supplier quality manual.pdf

SEWS "CONNECT WITH THE BEST"

Sumitomo Electric Wiring Systems, Inc.Supplier Quality Manual

Contentsi. Introduction / Sumitomo Business Principles

ii. Approval / Revision Record

I. Supplier Documentation and Quality Audits

A. Quality and Enviromental Requirements

B. Notice of Responsible Person of Quality Audits1. Supplier Commitment Form

C. Quality Systems Audits1. Full System Audits2. Mass Production Audit3. Pre-production Audit4. Countermeasure Audit5. Quality Assurance Confirmation Audit6. N+3 Audit

II. Part / Product Documentation

A. PPAP1. Advanced Notification of Initial Production Plan2. PPAP Checklist3. Initial Sample Inspection Report (ISIR)4. Evaluation Form (reporting functional data)5. Inspection Tools and Test Equipment6. Shipping Id & Packaging Standards7. Dimensional Requirements8. CPK Requirements9. Annual Requirements

B. Tool Transfer Approvals / Localizations1 Design Assembly Review Sheet

C. Initial Production Parts1. Initial Production Parts

D. Mass Production Parts1. Lot Retention2. CPK Requirements

E. Deviations for Non-Conforming Parts1. Deviations Request

SEWS SQA Manual Revision 11, 9/29/08 3 of 60


III. Problem Resolution

A. Problem Improvement Request1. Defect Notification Report (Form may differ by issuing plant)2. PIR (Form may differ by issuing plant)

B. Corrective Action Response1. Initial Response2. PIR Response3. 5 Phase

C. Controlled Shipping

IV. Supplier Rating

A. Quality1. Monthly Review2. Focus Suppliers

B. Delivery1. Monthly Review

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



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.



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.



Approval/ Revision Record

Title Name Signature / Date

Senior Vice President D. Anderson David Anderson 10/15/08

Assistant Vice President R. Whitaker Richard Whitaker 10/3/08

General Manager QA G. Albee Gil Albee 10/3/08

General Manager QA D. Gillenwater Debbie Gillenwater 1/22/09

Assistant General Manager SQA T. Fujimoto Terutsugu Fujimoto 2/4/09

Assistant General Manager QA K. Woosley Ken Woosley 11/3/08Assistant General Manager

Purchasing T. Ichino Takashi Ichino 1/16/09

Assistant General Manager QA S. Akin Steve Akin 1/19/09

Manager New Model SQA T.Minton Tom Minton 10/3/08

Manager OEM QA O.Gutierrez Omar Gutierrez 1/23/09

Manager Purchasing B.Brown Barry Brown 10/3/08

Manager Electronics Purchasing Yoshio Pierce Yoshio Pierce 1/15/09

Revision Levels: Date: Actions:0 3 08/21/1995 Previous Revisions

4 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.

5 07/01/2000 Revision of PIR procedure6 07/31/2002 Re-issue of manual7 01/10/2003 Addition of requirements (per end customer ) for IMDS8 10/30/2003 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.

9 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.

10 03/05/2007 Revised Supplier Rating and monthly scoring11 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



I. Supplier Documentation and Quality Audits

A. Quality and Environmental RequirementsUnless otherwise specified, suppliers shall be third party registered to ISO 9001: 2000 or TS-16949 by an accredited third-party 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 follow-up 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 AuditSEWS 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.



3. Pre-productioin AuditOnce 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 ChecklistCriteria 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 AuditA 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 AuditPeriodic 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 AuditSEWS 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.



II. Part / Product Documentation

A. PPAPSEWS 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 applicableLevel 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 analysisCapability 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.



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 Changesb) Assembly Changesc) Process Changesd) Packaging Changes

D. Initial Production Parts



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 Parts1. 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 ChangesAssembly ChangesProcess ChangesPackaging Changes to include box type or quantity

F. Deviations for Non-conforming PartsIn 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.



Types of DeviationA. 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 PeriodA 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 DieLimited Mold or Die deviation limits the non-conformity to particular molds or dies and will be applied when the non-conformity meets the required criteria for deviation and correction of the non-conformity is not justifiable.Documentation- Deviation Request Sheet

D. Appearance Limit SampleAn 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 non-conforming 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.



III. Problem Resolution

A. Problem Improvement RequestWhenever 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.



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.



Note: Please see the DNR PIR process flow for the SEWS Wire Harness Division for specific reporting requirements and information flows.

C. Controlled ShippingWhen necessary or designated by the OEM or SEWS customer, SEWS suppliers will adhere to OEM specific levels of Controlled Shipments.

Wire Harness Plant SQA JMC SQA MSC Supplier(Juarez Material Service Center) (El Paso Material Service Center)

Plant finds a defect in a PartIssue DNR

SQA JMC files DNR and Supplier makes Issues PIR to Supplier containment actionsSends samples issue 3D in 24 Hrs.Within 24 Hrs sends response to

SQA JMCNotifies MSC SQA for Issues RMA if necessaryreference only

SQA JMC makes containmentactions.Sends response to Plants Notifies SQA MSC for reference only Supplier makes

permanent actions andsends final report.

Makes containment actionsSQA MSC approves ?Yes No.

SQA JMC receives final reportand sends to plant.

Plant receives final reportand closes issue.

DNR - PIR process flow for Wire Harness Division

Sumitiomo Electric Wiring System, Inc.



IV. Supplier Rating

A. Quality

1. 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.



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 "FocusSupplier". Suppliers in this category will be required to participate in meetings with the customer. The frequency (weekly, BI-weekly, 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 ReportSEWS 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 OrderSupplier 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.*



SUPPLIER COMMITMMENT FORM

QUALITY SALES MANUFACTURING PRESIDENTNAME TITLE PHONE CELL FAX E-MAIL

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) SEWS CONNECT WITH THE BEST Based on ISO/ TS-16949 Specification

4.1 General requirements Evidence StatusHas 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) G NGWhere has Organization identified the processes needed for the QMS and their application throughout the organization? (See 4.2.2) G NGWere has Organization determined the sequence and interaction of QMS processes? (See 4.2.2) G NGWhat are the criteria and methods Organization uses to ensure that the operation and control of QMS processes are effective? G NGHas Organization provided resources and information needed to support the operation and monitoring of QMS processes? (See section 6) G NGHow does Organization monitor, measure and analyze QMS processes? (See section 8) G NGHow has Organization implemented actions necessary to achieve planned results and continual improvement of processes needed for the QMS? G NGAre processes needed for the QMS managed by the organization in accordance with the requirements of ISO 9001:2000? G NGWhen Organization outsources any process that affects product conformity with requirements, how is control ensured over such processes? (See 7.4) G NGWhere is the control of outsourced processes that affect product conformity with requirements identified within the QMS? (See 7.4) G NG

4.1.1 General requirements SupplementalDoes Organization have adequate control over outsourced processes to ensure conformity to all customer requirements? G NG

4.2 Documentation requirements4.2.1 General

Does Organization have documented statements of a quality policy and quality objectives? (See 5.3, 5.4.1) G NGDoes Organization have a quality manual? (See 4.2.2) G NGDoes 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) G NGAre adequate documents in place to ensure the effective planning, operation and control of Organizations processes? G NGDoes documentation include the records required by ISO 9001:2000? G NG

4.2.2 Quality manualWhere in the quality manual is the scope of the QMS identified, including details of and justification for exclusions? G NGWhere does the quality manual contain or reference the documented procedures established for the QMS? G NGWhere does the quality manual include a description of the interaction between the processes of the QMS? G NG

4.2.3 Control of documentsHow are the documents required by the QMS controlled? G NGCan you show me a documented procedure that defines the controls needed for each of the following? G NGa) approve documents for adequacy prior to issue? G NGb) review and update as necessary and re-approve documents? G NGc) ensure that changes and the current revision status of documents are identified? G NGd) ensure that relevant versions of applicable documents are available at points of use? G NGe) ensure that documents remain legible and readily identifiable? G NGf) ensure that documents of external origin are identified and their distribution controlled? G NGg) prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. G NG

4.2.3.1 Engineering specificationsWhat process do you have to assure the timely review, distribution and implementation of customer specifications and changes? G NGDoes it meet customer-required schedule(s)? G NGDoes the review occur in two weeks or less? G NGWhat records do you have showing implementation dates of changes? Is there evidence showing that documents are updated? G NG

4.2.4 Control of recordsWhat records exist that provide evidence of conformity to requirements and of the effective operation of the QMS? (Should be reviewed throughout the audit) G NGAre records legible, readily identifiable and retrievable? (Should be reviewed throughout the audit) G NGDoes Organization have a documented procedure defining the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records? G NG

4.2.4.1 Records retentionHave the record requirements been reviewed to ensure conformance with regulatory and customer requirements? G NG

5.1 Management commitmentHow does top management communicate the importance of meeting customer and legal requirements to the organization? G NGHas a company quality policy been established? (See 5.3) G NGWhat are the quality objectives established by top management? (See 5.4.1) G NGDoes top management conduct management reviews? (See 5.6) G NGHow does top management ensure the availability of resources to support and continually improve the QMS? G NG

5.1.1 Process efficiencyHow does top management review product realization and support processes to ensure effectiveness and efficiency? (5.6?) G NG

5.2 Customer focusHow does top management ensure that customer requirements are determined and met? G NG

5.3 Quality policyHow does top management ensure that the quality policy is appropriate to the purpose of the organization? G NGDoes the quality policy include a commitment to comply with requirements and continually improve QMS effectiveness? G NGAre the contents of the quality policy relevant to Organization, and measurable? G NGIs the quality policy communicated and understood within the organization? G NGIs there an established process to review the quality policy for continuing suitability?

G NG

5.4 Planning5.4.1 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 NGAre the quality objectives consistent with the quality policy? What are the measurements? G NG

5.4.1.1 Quality objectives SupplementalAre quality objectives and metrics included in the business plan? G NG

5.4.2 Quality management system planningHow 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 NGHow do you ensure that the integrity of the QMS is maintained when changes to the QMS are planned and implemented? G NG

5.5 Responsibility, authority and communication5.5.1 Responsibility and authority

How are responsibilities and authorities defined and communicated within the organization? (Verify throughout audit) G NG

5.5.1.1 Responsibility for qualityHow are managers responsible for corrective action informed of nonconforming products or processes? G NGAre they informed in a timely manner? G NGDo personnel responsible for product quality have the authority to stop production to correct quality problems? G NGWhat personnel on each shift have responsibility for ensuring product quality? G NG

5.5.2 Management representativeWho is your ISO 9001:2000 management representative? G NGDoes the management representative have responsibility and authority to G NGa) ensure that processes needed for the QMS are established, implemented and maintained? G NGb) report to top management on the performance of the QMS and any need for improvement? G NGc) ensure the promotion of awareness of customer requirements throughout the organization? G NG

5.5.2.1 Customer representativeWho has top management designated to ensure that customer requirements are addressed? G NGDoes their responsibility and authority include selection of special characteristics, setting quality objectives and related training, corrective and preventive actions, product design and development? G NG

5.5.3 Internal communicationHow is information regarding the effectiveness of the QMS communicated within the organization? G NG

5.6 Management review5.6.1 General

What is the frequency that top management reviews the organization's QMS? G NGWhat 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) G NGCan you show me records from recent management reviews? G NG

5.6.1.1 Quality management system performanceDo management reviews include all requirements of the quality management system and performance trends? (Verify records) G NGCan you show management review records including monitoring of quality objectives, and cost of poor quality metrics? (Verify records) G NGCan you show records providing evidence of achievement of the quality objectives specified in the business plan, and customer satisfaction with product supplied?

G NG

5.6.2 Review inputCan you show me that each of the following were included in review(s)? G NGa) results of audits, G NGb) customer feedback, G NGc) process performance and product conformity, G NGd) status of preventive and corrective actions, G NGe) follow-up actions from previous management reviews, G NGf) changes that could affect the quality management system, and G NGg) recommendations for improvement G NG

5.6.2.1 Review input SupplementalDo records show input to management review includes analysis of actual and potential field-failures and their impact? (See also 7.3.4.1) G NG

5.6.3 Review output

What decisions or actions have resulted from management reviews for each of the following? G NGa) improvement of the effectiveness of the quality management system and its processes, G NGb) improvement of product related to customer requirements, and G NGc) resource needs. G NG

6.1 Provision of resourcesWhat resources has Organization provided to implement and maintain the QMS and continually improve its effectiveness? G NGWhat resources has Organization provided to ensure that customer requirements are met? G NG(See 6.2, 6.3, 6.4) G NG

6.2 Human resources6.2.1 General

(While auditing, select some personnel performing work affecting product quality) What are the education, training, skills and experience required by this job/task?

G NGHow does this person meet those qualifications? G NG

6.2.2 Competence, awareness and trainingHow do you determine the necessary education, training, skills and experience for people performing work affecting product quality? G NGWhat training or other actions do you provide to satisfy the needs of personnel? (records) G NGWhen you provide training or other actions to satisfy competence needs, how do you evaluate the effectiveness of those actions? (records) G NG

(Sample throughout organization) G NGHow do your activities contribute to the achievement of quality objectives? G NGWhere do you maintain records of education, training, skills and experience? G NG

6.2.2.1 Product design skillsWhat tools and techniques has the organization identified as necessary for product design personnel? G NGWhat records do you have showing that product design personnel are competent to design and are skilled in the identified tools and techniques? G NG

6.2.2.2 TrainingCan you show me documented procedures for identifying training needs and achieving competence of all personnel performing activities affecting product quality?

G NGWhat records do you have that personnel performing specific assigned tasks are qualified - especially to meet customer requirements. (See 6.2.2e) G NG

6.2.2.3 Training on the jobWhat kinds of on-the-job training do you provide for people in new or changed jobs?

G NGDoes this include contract and agency personnel? G NGHow do you inform personnel about the consequences to the customer of nonconformity to quality requirements? (Sample throughout organization) G NG

6.2.2.4 Employee motivation and empowermentWhat process has been established to motivate employees to G NG- achieve quality objectives, G NG- to make continual improvements, and G NG- to create an environment to promote innovation? G NGDoes the process include the promotion of quality and technological awareness throughout the whole organization? G NGWhat 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? G NG(See 6.2.2d) G NG

6.3 Infrastructure

Are the buildings, workspace, and utilities provided appropriate to achieve conformity to product requirements? How are they maintained? G NGWhat kind of process equipment (both hardware and software) is necessary to conform to product requirements? How is the equipment maintained? G NGWhat supporting services (such as transport or communication) are needed to ensure that product meets requirements? How are they maintained? G NG

6.3.1 Plant, facility and equipment planningWhat groups are involved in developing plant, facility and equipment plans? G NG(Must be multidisciplinary) G NGCan you show that plant layouts optimize material travel, handling and floor space use, and facilitate synchronous material flow? G NGWhat methods are used to evaluate and monitor the effectiveness of existing operations? G NG

6.3.2 Contingency plansCan you show me contingency plans for each of the following? G NG- Utility interruptions G NG- Labor shortages G NG- Key equipment failure(s) G NG- Field returns G NG

6.4 Work environmentWhat kind of work environment is required to achieve conformity to product requirements? How is this environment managed and maintained? G NG

6.4.1 Personnel safety to achieve product qualityHow are product safety and potential risks to employees addressed by Organization?

G NG

6.4.2 Cleanliness of premisesDoes the organization maintain the state of order, cleanliness and repair needed for products and manufacturing processes? (Verify throughout audit) G NG

7.1 Planning of product realizationWhere are the processes needed for product realization identified? G NGIs 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) G NGWhere in the product realization process do you determine the quality objectives and requirements for products? G NGWhen planning for product realization, how do you establish processes, documents, and provide resources specific to the product G NGHow do you determine verification, validation, monitoring, inspection and test activities specific to the product, and the criteria for product acceptance? G NGWhat records exist showing that both the realization processes and the product meet requirements? G NGWhat are the outputs of product realization planning? Are they in a form suitable for Organization? G NG

7.1.1 Planning of product realization SupplementalDoes the quality plan include customer requirements and reference to technical specifications? G NG

7.1.2 Acceptance CriteriaWhere are acceptance criteria defined? When required, does the customer approve them? G NGWhen attribute data sampling, is the acceptance level zero defects? G NG

7.1.3 ConfidentialityHow does the organization ensure the confidentiality of customer-contracted products, projects under development, and related product information? G NG

7.1.4 Change controlWhat process is there to control and react to changes that impact product realization? G NG

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. G NGAre changes validated before implementation? G NGIs 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? G NGDo you have evidence that any additional verification/identification requirements required by the customer are met? G NG

7.2 Customer-related processes

7.2.1 Determination of requirements related to the productHow does Organization determine each of the following requirements? G NGa) requirements specified by the customer, including the requirements for delivery and post-delivery activities, G NGb) requirements not stated by the customer but necessary for specified or intended use, where known, G NGc) statutory and regulatory requirements related to the product, and G NGd) any additional requirements determined by the organization. G NG

7.2.1.1 Customer-designated special characteristicsHow do you meet customer requirements for designation, documentation and control of special characteristics? G NG

7.2.2 Review of requirements related to the productWhat kind of review is done to ensure that the organization has the ability to meet requirements before committing to supply product? G NGHow do you ensure that product requirements are defined and reviewed before committing to supply product? G NGHow do you ensure that contract or order requirements differing from those previously expressed are resolved before committing to supply product? G NGCan you show me records of the product requirement review results and actions resulting from them? G NGWhen customers dont have documented requirements, how do you confirm their requirements before accepting orders? G NGWhen product requirements are changed, how do you ensure that relevant documents are changed and that relevant personnel are made aware of the changes? G NG

7.2.2.1 Review of requirements related to the product SupplementalIf you have waived the requirement for a formal review above, have you obtained customer authorization? G NG

7.2.2.2 Organization manufacturing feasibilityWhat documents do you have that show investigation and confirmation of manufacturing feasibility in the contract review process for proposed products, including risk analysis? G NG

7.2.3 Customer communicationWhat method(s) are used to communicate with customers regarding G NG- product information? G NG- enquiries, contracts, or order handling, including amendments? G NG- feedback, including customer complaints? G NG

7.2.3.1 Customer communication SupplementalDo your customers require information to be communicated in specific languages and/or formats? G NGIf so, how do you meet those requirements? G NG

7.3 Design and development7.3.1 Design and development planning

Can you explain to me the process used by Organization to plan and control the design and development of product? G NGWhat are the stages in the design and development process? G NG

How do you determine the review, verification and validation activities appropriate to each design and development stage? G NGHow /where are design and development responsibilities and authorities defined?

G NGHow does Organization ensure effective communication and clear assignment of responsibility between different groups involved in design and development? G NGAs product design and development progresses, how are the planning outputs updated? G NG

7.3.1.1 Multidisciplinary approachDo you use a multidisciplinary approach to prepare for product realization? Does it include: G NG- development/finalization and monitoring of special characteristics G NG- development and review of FMEAs, including actions to reduce potential risks, G NG- development and review of control plans. G NG

7.3.2 Design and development inputsWhat are the design inputs relating to each of the following product requirements?

G NGa) functional and performance requirements, G NGb) applicable statutory and regulatory requirements, G NGc) where applicable, information derived from previous similar designs, and G NGd) other requirements essential for design and development. G NGWhere are they recorded? G NGHow & when are the design and development inputs reviewed for adequacy? G NGHow does Organization ensure that requirements are complete, unambiguous and dont conflict with each other? G NG

7.3.2.1 Product design inputWhere are product design input requirements documented? G NG(including the following: G NG- contract reviews of requirements such as special characteristics, identification, traceability and packaging; G NG- 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; G NG- targets for product quality, life, reliability, durability, maintainability, timing and cost.)

G NGCan you show me they are reviewed? G NG

7.3.2.2 Manufacturing process design inputWhere are manufacturing process design input requirements documented? (including the following: G NG- product design output data G NG- targets for productivity, process capability and cost, G NG- customers requirements, if any, and G NG- experience from previous developments.) G NGCan you show me they are reviewed? G NG

7.3.2.3 Special characteristicsCan you show me that all special characteristics are identified and included in drawings, FMEAs, control plans, and operator instructions? G NGAre the customer-specified (or equivalent) symbols used? G NGDo they meet customer-specified definitions? G NGDo they include process steps that affect special characteristics? G NG

7.3.3 Design and development outputsHow can design and development outputs be verified against the inputs? (see 7.3.5q1) Are these outputs approved prior to release? G NGCan you show me examples of design and development outputs and how they meet the input requirements? G NGWhat outputs include information for purchasing, production and service? G NGWhere are product acceptance criteria specified? G NGWhere are product characteristics needed for safe and proper use specified? G NG

7.3.3.1 Product design outputs Supplemental

Can you show that the product design outputs include G NG- design FMEA, reliability results G NG- product special characteristics, specifications, G NG- product error-proofing, as appropriate, G NG- product definition including drawings or mathematically based data, G NG- product design reviews results, and G NG- diagnostic guidelines where applicable G NGAre the outputs expressed in terms that can be verified and validated against product design input requirements? G NG

7.3.3.2 Manufacturing process design outputCan you show that the manufacturing process design outputs include G NG- specifications and drawings, G NG- manufacturing process flow chart/ layout, G NG- manufacturing process FMEAs, G NG- control plans, G NG- work instructions, G NG- process approval acceptance criteria, G NG- data for quality, reliability, maintainability and measurability G NG- results of error-proofing activities, as appropriate, and G NG- methods of rapid detection and feedback of product/manufacturing process nonconformities. G NGThe manufacturing process design output shall be expressed in terms that can be verified against manufacturing process design input requirements and validated.

G NG

7.3.4 Design and development reviewAt what stages of design and development do you perform reviews to evaluate if the results meet requirements? (See 7.3.1q2b) G NGCan you show me some problems that have been identified and actions proposed at these reviews? G NGWhat functions are represented at these reviews? G NGAt each stage, are all functions concerned with that stage represented? G NGCan you show me records of the results of the reviews and any necessary actions taken? G NG

7.3.4.1 MonitoringCan you show me reports of analysis of measurements at specified design and development stages? G NGAre summary results included in management reviews? (See 5.6.2) G NG

7.3.5 Design and development verificationWhat verification activities are performed to ensure that the design and development outputs have met the input requirements? (See 7.3.3q1) G NGCan you show me records of the results of the verification activities and resulting actions? G NG

7.3.6 Design and development validationWhat design and development validation activities are performed to ensure that the product is capable of meeting the requirements for the intended use? G NGDo records show that validation is done before product shipment? G NGIf not, is the justification recorded? G NGCan you show me records of the validation activity results and any follow-up actions?

G NG

7.3.6.1 Design and development validation SupplementalIs design and development validation performed in accordance with customer requirements, including program timing? G NG

7.3.6.2 Prototype programmeDo your customer(s) require a prototype program and control plan? G NGIf so, can you describe the program? G NGCan you show me the control plan(s)? G NG

Does Organizations prototype program use the same suppliers, tooling and manufacturing processes as will be used in production? If not, what is the justification? G NGWhat records show that performance-testing activities are monitored for timely completion and conformance to requirements? G NGAre any prototyping services outsourced? G NGIf so, who is responsible for the outsourced services, including technical leadership?

G NG

7.3.6.3 Product approval processWhat product and/or process approval procedure(s) do your customer(s) require?

G NGCan you show me records of both process and product approvals? G NGDo you have evidence that the product and manufacturing process approval procedures are applied to suppliers? (See 7.4.2) G NG

7.3.7 Control of design and development changesHow are design and development changes identified? Where are the records kept?

G NGAre changes reviewed, verified, validated, and approved before implementation?

G NGCan 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? G NGCan you show me records of the results of change reviews and any necessary actions? G NG

7.4 Purchasing7.4.1 Purchasing process

How do you ensure that purchased product conforms to specified purchase requirements? G NGHow do you determine the type and extent of control applied to the supplier and the purchased product? G NGHow do you evaluate and select suppliers? (based on their ability to supply product in accordance with Organizations requirements) G NGCan you show me the criteria for selection, evaluation and re-evaluation of suppliers?

G NGCan you show me records of the results of supplier evaluations and any necessary actions? (verify that criteria have been met) G NG

7.4.1.1 Regulatory conformityWhat evidence is there that all purchased products or materials used in product conform to regulatory requirements? G NG

7.4.1.2 Supplier quality management system developmentWhat supplier development actions are being taken toward the goal of supplier conformity with TS 16949? G NGDo your suppliers quality management systems conform with ISO 9001:2000? (see below) G NGIf not, do you have written waivers from applicable customer(s)? G NG

7.4.1.3 Customer-approved sourcesDo your customer(s) specify supplier(s) in contracts/ purchase orders? G NG(This includes products, materials, services, tooling, & gages, ) G NGIf so, can you show that the customer-designated sources are being used as required? G NG

7.4.2 Purchasing informationDo orders/contracts include requirements for approval of product, procedures, processes and equipment? G NGDo require any qualification of supplier personnel? If so, can you show where the requirement is documented? G NGDo you have any QMS requirements of your suppliers? If so, can you show me where they are required? G NGHow does Organization ensure the adequacy of purchasing requirements before communicating them to the supplier? G NG

7.4.3 Verification of purchased productWhat inspection or other activities are used to ensure that purchased product meets your purchasing requirements? G NGDo you ever perform product verification at the supplier's site? G NGIf so, where are the verification arrangements and method of product release identified? G NG

7.4.3.1 Incoming product qualityWhat processes are in place to assure the quality of purchased product? G NG(Must include one or more of following: G NG- evaluation of supplier statistical data G NG- receiving inspection and/or testing G NG- second- or third-party audits of suppliers, along with records of acceptable quality

G NG- laboratory part evaluation G NG- another method agreed with the customer) G NG

7.4.3.2 Supplier monitoringHow do you monitor supplier performance? G NG(Must include the following indicators:) G NG- delivered product quality G NG- customer disruptions including field returns G NG- delivery schedule performance (including incidents of premium freight) G NG- special status customer notifications related to quality or delivery issues G NGHow do you promote supplier monitoring of the performance of their manufacturing processes? G NG

7.5 Production and service provision7.5.1 Control of production and service provision

When carrying out production (or service) are all of the following controlled conditions in place? G NGa) Is information that describes the characteristics of the product available? G NGb) Are appropriate work instructions available (if needed)? (See 7.5.1.2) G NGc) Is suitable equipment used for carrying out production (or service)? G NGd) Are appropriate gages, etc. used in production (or service)? (See 7.6) G NGe) Are appropriate kinds of monitoring and measurement done? (See 8.2.4) G NGf) Are proper release, delivery and post-delivery activities in place? G NG

7.5.1.1 Control planCan you show me control plans for system, subsystem, and component/ material levels for product supplied? G NGCan you show me control plans for both pre-launch and production? G NGCan you show how the control plans take into consideration design FMEA and process FMEA information? G NG(Review control plans to ensure they: G NG- list controls used for manufacturing process control G NG- include methods for monitoring of control of special characteristics G NG- include customer-required information, if any) G NGCan you show that specified reaction plans have been carried out when a process becomes unstable or not statistically capable? G NGWhat conditions initiate the review and update of control plans? G NG

7.5.1.2 Work instructionsDo all employees responsible for processes that impact product quality have documented work instructions? G NG(Verify throughout audit) G NGAre they accessible for use at the workstation? G NGHow are the work instructions developed? G NG

7.5.1.3 Verification of job set-upsCan you show me records of job setups that are being performed? G NGDo they occur at the initial run of a job, material changeover, or job change? G NGWhat work instructions do you have for job setup personnel? G NGWhat statistical methods are used to verify job setups? G NG

7.5.1.4 Preventive and predictive maintenanceHow do you identify key process equipment? G NGCan you walk me through your total preventive maintenance system? G NG(Verify that the TPM system includes the following: G NG- planned maintenance activities G NG- packaging and preservation of equipment, tooling and gauging G NG- availability of replacement parts for key manufacturing equipment G NG- documenting, evaluating and improving maintenance objectives) G NGWhat predictive maintenance methods do you use? G NGCan you demonstrate that predictive maintenance has resulted in continual improvement of the effectiveness and efficiency of production equipment? G NG

7.5.1.5 Management of production toolingWhat resources have Organization provided for tool and gage design, fabrication and verification activities? G NGDoes the production tooling management system include: G NG- maintenance and repair facilities and personnel G NG- storage and recovery G NG- set-up G NG- perishable tool change programs G NG- tool design modification documentation, including engineering change level G NG- tool modification and revision to documentation G NG- tool identification, defining the status, such as production, repair or disposal. G NGAre any tooling management activities outsourced? If so, how are these activities monitored? G NG

7.5.1.6 Production schedulingCan you demonstrate that customer scheduling requirements (such as just-in-time) are being met? G NG

7.5.1.7 Feedback of information from serviceWhat is your process to communicate information on service concerns to manufacturing, engineering, and design? G NG

7.5.1.8 Service agreement with customerDo you have any service agreement(s) with customers? If so, how do you verify the effectiveness of G NG- any organization service centers, G NG- any special-purpose tools or measurement equipment, and G NG- the training of service personnel? G NG

7.5.2 Validation of processes for production and service provisionDo you have any production or service processes where the resulting output cannot be verified later? (This applies to all processes in TS 16949) G NGIf so, how to you validate them? G NGCan you show me records that demonstrate that the validation done has met the requirements? G NGHow are these special processes reviewed and approved? G NGCan you show me records of personnel and equipment qualification? G NGWhere are specific methods and procedures defined? G NGCan you show me records for these processes? G NGWhen changes are made to processes, how do you revalidate them? G NG

7.5.2.1 Validation of processes for production and service provision SupplementalAre all production processes validated per 7.5.2 above? G NG

7.5.3 Identification and traceabilityHow do you identify product throughout your processes? (Verify in production, storage, segregation areas, etc.) G NGHow is product inspection status identified? (Verify in production, storage, segregation areas, etc.) G NGCan you show me unique identification records for products requiring traceability?

G NG

7.5.3.1 Identification and traceability SupplementalIs all product suitably identified? G NG

7.5.4 Customer propertyDo you use any customer-owned property? (Product, packaging, drawings, tooling, gages...) G NG(If so, ask questions below) G NGHow do you ensure that customer-owned property is identified, verified, protected, and safeguarded? G NGIf any customer property is lost, damaged etc., how is it reported to the customer? Can you show me records regarding this? G NG

7.5.4.1 Customer-owned production toolingHow are customer-owned tools and equipment identified? G NG

7.5.5 Preservation of productHow do you preserve the conformity of product during internal processing and delivery? G NG(Verify product throughout audit) G NGHow do identification, handling, packaging, storage and protection address the preservation of product? G NGDoes this also apply to component parts? G NG

7.5.5.1 Storage and inventoryHow do you assess the condition of product in stock to detect deterioration? G NGCan you walk me through your inventory management system? G NGHow does the system optimize inventory turns over time and assure stock rotation?

G NGHow is obsolete product controlled to prevent its unintended use or delivery? G NG(See 8.3) G NG

7.6 Control of monitoring and measuring devicesHow do you determine the measurements to be taken and the measuring equipment needed to demonstrate conformity with requirements? G NGWhat process is in place to ensure that measurements are taken per the requirements? G NGa) 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?

G NGb) What process is used to adjust or re-adjust measuring and test equipment when needed? G NGc) How are measuring tools identified to enable the calibration status to be determined? G NGd) How do you safeguard measuring equipment from adjustments that would invalidate the measurement results? G NGe) How do you ensure that measuring its test equipment is protected from damage and deterioration during handling, maintenance and storage? G NGWhen equipment is found to be out of calibration, how do you assess and record the validity of the previous measuring results? G NGWhat actions do you take on the equipment and any product affected? G NGCan I see your records of the results of calibration and verification? G NGDo 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?

G NG

7.6.1 Measurement system analysisCan you show me R&R studies for each type of measuring and test equipment system referenced in the control plan? G NG(Or other statistical studies analyzing the variation in measurement & test results)

G NGDo the methods and acceptance criteria conform to those in customer reference manuals on MSA or does the customer approve them? G NG

7.6.2 Calibration/verification recordsCan you show that calibration records include: G NG

- equipment identification, including the measurement standard against which the equipment is calibrated, G NG- revisions following engineering changes, G NG- any out-of-specification readings as received for calibration/verification, G NG- an assessment of the impact of out-of-specification condition, G NG- statements of conformity to specification after calibration/ verification, and G NG- notification to the customer if suspect product or material has been shipped?

G NG

7.6.3 Laboratory requirements7.6.3.1 Internal laboratory

Does Organization have an internal laboratory? G NGIf so, can you show me a documented laboratory scope including its capability to perform inspection, test, or calibration services? G NGWhere are laboratory technical requirements specified for G NG- adequacy of laboratory procedures, G NG- competency of the laboratory personnel, G NG- testing of the product, G NG- capability to perform these services correctly, traceable to the relevant process standard, and G NG- review of the related records? G NGHave these requirements been implemented? G NG

7.6.3.2 External laboratoryCan you show me laboratory scope(s) for external/commercial/independent laboratory facilities that include the capability to perform the required inspection, test or calibration? G NGCan I see evidence that each laboratory is either accredited, or is acceptable to the customer(s)? G NG

8.1 GeneralHow do you plan and implement measurement, analysis and improvement processes needed to demonstrate products conform to requirements? G NGHow do you plan and implement measurement, analysis and improvement processes needed to ensure conformity of the QMS? G NGHow do you plan and implement measurement, analysis and improvement processes needed to continually improve the effectiveness of the QMS? G NGHow do you determine what methods to use, including statistical techniques? How do you determine the extent of their use? G NG

8.1.1 Identification of statistical toolsHave appropriate statistical tools for each process been determined and included in the control plan? (see 7.5.1.1) G NG

8.1.2 Knowledge of basic statistical conceptsHow does Organization ensure that basic statistical concepts are understood and utilized throughout the organization? (verify throughout audit) G NG

8.2 Monitoring and measurement8.2.1 Customer satisfaction

How do you obtain information about customer perception as to whether Organization has met customer requirements? G NGHow is this information used? G NG

8.2.1.1 Customer satisfaction SupplementalWhat realization process performance indicators are used to monitor customer satisfaction? G NGDo they include at least: G NG- delivered part quality performance, G NG- customer disruptions including field returns, G NG- delivery schedule performance (including incidents of premium freight), and G NG- customer notifications related to quality or delivery issues? G NGHow do you monitor manufacturing processes to demonstrate compliance with customer requirements for product quality and process efficiency? G NG

8.2.2 Internal auditAre 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) G NGDo they determine whether the QMS is effectively implemented and maintained? (Review records) G NGCan 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? G NGWhere are the audit criteria, scope, frequency and methods defined? G NGCan you demonstrate that selection of auditors and the conduct of audits are objective and impartial, and that auditors dont audit their own work? G NGCan you show me your internal audit procedure? G NGCan you show me the records of internal QMS audits? G NGWho 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)

G NGWhat activities are done to verify the actions taken, and how are the verification results reported? G NG

8.2.2.1 Quality management system auditDo you have audit records showing that the entire QMS is being audited? G NG

8.2.2.2 Manufacturing process auditDo you have records showing that each manufacturing process is being audited to determine its effectiveness? G NG

8.2.2.3 Product auditAre there records showing that products are being audited at appropriate stages of production and delivery? G NGDo the audits verify conformity to all specified requirements? G NG

8.2.2.4 Internal audit plansCan you show me an annual audit plan? G NGDoes it show that audits cover all QMS processes, activities and shifts? G NGIs there evidence that audit frequency is increased due to nonconformances or customer complaints? G NGAre specific checklists used for each audit? G NG

8.2.2.5 Internal auditor qualificationHow do you determine competence of internal auditors to audit the requirements of TS 16949? (See 6.2.2.2 also customer specific requirements).

G NG

8.2.3 Monitoring and measurement of processesWhat methods are used to monitor and measure the QMS processes? G NGCan you show that they have achieved the desired results? G NGWhen the desired results are not achieved, what actions are taken to ensure that the product meets requirements? G NG

8.2.3.1 Monitoring and measurement of manufacturing processesCan you show me process studies that have been performed on new manufacturing processes? G NGCan you show examples of results of process studies being documented with specifications? Are they used for instructions? G NGDo the documents include objectives for manufacturing process capability, reliability, maintainability, availability, and acceptance criteria? G NGDo records show that manufacturing process capability or original customer-approved performance is being maintained? G NGMay I have a copy of the process flow diagram and control plan for (mfg. process ) to review the production line with? G NG(Review for adherence to specified requirements) G NGCan yo

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