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

Audit (as per ISO 9000:2000) Systematic, independent and documented 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)

Audit criteria: Set of policies, procedure or requirements 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)

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)

STQC CERTIFICATION SERVICES (EASTERN REGION) INTERNAL 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)

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)

STQC CERTIFICATION SERVICES (EASTERN REGION) INTERNAL AUDIT COURSE TYPES OF AUDIT System Quality Audits Process Product Internal Audit First Party Second Party External Third Party STQC CERTIFICATION SERVICES (EASTERN REGION)

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)

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)

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)

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)

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)

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 AUDIT COURSE INTERNAL QUALITY 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)

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)

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)

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)

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)

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

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)

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)

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)

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)

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)

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)

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)

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

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