internal quality audit course performing audit stqc certification services (eastern region)
TRANSCRIPT
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Internal Quality Audit CourseInternal Quality Audit Course
PERFORMING AUDIT
STQC CERTIFICATION SERVICES (EASTERN REGION)
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INTERNAL QUALITY AUDITINTERNAL QUALITY AUDIT
PERFORMING AUDITKey issues
• Right persons / Auditee• Representative samples• Right Questions• Handling Audit Trails• Taking notes• Recognising Non-conformance* Understanding of above issues helpful in controlling audit time
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INTERNAL QUALITY AUDITINTERNAL QUALITY AUDIT
Right Auditee Responsibility /Authority
Activities Maintaining records
Danger of Hearse Loss of Time Omission of Audit scope
•
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INTERNAL QUALITY AUDITINTERNAL QUALITY AUDIT
Representative Samples
• Considerations Activities performed most of the time
What happens during Crisis
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Representative Samples
• Aspects providing inputs Quality Manual /Other documents Checklists Important process stage Records originated / Maintained Personnel involved
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Representative Samples
• Strategy to follow Horizontal Vertical
Up/ Down Stream
MixedMore Samples examined in Horizontal Approach
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ISO 17025:1999 audit consists of two parts•System audit•Technical audit
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AUDIT TECHNIQUES
•Documentation/ record review•Interview with personnel•Observation of work in progress/witnessing test/ calibration•Examination of resources•Inspection/re-inspection of products (actually getting carried out test/calibration jobs)
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ISO 9000 IN EDUCATIONAL &ISO 9000 IN EDUCATIONAL &TRAINING INSTITUTETRAINING INSTITUTE
AUDIT TECHNIQUES
•Horizontal audit: more aspects to be covered
•Vertical audit: few aspects to be covered in more depth
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• Thematic Questions• Expansive Questions• Opinion Questions• Investigative Questions• Repetitive ( Dumb ) Questions• Hypothetical Questions• Closed Questions
• For logical conclusions• Leading questions
Establishing Rapport with AuditeeMore Open-ended QuestionsAvoid Repetitive QuestionsCaution with asking Hypothetical & closed Questions
STQC CERTIFICATION SERVICES (EASTERN REGION)
Asking Right Questions
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Internal Quality Audit CourseInternal Quality Audit Course
Audit Trails• Responsibilities & Authorities defined for
activities• Reference to specified requirement• Decision to persue
• Within the area• With other Dept./Areas
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Internal Quality Audit CourseInternal Quality Audit Course
Recognizing Non-conformance• What could go wrong if the non-conformance
remains uncorrected• What is the likelihood of such a thing going wrong
Seriousness on Non-conformance can then be judged
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Internal Quality Audit CourseInternal Quality Audit Course
Recognizing Non-conformance• Minor
• Isolated case• Minor problem area which warrants attention
• Major• Significant deviations from Standard requirements
• Break down of Quality System in a Dept./Area• Significant quantity of MINORS
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Audit ProcessIssues /Practices to be avoided
• Personal Bias• Desk Audit : Audit where the action is • Competence Issue : Handle discreetly• Personal identity• Token discrepancy
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Additional Tips• Speak and ascertain from right people• Avoid Hear-say• Be nosey , but polite• Control Audit time
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INTERNAL QUALITY AUDITINTERNAL QUALITY AUDIT
Audit Reporting
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INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
Audit Reporting
• Reporting on COMPLIANCE• Reporting on NON-COPLIANCE ( Non-compliance)
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INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
Taking notes Recording Audit sample examined for Dept. audited
- Persons contacted - ISO 9000 Clauses involved- Area seen - Process stage involved- Documents examined - Records verified - Audit trails identified/followed- Compliance/Non-compliance - Reference of non-compliance
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INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
Taking notes
Record aspect to be followed up in next assessment
Positive reporting helps to determine depth in Auditing , Basis for selecting sample and judging system EFFECTIVENESS
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INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
STQC CERTIFICATION SERVICES (EASTERN REGION)
Clauseref. ofISO9001/2/3
Ref. inassessmentcheck list
Details of audit sample examined&observations on compliance.Identify persons contacted;places/work-station visited;documents and records verified
Ref. of Non-conformancereported
AUDIT REPORTING FORMAT
AREA/ACTIVITY OF AUDIT:
SIGNATURE OF AUDITOR
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INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
Non-compliance Reports• May be reviewed at various stages
• Audit• Subsequent review with MR/ Assessment team• Management review (Internal Audit)• Closing Meeting ( External Audit )• Subsequent reference by organisation , Certification body , next assessment team
• Some one has to take corrective action Raising Non-conformance reports thus assumes
special significance
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INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
Recording of Non-compliance Reports• Aspect to be considered
• Exact observation of the facts• Where was it found ?• What was found ?• Why it is a Non-compliance ?• Who was there ?• Use local Terminology• Make it retrievable• Make it helpful ( Only in Internal Audit ) : WHY ?
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INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
STQC CERTIFICATION SERVICES (EASTERN REGION)
Non-conformance reportno.
Non-Conformance details Ref of ISO9001/2 ; QSDocuments
Remarks of auditeeon correctiveactions
NON-CONFORMANCE REPORTING FORMAT
AREA/ACTIVITY OF AUDIT: DATE:
SIGNATURE OF AUDITOR SIGNATURE OF AUDITEE
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INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
STQC CERTIFICATION SERVICES (EASTERN REGION)
Non-conformance reportno.
Non-Conformance details Ref of ISO9001/2 ; QSDocuments
Remarks of auditeeon correctiveactions
NC/CD/01
ASAINST REQUIREMENTOF QSP 04, NO NEEDSASSESSMENT REPORTAND AUDIT REPORTSMADE AVAILABLE ONA NE W PAPER ONELRCTRONICMANUFACTURINGPRACTICE
4.4
NON-CONFORMANCE REPORTING FORMAT
AREA/ACTIVITY OF AUDIT: DATE:
SIGNATURE OF AUDITOR SIGNATURE OF AUDITEE
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INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
Recording of Non-compliance• Should be• SIMPLE• CRISP• NEATLY WORDED
Non-compliance should not be subjected to INTERPRETATION
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INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
Summary Report
•DEPT/AREA/ACTIVITY•AUDIT NONCONFORMANCE REPORTS•AUDIT TEAM•DATES OF ACTUAL AUDITS•TOTAL NUMBER OF NON-CONFORMANCES• NO OF NON-CONFORMANCES DUE SYSTEM NOTDEFINED•NO OF NON-CONFORMANCES DUE SYSTEM NOT•IMPLEMENTED•NO OF NON-CONFORMANCES DUE SYSTEM NOTIMPLEMENTED•SUMMARY
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INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
SYSTEM EFFECTIVENESS
• Informed judgement of Assessors
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INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
SYSTEM EFFECTIVENESS• Information from Internal failures
Possibilities• Avoidable changes in drawings, Documents /POs• Avoidable reworks , concession scraps etc.
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INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
SYSTEM EFFECTIVENESS• Information from External failures
Possibilities• Trends in Customers complaints• Status on Corrective actions arising out of external audits
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INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
SYSTEM EFFECTIVENESS• Trends
Staff attitude to Management• Access of MR to Management• Dressing up of non-compliances for TOP Management
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INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
SYSTEM EFFECTIVENESS• Trends
Management attitude• Status on Audit Report
- Commitment
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INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
SYSTEM EFFECTIVENESS• Trends
• Effectiveness in Management review• Meeting Q. Policy & Objectives
• Adequacy in Internal Quality audit• Matching with external audit
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INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
SYSTEM EFFECTIVENESS :Audit Report(External Audit)• Name of the Organisation• Scope of the Assessment• Participation in Closing Meeting• Nos of Non-Conformances Observed - No of Major - Nos. Of Minor - Nos. Minor as major - Nos where system not defined - Nos where system not implemented - Nos. Where practice not effective • Summary ( Informed Judgement ) in 200 words• Nos. Of Non-conformances closed out during Assessment• Areas not reviewed / not applicable• Recommendation
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INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
THANK YOU
STQC CERTIFICATION SERVICES (EASTERN REGION)