internal quality audit course performing audit stqc certification services (eastern region)

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



Right Auditee Responsibility /Authority

Activities Maintaining records

Danger of Hearse Loss of Time Omission of Audit scope

•



Representative Samples

• Considerations Activities performed most of the time

What happens during Crisis



• Aspects providing inputs Quality Manual /Other documents Checklists Important process stage Records originated / Maintained Personnel involved



• Strategy to follow Horizontal Vertical

Up/ Down Stream

MixedMore Samples examined in Horizontal Approach


ISO 17025:1999 audit consists of two parts•System audit•Technical audit


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)


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


• 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


Asking Right Questions


Audit Trails• Responsibilities & Authorities defined for

activities• Reference to specified requirement• Decision to persue

• Within the area• With other Dept./Areas



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



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


Audit ProcessIssues /Practices to be avoided

• Personal Bias• Desk Audit : Audit where the action is • Competence Issue : Handle discreetly• Personal identity• Token discrepancy


Additional Tips• Speak and ascertain from right people• Avoid Hear-say• Be nosey , but polite• Control Audit time



Audit Reporting


INTERNAL AUDIT COURSEINTERNAL AUDIT COURSE

Audit Reporting

• Reporting on COMPLIANCE• Reporting on NON-COPLIANCE ( Non-compliance)



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



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




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


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



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 ?




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



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


Recording of Non-compliance• Should be• SIMPLE• CRISP• NEATLY WORDED

Non-compliance should not be subjected to INTERPRETATION



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



SYSTEM EFFECTIVENESS

• Informed judgement of Assessors



SYSTEM EFFECTIVENESS• Information from Internal failures

Possibilities• Avoidable changes in drawings, Documents /POs• Avoidable reworks , concession scraps etc.



SYSTEM EFFECTIVENESS• Information from External failures

Possibilities• Trends in Customers complaints• Status on Corrective actions arising out of external audits



SYSTEM EFFECTIVENESS• Trends

Staff attitude to Management• Access of MR to Management• Dressing up of non-compliances for TOP Management




Management attitude• Status on Audit Report

- Commitment




• Effectiveness in Management review• Meeting Q. Policy & Objectives

• Adequacy in Internal Quality audit• Matching with external audit



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



THANK YOU


internal quality audit course performing audit stqc certification services (eastern region)

Documents

audit sample

vertical audit

audit process issues

certification body

personal bias desk audit

signature of auditor

openended questions

quality system