INTERNAL QUALITY AUDIT COURSE QUALITY SYSTEM AUDIT PRINCIPLES C. DAS, ADDITIONAL DIRECTOR STQC...

INTERNAL QUALITY AUDIT COURSEINTERNAL 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

process for obtaining audit evidence and

evaluating it objectively to determine the

extent to which audit criteria are fulfilled



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 COURSEINTERNAL AUDIT COURSE

SYSTEM FOR QUALITY AUDITSA 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



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


INTERNAL AUDIT COURSEINTERNAL AUDIT COURSEAUDIT 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


INTERNAL AUDIT COURSEINTERNAL AUDIT COURSETYPES OF AUDIT

System

Quality Audits Process

Product

Internal Audit First Party

Second Party

External

Third Party



SCOPE OF AUDIT

•Quality System Elements

Ref. Standard ISO 9001:2000/ ISO/IEC 17025:1999•Location of the organization•Company-wide/departments•Product/Services



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


INTERNAL AUDIT COURSEINTERNAL AUDIT COURSEAUDIT 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



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



SPECIFIED REQUIREMENTS

•Basis

- Contractual requirements

- Organization’s requirements

- Standard (ISO 9001:2000/ISO/IEC 17025:19999)

Precedence to be given in the same order�



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


INTERNAL AUDIT COURSEINTERNAL 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




AUDIT SAMPLE

• Need to representative from

- People

- Processes (tests or calibrations)

- Workstations/stages

- Documents

- Records

• Checklists provide aid in drawing representative sample



ASKING RIGHT QUESTIONS

•Audit process requires auditor to hear more what the auditee has to say

- Need to restrict to ask appropriate questions



AUDIT TRAILS

• Need to follow

- Within Deptt./Area under audit

- Relevance to other deptt



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



NON-CONFORMANCES (CONTD..)

•Recognizing•Seriousness•Recording

� More details- During audit reporting



JUDGING SYSTEM EFFECTIVENESS

•Based on conclusions from audit findings


AUDIT FREQUENCY

•Status of implementation•Follow up on non-conformances from internal/external audits


INTERNAL QUALITY AUDIT COURSE INTERNAL QUALITY AUDIT COURSE


PHASES OF AUDIT

•Planning

•Execution / Preparation

Reporting

•Follow up / Closing out of Corrective action



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)



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



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’



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’



INPUTS TO CHECK LIST

•Company’s catalogues•Quality Manual, Procedures & Plans•Information from previous audits•Known quality problems•Management priorities•Auditor’s own consideration



CHECK LIST

Ref Look at Sample Look for Result

Cal Calibration 05

Proced Reports

No


ISO 9000 IN EDUCATIONAL &ISO 9000 IN EDUCATIONAL &TRAINING INSTITUTETRAINING INSTITUTE

THANK YOU



Date post:	27-Mar-2015
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