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Two Hour ISO/TS 16949:2002Executive Overview

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Date:

OutlineTS 16949:2002 Executive Overview

Quality Management Principles Process ApproachNew/Changed Requirements related to Management Responsibility

TS 16949 Is . . .A process approach for:

Implementing an effective quality management system, and

Enhancing customer satisfaction through continual improvement

Based on ISO 9001:2000

What does ISO 9000 accomplish?Gives the organization confidence that customer requirements are being met;

Gives the customer confidence that products and services are consistent;

Provides or sustains market entry; and

Helps an organization achieve, sustain, and improve product/service quality by managing the processes that create them.

Goals for TS 16949Provide a model for continual improvement in the automotive supply chain, emphasizing defect prevention and reduction of variation;

Define fundamental quality system requirements AND customer specific requirements (i.e. TS 16949 plus) uniquely applicable to the automotive industry; and

Avoid the need for multiple certification audits.

Why Standardize Quality Management Systems?Provides a common basis for doing business and managing quality, globally;

Allows diverse companies to exchange products and services with greater confidence; and

Reduces the need to satisfy multiple (often contradictory) standards.

ISO 9000 is the Most Successful Standard in ISO History Over 500,000 registrations world-wide in over 160 countries from all continents

Over 40 sectors or industry classificationsled by: electrical/optical equipment, metal products, construction, machinery, wholesale/retail trade

but growing in acceptance by many others, including: engineering, information technology, health/social work, utilities, transportation, public administration, education, and other services.

Why did the ISO 9001/2:1994 Standards Need Revision?Bias

Wording/terms biased towards manufacturing

Problems with the 20 element model

Difficult for small businesses to adaptFlow incompatible with how companies do businessIncompatible with other models (ISO 14000 EMS e.g.)Not sufficiently forward looking

Does not smoothly facilitate the move from baseline quality to performance excellence required by evolving user and customer needs (MBNQA, e.g.).

One World One Quality SystemQS 9000 standards contain loopholes

Too many companies have only sought to meet minimum requirements and then only by twisting the intent of the existing standards

There is a growing demand for performance excellence

QS 9000 is not sufficiently performance oriented

ISO 9001:2000 is process/performance oriented, but by itself is not yet viewed as a performance excellence standard for automotive manufacturers

The Performance Pyramid

Competitive Advantage

EfficientQuality Management System

Effective Quality Management SystemBusiness Vision

Performance ExcellenceMalcolm Baldrige Criteria

Performance ImprovementTS 16949

Baseline Performance:ISO 9001:2000# 1

ISO 9001:2000Quality Management PrinciplesCustomer Focus

Leadership

Involvement of People

Process Approach

System Approach

Continual Improvement

Factual Approach to Decision Making

Mutually Beneficial Supplier Relationships

Customer FocusOrganizations depend on their customers and therefore should:

understand current and future customer needs;

meet customer requirements; and

strive to exceed customer expectations.

LeadershipLeaders should:

establish unity of purpose and direction of the organization, and

create and maintain the internal environment in which people can become fully involved in achieving the organizations objectives.

Process ApproachMonitor more than process output: (typically through inspection activities)

Monitor inputs and transformation activities as well: (i.e. define/control input, develop controls and mechanisms to manage the activity, and define/measure output in terms of desired results that are linked to established the organizations performance and improvement objectives)

What is a Process?Activity that transforms input into outputActivityInputOutputResources:

PeopleFacilities/EquipmentMaterialMethodsResults:

ProductsServicesPerformance

How is a Process Managed?ActivityInputOutputRight Resources:

Qualified PeopleRight Facilities/EquipmentCorrect MaterialsProven MethodsDesired Results:

Quality ProductsQuality ServicesCustomer SatisfactionMonitor & Measure the Processmake sure the inputs are right, the transformation activities consistently work, and the desired results are achieved, then - improve the process as needed

How is a Process Measured?ActivityInputOutputRight Resources:

Qualified PeopleRight Facilities/EquipmentCorrect MaterialsProven MethodsDesired Results:

Quality ProductsQuality ServicesCustomer Satisfaction

EfficientNo WasteEffectiveDesired Results Achieved

System ApproachIdentify, understand, and manage interrelated processes (system)

the output of one process is the input to one or more subsequent processes in the systemthese interfaces must be managed to ensure the outputs of a process meet the input requirements of related process(es) that follow

Benefits of the System ApproachClear understanding of processes and their interactions with other processes

Better control of linkages between related processes and people who perform them

Facilitates continual improvement

TS 16949 implementsthe PDCA improvement cyclePlanClause 5. Management responsibility - everything flows from Management who define the requirements for the systemClause 6. Resource management - from these requirements the resources will be identified and management must ensure they are provided and applied within the system

DoClause 7. Product (and/or service) realization - the necessary process are established and carried out

TS 16949 implementsthe PDCA improvement cycleCheckClause 8. Measurement, analysis and improvement - processes and products will be monitored and measured against policies, objectives and requirements for the product and results/opportunity for improvement reported

ActClause 8. Measurement, analysis and improvement - acting upon data reported in the check cycle, improvement actions can be taken - directly, or as an output of the Management Review process (Clause 5.6)

Involvement of PeoplePeople at all levels are the essence of an organization, andtheir full involvement enables . . .their abilities to be used . . .for the organizations benefit

Continual ImprovementContinual improvement of the organizations overall performance should be a permanent objective:

improvement activities must planned (take action to achieve a desired result) and monitored for effectiveness

Continual

Continuous

Plan Do

Act CheckQMS

Results

Baseline Performance Improvement Objective Improve Processthrough PDCA CycleMeasure/Monitor Results Against Objectives - Improve Process and Change QMS as Needed to Achieve and Sustain Desired ResultsThe QMS Sustains the Gains ofContinual Improvement

Factual Approach to Decision MakingEffective decisions are:

based on the analysis of data and information.

Performance Against Desired ResultsActions are taken when targets/goals NOT achieved, especially as they may relate customer targets/goals for:

Zero Defects (PPM)Capability (Cpk, Ppk)Efficiency (thruput, scrap, waste)On-Time Delivery (schedule adherence)Expediting Costs (premium freight)

Mutually BeneficialSupplier RelationshipsAn organization and its suppliers are inter-dependent so:

a mutually beneficial relationship enhances the ability of both to create value.

TS 16949:2002 Supplier ExpectationsISO 9001:2000 Registration, and customer approved processes for:

Advanced Product Quality Planning (APQP)Production Part Approval Process (PPAP)Process Control (Control Plan, Flow Diagrams, SPC)Containment ProcessCorrective/Preventive Action Process (utilizing 8D or other disciplined problem solving process)Targeted Improvement; e.g. quality (PPM), capability (Cpk/Ppk), schedule (on-time delivery), cost of quality (scrap, rework, etc), efficiency (productivity/throughput)

The ISO 9000:2000 standards include 3 documents...ISO 9000:2000Quality Management Systems -Fundamentals and VocabularyISO 9004:2000Quality Management Systems -Guidelines for Performance Improvements ISO 9001:2000Quality Management Systems -Requirements

Role of ISO 9000:2000Defines quality managementprinciplesterms and definitionsfundamentals:- systems approach- process approach- continual improvement

ISO 9000:2000 is a normative reference (i.e. part of the requirements), replaces:ISO 8402:1994 and ISO 9000-1:1994

Role of ISO 9001:2000Specifies quality system requirements:for achieving customer satisfactionapplicable to entire enterpriseNote:permissible exclusions (like design)must be justified, and are limited to requirements within Clause 7 - Product Realization

ISO 9001:2000 replaces:ISO 9001/2/3:1994

Role of ISO 9004:2000Provides guidelines for performance improvement, based onquality management principles and approaches defined in ISO 9000, and

continual improvement of the quality management system itself

note:however, ISO 9004 is NOT intended as aguideline for implementing or assessingimplementation of ISO 9001 requirements

ISO 9004:2000 replaces:

ISO 9004-1, 9004-2, 9004-3 & 9004-4

ISO 9001 and ISO 9004are the Consistent PairComprised of the following 8 clauses:1. Scope

2. Normative references (part of the requirements)

3. Terms and definitions

4. Quality management system

5. Management responsibility

6. Resource management

7. Product (and/or service) realization

8. Measurement, analysis & improvement

TS 16949 incorporates all ISO 9000:2000 standards and ...Customer Requirements / Guidance

Advanced Product Quality Planning (APQP) & Control PlanFailure Mode Effects Analysis (FMEA)Production Part Approval Process (PPAP)Fundamental Statistical Process Control (SPC)Measurement Systems Analysis (MSA)Quality System Assessment (QSA) Checklist ISO/TS 16949:2002Quality Management Systems - particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part organizations

Role of TS 16949Developed as a stand-alone documentIncludes ISO 9001:2000 in its entiretyNumerous additional automotive customer requirements

EXERCISE #1Pick one of the eight quality management principles and list three of the most important actions you think your organization should take in applying this principle. 1. __________________________________________________________2. __________________________________________________________3. __________________________________________________________

How well does your organization do each of the actions identified above?1. __________________________________________________________2. __________________________________________________________3. __________________________________________________________

How can top management become more involved in implementing the principles and requirements associated with TS 16949?1. __________________________________________________________2. __________________________________________________________3. __________________________________________________________

TS 16949 in a nutshellClause 4.1 Establish a quality management system and continually improve its effectiveness

a) identify processes needed for the QMSb) determine the sequence and interaction of these processesc) determine criteria and methods needed to ensure these processes are effectived) ensure availability of resources and information need to support the operation and monitoring of these processese) monitor, measure and analyze these processes, andf) implement actions need to achieved planned results and continual improvement of these processes

5.1 Management commitment - top management must demonstrate commitment to development and implementation of the quality system and continually improving its effectiveness through specific activities:Clause 5 - Management responsibilitycommunicate importance of meeting customer (and regulatory/legal) requirementsestablish quality policy and objectivesconduct management reviewsensure availability of necessary resources

QS-9000 1998 Cross Reference: 4.1.1Note: Management must provide evidence of their commitment to (i.e. involvement in) the QMS and its continual improvement

5.1.1 Process efficiency top management shall review the product realization processes and the support processes to assure their effectiveness and efficiency. Clause 5 - Management responsibility

QS-9000 1998 Cross Reference: NoneNote: Management to review product realization processes for effectiveness and efficiency; organization may also identify key manufacturing oriented processes and their associated support processes and describe how they are managed to achieve and improve effectiveness and efficiency. Review cost trends and benchmarking of key processes.

Clause 5 - Management responsibility5.2 Customer focus - in addition to commitment to specific activities, top management must:ensure customer needs and expectations are determined, turned into requirements, and that those requirements are metcustomer requirements (identified per Clause 7.2.1) must be met with the aim of enhancing customer satisfaction (a perception that must be measured per Clause 8.2.1)

QS-9000 1998 Cross Reference: 4.3.2Note: Management must pursue the enhancement of customer satisfaction; typically this is through appropriate focus on customer oriented processes (see Section 7.2): i.e. those with significant input from customers, and describe how they are managed to enhance customer satisfaction.

Clause 5 - Management responsibility5.3 Quality policy - this clause follows on from the general requirements for top management and requires them to establish quality policy that:is appropriate for the organizations purpose,includes a commitment to meeting requirements and continually improving the QMS by:establishing and periodically reviewing the quality policy for continuing suitability,establishing and reviewing measurable quality objectives for achievement, andcommunicating policy and objectives at appropriate levels throughout the organization

QS-9000 1998 Cross Reference: 4.1.1Note: Policy must include statement on commitment to continually improve QMS.

Clause 5 - Management responsibility5.4 Planning 5.4.1 Quality objectives. Must be measurable & consistent with quality policyMust be established at relevant functions and levels in the organizationMust include those needed to meet product requirements (identified per Clause 7.1 a)5.4.1.1 Supplemental top management shall define quality objectives and measurements that shall be included in the business plan and used to deploy the quality policy

QS-9000 1998 Cross Reference: NoneNote: Establish quality objectives for relevant functions and levels; objectives to be measurable.

QS-9000 1998 Cross Reference: 4.1.4 & 4.1.5Note: Business Plan requirements much less prescriptive; a process should be in place to create, disseminate and monitor quality objectives in Business Plan. The objectives should be customer focused, stipulated and deployed, measurable, measured, used to facilitate an effective and efficient review by management and utilized for corrective action and continual improvement. Quality objectives should address customer expectations and be achievable within a defined time period.

Clause 5 - Management responsibility5.4 Planning (continued)5.4.2 Quality management system planning. Top management must plan to ensure that the QMS meets the requirements of clause 4.1The integrity of the QMS must be maintained when changes are planned and implemented

Quality Policy Statement

Deliver High Quality Products On-Time at Competitive Pricesthrough Process Management and Continual Improvement

Measurable Objectives

Improve Customer Satisfaction (satisfy new customers, achieve higher levels of satisfaction of loyal customers)

Improve Supplier Performance (through timely supplier corrective action and supplier development activities)

Improve Processes(through teamwork aimed at reducing scrap, rework, waste, cycle time variation, etc.)

Improve Product Quality(through teamwork aimed at reducing defects, returns, within spec variation, etc.)

Improve On-Time Delivery Performance(through better planning and resource management)

Sample Policy and Objectives

Clause 5 - Management responsibility5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority. Responsibilities and authorities must be defined and communicated with the organization

QS-9000 1998 Cross Reference: 4.1.2Note: Greater flexibility in how responsibility and authority is documented.

Clause 5 - Management responsibility5.5 Responsibility, authority and communication 5.5.1.1 Responsibility for QualityManagement with responsibility and authority for corrective action need to be promptly informed of products and process nonconformitiesPeople responsible for product quality must have the authority to stop production for quality problemsAll shifts must have people responsible for ensuring product quality

QS-9000 1998 Cross Reference: 4.1.2.1.a, 4.1.2.2, 4.1.2.5 Note: : Documentation requirements for identifying and recording quality problems removed; added requirements to: identify responsibility for stoppage of production to correct quality problems, and to provide accountability across all shifts.

Clause 5 - Management responsibility5.5 Responsibility, authority and communication (cont.)5.5.2 Management representative. Top management shall appoint a member of management toEnsure QMS processes are established & maintainedReport to top mgmt on QMS performanceEnsure organizational awareness of customer requirements 5.5.2.1 Customer Representative. Top management must appoint someone to ensure that customer requirements are addressed.

QS-9000 1998 Cross Reference: NoneNote: Management to designate personnel to ensure customer needs are met by QMS. The customer rep should participate in decision points related to product release, engineering release and activities related to customer requirements.

QS-9000 1998 Cross Reference: 4.1.2.3Note: Representative to also ensure promotion of awareness of customer requirements. The management representative can also act as liaison with external parties on matters related to QMS.

Clause 5 - Management responsibility5.5.3 Internal communication. Top management must ensure processes are established to communicate effectiveness of the QMS.

QS-9000 1998 Cross Reference: NoneNote: Management to ensure internal communication processes are created and used to address QMS effectiveness; also see clause 7.2.3 regarding customer communications

Clause 5 - Management responsibility5.6 Management review 5.6.1 General. Top management must review the suitability, effectiveness, and adequacy of the QMS at planned intervals; and must evaluate the need for change, including changes to policy and objectives. 5.6.1.1 QMS Performance. Reviews shall include all QMS requirements and performance trends; monitoring of quality objectives; reporting and evaluation of cost of quality; and evidence (records) of achievement of quality objectives and customer satisfaction. Evidence includes quality objectives specified in the business plan.

QS-9000 1998 Cross Reference: 4.1.3, 4.1.3.1 Note: Review expanded to include QMS improvement opportunities and need for changes

QS-9000 1998 Cross Reference: 4.1. 3.1, 4.1.5 Note: Must go beyond company level data; i.e. review evidence of achievement of business plan quality objectives and customer satisfaction; benchmarking and competitive data comparisons not specified. Examples of measurement include gap analysis, timeliness, error rates and corrective action effectiveness. Cost of quality includes both internal and external costs.

Clause 5 - Management responsibility5.6 Management review 5.6.2 Review input. Specific review inputs are required including performance trends related to audit results, customer feedback, product conformance, process performance, changes that could affect the QMS, and status of actions taken, as well as recommendations for improvement.5.6.2.1 Supplemental. Review input shall include analysis of actual and potential field failures and their impact on quality, safety, and the environment

QS-9000 1998 Cross Reference: 4.14.2.1, 4.14.3Note: If the products is manufactured or distributed in a number of markets, the organization must ensure that there is a defined structure and decision process for info on field failures and/or product returns. Information should be collected in one central location and then disseminated and acted upon at all affected locations.

QS-9000 1998 Cross Reference: None Note: Specifies information on sources to be included in review. See Clause 7.3.4.1 - Monitoring must be included in management review.

Clause 5 - Management responsibility5.6 Management review 5.6.3 Review output. Decisions and actions as well as resource needs to carry them out must be documented.

QS-9000 1998 Cross Reference: None Note: Specifies information on sources to be included as outputs.

EXERCISE #2List your organizations three most significant challenges or business needs over the next 2-3 years (consider any external changes that will affect your organization):1. __________________________________________________________2. __________________________________________________________3. __________________________________________________________

What are your organizations goals and objectives?1. __________________________________________________________2. __________________________________________________________3. __________________________________________________________

How can you use TS 16949 to help deal with business needs and external challenges? _________________________________________________________________________________________________________________________________________________________________________________

Quality System AttributesWords of wisdom from Victor Schur (Sears):

A Quality System must be S.E.D.A. --- Suitable- Documented- Effective- Auditable

Words of wisdom from Ian Durand (US Technical Advisory Group to ISO TC 176):

The basis of a quality system is to say what you do, do what you say, record what you did, check the results, and act on the difference.

Use of Audits to Assess QMS Effectiveness has shifted9001:1994Internal auditEffectiveness assessed in audit reportManagement review9001:2000/TS 16949Customer satisfactionManagement determines effectiveness by analyzing all available data and informationManagement reviewInternal auditOther data

Customer Oriented Processes

The Octopus Model

Examples of COPs

COP 4.1 Customer-Oriented Process (COP) Model

Contracting Officer .

Sales Manager .

Servicing Manager .

Shipping Manager .

Engineering Manager .

Quality Manager .

Production Manager .

Market Analysis and Sales

Bid / Quote Submission

Order / Release Processing

New / Changed Product or Mfg Process?

Product and/or Manufacturing Process Design

Production

Post Delivery Servicing?

Yes

No

Inspection and Test

Warranty Workor Post Delivery Servicing

Delivery

No

Invoicing and Payment Processing

Customer Feedback and Complaint Processing

Yes

Approved by: Chief Executive OfficerSignature/Date:

Reviewed by: ISO Management RepresentativeSignature/Date:

Rev: 12/15/03

Organization:

Interaction of COPs, SOPs and MOPs

Rev 12/15/03

Support

Oriented

Processes

(SOPs)

Management Oriented Processes (MOPs)

Customer

Oriented

Processes

(COPs)

OP 6.2.2, Competence, Awareness and Training

OP 6.3, Facilities and Equipment Maintenance

OP 7.1, Product Quality Planning (includes APQP)

OP 7.2.2, Product Requirements

OP 7.3, Design and Development (includes FMEA, PPAP)

OP 7.4.1, Supplier Evaluation

OP 7.4.2, Purchasing

OP 7.5.1, Job Planning and Control

OP 7.5.2, Validation of Product Realization Processes

OP 7.5.3, Product Identification and Traceability

OP 7.5.4, Control of Customer Supplied Property

OP 7.5.5, Preservation of Product

OP 7.6, Control of Monitor/Meas. Devices (includes MSA)

OP 8.1, Statistical Techniques (includes SPC)

OP 8.2.1, Customer Satisfaction

OP 8.2.3, Monitoring and Measurement of Processes

OP 8.2.4, Monitoring and Measurement of Product

OP 8.3, Control of Nonconforming Product

OP 4.2.3, Control of Documents

OP 4.2.4, Control of Records

OP 5.6, Management Review

OP 8.2.2, Internal Audit (includes QSA)

OP 8.5, Continual Improvement

Market Analysis and Sales

X

X

X

Bid / Quote Submission

X

X

X

X

X

Order / Release Processing

X

X

X

X

X

Product or Manufacturing Process Design

X

X

X

X

X

X

X

Product or Mfg Process Validation

X

X

X

X

X

X

X

Production

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Inspection and Test

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Delivery

X

X

X

X

X

Warranty Work or Post Delivery Servicing

X

X

X

X

X

Invoicing and Payment Processing

X

X

X

X

X

Customer Feedback and Complaint Processing

X

X

X

X

X

X

X

Exercise # 2Map what you perceive to be the customer oriented process (COP) model for your organization.

Identify support oriented processes (SOPs) in place to aid in effective implementation of your organizations COPs.

Identify management oriented processes (MOPs) in place to aid in achieving management objectives or requirements of ISO/TS 16949:2002 and related customer requirements documents.

Present your COP/SOP/MOP model to the group and explain how this structure can aid in helping the organization establish/implement and effective continual improvement program.

Process Approach (Managers Define / Auditors Assess)1. Process Scope and Boundaries2. Process Flow, including:2.1 Inputs used to effect process completion2.2 Events that start process activity2.3 Activities required to complete the process2.4 Validation that process is effective2.5 Events that signal process completion2.6 Outputs resulting from process completion3.Process metrics and statistics (to monitor/measure)4.Process Change Management5.Tools used to fulfill process requirements6.Controlled Documents7.Quality Records

Turtle Diagram

Turtle Diagram (Guide), WI 8.4-2 Rev 12-15-03

WHATMaterial What are the supplied materials? Do they contribute to the making of nonconforming materials? How do you know the supplied parts are meeting requirements?

Process Equipment/ToolsHow were the equipment/tools selected for the process? Are the equipment/tools for the job adequate and available when needed?How are equipment/tools for the job identified, controlled and maintained?

What else needs to be in place prior to commencing the job?

WHODirectly Involved PartiesWho is setting the job up? Who is producing product?Who is determining the (inspection) status of the product?Who is determining the disposition of nonconforming product?Who is the process owner (responsible for managing the process)?

Linkages/Interfaces with Other Involved PartiesWhat Support Process personnel are involved? How? What supplier, customer or other external personnel are involved? How?

How is competency determined for all parties involved?

HOWProcedures/Control DocumentsHow are the process control conditions defined (i.e. what work instructions, inspection instructions, control plans, procedures governing the control of nonconforming material, etc., exists)? Are they available and used?Where is the control methodology breaking down ?

Support ProcessesWhat processes/systems are needed to support the work? (i.e. maintenance, housekeeping, logistics, storage, packaging, measuring, data analysis, etc.) Have any nonconforming materials been traced to support processes

INPUTIdentify what the customer wants/needs.

Input Requirements (specifications)

List sources of product requirements (i.e. customer, organization & regulatory requirements documents).

How were these requirements collected and reviewed for accuracy and completeness?

OUTPUTIdentify what the customer gets.

Output Requirements (criteria and records)

What output criteria are used to determine if what should have been produced has been produced?

What measures are used to demonstrate or ensure product compliance? (see measures) Consider:- ppm- delivery performance- response time- time for returned product test/analysis - quality cost

PROCESS Name/DescriptionList COP or Other Process Title

Steps/ActivitiesList Key Process Steps/Activities

MEASURES

Who decides what measures to use to judge this process?What are the metrics used to show if the process is effective?Why were these measures selected?How is data collected? Who does the analysis? How is it reported?How is data used to identify and resolve/prevent problems?What actions are taken based on the data collected?How are actions tracked to assess their impact?Has the corrective action worked?

Exercise # 3Map a customer oriented process (COP) using the deployment flowcharting technique from a pre-determined start and stop point.

Complete a TURTLE DIAGRAM (or Process Assessment Worksheet) of this COP (use tool of choice using the form and instructions included as course handouts).

Identify key process performance measures that are (or could be) applicable to this COP.

Document (or estimate) current COP performance.

Determine if current performance is acceptable or in need of improvement. If in need of improvement, establish a measurable improvement objective for this COP (i.e. can be tracked and achieved within a specified time frame), a list of recommended actions to achieve the objectives, and required resources.

Participate in a (mock) management review meeting presenting summary results of your COP data analysis, including fact based justification for recommendations.

Where can I obtain more information?On the world-wide web:ISO web sitewww.iso.orgTC 176 web sitewww.bsi.org.uk/iso-176-sc2ASQ web sitewww.asq.orgAIAG website www.aiag.orgIsoQual, Inc.websitewww.qualitymap.com

Other questions?

IsoQual, Inc. StaffEmail:isoqual@bellsouth.net or call (502) 299-6122