Download - QMS 2000 Slide Brief)
WWELCOMEELCOMETO TO
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