Internal Quality Audit CourseInternal Quality Audit Course
PERFORMING AUDIT
STQC CERTIFICATION SERVICES (EASTERN REGION)
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
STQC CERTIFICATION SERVICES (EASTERN REGION)
INTERNAL QUALITY AUDITINTERNAL QUALITY AUDIT
Right Auditee Responsibility /Authority
Activities Maintaining records
Danger of Hearse Loss of Time Omission of Audit scope
•
STQC CERTIFICATION SERVICES (EASTERN REGION)
INTERNAL QUALITY AUDITINTERNAL QUALITY AUDIT
Representative Samples
• Considerations Activities performed most of the time
What happens during Crisis
STQC CERTIFICATION SERVICES (EASTERN REGION)
Representative Samples
• Aspects providing inputs Quality Manual /Other documents Checklists Important process stage Records originated / Maintained Personnel involved
STQC CERTIFICATION SERVICES (EASTERN REGION)
Representative Samples
• Strategy to follow Horizontal Vertical
Up/ Down Stream
MixedMore Samples examined in Horizontal Approach
STQC CERTIFICATION SERVICES (EASTERN REGION)
ISO 17025:1999 audit consists of two parts•System audit•Technical audit
STQC CERTIFICATION SERVICES (EASTERN REGION)
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)
STQC CERTIFICATION SERVICES (EASTERN REGION)
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
STQC CERTIFICATION SERVICES (EASTERN REGION)
• 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
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
STQC CERTIFICATION SERVICES (EASTERN REGION)
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
STQC CERTIFICATION SERVICES (EASTERN REGION)
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
STQC CERTIFICATION SERVICES (EASTERN REGION)
Audit ProcessIssues /Practices to be avoided
• Personal Bias• Desk Audit : Audit where the action is • Competence Issue : Handle discreetly• Personal identity• Token discrepancy
STQC CERTIFICATION SERVICES (EASTERN REGION)
Additional Tips• Speak and ascertain from right people• Avoid Hear-say• Be nosey , but polite• Control Audit time
STQC CERTIFICATION SERVICES (EASTERN REGION)
INTERNAL QUALITY AUDITINTERNAL QUALITY AUDIT
Audit Reporting
STQC CERTIFICATION SERVICES (EASTERN REGION)
INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
Audit Reporting
• Reporting on COMPLIANCE• Reporting on NON-COPLIANCE ( Non-compliance)
STQC CERTIFICATION SERVICES (EASTERN REGION)
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
STQC CERTIFICATION SERVICES (EASTERN REGION)
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
STQC CERTIFICATION SERVICES (EASTERN REGION)
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
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
STQC CERTIFICATION SERVICES (EASTERN REGION)
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 ?
STQC CERTIFICATION SERVICES (EASTERN REGION)
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
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
INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
Recording of Non-compliance• Should be• SIMPLE• CRISP• NEATLY WORDED
Non-compliance should not be subjected to INTERPRETATION
STQC CERTIFICATION SERVICES (EASTERN REGION)
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
STQC CERTIFICATION SERVICES (EASTERN REGION)
INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
SYSTEM EFFECTIVENESS• Information from Internal failures
Possibilities• Avoidable changes in drawings, Documents /POs• Avoidable reworks , concession scraps etc.
STQC CERTIFICATION SERVICES (EASTERN REGION)
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
STQC CERTIFICATION SERVICES (EASTERN REGION)
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
STQC CERTIFICATION SERVICES (EASTERN REGION)
INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
SYSTEM EFFECTIVENESS• Trends
Management attitude• Status on Audit Report
- Commitment
STQC CERTIFICATION SERVICES (EASTERN REGION)
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
STQC CERTIFICATION SERVICES (EASTERN REGION)
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
STQC CERTIFICATION SERVICES (EASTERN REGION)
INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE
THANK YOU
STQC CERTIFICATION SERVICES (EASTERN REGION)