EXTERNAL PROVIDER QUALITY ASSURANCE MANUAL
DENSO TEN AMERICA LimitedEXTERNAL PROVIDERQUALITY ASSURANCEMANUALT-QA029 Rev. IApril 2018EPQAM Approval,CreatedCheckedApproved – QAApproved - PurchasingJorge Di CostanzoManager- SQEKheng LeeManager- QMSPaul V. PompiliusV.P.- QualityTamerlane LattaoSr. Manager- Purchasing
DENSO TEN AMERICA LimitedTABLE OF CONTENTSFOREWORD31 INTRODUCTION4DO8 OPERATION161.1 Purpose8.1 Change Control Engineer and Process Changes1.2 Scope8.2 Traceability1.3 TNAM Quality Policy8.3 Production Part Approval Process1.4 Certification Requirements8.4 Special Characteristics1.5 Distribution8.5 Parts that require special controls2 NORMATIVE REFERENCE78.6 Special Labeling for Stratification / Identification3 TNAM TERMS, DEFINITIONS, ACRONYMS78.7 Notification Of Non-Conformance, Control ofNon-Conformance, Rework, DeviationPLAN8.8 Substances Of Concern4 CONTEXT OF THE ORGANIZATION94.1 SWOT ANALYSIS.- Strengths WeaknessesOpportunities Threats8.9 Appearance items, Limit Samples, and Mating Parts8.10 Advance Product Quality Planning5 LEADERSHIP95.1 Customer Focus8.11 Outsourced Process8.12 Directed Provided PartsCHECK5.2 Quality Policy and Goals5.3 Cost Recovery – Compliance vs. Non-Compliance9. - PERFORMANCE EVALUATION5.4 𝐞𝟑9.1 External Providers Report Card5.5 TNAM Audits9.2 Customer Satisfaction6 PLANNING10 IMPROVEMENT6.2 Preventive Actions and Risk Analysis7 SUPPORTACT146.1 Project Management – 4M Gantt Chart272810.1 Problem Solving Flow1510.2 Containment and New Business Hold Process7.1 6S, Resources – 4M10.3 Corrective and Preventive Action Request7.2 Competence10.4 Field Quality10.5 Continual ImprovementCONFIDENTIALDo not reproduceEPQAM T-QA029 Rev. I2 3 2
DENSO TEN AMERICA LimitedFOREWORDThe Specific Requirements outlined in this manual are in addition to requirements communicated by documented information, suchas drawings, specifications, contracts, and TNAM’s Customer Pass Through requirements – as detailed by TNAM QAThis revision of TNAM's External Provider Specific Requirements Manual, T-QA029, is based on the standard IATF 16949. The purposeof the new structure is to provide a clear presentation of the requirements. This revision “I” of the manual cancels and replacesrevision “H.”Confidentiality agreement between TNAM and the External Provider applies for this manual and all Quality related informationexchanged at any given time. This manual is the property of TNAM; it must not be reproduced in whole or in part without prior writtenconsent from TNAM.In order to facilitate the review of the manual, we have implemented the use of the following highlights,Highlights for key informationCONFIDENTIALDo not reproduceEPQAM T-QA029 Rev. I3 3 2
DENSO TEN AMERICA Limited1INTRODUCTIONAt TNAM we understand the importance and value of having open and clear communication with our External Providers1.1 PURPOSETNAM recognizes the importance of our External Providers, and treats them as an extension of our business in our efforts to achievetotal customer satisfaction. External Providers must strive to achieve a “Zero Defects” goal and perform Value Analysis/ValueEngineering (VA/VE) activities on products and processes. Continuousimprovement efforts and compliance to requirements will assure anExternal Provider’s preferred status.This manual represents a compilation of quality assurance (QA) activitiesand specific requirements from TNAM. External Providers must adhere tothese requirements.The purpose of this manual includes but it is not limited to the following, To provide guidance to compliance requirements, To communicate TNAM’s minimum Quality Assurancerequirements and expectations, To assure, maintain, and raise the quality level of the deliveredgoods or services, To provide for continual improvement, defect prevention and riskmitigation, To facilitate waste reduction.1.2 SCOPEThis manual should be applied for both the Production Preparation and Mass Production stages.This External Provider Quality Assurance Manual is applicable for North American procured External Providers of products, processes,and services that affect customer requirements.1.3 TNAM QUALITY POLICYOur Quality Policy: Total Customer satisfactionWe will provide products and services that meet or exceed quality, performance, and delivery requirements by demonstratingleadership necessary to achieve total customer satisfaction. Continual ImprovementWe will continually improve the quality of our products and the effectiveness of our quality management system and processesbased on objective measurements and risk management. World Class Quality SystemWe will comply with IATF 16949 and Customer Specific Requirements, including applicable statutory and regulatory requirements.CONFIDENTIALDo not reproduceEPQAM T-QA029 Rev. I4 3 2
DENSO TEN AMERICA Limited1.4 CERTIFICATION REQUIREMENTSCompliance to IATF 16949 standard is required as per IATF scheme timingTNAM requires External Providers to develop fundamental quality systems that cover for the expectations listed on this manual andprovide for continuous improvement and emphasizes defect prevention while reducing variation and waste.TNAM External Providers shall be IATF 16949 certified per the standard, or have a plan in place to achieve certification. At a minimum,External Providers shall be ISO 9001 certified by an accredited third-party certification body in addition to meeting the MinimumAutomotive Quality Management System Requirements (MAQMSR). Waiver to these requirements has to be in writing and approvedby TNAM Purchasing and Quality Management.Per IATF 16949, External Providers can follow the QMS development sequence depicted in the following image,However, External Providers that are distributors, trading, forwarding company, or sales offices, shall obtain ISO 9001 MAQMSR orIATF 16949 certification from the manufacturer as per TNAM requirements. TNAM may request to verify the manufacturer’s QMScertificate.CONFIDENTIALDo not reproduceEPQAM T-QA029 Rev. I5 3 2
DENSO TEN AMERICA LimitedTNAM’s Tier 1 External Providers are responsible to assure tier 2 and after providers have Quality Management systems that meet therequirements of this quality manual.In the given case the External Provider is ISO 9001 certified only, it must also comply with the Sub-Tier Requirements listed below,1.2.3.4.5.6.7.8.9.Control PlansProcess ApproachPerformance Evaluation- Customer Satisfaction, Sub-tier providers, and Problem SolvingInternal AuditingControl of non-conforming ProductCore Tools (SPC, FMEA, MSA, APQP, PPAP) Implemented per TNAM expectationsManagement ResponsibilityDetermination and documentation of Special Characteristics and Pass Through CharacteristicsAIAG Special Process Assessment – as applicable (discuss with TNAM SQE in a case-by-case basis)a) AIAG CQI-8: Layered Process Audit Guidelineb) AIAG CQI-9 Special Process: Heat Treat System Assessmentc) AIAG CQI-11 Special Process: Plating System Assessmentd) AIAG CQI-12 Special Process: Coating System Assessmente) AIAG CQI-14: Consumer-Centric Warranty Managementf) AIAG CQI-15 Special Process: Welding System Assessmentg) AIAG CQI-16: Guidance Manualh) AIAG CQI-17 Special Process: Soldering System Assessmenti) AIAG CQI-18: Effective Error Proofingj) AIAG CQI-19: Sub-Tier Supplier Management Guidelinek) AIAG CQI-20: Effective Problem Solving Practitioner Guidel) AIAG CQI-21: Effective Problem Solving Leader Guidem) AIAG CQI-22: The Cost of Poor Quality Guiden) AIAG CQI-23 Special Process: Molding System AssessmentNOTE: consult with TNAM SQE and AIAG site for the latest version and applicable documents1.5 DISTRIBUTIONThe official controlled copy of this manual is the digitally signed PDF document and visible to all authorized users. All printed copies areconsidered uncontrolled copies used for reference only. The manual will be distributed/posted by TNAM when there is a revision, orwhenever an External Provider requests a copy. The External Provider is responsible as follows,oooObsolete revisions are disposed,Establish an area to have it readily available for further consultation within your company,A permanent management level position must be designated to be responsible for comprehension, deployment and ongoinginternal training of TNAM's requirements.Should you have any questions about the Manual, please contact TNAM’s Quality group.CONFIDENTIALDo not reproduceEPQAM T-QA029 Rev. I6 3 2
DENSO TEN AMERICA Limited2 NORMATIVE REFERENCEThe latest edition of IATF 16949, Automotive Quality Management System Standard,AIAG related Standards and Supporting booklets,3 TNAM SPECIFIC TERMS, DEFINITIONS AND ACRONYMSSee IATF 16949 requirements for industry definitions4MRefers to process inputs; Man, Machine, Method, Materials6SIt consists of the following steps, Sorting, Straighten/Shifting (set in order), Shine / Sweeping, Standardize, Sustain, and SafetyAMC“Affiliated Manufacturing Company”, refers to DTEN manufacturing locations throughout the world, such as TNMX, TNTH, TNPH, etc.CNF“Cause Not Found”, refers to situations where the phenomenon can be confirmed but the cause cannot be identifiedCPAR - SCAPAR“Corrective and Preventive Action Request.” “Supplier Corrective and Preventive Action Request.”Customer Pass Through RequirementsRequirements specified by TNAM’s customers that are applicable to lower tier providers. Such as AIAG CQI requirements. ConsultTNAM Quality contacts for details on applicability.Direct Provide PartsWhen specified by DTEN, the External Provider shall purchase products, materials, or services from DTEN-directed sources.𝐞𝟑“Educate, Enforce, Escalate”, is a structured system developed by TNAM Quality to support our External Providers in effectivelycomplying to the requirements on this manualEPRC“External Provider Report Card”TNMXDENSO TEN MEXICO, S.A. DE C.V.IPO“International Procurement Office”, refers to DTEN Purchasing locations throughout the world, such as TNSG, TNTT, TNJP, etc.IPQM“Initial Production Quality Management”, DTEN’s equivalent to Advanced Product Quality PlanningIPR“Initial Production Part Report”, it is a format used by Incoming Inspection section to document initial details on an anomaly identifiedon production parts.CONFIDENTIALDo not reproduceEPQAM T-QA029 Rev. I7 3 2
DENSO TEN AMERICA LimitedMAQMSR“Minimum Automotive Quality Management System Requirements”, refers to requirements that complement an ISO 9001certification for Automotive intended products or servicesNONC“Notification of Nonconformance Shipment”, it is used by the External Provider to notify TNAM in the event that nonconformingproduct has been shipped.NTF“No Trouble Found”, refers to a phenomenon that was reported seen but cannot be duplicated by the analysis/confirmation entityPTC“Pass Through Characteristics” are functional components characteristics that are not used by TNAM “tear1” during the process butthey are used by TNAM customers “OEM”, so if there are quality issues from the External Provider “tear2”, they will only be detectedon the OEM. The External Provider owns the final check on these characteristics“Poka Yoke” from the Japanese Poka mistake, Yoke prevention Mistake proofing device or method to mitigate the risk of causing or letting escape potential defects. There are various levels of PokaYokes, depending on the level of assuranceQCD“Quality, Cost, Delivery”Special Controls PartThis classification is assigned by DTEN to parts that can lead to important or large-volume of defects, and therefore require specialmanagementCONFIDENTIALDo not reproduceEPQAM T-QA029 Rev. I8 3 2
DENSO TEN AMERICA Limited4 CONTEXT OF THE ORGANIZATION4.1 SWOT ANALYSIS.- STRENGTHS WEAKNESSES OPPORTUNITIES THREATSTNAM recommends External Providers to be aware of their Strengths, Weaknesses, Opportunities, Threats, and emerging technologiesin their fields. The purpose is twofold,1.2.To anticipate possible scenarios and prevent negative consequences that could have a ripple effect, andTo look for favorable conditions that can offer benefits i.e. Improved QCDTNAM Purchasing do the follow up on External Provider risk level and mitigation.5 LEADERSHIP5.1 CUSTOMER FOCUSTop management needs to be participative, actively engaged, involved and committed. Top management delegates authoritywithin the organization and ensures resources to achieve customer satisfaction.In order to ensure that TNAM requirements are met, top management shall communicate the escalation contact list, including rolesand responsibilities, of those in charge of leading key activities, including but not limited to the following,a)b)c)d)e)f)problem solving,preventive action implementation,capacity analysis,technical support,improvement activities, audits follow up, andTNAM report card follow upTo designate the contact personnel use the “Designation of External Provider Representative form - FM529.” Please identify arepresentative for all shifts. Notify TNAM of any changes within 5 working days.The External Provider shall secure the appropriate resources -personnel and equipment, to comply with communication language andformat as required by TNAM.5.2 QUALITY POLICY AND GOALSThe External Provider top management plays a key role in the development of the Quality Management System to ensure that thequality policy and quality goals are supportive of TNAM requirements.CONFIDENTIALDo not reproduceEPQAM T-QA029 Rev. I9 3 2
DENSO TEN AMERICA Limited5.3 COST RECOVERY – COST OF COMPLIANCE VS. COST OF NON-COMPLIANCE5.3.1 PurposeIt is wiser to invest into compliance and defect prevention than having to deal with the cost of non-conformances. As nonconformances trickle down the pipeline, the cost of dealing with them grows exponentially. TNAM encourages the External Providersto implement a QMS that has the right investment into compliance.5.3.2 PolicyExternal Providers can be held responsible for all costs associated with TNAM or TNAM’s customers receipts of defective material.Any defect situation requiring cost recovery will be communicated to you by TNAM Purchasing or Quality. Costs may include, but arenot limited to:ooooooooooooAdministrativeSorting of suspect materialReworkCustomer ChargesPremium FreightProduction DowntimeThird party containmentScrapPPAP DelaysOvertimeLaboratory TestingTravelCONFIDENTIALDo not reproduceEPQAM T-QA029 Rev. I10 3 2
DENSO TEN AMERICA Limited5.4 𝐞𝟑e3 is part of TNAM’s External Provider Management/Development activities. At TNAM we believe inooogood communication of expectations educateobjective feedback/evaluation enforceworking as a team focusing resources when the situations merits escalateThe goal is to have an effective External Provider Chain Management that results in a consistent supply delivered on time with therequired level of QualityCONFIDENTIALDo not reproduceEPQAM T-QA029 Rev. I11 3 2
DENSO TEN AMERICA Limited5.4.1 Educate1)By ensuring the External Provider has a thorough understanding of TNAM’s specific requirements. This is achieved bydocumenting and communicating2)TNAM SQE’s provide ongoing training. External Providers are encouraged to request training as they see it necessary.Trainings are available as needed.5.4.2 Enforce3)Enforcing refers to monitoring the results vs. targets. In 2nd quarter FY 2016, TNAM’s Performance Report is comprehensiveand visual. The intent is to provide guidance for Continuous Improvement. For details, look at the Performance Evaluationsection on this manual.5.4.3 Escalate4)TNAM has an escalation process that is applicable when the basic expectations are not met- Quality and Responsiveness.Escalation normally involves, 1) a development of an improvement plan, 2) Face to face leadership review, 3) 2nd partyaudits to the External Provider facilities𝒆𝟑 What does it mean to you our External Provider, what is the expected behavior?1.2.3.Trust and open communication sharing pertinent information,Cooperate in developing relationship, andLeadership to your quality, ensure resources needed to support QMS are available5.5 TNAM AUDITSThe External Provider is expected to periodically perform self-assessment internal audits using the TNAM Audit Survey or equivalentThe goal of the audits is to understand capabilities and identify continuous improvement opportunities. With prior notification TNAMndwill conduct 2 Party audits at External Providers and sub-tier facilities - manufacturing, design, and support,CONFIDENTIALDo not reproduceEPQAM T-QA029 Rev. I12 3 2
DENSO TEN AMERICA LimitedGenerally the audits take place as follows,1.2.Potential External Providers will be audited as part of TNAM sourcing process,Current External Providers may be audited for the following reasons,a) If there are ongoing quality problems,b) Launch of new parts – in such case, you may be required to provide a Master Planning Sheet and schedule of newproject milestonesc) Tool moves/relocation, or facilities layout changes. Tool moves to a different manufacturing facility may require aQuality System audit of the new facility. It is prohibited to move tools without prior notification and approval fromTNAM.d) QCD related initiativese) And others as required by TNAM QATNAM will send a Pre-assessment survey before any type of audit. The External Provider is to return the pre-assessment form prior toTNAM conducting the audit. Following the audit TNAM will forward our findings and any needed corrective actions. Results of theaudit will be used in the sourcing decision.CONFIDENTIALDo not reproduceEPQAM T-QA029 Rev. I13 3 2
DENSO TEN AMERICA Limited6 PLANNING6.1 PROJECT MANAGEMENT – 4M GANTT CHARTClosed loop communication, and PDCA Project Management are key to effectively preventing and resolving challenges.Top management involvement nominating and empowering/supporting a Leader for project management is fundamental for success.4M need to be part of the input for a PDCA project management, including but not limited to new parts launches, problem solvingprocess, and change management.6.2 PREVENTIVE ACTIONS AND RISK ANALYSISBy definition Preventive Action is an action to eliminate the cause of a potential nonconformity or other undesirable potentialsituation.Implementation of Preventive Actions is an essentialelement of an effective QMS. A systemic Risk AnalysisProcess will result in implementation of Preventive Actionsand consequently increased levels of CustomerSatisfaction.The External Provider shall use FMEA process as a basictool for prioritizing risk mitigation and implementation ofPreventive Actions.The External Provider is required to have evidence of riskanalysis activity from a 4M point of view.The figure is an aide in deciding how to go aboutprioritizing Preventive Actions, use this along with cost vs.benefit trade-offs.CONFIDENTIALDo not reproduceEPQAM T-QA029 Rev. I14 3 2
DENSO TEN AMERICA Limited7 SUPPORT7.1 6S, RESOURCES – 4M7.1.1 6S is the base of an efficient, safe, and error free organization. It mainly supports standardization and provides a highly visualwork place making problems obvious. It consists of the following steps, Sorting, Straighten/Shifting (set in order), Shine / Sweeping,Standardize, Sustain, and Safety. The External Provider shall have a 6S or similar program in place that achieves a professional workenvironment.7.1.2 4M resources shall be adequate to support all activities outlined in this manual. The manufacturing facility is to be organized in away that it optimizes the flow and use of floor space. Adhering to handling and visualization principles such as, 1) correct parts andidentification, 2) correct location, 3) correct quantity7.2 COMPETENCEThe External Provider shall evaluate the training system in terms of its effectiveness supporting compliance to TNAM requirementsThe External Provider shall have a training process applicable for all personnel performing activities affecting conformity torequirements. This process, as a minimum needs to contain the following evaluation,ensure resources needed to
a) AIAG CQI -8: Layered Process Audit Guideline b) AIAG CQI -9 Special Process: Heat Treat System Assessment c) AIAG CQI -11 Special Process: Plating System Assessment d) AIAG CQI -12 Special Process: Coating System Assessment e) AIAG
critical issues the University has established a Quality Assurance Directorate, which is mandated to develop a Quality Assurance Framework and a Quality Assurance Policy. The Quality Assurance Framework would clearly spell out the Principles, Guidelines and Procedures for implementing institutional quality assurance processes.
This quality assurance manual specifies the methods to prepare and submit Quality Assurance Process Design Diagram for products and parts to be supplied to NSK by suppliers. 2. Purpose Each supplier should prepare quality assurance process design diagram clearly showing the quality assurance methods used in each products and parts production .
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Software Quality Assurance Plan (SQAP) for the SRR-CWDA-2010-00080 H-Area Tank Farm (HTF) Performance Revision 0 Assessment (PA) Probabilistic Model August 2010 Page 5 of 15 1.0 SCOPE This Software Quality Assurance Plan (SQAP) was developed in accordance with the 1Q Quality Assurance Manual, Quality Assurance Procedure (QAP) 20-1, Rev. 11.
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Quality Assurance Representative. The Site Manager will appoint a member of the Project Office to control all Quality Assurance issues including - Assisting the Site Manager to co-ordinate and develop the Quality Assurance Plan. Advise Engineers, General Foremen, Foremen and Chargehands in all matters of Quality Assurance.
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The NELAC Manual was used to insure the Quality Assurance Manual more fully addressed the issues that regulators and clients would be looking for in our Quality Assurance Manual and to anticipate possibly getting accredited under NELAC in the near future. Revision 9.1 (January 28, 2004) The Quality Assurance Manual underwent the annual review.
