INTERNAL QUALITY AUDIT COURSE QUALITY SYSTEM AUDIT PRINCIPLES

INTERNAL QUALITY AUDIT COURSE QUALITY SYSTEM AUDIT PRINCIPLES C. DAS, ADDITIONAL DIRECTOR STQC CERTIFICATION SERVICES (EASTERN REGION)

INTERNAL 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 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 COURSE SYSTEM FOR QUALITY AUDITS A 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 COURSE REQUIREMENTS FOR QUALITY SYTEM AUDIT QUALITY AUDIT IS A FORMAL ACTIVITY, CARRIED OUT AGAINST CHECKLIST/ 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 COURSE AUDIT 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 COURSE TYPES OF AUDIT Quality Audits Internal Audit System Process Product First Party Second Party External Third Party STQC CERTIFICATION SERVICES (EASTERN REGION)

INTERNAL 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 STQC CERTIFICATION SERVICES (EASTERN REGION)

INTERNAL 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 COURSE AUDIT 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 STQC CERTIFICATION SERVICES (EASTERN REGION)

INTERNAL 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 STQC CERTIFICATION SERVICES (EASTERN REGION)

INTERNAL 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 STQC CERTIFICATION SERVICES (EASTERN REGION)

INTERNAL 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 QUALITY AUDIT COURSE INTERNAL 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 STQC CERTIFICATION SERVICES (EASTERN REGION)

INTERNAL AUDIT COURSE AUDIT SAMPLE • Need to representative from - People - Processes (tests or calibrations) - Workstations/stages - Documents - Records • Checklists provide aid in drawing representative sample STQC CERTIFICATION SERVICES (EASTERN REGION)

INTERNAL 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 STQC CERTIFICATION SERVICES (EASTERN REGION)

INTERNAL AUDIT COURSE AUDIT TRAILS • Need to follow - Within Deptt. /Area under audit - Relevance to other deptt STQC CERTIFICATION SERVICES (EASTERN REGION)

INTERNAL AUDIT COURSE 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 STQC CERTIFICATION SERVICES (EASTERN REGION)

INTERNAL AUDIT COURSE NON-CONFORMANCES (CONTD. . ) • Recognizing • Seriousness • Recording More details- During audit reporting STQC CERTIFICATION SERVICES (EASTERN REGION)

INTERNAL AUDIT COURSE JUDGING SYSTEM EFFECTIVENESS • Based on conclusions from audit findings STQC CERTIFICATION SERVICES (EASTERN REGION)

INTERNAL QUALITY AUDIT COURSE AUDIT FREQUENCY • Status of implementation • Follow up on non-conformances from internal/external audits STQC CERTIFICATION SERVICES (EASTERN REGION)

INTERNAL AUDIT COURSE PHASES OF AUDIT • Planning • Execution / Preparation Reporting • Follow up / Closing out of Corrective action STQC CERTIFICATION SERVICES (EASTERN REGION)

INTERNAL 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) STQC CERTIFICATION SERVICES (EASTERN REGION)

INTERNAL 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 STQC CERTIFICATION SERVICES (EASTERN REGION)

INTERNAL 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 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 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 STQC CERTIFICATION SERVICES (EASTERN REGION)

INTERNAL AUDIT COURSE CHECK LIST Ref Look at Calibration Proced Reports No Sample 05 Look for Result STQC CERTIFICATION SERVICES (EASTERN REGION)

ISO 9000 IN EDUCATIONAL & INTERNAL QUALITY AUDIT COURSE TRAINING INSTITUTE THANK YOU STQC CERTIFICATION SERVICES (EASTERN REGION)