internal quality audit course quality system audit principles c. das, additional director stqc...
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INTERNAL QUALITY AUDIT COURSEINTERNAL QUALITY AUDIT COURSE
QUALITY SYSTEM
AUDIT PRINCIPLES
C. DAS,
ADDITIONAL DIRECTOR
STQC CERTIFICATION SERVICES (EASTERN REGION)
INTERNAL QUALITY AUDIT COURSEINTERNAL QUALITY AUDIT COURSE
Audit (as per ISO 9000:2000)Systematic, independent and documented
process for obtaining audit evidence and
evaluating it objectively to determine the
extent to which audit criteria are fulfilled
STQC CERTIFICATION SERVICES (EASTERN REGION)
INTERNAL QUALITY AUDIT COURSEINTERNAL QUALITY AUDIT COURSE
Audit criteria: Set of policies, procedure or requirements
used as reference
Audit evidence
Records, statement of fact or other information
which are relevant to the audit criteria and
verifiable STQC CERTIFICATION SERVICES (EASTERN REGION)
INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
SYSTEM FOR QUALITY AUDITSA SYSTEMATIC INVESTIGATION OF THE INTENT, THE
IMPLEMENTATION & THE EFFECTIVENESS OF SELECTED
ASPECTS OF THE QUALITY SYSTEM OF AN ORGANISATION
•Audit, in itself, is a system having policy, procedure, resources & support•Audit is a sampling activity•Audit DOES NOT establish that there are NO DESCREPANCIES in a
Quality System•Discrepancy forms the output of an audit
STQC CERTIFICATION SERVICES (EASTERN REGION)
INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
REQUIREMENTS FOR QUALITY SYTEM AUDIT
QUALITY AUDIT IS A FORMAL ACTIVITY, CARRIED OUT AGAINST CHECK-
LIST/ PROCEDURES/POLICIES, TO INDEPENTLY EXAMINE OBJECTIVE
EVIDENCE & VERIFY COMPLIANCE WITH SPECIFIED REQUIREMENTS AND
ALSO JUDGE EFFECTIVENESS
•Formal•Independent•Objective evidence•Specified requirements•Effectiveness
STQC CERTIFICATION SERVICES (EASTERN REGION)
INTERNAL AUDIT COURSEINTERNAL AUDIT COURSEAUDIT STAGES
•STAGE I : ADEQUACY
- Is the system defined?
STANDARD TO DOCUMENTS•STAGE II : COMPLIANCE
-Is the documented System Implemented ?
: DOCUMENT TO IMPLEMENTATION•STAGE III: EFFECTIVENESS
- Is the implemented system effective ?
: IS THE DESIRED OUTPUT/OBJECTIVE ACHIEVED
STQC CERTIFICATION SERVICES (EASTERN REGION)
INTERNAL AUDIT COURSEINTERNAL AUDIT COURSETYPES OF AUDIT
System
Quality Audits Process
Product
Internal Audit First Party
Second Party
External
Third Party
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INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
SCOPE OF AUDIT
•Quality System Elements
Ref. Standard ISO 9001:2000/ ISO/IEC 17025:1999•Location of the organization•Company-wide/departments•Product/Services
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INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
AUDIT OBJECTIVES (GENERAL)
•To determine compliance/non-compliance of the Quality System•To determine effectiveness of the implemented Quality System in
meeting specified Quality objectives•To afford an opportunity to improve the Quality System
STQC CERTIFICATION SERVICES (EASTERN REGION)
INTERNAL AUDIT COURSEINTERNAL AUDIT COURSEAUDIT OBJECTIVES (SPECIFIC) INTERNAL•For evaluation of the organization’s Quality System against
the System Standard•To verify that it continues to meet the requirements•To follow up corrective action from a previous audit•To correct non-compliance before external bodies find them•As a consequence of particular circumstances
*Variation in product quality
*Organizational modification -management/policy/techniques/technology•To determine FREQUENCY of audit•To improve product quality
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INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
IMPORTANT ASPECTS TO BE CONSIDERED
•Knowledge of specified requirements•Collecting objective evidence for compliance or otherwise•Drawing representative sample•Asking right questions•Following Audit Trails•Recognizing non-conformances•Judging effectiveness• Audit Frequency
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INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
SPECIFIED REQUIREMENTS
•Basis
- Contractual requirements
- Organization’s requirements
- Standard (ISO 9001:2000/ISO/IEC 17025:19999)
Precedence to be given in the same order�
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INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
OBJECTIVE EVIDENCE
•Evidence which exists•Uninfluenced by emotion or prejudice•Can be stated•Can be documented•Is about quality•Can be quantitative (countable)•Can be qualitative (measured by degree)•Can be verified
STQC CERTIFICATION SERVICES (EASTERN REGION)
INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE OBJECTIVE EVIDENCE (CONTD..)•Available from
- Quality Manual and other documents
- Quality records
- Statement of Auditees•Objective evidence need to be
- Verifiable
- Traceable• Someone has to take corrective actions
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INTERNAL QUALITY AUDIT COURSEINTERNAL QUALITY AUDIT COURSE
INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
AUDIT SAMPLE
• Need to representative from
- People
- Processes (tests or calibrations)
- Workstations/stages
- Documents
- Records
• Checklists provide aid in drawing representative sample
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INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
ASKING RIGHT QUESTIONS
•Audit process requires auditor to hear more what the auditee has to say
- Need to restrict to ask appropriate questions
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INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
AUDIT TRAILS
• Need to follow
- Within Deptt./Area under audit
- Relevance to other deptt
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NON-CONFORMANCE•A condition averse to quality•Violation of specified requirements
BECAUSE OF•Lack of system/method/procedure
- System Non-conformance•Lack of implementation or Practice not in line with intent
- Implementation Non-conformance•System/practice not effective
- Effectiveness Non-conformance
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NON-CONFORMANCES (CONTD..)
•Recognizing•Seriousness•Recording
� More details- During audit reporting
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JUDGING SYSTEM EFFECTIVENESS
•Based on conclusions from audit findings
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AUDIT FREQUENCY
•Status of implementation•Follow up on non-conformances from internal/external audits
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INTERNAL QUALITY AUDIT COURSE INTERNAL QUALITY AUDIT COURSE
INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
PHASES OF AUDIT
•Planning
•Execution / Preparation
Reporting
•Follow up / Closing out of Corrective action
STQC CERTIFICATION SERVICES (EASTERN REGION)
INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
GUIDELINES FOR AUDITING QUALITY SYSTEMS
(ISO 10011)
• Part I : Auditing• Part II : Qualification Criteria for Quality System Auditors•Part III : Management of audit programs
ISO 19011 Guidelines on Quality and Environmental Auditing� ( in CD stage)
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INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
AUDIT PLANNING•Defined and understand audit objectives•Define SCOPE of audit•Identify RESOURCES required•Study Quality System Documentations•Workout & agree DATE of audit•Preliminary visit & LOGISTIC arrangements•Workout audit STRATEGY•Make audit PROGRAM•Prepare CHECK LIST•BRIEF audit team
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INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
AUDIT CHECK LIST•Check list defines samples•Samples, as objective evidence, permit an informed judgement•Samples must be relevant to audit objectives & representative as far as
possible•Criteria check list•Audit check list•Think in terms of
‘ What to LOOK AT’
‘ What to LOOK FOR’
STQC CERTIFICATION SERVICES (EASTERN REGION)
INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
AUDIT CHECK LIST•Check list defines samples•Samples, as objective evidence, permit an informed judgement•Samples must be relevant to audit objectives & representative as far as
possible•Criteria check list•Audit check list•Think in terms of
‘ What to LOOK AT’
‘ What to LOOK FOR’
STQC CERTIFICATION SERVICES (EASTERN REGION)
INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
INPUTS TO CHECK LIST
•Company’s catalogues•Quality Manual, Procedures & Plans•Information from previous audits•Known quality problems•Management priorities•Auditor’s own consideration
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CHECK LIST
Ref Look at Sample Look for Result
Cal Calibration 05
Proced Reports
No
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ISO 9000 IN EDUCATIONAL &ISO 9000 IN EDUCATIONAL &TRAINING INSTITUTETRAINING INSTITUTE
THANK YOU
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INTERNAL QUALITY AUDIT COURSEINTERNAL QUALITY AUDIT COURSE