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QUALITY MANAGEMENT QUALITY MANAGEMENT SYSTEM SYSTEM

AN EXPSOUREAN EXPSOURE

ByBySuhas AgawaneSuhas Agawane

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

WHY KNOW QUALITY

QUALITY IS FREE

... Philips Crosby... Philips Crosby

Cost of Quality

• Internal Failure costInternal Failure cost• ScrapScrap• ReworkRework• RetestRetest• DowntimeDowntime

• Yield lossYield loss• Re-inspectionRe-inspection• DispositionDisposition

Cost of Quality

• External failure costExternal failure cost• Customer complaint processing.• Reworking of returned items.• Warranty costs.• Lost opportunity costs.

Cost of Quality

• Appraisal costAppraisal cost• Incoming material inspection.• In-process and final, inspection and test.• Maintenance and calibration of inspection and test

equipment.

Cost of Quality

• Prevention costPrevention cost• Quality planning• Incoming material

inspection• Quality system audits

• Training • Supplier assessments• New product design

reviews• Process control

Relationship between Quality Cost Elements

5

10

15

20

25

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Total Cost

Internal failure cost

Appraisal cost

Prevention cost

External failure cost

Maturity of the Quality System

QUALITY

COSTS

(%Of SALES)

DISADVANTAGES OF CUSTOMER EVALUATIONDISADVANTAGES OF CUSTOMER EVALUATION

• Expensive for customer , especially if supplier is located overseas

• Subjective nature of each assessment

• Experts , drawing conclusion on their company’s 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

Quality(3.1.1)degree to which a set of inherent

characteristics fulfils requirements

Customer Satisfaction(3.1.4)customer’s perception of the degree

to which the customer’s requirementshave been fulfilled

Capability(3.1.5)ability of an organization,system orprocess to realize a product that will

fulfill the requirements for the product

Grade(3.1.3)category or rank given to the different

quality requirements for products,processes or systems having the same

functional use

Characteristic(3.5.1)Distinguishing feature

Management(3.2.6)coordinated activities to direct

& control an organization

Top management(3.2.7) person or group of peoplewho directs & controls anOrg. at the highest level

Quality management(3.2.8)coordinated activities to

direct & control an organization with regard to

quality

System(3.2.1)set of interrelated or interacting elements

Quality policy(3.2.4)overall intentions &

direction of an organizationrelated 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 system(3.2.3)

mgt.system to direct & controlan organization with regard to

quality

Quality planning(3.2.9)part of quality mgt.focused on

setting quality objectives &specifying necessary operationalprocesses & resources to fulfill

the quality objectives

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 fulfillingquality requirements

Quality improvement(3.2.12)

part of quality mgt.focused on increasing

the ability to fulfillquality reqt.

Quality Assurance(3.2.11)

part of quality mgtfocused on providing

confidence that qualityReqts. will be fulfilled

Requirement(3.1.2)Conformity(3.6.1)

fulfillment of a requirement

Nonconformity(3.6.2)non-fulfillment of a

requirement

Defect(3.6.3)non-fulfillment of a

requirement related to an intended or specified use

Deviation permit(3.6.12)permission to depart from

the originally specifiedrequirements of a product

prior to realization

Concession(3.6.11)permission to use or release a product that does not conform to

specified requirements

Scrap(3.6.10)action on a non

conforming productto preclude its originally

intended use

Preventive action(3.6.4)action to eliminate the causeof a potential nonconformityor other undesirable potential

Corrective actions(3.6.5)action to eliminate the cause

of a detected nonconformity orother undesirable situation

Correction(3.6.6)action to eliminate a detected

nonconformity

Rework(3.6.7)action on a nonconforming

product to make it conform tothe requirements

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 onesRepair(3.6.9)

action on a nonconformingproduct to make it acceptable

for the intended use

US MIL SPECS

AQAP1 4 9

DEF. STANS. (UK)05/21 05/24 5/29

BS 5750 1979Pt1 Pt2 Pt3

Pt4 Pt5 Pt6

ISO 9000 SERIES1987, 1994,2000

Q I I

Q I I

G G G

EVOLUTION OF ISO 9000 SERIES

PROCEDURES VS. PROCESS

1. PROCEDURES ARE DRIVEN BY COMPLETION OF TASK 2. PROCEDURES ARE IMPLEMENTED

2. PROCESSES ARE OPERATED

3. PROCEDURES STEPS ARE COMPLETED BY DIFFERENT PEOPLE IN DIFFERENT DEPARTMENTS WITH DIFFERENT OBJECTIVES

4. PROCEDURES ARE DISCONTINUOUS

4. PROCESSES TO FLOW TO CONCLUSION

5. PROCEDURES FOCUS ON SATISFYING THE RULES

6 PROCEDURES DEFINE THE SEQUENCE OF STEPS TO EXECUTE A TASK

5. PROCESSES FOCUS ON SATISFYING THE CUSTOMER

6. PROCESSES TRANSFORM INPUTS INTO OUTPUTS THROUGH THE USE OF RESOURCES

7. PROCEDURES BY DRIVEN BY HUMAN 7. PROCESSES ARE DRIVEN BY PHYSICAL FORCES SOME OF WHICH MAY BE ACTIVATED BY HUMANS

8. PROCEDURES EXIST, THEY ARE STATIC 8. PROCESSES EXIST, THEY ARE DYNAMIC

9. PROCEDURES CAUSE PEOPLE TO TAKE ACTIONS AND DECISIONS

9. PROCESSES CAUSE THINGS HAPPEN

1. PROCESSES ARE DRIVEN BY ACHIEVEMENT OF A DESIRED OUTCOME

3. PROCESS STAGES ARE COMPLETED BY DIFFERENT PEOPLE WITH THE SAME

OBJECTIVES-DEPTS. DO NOT MATTER

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.

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

DoImplement the processes

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

ActTake actions to continually improve process performance

EXTERNAL

CUSTOMER

EXTERNAL

CUSTOMER

PROCESS A

InternalCustomer

InternalCustomer

Input A

Input B

Output A

Input C

Output B

Input F

Input E

Input D

Output C

Output D

Output E

Output F

Feedback

PROCESS B

PROCESS E

PROCESS C PROCESS D

PROCESS F

A P

DC

A P

DC

A P

DC

A P

DC

A P

DC

A P

DC

A P

DC

C

U

S

T

O

M

E

R

ustomer Focus

Contin al Improvements

Proces Approach

System Approach To Managemen

Involvement f People

Factual Approach To Decision

aking

adershipL

Mutually Beneficial Supplier elationship

Eight Quality Management Principles

CONTINUAL IMPROVEMENT OF QUALITYMANAGEMENT SYSTEM

Customer (ISO 9001) & other

interested parties(ISO 9004)

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

Satisfaction

Management responsibility

Measurementanalysis

improvement

Productrealization

ProduceRequirements

Resource Management

Input

Output

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 SYSTEM DOCUMENTATION

Quality

Manual

Level 1

(Overall System Description)

Quality Management System Description ,

Quality Policy & Objectives

Internal & External Use

Ext knows about organization’s control system

Procedure / Process

Manual

Level 2

(Who,What,When, Where,Why)

Description of activities/ Process

Quality Management Actions

Internal Use

Dept / Section Heads

About day-to-day operation

Work Instruction / Checklist

Manual

Level 3

(How)

Do’s & Do not do Instructions / Steps

Internal Use

Operators & Technicians

Action guidelines

Data And Record

Level 4

(Evidence/ Results/ Support Ref)

Forms , Standardized Reports, Data & Information

Internal Use

To demonstrate system compliance Data Analysis

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 Results of the review of requirements relating to the product and actions arising from the review

7.3.2 Design & development inputs!

7.3.4 Results of design and development reviews and any necessary actions.

7.3.5 Results of design and development verification and any necessary actions.

7.3.6 Results of design and development validation and any necessary actions.

7.3.7 Results of the review of changes and necessary actions.

7.4.1 Results of supplier evaluations and actions arising from the evaluations.

7.5.2 As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement.

7.5.3 The unique identification of the product, where traceability is a requirement.

7.5.4 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 Validity of previous results when measuring equipments is found not to conform with its requirements

7.6 Results of calibration and verification of measuring equipment

8.2.2 Internal audit results

8.2.4 Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product.

8.3 Nature of the product non conformities and any subsequent action taken including concessions obtained.

8.5.2 Results of corrective actions.

8.5.3 Results of Preventive actions.

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

WHAT AUDITOR LOOKS FOR:

ExistingImplementationResults

AUDITING

Of System

Compliance

Effectiveness

Performance