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Performance Based Internal Quality Audit Guide
1. INTERNAL QUALITY AUDIT (IQA) GUIDANCE 1 INTRODUCTION 2 AUDIT PREPARATION 3 CONDUCTING THE AUDIT 4 REPORT MAKING 5 REQUIREMENT AREA OF APPLICABILITY LIST
2. INTRODUCTION AUDIT systematic, independent and documented process for obtaining audit evidence (3.3) and evaluating it objectively to determine the extent to which the audit criteria (3.2) are fulfilled NOTE 1 Internal audits, sometimes called first-party audits, are conducted by, or on behalf of, the organization itself for management review and other internal purposes, and may form the basis for an organization’s self-declaration of conformity. In many cases, particularly in smaller organizations, independence can be demonstrated by the freedom from responsibility for the activity being audited. AUDIT CRITERIA set of policies, procedures or requirements NOTE Audit criteria are used as a reference against which audit evidence (3.3) is compared. AUDIT FINDING results of the evaluation of the collected audit evidence (3.3) against audit criteria (3.2) NOTE Audit findings can indicate either conformity or nonconformity with audit criteria or opportunities for improvement. I. TERM & DEFINTION
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5. INTRODUCTION IV. AUDIT TRIANGLE REQUIREMENTS IMPLEMENTATION DOCUMENT COMLIANCE ADEQUACY The finding could be major for external audit Lower severity
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21. REPORT MAKING II. GUIDANCE – FINDING STATEMENT WRITING(REPORT MAKING) In order to make report which understandable by auditee and traceable for the future follow up process, finding statement should consist the component bellow : P roblem – Statement of the problem encountered, suggested the statement of weakness against ISO requirement section, eg: Ineffectiveness of training management… Lack of evidence for ensuring the competence of employee… Unable to convince the provision of competence employee…. L ocation – Statement of area where the evidence observed, eg: MCL entry… Warehouse team… CPL lab…. O bjectives evidence – Statement of evidences founded, eg: Operator A have no competence evaluation report an, and not well understand how to set temperature X… R eference – Statement of the audit criteria not fulfilled, eg: This not comply with ISO 9001 requirement clause 6.2 Note:The sequence can be randomized, such as POLR, RPOL, RPLO, etc.
22. REPORT MAKING II. GUIDANCE – FINDING STATEMENT WRITING(REPORT MAKING) continued Sample of correct statement: It is observed that training management not effective as it founded at MCL entry area 3 operator (a,b,c) unable to set the temperature station x correctly, and they have no competency evaluation record . It’s not comply with ISO 9001 requirement clause 6.2 Incomplete Statement Training management not effective at MCL entry area . It’s not comply with ISO 9001 requirement clause 6.2 ( no objective evidence, debatable by auditee, & difficult to address the right employee ) MCL entry operator unable to set the temperature station x correctly, and they have no competency evaluation record . (no problem statement uneasy to catch bigger issue, No clear evidence, no reference to judge the NC)
23. REQUIREMENT AREA OF APPLICABILITY LIST General 7.5.1 11. Sales, MO, PPIC, Finance 7.2 8 Product Development 7.3 9. Purchasing 7.4 10. General 7.1 7 MFG, Maintenance, W/H 6.4 6 Maintenance, MFG, IT 6.3 5 HR 6.2 4 General 6.1 3 General 5 2 General 4 1 Applicable Area Requirement No. No. General 8.5 22 General 8.2.3 19. MFG, W/H 8.3 20. General 8.4 21 Maintenance, MFG 7.6 16. CS 8.2.1 17. General 8.2.2 18. Exclude 7.5.4 14. W/H, MFG 7.5.5 15. MFG 7.5.2 12. MFG, W/H 7.5.3 13. Applicable Area Requirement No. No.
