aiag_mexico_city.pdf

7/24/2019 AIAG_Mexico_City.pdf

1/50

2003 AIAG

IntroductionIntroduction

AUTO-TECH 2004

Terri Pratt Delphi Corporation

Kelli Rogers American Axle andManufacturing, Inc.

Speakers:


2/50

2 2003 AIAG

AUTO TECH 2003

CQICQI -- 77


3/50

3 2003 AIAG

AUTO TECH 2003

www.AIAG.ORGwww.AIAG.ORG


4/50

4 2003 AIAG

AUTO TECH 2003

Steps to ImplementationSteps to ImplementationDetermine th e Scope of

QMSDevelop Transition /

Cert ification PlanIdentif y & Unde rstand

What is New

Per fo rm Gap Analys is

DetermineDocumen tation Strateg y

Rev ise, Refere nce or

Create Document ation

Train Employees o nQMS

Implement QMS Conduct Internal Audit

Corre ct Deficiencies &Verify Effectiv eness of

Solutions

Conduct ManagementReview

Does QMSRefle ct a Proce ss

Approach?

AreISO/TS

16949:2002Requirements

Met?

Align QM S to Refle ctProc ess Approach

YES

YES

NO

NO

1 2 3

4

5

6

78

9

10

11

12

13

14


5/50

5 2003 AIAG

AUTO TECH 2003

1.0 Overview1.0 Overview

IATF ISO/TS16949:2002 publicationsISO/TS 16949:2002 Technical Specification

Automotive Certification Scheme for ISO/TS16949:2002IATF Guidance to ISO/TS 16949:2002

Quality System Assessment Checklist(May be purchased through www.aiag.org)


6/50

6 2003 AIAG

AUTO TECH 2003


Core Tools

PPAP APQPMSA

SPCFMEA

(May be purchased through www.aiag.org)


7/50

7 2003 AIAG

AUTO TECH 2003


ISO 9001:2000 Base Standard

ISO 9001:200 Quality management systems Requirements5.4 Planning5.4.1 Quality objectives

Top management shall ensure that quality objectives, including

those needed to meet requirements for product (see 7.1 a) areestablished at relevant functions and levels within theorganization. The quality objectives shall be measurable andconsistent with the quality policy.

5.4.1.1 Quality objectives SupplementalTop management shall define quality objectives andmeasurements that shall be included in the business plan andused to deploy the quality policy


8/50

8 2003 AIAG

AUTO TECH 2003


www.iso.com


9/50

9 2003 AIAG

AUTO TECH 2003


International Automotive Oversight Bureauwww.IAOB.ORG

FAQS,Sanctioned Interpretations,

Customer Specifics


10/50

10 2003 AIAG

AUTO TECH 2003

www.IAOB.ORGwww.IAOB.ORG


11/50

11 2003 AIAG

AUTO TECH 2003

2.0 Whats New and Different2.0 Whats New and Different

Base Standard Change in TermsChanges in Intent Format

Shalls FocusDocumentation Customer SpecificsAuditing Accreditation Function

Global Accreditation ProcessSite Certification ProcessDe-certification Process

Who can be registeredCOPS Customer Oriented Processes


12/50

12 2003 AIAG

AUTO TECH 2003

2.1 Customer Oriented Process (COPs)2.1 Customer Oriented Process (COPs)

In ISO/TS 16949:2002, the IATF has adopted a concept calledCustomer Oriented Processes, or COPs. COPs are referred to in theChecklist to ISO/TS 16949:2002.

The IATF;Expects auditors to audit based upon the Customer OrientedProcesses (COP).Refers to the fact that any organization needs customer input tocomply to specified and expected needs of the customer (output) inorder to achieve customer satisfaction.

Accomplished by value adding processes of product realization andappropriate support processes, both enabled by managementprocesses and provided resources.


13/50

13 2003 AIAG

AUTO TECH 2003

2.2 New Requirements (n=15)2.2 New Requirements (n=15)

5.1 Management commitment5.1.1 Process efficiency5.4.1 Quality objectives5.5.2.1 Customer representative5.5.3 Internal communication6.2.2.4 Employee motivation and empowerment6.3 Infrastructure7.2.3 Customer communication7.3.2.1 Product design input7.3.2.2 Manufacturing process design input7.3.3.2 Manufacturing process design output7.4.3.2 Supplier monitoring8.1 Measurement, analysis and improvement General8.2.2.5 Internal auditor qualifications8.5.1.2 Manufacturing process improvement


14/50

14 2003 AIAG

AUTO TECH 2003




What is New



Rev ise, Refere nce or

Create Document ation




Solutions



Approach?

AreISO/TS


Met?


YES

YES

NO

NO

1 2 3

4

5

6

78

9

10

11

12

13

14


15/50

15 2003 AIAG

AUTO TECH 2003

Step 5Step 5 -- Process ApproachProcess Approach

QS-9000Documented quality system document what you do,

do what you document

ISO/TS16949

Customer satisfaction and measures of processeffectiveness


16/50

16 2003 AIAG

AUTO TECH 2003

QSQS -- 90009000


17/50

17 2003 AIAG

AUTO TECH 2003

ISO/TS 16949 Process ApproachISO/TS 16949 Process Approach

(Process Approach)


18/50

18 2003 AIAG

AUTO TECH 2003

What is a process?What is a process?

Set of interrelated or interacting activitieswhich transforms inputs to outputs

INPUTS OUTPUTSPROCESS STEPS


19/50

19 2003 AIAG

AUTO TECH 2003

Building Blocks of a ProcessBuilding Blocks of a Process

Management ResponsibilityResource ManagementProduct RealizationMeasurement, Analysis and Improvement


20/50

20 2003 AIAG

AUTO TECH 2003

Model of a ProcessModel of a Process -- Based QualityBased Quality

Management SystemManagement System

Continual Improvement of theQuality Management System

ManagementResponsibility

Resource

Management

Measurement,

Analysis,Improvement

Quality ManagementSystem

Customers Customers

InputProduct

Output

Productrealization

Requirements

Satisfaction

Key:Value-adding activitiesInformation flow


21/50

21 2003 AIAG

AUTO TECH 2003

Setting up the Quality ManagementSetting up the Quality Management

SystemSystemProcess IdentificationProcess MappingEffectiveness

Auditing

Documentation to Certification Body


22/50

22 2003 AIAG

AUTO TECH 2003

Process IdentificationProcess Identification

Market Analysis/Customer RequirementsBid/Tender Order/RequestProduct and Process Design

Product and Process Verification/ValidationProduct ProductionDelivery

PaymentWarranty/ServicePost Sales/Customer Feedback


23/50

23 2003 AIAG

AUTO TECH 2003

Process Identification ToolProcess Identification Tool


24/50

24 2003 AIAG

AUTO TECH 2003

Process MappingProcess Mapping

With What?

(Materials/Equipment)

With Who?

(Competence/Skills/Training)

ProcessInputs Outputs

How Many?

(Measurement/ Assessment)

How?

(Methods, Procedures,Techniques)


25/50

25 2003 AIAG

AUTO TECH 2003

ExampleExample -- Process MappingProcess Mapping

Supplier Database

Shipping Database

Supplier Quality AssuranceManagement (inbound)

Customer Service Manager(outbound)

PC&L Supervisor (internal)

Delivery

ISO/TS 16949

CustomerSpecifics

Schedule

DeliveryReport

SPDP

CustomerSatisfaction

Adherence to Schedule

Supplier Development

Tracking

SPDP Procedures

PC&L Procedures


26/50

26 2003 AIAG

AUTO TECH 2003

ExampleExample -- Process MappingProcess Mapping

Process Audit ing Approach

WHAT is used in the process?Materials/Equipment

4.1 General Management Requirements4.2 Documentation Requirements5.3 Quality Policy

5.4 Planning Quality Objectives6.3 Infrastructure7.1 Planning & Product Realization7.2 Customer Related Processes7.3 Design & Development7.4 Purchasing7.5 Production & Service

WHO is involved?Competence/Skills/Training

(examples: skills, matrix, temporary employees, OJT, Quality Auditor qualifications)4.1 General Management Requirements

4.2 Documentation requirements5.3 Quality Policy5.1 Management Commitment5.5 Responsibility, authority, communication6.2 Human Resources Training7.3 Design/development7.3.1.1 Multi-disciplinary6.1 Provision of Resources

HOW is the process done?Methods/Procedures/Techniques

(including preventive maintenance)4.1 General Management Requirements4.2 Documentation Requirements5.3 Quality Policy4.2.2 Quality Manual6.3 Infrastructure6.4 Work Environment7.1 Product Realization7.3 Design & Development7.5 Product & Service7.6 Control of Monitoring and Measuring Devices8.3 Control of Nonconforming Material

HOW MANY What measurements are used toreport the process?

Measurement and Analysis(examples: PPM, delivery, uptime, scrap, efficiencies, customer disruptions, field returns)4.1 General Management Requirements4.2 Documentation Requirements5.3 Quality Policy5.2 Customer Focus5.6 Management Review7.6 Control of Inspection, Measuring and Test Equipment8.1 statistical concept8.2 Monitoring and measuring8.3 Control of Nonconforming material8.4 Analysis of Data8.5 Improvement - MSA SPC Internal Audits

Process(Process Owner must be

identified and interviewed)(Transformation of inputs into outputsanalyzed in general terms)

Inputs(Customer inputs to process, such asQMS requirements, customerrequirements, regulatory & safety, productreliability. Inputs may be a document,materials, tooling, schedule, etc.)

Outputs(Outputs to customer, both internal orexternal customer satisfied. Outputs maybe a product, document, and should be toactual measure of effectiveness)


27/50

27 2003 AIAG

AUTO TECH 2003

EffectivenessEffectiveness

Compare outputs to inputsCompare outputs to objectives

Analyze metrics being usedDetermine metrics to be used

Track progressTake actions to drive continual improvement


28/50

28 2003 AIAG

AUTO TECH 2003

Benefits of Using the Process ApproachBenefits of Using the Process Approach

Improved understanding of interfaces andinteractions

Alignment of organization activities tocustomer metricsCustomer feedback through metrics provides

customers perspective of effectivenessCommon languageImproved organizational efficiency

Audits tailored to individual organizations Audits focused on activities and objectivesmost important to customer satisfaction


29/50

29 2003 AIAG

AUTO TECH 2003




What is New



Rev ise, Refere nce or Create Document ation




Solutions



Approach?

AreISO/TS


Met?


YES

YES

NO

NO

1 2 3

4

5

6

78

9

10

11

12

13

14


30/50

30 2003 AIAG

AUTO TECH 2003

Step 8Step 8 Documentation StrategiesDocumentation Strategies

Matrix Approach

Revise Current Documentation

Revamp System


31/50

31 2003 AIAG

AUTO TECH 2003

Matrix ApproachMatrix Approach

A matrix that shows the linkage between therequirements of ISO/TS 16949 and the organizationscurrent policies, procedures and work instructions

(example Process Identification Tool)

Advantages:

Saves time and resources by not having to recreatedocumentationPotentially reduces training needed since teammembers are already familiar with the QMS.

DisadvantagesPromotes an elemental approach based QMS

Creates another layer of documentation


32/50

32 2003 AIAG

AUTO TECH 2003

Revise Current DocumentationRevise Current Documentation

Updating current policies, procedures and workinstructions to reflect sequence, interaction andeffectiveness based on the process approach

Advantages;Evaluates and deletes unnecessary documentation

DisadvantagesExisting documentation may retain the format of anelemental approach


33/50

33 2003 AIAG

AUTO TECH 2003

Revamp SystemRevamp System

The organization focuses on customer satisfactionmetrics and creates a QMS around these

Advantages Allows an organization to take a fresh, unbiased lookat each requirement

Gain a better understanding of i ts businessprocesses, eliminate unnecessary steps and reduceexcess documentation

DisadvantagesRequires the most t ime and resources


34/50

34 2003 AIAG

AUTO TECH 2003




What is New



Rev ise, Refere nce or Create Document ation




Solutions



Approach?

AreISO/TS


Met?


YES

YES

NO

NO

1 2 3

4

5

6

78

9

10

11

12

13

14


35/50

2003 AIAG

Step 12Step 12 -- AuditsAudits

Product Audit

Manufacturing Process Audit

Quality Management System Audit

Internal Audit Plan


36/50

36 2003 AIAG

AUTO TECH 2003

Quality Management System AuditQuality Management System Audit

Review list of customers & customer specificrequirements

Identify process ownersReview process measurementsCompare business goals and objectives tocustomersUnderstand basic business processes andfollow the processReview linkages and interactions


37/50

37 2003 AIAG

AUTO TECH 2003

Quality System Audit ProcessQuality System Audit Process

Auditing Report Database

Process Mapping

Trained Auditors to ISO/TS16949 and customer specific

(such as core tools)

Quality System Auditing Process

ISO/TS 16949

ISO 19011

CustomerSpecifics

QMS Manuals

Schedule

Audit Report

RevisedSchedule

Adherence to Schedule

Tracking Processes Auditedto include all requirements

Trend analysis

QMS Procedures for Auditing

Process Audit Approach


38/50

38 2003 AIAG

AUTO TECH 2003

Manufacturing Process AuditManufacturing Process Audit

Each manufacturing processWhat are planned activities?

Does actual practice follow those plannedactivities?Do the customer metrics indicate the controlplan is effective?


39/50

39 2003 AIAG

AUTO TECH 2003

Manufacturing Process Audit FocusManufacturing Process Audit Focus

Customer ratings and customer complaintsInternal nonconformity reports

Process flow charts, PFMEA, control plans,work instructionsInternal communicationEmployee competencyQuoted production capacity

Preventive/predictive maintenance


40/50

40 2003 AIAG

AUTO TECH 2003

Product AuditProduct Audit

Inputs:DrawingsSpecificationsWork InstructionsInspection InstructionsVisual AidsFMEAControl PlanApprovedInternal NonconformitiesCustomer Complaints

Outputs:Audit ReportCorrective Actions (ifneeded)

Product Realization:Product sampling & Product inspection

List number of parts examined and those foundnonconforming

Measurements taken:

Marking/Identification

Packaging according to specification

Dimension inspection (selected dimensionsaccording to the customer or organizationsdrawing)

Visual inspection

Gauging

Physical properties (such as torque, Newtons,heat)

Chemical properties (material inspection reports)

List of any nonconformities (if found)

Corrective Action Follow-up Recommendation(if necessary)

Resource Management :Qualified AuditorsAppropriate Measurement and Test EquipmentDatabases for inputting results

Management Responsibility :Responsible management review of resultsResources assigned to perform audits

Measurement Analysis& Improvement:Audit ReportCustomer ComplaintsControl of Nonconforming Product

Product Audit


41/50

41 2003 AIAG

AUTO TECH 2003

Steps to ImplementationSteps to Implementation

ConductPre-Audit

Certif ication BodyCondu cts Document

Review

ConductCertif ication Audit

Pre-AuditDesired?

YES

NO

15

17

16

18

ConductSurv eillance Audits

At App ropriateIntervals

19

ConductRe-Certification

Aud it

20

Step 15Step 15 Documentation to CertificationDocumentation to Certification


42/50

42 2003 AIAG

AUTO TECH 2003

Step 15Step 15 -- Documentation to CertificationDocumentation to CertificationBodyBody

Number of employees, address, etc.Scope of certificationProduct design responsibili tySites to be registeredRemote activitiesQuality management systems certifications obtainedQuality manualInternal audit and management review planning andresults from previous 12 months

List of customer specific requirementsCustomer complaint statusOperational performance trends for the previous 12months minimum


43/50

43 2003 AIAG

AUTO TECH 2003

Pitfalls to AvoidPitfalls to Avoid

Pre-AuditSelecting a Certification Body

Switching Certification BodiesTimeliness of CertificationScheduling of Multiple Sites


44/50

44 2003 AIAG

AUTO TECH 2003


Preparing the QMSMeasuring the Processes

Customer Requirements


45/50

45 2003 AIAG

AUTO TECH 2003


During the auditManagement responsibility

Competence, Awareness & Training


46/50

46 2003 AIAG

AUTO TECH 2003


3 rd Party AuditorsValue added audits

Auditor qualifications

f ll d


47/50

47 2003 AIAG

AUTO TECH 2003


Post Audit ActivitiesFollow-up of nonconformances

dA di


48/50

48 2003 AIAG

AUTO TECH 2003

AppendicesAppendices

Comparison of ISO/TS 16949:2002 and QS-9000Process Identification tool

Process ExamplesQMS and Process Audit examples4 pack ExplanationTraining RecommendationsContact Information

C l iC l i


49/50

49 2003 AIAG

AUTO TECH 2003

ConclusionConclusion

Guide to transition between QS-9000 andISO/TS 16949:2002Helps companies understand the structure andimportance of the process approachFocuses on Customer SatisfactionIn addition to the guide, utilize sources such asthe IAOB, ISO, AIAG and others that havesuccessfully transitioned .


50/50

2003 AIAG

The EndThe End

Questions

aiag_mexico_city.pdf

Documents