Audit Technique

Audit Technique about ISO 9001:2015 & GMP,HACCP

1. GMP & HACCP and ISO 9001:2015 Audit

2. Why do we have to audit??? Step 11, Principles 6 of HACCP ISO 9001:2015 Clause Requirements To ensure & maintain the effectiveness of QMS implementation Evaluate the QMS effectiveness & search for opportunities for improvement One of the tools for continuous improvement Reference ISO 19011:2011 Guidelines for auditing management system

3. Why do we have to do the audit & verification?? Verification Audit Plan Compare the results against target can do in some part of work Daily operation control Solve the daily problem can verify ourselves all QMS system informal PDCA Independence Verification VS Audit

4. What should be kept in mind during audit: Identification of recur non conformance How to deal “not accept the audit results” problem The necessary to issue “CAR” How to solve chronic problem with P-D-C-A cycle

5. Why we have to the audit ??? Management control measures One of the tools for continuous improvement Help identify non conforming and make the corrective action Ensure that the QMS is going on and complied with the requirements

6. Definitions: Audit: systematic , independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled Audit Evidence Records, statement of fact or other information which are relevant to the audit criteria and Verifiable Audit Criteria Set of policies, procedures, requirements Audit finding Result of the evaluation of the collected “audit evidence” against “audit criteria” Note: audit finding can indicate either conformity or nonconformity with audit criteria or opportunities for improvement

7. Definitions: Auditor: Person who conducts an audit Auditee : Organization being audit Competence: (audit) demonstrated personal attributes and demonstrated ability to apply knowledge and skills Non-Conformity: Non-fulfillment of a requirement Conformity: Fulfillment of a requirement

8. Definitions: Corrective action request: Record or report establish by auditor to auditee for corrective action Corrective action: Action to eliminate the cause of detected nonconformity or other undesirable solution

9. Principles of Audit: Integrity: the foundation of professionalism Fair presentation: the obligation to report truthfully and accurately Due professional care : the application of diligence and Judgment in auditing Confidentiality: security of information Independence: the audit conclusions the basis for the impartiality of the audit and objectivity of the audit conclusions Evidence-based approach: the rational method for reaching reliable and reproducible audit conclusions in a systematic audit process Related to the auditor Related to the audit process

10. Type of Audit First Party Audit Internal Audits To get the evidence of system compliance To obtain useful information for improvement Management tools to evaluate the effectiveness of Quality System 2. Second Party Audit Customer/ Supplier 3. Third Party Audit Certification Body Regulatory Authority

11. Audit Methods 2 type of audit methods System audit 2. Compliance audit

12. Audit Methods 1. System Audit Review related document against requirements First Stage of audit Analyze related Documents Use the basic knowledge of the business Must be done Before compliance audit

13. Audit Methods 2. Compliance Audit Actual work VS document Sampling by observe the related activities Interview the operator obtain the evidence Perform by independence auditor

14. Audit Program Management Planning Appoint the auditor

15. Audit Empowerment Audit program 2 0xx 1 Planning 2. Execute the program 3. Report 4. Follow up KPI Improve the process Capability of auditor Audit process How to manage the Audit process

16. Planning 1.1 Establish documented procedure for Internal audit process 1.2 Establish audit program 1.3 Preparation before audit

17. 1.1 Procedure : Internal Audit Documented the audit process Scope of audit must cover all activities in QMS Criteria for determine the audit frequency

18. 1.2 Establish audit program Audit scope must cover all activities and area Every area must be audit at least once a year Frequency of audit depends on ; the important of that area and previous audit result Audit program must be approved by authorize persons before use

19. 1. Audit according to flow process Audit Trial Department A Department B Department C Forward Trace Backward Trace 1 Purchase 2 Production 3 Storage & distribute

20. 1. Audit by activity Audit Trial 1 Purchase 2 production 3 Storage & Distribution Department A Department B Department C

21. Internal audit schedule 20xx by activities / area Area Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec FMR activity Production R & D Warehouse Audit schedule X Audit re-schedule Audit performed with CAR Audit performed no CAR Follow up schedule Follow up incomplete Follow up all CAR closed out X Prepared by ………………………………/…/….. Approved by ………………………………/…/…..

22. Internal audit schedule 20xx by activities / area Area Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec QMR activity Production R & D Warehouse Audit schedule X Audit re-schedule Audit performed with CAR Audit performed no CAR Follow up schedule Follow up incomplete Follow up all CAR closed out X Prepared by …… Mr. Bean ……/…/….. Approved by ……… Mrs. Bean …/…/….. X X

23. How to select and appoint the auditor 1.Competency Education T raining Experience Skill 2. Personal Characteristics …..Auditor must not be appointed to audit his/ her own work………

24. Auditor Should….. Ethical conduct Open mind Dealing skill Be observant Understand the process Agility Precision Decision making self confidence Auditor Should not….. Aggressive Passive Assertive

25. The audit process Step 1. Planning and preparation for audit Step 2. Executing the Audit Step 3. Report the audit results Step 4. Follow up

26. Step 1. Planning and prepare for audit

27. Step 1. Planning and prepare for audit Preparation for audit: Contact Auditee , Confirm the audit schedule Review the documents Prepare audit schedule for Each activities (document) Prepare audit check list

28. Contact Auditee , Confirm the audit schedule Benefit of schedule preparation Clarify the audit objectives Transparency ensure that the audit cover all concern activities Efficiency Review the documents Audit criteria Document related to audit operation records Problem, CAR that occur before (if any) Step 1. Planning and prepare for audit

29. Prepare audit schedule for Each activities (document) Planning the audit for each area Prepare the work for each auditor Review the important issue Step 1. Planning and prepare for audit

30. Prepare audit check list Objectives of checklist: Scope the audit activities Control the audit plan & time use reference for establish Record Step 1. Planning and prepare for audit How to Prepare audit check list Checklist should help auditor to: Where and what we are going to see What issue we are going to ask Who we are going to talk to Why we have to get the information

31. Checklist Audit Schedule Audit report form Note book Reference Pen Writing board etc. Essentials Tools for Auditor

32. Sample of Checklists Auditee Department: HR Process to be Audit…Training… Important issue of the process to be audit Your question Audit Evidence Audit Findings Audit Criteria Information Related Documents C NC O Process to ensure the staff competency How to measure the effectivenes s of the process How to ensure staff awareness

33. Workshop

34. Step 2. Executing The Audit

35. Opening Meeting Audit Closing Meeting Step 2. Executing The Audit Opening Meeting Objectives: Meeting with responsible manager in that manager Transparency Describe audit process Confirm Schedule Answer Question….(if any)

36. How we start opening meeting ???? Step 2. Executing The Audit Opening Meeting Introduce your self and responsibility Confirm objectives, scope, criteria Confirm schedule Describe the audit process, use of evidence Confirm communication channel, etc Practice help :19011:2011

37. Audit Step 2. Executing The Audit Searching for information & evidence that reflect the organization activities by: Review the documents Interview the operator Observe the process

38. Step 2. Executing The Audit Sources of Information Interview the operator Observe the activities, status and environment Review documents and records KPI Information sources

39. Step 2. Executing The Audit Auditor responsibilities: Ask question Listen to the answer Observe the process Review the finding Make records Ask for corrective action (if any)….

40. Step 2. Executing The Audit 3 Types of the question to ask during the audit… ? Opened Questions ? Probing Questions ? Closed Questions Using the topic in the checklist as a guideline…..

41. Step 2. Executing The Audit Let the auditee explain his/her job to you… How he/she does the job … What is the important part to control job quality… You have to control the length of the answer… Begin the question with: What is it to be done? How? Who, Where, When, Why Opened Questions

42. Step 2. Executing The Audit Continue from the last question To find out the issue in details For example Would you please explain more about ..... ? In case that this thing happened, what will you do? Please show me the record ............. Probing Questions

43. Step 2. Executing The Audit Closed Questions To confirm your understanding to the answer aim to make sure that it is “Yes” or “No” “Have” or “Not have” … Did you record in this form after you finish this job?

44. Step 2. Executing The Audit Please avoid to use the following type of question: Question that is not related to the objectives or scope of audit Question that lead to your desire answer or your understanding Unclear question Containing more than one question in one sentence… Active Listening: Pay attention to the answer Friendly act Ask the auditee to make conclusion if the answer is too long… Concentrate to the answer Do not interrupt auditee Give suitable time for the answer Review your understanding again before making conclusion

45. Step 2. Executing The Audit Observe Working procedure M/C, equipment, operator Material Environment Law / Regulation

46. Step 2. Executing The Audit How to confirm the finding: Review the related record Ask more than one person and compare the answer Observe the activity Mock up the situation Use checklist as a guideline and record in the checklist Record all necessary related information for example… Name and position of the interviewed person the answer ( in short form) type, name of document / document status device, equipment and ID number number of the sampling unit time and location requirement for the controlled environment (if any)

47. Step 2. Executing The Audit Conducting interviews: Interview the right person do it during the normal working environment Build the friendly situation before describe the reason of the interview and explain why you have to make record can begin by letting he/she explain her job always review the your conclusion with auditee say “Thank you for your kind cooperation” every time

48. Step 2. Executing The Audit Conducting interviews: ask the right person use Checklists record be steady and calm search for the truth select related sample inform auditee immediately when non conform was found humor Be honesty Tip…

49. Step 2. Executing The Audit If non conform is found during the audit, auditor has to inform the auditee immediately !!! Auditors meeting after audit: Review the evidence and collect the idea Discuss the unclear issues Make the conclusion Prepare the information for writing the audit report Prepare to inform the audit result to auditees

50. Sources of information Collecting: interview observe, review doc. Audit Evidence, verify Evaluate against Audit Criteria Audit Findings Reviewing Audit Conclusion Conform Non Conform Conclusion of audit Process from collecting The information to The conclusion… Inform to do the Corrective action

51. Step 2. Executing The Audit Audit conclusion: Compliance to the criteria in the audited area Effectiveness of the system, maintenance & improvement Competence of the reviewing system by management to ensure the maintenance of the system (suitable, effective, continual improvement. Audit Conclusion

52. Step 3. Report the audit result

53. Step 3. Report the audit result Classified type of audit finding Non-conformity , NC Performance that is not complied with the audit criteria or not complied with the document in quality management system Observations, O Performance that is not NC but has potential to become NC if there is no action taken CA PA

54. Step 3. Report the audit result Not comply with process in procedure, WI, etc in QMS Not comply with ISO 9001:2008 criteria Affect the quality of product Affect to effectiveness of QMS Has potential to become NC NC/CAR NC/CAR NC/CAR NC/CAR O/ PAR

55. Step 3. Report the audit result L E N R Location Evidence Nature of NC Requirement At packaging storage room, “Packaging inspection record (REC/WH-01)” date 20/5/2013 did not record the inspection result of package sp-01 which is not complied with inspection process inWI-WH-01 and ISO 9001 Clause 7.4.1 How to issue CAR

56. Workshop

57. Step 3. Report the audit result Corrective action request, CAR The audit finding that is identified as NC must be report to auditee immediately and discuss until the issue is clarified after auditor meeting, audit finding must be report to area manager focus on process not person area manager has to sign in audit report/ CAR/ PAR

58. Step 3. Report the audit result Closing Meeting (with area manager) For :- Report audit results and conclusion Let management have direct information Discuss the unclear issue, Should covered: Meeting between the auditor before making the report Conclude the overall of audit finding Closing meeting to describe the results of audit finding Next step to be taken by auditor, auditee

59. Step 3. Report the audit result Corrective & Preventive Action Searching for the root cause(s) use of P-D-C-A Analysis of related information Planning for the problem solving Execution of the plan Evaluation the effectiveness

60. Step 3. Report the audit result Information from audit process that is already classified, grouped to determine the Effectiveness of QMS Trend of implementation Corrective action 4C Correct Complete Clear Concise Audit Conclusion

61. Step 3. Report the audit result Topic to be review the audit result The evidence : clear and traceable Determination : precise & concise Report writing : easy to understand review of non-agree NC

62. Step 4. The Follow up

63. Step 4. The Follow up Audited area must completed corrective action before the follow up The follow up activities are : Review the corrective action activities Review the results of the corrective action : records,documents that is changed from the action taken

64. Step 4. The Follow up CAR Closed The corrective actions results is effective enough to ensure that the same problem will not occur again Auditor records in CAR and close the issue

65. Corrective action results is not effective or there is no action taken Record Submit to QMR or management Audit follow up that can not close Effective audit should…….. Clear objective Auditor is well trained Audit plan is well prepared Open, not a surprise audit Agree on audit results All NC are reviewed between Auditor/ auditee The audit result is used for adjust the audit frequency

66. Improvement of auditor competency Re-Training Internal meeting, sharing the Knowledge and experience Observe the Audit Activity Of other organization Persuade to do the job

67. Corrective action results is not effective or there is no action taken Record Submit to QMR or management Audit follow up that can not close Effective audit should…….. Clear objective Auditor is well trained Audit plan is well prepared Open, not a surprise audit Agree on audit results All NC are reviewed between Auditor/ auditee The audit result is used for adjust the audit frequency