Performance Based Internal Quality Audit Guide

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  • 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
  • 3. 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.
    Comply with ISO requirement or document
  • 4. INTRODUCTION
    • interviews with employees and other persons;
    • observations of activities and the surrounding work environmental and conditions;
    • documents, such as policy, objectives, plans, procedures, standards, instruction, licenses and permits specifications, drawings, contracts and orders;
    • records, such as inspection records, minutes of meeting, audit reports, records of monitoring programs and the results of measurements;
    • data summaries, analyses and performance indicators;
    • information on the auditee's sampling programs and on procedures for the control of sampling and measurement processes;
    • reports from other sources, for example, customer feedback, other relevant information from external parties and supplier ratings;
    • computerized databases and web sites.
    III. SOURCE OF INFORMATION The option of source of information to find out and collect evidence for evaluating compliance degree, include;
  • 5. INTRODUCTION IV. AUDIT TRIANGLE REQUIREMENTS IMPLEMENTATION DOCUMENT COMLIANCE ADEQUACY The finding could be major for external audit Lower severity
  • 6. AUDIT PREPARATION
    • Understanding source of information
    • Knowing the applicable KPI of area being audited
    • Knowing the achievement or issue/failure of KPIs
    • Knowing the activities and understanding applicable document regarding the issue or failure
    • Step Should Be Done:
    • Contact commercial teams or VP/manager of area being audited
    • Learning the applicable documents / conduct document review
    • Identify document weaknesses if possible
    • Identify critical point of document
    • UNDERSTANDING PROCESS OF AREA BEING AUDITED
  • 7. AUDIT PREPARATION Applicable form; FRM.QAS.06
    • Availability of applicable KPI
    • 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
  • 8. 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
  • 9. AUDIT PREPARATION
    • Availability of position competence criteria
    • Availability of competence record of all employees
    • Availability of competence evaluation record, especially for new hired, mutation, or promotion process
    • Availability of training/action plan & record as applicable for any deviation from competence criteria
    • Availability of training/action effectiveness evaluation record.
    • Training management and hiring procedure as any problem in previous point (please write down the critical point of the these procedure.
    II. CHECKLIST MAKING – HR only Note: Sampling approaches, New person/position or record of employees which identified lack of competence during audit at others area.
  • 10. AUDIT PREPARATION
    • Availability of method to identify/determine customer needs/requirement
    • Availability of record regarding the monitoring of perception of customer satisfaction, (please identify the most critical concern and inform related area auditors to check its achievement)
    • Availability of record regarding the review of customer needs / concern
    • Availability of system or action plan for ensuring the fulfillment of critical customer needs/concern
    • Availability of action plan progress monitoring and its required action
    II. CHECKLIST MAKING – Customer Satisfaction Related Processes (additional) Note: Could integrated with other process, and so the checklist are integrated
  • 11. AUDIT PREPARATION
    • Availability of audit plan and management review schedule
    • Availability of record of audit result and management review result
    • Availability of monitoring system of finding and management review action
    • Timely of closing the finding (internal and external) and management review action, and it required action or others note
    • Critical point of internal audit or management review procedure
    • Critical point of document control procedure
    II. CHECKLIST MAKING – QMS Only
    • Note: the item to be covered should be determined based on audit scope or
    • objective, for example: if the focus of audit is:
    • management review in checklist only state the management review matter, and so other ways
    • Document control, in checklist only state critical point of document control procedure.
  • 12. CONDUCTING THE AUDIT
    • 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)
    • Process parameter observation
    • Data or Record review
  • 13.
    • Introduce & explain the purpose of your coming as required
    • Request to auditee to explain their KPI/Business plan goal
    • Request to auditee to explain the method & tools of monitoring KPI achievement
    • Ask the evidence of monitoring result
    • Identify un achieved or negative trend KPI, if none ask auditee to explain;
      • The problems considered critical / have significant impact, then go to #6
      • The improvement considered having significant contribution, than go to #7
    • Ask auditee to explain its cause, improvement action, Its result & further action as required
    • As report or evidence, identify the needs for document revision/creation, such as: Changes of working method, Specification, equipment that lead working method changes, etc.
    • Identify the possibility of become best practice or having weaknesses, challenge auditee for clarification.
    • Ask auditee to show the document, write down its number or changes to check the implementation.
    III. Guidance of Auditing Process Owner / Desk Audit Note: Italic text might lead to finding whether NC, negative observation, or positive observation CONDUCTING THE AUDIT
  • 14.
    • Introduce & explain the purpose of your coming as required
    • ask auditee to explain his/her area responsibilities,
    • Select the activity you intended for check refer to checklist or result of previous audit with manager, ask auditee to explain how to perform
    • Compare with required by standard/document/checklist as applicable
    • Ask auditee to explain why doing that if any deviation, please do not mention the deviation
    • Ask question about which document is applicable to the jobs, and ask to show
    • Let he/she to know the deviation, explain the losses experienced or contact his/her supervisor to explain.
    • Notify auditor for HR area or document control as applicable, for further verification.
    IV. Guidance of Implementation / Field Auditing Note: Italic text might lead to NC CONDUCTING THE AUDIT
  • 15.
    • Introduce & explain the purpose of your coming as required
    • Explain about competence issue
    • Ask auditee to show the competence record of employee having competence issue. Verify the intended issue
    • If lack of intended competency, ask auditee to show the competence evaluation of the employee to fill his/her position.
    • If not available ask more sample of employee evaluation result.
    • Ask auditee to show the record of action plan to address evaluation result and its result evaluation.
    • If no action plan, ask auditee to show general employee development plan and its implementation status & monitoring
    V. Guidance of HR Auditing If any competence issue from other area audit, then use trace backward audit
    • Note:
    • Italic text might lead to NC, especially #5 & # 7 might become major
    • If no trigger issue the audit just follow the check list by asking record sample to auditee take up to 3 new hired / new posted employee (trace forward)
    CONDUCTING THE AUDIT
  • 16.
    • 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
    • Note:
    • 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
  • 17. 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
    • etc
    CONDUCTING THE AUDIT
  • 18. VIII. Guidance of Find a Potential Finding
    • Try to probe refer to probing guidance
    • 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
  • 19.
    • 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
  • 20. 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
  • 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.