Quality System Awareness ( ISO/TS 16949:2002)

Quality
Degree to which a set of inherent characteristics fulfills requirements.

Requirements
Need or expectation that is stated , generally implied or obligatory

System
Set of interrelated or interacting elements.

Management System
System to establish policy and objectives and to achieve those objectives.

Quality Management System

Management System to direct and control an organization with regard to Quality

Quality
Quality is Conformance with requirement Quality is fitness for purpose Quality is fitness for use Quality is User Dependent

Quality
Understand Customer needs Design the process to meet these needs

Design & develop product defect free

Use Right Equipment Ensure reliability in inputs purchased from suppliers

Give clear instruction manuals

Adhere to Safety and environment requirements Provide efficient backing service

Use of feedback from field experience

Good proper training

TO ACHIEVE CONSISTENCY IN OUTPUT

1. Customers want

Commitment
Assured quality Reliability

Satisfaction
2. Supplier wants Regular flow of orders Timely payments Technical support 3. Organization wants Profits (ROI) Growth in sales Happy customers Happy employees

Year 2000 Family of Standards

CORE STANDARDS (4)
ISO 9000 : 2000 Quality Management Systems - Fundamentals and Vocabulary

ISO 9001 : 2000

ISO 9004 : 2000

Quality Management Systems : Requirements

Quality Management Systems : Guidelines for performance improvements

ISO 19011 : 2002

Guidelines for quality and environmental management system auditing.

Contd...

CONTRASTS
1994 2000
SKILLS CONFORMITY ORDER DRIVEN QUALITY ASSURANCE PRODUCT MEASUREMENT DOCUMENTED PROCEDURES METING PRODUCT REQUIREMENTS COMPETENCE PERFORMANCE MARKET DRIVEN CUSTOMER SATISFACTION PRODUCT, PROCESS AND SYSTEM MEASUREMENT MANAGES PROCESSES MEETING NEEDS AND EXPECTATIONS OF ALL INTERESTED PARTIES

KEY POINTS IN ISO 9001:2000

PROCESS APPROACH PRINCIPLE P-D-C-A CYCLE TO MANAGE PROCESSES CONTINUAL IMPROVEMENT CUSTOMER SATISFACTION MEETING REGULATORY REQUIREMENTS

WHAT IS A PROCESS
Method Procedure,documented or not

INPUT
Examples of resources: Materials( RM ,Parts) Manpower(competent) Machinery(Infrastructure) Measurement(Testing Equipment)

TRANSFORMATION PROCESS
A value adding Transformation

OUTPUT
Result of Process

Environment( work Env.)

TRANSFORMATION OF INPUT INTO VALUE ADDED OUTPUT

Model of the Process Approach

Continual improvement of the quality management system

Management responsibility

Customers Customers Resource management Measurement, analysis and improvement Satisfaction

Input Requirements
Key

Product realization
Value-adding activities Information flow

Product

Output

F0219 Issue 1

237_1_CN.PPT/61

Process Approach
Any activity or operation which receives inputs and converts them to output is considered as a process. The standard encourages the adoption of the process approach for the management of the organisation and its processes, and as a means of readily identifying and managing the opportunities for improvement. The systematic identification and management of the processes employed within an organisation, and interactions between such processes may be referred to as the "Process approach".
Page 20 of 49

VP TQMI PUNE

JUNE 2002

Perceived Benefits of a Process Model

Provides a structure for the quality management system of an organisation that addresses all aspects of the organisation from the identification of customer needs to the realisation of desired results. Applies to any size or type of organisation. Directs management attention to both people and product. Highlights process ownership and responsibility for corrective and preventive action providing a basis for improvement.
Page 23 of 49

VP TQMI PUNE

JUNE 2002

Quality Management Systems Approach

Determining the needs and expectations of the customer and other interested parties; Establishing the quality policy and quality objectives of the organisation; Determining the processes and responsibilities necessary to attain the quality objectives; Determining and providing resources necessary to attain the quality objectives;

VP TQMI PUNE

Page 13 of 49

JUNE 2002

Quality Management Systems Approach

Establishing methods to measure the effectiveness and efficiency of each process; Applying these measures to determine the effectiveness and efficiency of each process; Determining means of preventing nonconformities and eliminating their causes; Establishing and applying a process for continual improvement of the quality management system.

VP TQMI PUNE

Page 14 of 49

JUNE 2002

Advantages
To Customers
Product conforming to the requirements Dependable and reliable product

Improved supply
Less noncompliance Competitive pricing Favorable response to changes

Advantages
To Organisation
Reduced rejection rate Improved operational results Consistency in output

Improved customer satisfaction

Increased market share Increased return on investment

Advantages
To Employees
Defined roles & responsibilities Increased job satisfaction Improved morale Better working conditions Involvement

Advantages to Suppliers and Partners

Stability
Growth Partnership and mutual understanding

Advantages to Society
Fulfillment of legal & regulatory requirements

Improved health and safety

Reduced environmental impact

8 MANAGEMENT PRINCIPLES
1. CUSTOMER FOCUSED ORGANIZATION 2. LEADERSHIP 3. INVOLVEMENT OF PEOPLE 4. PROCESS APPROACH 5. SYSTEM APPROACH TO MANAGEMENT 6. CONTINUAL IMPROVEMENT 7. FACTUAL APPROACH TO DECISION MAKING 8 8. MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIP

1. CUSTOMER FOCUSSED ORGANISATION

ORGANIZATIONS DEPEND ON THEIR CUSTOMERS AND THEREFORE SHOULD UNDERSTAND CURRENT AND FUTURE CUSTOMER NEEDS, SHOULD MEET CUSTOMER REQUIREMENTS AND STRIVE TO EXCEED CUSTOMER EXPECTATIONS A PROFIT FOCUS IS AN INWARD SEEKING FOCUS, A CUSTOMER FOCUS IS AN OUTWARD SEEKING FOCUS THE TRANSITION INWARD SEEKING FOCUS TO OUTWARD SEEKING FOCUS

2. LEADERSHIP
LEADERS ESTABLISH UNITY OF PURPOSE AND DIRECTION OF THE ORGANIZATION. THEY SHOULD AND MAINTAIN THE INTERNAL ENVIRONMENT IN WHICH PEOPLE CAN BECOME FULLY INVOLVED IN ACHIEVING THE ORGANIZATIONS OBJECTIVES. LEADERS PROVIDE A ROLE MODEL CONSISTENT WITH THE VALUES OF THE ORGANIZATION. LEADERS MEASURE THE RIGHT THINGS. LEADERS ARE RESPONSIBLE TO CREATE THE INTERNAL ENVIRONMENT.

THE TRANSITION: AGGRAVATION TO MOTIVATION

3. INVOLVEMENT OF PEOPLE
PEOPLE AT ALL LEVELS ARE THE ESSENCE OF AN ORGANIZATION AND THEIR FULL INVOLVEMENT ENABLES THEIR ABILITIES TO BE USED FOR THE ORGANIZATIONS BENEFIT. MANAGEMENT SHOULD TAP THIS SOURCE OF KNOWLEDGE, ENCOURAGE PERSONNEL TO MAKE A CONTRIBUTION & UTILIZE THEIR PERSONAL EXPERIENCE. MANAGEMENT SHOULD BE OPEN. CLOSED-DOOR MANAGEMENT LEADS TO DISTRUST. MANAGERS SHOULD OPERATE WITH INTEGRITY BY INVOLVING PEOPLE.

THE TRANSITION:

OPERATE TO CO-OPERATE

4. PROCESS APPROACH
A DESIRED RESULT IS ACHIEVED MORE EFFECTIVELY WHEN ACTIVITIES & RELATED RESULTS ARE MANAGED AS A PROCESS.
PROCESSES ADD VALUE TO THE INPUT. PROCESSES ARE DYNAMIC & THEY CAUSE THINGS TO HAPPEN. IN AN EFFECTIVE PROCESS RESULTS WILL MATCH WITH THE PURPOSE OF THE ORGANIZATION. PROCESSES NEED TO BE MANAGED EFFECTIVELY FOR THE REQUIRED RESULTS TO BE PRODUCED. THE PROCESS APPROACH TO MANAGEMENT IS ABOUT MANAGING PEOPLE.

THE TRANSITION: PROCEDURE APPROACH TO PROCESS APPROACH

5. SYSTEM APPROACH TO MGMT.

IDENTIFYING, UNDERSTANDING AND MANAGING INTERRELATED PROCESSES AS A SYSTEM CONTRIBUTES TO THE ORGANIZATIONS EFFECTIVENESS AND EFFICIENCY IN ACHIEVING ITS OBJECTIVES. A SYSTEM APPROACH TO MANAGEMENT MEANS MANAGING THE ORGANIZATION AS A SYSTEM OF PROCESSES. SYSTEM APPROACH IS DYNAMIC AND NOT STATIC. INDIVIDUAL PROCESSES MAY BE PERFORMING WELL BUT AS A SYSTEM THEY SHOULD CONTRIBUTE TO THE ORGANIZATIONS EFFECTIVENESS AND EFFICIENCY IN ACHIEVING ITS OBJECTIVES. THE TRANSITION: FUNCTIONAL APPROACH TO SYSTEM APPROACH

6. CONTINUAL IMPROVEMENT
CONTINUAL IMPROVEMENT OF THE ORGANIZATIONS OVERALL PERFORMANCE SHOULD BE A PERMANENT OBJECTIVE OF THE ORGANIZATION. THREE KEY AREAS WHERE IMPROVEMENT IS NECESSARY FOR ORGANIZATION TO ACHIEVE AND SUSTAIN SUCCESS. PERFORMANCE ------------ METHODS ---------- TARGETS IT IS A RECURRING ACTIVITY TO INCREASE THE ABILITY TO FULFILL REQUIREMENTS. CONTINUOUS MEANS WITHOUT BREAKS OR INTERRUPTIONS (eg. CONTINUOUS STATIONARY). CONTINUAL MEANS REPEATED REGULARLY AND FREQUENTLY. THE TRANSITION: ERROR CORRECTION TO COURSE CORRECTION

7. FACTUAL APPROACH TO DECISION MAKING

EFFECTIVE DECISIONS ARE BASED ON THE ANALYSIS OF DATA AND INFORMATION.
THE FACTUAL APPROACH LEADS US TO CONTROL ACTIVITIES BASED ON FACT AND NOT ON OPINIONS AND EMOTIONS. DATA COLLECTION SHOULD MEET A PURPOSE. WITHOUT A PURPOSE, DATA COLLECTION IS A WASTE OF RESOURCES. THIS PRINCIPLE CAN BE DANGEROUS IF USED IN ISOLATION AND OUT OF CONTEXT. THE TRANSITION: SUBJECTIVE TO OBJECTIVE

8. MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIP

AN ORGANIZATION AND ITS SUPPLIERS ARE INTERDEPENDENT AND A MUTUALLY BENEFICIAL RELATIONSHIP ENHANCES THE ABILITY OF BOTH TO CREATE VALUE.
SUPPLIERS NOW SUPPLY PRODUCTS AND SERVICES THAT WERE IN-HOUSE AT ONE POINT OF TIME. WITH THE REDUCTION OF SUPPLIERS PER COMMODITY, WE ARE DEPENDENT ON SUPPLIERS AS MUCH AS THEY ARE DEPENDENT ON US FOR BUSINESS. THE TRANSITION: ADVERSARIAL APPROACH TO ALLIANCE APPROACH

MANAGEMENT PRINCIPLES IN ISO 9001:2000

QMS PRINCIPLE

REFLECTION IN ISO 9001:2000

CUSTOMER FOCUSSED ORG.

COMMUNICATION WITH CUST. CARE FOR CUST. PROPERETY DETERMINATION OF CUST. N/E APPOINTMENT OF M. R. MGMT. COMMITMENT

LEADERSHIP

SETTING OF POLICY, OBJECTIES PLANNING INTERNAL COMMUNICATION CREATING AN EFFECTIVE ENV.

MANAGEMENT PRINCIPLES IN ISO 9001:2000.

INVOLVEMENT OF PEOPLE
PARTICIPATION IN DESIGN REVIEWS DEFINING OBJECTIVES, RESP. & AUTH CREATING AN MOTIVATING ENV. INTERNAL COMMUNICATIONS IDENTIFYING COMPETENCE NEEDS IDENTIFYING PROCESSES DEFINING PROCESS INPUTS/ OUTPUTS PROVIDING INFRASTRUCTURE, INFO, RESOURCES FOR PROCESSES TO FUNCTION ESTABLISHING, IMPLEMENTATION & MAINTAINING THE MANAGEMENT SYS. SEQ., INTERRELATION OF PROCESSES LINKAGE BETWEEN PROCESSES

PROCESS APPROACH

SYSTEM APPROACH TO DECISION MAKING

MANAGEMENT PRINCIPLES IN ISO 9001:2000.

CONTINUAL IMPROVEMENT
FACTUAL APP. TO DECISION MAKING MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIP

IMPROVEMENT PROCESS REVIEWING DOCUMENTS & PROCESSES FOR OPPERTUNITIES FOR IMPROVEMENT
REVIEWS, MEASUREMENTS & MONITORING TO OBTAIN FACTS CONTROL ON MEASURING DEVICES CONTROL ON SUPPLIERS EVALUATION ON SUPPLIERS ANALYSIS AND REVIEW OF SUPPLIER DATA

List of Mandatory Documented Procedures

1.
2.

Control of Documents (4.2.3)

Control of Records (4.2.4)

3.
4.

Internal Audit (8.2.2)

Control of Nonconforming product (8.3)

5.
6.

Corrective Action (8.5.2)

Preventive Action (8.5.3)

List of Records
Results of management reviews (5.6.1) Records of education, experience, training and qualifications (6.2.2e) Records to provide evidence that realisation process and resulting product meet requirements (7.1d) Results of customer requirement reviews and actions arising from reviews (7.2.2) Design and development input relating to product requirements (7.3.2) Records of design and development reviews and any necessary actions (7.3.4) Results of design and development verification and any necessary actions (7.3.5). Results of design and development validation and any necessary actions (7.3.6). Contd...

List of Records
Results of the review of design and development changes and any necessary actions (7.3.7). Results of evaluation of suppliers and any necessary actions arising from the evaluation (7.4.1). Evidence of validated processes (7.5.2d) Traceability (where it is requirement) (7.5.3) Records of customer property lost/ damaged otherwise found unsuitable (7.5.4) Results of calibration and verification (7.6a) Records of internal audit (8.2.2) Records of product conformity with acceptance criteria indicating authority responsible for release of product (8.2.4) Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained (8.3) Records of results of corrective actions taken (8.5.2e) Records of results of preventive actions taken (8.5.3d).

Introduction
ISO/TS 16949 aligns US,GERMAN,FRENCH and Italian automotive quality system standards. Together with ISO9001:2000, this standard specifies sector specific supplemental requirement. Prepared by the INTERNATIONAL AUTOMOTIVE TASK FORCE

JAPAN AUTOMOBILE MANUFACTURERS ASSOCIATION with support from ISO/TC/176

Auto Requirement

Big - 3 Ford GM Chrysler

Auto Requirement

Big - 3 UK France Italy German (supported by JAMA)

ISO 9000:94 QS - 9000 15/12/2006 obsolete AIAG - Automotive Industries Action Groups

ISO 9000:2000
ISO/TS-16949:2002 IATF - International Automotive Task Force

GOALS
Development of fundamental quality systems that provide for, continual improvement, defect prevention, reduction of variation and waste in the supply chain.
Coupled with customer-specific requirements that may apply defines the fundamental quality management system requirements for those who subscribe to this document. Intended to avoid multiple certification and to provide a common approach to a QMS.

SCOPE

In conjunction with ISO9001:2000,this defines the QMS requirements for the design/ development, production, and, when relevant, installation and servicing of automotive related products Is applicable to production and service part organisation sites where customer specified products are manufactured Is applicable to remote locations which cannot obtain stand-alone certification Applicable throughout the automotive supply chain
237_1_CN.PPT/38

F0219 Issue 1

TERMS AND DEFINITIONS

The terms and definitions given in ISO9000:2000 will be applicable

For terms which are differing from the above TS gives the definitions Some of the examples are as follows:

F0219 Issue 1

237_1_CN.PPT/39

EXAMPLES

Control Plan

Documented descriptions of the systems & process required for controlling product ( see annex A).

Error Proofing

Product and manufacturing process design and development to prevent manufacture of non-conforming products.
F0219 Issue 1 237_1_CN.PPT/40

Product Quality Planning Cycle

Feedback assessment and corrective action Product and Process validation Plan and Define Product Design & Development

Process design & Development

F0219 Issue 1

237_1_CN.PPT/41

ISO 9001:2000 / TS 16949

ISO
8.2.2 Internal audit (Contd)
The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure.

The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see 8.5.2) NOTE See ISO 10011-1, ISO 10011-2 and 10011-3 for guidance
F0219 Issue 1 237_1_CN.PPT/42

ISO 9001:2000 / TS 16949

TS 16949
8.2.2.1 Quality management system audit NEW
The organisation shall audit its quality management system to verify compliance with this Technical Specification and any additional quality management system requirements.

F0219 Issue 1

237_1_CN.PPT/43

ISO 9001:2000 / TS 16949

TS 16949
8.2.2.2 Manufacturing process audit NEW
The organisation shall audit each manufacturing process to determine its effectiveness.

F0219 Issue 1

237_1_CN.PPT/44

ISO 9001:2000 / TS 16949

TS 16949
8.2.2.3 Product audit NEW
The organisation 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.

F0219 Issue 1

237_1_CN.PPT/45

ISO 9001:2000 / TS 16949

TS 16949
8.2.2.4 Internal audit plans 4.17.1
Internal 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.

F0219 Issue 1

237_1_CN.PPT/46