INTERNAL QUALITY AUDIT (IQA) GUIDANCE 1 INTRODUCTION 2 AUDIT PREPARATION 3 CONDUCTING THE AUDIT 4 REPORT MAKING 5 REQUIREMENT AREA OF APPLICABILITY LIST
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
INTRODUCTION II. AUDIT FINDING CRITERIA NC – Non Compliance: OBS – Observation: CP – Compliance:
Documentation & practice comply with ISO requirement with some weakness(es) identified regarding auditor experience or practice in others area.
Any practice which could become best practice for others area .
The absence, or failure to implement & maintain 1 or more of quality management system requirement (ISO 9001) , or
Deviation between practice or actual with procedure, or
Condition which rise doubt base on evidence about the quality or process performance such as; Un tolerable nonprime product frequently (> 2 cases / 3 month) pass to customer, > 3 last consecutive of KPI achievement failure, etc.
Availability of action plan and its progress monitoring and further action follow up
Availability of KPIs achievement monitoring data, Identify KPIs failure or negative trends if any
Availability of problem data affecting KPIs achievement, especially the failure or negative trend.
Availability of cause analysis, Action selection and its result evaluation (CARR/PAR implementation) of significant problem.
Availability applicable document related to KPI failure or negative trend, or its related improvement action (for confirmation only)
Check the compliance of DR process of applicable document if any changes
II. CHECKLIST MAKING - GENERAL Part 1 – Off site / KPI Related / Process Owner Audit Item to be included as point check are consisted of 2 but as integral part, and made based on previous process understanding : Note: For HR please see different checklist guidance
AUDIT PREPARATION II. CHECKLIST MAKING – GENERAL ( Continued) Part 2 – On Site / Implementation Check
Critical point of applicable/related document (please write down all critical point of the document/procedure as point check)
Check the training record or DR understanding of the users if any deviation
Actual condition for non human jobs, such as: Process spec, Tools type, tools condition, etc
Record of working result or process parameter monitoring
Availability of cause analysis and or action for any deviation
introduction to auditee and explain purposes of your coming;
Confirm his/her role, ask the persons you intended for as required
Reemphasize the improvement opportunity identification aim of audit ;
I. Greeting / Opening the Audit This is essentials for ensuring the validity of evidence by interviewing the wrong person (auditee), and making auditee feel free and open to talk. Bellow are the minimum step prior detail interview with auditee.
II. Conducting Audit / Gathering Audit Evidence
Please follow the point check in the checklist by considering the source of information to
determine audit method, which might include:
Interview or activity observation (For interview: Please see interview guidance & Questioning Guidance)
Introduce & explain the purpose of your coming as required
Explain about awareness issue
Ask auditee to show the record of understanding related to intended document
If not available, ask auditee to show ask more sample of other document understanding record.
VI. Guidance of Auditing Document Controller If any lack awareness issue during other area audit
Italic text might lead to NC, especially #4 might become major
If no issue, the audit just follow critical point check in checklist by verifying record sample sample CONDUCTING THE AUDIT
VII. Guidance of Probing The Problem When find any problem, please try to probe deeper to find the real problem for ensuring the determination of right PIC, area responsible, and effectiveness of action. Since the first problem might only symptom. Such the bellow case: Employee setting the temperature deviate from spec
Bellow are the list of possible real problem:
Ineffective training management
Ineffective equipment maintenance which caused setting difficulty
Lack of management commitment about resource provision
Ineffective document control system
Ineffective communication system, since the problem not forwarded to responsible area
Take copy of evidence or write the data of evidence
Find out related losses/benefits of the finding, might from previous experience by asking employee supervisor, asking process customer external or internal as required.
In order make value added finding, knowing the real problem and having evidence between finding and losses or benefits is essentials. Bellow are the step after identify potential finding. Give marker / identification to the potential finding notes in audit note for easier report making. CONDUCTING THE AUDIT
interviews should be held with persons from appropriate levels and functions performing activities or task within the scope of that audit;
interviews should be conducted during the normal working hours and, where practical, at the normal workplace of the person being interviewed;
every attempt should be made to put the person being interviewed at ease prior to and during the interview;
the reason for the interview and any note taking should be explained;
interviews can be initiated by asking the persons to describe their work;
questions that bias the answers (i.e. leading questions) should be avoided;
the results from the interview should be summarized and reviewed with the interviewed person;
the interviewed persons should be thanked for their participation and cooperation.
IX. GUIDANCE – CONDUCTING INTERVIEW Interviews are one of the important means of collecting information and should be carried out in a manner adapted to the situation and the person interviewed. However, the auditor should consider the following: CONDUCTING THE AUDIT
REPORT MAKING I. GUIDANCE – COMPILING AUDIT RESULT Audite not should be compiled in appropriate manner to make report which understandable by auditee and traceable for the future follow up process, bellow are the step:
Sort identified potential finding its associate evidence
Evaluate with applicable audit criteria, try to closest ISO requirement as possible for NC.
Determine the finding category
Update the criteria of applicable point check in checklist, write the problem into note/ Comment column
Contact MR for any issue
Problem & its evidence Audit Criteria Finding Category
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.
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)
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.