WELCOME TO QUALITY MANAGEMENT SYSTEM AN EXPSOURE By Suhas Agawane

WHY KNOW QUALITY

To grow, one has to make profit To make profit, one has to sell To sell, one has to be competitive To become competitive, one has to earn goodwill. To earn goodwill, one has to constantly improve quality To improve quality, one has to be conscious about the quality To become conscious about the quality, one has to commit on quality

To commit on quality, one has to make his intention to know about the quality

QUALITY IS FREE
... Philips Crosby

Cost of Quality
Internal Failure cost Scrap Rework Retest Downtime Yield loss Re-inspection Disposition

Cost of Quality
External failure cost Customer complaint processing. Reworking of returned items. Warranty costs. Lost opportunity costs.

Cost of Quality
Appraisal cost Incoming material inspection. In-process and final, inspection and test. Maintenance and calibration of inspection and test equipment.

Cost of Quality
Prevention cost Quality planning Incoming material inspection Quality system audits Training Supplier assessments New product design reviews Process control

Relationship between Quality Cost Elements

Q U A L I T Y C O S T S % ( f O S A L E ) S

25 20 15

Total Cost

Internal failure cost 10 5 External failure cost Appraisal cost Prevention cost

10

11

12

13

14

15

Maturity of the Quality System

DISADVANTAGES OF CUSTOMER EVALUATION Expensive for customer , especially if supplier is located overseas Subjective nature of each assessment Experts , drawing conclusion on their companys own experience , may have different perception of effectiveness of quality system Time & money spent by organization , in preparation of such evaluation visit

Requirement(3.1.2)
need or expectation that is stated , generally implied or obligatory

Grade(3.1.3)
category or rank given to the different quality requirements for products, processes or systems having the same functional use

Quality(3.1.1)
degree to which a set of inherent characteristics fulfils requirements

Capability(3.1.5)
ability of an organization,system or process to realize a product that will fulfill the requirements for the product

Characteristic(3.5.1)
Distinguishing feature

Customer Satisfaction(3.1.4)
customers perception of the degree to which the customers requirements have been fulfilled

System(3.2.1) set of interrelated or interacting elements

Management(3.2.6) coordinated activities to direct & control an organization

Top management(3.2.7) person or group of people who directs & controls an Org. at the highest level Quality policy(3.2.4) overall intentions & direction of an organization related to quality formally expressed by top mgt Quality objective(3.2.5) something sought,or aimed at,related to quality

Management system(3.2.2) system to establish policy & objectives & to achieve those objectives Quality management(3.2.8) coordinated activities to direct & control an organization with regard to quality

Quality management system (3.2.3) mgt.system to direct & control an organization with regard to quality

Continual improvement(3.2.13) recurring activity to increase the ability to fulfill requirements Quality control (3.2.10) part of quality mgt. focused on fulfilling quality requirements Quality Assurance Quality improvement (3.2.11) (3.2.12) part of quality mgt part of quality mgt. focused on providing focused on increasing confidence that quality the ability to fulfill Reqts. will be fulfilled quality reqt.

Quality planning(3.2.9) part of quality mgt.focused on setting quality objectives & specifying necessary operational processes & resources to fulfill the quality objectives

Defect(3.6.3) non-fulfillment of a requirement related to an intended or specified use Preventive action(3.6.4) action to eliminate the cause of a potential nonconformity or other undesirable potential Corrective actions(3.6.5) action to eliminate the cause of a detected nonconformity or other undesirable situation

Requirement(3.1.2) Conformity(3.6.1) fulfillment of a requirement Deviation permit(3.6.12) permission to depart from the originally specified requirements of a product prior to realization Concession(3.6.11) permission to use or release a product that does not conform to specified requirements

Nonconformity(3.6.2) non-fulfillment of a requirement

Scrap(3.6.10) action on a non conforming product to preclude its originally intended use Correction(3.6.6) action to eliminate a detected nonconformity

Rework(3.6.7) action on a nonconforming product to make it conform to the requirements

Repair(3.6.9) action on a nonconforming product to make it acceptable for the intended use

Re grade(3.6.8) alteration of the grade of a nonconforming product in order to make it conform to requirements differing from the initial ones

EVOLUTION OF ISO 9000 SERIES

US MIL SPECS AQAP 1 4 9 DEF. STANS. (UK) 05/21 05/24 5/29 Q I I

BS 5750 1979 Pt1 Pt2 Pt3 Q Pt4 G I Pt5 G I Pt6 G

ISO 9000 SERIES 1987, 1994,2000

PROCEDURES VS. PROCESS

1. 2. 3. PROCEDURES ARE DRIVEN BY COMPLETION OF TASK PROCEDURES ARE IMPLEMENTED PROCEDURES STEPS ARE COMPLETED BY DIFFERENT PEOPLE IN DIFFERENT DEPARTMENTS WITH DIFFERENT OBJECTIVES PROCEDURES ARE DISCONTINUOUS PROCEDURES FOCUS ON SATISFYING THE 5. RULES PROCEDURES DEFINE THE SEQUENCE OF STEPS TO EXECUTE A TASK PROCEDURES BY DRIVEN BY HUMAN 7. 1. 2. 3. PROCESSES ARE DRIVEN BY ACHIEVEMENT OF A DESIRED OUTCOME PROCESSES ARE OPERATED PROCESS STAGES ARE COMPLETED BY DIFFERENT PEOPLE WITH THE SAME OBJECTIVES-DEPTS. DO NOT MATTER PROCESSES TO FLOW TO CONCLUSION

4. 5. 6 7.

4.

PROCESSES FOCUS ON SATISFYING THE CUSTOMER 6. PROCESSES TRANSFORM INPUTS INTO OUTPUTS THROUGH THE USE OF RESOURCES

PROCESSES ARE DRIVEN BY PHYSICAL FORCES SOME OF WHICH MAY BE ACTIVATED BY HUMANS 8. 9. PROCESSES EXIST, THEY ARE DYNAMIC PROCESSES CAUSE THINGS HAPPEN

8. 9.

PROCEDURES EXIST, THEY ARE STATIC PROCEDURES CAUSE PEOPLE TO TAKE ACTIONS AND DECISIONS

What is meant by continual improvement?

Continual improvement requires an organization to focus on continually increasing the effectiveness and/or efficiency of its processes, to fulfill its policies and objectives. Continual improvement (where continual highlights that an improvement process requires progressive consolidation steps) responds to the growing needs & expectations of the customers & ensures a dynamic evolution of the quality management system.

Act
Take actions to continually improve process performance

Plan
How to improve next time? Establish the objectives & processes necessary to deliver results in accordance with customer requirements & the org. policies;

Check
Monitor & measure processes & product against policies, Objectives & requirements for the product & report the results

Do
Implement the processes

E X T E R N A L C U S T O M E R

A P C D Input E
PROCESS E

Output E

Input A
PROCESS A

Output A A P C D Input C
PROCESS C

A P C Input D
PROCESS D

D Output D A P C D

E X T E R N A L C U S T O M E R

Input B
PROCESS B

A P C Output B D

Output C

A P C D Internal Customer Input F

PROCESS F

Output F Internal Customer Feedback

A P C D

C
Contin Proces System Approach To Managemen Involvement Factual Approach To Decision L Mutually Beneficial Supplier

ustomer Focus al Improvements Approach

U S T O M E R

f People aking adership elationship

Eight Quality Management Principles

CONTINUAL IMPROVEMENT OF QUALITY MANAGEMENT SYSTEM

Customer (ISO 9001) & other interested parties (ISO 9004)

Management responsibility

Customer (ISO 9001) & other interested parties (ISO 9004)

Resource Management

Measurement analysis improvement

Satisfaction

Requirements

Output Input Product realization Produce

Header Clauses of ISO 9001 (2000)

4.0 Quality Management System 5.0 Management Responsibility 6.0 Resource Management 7.0 Product Realization 8.0 Measurement, analysis and improvement

Quality Manual

Level 1 (Overall System Description) Quality Management System Description , Quality Policy & Objectives

Internal & External Use Ext knows about organizations control system

Procedure / Process Manual

Level 2 Internal Use (Who,What,When, Where,Why) Dept / Section Heads Description of activities/ Process About day-to-day operation Quality Management Actions

Work Instruction / Checklist Manual

Level 3 Internal Use (How) Operators & Technicians Dos & Do not do Instructions / Steps Action guidelines Level 4 Internal Use (Evidence/ Results/ Support Ref) To demonstrate system Forms , Standardized Reports, Data & compliance Data Analysis Information

Data And Record

QUALITY SYSTEM DOCUMENTATION

MANDATORY DOCUMENTED PROCEDURES REQUIRED BY ISO 9001-2000

ISO 9001-2000 specifically requires the organization to Documented procedures for the following six activities

4.2.3 CONTROL OF DOCUMENTS 4.2.4 CONTROL OF QUALITY RECORDS 8.2.2 INTERNAL AUDIT 8.3 CONTROL OF NON-CONFORMITY 8.5.2 CORRECTIVE ACTION 8.5.3 PREVENTIVE ACTION

MANDATORY RECORDS REQUIRED BY ISO 9001-2000 5.6.1 Management reviews

6.2.2(e) Education, training, skills & experience 7.1 (d) Realization processes and resulting product meet requirements 7.2.2 7.3.2 7.3.4 7.3.5 7.3.6 7.3.7 7.4.1 7.5.2 7.5.3 7.5.4 Results of the review of requirements relating to the product and actions arising from the review Design & development inputs! Results of design and development reviews and any necessary actions. Results of design and development verification and any necessary actions. Results of design and development validation and any necessary actions. Results of the review of changes and necessary actions. Results of supplier evaluations and actions arising from the evaluations. As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement. The unique identification of the product, where traceability is a requirement. Customer property that is lost, damaged or otherwise found to be unsuitable for use.

MANDATORY RECORDS REQUIRED BY ISO 9001-2000 7.6 (a) Standards used for calibration or verification of measuring equipment where no international or national measurement standards exist. 7.6 7.6 8.2.2 8.2.4 8.3 8.5.2 8.5.3 Validity of previous results when measuring equipments is found not to conform with its requirements Results of calibration and verification of measuring equipment Internal audit results Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product. Nature of the product non conformities and any subsequent action taken including concessions obtained. Results of corrective actions. Results of Preventive actions.

Time spent in Documentation is not a Waste, but an Investment

AUDITING
Definition:
Quality auditing is systematic, independent and documented process for obtaining audit evidences and evaluating it objectively to determine the extent to which audit criteria are fulfilled.

AUDITING
AUDIT PURPOSE:
To determine whether organization is following
systems or not To check compliance to specified standard To determine effectiveness of quality system To identify & prioritize areas for improvement To check readiness for compliance audit

AUDITING
AUDITING PROCESS STAGES:

Planning Implementation Reporting Follow up

AUDITING
WHAT AUDITOR LOOKS FOR:
Existing Implementation Results
Compliance

Of System

Effectiveness Performance