audit designed to access the suppliers conformity to controls and standards agreed upon during the part approval process. The audit, if requested, will take place a minimum of 3 months after the part has been in mass production.
Suppliers of SEWS will be notified prior to the audit and should meet all reasonable requirements of the SQA representative. Please be prepared to provide the necessary staff and documentation for each of the above listed audits. If the supplier does not meet the requirements, a failing score may be issued and production may be delayed for SEWS product.
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II. A.
SEWS requires that all suppliers submit a Level 3 PPAP for new components and/or any changes in product or process for current mass production parts. Initial notification may be submitted via an Advanced Notification of Initial Production Parts. Level 3 PPAPs should be submitted using the AIAG guidelines and format. SEWS reserves the right to waive AIAG PPAP requirements in lieu of specified documentation to meet SEWS and the end customers requirements, if the end customer does not require compliance to TS 16949 or issues a waiver to cover the deviation from the AIAG standard. PPAP documentation must be submitted in a timely manner based upon project timing. Suppliers should follow the AIAG PPAP Manual to insure complete compliance and a prompt approvals. Suppliers are not allowed to ship product without PPAP approvals or a waiver from SQA to ship prior to full PPAP approval. When SEWS product is supplied to Honda, the minimum process requirements for control plans will be applicable Level three PPAP includes the following (please refer to AIAG manual to assure full compliance): Part Submission (CFG-1001 or NAOP 4.5-1 F-PSW) Minimum 5 Sample Parts (per cavity if applicable) Engineering Drawings numbered for inspection results Process Flow Chart Failure Mode Effect Analysis (FMEA) Process Control Plans (Control Plans, MQC, PQCT) Minimum Process Requirements (MPR) to be incorporated for Honda product Inspection results - dimensional (ISIR form) Inspection results - functional (Evaluation form) Material Certification Appearance Approval Report (if applicable) Process Capability Results ( On critical dimensions) Inspection Equipment list (As per control plan) Gage R&R (All gages used in dimensional checks of the component) Customer material requirements per Annex II of 2000/53/EC IMDS- International Material Data System (Reporting System) For more information on environmental procedures and requirements go to www.sewsus.com and click enter, then click Supplier Information where you will find the link for IMDS-ELV Requirements As part material reporting requirements suppliers will capture a screen shot of accepted IMDS submittal and include with PPAP Lab Accreditation Single cavity tool: A 100% dimensional layout on all tolerance and non-reference dimensions for a minimum of three (3) production parts produced from the tool. Parts must be clearly identified as the measurement samples. Multiple cavity tool: A 100% dimensional layout on all tolerance and non-reference dimensions for a minimum of one part per cavity from the production tool. Part must be clearly identified as the measurement sample. Bulk Material: Please refer to the AIAG PPAP manual for applicable requirements. When identified, suppliers will be required to complete dimensional studies to the SEWS internal issued drawing and or the customer issued drawing. Requirements for the customer issued drawings include but are not limited to: 100% dimensional analysis Capability Study (CPK) on all tolerance dimensions. Capability Study for functional testing on all areas identified on the drawing. Capability Study for functional testing identified as critical by SEWS.
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SEWS "CONNECT WITH THE BEST" Dimensional studies completed to the customer drawing must meet all requirements, functionally and dimensionally. Tool correction will be required if the supplier cannot meet the above dimensional and functional requirements. Failure to correct the tool will result in the supplier monitoring the areas which do not meet customer requirements 100% throughout the life of the component or until the tool is corrected to meet the customer drawing and or requirements. Generally, annual PPAP submittal is not a requirement, but when identified as a requirement by SEWS SQA annual PPAPS will be required. Once a PPAP is submitted and approved to the above requirements there shall be no changes to the process regardless of prior PPAP approvals such as but not limited to prior approved raw material, mass production equipment, assembly equipment, and location changes. When a PPAP is submitted and approved SEWS considers this the most current and up to date process and there will be no deviation from the current approved PPAP without written approval from SEWS. When applicable suppliers will be required to adhere to all GP12 requirements. SEWS will identify to the supplier when such conditions exist. PPAP and PPAP sample retention shall consist of life of the product plus service.
B.
C.
D.
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For a PPAP that is submitted for components that are already in mass production, i.e. replacement tooling, supplier change, additional tooling, upon approval of the PPAP the first shipment of new components will be identified with an Initial Production Parts tag. This IPP tag will reference a SEWS internally issued number that will be assigned to that particular component PPAP. Failure to do so will result in a rejection of the first shipment of new components and a PIR issued against the supplier.
E.
F.
In principle, suppliers are fully responsible to ensure that all products shipped to SEWS conform to all applicable specifications and drawings. When a specification or drawing cannot be met, the supplier may apply for a deviation, however the supplier must be able to provide evidence that one or more of the following criteria applies: Part must comply with all finished goods PPAP requirements of SEWS customers. Non-conformity cannot be corrected even if the material, mold or die is changed or reworked. Rework or change to mold/die would result in an interruption to SEWS assembly process. The deviation does not affect fit or function. Anything that is deemed functional will not be considered. Under no circumstance will it be acceptable to ship nonconforming parts to SEWS without prior written approval from Supplier Quality Assurance. It will be at the discretion of SEWS to notify the customer and gain approval for functional deviations . When identified by SEWS, suppliers will be required to present deviation request in person.
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SEWS "CONNECT WITH THE BEST" Types of Deviation A. Limited Quantity A Limited Quantity deviation limits the quantity of non-conforming parts to be used and will be applied when a certain amount of non-conforming parts have already been produced or a certain amount of parts are needed urgently to support SEWS production. Documentation- Deviation Request Sheet B. Limited Period A Limited Period deviation limits the period during which non-conforming parts may be used and will be applied when corrections to the mold or die require a lot of time and it becomes necessary to use the non-conforming parts until corrections are made. Documentation- Deviation Request Sheet C. Limited Mold or Die Limited Mold or Die deviation limits the non-conformity to particular molds or dies and will be applied when the nonconformity meets the required criteria for deviation and correction of the non-conformity is not justifiable. Documentation- Deviation Request Sheet Appearance Limit Sample An Appearance Limit Sample deviation allows the use of parts with aesthetic non-conformities that are not clearly defined in the drawing or specifications (blemishes, markings, flow lines, etc.). This deviation will be applied when parts do not meet internal specifications for appearance, but still meet all functional and dimensional requirements. Documentation- Sample Limit Sheet To request a deviation for characteristics designated on Sumitomo drawing or specification, the Supplier shall submit a deviation request sheet, inspection data (ISIR) on the Non-conformity and three samples. In the case of multiple production tooling, samples will be required from each mold or cavity affected. Quantity for samples and test requirements should be negotiated with SEWS Q.A. In the case of appearance, non-conformities not designated on the drawing or specification, the supplier shall submit 3 samples or detailed photos. If approved, Q.A. will send one illustration back to the supplier for the supplier to use as reference. SEWS will provide disposition on each deviation and will notify the supplier. The supplier shall not deliver the nonconforming parts without written approval from SEWS. The supplier must identify the first lot of deviated parts by attaching the approved deviation form to the first shipment of deviated parts. The first shipment of deviated parts after the deviation has expired must be labeled with IPP to the receiving facility.
D.
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Whenever SEWS finds a problem or defect with mass production parts from any supplier, SEWS SQA will evaluate the Defect Notification Report and make a determination of the actions the supplier will be required to take. SQA will investigate and decide the severity of each report issued by manufacturing. The defect severity and the quantity of components will be key factors in the resolution of the problem. 1. Notification of potential supplier defect: The original Defect Notification Report (DNR), supplied by the issuing plant, is an alert to SQA that the potential for a defect exists. The DNR can be forwarded to the supplier, but a formal countermeasure is not required from the supplier at this point. This action will be for informational purposes to notify the supplier they have had an issue or abnormality. If the DNR is deemed a supplier defect, a PIR will be issued. 2. PIR (Problem Improvement Request) SQA can request a formal countermeasure without request for IIR (Initial Investigation Response). SQA will issue a PIR to the supplier. The supplier shall examine the cause(s) for the defect and cause(s) for the flow-out and shall implement an appropriate countermeasure for each. The supplier must report causes and countermeasures to SEWS within the "Needed by" date shown on the PIR. SQA can request a formal countermeasure with the request of the IIR (Initial Investigation Response). SQA will issue a PIR to the supplier. The supplier will be required to submit an IIR to SEWS on the Initial Investigation Report form within 24 hours of the receipt of the PIR. The IIR will inform SEWS of the initial actions of the supplier for containment of the defect, details for certification of good product, sort and rework plans, and the investigation proceedings. The PIR Countermeasure Response shall provide details on how the defect occurred and why the flow-out of the defect was not detected. The Countermeasure for both the defect and flow-out will be issued to SEWS on the PIR Countermeasure Response (Attachment PIR Countermeasure Response) form. The PIR Countermeasure Response shall be submitted to SEWS within 14 days or as determined by SEWS SQA. 3. Sort and Rework Requirements SEWS requires that the supplier designate a representative to be on site for all sort and rework activities to include onsite supervision and administration within 24 hours of notification. The supplier shall provide the manning for the sort or implementation of a third party sort. In the event of a customer initiated sort suppliers will be responsible for any and all costs incurred for a customer initiated third party sort. SEWS will hold final approval of all sort and rework plans. Sumitomo suppliers are selected based on their ability to provide superior performing products, superior value, superior technologies and processes, and superior customer service. Suppliers awarded with Sumitomo business will be held accountable and responsible for all costs incurred due to defective product identified during Sumitomo manufacturing / installation, or end-customer use of the product. Suppliers are responsible for all costs incurred while the defect situation is contained and remedied. Expenses such as, but not limited to the following, will be charged to the supplier: There shall be a minimum administrative cost of $100 per shipment of non-conforming product. Non-conforming product is defined as deviation from the SEWS engineering specification or engineering drawing. Replacement of defective/suspect raw material with validated stock. Premium freight charges to replace defective stock with validated stock. SEWS SQA Manual Revision 11, 9/29/08
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SEWS "CONNECT WITH THE BEST" Warehousing/storage fees accumulated through the disposition of defective/suspect raw materials and/or finished goods. All necessary travel expenses required to disposition defective/suspect raw materials and/or finished goods. Rework or repair materials, tooling, gauges, testing equipment or third party testing. Labor for sorting or reworking defective/suspect raw material will be a $50/hourly rate per employee if conducted by SEWS. Third party sorting or rework costs. Production downtime at Sumitomo facilities will incur fully burdened labor rate. Production overtime at Sumitomo facilities. Administrative, corporate and management support fees. Shipping fees related to the return of suspect/defective materials. Duties, taxes and fees related to scrapping materials outside the U.S. Labor for sorting or reworking finished goods will be a $50/hourly rate per employee if conducted by SEWS. Scrapping or reworking of finished goods due to defective supplier materials. Excess and additional freight charges and air shipments. Production downtime at customer locations, to include all costs incurred by SEWS from the customer. Recovery costs due to a vehicle recall. Follow up actions and assessments, as appropriate. All other fees associated with a defective condition. SEWS will hold approval on finalization of all sort and rework to ensure that all requirements are met and satisfied. The supplier will not be released from the sort and rework requirements until such approval is released and issued to the supplier. All costs are calculated based on U.S. currency. Debits are issued to the supplier through the Accounting Department in cooperation with your responsible buyer. Suppliers are responsible for any and all costs incurred due to rework or defective material.
B.
Identification of countermeasure parts The supplier is required to identify each container of temporary countermeasure parts stating parts certified on what date and for what non-conformance. These tags should appear on all containers until the permanent countermeasure is implemented. The supplier shall place a PIR C/M label on the first 3 shipments of permanent countermeasure parts. This will notify SEWS Receiving Inspection to take appropriate actions to verify the countermeasure. Countermeasure reporting The supplier shall respond with Initial investigation response and/or Countermeasure report within the due date shown on the PIR (Normally 24 hours for IIR and 14 days or as identified by SEWS SQA for permanent countermeasure response) All countermeasures shall be reported on the PIR Countermeasure Response form unless prior arrangements have been made with SQA for submission on another type of document.
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SEWS "CONNECT WITH THE BEST" Note: Please see the DNR PIR process flow for the SEWS Wire Harness Division for specific reporting requirements and information flows.
Plant finds a defect in a Part Issue DNR SQA JMC files DNR and Issues PIR to Supplier Sends samples Within 24 Hrs Notifies MSC SQA for reference only SQA JMC makes containment actions. Sends response to Plants Notifies SQA MSC for reference only Supplier makes permanent actions and sends final report. Makes containment actions SQA MSC approves ? Yes No. Supplier makes containment actions issue 3D in 24 Hrs. sends response to SQA JMC Issues RMA if necessary
SQA JMC receives final report and sends to plant. Plant receives final report and closes issue.
C.
Controlled Shipping
When necessary or designated by the OEM or SEWS customer, SEWS suppliers will adhere to OEM specific levels of Controlled Shipments.
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Quality
Monthly Report
SEWS Purchasing will send a report every month that will rate each supplier with reference to the number of PIRs written, PIR type, the severity of the defect, and if the countermeasure response is overdue. These reports should be reviewed and tracked by the suppliers management for accuracy and negative trends. The monthly scoring is as follows: 1 90-100 Supplier meets or exceeds SEWS expectations. 2 80-89 Supplier meets SEWS expectations but requires some improvements. Should the scoring remain at this level for a consistent time period, SEWS may visit the supplier to conduct a general process audit and investigate the root cause of problems attributing to the reduced rating. If necessary, corrective actions may be issued and a follow-up audit may occur. 3 70-79 Supplier does not meet SEWS expectations, immediate improvements are required before the supplier can be eligible for new business. SEWS may arrange a process audit with the supplier. Immediate corrective actions may be mandated for those areas requiring improvement. The supplier may still be allowed to "bid" on new business, in the interest of competitive analysis, if deemed necessary by the responsible buyer and/or Purchasing Manager. 4 Below 70 Supplier is in jeopardy of being de-sourced. SEWS will convene to collectively determine whether the supplier has opportunity for improvement or whether it is in the best interest of Sumitomo to begin preparations for future termination of any or all transactions between SEWS and the supplier. 5 Sub Score Consideration Suppliers who have scores in any individual section (Quality, Cost, or Delivery) which have been deemed by SEWS to be below satisfactory standards may be subject to additional corrective action requests, audits, and de-sourcing discussions in addition to those outlined above.
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SEWS "CONNECT WITH THE BEST" 2. Focus Suppliers (Zero Defect Activity ZD)
Suppliers with recurring problems or suppliers that fail to respond to Problem Improvement Requests may be selected as a "Focus Supplier". Suppliers in this category will be required to participate in meetings with the customer. The frequency (weekly, BIweekly, monthly, etc.) and means (telephone, face-to-face, etc.) will be decided by the customer and informed to the supplier. Additional inspection and reporting may also be required. Frequently, focus suppliers will be requested to attend meetings at a SEWS facility to review and present Quality Improvement Plans.
B.
Delivery
1. Monthly Report SEWS will send a report every month, included with the quality report that will rate each supplier with reference to delivery issues. This report will track late deliveries to SEWS as well as premium freight occurrences.
V.
Supplier acknowledges and agrees that the requirements of this Supplier Quality Manual shall become a part of, and shall be incorporated by reference in any subsequent purchase order issued by SEWS to the supplier. * Notice: Any forms contained within or referenced by this manual may differ from issuing plant.*
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SALES
MANUFACTURING
PRESIDENT
The undersigned supplier acknowledges receipt of the Supplier Quality Manual of Sumitomo Electric Wiring ____________________________________ Print Name of Supplier ___________________________________ Print Name of Authorized Representative __________________________________ Signature of Authorized Representative ___________________________________ Date Signed
SEWS
4.1 General requirements Has Organization established, documented, implemented and maintained a QMS and continually improved its effectiveness in accordance with ISO 9001:2000? (Questions in section 4.1 are verified throughout the audit) Where has Organization identified the processes needed for the QMS and their application throughout the organization? (See 4.2.2) Were has Organization determined the sequence and interaction of QMS processes? (See 4.2.2) What are the criteria and methods Organization uses to ensure that the operation and control of QMS processes are effective? Has Organization provided resources and information needed to support the operation and monitoring of QMS processes? (See section 6) How does Organization monitor, measure and analyze QMS processes? (See section 8) How has Organization implemented actions necessary to achieve planned results and continual improvement of processes needed for the QMS? Are processes needed for the QMS managed by the organization in accordance with the requirements of ISO 9001:2000? When Organization outsources any process that affects product conformity with requirements, how is control ensured over such processes? (See 7.4) Where is the control of outsourced processes that affect product conformity with requirements identified within the QMS? (See 7.4) 4.1.1 General requirements Supplemental Does Organization have adequate control over outsourced processes to ensure conformity to all customer requirements? 4.2 Documentation requirements 4.2.1 General Does Organization have documented statements of a quality policy and quality objectives? (See 5.3, 5.4.1) Does Organization have a quality manual? (See 4.2.2) Does Organization have the documented procedures required by ISO 9001:2000? (See 4.2.3, 4.2.4, 8.2.2, 8.3, 8.5.2, 8.5.3) Are adequate documents in place to ensure the effective planning, operation and control of Organizations processes? Does documentation include the records required by ISO 9001:2000? 4.2.2 Quality manual Where in the quality manual is the scope of the QMS identified, including details of and justification for exclusions? Where does the quality manual contain or reference the documented procedures established for the QMS? Where does the quality manual include a description of the interaction between the processes of the QMS? 4.2.3 Control of documents How are the documents required by the QMS controlled? Can you show me a documented procedure that defines the controls needed for each of the following? a) approve documents for adequacy prior to issue? b) review and update as necessary and re-approve documents? c) ensure that changes and the current revision status of documents are identified? d) ensure that relevant versions of applicable documents are available at points of use? e) ensure that documents remain legible and readily identifiable? f) ensure that documents of external origin are identified and their distribution controlled? g) prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
G G G G G G G G G G
NG NG NG NG NG NG NG NG NG NG
NG
G G G G G
NG NG NG NG NG
G G G
NG NG NG
G G G G G G G G G
NG NG NG NG NG NG NG NG NG
4.2.3.1 Engineering specifications What process do you have to assure the timely review, distribution and implementation of customer specifications and changes? Does it meet customer-required schedule(s)? Does the review occur in two weeks or less? What records do you have showing implementation dates of changes? Is there evidence showing that documents are updated? 4.2.4 Control of records What records exist that provide evidence of conformity to requirements and of the effective operation of the QMS? (Should be reviewed throughout the audit) Are records legible, readily identifiable and retrievable? (Should be reviewed throughout the audit) Does Organization have a documented procedure defining the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records? 4.2.4.1 Records retention Have the record requirements been reviewed to ensure conformance with regulatory and customer requirements? 5.1 Management commitment How does top management communicate the importance of meeting customer and legal requirements to the organization? Has a company quality policy been established? (See 5.3) What are the quality objectives established by top management? (See 5.4.1) Does top management conduct management reviews? (See 5.6) How does top management ensure the availability of resources to support and continually improve the QMS? 5.1.1 Process efficiency How does top management review product realization and support processes to ensure effectiveness and efficiency? (5.6?) 5.2 Customer focus How does top management ensure that customer requirements are determined and met? 5.3 Quality policy How does top management ensure that the quality policy is appropriate to the purpose of the organization? Does the quality policy include a commitment to comply with requirements and continually improve QMS effectiveness? Are the contents of the quality policy relevant to Organization, and measurable? Is the quality policy communicated and understood within the organization? Is there an established process to review the quality policy for continuing suitability?
G G G G
NG NG NG NG
G G
NG NG
NG
NG
G G G G G
NG NG NG NG NG
NG
NG
G G G G G
NG NG NG NG NG
5.4 Planning 5.4.1 Quality objectives Has top management established quality objectives (including those needed to meet requirements for product) at relevant functions and levels within the organization? G Are the quality objectives consistent with the quality policy? What are the measurements? 5.4.1.1 Quality objectives Supplemental Are quality objectives and metrics included in the business plan? 5.4.2 Quality management system planning How do you ensure that the planning of the QMS is carried out in order to meet the requirements given in ISO 9001:2000 section 4.1, as well as the quality objectives? G How do you ensure that the integrity of the QMS is maintained when changes to the QMS are planned and implemented? G NG NG G NG NG
NG
5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority How are responsibilities and authorities defined and communicated within the organization? (Verify throughout audit) 5.5.1.1 Responsibility for quality How are managers responsible for corrective action informed of nonconforming products or processes? Are they informed in a timely manner? Do personnel responsible for product quality have the authority to stop production to correct quality problems? What personnel on each shift have responsibility for ensuring product quality? 5.5.2 Management representative Who is your ISO 9001:2000 management representative? Does the management representative have responsibility and authority to a) ensure that processes needed for the QMS are established, implemented and maintained? b) report to top management on the performance of the QMS and any need for improvement? c) ensure the promotion of awareness of customer requirements throughout the organization? 5.5.2.1 Customer representative Who has top management designated to ensure that customer requirements are addressed? Does their responsibility and authority include selection of special characteristics, setting quality objectives and related training, corrective and preventive actions, product design and development? 5.5.3 Internal communication How is information regarding the effectiveness of the QMS communicated within the organization? 5.6 Management review 5.6.1 General What is the frequency that top management reviews the organization's QMS? What kinds of information are reviewed in management reviews? (must include suitability, adequacy and effectiveness of QMS; improvement; & changes to the QMS, quality policy and objectives) Can you show me records from recent management reviews? 5.6.1.1 Quality management system performance Do management reviews include all requirements of the quality management system and performance trends? (Verify records) Can you show management review records including monitoring of quality objectives, and cost of poor quality metrics? (Verify records) Can you show records providing evidence of achievement of the quality objectives specified in the business plan, and customer satisfaction with product supplied?
NG
G G G G
NG NG NG NG
G G G G G
NG NG NG NG NG
NG
NG
NG
NG
G G
NG NG
G G
NG NG
G 5.6.2 Review input Can you show me that each of the following were included in review(s)? a) results of audits, b) customer feedback, c) process performance and product conformity, d) status of preventive and corrective actions, e) follow-up actions from previous management reviews, f) changes that could affect the quality management system, and g) recommendations for improvement 5.6.2.1 Review input Supplemental Do records show input to management review includes analysis of actual and potential field-failures and their impact? (See also 7.3.4.1) 5.6.3 Review output
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What decisions or actions have resulted from management reviews for each of the following? a) improvement of the effectiveness of the quality management system and its processes, b) improvement of product related to customer requirements, and c) resource needs. 6.1 Provision of resources What resources has Organization provided to implement and maintain the QMS and continually improve its effectiveness? What resources has Organization provided to ensure that customer requirements are met? (See 6.2, 6.3, 6.4) 6.2 Human resources 6.2.1 General (While auditing, select some personnel performing work affecting product quality) What are the education, training, skills and experience required by this job/task? How does this person meet those qualifications? 6.2.2 Competence, awareness and training How do you determine the necessary education, training, skills and experience for people performing work affecting product quality? What training or other actions do you provide to satisfy the needs of personnel? (records) When you provide training or other actions to satisfy competence needs, how do you evaluate the effectiveness of those actions? (records) (Sample throughout organization) How do your activities contribute to the achievement of quality objectives? Where do you maintain records of education, training, skills and experience? 6.2.2.1 Product design skills What tools and techniques has the organization identified as necessary for product design personnel? What records do you have showing that product design personnel are competent to design and are skilled in the identified tools and techniques? 6.2.2.2 Training Can you show me documented procedures for identifying training needs and achieving competence of all personnel performing activities affecting product quality?
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G What records do you have that personnel performing specific assigned tasks are qualified - especially to meet customer requirements. (See 6.2.2e) 6.2.2.3 Training on the job What kinds of on-the-job training do you provide for people in new or changed jobs? Does this include contract and agency personnel? How do you inform personnel about the consequences to the customer of nonconformity to quality requirements? (Sample throughout organization) 6.2.2.4 Employee motivation and empowerment What process has been established to motivate employees to - achieve quality objectives, - to make continual improvements, and - to create an environment to promote innovation? Does the process include the promotion of quality and technological awareness throughout the whole organization? What process has been established to measure the extent to which personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives? (See 6.2.2d) 6.3 Infrastructure G G G G
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Are the buildings, workspace, and utilities provided appropriate to achieve conformity to product requirements? How are they maintained? What kind of process equipment (both hardware and software) is necessary to conform to product requirements? How is the equipment maintained? What supporting services (such as transport or communication) are needed to ensure that product meets requirements? How are they maintained? 6.3.1 Plant, facility and equipment planning What groups are involved in developing plant, facility and equipment plans? (Must be multidisciplinary) Can you show that plant layouts optimize material travel, handling and floor space use, and facilitate synchronous material flow? What methods are used to evaluate and monitor the effectiveness of existing operations? 6.3.2 Contingency plans Can you show me contingency plans for each of the following? - Utility interruptions - Labor shortages - Key equipment failure(s) - Field returns 6.4 Work environment What kind of work environment is required to achieve conformity to product requirements? How is this environment managed and maintained? 6.4.1 Personnel safety to achieve product quality How are product safety and potential risks to employees addressed by Organization?
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G 6.4.2 Cleanliness of premises Does the organization maintain the state of order, cleanliness and repair needed for products and manufacturing processes? (Verify throughout audit) 7.1 Planning of product realization Where are the processes needed for product realization identified? Is the planning of product realization consistent with the requirements of the other processes of the QMS? (Verify there are no inconsistencies or conflicts between quality system procedures) Where in the product realization process do you determine the quality objectives and requirements for products? When planning for product realization, how do you establish processes, documents, and provide resources specific to the product How do you determine verification, validation, monitoring, inspection and test activities specific to the product, and the criteria for product acceptance? What records exist showing that both the realization processes and the product meet requirements? What are the outputs of product realization planning? Are they in a form suitable for Organization? 7.1.1 Planning of product realization Supplemental Does the quality plan include customer requirements and reference to technical specifications? 7.1.2 Acceptance Criteria Where are acceptance criteria defined? When required, does the customer approve them? When attribute data sampling, is the acceptance level zero defects? 7.1.3 Confidentiality How does the organization ensure the confidentiality of customer-contracted products, projects under development, and related product information? 7.1.4 Change control What process is there to control and react to changes that impact product realization?
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How are the effects of changes assessed, including changes caused by suppliers? , and verification and validation activities shall be defined, to ensure compliance with customer requirements. Are changes validated before implementation? Is impact on form, fit and function (including performance and/or durability) reviewed with the customer for proprietary designs so that all effects can be properly evaluated? Do you have evidence that any additional verification/identification requirements required by the customer are met? 7.2 Customer-related processes 7.2.1 Determination of requirements related to the product How does Organization determine each of the following requirements? a) requirements specified by the customer, including the requirements for delivery and post-delivery activities, b) requirements not stated by the customer but necessary for specified or intended use, where known, c) statutory and regulatory requirements related to the product, and d) any additional requirements determined by the organization. 7.2.1.1 Customer-designated special characteristics How do you meet customer requirements for designation, documentation and control of special characteristics? 7.2.2 Review of requirements related to the product What kind of review is done to ensure that the organization has the ability to meet requirements before committing to supply product? How do you ensure that product requirements are defined and reviewed before committing to supply product? How do you ensure that contract or order requirements differing from those previously expressed are resolved before committing to supply product? Can you show me records of the product requirement review results and actions resulting from them? When customers dont have documented requirements, how do you confirm their requirements before accepting orders? When product requirements are changed, how do you ensure that relevant documents are changed and that relevant personnel are made aware of the changes? 7.2.2.1 Review of requirements related to the product Supplemental If you have waived the requirement for a formal review above, have you obtained customer authorization? 7.2.2.2 Organization manufacturing feasibility What documents do you have that show investigation and confirmation of manufacturing feasibility in the contract review process for proposed products, including risk analysis? 7.2.3 Customer communication What method(s) are used to communicate with customers regarding - product information? - enquiries, contracts, or order handling, including amendments? - feedback, including customer complaints? 7.2.3.1 Customer communication Supplemental Do your customers require information to be communicated in specific languages and/or formats? If so, how do you meet those requirements? 7.3 Design and development 7.3.1 Design and development planning Can you explain to me the process used by Organization to plan and control the design and development of product? What are the stages in the design and development process?
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How do you determine the review, verification and validation activities appropriate to each design and development stage? How /where are design and development responsibilities and authorities defined? How does Organization ensure effective communication and clear assignment of responsibility between different groups involved in design and development? As product design and development progresses, how are the planning outputs updated? 7.3.1.1 Multidisciplinary approach Do you use a multidisciplinary approach to prepare for product realization? Does it include: - development/finalization and monitoring of special characteristics - development and review of FMEAs, including actions to reduce potential risks, - development and review of control plans. 7.3.2 Design and development inputs What are the design inputs relating to each of the following product requirements? a) functional and performance requirements, b) applicable statutory and regulatory requirements, c) where applicable, information derived from previous similar designs, and d) other requirements essential for design and development. Where are they recorded? How & when are the design and development inputs reviewed for adequacy? How does Organization ensure that requirements are complete, unambiguous and dont conflict with each other? 7.3.2.1 Product design input Where are product design input requirements documented? (including the following: - contract reviews of requirements such as special characteristics, identification, traceability and packaging; - a process to deploy information gained from previous design projects, competitor analysis, supplier feedback, internal input, field data, and other relevant sources, for current and future projects of a similar nature; - targets for product quality, life, reliability, durability, maintainability, timing and cost.) Can you show me they are reviewed? 7.3.2.2 Manufacturing process design input Where are manufacturing process design input requirements documented? (including the following: - product design output data - targets for productivity, process capability and cost, - customers requirements, if any, and - experience from previous developments.) Can you show me they are reviewed? 7.3.2.3 Special characteristics Can you show me that all special characteristics are identified and included in drawings, FMEAs, control plans, and operator instructions? Are the customer-specified (or equivalent) symbols used? Do they meet customer-specified definitions? Do they include process steps that affect special characteristics? 7.3.3 Design and development outputs How can design and development outputs be verified against the inputs? (see 7.3.5q1) Are these outputs approved prior to release? Can you show me examples of design and development outputs and how they meet the input requirements? What outputs include information for purchasing, production and service? Where are product acceptance criteria specified? Where are product characteristics needed for safe and proper use specified? 7.3.3.1 Product design outputs Supplemental
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Can you show that the product design outputs include - design FMEA, reliability results - product special characteristics, specifications, - product error-proofing, as appropriate, - product definition including drawings or mathematically based data, - product design reviews results, and - diagnostic guidelines where applicable Are the outputs expressed in terms that can be verified and validated against product design input requirements? 7.3.3.2 Manufacturing process design output Can you show that the manufacturing process design outputs include - specifications and drawings, - manufacturing process flow chart/ layout, - manufacturing process FMEAs, - control plans, - work instructions, - process approval acceptance criteria, - data for quality, reliability, maintainability and measurability - results of error-proofing activities, as appropriate, and - methods of rapid detection and feedback of product/manufacturing process nonconformities. The manufacturing process design output shall be expressed in terms that can be verified against manufacturing process design input requirements and validated.
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G 7.3.4 Design and development review At what stages of design and development do you perform reviews to evaluate if the results meet requirements? (See 7.3.1q2b) Can you show me some problems that have been identified and actions proposed at these reviews? What functions are represented at these reviews? At each stage, are all functions concerned with that stage represented? Can you show me records of the results of the reviews and any necessary actions taken? 7.3.4.1 Monitoring Can you show me reports of analysis of measurements at specified design and development stages? Are summary results included in management reviews? (See 5.6.2) 7.3.5 Design and development verification What verification activities are performed to ensure that the design and development outputs have met the input requirements? (See 7.3.3q1) Can you show me records of the results of the verification activities and resulting actions? 7.3.6 Design and development validation What design and development validation activities are performed to ensure that the product is capable of meeting the requirements for the intended use? Do records show that validation is done before product shipment? If not, is the justification recorded? Can you show me records of the validation activity results and any follow-up actions?
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7.3.6.1 Design and development validation Supplemental Is design and development validation performed in accordance with customer requirements, including program timing? 7.3.6.2 Prototype programme Do your customer(s) require a prototype program and control plan? If so, can you describe the program? Can you show me the control plan(s)?
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Does Organizations prototype program use the same suppliers, tooling and manufacturing processes as will be used in production? If not, what is the justification? What records show that performance-testing activities are monitored for timely completion and conformance to requirements? Are any prototyping services outsourced? If so, who is responsible for the outsourced services, including technical leadership?
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7.3.6.3 Product approval process What product and/or process approval procedure(s) do your customer(s) require? Can you show me records of both process and product approvals? Do you have evidence that the product and manufacturing process approval procedures are applied to suppliers? (See 7.4.2) G G G NG NG NG
7.3.7 Control of design and development changes How are design and development changes identified? Where are the records kept? G Are changes reviewed, verified, validated, and approved before implementation? G Can you show me evidence that the review of design and development changes includes evaluation of the effect on component parts and products in the field? Can you show me records of the results of change reviews and any necessary actions? 7.4 Purchasing 7.4.1 Purchasing process How do you ensure that purchased product conforms to specified purchase requirements? How do you determine the type and extent of control applied to the supplier and the purchased product? How do you evaluate and select suppliers? (based on their ability to supply product in accordance with Organizations requirements) Can you show me the criteria for selection, evaluation and re-evaluation of suppliers? Can you show me records of the results of supplier evaluations and any necessary actions? (verify that criteria have been met) 7.4.1.1 Regulatory conformity What evidence is there that all purchased products or materials used in product conform to regulatory requirements? 7.4.1.2 Supplier quality management system development What supplier development actions are being taken toward the goal of supplier conformity with TS 16949? Do your suppliers quality management systems conform with ISO 9001:2000? (see below) If not, do you have written waivers from applicable customer(s)? 7.4.1.3 Customer-approved sources Do your customer(s) specify supplier(s) in contracts/ purchase orders? (This includes products, materials, services, tooling, & gages, ) If so, can you show that the customer-designated sources are being used as required? 7.4.2 Purchasing information Do orders/contracts include requirements for approval of product, procedures, processes and equipment? Do require any qualification of supplier personnel? If so, can you show where the requirement is documented? Do you have any QMS requirements of your suppliers? If so, can you show me where they are required? How does Organization ensure the adequacy of purchasing requirements before communicating them to the supplier? G G NG NG NG NG
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7.4.3 Verification of purchased product What inspection or other activities are used to ensure that purchased product meets your purchasing requirements? Do you ever perform product verification at the supplier's site? If so, where are the verification arrangements and method of product release identified? 7.4.3.1 Incoming product quality What processes are in place to assure the quality of purchased product? (Must include one or more of following: - evaluation of supplier statistical data - receiving inspection and/or testing - second- or third-party audits of suppliers, along with records of acceptable quality laboratory part evaluation another method agreed with the customer)
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7.4.3.2 Supplier monitoring How do you monitor supplier performance? (Must include the following indicators:) - delivered product quality - customer disruptions including field returns - delivery schedule performance (including incidents of premium freight) - special status customer notifications related to quality or delivery issues How do you promote supplier monitoring of the performance of their manufacturing processes? 7.5 Production and service provision 7.5.1 Control of production and service provision When carrying out production (or service) are all of the following controlled conditions in place? a) Is information that describes the characteristics of the product available? b) Are appropriate work instructions available (if needed)? (See 7.5.1.2) c) Is suitable equipment used for carrying out production (or service)? d) Are appropriate gages, etc. used in production (or service)? (See 7.6) e) Are appropriate kinds of monitoring and measurement done? (See 8.2.4) f) Are proper release, delivery and post-delivery activities in place? 7.5.1.1 Control plan Can you show me control plans for system, subsystem, and component/ material levels for product supplied? Can you show me control plans for both pre-launch and production? Can you show how the control plans take into consideration design FMEA and process FMEA information? (Review control plans to ensure they: - list controls used for manufacturing process control - include methods for monitoring of control of special characteristics - include customer-required information, if any) Can you show that specified reaction plans have been carried out when a process becomes unstable or not statistically capable? What conditions initiate the review and update of control plans? 7.5.1.2 Work instructions Do all employees responsible for processes that impact product quality have documented work instructions? (Verify throughout audit) Are they accessible for use at the workstation? How are the work instructions developed? 7.5.1.3 Verification of job set-ups Can you show me records of job setups that are being performed? Do they occur at the initial run of a job, material changeover, or job change? What work instructions do you have for job setup personnel? What statistical methods are used to verify job setups?
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7.5.1.4 Preventive and predictive maintenance How do you identify key process equipment? Can you walk me through your total preventive maintenance system? (Verify that the TPM system includes the following: - planned maintenance activities - packaging and preservation of equipment, tooling and gauging - availability of replacement parts for key manufacturing equipment - documenting, evaluating and improving maintenance objectives) What predictive maintenance methods do you use? Can you demonstrate that predictive maintenance has resulted in continual improvement of the effectiveness and efficiency of production equipment? 7.5.1.5 Management of production tooling What resources have Organization provided for tool and gage design, fabrication and verification activities? Does the production tooling management system include: - maintenance and repair facilities and personnel - storage and recovery - set-up - perishable tool change programs - tool design modification documentation, including engineering change level - tool modification and revision to documentation - tool identification, defining the status, such as production, repair or disposal. Are any tooling management activities outsourced? If so, how are these activities monitored? 7.5.1.6 Production scheduling Can you demonstrate that customer scheduling requirements (such as just-in-time) are being met? 7.5.1.7 Feedback of information from service What is your process to communicate information on service concerns to manufacturing, engineering, and design? 7.5.1.8 Service agreement with customer Do you have any service agreement(s) with customers? If so, how do you verify the effectiveness of - any organization service centers, - any special-purpose tools or measurement equipment, and - the training of service personnel? 7.5.2 Validation of processes for production and service provision Do you have any production or service processes where the resulting output cannot be verified later? (This applies to all processes in TS 16949) If so, how to you validate them? Can you show me records that demonstrate that the validation done has met the requirements? How are these special processes reviewed and approved? Can you show me records of personnel and equipment qualification? Where are specific methods and procedures defined? Can you show me records for these processes? When changes are made to processes, how do you revalidate them? 7.5.2.1 Validation of processes for production and service provision Supplemental Are all production processes validated per 7.5.2 above? 7.5.3 Identification and traceability How do you identify product throughout your processes? (Verify in production, storage, segregation areas, etc.) How is product inspection status identified? (Verify in production, storage, segregation areas, etc.) Can you show me unique identification records for products requiring traceability?
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7.5.3.1 Identification and traceability Supplemental Is all product suitably identified? 7.5.4 Customer property Do you use any customer-owned property? (Product, packaging, drawings, tooling, gages...) (If so, ask questions below) How do you ensure that customer-owned property is identified, verified, protected, and safeguarded? If any customer property is lost, damaged etc., how is it reported to the customer? Can you show me records regarding this? 7.5.4.1 Customer-owned production tooling How are customer-owned tools and equipment identified? 7.5.5 Preservation of product How do you preserve the conformity of product during internal processing and delivery? (Verify product throughout audit) How do identification, handling, packaging, storage and protection address the preservation of product? Does this also apply to component parts? 7.5.5.1 Storage and inventory How do you assess the condition of product in stock to detect deterioration? Can you walk me through your inventory management system? How does the system optimize inventory turns over time and assure stock rotation? How is obsolete product controlled to prevent its unintended use or delivery? (See 8.3) 7.6 Control of monitoring and measuring devices How do you determine the measurements to be taken and the measuring equipment needed to demonstrate conformity with requirements? What process is in place to ensure that measurements are taken per the requirements? a) How do you ensure that measuring and test equipment is calibrated or verified proper frequencies with NIST traceable standards? If no such standards exist, where do you record the basis used for calibration or verification? b) What process is used to adjust or re-adjust measuring and test equipment when needed? c) How are measuring tools identified to enable the calibration status to be determined? d) How do you safeguard measuring equipment from adjustments that would invalidate the measurement results? e) How do you ensure that measuring its test equipment is protected from damage and deterioration during handling, maintenance and storage? When equipment is found to be out of calibration, how do you assess and record the validity of the previous measuring results? What actions do you take on the equipment and any product affected? Can I see your records of the results of calibration and verification? Do you use computer software for monitoring and measurement? If so, is its ability to perform that function confirmed prior to initial use and reconfirmed as necessary?
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G 7.6.1 Measurement system analysis Can you show me R&R studies for each type of measuring and test equipment system referenced in the control plan? (Or other statistical studies analyzing the variation in measurement & test results) Do the methods and acceptance criteria conform to those in customer reference manuals on MSA or does the customer approve them? 7.6.2 Calibration/verification records Can you show that calibration records include:
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- equipment identification, including the measurement standard against which the equipment is calibrated, - revisions following engineering changes, - any out-of-specification readings as received for calibration/verification, - an assessment of the impact of out-of-specification condition, - statements of conformity to specification after calibration/ verification, and - notification to the customer if suspect product or material has been shipped?
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7.6.3 Laboratory requirements 7.6.3.1 Internal laboratory Does Organization have an internal laboratory? If so, can you show me a documented laboratory scope including its capability to perform inspection, test, or calibration services? Where are laboratory technical requirements specified for - adequacy of laboratory procedures, - competency of the laboratory personnel, - testing of the product, - capability to perform these services correctly, traceable to the relevant process standard, and - review of the related records? Have these requirements been implemented? 7.6.3.2 External laboratory Can you show me laboratory scope(s) for external/commercial/independent laboratory facilities that include the capability to perform the required inspection, test or calibration? Can I see evidence that each laboratory is either accredited, or is acceptable to the customer(s)? 8.1 General How do you plan and implement measurement, analysis and improvement processes needed to demonstrate products conform to requirements? How do you plan and implement measurement, analysis and improvement processes needed to ensure conformity of the QMS? How do you plan and implement measurement, analysis and improvement processes needed to continually improve the effectiveness of the QMS? How do you determine what methods to use, including statistical techniques? How do you determine the extent of their use? 8.1.1 Identification of statistical tools Have appropriate statistical tools for each process been determined and included in the control plan? (see 7.5.1.1) 8.1.2 Knowledge of basic statistical concepts How does Organization ensure that basic statistical concepts are understood and utilized throughout the organization? (verify throughout audit) 8.2 Monitoring and measurement 8.2.1 Customer satisfaction How do you obtain information about customer perception as to whether Organization has met customer requirements? How is this information used? 8.2.1.1 Customer satisfaction Supplemental What realization process performance indicators are used to monitor customer satisfaction? Do they include at least: - delivered part quality performance, - customer disruptions including field returns, - delivery schedule performance (including incidents of premium freight), and - customer notifications related to quality or delivery issues? How do you monitor manufacturing processes to demonstrate compliance with customer requirements for product quality and process efficiency?
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8.2.2 Internal audit Are internal audits being conducted at planned intervals? Do they determine whether the QMS conforms to the requirements of ISO 9001 and to the other requirements established by Organization? (Review records to demonstrate conformance) Do they determine whether the QMS is effectively implemented and maintained? (Review records) Can you show me an audit plan that takes into consideration the importance of the processes and areas to be audited, and the results of previous audits? Where are the audit criteria, scope, frequency and methods defined? Can you demonstrate that selection of auditors and the conduct of audits are objective and impartial, and that auditors dont audit their own work? Can you show me your internal audit procedure? Can you show me the records of internal QMS audits? Who ensures that actions are taken to eliminate detected nonconformities and their causes? Are they being taken care of in a timely manner? (verify with records) What activities are done to verify the actions taken, and how are the verification results reported? 8.2.2.1 Quality management system audit Do you have audit records showing that the entire QMS is being audited? 8.2.2.2 Manufacturing process audit Do you have records showing that each manufacturing process is being audited to determine its effectiveness? 8.2.2.3 Product audit Are there records showing that products are being audited at appropriate stages of production and delivery? Do the audits verify conformity to all specified requirements? 8.2.2.4 Internal audit plans Can you show me an annual audit plan? Does it show that audits cover all QMS processes, activities and shifts? Is there evidence that audit frequency is increased due to nonconformances or customer complaints? Are specific checklists used for each audit? 8.2.2.5 Internal auditor qualification How do you determine competence of internal auditors to audit the requirements of TS 16949? (See 6.2.2.2 also customer specific requirements).
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G 8.2.3 Monitoring and measurement of processes What methods are used to monitor and measure the QMS processes? Can you show that they have achieved the desired results? When the desired results are not achieved, what actions are taken to ensure that the product meets requirements? 8.2.3.1 Monitoring and measurement of manufacturing processes Can you show me process studies that have been performed on new manufacturing processes? Can you show examples of results of process studies being documented with specifications? Are they used for instructions? Do the documents include objectives for manufacturing process capability, reliability, maintainability, availability, and acceptance criteria? Do records show that manufacturing process capability or original customerapproved performance is being maintained? May I have a copy of the process flow diagram and control plan for (mfg. process ) to review the production line with? (Review for adherence to specified requirements) Can you show that process events like tool changes or machine repairs are being recorded (on control charts)? Can you show me that reaction plans have been followed for characteristics that are not statistically capable or are unstable?
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Do the reaction plans include containment of product and 100 % inspection as appropriate? Have corrective action plan(s) been completed by the organization, with timing and responsibilities to assure that processes become stable and capable? When required, have CA plans been reviewed and approved by the customer? Can you show me records of effective dates of process changes? 8.2.4 Monitoring and measurement of product What characteristics are checked to verify that product requirements have been met?
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G At what stages of the product realization process do monitoring and measuring activities take place? How is evidence of conformity with acceptance criteria maintained? Can you show me records that indicate who has authorized release of product to the next stage of the process? How do you ensure that product is not released until the all requirements have been met? If product must be released prior to this, how is it approved? 8.2.4.1 Layout inspection and functional testing Can you show me layout inspection and functional verification results? Do they address applicable customer specifications and correlate with the control plan requirements? Are results available for customer review? 8.2.4.2 Appearance items Do you provide parts designated by customer(s) as appearance items? If so can you show that you have: - appropriate resources including lighting for evaluation, - masters for colour, grain, gloss, metallic brilliance, texture, distinctness of image (DOI), as appropriate, - maintenance and control of appearance masters and evaluation equipment, and - verification that personnel making appearance evaluations are competent and qualified to do so 8.3 Control of nonconforming product How do you ensure that nonconforming products are identified and controlled to prevent unintended use or delivery? (Verify product throughout audit) Can you show me your documented procedure defining the controls for dealing with nonconforming product? Does it include related responsibilities and authorities? When you have nonconforming product, what methods do you use to deal with it? Can you show me records of nonconforming product and any actions taken? Are there any records of concessions obtained? When nonconforming product is corrected, can you demonstrate that it is re-verified to ensure it conforms to requirements? When nonconforming product is detected after shipment, what actions are taken, such as containment? (Verify corrective action records) 8.3.1 Control of nonconforming product Supplemental How are unidentified or suspect products treated? 8.3.2 Control of reworked product Can you show me instructions for rework? Do they include re-inspection requirements? Are they accessible and utilized? 8.3.3 Customer information Do you have evidence that customers are promptly notified if nonconforming product is shipped? 8.3.4 Customer waiver G G G G
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NG NG NG
NG
Can you show me records of customer approvals prior to processing, whenever deviations from approved product or manufacturing processes occur? Do the records indicate expiration date and/or quantity authorized? How do you ensure that original requirements are met when the authorization expires? How do you identify material shipped on an authorization? Do you have records that this process is applied to purchased products also? Do you review and agree with supplier deviation requests before submitting them to the customer for approval? 8.4 Analysis of data What data is collected and analyzed to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of its effectiveness can be made? What information does this analysis provide relating to: - customer satisfaction? (See 5.6) - conformity to product requirements? (See 5.6) - characteristics and trends of processes and products? (See 5.6) - suppliers? (See 7.4.1) 8.4.1 Analysis and use of data How do you compare trends in quality and operational performance with progress toward objectives? Does the comparison lead to action to supporting the following? - development of priorities for prompt solutions to customer-related problems; - determination of key customer-related trends and correlation for status review, decision-making and longer term planning; - an information system for the timely reporting of product information arising from usage. 8.5 Improvement 8.5.1 Continual improvement Can you demonstrate that Organizations QMS effectiveness continually improves? What tools do you use? (See 5.6, 8.2.2, 8.4, 8.5.2, 8.5.3) 8.5.1.1 Continual improvement of the organization Where has Organization defined a process for continual improvement? 8.5.1.2 Manufacturing process improvement Can you show that CI efforts focus on control and reduction of variation in product and process characteristics (after capability, stability, and conformity)? 8.5.2 Corrective action Do corrective actions records identify and address root cause(s)? (Do root causes match actions?) Are actions taken appropriate to the severity of the problem? Can you show me a documented procedure defining requirements for each of the following? a) reviewing nonconformities (including customer complaints) b) determining the causes of nonconformities c) evaluating the need for action to ensure that nonconformities do not recur d) determining and implementing action needed e) records of the results of action taken f) reviewing corrective action taken Can you show me records of corrective actions taken? 8.5.2.1 Problem solving Where is the process for problem solving defined? Does it lead to root cause identification and elimination? (Review records) If one or more customer requires a specific problem-solving format can you show me records documented as required? 8.5.2.2 Error-proofing
G G G G G G
NG NG NG NG NG NG
G G G G G G
NG NG NG NG NG NG
G G G G G
NG NG NG NG NG
G G G
NG NG NG
NG
NG
G G G G G G G G G G G
NG NG NG NG NG NG NG NG NG NG NG
G G G
NG NG NG
Can you show that error-proofing methods are used in the corrective action process? G 8.5.2.3 Corrective action impact Can you show that corrective actions are applied to other similar processes and products? 8.5.2.4 Rejected product test/analysis Can you show me records of analysis of parts rejected by customer manufacturing plants, engineering facilities and dealerships? How long does the analysis take? Are records made available (to customers) upon request? Is the time consistent with the determination of root cause, corrective action and monitoring the effectiveness of implementation? 8.5.3 Preventive action How do you determine potential nonconformities to take action one? Do preventive action records identify and address root cause(s)? Are actions taken appropriate to the severity of the problem? Can you show me a documented procedure defining requirements for each of the following? a) determining potential nonconformities and their causes, b) evaluating the need for action to prevent occurrence of nonconformities, c) determining and implementing action needed, d) records of results of action taken (see 4.2.4), and e) reviewing preventive action taken. Can you show me records of preventive actions taken? NG
NG
G G G G
NG NG NG NG
G G G G G G G G G G
NG NG NG NG NG NG NG NG NG NG
Approved by
Reviewed by
Prepared by
Score
Control Plan Audit Judging Criteria 21 pts (70%) and above = OK less than 21 pts (70%) = NG Added Notes If any item is scored below 3 the audit will be considered as "FAIL" - items with 1 or 2 points need countermeasures / improvements Detail ISO Acquisition Material Type Regrind Percentage Major Supplier Manufacturing Equipments Inspection Equipments
0%
Mass-Production Audit
Point 5 5 5 5 5 5 30
P/N
P/Name
Evaluation Method of Quality Assurance System Conduct the evaluation for check items below Circle the appropriate confirmation method used and refer to score points 5 points - Perfect (Excellent) 4 points - Nearly Perfect (Good) 3 points - Acceptable (Improvement Necessary) 2 points - Need some reforms (Immediate Improvement Necessary) 1 point - Need absolute reforms (Urgent Countermeasure) Confirmation Method Point
Total Evaluation
1. Material Control Instructions - receiving, storage, prevent damage, staging, mixing 1-1 materials, surplus (partials), shipping, non-conforming materials and finished product. Ordering lead time, Production schedule, updated BOM, component lot 1-2 control 1-3 1-4 Practices First-in-First-Out (FIFO) for material control from receiving, to storage, to staging, and finally finished product shipping Correct and clear label info (prevent mix/ traceability) - receiving, mat'l mix, staging, prod, finish product. Packing / shipping standards available.
Notification process of new component, changes, and deviation requests are documented, filed, and controlled. Internal quality audits and external quality audits are implemented. Has PPAP level 3 been submitted (with complete documents and up to date certification)? Is PPAP approved?
Product
0.00
5. Quality Awareness Interview 5-1 0.00 5-2 Quality slogans or posters are displayed for everyone to see. Quality Targets - internal and external measurables are clearly defined (in numeric value), with feedback system. Quality Measurables -quality information displayed, management reviews, quality work cells, problem solving methods and system, kaizen. Quality Management System (QMS) presence and awareness. Actual Check Actual Check Actual Check Interview Interview Interview
Subtotal 2. Process Control 2-1 2-2 2-3 2-4 2-5 2-6 Production sites are kept tidy, well organized, and clean - 5S implemented. Documents in production area are well arranged and organized (work instructions, work and process parameters, etc.) Quality control process charts are available and are consistent with control plans. Clear classification is done between conforming and defective items; between inspected and uninspected items. Component's functional tests are conducted. Clear definition of lot classification for traceability purpose. Actual Check Actual Check Actual Check Actual Check Actual Check Interview Interview Interview Interview Interview
5-3 5-4
0.00
6. Training and Safety Training planned, conducted, documented, recorded - quality, work methods (5Rs/6Ss), 6-1 process/product, operations standards and safety, etc. 6-2 6-3 Safety standards, assurance, and feedback (PPEs, slogans, audits, labels, etc.) Safety activities, procedures, and programs (signs, alarms, tags, markings, etc.)
Interview Interview
0.00
0.00
3. Maintenance Maintenance status of tooling and equipment. Critical replacement parts 3-1 identification with minimum inventory levels. 3-2 3-3 3-4 Storage condition of tooling and critical replacement parts. Records of actual manufacturing condition is stored. Daily and regular inspections of facilities are conducted.
Countermeasures/ Improvements. (If more space is needed attach spread sheet) Issue Item
Action Plan
Verification
Status
0.00
4. Quality Control 4-1 4-2 4-3 4-4 4-5 4-6 4-7 4-8 Quality Assurance System (documentation, implementation, and structure). Quality assurance process flow from product development, material receiving, production, packaging, and shipping. Quality forms, inspection standards, checksheets, specs, ECI, evaluation tests, drawings - organized, recorded, and controlled. Standard actions when NG parts are found and abnormal situation arises. Quality Problems - claim details, analysis, countermeasures, improvements, and controls are recorded and filed. Lot samples are stored at least 3 months (SEWS standard). 1st piece and last piece documented and retained. Advance Product Quality Planning (APQP) activities are well planned and implemented for mass production preparation. Calibration of measuring instruments - done regularly, frequency established, gage R&R complete, inspection device to correct design level. Actual Check Actual Check Actual Check Actual Check Actual Check Actual Check Actual Check Actual Check Interview Interview Interview Interview Interview Interview Interview Interview
Score
Approved by
Reviewed by
Prepared by
0%
9001, 9002, QS, TS, 14000, Compliant
Pre-Production Audit
Point 5 5 5 5 5 5 30
P/N
Evaluation Method of Quality Assurance System
P/Name
Judging Criteria All eval items at least a score of 3 and overall score of above 70% = PASS Added Notes -" " requires related forms and documents - items with 1 or 2 points must have countermeasures / improvements Detail ISO Acquisition Material Type Regrind Percentage Major Supplier Manufacturing Equipments Inspection Equipments Notification process of new component, changes, and deviation requests are documented, filed, and controlled. Actual Check Actual Check Actual Check
* For new supplier evaluation, add another sheet for manufacturing and inspection equipment list.
Protector, Clip Assy (Color) Connector Product Total Evaluation Grommet Rubber Metal Bracket IC Others
Conduct the evaluation for check items below Circle the appropriate confirmation method used and refer to score points 5 points - Perfect (Excellent) 4 points - Nearly Perfect (Good) 3 points - Acceptable (Improvement Necessary) 2 points - Need some reforms (Immediate Improvement Necessary) 1 point - Need absolute reforms (Urgent Countermeasure) Confirmation Method Point
1. Material Control 1-1 1-2 1-3 1-4 Instructions - receiving, storage, prevent damage, staging, mixing materials, surplus (partials), shipping, non-conforming materials and finished product. Ordering lead time, Production schedule, updated BOM, component lot control Practices First-in-First-Out (FIFO) for material control from receiving, to storage, to staging, and finally finished product shipping Correct and clear label info (prevent mix/ traceability) - receiving, mat'l mix, staging, prod, finish product. Packing / shipping standards available. Actual Check Actual Check Actual Check Actual Check Interview Interview Interview Interview 0.00
4-9
4-10 Internal quality audits and external quality audits are implemented. Has PPAP level 3 been submitted (with complete documents and up to date certification)? 4-11 Is PPAP approved?
Subtotal 5. Quality Awareness 5-1 5-2 Quality Management System (QMS) presence and awareness. Quality slogans or posters are displayed for everyone to see. Quality Targets - internal and external measurables are clearly defined (in numeric value), with feedback system. Quality Measurables -quality information displayed, management reviews, quality work cells, problem solving methods and system, kaizen. All QA members and management level associates have read SEWS Quality Manual and its recent revisions. (List of associates necessary). Actual Check Actual Check Actual Check Actual Check Actual Check Interview Interview Interview Interview Interview
Subtotal 2. Process Control 2-1 2-2 2-3 2-4 2-5 2-6 Production sites are kept tidy, well organized, and clean - 5S implemented. Documents in production area are well arranged and organized (work instructions, work and process parameters, etc.) Quality control process charts are available and are consistent with control plans. Clear classification is done between conforming and defective items; between inspected and uninspected items. Component's functional tests are conducted. Clear definition of lot classification for traceability purpose. Actual Check Actual Check Actual Check Actual Check Actual Check Actual Check Interview Interview Interview Interview Interview Interview
Subtotal 6. Training and Safety 6-1 6-2 6-3 Training planned, conducted, documented, recorded - quality, work methods (5Rs/6Ss), process/product, operations standards and safety, etc. Safety standards, assurance, and feedback (PPEs, slogans, audits, labels, etc.) Safety activities, procedures, and programs (signs, alarms, tags, markings, etc.) Actual Check Actual Check Actual Check Interview Interview Interview
0.00
Subtotal 3. Maintenance 3-1 3-2 3-3 3-4 Maintenance status of tooling and equipment. Critical replacement parts identification with minimum inventory levels. Storage condition of tooling and critical replacement parts. Records of actual manufacturing condition is stored. Daily and regular inspections of facilities are conducted. Actual Check Actual Check Actual Check Actual Check Interview Interview Interview
0.00
1 5 4.5
Interview 0.00
Training / Safety 6
Subtotal 4. Quality Control 4-1 4-2 4-3 4-4 4-5 4-6 4-7 4-8 Quality Assurance System (documentation, implementation, and structure). Quality assurance process flow from product development, material receiving, production, packaging, and shipping. Quality forms, inspection standards, checksheets, specs, ECI, evaluation tests, drawings organized, recorded, and controlled. Standard actions when NG parts are found and abnormal situation arises. Quality Problems - claim details, analysis, countermeasures, improvements, and controls are recorded and filed. Lot samples are stored at least 3 months (SEWS standard). 1st piece and last piece documented and retained. Advance Product Quality Planning (APQP) activities are well planned and implemented for mass production preparation. Calibration of measuring instruments - done regularly, frequency established, gage R&R complete, inspection device to correct design level. Actual Check Actual Check Actual Check Actual Check Actual Check Actual Check Actual Check Actual Check Interview Interview Interview Interview Interview Interview Interview Interview
5 Quality Awareness
3 Maintenance
Quality Control
B. Timing of Pre-production Audit The Pre-production should be performed after the supplier has submitted a Level III PPAP and no later than eight weeks prior to start of regular production.
Check Point
Point
Evaluation Criteria
Point
2 1 5 4 3 2 1 5 Master List is available but not currently being used. No Master List of Forms, Procedure, or Instructions Standards exist and are comprehensive.
Evaluation Criteria
Standards exist and are comprehnsive with minor findings. Standards exist and are followed with room for improvement Standards exist but are not followed No standards. Quality problems are analyzed to confirm condtion and countermeasures are implemented. Problem history is defined and recorded with root cause applied to similar processes and components. Quality problems are analyzed to confirm condtion and countermeasures are implemented. Problem history is defined and recorded with root cause applied to similar processes and components. Still minor findings System is in place. Defects are noted and analyzed. There is still room room for improvement.
x
N + 3 Process Audit Mass Production Verification Countermeasure Effectiveness
Item Spec. Maturation * Design/Specification Tooling * Tool Level * Tool Problem & C/M * Tool PM Log * MP Approval * Inspection Fixture Equipment/Facilities * Machine * Manufacturing Fixture * In-Process / Final Inspection Equip. * Maintenance * Housekeeping Process * Build Associate / Manpower * Production Material * Handwork * Line Speed / Cycle Time * Reject Rate/Scrap Rate * Part Functionality * Associate Training * PFMEA (if required) * PCP * Operation Standards / Process Parameters * Process Data Collection Sheets * Lot Control and/or LNDD * Sample Boards * PIR Supply * Bill of Material * Packaging * Inventory * Production * Transportation / Delivery Supplier Management Approval * Percentage of Items OK * SQA Engineer ~ New Model * SQA Engineer ~ Mass Production * SQA Management ~ New Model * SQA Management ~ Mass Production * Manpower plan established * Lead time eval of raw material * No Handwork * MP * 100% MP / all problems c/m'd
Target * PPH & Mfg concerns fixed* All deviations issued and approved for all design concerns
Act
Comments
* Preventive Maintenance History / Tooling Log / Frequency Scheduling * PPAP Approval * 100% MP Ready / Poke Yoke
* Machine PM History / Frequency Scheduling * Machine Fixturing PM / Poke Yoke * Capability / Repeatability / Poke Yoke / Lighting * Maintenance Records / PM Established and followed * Visual / 5S programs
* Verification of actual versus quoted * Tracking of In-Process Defects / Corrective Actions / Countermeasures * On Going 1st piece last piece functional verification * Verification of actual associate records * FMEA, reflects PPH C/M's * Original PPAP CP comparison * Process Parameters set to standard / within tolerance / match PPAP level * First article inspection reports / Dock audits / supporting inspection reports * Tracked and logged per run / tracked and logged as FIFO standards * Visual displays per product / go - no go / limit samples / 1st piece approvals / mating components * No PIRS / PIRS closed out
* Check complete / errors identified * Requirements identified / Confirmation of packaging standard * MP order image complete for tier 2 * Historical production spike analysis * On time delivery tracked and reported
ANSWER
DE
APPROVAL Prototype PE
QA
COMPLETION DATE:
PART NAME
ANSWER (FOR SUMITOMO USE ONLY) JUDGEMENT APPROVAL REJECTION COMMENT OR RECOMMENDATION
CONTROL #: {NMEG-XX}
CONTROL #: {NMEG-XX}
No.
Process
Note
Start-up Checks G e n e r a l I t e m s Operations Standards Process operations standards Correct Material M a t e r i a l Re-Grind Control Material Drying Equipment
Visual
maintenance schedule and tracking method to alert scheduled maintenance. PM schedule must be based on manufacturer Preventative Maintenance recommendations and past problem history. Only trained or authorized assoociates should have the ability to change equipment parameters and controls.
Equipment controls
Visual
100%
Must have process operations standards at each process. Operations standards to include the detail of part(s) to be manufactured including materials, components, and process order as well as machine, tooling, and equipment settings. Operations standards must have sign off by line associates and Check at Process start-up management. and after any change Must have procedure to identify correct material is used to mold part. Must have procedure to verify percentage of regrind. Must have procedure to verify material moisture content per material data sheet Must have method to protect material from contamination throughout process. (ie..gaylord with covers, etc..) Must have procedure to control color concentrate percentage and confirm the color of the final product. Document Actual specification and tolerance Document Actual specification and tolerance Document Actual specification and tolerance Document Actual specification and tolerance Document Actual specification and tolerance Document Actual specification and tolerance Document Actual specification and tolerance Verify at start up and at mold change. Verify at start up and at mold change. Verify at start up and at mold change. Verify at start up and at mold change. Verify at start up and at mold change. Verify at start up and at mold change. Verify at start up and at mold change. Verify at start up and at mold change. Verify at start up and at mold change. Verify at start up and at mold change. Verify at start up and at mold change. Verify at start up and at mold change. Verify at start up and at mold change. Verify at start up and at mold change. Verify at start up and at mold change. Verify at start up and at mold change. Verify at start up and at mold change. Verify at start up and at mold change. Verify at start up and at mold change. Verify at start up and at mold change. Verify at start up and at mold change. 1 shot/ start-up and end of lot 1 shot / every lot 1 shot/ start-up and end of lot 1 shot/ start-up and end of lot 1 shot/ start-up and end of lot 1 shot/ start-up and end of lot 1 shot/ start-up and end of lot 1 shot/ start-up and end of lot
Raw Material
Material contamination
Visual
Process Audit
Color Concentrate
Process Audit Process Check Sheet Process Check Sheet Process Check Sheet Process Check Sheet Process Check Sheet Process Check Sheet Process Check Sheet Process Check Sheet Process Check Sheet Process Check Sheet Process Check Sheet Process Check Sheet Process Check Sheet Process Check Sheet Process Check Sheet Process Check Sheet Process Check Sheet Process Check Sheet Process Check Sheet Process Check Sheet Process Check Sheet
Velocity P a r a m e t e r s Hold and pack Injection time Injection Peak pressure Minimum cushion Screw recovery Cooling time M o l d i n g P a r a m e t e r s Nozzle and heater band (zone) temperature control Hot runner (zone) temperature control, if applicable Thermolator control Mold temperature Water hook up control. (ie..color code in and out connections) Opening control Closing control Clamp Clamp Tonnage Mold position M o l d i n g
M o l d i n g
Barrel
Visual
Visual Visual
Document Actual specification and tolerance Document Actual specification and tolerance Document Actual specification and tolerance Document Actual specification and tolerance
Document Actual specification and tolerance Mold safety control Document Actual specification and tolerance Injection / Mold Release Speed control Document Actual specification and tolerance Position control Document Actual specification and tolerance Speed control Document Actual specification and tolerance Position control Cycle Time Document Actual specification and tolerance Shall have no flash, deformation, short-shot, weld defect, etc. Shall comply with the drawing (measure the dimensions of important points) Max. 49N (5kgf) Min. 147N (15kgf) Max. 49N (5kgf) Min. 147N (15kgf) Min. 147N (15kgf)
Visual
Visual
Visual
Visual
Visual
Appearance Dimension Lock Insertion force I n p r o c e s s Lock Retention force Clip Insertion force Quality Checks Clip Retention force Collar Retention force Bracket Insertion force
Visual Visual check per inspection standard Check by caliper / CMM, etc. Push-Pull tester Push-Pull tester Push-Pull tester Push-Pull tester Push-Pull tester Push-Pull tester
Inspection report Inspection report Inspection report Inspection report Inspection report Inspection report Inspection report Inspection report If temperature chamber is not available use freezer for 2 hours Use a tester with a constant speed. Use speed of 100mm/min. unless otherwise specified Measure the outer pitch dimension
Max. 49N (5kgf) 0 C x 30 min for PA parts and -10 C x 30 min for PP parts. Flex hinges 3 times after cooling ~ no cracks are allowed 1 shot / every lot Maintain part moisture content of 2% ~ 3%
Termperature Chamber Inspection report Weight measurement or moisture anayzer Inspection report
DNR PARTE II
PROVEEDOR:
Supplier
PLANTA:
Plant
NOMBRE DE PARTE:
Part Name DESCRIPCION DETALLADA DEL PROBLEMA: Detail ProblemDescription
EMITIDO POR:
By:
FECHA:
Date EN LINEAS: Lines BODEGA: Warehouse EN TRAILERS: Trailers EN TRANSITO ENTRE HARTEC Y PLANTA (fecha de arrivo)
NUM. PARTE DE EL OTRO COMPONENTE INVOLUCRADO EN EL DEFECTO. Part number of other involved component Cual(es) es(son) el(los) numero(s) de cavidad de la(s) piez(s) defectuosa(s) What is the cavity numbers of the defects? (ex. 1, 2, 5) EL DEFECTO ES FUNCIONAL o VISUAL? Functional/Visual defect? Es Posible utilizarlo? PORQUE? Can you use it? Why? CUANTAS y CUALES LINEAS USAN EL COMPONENTE: Quantity and which lines use the material EN CUANTAS y CUALES LINEAS SE PRESENTA EL PROBLEMA? How many and which lines have the issue? LISTADO DE TODOS LOS LOTES SOSPECHOSOS:
List of ALL suspect LOTs number(s)
Manufacturing date: fecha manufactura
Cual es numero de piezas defectuosas (ejemplo 1 de 100?) What is the frequency of this defect? (one out of 100?)
Lote # / Serie #
Cantidad: quantity
Lote # / Serie #
Cantidad: quantity
FOTOGRAFIA DE ETIQUETA DE HARTEC: FOTOGRAFIAS DE EL PROCESO,EQUIPO, HERRAMIENTA, etc... DONDE SE UTILIZA EL COMPONENTE: Process, equipment, tooling' pictures
Generar video (si es posible). Can you do a video camera?
Hartec label
0 0 01/00/00
Containment Actions by Plant Fecha Inicio Start Fecha Final date Complete date
Accion action
Responsable responsible
Resultados results/data
0 0 01/00/00
INFORMACION ADICIONAL (si cree que es importante para un mejor entendimiento de el problema y evidencia de que Additional information es un problema 100% responsabilidad de el proveedor )
Part #
RULE / STANDARD
(WHAT IS THE RULE OR STANDARD FOR THE PROCESS)
PIR #
ACTUAL (FACT)
(WHAT ACTUALLY HAPPENED IN THE PROCESS)
POINT AT ISSUE
(PROBLEM RECEIVED BY CUSTOMER)
F L O W O U T
Containment Plans
Results
Responsible
Target Date
(add pictures)
COMMENTS
Part #
RULE / STANDARD
(WHAT IS THE RULE OR STANDARD FOR THE PROCESS)
PIR #
ACTUAL (FACT)
(WHAT ACTUALLY HAPPENED IN THE PROCESS)
POINT AT ISSUE
(PROBLEM RECEIVED BY CUSTOMER)
OCCURRENCE WHY
(WHY DID DEFECT OCCUR)
WHY
WHY
WHY
FLOWOUT WHY
(WHY DID DEFECT GET TO THE CUSTOMER)
WHY
WHY
WHY
CAUSE
(OCCURRENCE)
CAUSE
(FLOWOUT)
PIR #
PROBLEM STATEMENT
1-A
PROBLEM DEFINITION
(PROBLEM SIDE)
1-B
PROBLEM DEFINITION
Part check results, factor analysis, quality condition of current part / process.
2-A
2-B
WHY 5
PROBLEM
WHY
WHY
CORRECTIVE COUNTERMEASURE(S)
CONFIRM COUNTERMEASURE(S)
Actual effects
FEEDBACK / FEEDFORWARD
WHO DATE
FOLLOW-UP DATE
1-C
4M
PROBLEM DEFINITION
(BRAINSTORMING)
1-D
PROBLEM DEFINITION
(FISHBONE CHART)
Possible Causes
Clarification
Etc.
Method
Man
Material
Machine
After completion of Fishbone Chart, number each step from big bone to smallest bone. These numbers will correspond to steps of Q & A Analysis.
Group Members:
Date Audited
All answers are Y/N/NA 1. Warrant information Correct Form? (CFG-1001 or NAOP 4.5-1 F-PSW Part name and number completed? Agree with design record? Safety/Gov. Marked? Agree with design record? Eng. Chg. Level and date completed? Agree with design record? Additional Eng. Change's and date? Applicable? Weight completed? (4 decimals) Explanation/Comments: Note here if referencing other approved package, e.g. Family tool. Production Rate/ 8 hrs. (PPAP 3rd Edition) 1 Warrant per part number Reason for submission DUNS/Supplier code correct Signature EWO (If applicable) 2. Keyed Print/Design record Submitted? Is the blue print distributable? (PD-Part Drawing) All dimensions and notes Keyed (if applicable) Customer approval Critical Characteristics called out on drawing 3. Change Documents Submitted or designated as N/A on PPAP checklist? If submitted, is information documented on the warrant/ 4. Dimensional/Inspection Report/Engineering Approval Submitted and corresponding to Part Drawing? Signed copy from engineer? Part Number, Name, tool number and ECL Completed? If ECN Number is noted, check "If additional Engr. Change" field on Warrant is completed. Results per cavity/Tool/Line within tolerance or deviation request. ECL level and date of ECL 5A. Material/Performance Test Results Submitted? Or designated as N/A on PPAP approval checklist. Supplier Name, part Number, Name, and Laboratory Name Completed? Test results are dated within 1 year of PPAP Submission date? Signed? design record change level and date of design record for parts tested. Number of parts tested. (Performance testing only) Evidence of approval. No blanket statement of conformance. Reference Spec if applicable (OnStar or others) Deviation request (If necessary, including time period) 5B. Lab Accreditation Submitted Report source company? (Lab Letterhead Rqd.) Valid accreditation? (A2LA, GM-10, ISO Guide 25) Scope of Accreditation includes the testing performance. Submitted material certification laboratory? 6. Flow Diagram Submitted complete and adequate? Part Number/Description? Prepared by & date completed? Numbering sequence follows the PFMEA and the Control Plan. All operation included. (Rework, inspection, )
7A/B. FMEA PFMEA Submitted? DFMEA submitted? FMEA's address all obvious failure modes. All failure modes associated with special characteristics are detailed Part number listed? High severity action plans completed (Updated for any part failure history?) Date of completion Complete and adequate 8. Control plans Pre-launch (GP12)) submitted, complete and adequate? Production Control plan submitted, complete and adequate Part Number/Latest Engineering Change Level (ECL) Completed? Part Name/Description and Supplier name completed? Date of original and Revision completed? Are KPC's Identified? Complete and adequate? MPR requirements are met for product supplied for application to Honda 9. Capability Studies Are KPC's submitted? Part number and date documented? Is specification and limits defined? Raw Data included? Variable Study sample Size Correct? (100 pcs) Acceptable variable Study? (PPK and CPK 1.67 min) Attribute Study Sample size Correct? (300 pcs) 10. Gage R&R Submitted All gages detailed in the Control Plan submitted? Acceptable % R&R? (less than 10%) or >10% and <30% if breakpoint <37.8 and % Gage R&R <30% (If MSA is used criteria used and decision made.) Part number Completed? Gage number and Name completed? Raw Study Data Completed? Name and Date Completed? 11. IMDS Requirements All data submitted and meets IMDS guidelines? www.mdsystem.com Electronic copy to IMDS website? Should use SEWS ID# 56697. Hard copy w/ PPAP? Data contains percentage per raw material? Sum of each subcomponent percentage should equal 100% Is part weight included?
12. SQA Material Approval Check IPS ( Integrated Procurement System) to see if part is listed Has part been approved in certification box. 13. X-ray Part Sample Parts Sample parts has been X-rayed NMS0C - ____ -_____. Part pass or failed 14. IPP Notification Sheet NMEG - _____________________ Sheet sent with PSW approval to supplier.
LIFETIME MOLD/DIE
CAUSE
COUNTERMEASURE
DATE
Judgement ACCEPT
SIGNATURE
RESPONSIBLE PERSON/DATE REJECT PERSON IN CHARGE/DATE QUALITY SECTION ACCEPT RESPONSIBLE PERSON/DATE REJECT PERSON IN CHARGE/DATE PURCHASING ACCEPT RESPONSIBLE PERSON/DATE REJECT PERSON IN CHARGE/DATE Customer Approval Required/ PPAP Submission Required No Customer Approval Required- No customer spec or drawing requirement
Sumitomo Electric Wiring Systems, Inc. W/H COMPONENT DEVIATION REQUEST SHEET
SEWS PART NO: SEWS PART NAME: PROGRESS OF PARTS SUPPLIER INFORMATION ISSUE NO. SUBMISSION DATE: SUPPLIER NAME: SUPPLIER RESPONSIBLE DEPARTMENT APPROVED BY CHECKED BY ISSUED BY
CAVITY NO:
LOT NO:
TYPE OF DEVIATION
Limited Quantity Limited Production Date Lifetime Mold/Die
CAUSE
COUNTERMEASURE
RESPONSIBLE PERSON
Judgement
ACCEPT REJECT
Responsible Person
Print Name: Print Name:
Manager
SEWS PURCHASING
ACCEPT REJECT
Customer Approval Required/ PPAP Submission Required No Customer Approval Required- No customer spec or drawing requirement
FUNCTIONAL EVALUATION
PART No:
DATE:
COMMENTS:
COMMENTS:
SIGNATURE
JUDGMENT
OK
QUALITY ENGINEER ITEM NUMBER TEST CONTENT TEST CONDITION TOLERANCE
Cavity No.
NG CHECK
INSPECTOR
Supplier
Sumitomo
Supplier
Sumitomo
Supplier
Sumitomo
Supplier
Sumitomo
Supplier
Sumitomo
Supplier
Sumitomo
Supplier
Sumitomo
Supplier
Sumitomo
Supplier
Sumitomo
Supplier
10
Sumitomo
Supplier
11
Sumitomo
Supplier
12
Sumitomo
Supplier
13
Sumitomo
DATE:
RESULT
There were no defects. There were some defects.
COMMENTS: RAW MATERIAL SUPPLIER NAME: COMPOUND No: COLOR OF PART:
WEIGHT OF PART:
COMMENTS:
SIGNATURE
JUDGMENT
OK
QUALITY ENGINEER INSPECTOR
NG
CHECK
Supplier
Sumitomo
Supplier
Sumitomo
Supplier
Sumitomo
Supplier
Sumitomo
Supplier
Sumitomo
Supplier
Sumitomo
Supplier
Sumitomo
Supplier
Sumitomo
Supplier
Sumitomo
Supplier
10
Sumitomo
Supplier
11
Sumitomo
Supplier
12
Sumitomo
Supplier
13
Sumitomo
Supplier
14
Sumitomo
Supplier
15
Sumitomo
Supplier
16
Sumitomo
Supplier
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Tool Maker
Component Supplier
Approvals Parts meet specification? Deviation Required? Tool Revision Required? Drawing Change Required? Parts meet specification? Deviation Required? Tool Revision Required? Drawing Change Required? Parts meet specification? Deviation Required? Tool Revision Required? Drawing Change Required? Parts meet specification? Deviation Required? Tool Revision Required? Drawing Change Required? Parts meet specification? Deviation Required? Tool Revision Required? Drawing Change Required? Parts meet specification? Deviation Required? Tool Revision Required? Drawing Change Required?
Comments/Signatures of Responsible Person(s): Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No No No No No No No No No No No No No No No No No No No No No No No No