:/QMS (e.g. ISO 9001/9004:2000 , QS-9000 , ISO/IEC 17025 , ISO/TS 16949) & (Conceptual Application & Assessor Handbook)

Presented by Rock Chang Country Manager Underwriters Laboratories Inc. (Taiwan) Issued: May 28, 2001 Revised: October 15, 2002 ()

Course Objectives

( Knowledge Management) / (Knowledge Representation): (Implicit Knowledge) (Explicit Knowledge) , (Knowledge Sharing)!

: (e.g. ISO &) (e.g.)

:()

ISO/TS 16949:2002 6.2.2.4 :Employee motivation and empowerment (/)The organization shall have a process to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment to promote innovation. The process shall include the promotion of quality and technological awareness throughout the whole organization. ( , , , )

Data (8.4) Information Knowledge (is power):ISO 9004:2000 Management should treat data ( 8.4 Analysis of data) as a fundamental resource for conversion to information and the continual development of an organizations knowledge , which is essential for making factual decisions(7th Quality Management Principle -- Factual approach to decision making /Management by (quality) Objective /CI/CA/PA) and can stimulate innovation(e.g. 7.3 Design & Development)

: ( i.e. ) , ( i.e. Innovalue )

?( Input) ( Output): Process approach! Learning Organization (Organizational Learning) Double-loop Learning: Tactical (Operational), Strategic Feedback & Learning!e.g. CAR, ECN, SWOT, FMEA, BSC

ISO 9001:2000? ?

() (Small Businesses) (ISO 9001: 1994) (ISO 9001:1994 ) 199420: ISO 9001:1994auditor-friendly (easy to audit but difficult for org.)vs. ISO 9001:2000 organization-friendly ISO 14001 (QMS) (Business Processes) : ISO 9001 focuses on how to manage a business to achieve planned/desired results (i.e. effectiveness), not on individual clauses vs. 20: The supplier shall.

QS-9000 (Emphasis on Top Management ): 5/ (Emphasis on Corporate Registration/Certification): cost & QMS effective! ULincome! Beyond certification towards performance improvement.

New structure of the standards should not oblige organizations to change their system documentation to match the structure of the standards.System documentation is unique to each organization.Requirements from the old ISO 9001:1994 have been either:Maintained (Example-purchasing)Simplified (Example-calibration)Eliminated (Example-documentation)Structure changes

Features of ISO 9001:2000Most requirements come from either:8 Quality Management Principles1994 version of ISO 9001ISO 14001:1996QS-9000 (Automotive industry)

Single requirements standard (no more ISO 9002/3) Need for clear scope statementsClause 1.2 Application (ISO/TC 176 Guidance Document + IAF Communique)Special significance of Design & DevelopmentProcess approach and PDCAComparison (Maybe a little unfair on ISO 9001:1994!)ISO 9001:1994 Documented procedures evidenced by recordsISO 9001:2000 Defined and managed processes evidenced by results

ISO 9001:2000 (AssessmentPhilosophy) ? : , , , , , ,

:Procedure (ISO 9000:2000 3.4.5)Specified way to carry out an activity or a process NOTE 1 procedures can be documented or not.NOTE 2 When a procedure is documented, the term written procedure or documented procedure is frequently used. The document that contains a procedure can be called a procedure document.

: ! QMS driven by quality policy, quality objectives and continuous improvement targets (, !)

TL 9000 4.1.1 Quality Objectives -- Objectives for quality shall include targets for the TL 9000 metrics defined in the TL 9000 Quality System Metrics handbook.

: QMS Quality Management System ()

QMS (Business Processes) .::, AR (Action Request) The practice of .is not documented in procedure ! Flexible Requirements: !* Assessors (intent) / (approaches/ways)* DOES NOT mean assessors will accept less objective evidence of compliance ( assessors!)

Assessors () (QMS) (effectiveness).

- ISO 9001: 2000 4 (processes) (Business Processes) .* Assessors (Business Systems) (Business Processes), (Quality Objectives) (Business Objectives) . e.g. QMS () 9 () QMS ERP/SCM/CRM (/JITe/M/IT)e/M

* ISO 9001:2000 process (sub- clause process) 4 processes (5~8)

(eight quality mgmt principles)Top mgmt (improved performance):Customer focus (//): e.g. : maybe () (process out)community () Clause 5.2 - Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction.

Remarks: Top Mgmt/Top Mgmt(ensuredelegation)process7.2 Customer-related process7.2.3 Customer communication8.2.1 Customer satisfactione.g. Customer-in

Leadership (/):e.g. clause 5Top Mgmt Involvement. 5.1 Mgmt commitment: Org cant hire a consultant to write a procedure for (top) mgmt commitment!3. Involvement of people ()TL 9000 4.1.1.C.1 Mgmt with executive responsibility should demonstrate their active involvement in long- and short-term quality planning.QS-9000 APQPMgmt Support.QMSQA

4. Process approach (): e.g. e/M(Mobilize: M Commerce) C.I.ISO 9001: 2000ISO ( i.e.)ISO()

5. System approach to mgmt ( interrelated processes): e.g. 4 processes (mgmt, resource, production/service-provision, MAI) & linkagescreate synergy() & integration() the whole exceeds the sum of the parts. functional & departmental barriers/silos/boundaries (via communication..):()! GEs Boundaryless ()!6. Continual improvement ():Good-Better-BestBetter(Q) -Cheaper(C)- Faster(D)7. Factual approach to decision making (/): Clause 8e.g. A saying: If you cant measure it, you cant manage it ! (!)e.g. Piles and piles of records gathered but sit there to collect dust.

8. Mutually beneficial supplier relationships (): !Not strongly incorporated in ISO 9001:2000, but in ISO 9004:2000. inter-departments/internal customers: breaking the barriers between departments.(!) e.g. (Synergy): 1+1 2 ? What if /? (a story: interviewee interviewer:?!) ISO 9000

: 3(Customer focus, Leadership & Involvement of people)soft requirements (harder to audit!)* 21TS 16949:2002 NOTE The knowledge and use of the eight quality management principles referred to in ISO 9000:2000 and ISO 9004:2000 should be demonstrated and cascaded through the organization by top management. ISO 9000:2000ISO 9004:2000

FAQ: ISO 9001:1994ISO 9001:2000: a)QMS (e.g. High-tech Industry)/& process.

b) (Process Focus) ISO 9001:19942020(Business Processes)clause 4.1: (the organization must start managing its processes) a).Remarks: ISO 9001:1994QMS20/(many ISO 9001:1994 compliant systems were actually a loose collection of 20 semirelated activities rather than a systematic approach to management.)

ISO 9001:2000ISO 90011994ISO 9001, ISO 9002 & ISO 90037.3 Design and Development ()(exclusion)Exclusion () of ISO 9001:2000 requirementsNot Applicable due to the nature of an organization and its product: (nature) ISO 9001:2000 (exclusion)Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to reqmts within clause 7, and such exclusions do not affect the organizations ability, or responsibility, to provide product that meets customer and applicable regulatory reqmts.

(exclusions) 7 (clause 7) : Product Realization (ability) (responsibility). QS-9000 .

(Exclusions) : 7.3 Design and Development :

(Major AR if QM addresses N/A for.)

7.5.2 Validation of Processes (Special Processes) ()7.5.3 Identification and Traceability

clausepartially applicable Identificationapplicable ()Traceability7.5.4 Customer Property (IP: Intellectual Property) QMS(Minor AR if QM addresses N/A for)7.6 Use of Measuring and Monitoring Devices (, but how aboutxx?)

Where the overall responsibility for product realization belongs to an organization, process outsourcing ( ) is not valid justification for exclusion: / (processes) (exclusions) (Appriopriate Controlitem H Stronger Purchasing Control)

Remarks: design ISO 9000 , ScopeThe Management of subcontracted (outsourced) XXX () design. The manufacture of XXX () Accredited ISO 9000 , Scope The design and manufacture of XXX ()

Regulatory/Customer Permission to exclude applicable requirements not valid justification.:

e.g. AISO 9002:1994risk classQMSISO 9001:2000 UpgradeA (the activity does affect its ability to meet customer requirements)A7.3 (Design and Development) QMS (Scope of Registration) (limited scope)

Design and Development IAF Guidance 2./(design responsible) (perform) / (design & development)/ () (outsource) 7.3 () (QMS) 7.3 ()

Design and developmentISO 9000:2000 definition (Clause 3.4.4)Set of processes that transforms requirements into specified characteristicsDistinguishing feature(Physical, sensory, behavioural,Temporal, ergonomic, functional)Need or expectation that is stated, generally implied or obligatory.

NOTE 1 the terms design and development are sometimes used synonymously and sometimes used to define different stages of the overall design and development process.e.g. software, developmentdesign

Customer/regulatory/product requirements:design input (//:) vs. product characteristics/specifications:design output(/:)

- () (product characteristics) (product specifications) (product realization processes) (customer and/or regulatory body requirements) (define) (product specifications)(product design and development)

- (Product Spec.) -Product Spec. () vs. Process Spec. () e.g. / The (design and) provision of electro-plating (painting)ISO/TS 16949:2002The only permitted exclusions for this Technical Specification relate to 7.3 where the organization is not responsible for product design and development.Permitted exclusions do not include manufacturing process design. ()

:i) (design and development) (product) service () e.g. ISO 9002

: Yes, , , ,

No, meaning ( Service product) ISO 9001: 1994 4.4

ii) (design and development process) (outsource)ISO 9001:2000clause 4.1 where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the QMS.

iii) QMS/iv) clause 7.3 (Design and Development) (subclauses) clause 7.3e.g.OEM: Original Equipment Manufacturer ()ODM: Original Design Manufacturer () EMS: Electronics Manufacturing Service (/):

v) QS-9000 4.4A supplier is defined as design-responsible if it has the authority to esbablish a new, or change an existing product specification for any product shipped to a customer. Customer approval of a design responsible suppliers product does not waive the suppliers design responsible status.: (authority) () (design responsible) () (a design responsible suppliers product)

FAQ: (R&D) , ULSPT-1 SPT-2(UL 62) , ISO 9001:20007.3() ? If not, , !?Ans: 1. R&D , product characteristics(distinguishing features)/product specs (design output)? UL62 safety requirements (design input) , non-safety requirements(e.g. )! /UL (customer/UL safety requirements:design input) (define) / (product characteristics/specs:design outpout) 7.3 () !

2. , 7.3.3Design and development outputs:The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release. Design and development outputs shalla) meet the input requirements for design and developments,b) provide appropriate information for purchasing, production and for service provision,c) contain or reference product acceptance criteria, andd) specify the characteristics of the product that are essential for its safe and proper use. design outputs? / 7.3!

Product specification(design output): /:()// Product specifications (design output)design input customer/product/regulatory requirements!

3.: () 7.3 /(Design Records), i.e. Design Inputs(7.3.2), Design Review(7.3.4), Design Verification(7.3.5), Design Validation(7.3.6)Design Changes(7.3.7) , ,

4. 7.3auditor , () , /

(Registrars) ISO 9002 Applicable design interfaces to be assessed at plant level OEM vs. Remote Design Center

Remarks: Assessing interfaces starts with determining responsibilities and the communication channels between the locations. Assess the inputs/outputs using the process approach.

Activities (Steps) vs. Process () vs. Process Approach (/) :

3 puts : Input -Throughput/Activities- Output Set of interrelated or interacting ACTIVITIES (steps) which transforms inputs into outputs. ()

A PROCESS is any set of associated ACTIVITIES (steps) having inputs and generating outputs. ( , process)

For an organization to function effectively and efficiently, it has to identify and manage numerous linked activities. An activity using resources, and managed in order to enable the transformation of inputs into outputs, is considered as a process. Often the output from one process directly forms the input to the next. ( , , , , )

The application of a system of processes within an organization, together with the identification and interactions and managing of these processes can be referred to as the process approach. , / ? , , , /

An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as their combination and interaction. , ,

When used within a QMS, such an approach emphasizes the importance of Understanding and fulfilling the requirements,The need to consider processes in terms of added value,Obtaining results of process performance and effectiveness, andContinual improvement of processes based on objective measurement. , : (), , / ,

PROCESS(Set of interrelated or interacting activities)INPUTOUTPUTMONITORING AND MEASUREMENT OPPORTUNITIES (Before, during and after the process)PRODUCT (Result of a process)PROCEDURE (Specified way to carry out an activity or a process may be documented or not)EFFECTIVENESS OF PROCESS = ABILITY TO ACHIEVE DESIRED RESULTS (Focus of ISO 9001:2000)EFFICIENCY OF PROCESS=Results acieved vs resources used (Focus of ISO 9004:2000)(Includes Resources)Focus of TS-2: Effectiveness+Efficiency

PDCA/PDSA (Plan-Do-Check-Act Plan-Do-Study-Act: ---): Process approach PDCA/:* Define the work (Plan )* Execute the work (Do )* Measure the results (Check )* Identify improvements (Act ): CI , CA & PA ISO 9001:2000 Plan Act, (e.g. SPC/Control Charts, FMEA : Nice chart, but no action s (statistics)PC (Process Control) Useless!)

The objective w/o method is useless

Better (Q)Cheaper (C)Faster (D)

Monitor and measure processes and product against policies, objective and requirements for the product and report the results.Check:

PDCA vs. Process Approach/InteractionExisting process: PDCAC

PROCESS CONTROL SYSTEM MODEL WITH FEEDBACKTHE WAY WE WORK/ BLENDING OF RESOURCESSTATISTICAL METHODSVOICE OF THE PROCESSMENMACHINESMATERIALS METHODSENVIRONMENTVOICE OF CUSTOMERSCUSTOMERSIDENTIFYING CHANGING NEEDS AND EXPECTATIONS INPUTS PROCESS/SYSTEM OUTPUTSPRODUCTS OR SERVICES

8. Measurement, Analysis and Improvement ProcessesExamples:Processes to demonstrate:Conformity of productConformity of management systemContinual improvement5. TOP Management ProcessesExamples:Process to define quality policy and objectivesCommunication processManagement review6. Resource Management ProcessesExamples:Determination and provision of resourcesHuman resourcesInfrastructure definitionWork environment definition7. Product Realization ProcessesExamples: PlanningCustomer related processesDesign & development processPurchasing processProduction & service provisionControl of monitoring and measuring devices(Fig 1)4.1 Quality Management System Processes

CorrectIdentify Core Processes (COPs)Needs & Expectations

ISO 9001: 2000 8.2.3 Monitoring and measurement of processes ()The organization shall apply suitable methods for monitoring and, where applicable, measurement of the QMS processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure conformity of the product. ( , , QMS// , , )

ISO 9004: 2000 8.2.2 Measurement and monitoring of processes ()The organization should identify measurement methods and should perform measurements to evaluate process performance. The organization should incorporate these measurements into processes and use the measurements in process management.

( , , , )

:If you cant measure it, you cant manage it ! (!) (i.e. missing measurements) (robust) (missing measurements) (Key Measurable/KPI) senior managementKPIs data : We cant measure what we want, so we have decided to want what we can measure! , GE Jack Welch:What you measure is what you get what you reward is what you get!

Measurements should be used for managing daily operations, for evaluation of the processes that may be suitable for small-step or ongoing continual improvements, as well as for breakthrough projects, according to the vision and strategic objectives of the organization.

( , , , ,/)

Measurements of process performance should cover the needs and expectations of interested parties in a balanced manner (e.g. BSC). Examples include

:

-capability, (, e.g. Cpk)-reaction time, (/)-cycle time or throughput e.g. (manufacturing cycle effectiveness, MCE)= (Processing Time) (Throughput Time)-measurable aspects of dependability, ()-yield, ()-First-pass yields ()

-the effectiveness and efficiency of the organizations people, ()-utilization of technologies, ()-waste reduction, and ()-cost allocation and reduction. ()Determine Process EffectivenessISO 9000:2000 3.2.14 defines effectiveness as Extent to which planned activities are realized and planned results achieved

In determining process effectiveness, the assessor should verify that the processes of the QMS result in:-Results of (specific) process audit-Internal Audit Results-Financial measures (e.g.failure costs.)-Self-assessment (internal audit)-Achievement of the quality policy and objectives (departmental/sectional goals)-Achievement of planned arrangements-Achievement of customer satisfaction (Internal Customer:user: those receiving the output of the process)-Achievement of continual improvement

ISO 9001:1994ULprocess approachaudit (APQPQuality Planning): linked/interacted/interrelated (/) :The revised ISO 9001:2000 standard now follows a process approach: Clause 7Product Realization Processes (e.g./)& Clauses 4, 5, 6 & 8 Associated Support Processes(e.g./)

():COP:Customer Oriented/Focused Process/Procedure():/

A)/ISO 9001:1994, clause 4.2--

(1). Intent/Adequacy of Procedures / ?

(2). Implementation or ?

(3). Effectiveness ? (ISO 9004 : 2000 QMSGuidelines for performance improvementsEfficiency Interested Parties : , , /, /, .)

B) /ISO 9001:2000, Clause 4.1

A process/plan/method/approach?Implemented?Effective/achievement of planned/desired results (outcome)?Continual improvement? process , e.g. ,

4.1 f The organization shall implement actions necessary to achieve planned results () and continual improvement of these processes ()

: CI ISO 9001:2000 , (process)Assessor(local)(centralized)CI

Effectiveness : Extent to which planned activities are realized and planned results achieved (Focus of ISO 9001:2000)

Efficiency : Relationship between the result achieved and the resources used (Focus of ISO 9004:2000)

Focus of TS-2: Effectiveness + Efficiency

* (a). Do what you write. ()(Common AR: The procedure does not reflect the current practice in that.)(b). Do what you say. () (c). Write what you do/say./

Be careful on (c) ISO 9001:2000

Auditor process mapping & flowchartingCompany procedureflowchartingpeople-friendly and simple to audit! :

(Procedure 12)Procedure owner: Routine requirements generated from system to (Form PR 001) (authorized signatory list: Form AS 001)

Request entered on system (purchasing system software instruction manual) Suitable supplier located (approved vendore list: Form 015)(supplier appraisal procedure: Procedure 15) Order reviewed

Order correctRequest returned to originatorSystem processing completed

Copy to supplierCopy to file

Input: BOMPR (Purchase Requisition )Stimulus()/ trigger()Activities: checkPRs/(list of authorized signatories: AS001)PRsPurchasing SystemAVL (-Form 015)follow-Procedure 15(PO)Purchasing System (check Purchasing System Software Instruction Manual)Output: PO (-Form PO001) copy (Warehousing)copy

effectively/efficiently/ ApproachProcess Approach/Sequence/Interaction (ISO 9001:2000 clauses 4.1b & 4.2.2c)/PDCAISO 9001:2000(Product Realization Process/core process interacted with support processes or other core processes)e.g. How to audit IQC Process/Activity/Function (clauses 7.4.3 & 8.2.4):-Implementation(D) (Note: Highly-qualified auditorAdequacy of Procedure, IQC Procedure/SOP/SIP, )

-Incoming Inspection is triggered by Material Receivers RequestInput (everything begins with some kind of stimulus) /Process Interaction-Critical Materials List (Input)samplecritical materials-IQC Inspectordemonstrate(Random) Sampling ()capable (accuracy & precision)gageby checking gages precision/resolution /and calibration record (bias/accuracy) against Specs/Drawing/Acceptance Criteria established. (One-man teamfocusing on calibration/support processlocal activities)-sample worst-case specificationgagecapability (clause 7.6)

-calibration range () cover usage range () - process/production pathauditorsamplegagespec. (worst-case spec.) (e.g. gage number, location, ) passauditorverifyaccuracy & precision (2-, or 3-man team)-Inspector (inspection data)? (clause 8.3)? Reject/Critical NCPfollow clause 8.5.2 Corrective Action by using e.g. Vendor CAR? (output) linkMaterial Warehousing (Process Interaction with Warehousing)?

(output) linkclause 7.4.1 Purchasing ProcessCriteria for selection, evaluation and re-evaluation shall be established (e.g. Vendor Rating) (Process Interaction with Purchasing)-Inspectoractivities (throughput) clause 6.2.2 Competence, Awareness and Training & Effectiveness-Auditor2~3(C)IQC procedure/plan/method to see if practices observed (D) match procedure descriptions or plan/method established (P) ()clause 8.2.3 (Monitoring & measurement of processes)Continual Improvement (): e.g. any changes to documents, designs or the way business is conducted? process , process (/)(A) ?

-Auditorsauditcompany-wide clauses e.g. clauses 4.2.2 (Quality Manual), 4.2.3 (Control of Documents), 4.2.4 (Control of Records) 5.1 (Mgmt Commitmenta. Communicating to the org. the importance of meeting customer reqmts), 5.3 (Quality Policy ), 5.4.1 (Quality Objectives), 5.5.1 (Responsibility and Authority), 5.5.3 (Internal Communication), 6.3 (Infrastructure), 6.4 (Work Environment), 7.5.3 (Identification and Traceability), 8.2.2 (Internal Audit), 8.2.3 (Monitoring and Measurement of Processes), 8.4 (Analysis of Data), 8.5.1 (Continual Improvement), 8.5.3 (Preventive Action).

- ,IQCQA , Purchasing IQC Processes, Process Interaction , !

UL/ Process Approach Corrective Action System? (Associated Supporting Process): ULinterviewedRegistrarAssessorCorrective Action CAR()

Show me CAR Tracking Log & /CARsCAR (e.g. critical NCPs, IQC reject vendor CAR/)? (Input/Process Interaction with 8.3 Control of NCP)SampleCARsroot-cause identificationcorrective action(s) recommended ()(throughput) If /Action taken was tested to be effectiveleads to output/Process Interaction.trigger

-- Pattern/trend of CARs Preventive Action/ Mgmt by (Quality) Objective /C.I. Target (output/process interaction with 8.4 Analysis of Data/8.5.3 PA/5.4.1 Quality Objectives/8.5.1 C.I.)- (throughput)2~3& .Remarks: Business Processesprocess interactions are normally occurred via the usage of forms/. e.g. CFT meeting minutes)/ triggers CAR CAR triggers ECNCAR triggers FMEA review & updateCAR triggers increasing internal audit frequencyPattern of CARs triggers PAtrigger

ISO 9001: 20004.1 General requirementsThe organization shallidentify the processes needed for the quality management system and their application throughout the organization ,determine the sequence and interaction of these processes, .4.2.2 Quality manual .c) A description of the interaction between the processes of the quality management system.

ISO 9001:2000 Agenda () :

Process-based , Clause-based

Ensure the availability of top management:Must UL request that all members of Top Management be available for the audit?

It is highly recommended but not required that all members of Top Management be available for the audit. The new standard has placed considerable emphasis on the role of Top Management, and it is in the clients best interest to have as many members of Top Management present during the audit as possible.

Auditor Quality Manuala description of the interaction between the processes of the QMS // (via phone call) user-friendlyagenda.

FAQ: the interaction between the processes of the QMS() process interactions?Ans: No! (see 4.2.2 c & 4.1 NOTE 4 processes)&

: org.business? Processes/process sequence & interaction? audit !

:

Process sequence/interaction:

Process-based agenda:

Tentative Agenda Date TimePath 1Path 2Path 39/24/0109:00 Opening Meeting 09:20 Plant Tour 09:40 12:00 Lunch 13:00--Continue-- , --Continue-- 17:30 Daily Briefing

09/25/0109:00 --Continue--

12:00 Lunch 13:00 --Continue----Continue--

17:30 Daily Briefing 19:40-21:00( Night Shift)

09/26/0109:00/ 13:00--Continue-- 17:30 Daily Briefing

09/26/0109:00--Continue-- --Continue-- --Continue-- 12:00 Lunch 13:00 Report Writing 15:00 Closing Meeting

10/02/0109:00(Off-site in Taipei) 13:00--Continue-- 17:30 Daily Briefing

(Auditability) of ISO 9001:2000 prescriptive/traceable/ verifiable/specific requirements, e.g. clause 8.2.2 Internal audit () requirements:A documented procedure.Auditing at planned intervals.Audit planning based on status and importance.Reporting of results.Maintaining of records.Taking Action on detected nonconformities & their causes.Verifying of actions.Reporting of verification results.

prescriptive clauses/requirements ( i.e. hard clauses/requirements)Auditabilityopen-ended interview questioning technique: Show me the document, record, procedure, plan, schedule, material or activity. , / /Process Approach / PDCANonprescriptive or less prescriptive (soft clauses/ requirements) Auditability : e.g. 6.3 Infrastructure, 6.4 Work Environment & 7.5.5 Preservation of product: The organization shall preserve the conformity of product during internal processing and delivery to the intended destinationprocedure, schedule, inspection, plan, method or record

NonprescriptivegeneralAuditorAuditee (auditor): Auditor (looking for a needle in a haystack)AuditorAuditee: Show me why there is no needle in the haystack!by /Process Approach / PDCAAuditoropen-ended questions:Is there a plan or method (or process) for conforming to the requirements? What is it? Has it been established?(planmethodprocess)

Has it been implemented (deployed)? (/plan, method/process?)Have planned results (outcomes) been achieved? (/)Is there improvement? Has the system/ process been changed? ( System/process)*/ Process Approach / PDCA (), Auditor!

* AR/: e.g.:No assurance (process/system in place) that ..as evidenced by (/) There was no objective evidence to indicate that .() The procedure does not reflect the current practice in that.()

* AR , , , ARauditee e.g. Those famous last words like as appropriate, as applicable, where appropriate, as practicable, and appropriate indicated in ISO 9001:2000 requirements, Clauses 7.3.6/7.3.7/7.4.2/ 7.5.1. self-developed sampling plan without statistical validity, MIL-STD-105E (AQL), assessors The sampling plan used by .is not statistically valid ()

6.3 InfrastructureThe organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicableBuildings, workspace and associated utilities,Process equipment (both hardware and software), and Supporting services (such as transport or communication).

Assessoradversely affect conformity to product requirements/unable to achieve conformity to product requirementsCorrective Action Plan/ARcompany managementidentify the root cause of the ARlack of infrastructurexx/xxxARconsultantWhere to assess: 1. APQP (Planning of Product Realization) 2. Management Review 3. Business Planning 4. Internal Audit 5. Customer Complaint Handling / Customer Satisfaction..

6.4 Work Environment: The organization shall determine and manage the work environment needed to achieve conformity to product requirements.

Assessors , AR ? (!assessoradversely affect conformity to product requirementsCA Plan)

ISO 9004:2000 6.4 Work Environment (, intent)Management should ensure that the work environment has a positive influence on motivation , satisfaction and performance of people in order to enhance the performance of the organization. Creation of a suitable work environment, as a combination of human and physical factors, should include consideration of -creative work methods and opportunities for greater involvement to realize the potential of people in the organization.-safety rules and guidance, including the use of protective equipment,-ergonomics (),

-workplace location,-social interaction,-facilities for people in the organization,-heat, humidity, light, airflow, and-hygiene, cleanliness, noise, vibration and pollution. 6.4 Work Environment: ISO 9001:2000(Health & Safety):Health and safety regulations should be considered to the extent that they impact the conformity and quality of an organizations product/service. e.g. For a sausage maker, does cutting finger affect product quality ? OHSISO 9001 ?

: assessors adversely affect quality and/or delivery, or customers are dissatisfied corrective action plan, AR! AR/(: CI/CA/PAAR !)

Process approachPDCA(plan, do, check & act)1(P)(D) (C)(A) 2(P) FQC(DC) (A)

Automotive Value-Added Assessment vs. CSPM-driven Audit PlanningBest Practice #Auto 1: Effective Automotive Sector Auditing - Using Customer Satisfaction Performance Metrics to Guide On-site Audit Focus.It was important that the OEMs see an improvement in supplier performance - and that the supplier performance metrics should be a first item on any audit. If these were beneath expectations, they should be used as a guide for auditing potentially non-conforming systems. Auditors should look at each OEMs metrics relevant to a site (not just one chosen for contract review) at every audit event.

Output matters - use Customer Satisfaction Performance Metrics, CSPM, as an indicator of QMS effectiveness and implementation; Request current CSPM before the audit, perhaps in the audit plan;Review the CSPM as the first item of the audit;Include a notice to the client of the flexibility of the auditor to change the audit track or timing based on the results of the initial review of CSPM;

RAB supports a less rigid audit plan to handle this variability; Auditor should maintain an awareness of the applicable CSPM requirements by each OEM;Poor CSPM results should guide the auditor towards evaluations of potential source deficiencies in the QMS;If auditor is not satisfied, system deficiencies can become a documented basis for issuing non-conformance;The CSPM and revised audit trail are documented;

Insufficient coverage of required surveillance items - because of unplanned auditing resulting from evaluating CSPM and related system non-conformities - is not acceptable; added effort should be planned.

TS-2 Rule:The organization shall provide the following documentation to the CB for review, and for use in planning the audit:

Quality manual (for each site to be audited)Internal audit and management review planning and results from previous twelve monthsList of qualified internal auditorsList of customer specific requirements Customer complaints statusOperational performance trends for the previous 12 months, minimum.

QS-9000 4.1.5 Analysis and Use of Company Level DataThe supplier shall document trends in quality, operational performance (productivity, efficiency , effectiveness, cost of poor quality) and current quality levels for key product and service features.

These should be compared with those of competitors and/or appropriate benchmarks.Trends in data and information should be compared with progress toward overall business objectives and lead to action to support:

Development of priorities for prompt solutions to customer-related problems, Determination of key customer-related trends and correlations to support status review, decision-making and longer-term planning.

TS-2 8.4.1 Analysis and use of dataTrends in quality and operational performance shall be compared with progress toward objectives and lead to action to support the following:Development of priorities for prompt solutions to customer-related problems;Determination of key customer-related trends and correlation for status review, decision-making and longer term planning;An information system for the timely reporting of product information arising from usage.NOTE Data should be compared with those of competitors and/or appropriate benchmarks.

IATF Guidance to TS-2:8.4.1 Analysis and use of dataOperational performance may include productivity, cost of poor quality , process efficiency and effectiveness, production output, quality performance, and equipment utilization.TS-2 Rule: 2.10 The audit plan shall include evaluation of all of the organizations QMS requirements for effective implementation of ISO/TS 16949:2002 as well as for effectiveness in practice. Assessment shall evaluate the effectiveness of the system, its linkages, its performance and its requirements.

Note: Effectiveness of the system should consider how well the system is deployed, as demonstrated by the measures defined by the organization to meet customer satisfaction and company objectives.Initial certification audit activities shall be conducted according to the following rules: Review effectiveness of the implementation of the ISO/TS 16949:2002 requirements and for effectiveness in practice, related to planned and achieved quality performance.

The Automotive Industrys (IATF) Categorization of QMS Processes are:Customer Oriented Processes (COPs): 10 COPsMarket Analysis/Customer RequirementsBid/TenderOrder/RequestProduct and Process DesignProduct and Process verification / validationProduct ProductionDelivery

Payment Warranty/Service Post Sales/Customer Feedback2) Support Processes:Support Processes:Sales & Marketing, Customer Services,Calibration/Maintenance, Purchasing, Human Resources, IT (Info. Technology), Procedures, Finance (i.e.: )3) Management Processes (Mgmt decisions/actions):Planning ( i.e. Business planning , Quality planning/APQP , QMS planning), Resource allocation,budgeting, periodic reporting, management meeting(management review)

TS-2 8.2.1.1 Customer satisfaction-SupplementalCustomer satisfaction with the organization shall be monitored through continual evaluation of performance of the realization processes. Performance indicators shall be based on objective data and include, but not be limited to:Delivered part quality performance,Customer disruptions including field returns,

Delivery schedule performance (including incidents of premium freight), andCustomer notifications related to quality or delivery issues.The organization shall monitor the performance of manufacturing processes to demonstrate compliance with customer requirements for product quality and efficiency of the process.

QS-9000 APP. I:Customer Performance RequirementsEffectiveness of a companys system must be measured by indicators which directly correlate and meet customer performance requirements, such as customer satisfaction (4.1.6), on-time delivery (4.14.6) or continuous improvement (4.2.5), and tracked by the use of these indicators. The presence of continued poor trends in these indicators, audit to audit, will jeopardize continued QS-9000 registration.

Customer SatisfactionTo satisfy the QS-9000 requirement for determining customer satisfaction (4.1.6), customers such as Chrysler, Ford, GM provide suppliers with performance reports either on-line, e.g. Chryslers PASS report and GMs PRR system, or monthly, e.g. GMs quad report for North American suppliers listing the relevant performance data. Certification bodies/registrars should ask suppliers for copies of such reports to determine customer satisfaction during the registration audit and during surveillance.

Misrepresentation of InformationMisrepresentation of customer complaint information (for customers subscribing to QS-9000) by a supplier to a certification body/registrar shall result in the certification body/registrar immediately invoking their delisting process for that supplier and immediately notifying the customer(s) involved.

PDCA C & A Segments C a [A: Correction , CI, CA & PA ] !

8.2.2 Internal Audit (): /QMS effectiveness (thorough & comprehensive)? 4.2.4 Records (e.g. audit schedule/agenda, reports/detail notes)? (ISO 9001:2000 An audit program...the results of previous audits)6.2.2 Auditors?

(ISO 9001:2000 Auditors shall not audit their own work)8.5.2/8.5.3/8.2.2 ?(ISO 9001:2000actions taken to eliminate detected nonconformities and their causes detail notes, thorough.interviewobserveAuditor competency(6.2.2)-- dissimilar process areas(clauses)

ISO/TS 16949: 20028.2.2.1 QMS auditThe organization shall audit its QMS to verify compliance with this Technical Specification and any additional QMS requirements.

8.2.2.2 Manufacturing process auditThe organization shall audit each manufacturing process to determine its effectiveness.8.2.2.3 Product auditThe organization shall audit products at appropriate stages of production and delivery to verify conformance to all specified requirements, such as product dimensions, functionality, packaging, labeling, at a defined frequency.

8.2.2.4 Internal audit plansInternal audits shall cover all quality management related processes, activities and shifts, and shall be scheduled according to an annual plan. When internal/external nonconformities or customer complaints occur, the audit frequency shall be appropriately increased.NOTE Specific checklists should be used for each audit.8.2.2.5 Internal auditor qualificationThe organization shall have internal auditors who are qualified to audit the requirements of this Technical Specification

Failure Modes

()

comprehensiveCheck-lists ()Check-listssample size

/ISO 9000Auditor Qualification Maintenance

Audit Skills

/AuditorsLead AuditorSchedule ; (Internal Customer)

Auditor Qualification Maintenance( ISO 10011-1,-2 & -3)1~2?d) unannounced audit (i.e. ISO 9001..importance and status)auditee

e) FAQ: Element 8.2.2. Internal Audit ()2nd-party (vendor) audit element 7.4.1 Purchasing process TS-2 7.4.1.1 Supplier QMS development 2nd-party audit (organization)(outsource)?: ISO 9001:2000 & TS-2! : ISO 9000:2000 2.8.2 First-party audits are conducted by, or on behalf of, the organization itself for internal purposes and can form the basis for an organizations self-declaration of conformity

ISO 9001:2000 4.1 where an organization chooses to outsource QS-9000 4.6.2.1 3rd-party : TS-2 4.1.1 & Guidance:delegate technical leadership

(: ISO 9001:2000 TS-2process 7.3Design & Development & 7.5 Production & Service provisionQS-9000TS-2production )

(: registrarIf soISO 9001:2000one-man company?)

Audit Checklist : (i.e. Big Picture) ! , ! (checklist)auditor/

Automotive Process Approach to auditing for ISO/TS 16949:2002 must not be driven by a clause or a section driven checklist. Instead the checklist should be a tool to verify the completeness of the audit, which means that the auditor shall audit all applicable requirements to an identified COP.

(ISO 9004)effectivenessefficiency()(process)(IT)(performance)(interested parties)

QMS(QS-9000) ---

(trending)Remarks: downward/unfavorable trendsTop Management!() ()

QS-9000 4.17.1cover all shifts (: graveyard shiftNCP) When internal/external nonconformances or customer complaints occur, the planned audit frequency should be increased (/)vs. ISO 9001:2000the status and importance of the processes and areas to be audited): Mechanism (system) for assuring this should be in place. e.g.CARAudit frequency increased?; Internal audit planner/scheduleraudit schedule/agendareviewCARs

Process oriented auditingIATF expects TS-2 auditors to audit Customer Owned Processes (COPCustomer Oriented Processes Core Processes). The COP is a model that was introduced by ISO 9001:2000 and refers to the fact that any organization needs customer input to comply to specified and expected needs of the customer (output). This is accomplished by value adding processes of product realization and appropriate support processes, both enabled by management activities and provided resources.

The audit approach of TS-2 must not be driven by an element or a section driven checklist. Instead the checklist shall be a tool to identify the completeness of the audit, which means that the auditor shall audit all applicable requirements to an identified COP.

Automotive Value-Added Assessment vs. CSPM-driven Audit PlanningBest Practice #Auto 1: Effective Automotive Sector Auditing - Using Customer Satisfaction Performance Metrics to Guide On-site Audit Focus.It was important that the OEMs see an improvement in supplier performance - and that the supplier performance metrics should be a first item on any audit. If these were beneath expectations, they should be used as a guide for auditing potentially non-conforming systems. Auditors should look at each OEMs metrics relevant to a site (not just one chosen for contract review) at every audit event.

Output matters - use Customer Satisfaction Performance Metrics, CSPM, as an indicator of QMS effectiveness and implementation; Request current CSPM before the audit, perhaps in the audit plan;Review the CSPM as the first item of the audit;Include a notice to the client of the flexibility of the auditor to change the audit track or timing based on the results of the initial review of CSPM;

RAB supports a less rigid audit plan to handle this variability; Auditor should maintain an awareness of the applicable CSPM requirements by each OEM; Poor CSPM results should guide the auditor towards evaluations of potential source deficiencies in the QMS;

If auditor is not satisfied, system deficiencies can become a documented basis for issuing non-conformance; The CSPM and revised audit trail are documented; Insufficient coverage of required surveillance items - because of unplanned auditing resulting from evaluating CSPM and related system non-conformities - is not acceptable; added effort should be planned.

MONITOR:Observe, supervise, keep under review, measure or test at intervals, especially for the purpose of regulation or controlMEASURE:Ascertain or determine the spatial magnitude or quantity of something, by the application of some object of known size or capacity or by comparison with some fixed unit

GlossaryCorrection (C):Action to eliminate a detected nonconformity NOTE 1 A correction can be made in conjunction with a corrective action NOTE 2 A correction can be, for example, rework or regrade Corrective Action (CA):Action to eliminate the cause of a detected nonconformity or other undesirable situationNOTE 1 There can be more than one cause for a nonconformity.

NOTE 2 Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence.NOTE 3 There is a distinction between correction and corrective action.

Preventive Action (PA):Action to eliminate the cause of a potential nonconformity or other undesirable potential situationNOTE 1 There can be more than one cause for a potential nonconformity.NOTE 2 Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.

Continual Improvement (CI):Recurring activity to increase the ability to fulfill requirements (ISO 9000)NOTE The process of establishing objectives and finding opportunities for improvement is a continual process through the use of audit findings and audit conclusions (8.2.2), analysis of data (8.4), management reviews (5.6) or other means and generally leads to corrective action (8.5.2) or preventive action (8.5.3).:(CI)ISO 90013(i. e. , ) , CAPA , ISO 9001: MR IA AOD CI CA PA: ISO 9001 tool kit , tools (e.g. MR, IA, AOD)

small-step, on-going improvement activities ( i.e. continuous/incremental/local improvement on existing processes) breakthrough projects (i.e. discontinuous improvement it will usually reveal entirely new business processes at which an organization must excel)/, e.g. 6-sigma strategies, Re-engineering (QS-9000: CI requirement does not replace the need for innovative improvement(//))ISO/TS 16949: optimization of characteristics and parameters of a product or process at a target value NOTE Continual improvement is only applicable where conformance has been established.

Customer Satisfaction (CS):Customers perception of the degree to which the customers requirements have been fulfilledNOTE 1 Customer complaints are a common indicator of low customer satisfaction but their absence does not necessarily imply high customer satisfaction.NOTE 2 Even when customer requirements have been agreed with the customer and fulfilled, this does not necessarily ensure high customer satisfaction.

Customer Delight (CD): ISO 9004: Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations (i.e. customer delight.)

CorrectionCA:8.2.3 Monitoring and measurement of processes: when planned results are not achieved,correctionand corrective action shall be taken, as appropriate, to ensure conformity of the product. 8.2.2 8.3

Problem Resolution CD Progression ():

Immediate/Interim/Remedial Action(s) e.g. rework/repair, regarde/downgrade, containment, scrap/reject, concession, G8DD3 (Develop the Interim Containment Action) , e.g. , (syndrome): , root-cause

C8.3(8.2.2& 8.2.3)QS-9000 4.9.2 & TS 16949 8.2.3.1Reaction Plan in Control Plan

CA8.5.2,PA8.5.38.4QS-9000 4.9.2 & TS 16949 8.2.3.1CA Planeliminating the cause(s) of a potential nonconformity, / 30 % Best approach: / / /

Root-Cause(s) elimination , i.e. ()!

Kaizen (Kaimeans change and Zenmeans good): continual improvement of all areas of a company, not just quality.Is there a way that is Better (Q), Cheaper (C) & Faster (D)? 8.5.1GS (Good Service):!!8.2.1

ISO 9004,6-sigma strategies, Excellence Models: !P.O.S ( Positively Outrageous Service):

(FAQ):ISO 9001actual values for measurementsInspection Report5010OK8.2.4Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing release of product. OKdefined acceptance criteria () Inspectorsrequired inspection (i.e. inspectorscompetence/qualification)?

Acceptance criteria: Subjective terms are not acceptable; objective criteria must be defined to ensure consistent inspections.() (visual inspections)QS-9000 (Appearance Items) Controls/InspectionsThe conformance/acceptance criteria must be clearly defined and the procedure for deciding if these criteria are met must produce consistent results over time)/)

:Acceptance Spec.Surface should be free from flaws. (.)

Surface should conform to master standard in color, texture, brightness and imperfection. (/)

CommentWhat is a flaw?-Do inspectors agree?-How measured?

Conform to what degree?How measured?

QS-9000 4.9.6 (Appearance Items) : Appropriate lighting for evaluation areas ()Masters for color, grain, gloss, metallic brillance, texture, distinctness of image (DOI) as appropriate ()Maintenance and control of appearance masters and evaluation equipmentSee ISO 9001:1994 4.11.2b (/)Verification that personnel making appearance evaluations are qualified to do so ()

-8.2.4 the acceptance criteriavalues with tolerances or minimum/maximum values must be specified (/)(Common AR: , Max. Min.).-Assessorshow checked OKinvestigate further by witnessing tests to validate records (inspectorchecked OK)

-/&Variable Data ()(vs. checked OK/GO-NO GOAttribute Data).consistent inspections ()?: kind of /interview (2):Interview Techniques vs. Qualitative Objective Evidence/ Quantitative Objective Evidence vs. Training/Competency can replace Work/Job Instructions, but Training/Competency can not replace Specifications

Scenario: 3-4 ISO 9001:2000-based QMS?--QMS, QMS(paperless QMS) ! How?(papers)-- : Training/Competency can replace work instructions, , e.g. ISO 9001:2000 communications &

-- QMS Documentation 10~20 , ISO 9001: 2000 , (copy right) , process sequence/interaction , ? -- World record: one-man companyISO 9001, ISO 9001:2000 5.5.3 Internal communication (: documented procedurescommunication?!)

--- , ISO 9001:1994 4.1~ 4.20 20 documented procedure , audit evidences focus Quantitative() Objective Evidences , 3~4 maintain ISO 9001/2: 1994-based QMS ?

QS-9000 4.10.1.1Acceptance Criteria for Attribute Characteristics--Acceptance criteria for attribute data sampling plans shall be zero defects. Appropriate acceptance criteria for all other situations (e.g. visual standards) shall be documented by the supplier and approved by the customer.

--- Zero Defect (/01) Cost Down , Tightened Inspection Normal Inspection Reduced Inspection Zero Defect Dock-to-Stock/Ship-to-Stock practice()--- highly stable & capable processes/products visual inspections.--- attribute characteristics(), Go/No-Go, Yes/Nodata attribute sampling plan, Mil-STD-105E--- Zero Acceptance Number Sampling Plans ( 01), AQL01 (e.g. Mil-STD-105E ) , refine/redefine / conformance criteria0101

why? : 8.3 Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (//):

1) 8.4 Analysis of Data ()2) 8.5.1 Continual Improvement () 3) 8.5.2 Corrective Action ()4) 8.5.3 Preventive Action ()5) QS-9000 4.13.2.1 Prioritized Reduction Plan: The supplier shall quantify and analyze nonconforming product and establish a prioritized reduction plan. Progress toward the plan should be tracked: () ::

(FAQ):Ans: (value/contribution consideration) nonconformity CARISO 9004:2000The org. can also consider recording information on those nonconformities that are corrected in the normal course of work. Such data can provide valuable information for improving the effectiveness and efficiency of processes 8.3 8.5.2 Corrective Action , 8.5.3 Preventive Actione.g. Pareto Analysis ():to separate the vital (critical) few causes from trivial manymeaning to look for the 20/80 rule of thumb()20% of the causes producing 80% of a problem

Check Sheet (/ causeshistorical data) Pareto Analysis of Effects/ Effect Pareto Chart:( 1)

Cause-and-Effect Diagram/ : ( 2)

Pareto Analysis of Causes/ Cause Pareto Chart: ( 3) CA/PA determined and taken :

Effect Pareto diagrams may be used to compare results before and after a change (CA) was made (taken) to show progress :( 4) Case closed if showing progress (evidence of verifying CA effectiveness)

(1)Pareto Analysis of Effects (2)Cause-and- Effect Diagram A B C D EEFFECT AMETHODSMANPOWERPOSSIBLE CAUSES OF EFFECT AMATERIALS MACHINES

3Pareto Analysis of Causes100 85 69 46 the 20/80 rule of thumb()20% of the causes producing 80% of a problem

DIFFERENCE BETWEEN TWO TIME PERIODSUNITS, HOURS OR DOLLARSUNITS, HOURS OR DOLLARSBEFORE CHANGEBEFORE CHANGE 4 Before-and-After Measurement

8.5.2 Corrective Action ()CAs shall be appropriate to the effects of the nonconformities encountered.

--/(risk level) () ()CA , i.e. among all possible solutions by/(X, , Y , ) , , , 100CA10

--().to define requirements for--a) reviewing nonconformities including customer complaints:

1: reviewsources of information (e.g. .)casesCA , CAprioritize()

2: 1. (): , 2. (): , 3.

:PCBSOP()() GM:SOP:(21) :?: : ?: : : ? : 21:2123??:SOP()

: ?SOP?SOP?SOP?SOP :SOP? ?? SOP?::()

e.g. 1) ISO/TS 169498.2.3.18.5.2.4CA: (control plan) () () unstable non-capable reaction plan (: containment100% inspection) , CA plan (); Root-Cause Analysis CA process! ISO/TS 16949 8.2.3.1:The organization shall initiate a reaction plan from the control plan for characteristics that are either unstable or non-capable. These reaction plans shall include containment of product and 100% inspection as appropriate. A corrective action plan shall then be completed by the organization, indicating specific timing and assigned responsibilities to assure that the process becomes stable and capable. The plans shall be reviewed with and approved by the customer when so required.

ISO/TS 16949 8.5.2.4 Rejected product test/analysisThe organization shall analyse parts rejected by the customers manufacturing plants, engineering facilities and dealerships. The organization shall minimize the cycle time of this process. Records of these analyses shall be kept and made available upon request. The organization shall perform analysis and, initiate corrective action to prevent recurrence.

NOTE Cycle time related to rejected product analysis should be consistent with determination of root cause, corrective action and monitoring the effectiveness of implementation.

e.g. 2): Rule #1: Customer is always right. Rule #2: If customer is wrong, go to rule #1

: nonconformitiesnonconforming incoming materials/parts()8.3 Control of nonconforming product()QS-9000/TS 16949: 2002Product with unidentified or suspect status shall be classified as nonconforming product () (e.g. NGgage)

-- b) determining the causes of nonconformities,-- c) evaluating the need for action to ensure that nonconformities do not recur,: CAs shall be appropriate to the effects of the nonconformities encountered-- d) determining and implementing action needed,-- e) records of the results of action taken, e.g. Root-Cause Analysis:Root Cause Analysis is a logical, systematic approach to identifying the basic reasons (causes, mechanisms, etc.) for a problem, failure, non-conformance, process error, etc. Whenever a significant problem occurs (i.e. low frequency of occurrence with high cost in time and/or money, or high frequency of occurrence), Root Cause Analysis should be implemented.

The result of Root Cause Analysis should always be the identification of the basic mechanism by which the problem occurs and a recommendation for corrective action. No corrective action required is an acceptable recommendation for corrective action when properly justified. Root Cause Analysis cannot be closed out until all required corrective action has been developed and implemented. When Root Cause Analysis is performed, all of the investigation, analysis, and results (including corrective action) must be completely documented.

--()to define requirements for (f) reviewing CA taken:CAISO/IEC 17025 4.10.2 (Root-) Cause analysisThe procedure for corrective action shall start with an investigation to determine the root cause(s) of the problem.Note: (Root-) Cause analysis is the key and sometimes the most difficult part in the corrective action procedure. Often the root cause is not obvious and thus a careful analysis of all potential causes of the problem is required. Potential causes could include client requirements, the samples, sample specifications, methods and procedures, staff skills and training, consumables, or equipment and its calibration.

Paynter Chart- The Paynter Chart is used to demonstrate the effectiveness of corrective actions. It has the same categories as the Pareto Chart and identifies when changes have been made.In some situations, problems may be connected. Therefore, the corrective action applied to a problem on the Pareto Chart may have an influence on other sub-problems. The corrective action may either improve another problem or have a negative effect. The Paynter Chart provides a means of evaluation, not only the problem that was the primary focus for Problem-Solving, but also others that might be affected.

The Paynter ChartAbstractThe Paynter chart is similar to a Pareto Chart except that each Pareto bar is split up into subgroups. This enables you to look at what subgroups are going into the makeup of the pareto bar and you can use it to spot trends or troublespots. Keywords: Paynter, gpaynter, paretoProduct: Statit, 4.3 5.2 The Paynter Chart is a tool that goes beyond a Pareto. A Pareto shows the problems with the most frequency. A Paynter Chart shows the Pareto information but breaks the Pareto Bars into subgroups. The Subgroups could be days, hours or subgroups from a p chart. The examples below illustrate the Paynter Chart.

This Paynter was run by restricting the number of groups to 5 and the number of subgroups to 4. In this case it took the last 4 subgroups to plot.

ISO/IEC 17025 4.10.3 Selection and implementation of corrective actionsWhere corrective action is needed, the laboratory shall identify potential corrective actions. It shall select and implement the action(s) most likely to eliminate the problem and to prevent recurrence (i.e. )

Common AR: CA/PA case was prematurely closed: : yes/--QS-9000 4.14.1.1:Problem Solving MethodsA Supplier shall use disciplined problem solving methods when an internal or external nonconformance to specification or requirement occurs.

When external nonconformance occur, the supplier shall respond in a manner prescribed by the customer. Refer to the customer documents.e.g. DC-7D, Ford-G8D(Global 8D Analysis), GM- Problem Reporting & Resolution (PR/R) Procedure--QS-9000 4.14.1.2: Mistake ProofingThe supplier shall use mistake proofing methodology in their corrective and preventive action process to a degree appropriate to the magnitude of the problems and commensurate with the risks encountered.

Corrective Action Impact 4.14.2.2: ISO 9001: 2000 PAWhere applicable, the supplier shall apply the corrective action taken, and controls implemented, to eliminate the cause of a nonconformity to other similar processes and products.--(QS-9000) linked to PFMEA review/update , Control Plan & Operators Instruction(Process Sheet) updates & increasing internal audit frequency (i.e. operational feedback & learning). :Ford G8D: ensuring that the CAP (Corrective Action Plan) has been transposed into the FMEA , Control Plan , and Process Sheets Verifying that the resulting data are brought forward into the Suppliers FMEA, Control Plan, and Process Sheets.

D7: (Prevent Recurrence)Strategic Questions Was the Process Failure Mode Effects Analysis (PFMEA) reviewed? Was the PFMEA revised adequately? Were the Control Plans revised? Were the Process Sheets revised?

QS-9000 4.17.1 When internal/external nonconformances or customer complaints occur, the planned audit frequency should be increased.

GLOBAL 8D D0. Prepare for the Ford G8D ProcessD1. Establish the TeamD2. Describe the Problem D3. Develop the Interim Containment Action(Common AR: Interim Containment Action Containment FMEA)D4. Define and Verify Root Cause and Escape Point( )(Remarks: Containment FMEA Containment Controlscontainment failuresEscape Points)D5. Choose and Verify Permanent Corrective Actions for Root Cause and Escape PointD6. Implement and Validate Permanent Corrective Actions

D7. Prevent Recurrence The PFMEA was not reviewed. The PFMEA was not adequately revised. Control Plans were not revised.Process sheets were not revised.D8. Recognize Team and Individual Contributions

8.5.3 Preventive Action () --- ISO 9001:1994 PAISO 9001:2000 8.5.3 (Preventive Action) 8.4 (Analysis of Data), (i.e. trending) identify /(potential nonconformities), , 8.4 (Analysis of Data)e.g. repeated CARs --- Trend/Pattern Analysis (evaluation of historical data for trends and criticality)

--QS-9000 4.13.2.1 Prioritized Reduction Plan: The supplier shall quantify and analyse nonconforming product and establish a prioritized reduction plan. Progress toward the plan should be tracked. (considered as PA)--QS-9000 4.1.5 Analysis and use of company level data: The supplier shall document trends in quality, operational performance (productivity, efficiency, effectiveness, cost of poor quality) and current quality levels for key product/service features Trends...compared with those of competitors.with progress toward overall business objectives and lead to action(PA)

--- ULISO 9001:1987ISO 9001:1994Trend AnalysisPACA (CA & PA).--- the development of D/PFMEAs P.A.,documented system whereby data is analysed to develop and update FMEAs ( e.g. a procedure and evidence of the analysis of TGW a review of past Things-Gone-Wrong/Lessons Learned(e.g. high warranty, campaigns, etc.)data to support development of a FMEA), FMEAs P.A.intent.--- the FMEA must be done before a product or process failure mode has been incorporated into a product or process.

---, a before-the-event, up-front, thoroughly thought-out and well-developed FMEA will eliminate/minimize late change crises, ECNs, CARs.---FMEAliving documentcritical nonconformities/customer complaints/TGW reportsCARFMEA review & update (common AR!)ARCAR formFMEA review & update required?; QS-9000 4.17.1 (i.e. operational feedback & learning)

Semiconductor Supplement Containment FMEA (CFMEA):An FMEA which identifies critical failure mechanisms which due to low detectability and/or high criticality require a containment screen. & 4.14.3.S(PA): The supplier should use containment FMEAs to facilitate and document containment actions.

Note: CFMEA/ Potential containment failure(s) e.g. ICNote: High Criticality = High Severity + High Occurrence: IC UL QS-9000apply QS-9000 Semiconductor Supplement!

:QS-9000 Applicability:QS-9000 applies to providers of : 1) Semiconductors in conjunction with the Semiconductor Supplement 2) QS-9000 and this Semiconductor Supplement applies to the internal and external suppliers of production and service semiconductor parts and materials. Every element of QS-9000 and this Semiconductor Supplement applies to semiconductor suppliers with the possible exception of design and /or service element.

3). QS-9000 Certificate Requirements:Certificates for semiconductors shall include wording that indicates that the requirements of the QS-9000 Semiconductor Supplement were included.: QS-9000citewording!

4). diodes() , transistors() , ICs() , TFT-LCDSemiconductors; in short, SIC Code 3674(Semiconductors & Related Devices)!

--- Reliability Prediction () --- Processes that provide early warning of approaching out-of-control operating conditions (processes) e.g. SPC/control charts--- : () FMEA: (potential failure mode: high severity ranking) (recommended action) (occurrence ranking) 30 %--- Dont expect to see or require separate procedures marked Preventive Action. It is often integrated into other procedures e.g.(Project Management)QIT (Quality Improvement Team) ---PA (Preventive Action) C.I. (Continual Improvement).

ISO/IEC 17025:19994.11 Preventive action4.11.1 Needed improvements and potential sources of nonconformances, either technical or concerning the quality system, shall be identified. If preventive action is required, action plans shall be developed, implemented and monitored to reduce the likelihood of the occurrence of such nonconformances and to take advantage of the opportunities for improvement.

4.11.2 Procedures for preventive actions shall include the initiation of such actions and application of controls to ensure that they are effective.Note 1: Preventive action is a pro-active process to identify opportunities for improvement rather than a reaction to the identification of problems or complaints.Note 2: Apart from the review of the operational procedures ( PA), the preventive action might involve analysis of data, including trend and risk analyses ( PA) and proficiency-testing results.

:CORRECTIVE ACTION PREVENTIVE ACTION () ()

--Eliminate an existing -- Eliminate a potential nonconformity nonconformity-- Dont let it happen again -- Dont let it happen at all-- Local in nature -- Global in nature-- Prevent recurrence -- Prevent potential occurrence-- Eliminate the cause of -- Eliminate the cause of a a detected nonconformity a potential nonconformity

CORRECTIVE ACTION--Reactive ()--Single Occurrence ()(existing nonconformity/out -of--specification occurrence)

--Action is required usually ()

PREVENTIVE ACTION --Proactive ()--Data Analysis / Trend or Risk Analysis (/) (e.g. using ---Trend Chartlooking at trend over time to see if there is any potential nonconformity )--Action is required only when there is unfavorable trend. NO ACTION is required for favorable trend. ()

CORRECTIVE ACTION PREVENTIVE ACTION--CAR/G8D -- CAR :& CA Impact Analysis could create an opportunity for PA applying the CA taken, and controls implemented, to eliminate the cause of a (potential) nonconformity to other areas, or other similar processes and products (CA /, )

CORRECTIVE ACTION PREVENTIVE ACTION -- Periodic/systematic review of current processes or practices/operational procedures/documentation. (/// /) -- Problem/Nonconformity Prevention Tools, e.g. FMEA, Reliability Prediction, Control Charts (SPC)

Same idea like SPC

UCL

CL

LCLtrend(Real-time action taken)(Just like control chart, the effectiveness for PA taken can be demonstrated in the trend chart)Example:timeKeep monitoring the trendPA takenRoot Cause:Poor trainingPA effectiveCORRECTIVE ACTION PREVENTIVE ACTION --Local Action --Management Action / Judgement (/)()(e.g. judgement made & responsibility assigned during Management Review-Who will do What by When: Case closed & PA Team dissolved when PA done). Example:

Remarks: Auditors add fuel to the fire! auditorsCAPA , The very people who should be correcting the users of ISO 9001 are instead validating the error !

CAExamples of Existing Nonconformities

26%30% 20%35

PAExamples of Potential Nonconformities

A200 , ,

CA ProceduresAccurately define an existing problem(/)Investigate all root causes()Identify most probable cause(s)(/)

Determine appropriate CA(CA)

PA ProceduresAccurately define a potential problem()Investigate all potential causes()Identify most probable potential cause(s)(/)Determine appropriate PA(PA)

CA ProceduresImplement CA( /CA)Follow-up to verify effectiveness of CA prior to closure(CA)Verify a minimum of twice prior to closure()

PA ProceduresImplement PA( /PA)Follow-up to verify effectiveness of PA prior to closure(PA)Verify a minimum of three times prior to closure (PAs take longer to effectively verify and close) (:PA )

CA ProceduresAllow at least 1 month between each verification for CA effectiveness.(CA ) PA ProceduresAllow at least 1 month between each verification for PA effectiveness.(PA )

Continual (Continuous) Improvement: Good-Better-Best Is there a way that is: Better(Q), Cheaper(C) & Faster(D)? (How can org do it better, cheaper and faster?)/ CI rather than wait for a problem to reveal opportunities for improvement. Breakthrough Projects ( CFT), 6-sigma Breakthrough Strategies, Re-engineering, the use of BSC()discontinuous improvement(); small-step, ongoing improvement activities continuous improvement()

ISO 9001:2000 C.I. QS-9000 C.I. .ISO 9001:2000 8.5.1 C.I.The org. shall continually improve the effectiveness of the QMS through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.Shall develop a prioritized action plan for C.I. in processes that have demonstrated stability, acceptable capability and performance. (Unstable/non-capable processes C.A., C.I.)--- C.I.,! stable/capable processes Cpk (PPAPCpk=1.67 ,C.I.); For attribute data, C.I. C.I.

PPAPCpk 1.67 , Cp3 , QS-9000 4.9.2When process/product data indicate a high degree of capability (e.g. Cp3), the supplier may revise the Control Plan, as appropriateby reducing inspection/sampling (cost) C.I. 4.9.3 Modified Process Control Requirements: In some cases, the customer may require either higher or lower capability or performance (see 4.9.2) requirements. In these cases, the Control Plan shall be annotated accordingly (i.e., in the Product/Process specification/Tolerance column of the suggested APQP Control Plan) C. I.?: PPAPCapability/ , Capability/effortsC.I.

Why C.I.? field failureLoss Function MentalityLoss to customer and/or society (e.g. )QS-9000 SPC Manual Sec. 6: .for some processes, the customer will be sensitive even to variation within engineering specifications. In these instances, the value of C.I. will not be realized until variation is reduced. DOE.processes C.I.:()

QS-9000 C. I. intent ,!(good-better-best):

: Q.C.D. ;innovative improvement

: Special Characteristics()

key indicators cost elements or price (e.g. 4.1.5 , 4.9.2 Cpk3,may revise the Control Plan)

Special Char.variable data () , C.I. means optimizing() the characteristics and parameters at a target value and reducing variation around that value Special Char. attribute data () , C.I. is not possible until characteristics are conforming. (If attribute data results do not equal zero defects NCP/C.A., C.I.)

8.2.1 Customer Satisfaction () & 7.2.3c Customer Communication (customer feedback, including customer complaints): -- A saying: !The importance of Receptionist/CS personnel.-- Proactive ! (/!)-- Customer complaints indicate low customer satisfaction; absence of them does not imply high customer satisfaction (No news good news , supplier!)

(customer complaints & returns)complaint data may fall short both in MAGNITUDE (a higher proportion of dissatisfied customers exists than is reflected in returns and complaint data//) and in CONTENT (the compilation and analysis of returns and complaints by reason may not parallel ()actual customer experience/)substantiated with objective evidence to demonstrate the validity. CS data(i.e. complaints & returns)CS/

-i.e.the merchandise does not return and neither does the customer-ISO 9001 : 2000 Clauses 7.2.3 / 8.2.1 QS-9000 Clause 4.1.6 :a) ISO 9001:2000 7.2.3 Customer CommunicationThe org. shall determine and implement effective arrangements for communicating with customers in relation toc) customer feedback, including customer complaints.

b) ISO 9001:2000 8.2.1 Customer Satisfaction: As one of the measurements of the QMS, the org. shall monitor information relating to customer perception () as to whether the org. has met customer reqmts. The methods for obtaining and using this information shall be determined.(Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements).: monitor (i.e. observe, supervise and control, maybe by measuring) measure

c) QS-9000 4.1.6 Customer SatisfactionThe supplier shall have documented process for determining CS including frequency of determination, and how objectivity and validity are assured. Trends in CS and key indicators of customer dissatisfaction shall be compared to those of competitors, or appropriate benchmarks, and reviewed by senior mgmt. NoteConsideration should be given to internal, external and final customer.

Fulfilling customer requirements does not necessarily ensure high customer satisfaction.Assessors must see : Process that goes beyond customer complaint handling alone.

Assessors might see : (The collection of customer-related information may be ACTIVE or PASSIVE)* Customer Satisfaction Surveys, e.g. ()* Periodic phone calls Mystery Shopper* Customer Report Cards ()* Customer Focus Group Report* Customer Visits/Meetings (senior managers) * Monitor / : e.g. Hotel* Complaints/Returns* Warranties/Service Reports* Toll-Free Telephone Calls Report

CUSTOMER SATISFACTION SURVEY() : (1)the results are usually not representative of a normal population. This result occurs because the only people who will take the time to fill out a survey are those who feel very strongly about a subject and , therefore, tend to be biased: (i.e. )

(2) Survey ABC (Almost Being Certain) PBC (Pretending to Be Certain) ABC PBC , Survey , , , ,

e.g. :10%~15%75%:33%50%(: )(3) 500 CS survey CS survey

FYI: (1). As a minimum, 95% (2). 5%100%65593-33333Pareto80/2080% (or ) 20% existing customers , CRM(Customer Relationship Management)

( Remarks: CRM?Pareto80/2080%20%(Data warehouse)(CRM; customer relationship management) ,

, , , , , , ; , CRM , , , CRM , , , BSCCRMtop-down (Vision) (Strategy) (Objectives) (Measures) (Stretch Targets) (Initiatives)/ )

(3). : (4).

ISO/TS 16949:2002 6.2.2.4 :

Employee motivation and empowerment (/)The organization shall have a process to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment to promote innovation. The process shall include the promotion of quality and technological awareness throughout the whole organization. ( , , , )

The organization shall have a process to measure the extent to which its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives.( , )No happy employees (internal customers), no happy customers ()!! !

e.g. : (a) (b) (c) & (d) e.g. BSC BOS / (top-town) (personal objectives) personal scorecard deployment process: To make strategy everyones everyday jobe.g. . e.g. . e.g. R.M./G.M. Briefing & Award

: , , , , , , , , , , (A vs. Bcheck-out)

Customer Delight (CD):`FANS (CS)

P.O.S-Positively Outrageous ServiceP.O.S.? : (unexpected) (via GS-Good Service) ()(Satisfied customer is worthless. Royal customer is a real asset)

Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations (i.e. customer delight.) ISO 9004:

PDCA d Segment!

(Clause 4.2 of ISO 9001:1994 & ISO 9001:2000) :

Job Instructions()Quality Manual()Level 1 ()Defines Approach & responsibility ( )Level 2 ()Defines Who, What, When (,)

Level 3 ()Answers How ()Level 4 ()Prompts recording of information, e.g. forms, tags, labels. Once recorded, the item may become a quality record (/)Quality Manual()Procedures()Other Documentation ()Job Instructions (/)

- ISO 9001:1994/QS-9000 Documents Quality Records : , (forms, tags, labels ) QMS Documents ( Self-Instructional Forms, Work Instruction, Sampling/Acceptance criteria ); Forms, Tags Labels , Quality Records.

- ISO 9001:2000 , Clause 4.2.1 The QMS documentation shall include.e) records required by this International Standard Clause 4.2.3 Records are a special type of document . e.g. Business Plan (), FMEAs, Design Records (), ECNs (), PPAP Records (), Meeting Minutes, AVL () . , !

: PCBULQS-9000ISO 9000QS-9000 (UL QS-9000PCB)QS-9000 4.6.2.1 Subcontractor Development () APQP

: UL UL auditorTypo erroroutput (i.e. ) ULAR (observation )ARoverkill/nit-pickAR (i.e. distribution /revision control)output ()e.g.Self-instructional Formscriteria/ULAR

--How detailed does such documented procedure have to be?4.2.1 NOTE 1 NOTE 2NOTE 1: Documented procedure means that the procedure is established, documented, implemented and maintained.NOTE: 2: (the extent of QMS documentation)~~ a). / b). processes & their interactions c). (the competence of personnel) e.g. Nuclear power plant vs. Hint: New process PDCA Existing process CAPD

ISO/IEC 17025:1999 International, regional or national standards or other recognized specifications that contain sufficient and concise information on how to perform the tests and/or calibrations do not need to be supplemented or rewritten as internal procedures if these standards are written in a way that they can be used as published by the operating staff in a laboratory. It may be necessary to provide additional documentation for optional steps in the method or additional details.(operators/ , )

ISO/IEC 17025 4.3.2.2 . Documents are periodically reviewed(:PA , ISO 9001)

ISO/IEC 17025 4.3.3.3 If the laboratorys documentation control system allows for the amendment of documents by hand pending the re-issue of the documents, the procedures and authorities for such amendments shall be defined. Amendments shall be clearly marked, initialled and dated. A revised document shall be formally re-issued as soon as practicable.( , , )ISO/IEC 17025 4.3.3.4 Procedures shall be established to describe how changes in documents maintained in computerized systems are made and controlled.( , )Remarks: ISO 9001 ISO/IEC 17025 , QMS ?

Document/Record Control : () ? ( , : ?)

Quantitative () vs. Qualitative ()Objective Evidence () :

* What we saw and what we heard * Data supporting the existence or verity() of something.* Objective evidence may be obtained through observation, measurement, test, or other means.

* , Objective Evidence quantitative information, records, meeting minutes..* Objective Evidence qualitative information, verity () of something, operator/top management interview , practices observed.

e.g. Employees may be tested for effectiveness of company communication programs (e.g. Clauses 5.1a/5.5.2c/5.5.3). But if employees/operators dont understand those PPM/SPC charts posted on the shop floor, this could be a problem. (If this is the communication method adopted by company).(programs , PPM/SPC charts)

Retrieval () of Records-- 4.2.4 Control of Records:Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.--/QMSstorageprotection/Noncritical Records

Critical Records(backup of records)protection()Disaster Recovery Plan(ISO 9001)e.g. (retrieve) & ; New York 911/: CBCB.

record keeperQMSsignificant/negative impact.e.g. ABCrecord holder/keeper(disposition)QMSsignificant/negative impact

e.g.auditorall design records must be shreddedauditorrecordsMaybe an AR!FAQ: 4.2.4 (Identification of records): to provide evidence (1) of conformity to requirements, and (2) of the effective operation of the QMS. , ISO 9001Records shall be maintained:5.6.1 6.2.2 (/)7.1 ()7.2.2 /

7.3 ( )7.4.1 7.5.2 ()/7.5.3 7.5.4() , 7.6 8.2.2 8.2.4 ()8.3 8.5.2 8.5.3 (: 8.2.1 CS records)

ISO/IEC 17025: 19994.12.1.4 The Laboratory shall have procedures to protect and back-up records stored electronically and to prevent unauthorized access to or amendment of these records.( , , )e.g. 12: , ; ,: , , !!

4.12.2.1 The laboratory shall retain records of original observations, derived data and sufficient information to establish an audit trail, calibration records, staff records and a copy of each test report or calibration certificate issued, for a defined period. The records for each test or calibration shall contain sufficient information to facilitate, if possible, identification of factors affecting the uncertainty and to enable the test or calibration to be repeated under conditions as close as possible to the original. The records shall include the identity of personnel responsible for the sampling, performance of each test and/or calibration and checking of results. (Lab /)

4.12.2.2 Observations, data and calculations shall be recorded at the time they are made and shall be identifiable to the specific task.(/ , , , ) 4.12.2.3 When mistakes occur in records, each mistake shall be crossed out, not erased, made illegible or deleted, and the correct value entered alongside. All such alterations to records shall be signed or initialled (and dated) by the person making the correction. In the case of records stored electronically, equivalent measures shall be taken to avoid loss or change of original data. ( , ; crossed out , )(Remarks:Why above? Why /? , .)

(Appropriate) CONTROL :

value:confidence/risk level consideration.!Adjustable based on performance! (hint: CA-PDCA cycle for existing process/ control!)

A) // (Documented Job Instructions/Operators Instructions/Workmanship Criteria.)e.g. ISO 9001:1994 Clauses 4.5/4.9/4.10., ISO 9001:2000 Clauses 4.2.1/7.5.1..

: ISO 9000 Registrar/Registrarauditors

Metal Stamping4operators(OEM)

CBauditorauditor

Common AR:auditorActual Practice