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SEWS "CONNECT WITH THE BEST"

Sumitomo Electric Wiring Systems, Inc. Supplier Quality Manual

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.

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III. Problem Resolution


A. Problem Improvement Request 1. Defect Notification Report (Form may differ by issuing plant) 2. PIR (Form may differ by issuing plant) Corrective Action Response 1. Initial Response 2. PIR Response 3. 5 Phase Controlled Shipping

B.

C.

IV. Supplier Rating


A. Quality 1. Monthly Review 2. Focus Suppliers Delivery 1. Monthly Review

B.

V.

Purchase Order

Sumitomo Business Principles


Sumitomo Electric Wiring Systems, Inc. (SEWS) and other companies of the Sumitomo Group share the Sumitomo "Business Principles", which have supported Sumitomo business ethics for over four hundred years. The principles of placing "prime importance on integrity and sound management" and "not pursuing easy gains or acting imprudently" remain valid at all times, and we should adhere to them always. As for "respecting humanity and attaching importance to technical expertise", it is no exaggeration to say that these values constitute the permanent corporate philosophy of our company. On the occasion of the parent company's centennial anniversary, and based on its tradition, the Sumitomo business principles have been redefined as shown below, to motivate us toward greater achievement in the years to come. Sumitomo shall: Offer the very best goods and services to satisfy customer needs. Build technical expertise, realize changes and strive for consistent growth. Contribute to creating a better society and environment, with a firm awareness of our social responsibility. Maintain high corporate ethics and strive to become a company worthy of society's trust. Nurture a lively corporate culture that enables employee self-improvement. Our Quality Pledge "Quality for a Better Tomorrow" a commitment made by Sumitomo Electric Wiring Systems to our customers our worldwide markets and to ourselves. Working as a team, we support this pledge by combining excellence in day-to-day communications with a world-class work ethic and state-of-the-art processes to produce products which consistently meet and exceed our customers expectations of quality, delivery and cost. Quality

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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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Approval/ Revision Record


Title Senior Vice President Assistant Vice President General Manager QA General Manager QA Assistant General Manager SQA Assistant General Manager QA Assistant General Manager Purchasing Assistant General Manager QA Manager New Model SQA Manager OEM QA Manager Purchasing Manager Electronics Purchasing Revision Levels: 03 4 Name D. Anderson R. Whitaker G. Albee D. Gillenwater T. Fujimoto K. Woosley T. Ichino S. Akin T.Minton O.Gutierrez B.Brown Yoshio Pierce Signature / Date

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.

Supplier Documentation and Quality Audits Quality and Environmental Requirements

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.

Notice of Responsible Person of Quality Assurance

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.

Quality System Audits

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.

Part / Product Documentation PPAP

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.

Prototype Tools and Prototype Components


To ensure that a certain level quality is maintained for prototype tools and components suppliers must adhere to the general prototype requirements contained in this manual.

C.

Tool Transfer Approvals / Localizations


Before new tools are transferred to the permanent production facility a Tool Transfer Approval must be submitted to SEWS for routing and approval. This Tool Transfer approval will consist of the initial dimensional analysis completed at the build origin before the tool is shipped. This dimensional analysis will be submitted to SEWS using the form contained in this manual. This approved dimensional analysis will accompany the tool transfer. The supplier will be required to achieve these same dimensions once the tool is ready for mass production. The supplier must utilize this form to ensure that deviation requests are addressed before the tool is shipped. Failure to complete the Tool Transfer Approval will delay production and PPAP approval resulting in a claim against the supplier for failure to meet timing. During the tool build if there are any discrepancies between the 2D and the 3D drawing the supplier will reference the 2D as the master and will contact SEWS Purchasing immediately. Purchasing will then distribute the conflict accordingly. SEWS will work with the supplier to resolve any issues. SEWS encourages feedback and suggestions from its suppliers during tool builds and prior to production. For proposed changes the supplier shall utilize the Design Assembly Review Problem Sheet. In the same manner, SEWS will propose changes utilizing the same form. The changes include but are not limited to: a) Design Changes b) Assembly Changes c) Process Changes d) Packaging Changes

D.

Initial Production Parts

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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.

Mass Production Parts


1. Lot retention and part documentation will be established on a part by part basis. When not specified, lot retention and part documentation shall consist of a period of three months to include first and last pieces of each run. 2. Control plans shall identify SEWS designated CPK dimensions and functional requirements to be verified at the start and end of each run. Control Plans must reflect adherence to SEWS MPR guidelines for product supplied for Honda product. 3. For Packaging and Bar Code Requirements SEWS suppliers shall comply with bar coding requirements as defined in SEWS Part Identification and Labeling Requirements To see the specification, go to http://www.sewsus.com and click on Supplier Information, then click on Labeling Requirements. http://www.sewsus.com and click on Supplier Information, then click on Labeling Requirements. 4. The practice of First In First Out (FIFO) will be implemented and followed for all necessary components used in production of SEWS components. The supplier will be responsible for controlling an internal system to ensure that the practice of FIFO is efficient to meet this standard. This will include, but not limited to, raw material, assembly components, production parts requiring secondary operations, assembly operations, and finished goods. 5. For changes to a mass production component, either initiated by SEWS or the supplier, the Advance Notification of Initial Production Parts will be utilized. This form will be used as the means of communication between SEWS and the supplier whenever there is a proposed change to the mass production component or the mass production operation. The changes include but are not limited to: Design Changes Assembly Changes Process Changes Packaging Changes to include box type or quantity

F.

Deviations for Non-conforming Parts

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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III. Problem Resolution A. Problem Improvement Request

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.

Corrective Action Response

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.

Sumitiomo Electric Wiring System, Inc.


DNR - PIR process flow for Wire Harness Division
Wire Harness Plant SQA JMC SQA MSC Supplier

(Juarez Material Service Center) (El Paso Material Service Center)

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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IV. Supplier Rating A.


1.

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.

Relation to Purchase Order

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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SUPPLIER COMMITMMENT FORM

QUALITY NAME TITLE PHONE CELL FAX E-MAIL

SALES

MANUFACTURING

PRESIDENT

RECEIPT AND ACKNOWLEDGEMENT OF SUPPLIER

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

Full Systems Audit (QAV) Based on ISO/ TS-16949 Specification

SEWS

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Evidence Status

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.

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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?

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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

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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?

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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?

G G G G G G

NG NG NG NG NG NG

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?

G G G G G G G G G

NG NG NG NG NG NG NG NG NG

G G

NG NG

G G G G

NG NG NG NG

NG

NG

G G

NG NG

G G G G G G G

NG NG NG NG NG NG NG

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).

G G G G G G G

NG NG NG NG NG NG NG

G G

NG NG

NG

NG

G G

NG NG

G G G G

NG NG NG NG

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?

NG

G G G

NG NG NG

G G G G G G G G

NG NG NG NG NG NG NG NG

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?

G G G G

NG NG NG NG

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

NG NG NG NG NG

G G G

NG NG NG

G G G G G G

NG NG NG NG NG NG

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

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

Mass-Production Audit Checksheet


New Supplier
Evaluation Item 1. Material Control 2. Process Control 3. Maintenance 4. Quality Control 5. Quality Awareness 6. Training and Safety Total Point 0.00 0.00 0.00 0.00 0.00 0.00 0.00

Audit Reference No.

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%

Sumitomo Electric Wiring Systems Supplier Quality Assurance


Protector, Clip Assy (Color) Connector Grommet Rubber Metal Bracket IC Others Interview Interview Company Name Address In-Charge Date of Visit Evaluated by

Mass-Production Audit
Point 5 5 5 5 5 5 30

P/N

Control Plan Audit

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.

4-9 4-10 4-11

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?

Actual Check Actual Check

Actual Check Actual Check Actual Check Actual Check

Interview Interview Interview

Actual Interview Check Subtotal

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

Actual Interview Check Subtotal

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.)

Actual Check Actual Check

Interview Interview

Actual Interview Check Subtotal

0.00

Actual Interview Check Subtotal

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.

Actual Check Actual Check Actual Check

Interview Interview Interview

Countermeasures/ Improvements. (If more space is needed attach spread sheet) Issue Item

Action Plan

Verification

Status

Actual Interview Check Subtotal

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

Pre-Production Audit Checksheet


New Supplier
Evaluation Item 1. Material Control 2. Process Control 3. Maintenance 4. Quality Control 5. Quality Awareness 6. Training and Safety Total Point 0.00 0.00 0.00 0.00 0.00 0.00 0.00

Audit Results PASS / FAIL

Score

Audit Reference No.

Approved by

Reviewed by

Prepared by

0%
9001, 9002, QS, TS, 14000, Compliant

Sumitomo Electric Wiring Systems Supplier Quality Assurance

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

Company Name Address In-Charge Date of Visit Evaluated by

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

Interview Interview Interview 0.00

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

5-3 5-4 5-5

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

Subtotal Countermeasures / Improvements

0.00 Points When Who Status

Supplier Evaluation Results Material Control

1 5 4.5

Interview 0.00
Training / Safety 6

4 3.5 3 2.5 2 1.5 1 0.5 0 Process Control 2

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

Pre-Production Audit Guidelines & Checksheet


1. Purpose The purpose of the Pre-production Audit activity is to verify a suppliers actual manufacturing process, while operating under normal operating conditions, and under Customer Requirement, is: A. Capable of producing quality components/systems/modules, as stated in the Production Part Approval Process (PPAP) B. Capable of meeting or exceeding the "daily contracted capacity within one production day," on a sustained basis Additionally, other elements of systems readiness will be reviewed and noted to ensure that potential start of production problems are identified and counter-measured. 2. Scope This procedure applies to all manufacturing and assembly processes contracted to Sumitomo Electric Wiring Systems, Inc. to: A. Produce new components B. Increase existing capacity on previously contracted volume C. Tool and equipment moves to new manufacturing locations The application of this procedure may be required for changes to existing processes where it is deemed that the capability and/or capacity of the system have been altered. Note: An exemption from this process can only be granted with the written approval of the Quality and Purchasing Directors of the procuring division 3. Type of Audit SEWS Supplier Quality will confirm the type of audit. The supplier will be notified of the need to perform a "Customer Monitored" or "Supplier Monitored" Pre-Production Audit as early in the Advanced Product Quality Planning Process as possible. 4. General Information A. Duration of Audit The duration of the run at rate will be sufficient to verify that the process can meet the contracted capacity while producing the component. The default length of the production run will be equal to the daily contracted hours. However, SQA may deviate from the default duration (upon approval from their manager) after taking into consideration the following factors: Product Complexity Shelf Life Storage & Packaging Cost Production Day Length

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.

Pre-Production Audit Criteria Item


1. Material Control 1-1 Instructions - receiving, storage, prevent damage, staging, mat'l mixing, surplus (partials), shipping, non-conforming materials and finished product. Work instructions and work flow are followed by material control personnel. Proper forms and logs are filled up. Feedbacks non-conforming materials and defects. Defect area and scrap area is available. 5 4 3 2 1 1-2 Ordering lead time, Production schedule, updated BOM, component lot controls Orders materials based on updated BOM at the right lead time to prevent production delays. Production schedule is planned and followed with component lot controls. 5 4 3 2 1 1-3 Practices First-in-First-Out (FIFO) for material control from receiving, storage, stage for prod, and finally finished product shipping FIFO is a habit for everyone from receiving materials, mixing materials, stage for production, and shipping of finished products. Check if FIFO is enforced or manual search FIFO is practiced. 5 4 3 2 1 1-4 Correct and clear label info (prevent mix/ Correct and clear labeling is practiced to prevent mix traceability) - receiving, mat'l mix, staging, and to have traceability. Packing and shipping prod, finish product. Packing / shipping standards are available and followed. standards available. 5 4 3 2 1 2. Process Control 2-1 Production sites are kept tidy, well organized, and clean. Well arrangement of production site Walking space Housekeeping Area well lit Floor markings for designation of equipment 2-2 Documents in production area are well Process parameters are posted in the arranged and organized (work instructions, appropriate locations (press, dryer, etc) work and process parameters, etc.) Work instruction are posted within easy reach of the operator 2-3 Quality control process charts are available and are consistent with control plans. The chart per each part number Examination by relative department Indication of relative standards/forms Matches the control plan Frequency established 2-4 Clear classification is done between conforming & defective items; between inspected & uninspected items. Installation of defects bod (red box) Fixed storage place for defects Process of defects treatment Classification of work-in-process products 2-5 Components' functional test is conducted. Clarification of necessary functional check Necessary inspection equipment. Established frequency Established method 2-6 Clear definition of lot classification for traceability purpose. Definition of lot classification Bar Code per package Relation between materials and lots Traceablity of manufacture conditions (lot no) Traceablity of inspection condition (lot no) Traceablity of materials (from lot numbers) 3. Maintenance 3-1 Maintenance status of tooling and equipment. Critical replacement parts identification with minimum inventory levels. Appearance of tooling and equipment - list Tooling and equipment maintenance schedule Maintenance based on shot count and time Tags - maintenance, repair, etc. Critical parts list and required minimum inventory 3-2 Storage condition of tooling and critical replacement parts. Fixed storage place - racks, location index, etc. Rust-proofing of tooling Storage after maintenance, tags Stacking of tooling and critical parts - condition 3-3 Records of actual manufacturing condition Work report daily record is stored. Machine parameters daily record Deviations approved, filed, recorded Record traceability 3-4 Daily and regular inspections of facilities are conducted. Appearance of facilities Facility check list / 5S audit check sheet Facililty maintenance - periodic check Lighting - production and inspection areas Management review of daily checks 4. Quality Control 4-1 Quality Assurance System (documentation, implementation, and structure). Clarification of organization and leaders Structure chart of Quality Assurance Clear Quality Policy 5 4 3 2 1 4-2 Quality assurance process flow from product development, material receiving, production, packaging, and shipping. Process/workflow standard Clarification/documentation of workflow Actual examples 5 4 3 2 1 4-3 Quality forms, inspection standards, Data storage condition checksheets, specs, ECI, evaluation tests, The latest document control system drawings - organized, recorded, and Master List of all documentation controlled. 5 4 3 There is the well-structured document of QA system There is the well-structured document of QA system with minor findings. There is adequate documenataion with rooom for impovement. There is documention, but not adequately structured. Personnel do not know the policy. No relative documention exists. Work flow is etablished and followed. Work flow is etablished and followed with minor findings. Work flow is etablished and followed with room for improvement. Work flow is established but is not implemented. No established work flow. Master list is complete and accurate. Master list is complete with minor findings. Master list is available but with room for improvement. 5 4 3 2 1 5 4 3 2 1 5 4 3 2 1 5 4 3 2 1 Maintenance on time, clean, tags, master list, crit parts inv (w/ prompt re-order) Maintenance on-time, clean, tags, master list, crit parts inv (w/o prompt) Maintenance delay, clean, tags, mater list, crit parts inv (don't meet req'ts) With maintenance schedule, maintenance quality (NG), no tags, oil leaks, pellets found anywhere No maintenance schedule, unclean, no tags, no master list, no crit parts inv Storage location is good, no rust, clean racks, with tags, with location index Storage location is good, no rust, clean racks, with tags, no location index Storage location is good, no rust, clean racks, no tags, no location index - minor problem Storage location is good, clean racks, with rust, no tags, no location index - major problem NG storage condition and no critical replacement parts. Work daily report, machine parameters daily report, deviations, traceability - available and updated Work daily report, machine parameters daily report, deviations, traceability - available and not updated Work daily report, machine parameters daily report, deviations, traceability - minor problem Work daily report, machine parameters daily report, deviations, traceability - major problem No records of actual manufacturing conditions. 5S is practiced with daily management reviews and follow up. 5S is practiced with daily management reviews. Some minor findings. 5S is practiced but with room for improvement. 5S procedure in place but not followed. No management review of housekeeping. No evidence of 5S. No structured plan or work instructions for 5S. Poor lighting in facility. 5 4 3 2 1 5 4 3 2 1 5 4 3 2 1 5 4 3 2 1 5 4 3 2 1 5 4 3 2 1 Production sites are kept tidy, well-organized and clean. Production sites are kept tidy, well-organized and clean with minor findings. Prodcution site is at an acceptable level. Some 5s is practiced. Production site is unorganized. System in place but not followed. Production site is unkept with no system in place. Documents are well organized and posted at all necessary locations. Documents are organized and posted with minor findings. Documents are posted but not in all necessary locations. Some Documents are posted. No instructions or paramaters are posted. Process controls are completed according to the control plan and established frequency. Process controls are completed according to the control plan and established frequency with minor findings. Chart exists but is not completed according to the control plan or frequency Chart exists but is not completed. No chart exists. Clear classification system exists and is followed with no findings. Clear classification system exists with minor findings. Classification systems exists. Classification systems exists but is not followed correctly. No classification system exists. Each check is conducted clearly and properly accoriding to the specification. Each check is conducted clearly and properly accoriding to the specification with minor findings. Functional testing is conducted with findings Functuinal testing is defined but not conducted according to the specification,control plan, or frequency. No functional check exists. Complete traceability throught the entire process. Almost complete traceabliliy with minor findings. Sytem is implemented and followed with findings. Sytem exists but is not implemented or followed. No lot classification or system for lot classication exists. Instructions available, forms and logs filled up, with defect and scrap area Instructions available (minor problem found), with defect and scrap area Instructions available (major problem found), with defect and scrap area Instructions and work process flow is unclear, no defect and scrap area No instructions, no defect and scrap area Order lead time, prod sched, BOM updates, lot control - implemented Order lead time, prod sched, BOM updates, lot control - minor problem Order lead time, prod sched, BOM updates, lot control - not followed No ordering lead time standard, prod sched not planned. BOM not updated, wrong material order is possible, prod delays FIFO is practiced - no findings (enforced or manual) FIFO is practiced - minor problem, 2 or less found FIFO is practiced - major problem, 3 or more found Plans for FIFO with activities schedule, limited space between materials. Does not practice FIFO / no plans of FIFO in the future. Correct/clear label info, good quality, bar coded, shipping standards - OK Correct/clear label info, good quality, shipping standards - OK / no bar code Correct/clear label info, good quality - OK / no shipping stand and bar code Incorrect/Unclear label info, NG label quality (easily torn / detached) No labeling standards.

Check Point

Point

Evaluation Criteria

Pre-Production Audit Criteria Item Check Point


Document disposal Document retention 4-4 Standard actions when NG parts are found Work instruction for NG parts and abnormal situation arises. WI details actions to take Segregation of parts Rejection of startup shots at resart Contigency Plans 4-5 Quality Problems - claim details, analysis, countermeasures, improvements, and controls are recorded and filed. Quality check of the initial products Quality check by inspection staff Record of quality check Record of defects Record of coutermeasures Application of the countermeasures to other products Record of defects and countermeasures Application of the countermeasures to other products Data storage condition 4-6 Lot samples are stored at least 3 months Lot sample storage (SEWS standard). 1st piece and last piece Storing regulations documented and retained. Storage period Actual status Log of samples with dates Samples clearly identified 4-7 APQP activities are well planned and implemented for mass production preparation. Regulation of preparation activities Preparation of planning sheet Follow-up level FMEA Performance test 4-8 Calibration of measuring instruments done regularly, frequency established, gage R&R complete, inpsection device to correct design level. Correction once a year Indication of expiry date They are controlled by a register Gages are labled Master List of all gages. Outside lab documentation on hand 4-9 Notification process of new component, changes, and deviation requests are documented, filed, and controlled. Internal procedure for handling of design changes, process changes, and assembly changes. Procedure to ensure customer notification Documentation of changes and evaluation 4-10 Internal quality audits and external quality audits are implemented. Are internal audits scheduled and performed Are results reviewed by management Are CAR reverifed to ensure compliance Supplier audits are performed and at what frequency How are follow up items addresses and closed 4-11 Has PPAP level 3 been submitted (with complete documents and up to date certification)? Is PPAP approved? Has PPAP been submitted Was timing met Was PPAP complete Was PPAP approved Was PPAP correct 5. Quality Awareness 5-1 Quality Management System (QMS) presence and awareness. QMS is implemented in the entire organization Quality Certification 5 4 3 2 1 5-2 Quality slogans or posters are displayed for everyone to see. Visible display of slogans/posters Place of display Contents - clear and easy-to-understand Slogans / posters latest version Slogans / posters condition of displays 5-3 Quality Targets - internal and external measurables are clearly defined (in numeric value), with feedback system. External - cust claims, warranty, rating Internal - defect reduction, scrap rate, audits Plan to achieve targets Structure of feedback system 5-4 Quality Measurables -quality information displayed, management reviews, quality work cells, problem solving methods and system, kaizen. Management reviews - frequency Quality problem countermeasures system Quality information is displayed Quality work cells presence, kaizen Global 8D, 5P, 6-Sigma, etc. 6. Training and Safety 6-1 Training planned, conducted, documented - Management of raining quality, work methods (5Rs/6Ss), Training records process/product, operations standards and Annual training plan and evaluation safety, etc. Training for operators and supervisors 6-2 Safety standards, assurance, and feedback system. Use of Personal Protective Equipment (PPE) Safe limits - environment / space condition Work under NIOSH limits, safety slogans MSDS and HMIS availability (chemical labels) Safety audits and concerns feedback 6-3 Safety activities, procedure, and programs. Caution signs and alarms in place Lockout and tag out maintenance procedure Switches & guards - periodic check-log program Well markings - aisles, equipments, etc. Everything is in its place 5 4 3 2 1 5 4 3 2 1 5 4 3 2 1 Training plan and structure implemented, updated training docs and records Training plan and structure implemented - for improvement Training is done - with plan but not to schedule (delays), no record updates Training is available - no structure, no plans. No training at all. Use PPEs, good work cond, with feedback - no incidents (1 year or more) Use PPEs, good work cond, with feedback - no incidents (6 mos) Use PPEs, good work cond, with feedback - with incidents (last 6 mos) With safety standards, not implemented No safety standards, assurance, and feedback system No incidents (1 year or more) No incidents (6 months) Signs-alarms, tags, check program, markings, in place - well organized Signs-alarms, tags, check program, markings, in place - not organized No safety activities and programs. 5 4 3 2 1 5 4 3 2 1 5 4 3 2 1 TS acquisition QS acquisition ISO acquisition / No ISO certification but compliant to ISO In process of obtaining ISO acquisition No Plans of Obtaining ISO acquisition and not ISO compliant Well-displayed as everyone can see, understood, updated and clean Well-displayed as everyone can see but not easy to comprehend Displayed but not reviewed and in bad condition (torn/dirty) Displayed but not in a good location No display Ext and int targets defined - PPMs, scrap rate, etc. (on-target) Ext and int targets defined - PPMs, scrap rate, etc. (slightly behind on target) Ext and int targets defined - with numeric value, with feedback (no challenge) Ext and int targets defined - no numeric value, no feedback No quality targets, no numeric value, no feedback Mgt. review 1/ mon, w/ method & system, w/ display, w/ work cells Mgt. review 1/ mon, w/ method & system, w/ display, no work cells Mgt. review 1/ mon, w/ method & system, no display, no work cells Measurables not reviewed in 3 mos, no feedback, no display, no work cells No measurables, no work cells, no display, no feedback 1 PPAP not been submitted, PPAP was submitted late, PPAP mising documentation, PPAP contains incorrect information 5 PPAP was submitted and approved. 5 4 3 2 1 5 4 3 2 1 Procedure is comprehensive and followed. No gaps were detected internally. Procedure is comprehensive and followed with minor findings. Procedure is followed but with room for improvement. Internal procedure exists but is not practiced. No internal procedure. Audits are performed as scheduled. CAR are reverfied to ensure compliance and effectiveness. Audits are performed as scheduled. CAR are reverfied to ensure compliance and effectiveness. Some minor findings. Audits are perfomed as scheduled but with room for improvement. Audits are scheduled but not performed on a consistant basis. Audits are not scheduled or performed. 5 4 3 2 1 5 4 3 2 1 APQP activities are planned and completed per the customer standard. APQP activities are planned and completed per the customer standard with minor findings. APQP activities are planned and completed with room for improvement. APQQ activities are planned but not completed No APQP activities are performed. Calibration is complete and up to date with no findings. Calibration is completed according to the standard with minor findings. Calibration is completed but with room for improvement. Calibration is completed but with major findings. Calibration is not completed 5 4 3 2 1 Lot samples are stored for three months. There is a log of samples w/ each sample clearly identified. Lot samples are stored for three months. There is a log of samples w/ each sample clearly identified. W/ minor findings. Lot samples are stored for three months. There is room for improvement in lableing and documentation. Lot samples are not clearly identified or stored for the approriate time period. The lot samples are not stored. 2 1 Quality defects are noted with no analysis. No system in place for problems. 3 4

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.

COUNTERMEASURE AUDIT REPORT


Date of Audit Auditor(s): Supplier PIR # Problem C/M DATE 1) Was countermeasure implemented within the specified scheduled time frame? a) Was an extension requested for Countermeasure implementation? b) Have all Countermeasure items been implemented? c) Did managers audit all countermeasures? d) Is there a follow up-audit scheduled? 2) Were modifications made to the tool, mold or die? a) Were dimensions confirmed and recorded? b) Were parts visually inspected and results confirmed? c) Was a PPAP package sent to the customer? d) Was a line trial conducted on countermeasure parts? e) Was advanced notification sent to customer? f) Were IPP tags on the 1st shipment of countermeasure parts? 3) Were modifications made to the process or machine? a) Were operation/inspection standards written or revised? b) Are new/revised standards properly posted? c) Have operators been properly trained on standards? 4) Were changes made at the sub-suppliers? a) Was sub-supplier standards (PPAP) revised? b) Were sub-supplier countermeasure revisions confirmed? 5) Was countermeasure implemented on similar products/processes? Comments: Yes N/A N/A N/A N/A 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 Part # Part Description Lot #

N/A N/A N/A N/A N/A N/A

N/A N/A N/A

N/A N/A N/A

NSQA-F-18 Countermeasure Audit SUMITOMO ELECTRIC WIRING SYSTEMS REV. 8-Jan-03

Supplier New Model Development Status Summary Sheet


MODEL : Supplier Name: Part Number:
'Actual' Status Symbol Key:

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

DESIGN/ASSEMBLY REVIEW PROBLEM SHEET


PRODUCT# EVENT DESIGN RELATED CONCERN PROCESS RELATED CONCERN

TRACKING No. Checked By WHO DATA Requested By

PROBLEM ITEM (WITH PICTURE)

COUNTERMEASURE (WITH PICTURE)

ANSWER

DE

APPROVAL Prototype PE

QA

COMPLETION DATE:

Sumitomo Electric Wiring Systems, Inc.


ADVANCED NOTIFICATION OF INITIAL PRODUCTION PARTS
SUPPLIER PART NO. RESPONSIBLE PERSON DATE CHANGE DESCRIPTION [CIRCLE APPLICABLE ITEM(S)] 1. NEW DESIGN PARTS 2. DESIGN CHANGE 3. NEW SUPPLIER/ FACTORY 4. MATERIAL CHANGE DESCRIBE CHANGE DATE INDICATION OF FIRST SHIPPING 5. PROD. METHOD CHANGE 6. PROCESS ORDER CHANGE 7. MACHINE/EQUIP. CHANGE 8. FIXTURE/TOOL CHANGE 9. INSP. METHOD CHANGE 10. DIE/MOLD CHANGE 11. PROD. WORKER CHANGE 12. SHIPPING/ PACKAGING SHIPPING

PART NAME

ANSWER (FOR SUMITOMO USE ONLY) JUDGEMENT APPROVAL REJECTION COMMENT OR RECOMMENDATION

QUALITY ASSURANCE DEPT. / DATE

PURCHASING DEPT. / DATE

CONTROL #: {NMEG-XX}

CONTROL #: {NMEG-XX}

Sumitomo Electric Wiring Systems, Inc. ~ Minimum Control Plan Requirements


Scope: The following requirements are applicable as minimum requirements and when specifications are not included on drawings or specifications. Specific drawing requirements or specifications will overide this standard Recording Method Inspection Item Specification Check frequency Check Method Must have a detailed check sheet to include verification of process controls. (ie..preset wrenches, alarms, poke yoke, etc..) Shift start up and after equipment maintenance. Process start-up check sheet

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.

Per documented schedule Visual

P.M. software or check sheets

Equipment controls

Per Training Program

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

Visual Visual Visual Visual

Process Control Sheet Process Audit Process Audit Process Audit

Raw Material

Material contamination

Visual

Process Audit

Color Concentrate

Visual Visual Visual Visual Visual Visual Visual Visual

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

Document Actual specification and tolerance

Barrel

Visual

Document Actual specification and tolerance

Visual Visual

Document Actual specification and tolerance

Document Actual specification and tolerance

Visual Visual 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

P a r a m e Hydraulic or Air t core pull e r s Cycle Time

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

Cold Hinge testing Water Absorbsion (PA materials)

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%

1 piece / every lot

Termperature Chamber Inspection report Weight measurement or moisture anayzer Inspection report

SUMITOMO ELECTRIC WIRING SYSTEMS NMDC-SQA

DNR PARTE II

(Si Aplica) (Llenado por SQA Hartec)

PLANTAS AFECTADAS: Affected Plants

REPORTE de "NOTIFICATION de DEFECTO"


" Defect Notification Report "
SE HA PRESENTADO EL MISMO PROBLEMA ANTERIORMENTE? CUANDO? Same issue happened before? When? NO. DE PARTE:
Part Number CANTIDAD DE PIEZAS DEFECTUOSAS. Defects Quantity

FECHA DE NOTIFICACION: Date NUMERO DE CONTROL: Control Number Revision #: Rev. #

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)

CANTIDADES DE MATERIAL SOSPECHOSO


Suspect material quantities

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

TOTAL OF SUSPECT PIECES USO DIARIO:


Daily use

Cual es numero de piezas defectuosas (ejemplo 1 de 100?) What is the frequency of this defect? (one out of 100?)

Describir el impacto de este defecto en tu proceso? Describe the impact


of this defect on your process

LISTADO DE TODOS LOS LOTES SOSPECHOSOS:


List of ALL suspect LOTs number(s) PO: orden de compra

Lote # / Serie #

PO: orden de compra

Cantidad: quantity

Manufacturing date: fecha manufactura

Lote # / Serie #

Cantidad: quantity

FOTOGRAFIAS DE EL COMPONENTE BUENO y SOSPECHOSO: Good & Suspect component's pictures

Asegurarse que en fotografias este clara y legible la informacion

FOTOGRAFIA DE ETIQUETA DE PROVEEDOR: Supplier label

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

ACCIONES DE CONTENCION por LA PLANTA:

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 )

PIR "CONTAINMENT ACTIONS" RESPONSE


SUPPLIER NAME
PROCESS
O C C U R R E N C E
(WHAT IS THE PROCESS)

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

Identification of Certified material

(add pictures)

COMMENTS

RECEIVED DATE: ACCEPTED: ______________ REJECTED: ______________

MANUFACTURING AREA MANAGER QA MANAGER/ASST. MANAGER PLANT / GENERAL MANAGER

DATE DATE DATE

QA ENGINEER QA SUPERINTENDENT QA MANAGER/ ASST. MANAGER

DATE DATE DATE

PIR C/M RESPONSE


SUPPLIER NAME
PROCESS
O C C U R R E N C E F L O W O U T U T
POINT AT ISSUE (WHAT IS THE PROCESS)

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)

COUNTERMEASURE FOR CAUSE

WHO AND WHEN

CAUSE
(FLOWOUT)

COUNTERMEASURE FOR FLOWOUT

WHO AND WHEN

SUPPLIER AUDIT (CONFIRM C/M IMPLEMENTATION & EFFECT) AND SIGN.


COMMENTS VERIFICATION OF C/M)

SEWS SECTION SIGNATURES


(QUALITY ASSURANCE COMMENTS) RECEIVED DATE: ACCEPTED: ______________ REJECTED: ______________

MANUFACTURING AREA MANAGER QA MANAGER/ASST. MANAGER PLANT / GENERAL MANAGER

DATE DATE DATE

QA ENGINEER QA SUPERINTENDENT QA MANAGER/ ASST. MANAGER

DATE DATE DATE

Issue Number: Issue Date: Response Due:

5 PRINCIPLES FOR PROBLEM SOLVING WORKSHEET


Supplier Approval Signatures/Dates
Approved By: Checked By: Prepared By: Approved By: Reviewed By:

PIR #

PROBLEM STATEMENT

Sumitomo Approval Signatures/Dates


Checked By:

1-A

PROBLEM DEFINITION

(PROBLEM SIDE)

WHAT FACTS ARE TRUE OF THIS PROBLEM AT THIS TIME!!!

1-B

PROBLEM DEFINITION

(CLARIFYING THE FACTS)

Part check results, factor analysis, quality condition of current part / process.

2-A

IDENTIFY ROOT CAUSE


1 WHY

(QUESTION AND ANSWER ANALYSIS)

From Fishbone chart

2-B
WHY 5

IDENTIFY ROOT CAUSE

Question and answer analysis, problem occurrence process, duplication test.

PROBLEM

WHY

WHY

Root Cause Statement / Illustration

Occurrence (HARD ITEM)

Non-Detection (SOFT ITEM)

CORRECTIVE COUNTERMEASURE(S)

Content of c / m, prediction of effects, potential problem analysis.

CONFIRM COUNTERMEASURE(S)

Actual effects

FEEDBACK / FEEDFORWARD
WHO DATE

Identify Temporary and Permanent.

INFO. TO OTHER ASSOC. OR DEPT.

FOLLOW-UP DATE

1-C
4M

PROBLEM DEFINITION

(BRAINSTORMING)

1-D

PROBLEM DEFINITION

(FISHBONE CHART)

BUILD FISHBONE FROM POSSIBLE CAUSES IN 1-C AT LEFT

Possible Causes

Clarification

HARD SIDE - MECHANICAL FACTORS

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.

SOFT SIDE - HUMAN FACTORS

Group Members:

Part # Part Name Supplier Name Contact

Date Audited

Sumitomo Programs Applicable

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.

Sumitomo Electric Wiring Systems, Inc.


DEVIATION REQUEST SHEET
PART NO: DATE: ISSUE NO. PART NAME: SUPPLIER NAME: CAVITY NO: RESPONSIBLE PERSON: LOT NO: PROGRESS INITIAL TYPE OF DEVIATION OF PARTS MASS PROD. LIMITED QUANTITY SAMPLES AND TEST: CONTACT SEWS COMPONENT SQA FOR REQUIREMENTS LIMITED PRODUCTION DATE DESCRIPTION OF NONCONFORMITY: USE SKETCH OR ATTACH DRAWING

LIFETIME MOLD/DIE

CAUSE

COUNTERMEASURE

DATE

JUDGEMENT (FOR SUMITOMO USE ONLY) CATEGORY OF APPROVAL


Limited Quantity ___________pcs. Limited Production __________date Lifetime Mold/ Die

REASONS AND COMMENTS ENGINEERING SECTION

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

Initial Shipment (PER HARTEC P.O.) Mass Production

CAVITY NO:

LOT NO:

TYPE OF DEVIATION
Limited Quantity Limited Production Date Lifetime Mold/Die

DESCRIPTION OF NONCONFORMITY: USE SKETCH OR ATTACH DRAWING

QUANTITY OR PERIOD OF DEVIATION

CAUSE

COUNTERMEASURE

RESPONSIBLE PERSON

EXPECTED COMPLETION DATE

JUDGEMENT (FOR SUMITOMO USE ONLY) CATEGORY OF APPROVAL


Limited Quantity Pcs Limited Production Date Lifetime Mold/Die

REASONS AND COMMENTS SEWS COMPONENT DE

Judgement
ACCEPT REJECT

Responsible Person
Print Name: Print Name:

Manager

SEWS NMDC NED CEG


ACCEPT REJECT

Signature and Date Print Name:

Signature and Date Print Name:

SEWS MSC SQA


ACCEPT REJECT

Signature and Date Print Name:

Signature and Date Print Name:

SEWS PURCHASING
ACCEPT REJECT

Signature and Date Print Name:

Signature and Date Print Name:

OTHER DEPT (OPTIONAL)


ACCEPT REJECT

Signature and Date Print Name:

Signature and Date Print Name:

Signature and Date

Signature and Date

Customer Approval Required/ PPAP Submission Required No Customer Approval Required- No customer spec or drawing requirement

FUNCTIONAL EVALUATION
PART No:

DATE:

PART NAME: DRAWING No:

RESULT (CHECK) 1. There was no defect. 2. There were some defects.

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

INITIAL SAMPLE INSPECTION REPORT


LOT No: PART No:

DATE:

PART NAME: DRAWING No: DIE/MOLD No: CAVITY No:

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

INSPECTION RESULT (mm)


ITEM NUMBER DIMENSION TOLERANCE
Cavity No.

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

17

Sumitomo

Supplier

18

Sumitomo

Supplier

19

Sumitomo

Supplier

20

Sumitomo

Supplier

21

Sumitomo

Supplier

22

Sumitomo

Supplier

23

Sumitomo

Supplier

24

Sumitomo

Supplier

25

Sumitomo

Supplier

26

Sumitomo

Supplier

27

Sumitomo

Supplier

28

Sumitomo

Supplier

29

Sumitomo

Supplier

30

Sumitomo

Supplier

31

Sumitomo

Supplier

32

Sumitomo

Supplier

33

Sumitomo

Supplier

34

Sumitomo

Sumitomo Electric Wiring Systems, Inc.


SUPPLIER'S INSPECTION & TEST EQUIPMENT LIST
ID EQUIPMENT NAME MEASURING RANGE AND UNITS (TOLERANCE) CALIBRATION
METHOD FREQUENCY RESPONSIBLE

SUPPLIER SIGNATURE DATE

Sumitomo Electric Wiring Systems, Inc.


TOOL TRANSFER APPROVAL SHEET
Part # Tool Maker Name Phone # Description Component Supplier Launch Date Purchasing Contact

Tool Maker

SWS Design Engineer

SWS Quality Engineer

SEWS Quality Engineer

SEWS Design Engineer

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

Distribution SEWS PurchasingComponent SupplierTool MakerSWS DESWS QASEWS Purchasing

SEWS QASEWS DESEWS PurchasingComponent SupplierTool Maker

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