Xin Sheng IMS ISo 9001, 14001 45001.pptx

IMS ISo 9001, 14001 45001

1. INTEGRATED MANAGEMENT SYSTEM ISO 9001, ISO 14001 & ISO 45001 AWARENESS & INTERNAL AUDITING BY PARABAKARAN

2. Instructor Introduction 2 Professional Summary: With over 15 years of comprehensive experience in Environmental Safety and Health (HSE), Parabakaran Balasubramaniam is a seasoned professional with specialized expertise in delivering impactful training programs. He holds a Master's Degree in Environmental Safety and Health from the University Malaysia Pahang and has dedicated 5 years specifically to the field of HSE training and consultancy. Key Skills and Competencies: Extensive knowledge in environmental safety regulations and compliance standards. Proven track record in designing and delivering engaging and effective HSE training modules. Strong understanding of risk assessment methodologies and hazard control strategies. Skilled in conducting safety audits and implementing corrective measures. Excellent communication and interpersonal skills for effective training delivery

3. Course learning objectives Better understanding of IMS components requirements. Application of the requirements in mono systems Application of the requirements in multi system Integration of the requirements into a single system (IMS) Auditing knowledge & skills Auditing of single, multi systems & IMS

4. CONCEPTS & PRINCIPLES

5. Summary of the Requirements of the Management System Standards ( OHSMS , QMS , EMS )

6. INTEGRATED MANAGEMENT SYSTEM PROCESS MAP

7. Annex SL The new standard adopts the HARMONISED STRUCTURE and terminology of Annex SL (used for the development of all new ISO Management System Standards) HarmonisedStructure - identical core text and common terms and core definitions for use in all Management System Standards: purpose - enhance the consistency and alignment of different management system standards organisations that integrate multiple standards (e.g. EMS,QMS,FSMS) will see the most benefit uses simplified language and writing styles to aid understanding and consistent interpretations of requirements. Benefits of implementing more than one MSS: Seamless integration. Shorter learning curve. Less cumbersome documentation.

8. Annex SL : high level structure Benefits Provides a common language and structure for ISO MS Standards

9. IMS Documentation Requirements Manual Procedures Process Flow Chart Standard Operating Procedures Exhibits Blank sample formats Plans OHS Policies Sample filled Aspects and Impacts Sample filled HIRA- Hazard and Risk sheet Filled formats EQHSMS Audit checklist Sample Risk Assessment Sheet

10. Context of the Organization Leadership Planning Support Operation Performance evaluation Improvement IMS Manual It covers sample copy of system manual and clause-wise details on how ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018 systems are implemented. It covers the context of organization, sample policy, objectives, scope, organizations structure as well as macro level each requirements from 4 to 10 of ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018 on how it is implemented in the organization. List of Manual

11. IMS Procedures IMS documents covers a sample copy of mandatory procedures as per ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018 covering all the details like purpose, scope, responsibility, how procedure is followed as well as the list of exhibits, reference documents and formats. List of Procedures Procedure for identification of compliance obligations Procedure for communication, participation and consultation Procedure for operational control Procedure for emergency preparedness response Procedure for monitoring and measurement Procedure for document and data control Procedure for internal audit

12. IMS Process Flow Chart It covers guideline for processes, flow chart and process model useful for process mapping. It covers process flow chart and activities of all the main and critical processes as listed below with input-output matrix for organization. It helps any organization in process mapping as well as preparing process documents for own organization. List of Process flow chart Process Flow Chart of Customer Service Process Flow Chart of Marketing Process Flow Chart of Production Process Flow Chart of Purchase Process Flow Chart of Quality Control Process Flow Chart of Research And Development

13. Standard Operating Procedures SOP for Diesel Generator Set SOP for Air Compressor SOP for Chilling Plant SOP for Hot Air Generator SOP for Change Control SOP for Ware House Operations SOP for Operation of Power Plant SOP for General Follow- up SOP for Cleaning & Washing SOP for Emergency plant shutdown It covers a guideline to establish controls on significant hazards, work instructions for operators as well as standard operating procedures. List of SOPs SOP for Handling of lab chemicals SOP for Material Safety Data Sheet SOP for Physical and environmental security SOP for Pre- startup safety review SOP for Management of Change SOP for Health and Safety committee SOP for Legal and other requirements SOP for Chemical Reaction SOP for Product Withdrawal SOP for Scrap management

14. IMS Exhibits IMS documents covers Skill Requirements, Disposal Of Non– Conforming Products, Objective Plan, Operational Control Plan, Matrix, Quality Plan, Organizational Knowledge, Communication Need and Expectations of Interested Parties etc. List of Exhibits Skill requirements Objectives and target Operational control plan Quality plan Material specifications Organizational knowledge Need and expectations of interested parties

15. IMS Blank Sample Formats List of Blank Formats Change Note Master List of Records Audit Plan Internal Audit Non–Conformity Report Communication Report Management review meeting Quality Objective Plan Corrective Action Report Investigation Report It covers a sample copy of blank forms that are required to maintain records as well as establish control and create system in the organization. Safety Inspection Check List Fire Frightening checklist Eye wash / shower check list Location List of Fire Extinguishers Ambulance Review Checklist Vehicle check report Emergency siren testing report Wind shock inspection report Pre- Startup Safety Review Form

16. IMS Policies List of Policies Electrical Work policy and standard Working at Height policy and standard Safe Driving policy and standard Work Permit policy and standard Working in Office policy and Office Safety standard Subcontractor Selection and OHS Controls policy and standard Incident Investigation and Reporting policy and standard IMS documents covers sample copy of policies for OHS.

17. Sample Filled Aspects & Impacts The ready to use Aspects and Impacts in filled form is given to prepare the aspects and impacts document for the organization. List of Aspects - Impacts Aspect- Impact for Engineering area Aspect- Impact for Environment area Aspect- Impact for ETP area Aspect- Impact for General area Aspect- Impact for production area Aspect- Impact for Waste disposal area

18. Sample filled HIRA- Hazard & Risk sheet The ready to use HIRA in filled form is given to prepare the HIRA document for the organization. List of HIRA Hazard- risk assessment sheet for Electrical area Hazard- risk assessment sheet for Engineering area Hazard- risk assessment sheet for ETP area Hazard- risk assessment sheet for General area Hazard- risk assessment sheet for Production area Hazard- risk assessment sheet for Utility services area Hazard- risk assessment sheet for Waste disposal area

19. IMS Filled Formats Change Note Master List of Records Audit Plan Internal Audit Non–Conformity Report Communication Report Training Report External Provider Registration Form It covers a sample copy of filled forms required to maintain records as well as establish control and create system in the organization. List of Filled Formats Spray Dryer Log Sheet Process change form Research and Development Plan Design Review Report pH Meter Calibration Report Gate Pass Service Report

20. EQHSMS Audit checklist IMS documents covers audit questions based on the ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018 requirements for each department as per the list of departments given below. Sample risk assessment sheet The ready-to-use risk template in editable form is given to prepare the risk document for the organization. It is given in an excel format and can be used as a template.

21. ISO 45001:2018 ISO 9001:2015 ISO 14001:2015 1 SCOPE 1 SCOPE 1 SCOPE 2 NORMATIVE REFERENCES 2 NORMATIVE REFERENCES 2 NORMATIVE REFERENCES 3 TERMS AND DEFINITIONS 3 TERMS AND DEFINITIONS 3 TERMS AND DEFINITIONS SIMILARITIES DIFFERENCES Generic requirements Performance improvement All can be used for certification No exclusion in EMS & OHSMS Scope EMS and OHSMS can be used in parts EMS & OHSMS no normative references All have different focuses

22. Clause 4: Context of the Organization ISO 45001:2018 ISO 9001:2015 ISO 14001:2015 4.1 Understanding the organization & its context 4.1 Understanding the organization & its context 4.1 Understanding the organization & its context SIMILARITIES DIFFERENCES Determination of relevant internal issues Determination of relevant external issues Climate change EMS emphasize actual and potential environmental issues. QMS is specific on monitoring and reviewing QMS (notes) listed the possible internal and external issues The focuses are different

23. Clause 4: Context of the Organization ISO 45001:2018 ISO 9001:2015 ISO 14001:2015 4.2 Understanding the needs and expectations of workers and other interested parties 4.2 Understanding the needs and expectations of interested parties 4.2 Understanding the needs and expectations of interested parties SIMILARITIES DIFFERENCES Determination of relevant interested parties Determination of relevant requirements of the interested parties Climate change QMS is specific on monitoring and reviewing Determining EMS and OHSMS compliance/legal rqts . The focuses are different

24. Clause 4: Context of the Organization ISO 45001:2018 ISO 9001:2015 ISO 14001:2015 4.3 Determining the scope of the OHS mgt system 4.3 Determining the scope of the QMS 4.3 Determining the scope of the EMS SIMILARITIES DIFFERENCES Determine boundaries and applicability Consider 4.1 and 4.2 Document scope OHS considers planned and performed works EMS considers units, functions and physical boundaries EMS requires scope to be available to interested parties EMS considers controls and influence QMS requires justification for exclusion

25. Clause 4: Context of the Organization ISO 45001:2018 ISO 9001:2015 ISO 14001:2015 4.4 OH & S management system 4.4 QMS & its processes (Title) - 4.4.1 (about QMS and its processes ) 4.4.2 (about documented information) 4.4 Env. management system SIMILARITIES DIFFERENCES Establish, implement, maintain & improve MS Establishing processes and their interactions QMS is detailed EMS requires usage of knowledge gained in 4,1 and 4,2

26. Clause 5: Leadership ISO 45001:2018 ISO 9001:2015 ISO 14001:2015 5.1 Leadership and commitment 5.1 Leadership and commitment (Title) 5.1.1 General 5.1.2 Customer focus 5.1 Leadership and commitment SIMILARITIES DIFFERENCES Taking responsibilities for commitments of the MS Ensuring assigned responsibilities OHS requires establishing OHS culture process for preventing reprisal attack Process for consultation and participation Supporting safety committees

27. Clause 5: Leadership ISO 45001:2018 ISO 9001:2015 ISO 14001:2015 5.2 OH & S policy 5.2 Policy (Title) 5.2.1 Establishing the quality policy 5.2.2 Communicating the quality policy 5.2 Environmental policy SIMILARITIES DIFFERENCES Appropriateness of purpose Compliance to requirements Continual improvement Documented Framework for objectives EMS requires commitment to protect environment EMS insist on comm. to interested parties OHS requires commitment to eliminate hazards & risks and consultation & participation

28. Clause 5: Leadership ISO 45001:2018 ISO 9001:2015 ISO 14001:2015 5.3 Organizational roles, responsibilities, accountabilities and authorities 5.3 Organizational roles, responsibilities and authorities 5.3 Organizational roles, responsibilities and authorities SIMILARITIES DIFFERENCES Assigning responsibilities for MS Establishing Reporting OHSMS specifically requires that responsibilities be documented QMS requires promotion of customer focus and protection of QMS integrity

29. Clause 5: Leadership ISO 45001:2018 ISO 9001:2015 ISO 14001:2015 5.4 Consultation and participation of workers --- --- SIMILARITIES DIFFERENCES NA OHS requires Processes for consultation and participation of all staff. Remove barriers and obstacles Specific consultation and participation requirements for non managerial staff

30. Clause 6: Planning ISO 45001:2018 ISO 9001:2015 ISO 14001:2015 6.1 Actions to address risks & opportunities 6.1 Actions to address risks & opportunities 6.1 Actions to address risks & opportunities 6.1.1 General 6.1.1 (about requirements when planning QMS) 6.1.1 General SIMILARITIES DIFFERENCES Consider 4.1 and 4.2 Requires assurance, prevention of undesirable effect and improvement OHS & EMS considers 4.3 EMS requires considering potential emergencies and documentation of risks/opportunity and processes OHS requires-Account of hazards, risks & opportunities, legal, risk assessment, changes

31. Clause 6: Planning ISO 45001:2018 ISO 9001:2015 ISO 14001:2015 6.1.2 Hazard Identification and assessment of risks and opportunities 6.1.2 (about addressing risks & opportunities) 6.1.2 Environmental aspects SIMILARITIES DIFFERENCES Identification/determine Assessment (methodology & Criteria) OHS & EMS all have varying requirements for determination /identification and assessment QMS did not have these requirements in 6.1.2

32. Clause 6: Planning ISO 45001:2018 ISO 9001:2015 ISO 14001:2015 6.1.3 Determination of legal requirements and other requirements - 6.1.3 Compliance obligations SIMILARITIES DIFFERENCES Determination of CO Establish how to access CO Maintain Doc Info OHS equally requires retaining Dc Info QMS did not have these requirements in 6.1.3

33. Clause 6: Planning ISO 45001:2018 ISO 9001:2015 ISO 14001:2015 6.1.4 Planning action - 6.1.4 Planning action SIMILARITIES DIFFERENCES Have action plan in place Integrate with other plans Maintain Doc Info Consider tech, finance, operation and bus rqts OHS added best practices and hierarchy of control QMS addressed requirements of this clause in 6.1.2

34. Clause 6: Planning ISO 45001:2018 ISO 9001:2015 ISO 14001:2015 6.2 OH & S objectives and planning to achieve them (Title) 6.2 Quality objectives and planning to achieve them (Title) 6.2 Environmental objectives and planning to achieve them (Title) 6.2.1 OH & S objectives 6.2.1 (about quality objectives) 6.2.1 Environmental objectives SIMILARITIES DIFFERENCES To be established functions and levels To meet specifics To be documented OHS & EMS measurement is based on practicability OHS requires consideration of consultation results.

35. Clause 6: Planning ISO 45001:2018 ISO 9001:2015 ISO 14001:2015 6.2.2 Planning actions to achieve OH & S objectives 6.2.2 (about achievement planning) 6.2.2 Planning actions to achieve environmental objectives -- 6.3 Planning of changes -- SIMILARITIES DIFFERENCES Specified elements of action plan OHS & EMS emphasis integration of action plan into business process OHS emphasis maintaining and retaining documented information Only QMS has 6.3

36. Clause 7: Support ISO 45001:2018 ISO 9001:2015 ISO 14001:2015 7.1 Resources 7.1 Resources 7.1 Resources -- 7.1.1 to 7.1.6 -- SIMILARITIES DIFFERENCES Determining and providing required resources Only QMS detailed the required resources as in 7.1.1 to 7.1.6

37. Clause 7: Support ISO 45001:2018 ISO 9001:2015 ISO 14001:2015 7.2 Competence 7.2 Competence 7.2 Competence 7.3 Awareness 7.3 Awareness 7.3 Awareness SIMILARITIES DIFFERENCES Determine competence Acquire competence and evaluate effectiveness & maintain record Awareness on policy, objectives, responsibilities and failure --- EMS added aspects OHS added hazards, incident investigation, removing themselves from danger

38. Clause 7: Support ISO 45001:2018 ISO 9001:2015 ISO 14001:2015 7.5 Documented information 7.5 Documented information 7.5 Documented information SIMILARITIES DIFFERENCES Same requirements

39. Clause 8: Operations ISO 45001:2018 ISO 9001:2015 ISO 14001:2015 8.1 Operational planning and control 8.1 Operational planning and control 8.1 Operational planning and control SIMILARITIES DIFFERENCES Establish processes & criteria Implement the controls Control changes Review consequences of unintended changes /emergencies Maintaining and retaining documentation Control of outsourced processes EMS and OHS recommends hierarchy of controls EMS considers lifecycle perspective. OHS emphasise Work adaptation Procurement control Hazard elimination Outsource control Control of contractors

40. Clause 8: Operations ISO 45001:2018 ISO 9001:2015 ISO 14001:2015 8.2 Emergency preparedness and response 8.2 Requirements for products & services 8.2 Emergency preparedness and response --- 8.3 to 8.7 ---- SIMILARITIES DIFFERENCES EMS & OHS addresses emergency preparedness and response QMS addresses product and service requirements Control of external provisions Control of production & service provision Product release Control of NC outputs

41. Clause 9: Performance Evaluation ISO 45001:2018 ISO 9001:2015 ISO 14001:2015 9.1 Monitoring, measuring, analysis and evaluation 9.1 Monitoring, measuring, analysis and evaluation 9.1 Monitoring, measuring, analysis and evaluation SIMILARITIES DIFFERENCES Determine what to monitor and measure Establish monitoring and measuring process (criteria, method, frequency, etc) Mtce of records EMS & OHS requires calibration and compliance evaluation QMS requires customer satisfaction monitoring and data analysis & evaluation

42. Clause 9: Performance Evaluation ISO 45001:2018 ISO 9001:2015 ISO 14001:2015 9.2 Internal audit 9.2 Internal audit 9.2 Internal audit SIMILARITIES DIFFERENCES Establish frequency Have programme Implement and report OHS requires reporting audit results to workers

43. Clause 9: Performance evaluation ISO 45001:2018 ISO 9001:2015 ISO 14001:2015 9.3 Management review 9.3 Management review 9.3 Management review SIMILARITIES DIFFERENCES Establish frequency Consider all inputs Retain record of output OHS requires communication of review output to workers

44. Clause 10: Improvement ISO 45001:2018 ISO 9001:2015 ISO 14001:2015 10.1 General 10.1 General 10.1 General SIMILARITIES DIFFERENCES Determine opportunities for improvement Implement the required action QMS gave specific examples of possible improvements in the note

45. Clause 10: Improvement ISO 45001:2018 ISO 9001:2015 ISO 14001:2015 10.2 Incident, Nonconformity & corrective action 10.2 Nonconformity and corrective action 10.2 Nonconformity & corrective action SIMILARITIES DIFFERENCES NC Correction NC Corrective action Retain records OHS included incidents and incidents investigation OHS requires participation of, and communication to workers.

46. Clause 10: Improvement ISO 45001:2018 ISO 9001:2015 ISO 14001:2015 10.3 Continual improvement 10.3 Continual improvement 10.3 Continual improvement SIMILARITIES DIFFERENCES Establish frequency Consider all inputs Retain record of output OHS requires communication of review output to workers

47. Session 1 Objectives Understand the purpose and typical structure of INTEGRATED MANAGEMENT SYSTEM ISO 9001, ISO 14001 & ISO 45001 Understand the INTEGRATED MANAGEMENT SYSTEM ISO 9001, ISO 14001 & ISO 45001 requirements relating to Internal Audits Understand the Plan Do Check Act (PDCA) Cycle Understand what is a process, key terminology, and the different types of processes and their significance for internal auditors

48. 4 A ud it A ct i v it i es 3 2 1 I n trod u ction to A u d it i ng T h e Pro c e s s A p p roa c h and Pro c e s s A u d it i ng Managi n g a n A u d it Progr a m Table of Content 5 A u d it o r Compet e nce and R e s p o nsi b i l it i es 6 Concl u sion

49. Introduction to Auditing

50. Auditing What is an audit? Systematic , independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled (ISO19011: 2002 clause 3.1) Why audit? Requirement of ISO 9001:2015 Monitor and measure the management system Promote continuous improvement of the management system

51. Principles of Auditing Principles relating t o auditor s : E t hical c o ndu c t Fair pre s enta t ion Due profes s ional c a re Principles relating t o audi t : Indepen d en c e Ev idenc e -based approach 4.0 Note: reference to ISO 19011:2002 Clause number

52. B e nefits of Auditing Verifies c o nformity t o requi r ements Inc r ea s es awarene s s and und e r s ta n ding P rovides a measureme n t of ef f ecti v eness of the management system to top manag e ment Redu c es ri s k of ma n a g em e nt system failure Identi f ies improvement opp o rtunities Continuous improvement i f pe r formed regula r ly

53. Types of A udit Registration / Certi f ication Produ c t Cu s to m er contra c t Gap a s s e s s m e nt / Pre-a s s e ss m ent Surveillance Combined audit / joint audit

54. Process Approach Auditing

55. Proc e ss Approa c h The pro c e s s app r oa c h empha s ize the importan c e o f : Unde r stan d ing and mee t ing requi r eme n ts Loo k ing at pro c e s ses i n terms of added value Obtaining res u lts of pro c e s s pe r formance Continual improvement of pro c e s s

56. Your Process A c t Do Plan Check PDCA (Pla n -D o -Check-Act ) Continual Improvement The Plan-do-Check-Act (PDCA) methodology applies to all processes • De p loy and con f orm w ith plan • • • • • Activities Controls Documentation Resources Objectives • • • Analyze/review Decide/change Improve effectiveness Measure and monitor for conformity and effectiveness

57. MANAGEMENT SYSTEM STANDARDS AND THE PROCESS APPROACH Is based upon the PDCA cycle which can be applied to processes Applies the PDCA cycle to implementing, operating, monitoring, exercising, maintaining and improving the effectiveness of a QMS ISO 19011:2002 does not explicitly mention process audits, but is written for application to all management system audits

58. A p plying the Pr o cess A p pr o ach t o A u dit i ng AUDITORS CAN APPLY THE PROCESS APPROACH TO AUDITING BY ENSURING THE AUDITEE: CAN DEFINE THE OBJECTIVES, INPUTS, OUTPUTS, ACTIVITIES, AND RESOURCES FOR ITS PROCESSES ANALYZES, MONITORS, MEASURES, AND IMPROVES ITS PROCESSES UNDERSTANDS THE SEQUENCE AND INTERACTION OF ITS PROCESSES

59. Proc e ss Auditing App r oach e s Individu a l Pro c e ss : Input / Output / Value-add e d Acti v ity P la n -Do-Che c k- Act Res o urc e s R el a tion s hip with other pro c e s se s : Flow / Sequen c e / Lin k age / Combination In t era c t i on / Communication E v iden c e Customer and s u pplier c o ntra c t ( s)

60. Proc e ss Auditing “Turtle Diag r a m ” With w hat? Res o urc e s With w ho? Per s onn e l What re s ults? P erforman c e indi c ators Outputs To Whom/ Where Inputs From Whom/ Where How done? Methods/ Documentation Process (specific value-added activities)

61. Proc e ss Auditing Exa m ple With w hat? Order processing system With w ho? Customers Competent sales and processing staff What results? O rder proce s sing time Number or o r de r s Va l ue of orde r s Contract accuracy Outputs Production/Service Delivery Inputs Customer requirements Sales staff H o w done? IT s y stem Processing s y stem Te r ms and c ond i tions Contract rev i ew procedure Contract Review

62. Managing an Audit Program

63. M a naging an Audit Progr a m Pro c e s s Flow PLAN DO C H ECK ACT A UTH O R I Z E ES T A BL ISH I M P L E M E N T M O N I T O R & R EVIEW I M P R OVE OBJE CT IVES E X T E N T R OLES R ES OURC ES P R O C E DUR ES S CH E DU LE A UD I T S E V AL U A T E A UD I T O R S SELE C T T EA M S D I R E C T A CT IVI T IES M AI N T AIN R E C O RD S MONITOR REVIEW IDENTIFY NEED FOR CA/PA IDENTIFY OPPORTUNITIES TO IMPROVE AUDITOR COMPETENCE & EVALUZATION SPECIFIC AUDIT ACTIVITIES

64. Audit Activities

65. Typical A udit A c tivities Pla n n i ng Preparati o n Preparing, Approving, Distributing Audit Report Reporting F o l lo w - up Con d ucti n g for O n -site A c ti v it i es P L AN DO C H ECK ACT 6.1

66. Audit Prog r am TOP MANAGEMENT SHOULD AUTHORIZE RESPONSIBILITY FOR PROGRAM MANAGEMENT TO: ESTABLISH, IMPLEMENT, REVIEW, AND IMPROVE THE AUDIT PROGRAM IDENTIFY THE NECESSARY RESOURCES AND ENSURE THEY ARE PROVIDED ORGANIZATION SHOULD DEVELOP AUDIT PROGRAM PROCESSES PROGRAM SHOULD BE MANAGED BY A MEMBER OF THE ORGANIZATION KEEP APPROPRIATE AUDIT RECORDS TO MONITOR AND REVIEW THE AUDIT PROGRAM

67. Audit Prog r am Re s ponsibi l ities TOP MANAGEMENT SHOULD AUTHORIZE RESPONSIBILITY FOR PROGRAM MANAGEMENT THOSE ASSIGNED RESPONSIBILITY SHOULD: ESTABLISH, IMPLEMENT, REVIEW, AND IMPROVE THE AUDIT PROGRAM IDENTIFY THE NECESSARY RESOURCES AND ENSURE THEY ARE PROVIDED

68. In i tiating the Audit Ini t iating the audit in c lu d e s : Appointing the audit team leader Defining audit objecti v es, s c ope, c r i t eria Determining feasibility of the audit Selecting the audit team Establishing initial c o ntact with the auditee 6.2

69. Defining Audit Objective s , Scope, Cri t eria Audit Obje c ti v es may includ e : Determining of the extent of conformity of auditee`s QMS with audit criteria Evaluation of capability of QMS to ensure compliance with statutory, regulatory, and contractual requirements Evaluation of effectiveness of the QMS to meet its objectives Identification of areas of improvement 6.2.2

70. Sele c ting the Audit Te a m For Team si z e and c o mpetence, c o n s ide r : Audit objectives, scope, criteria, and duration Whether audit is combined or joint Competence of team to meet objectives Statutory, regulatory, contractual and accreditation/certification requirements Independence of the team 6.2.4

71. Auditor Competence and Responsibilities

72. Auditor Co m pet e nce Audi t or c o mpetence i s ba s ed on: Personal attributes Application of knowledge and skills Competence is to be developed, maintained, and improved Competence is the demonstrated ability to perform a task 7.1

73. Personal Attributes Ethi c al Dipl om a tic Open- minded Auditor Co m pet e nce Personal A t t r ib u t es Obse r v ant Perceptive 7.2 V ersatile T ena c io u s Decisi v e Self-reliant

74. Auditor Co m pet e nce Ge n eric Kno w led g e and skills Auditor s k ills and c o mpetence c o uld in c lu d e : Audit principle s , pro c edure s , and tec h ni q u e s Management system and reference documen t s Or g ani z ational situ a tions La w s, regulation s , and other requi r eme n ts 7.3.1

75. Auditor Co m pet e nce Speci f ic Kno w led g e and skills Specific k n owledge and s k ills for quality auditors c o uld in c lu d e: Quality methods and techniques Quality terminology Quality management tools and their application Processes and products/services specific to the sector being audited 7.3.3

76. Auditor R e sponsibil i ties Arrive on ti m e Maintain c o nfidentiali t y B e objecti v e and eth i cal Suppo r t the audit team and team le a d e r Plan and prepa r e work do c uments In f orm auditees of the audit pro c e s s Do c ument and s u pp o rt all f i ndings Keep auditee informed Sa f egu a rd all do c uments Prepa r e the audit repo r t

77. Audit Activities (C o ntin u ed)

78. Audit Planning Determine the obje c ti v e of the audit Identi f y s p e c if i ed requi r ements Determine audit duration and re s ources needed Select the team Contact the auditee – ag r ee the date( s ) D r aw up audit plan B rief the team Prepa r e work do c uments

79. Conduc t ing Do c ument Re v iew A rev i ew of do c umentation: Should be conducted prior to on-site audit activities unless deferring review is not detrimental to the effectiveness of the audit May include relevant QMS documents, records, and previous audit reports May include a preliminary site visit 6.3

80. Pr e pare Work D ocum e nts Prepare work documents Use as a reference and for recording audit proceedings Include checklists, sampling plans and forms, ISO 9001:2015 standard, etc. Keep checklists flexible to allow changes resulting information collected during the audit Safeguard any confidential and proprietary information Retain work documents and records fr o m

81. Ch e cklists Pr e par a tion One Appro a ch i s t o: Identi f y audit s c ope and pro c e s s( e s) within s c ope Iden t i f y a p p licable f a c t o r s (in p ut s , ou t pu t s, res o urce s , etc . ) Us e these points and other requi r ements (ISO 9001-2015, system do c umentation, etc . ) t o: me a s u r e s, Plan what t o look at Plan what t o look for (audit evidence) Prepa r e c h e c kli s t

82. Ch e cklists St r uctu r e Audit c h e c kli s t str u ctu r e : Process/Activity Audited: Requirement Source Evidence Notes IMS Clause # or other requirement What to “look at” What to “look for” Notes

83. Conduct o n -Site Audit A ctivities Condu c t ope n ing meeting Communic a te du r ing the audit Ex plain roles and re s ponsibili t ies of participants Collect and verify information Generate audit findin g s Prepa r e audit c o n c lusions Condu c t clo s ing mee t ing 6.5

84. Opening Me e ting Hold opening meeting with auditee top management and those responsible for processes audited Meeting may be informal Chaired by team leader Audit team present Purpose is to confirm all prior arrangements 6.5.1

85. Re v i e w Sources of information Collect by appropriate sampling & verification Evaluate against audit criteria Collecting and Verif y ing Inf o rmation Audi t Conclusions

86. Auditing Pro c e s s Collect & Ve r ify info r m ation Collect information relevant t o: Audit objectives, scope, and criteria interfaces between functions, activities and processes Collect audit evidence by appropriate sampling and verify and record it Be aware on sampling limitations,if acting on the conclusion Use only information that is verifiable as audit evidence a u dit 6.5.4

87. Auditing Pro c e s s Te c hniques to Obt a in Audit Evid e nce In t erv i e w : Per s onn e l that manag e , pe r for m , and verify a c ti v it i es  A lso en s u r e they a r e r es p o n sible audited Listen c a refully t o res p onses for t he a cti v i t y being Observe: Identity, status, condition, processes, equipment, activities, environment, and people Listen: Information from relevant authority and that it is verifiable 6.5.4

88. Auditing Process Audit Evidence Review documents that describe: Activities Plans Controls Strategies Exercises tests Review records for evidence of conformity to documents Review records, statements of fact, or other information which are relevant to the audit criteria and verifiable Audit evidence may be qualitative or quantitative

89. Communication and interpersonal ski l ls Put auditee at ea s e Ask s h ort que s tions and listen Reflect rig h t at t i t ude, to n e of v oice, b o dy langua g e, and f acial expre s sions Sm i le and s h ow eye c o ntact A v oid interruptions A v oid of f -c u ff and c o nde s cending r e ma r ks Give praise when app r op r iate

90. Communication and interpersonal ski l ls Show intere s t B e tact f ul and polite S how pat i ence and under s t a nding Remember t o s a y plea s e and thank you Ask the rig h t pe r s o n Don`t s a y you und e r s tand when you do not

91. Questioning Techniques OPEN QUESTION USING WHY, WHO, WHAT, WHERE, WHEN, OR HOW GETS MORE THAN A YES OR NO ANSWER EXPANSIVE QUESTION FURTHER ELABORATES THE CURRENT POINT OPINION QUESTION ASKS OPINION ABOUT CURRENT POINT NON-VERBAL USES BODY LANGUAGE, FOR EXAMPLE: RAISE EYE-BROW TO ELICIT FURTHER INFORMATION

92. Questioning Techniques Repeti t i v e que s tion Repeats ba c k res p onse i n form of a que s tion Hypo t het i cal quest i on U s es what if, s u ppo s e tha t , etc. Clo s ed que s tion Gets yes or no an s wer Av oid using too of t en U s ed for c o nfirmation Si l en c e D r aws more information

93. Note Taking Notes c o uld be u s ed as referen c e for: I m mediate investigation In v estiga t ion la t er Us e by a c o lleague Subseque n t audits Notes taken du r ing an audit are a r e c o rd o f : The audit sample taken Wh a t was repo r ted Wh a t was ob s erved Notes may be referenced by s u b s equ e nt auditor

94. Sa m pl i ng Samples should test the effectiveness of the system and should be: Representative Structured Independently selected Sample size should be based on: Risk Importance Status Findings from the previous/current audit

95. Cont r ol of the Audit Che c kli s t i s an ai d , not a requi r ement I f potential audit trails app e ar, de c ide t o: Disrega r d Note for later Follow up immediately Following audit trails may ef f e c t : S ample si z e Audit plan

96. EXAMP L ES Cannot find document Uncooperative Noisy environment Long telephone calls U n prepared Constant interruptions Pro v ocation Long-winded auditees Interdepartmental or personality conflicts Diversionary tactics Language B o ast f ul Call e d a w ay Volunteered information Handling Difficult Situations

97. Es t ab l i s h the Fa c ts Judgm ent in t he Audit Pro c e s s Audit focus must be on conformity and effectiveness, NOT on finding nonconformities The auditee must be given the benefit of any doubt where there is insufficient audit evidence

98. Est a bl i sh t he Fac t s Discuss concerns Verify the findings Record all the evidence: Exact observation Where, what, etc. Establish why a nonconformity or otherwise State who (if relevant) – preferably by job title Obtain agreement with the facts

99. Gene r ate Audit Find i ngs 6.5.5 Evaluate audit evidence against audit criteria to generate audit findings Indicate if findings are conformities, nonconformities or opportunities for improvement Meet (audit team) to review findings Specify (with supporting evidence) or summarize conformity by location, function, or processes, as required by audit plan

100. Noncon f or m ity 6.5.5 Non-fulfillment of a specified requirement: Not doing it Partially doing it Doing it the wrong way Specified requirement: Conditions of the customer contract Quality standard (ISO 9001:2015) Quality management system Statutory or regulatory requirements

101. Gene r ate Audit Find i ngs Rec o rd non c onformity findings and s u ppo r ting evidence • Obtain auditee acknowledgement of accuracy and understandability Try and resolve differences of opinion Keep a record of unresolved issues N onconformities for 6.5.5

102. Noncon f or m ity - Min o r Failure to comply with a requirement which (based on judgment and experience) is not likely to result in QMS failure Single observed lapse or isolated incident Minimal risk of nonconforming product or service Examples:  A two month lapse in the internal audit program  A training record not available  No actions taken to improve system based on result findings previous

103. Noncon f or m ity - Major Absence or total breakdown of a system to meet a requirement A number of minors related to the same clause or requirement A nonconformity that experience and judgment indicate will likely result in QMS failure or significantly reduce its ability to assure controlled processes and products

104. Noncon f or m ity - Major Examples: No documented procedure for a required documented ISO 9001:2015 process/activity Document changes routinely made without authorization No awareness program for the quality management system No future planned internal audits Insufficient scope Numerous minor nonconformities found in the production process

105. Nonconfo r mi t y Cla s sif y ing the Nonconfo r mi t y Consider the seriousness: What could go wrong if the nonconformity remains uncorrected? Is it likely the system would detect it before the customer is affected? If you are not certain it is a nonconformity, it is not. You must have: A requirement that has been broken Proof that it has been broken

106. Nonconfo r mi t y Good Repo rt Ex a mpl e s Q M S Non c on f o rmity R e po rt I n ci d e n t Nu m b er : 1 C o m pany under audit: X Y Z , Inc. Area under Review: Purchasing Category: Major Minor Requirement: ISO 9001 C lause nu m ber 7.4 Clause 7.4.1 of ISO 9001:2015 requires that the organization establish criteria for evaluation and re-evaluation of suppliers. Nonconformity Findings: Upon speaking with the purchasing Manager, it was found that no evaluation of ABC supplier had taken place since the contract was signed and business begin with ABC supplier

107. Nonconfo r mi t y Poor Repo rt Ex a mpl e s The nonconformity statements below are inadequate due to the lack of specified requirements and detailed evidence: S teering Group meeting minu t es are not adequate The aut h ori t y level for t he Eme r ge n cy Con t roller must be do c umented for clarify pu r po s es

108. Pr e paring Audit C onclusions Audit team c o nfer p r ior t o the closing me e tin g : Scheduling of the audit plan T o plan for clo s ing mee t ing Purpo s e i s t o: Rev i ew audit findings and other information Agree on audit c o n c lusions T o prepa r e the au d it repo r t and re c om m e n dat i ons I f included i n audit plan, t o disc u ss audit follow-up 6.5.6

109. Audit Repo rt Pre pa r e, Appro v e & Dis tr ibute Audit reference Client and Audi t ee details A udit team detai l s List of auditee r e p r e s e n t ati v es Obje c ti v e s , s c ope, and c r iteria Audit plan – dates, pla c e s , areas a u dited and ti m ing S um m ary of audit pro c ess Audit Summary Unc e rtainty due t o s a mpling 6.6.1 6.6.2

110. Audit Repo rt Pre pa r e, Appro v e & Dis tr ibute Non c onfor m ity r e p o rts Rec o mmenda t ion Obstacles encountered Any areas i n audit s c ope not c o vered Any un r e s olved is s ues betwe e n the auditee and team Confirmation that audit obje c ti v es a c c o mplished Confiden t iali t y statement Di s tribution list 6.6.1 6.6.2

111. Audit Report Distribution Issue within agreed time period If delayed, provide reasons and agree on new issue date Report must be dated, reviewed, and approved as per procedures Distribute to recipients designated by audit client Report is property of audit client Recipients and audit team must respect the confidentiality of the report

112. Co m pleting the Audit 6.7 Audit is complete when all activities in audit plan have been carried out and audit report is distributed Maintain or dispose of audit documents based on contractual, regulatory, and audit program procedures Maintain confidentiality of audit documents, information, and report Notify audit client and auditee ASAP if disclosure of audit information is required.

113. Closing M e eting 6.5.7 Hold closing meeting to present audit findings and conclusions Cover situations encountered during audit that may decrease reliance on audit conclusions Discuss and resolve diverging audit findings and conclusions Keep a record if not resolved Provide recommendations for improvement where specified by audit objectives Keep minutes and attendance records Will normally be informal for internal audits

114. Completing the Audit Conducting the Follow-up 6.8 Audit conclusions may require corrective, preventive, or improvement actions Auditee decides and carries out these actions within agreed timeframe These actions are not part of the audit Audit team number should verify completion and effectiveness of actions taken This verification may be part of a subsequent audit Maintain independence in subsequent audit activities

115. Why? Reason Why 1 Why was our customer unhappy? The service has been delivered to late. The customer was unsatisfied. Why2 Why was the service not prepared on time? We did not prepare the service on time because it took much longer than we expected. Why3 Why did it take so much longer? Because we did not receive all approvals on time and underestimated the duration of the project. Why4 Why did we underestimate the project duration? Because we forgot to prepare a detailed list of all tasks. Why5 Why did we forget about it? Because we were running behind on other projects and failed to review our task list and time estimation during the project. Root Cause* Because we didn’t have a checklist to clearly identify all tasks that we must achieve to estimate time accurately. We need to develop a systematic approach to include these factors in future projects. Five Why Analysis The 5 Whys is a questions-asking method used to explore the root cause of a particular problem and to understand cause-effect relationships * Note the root cause(s ) of the problem here. Only the one who experienced the problem is qualified to perform the analysis. There are usually more than one root cause

116. COMPLETING THE AUDIT CORRECTIVE THE FOLLOW-UP Audi t ee rec e i v es the non c onfor m ity repo r t Audi t ee prepa r es and app r oves a c o r r e c ti v e a c tion pl a n A udi t ee submits the plan t o auditors Audi t ors evaluate and app r ove the plan Audi t ee implements the app r oved c o r r e c t i v e a c tion pl a n Audi t or verif i es the implementat i on and ef f e c ti v ene s s Re c ords of all a c t i ons taken by auditor and auditee 6.8

117. Cite the Source!! ISO 9001:2015 (“The STANDARD”) Clause 4.0/Context of the Organization Clause 4.4/QMS and its processes Clause 4.4.1 PROCESS INTERACTION DIAGRAM

118. The S T A N D A R D ( 4.4.1) s t a t es: “ The or g aniza t io n SH A LL : E s t ablish I m p le m e nt M a in t a i n C o n t inua ll y i m p r o v e t he QM S . ” in c lu d in g…. AUDITING THE CONTEXT OF THE ORGANIZATION

119. “ PROCESSES needed AND their INTERACTIONS … ”

120. C la u se 4 . 4 . 1 ( Qu ali t y M a n a ge m e nt S y s t em a n d i t s P r o c e ss e s) 1. What are we looking for when we audit a client’s processes & interactions? Required process inputs (4.4.1.a) Expected process outputs (4.4.1.a) Criteria & Methods (4.4.1.c) Monitoring/Measurement/Performance Indicators Resources needed to support the process (4.4.1.d) Process authority & responsibility assigned (4.4.1.e) Risks and opportunities identified (4.4.1.f)

121. The PROCESS INTERACTION Audit Too/ Process Interaction Diag r am ( I SO 9001:2015; C l ause 4.4.1) I' I' (4.4.l.d ) Resources , i.e . , 1 What?" P eople , Materials , Equipment , Work Environment, etc. {Auditor S p ecial l nterest Item} Ex p ertlse , I.e. "Whom?" Education , Knowledge , Tra i ning, Skills , Experience, etc . '- ./ '- ./ ::--- (4.4.1 . a) Inputs, I.e. What ln utl lized in ( 4.4.l.e ) P rocess Activities (4.4.l.e) R espo n sib l e Person(s) (4.4 . 1 . a) Outputs, i . e. What output(s) does this recess teed into? O ut go in g Pr ocess this p r ocess? I n c om i n g Pr ocess v ...- ........... I' I' ( 4 . 4 . 1 . 1 } Meth o d s of Control ( 4.4.l.c ) Measures of Effectiveness (Mo E ) in Place? • • Operationa l Risk Identification & Mgt. Ri s k Management/Matrix Measure J Effectlvene n - + Target? - Actua l ? -Met ? - Ac t l o n ? Quality (DPPMJFPY ? ) Time ( OT D ) ? ' ./ \. ./

122. T he P R O CES S I N TE R A CT I O N A u d it “ … determine the inputs required and the outputs expected from these processes … ”

123. T he P R O CES S I N TE R A CT I O N A u d it

124. T he P R O CES S I N TE R A CT I O N A u d it “ … determine and apply the criteria and methods needed to ensure the effective operation and control of these processes … ”

125. T he P R O CES S I N TE R A CT I O N A u d it p r o cesses…”

126. T he P R O CES S I N TE R A CT I O N A u d it “ … address the risks and opportunities as determined in accordance with the requirements of (Clause) 6.1 Risks and Opportunities”)” a

127. T he P R O CES S I N TE R A CT I O N A u d it O P T IO N A L Au d it o r a re a s o f s p ec i al i n t erest

128. The PROCESS INTERACTION Audit Too/ Process Interaction Diag r am ( I SO 9001:2015; C l ause 4.4.1) I' I' (4.4.l.d ) Resources , i.e . , 1 What?" P eople , Materials , Equipment , Work Environment, etc. {Auditor S ecial l nterest Item} Ex ertls e , I.e. "Whom?" Education , Knowledge , Tra i ning, Skills , Experience, etc . '- ./ '- ./ ::--- (4.4.1 . a) Inputs, I.e. What ln utl lized ln ( 4.4.l.e ) P rocess Activities (4.4.l.e) R espo n sib l e Person(s) (4.4 . 1 . a) Outputs, i . e. What output(s) does this recess teed into? O ut go in g Pr ocess this process? I n c om i n g P r ocess v ...- ........... I' I' ( 4 . 4 . 1 . 1 } Meth o d s of Control ( 4.4.l.c ) Measures of Effectiveness (Mo E ) in Place? • • Operationa l Risk Identification & Mgt. Ri s k Management/Matrix Measure J Effectlvene n -+ Target? - Actua l ? -Met ? - Ac t l o n ? Quality (DPPMJFPY ? ) Time ( OT D ) ? ' ./ \. ./

129. Internal Auditing Pitfalls - and Some Preventive Actions - Common / Frequent Stumbling Blocks and Some Preventive Steps and Tools for Planning, Conducting, Reporting, Closing Internal Audit

130. Four Phases to Internal Audits Planning and Preparing for the Audit Conducting the Audit Reporting Results and Writing NCRs Performing Root Cause Analysis and Implementing and Verifying Corrective Actions All four phases must be addressed for internal audits to be effective !

131. Planning and Preparing Pitfalls “We always scramble to get our audits done – sometimes we don’t finish them” Suggestion: Schedule defined processes within your QMS to be done each month – don’t overload auditors Alternate: Schedule an annual “blitz” of whole system

132. Planning and Preparing Pitfalls “Some of our processes always seem to have more problems or take longer to audit because they are more complex” Suggestion: Schedule additional audits of certain processes based on “status” or “importance”. This is a requirement of ISO 9001:2015, 9.2. Internal Audits

133. Planning and Preparing Pitfalls “Our auditors say they are not sure what to look for when they audit” Suggestion: Auditors should study applicable sections of the standard, quality manual and procedures, customer and legal requirements. Make a “Turtle” diagram of the process, make a checklist. Alternate: Hire professional “external” auditors

134. The Turtle Diagram

135. Conducting the Audit “Our auditors rarely report any problems. What they do report is inconsequential” Suggestion: Audit for effectiveness Four challenging questions: “How are you (or your job) doing?” “How do you know that?” “Are you improving?” “How do you know that? ”

136. Conducting the Audit “Our Certification’s auditor often finds that our procedures don’t match the work” Suggestion: Audit for three contrasts: Policy – Is it clearly stated in our manual? Procedure – Is it up to date, support the policy? Do our people understand it? Practice – Do we do what we say? Are innovative ways of doing things better being considered, evaluated, approved ? When did you last review procedures ?

137. Conducting the Audit “Our auditors don’t know how to follow audit trails or ask the probing questions” Suggestion: Conduct a “Learning Audit” = Evaluate auditors regularly using a more experienced auditor. Use the “Turtle Diagram” as a source of questions. Ask “Why?” five times when something doesn’t jive with the manual or procedures. Obtain copies of evidence for better reporting . Practice, evaluate, practice, evaluate !

138. Reporting the Audit “Our supervisors resent internal audits as useless fault finding” Suggestion: Start audit reports by summarizing the good areas, especially “best practices”. Include ideas/suggestions for resolving nonconformities (Yes, internal auditors CAN consult!!). Constantly preach that nonconformities are not the end of the world or cause for personnel punishment, but Opportunities for Improvement !

139. Reporting the Audit “Our nonconformity write-ups are often difficult to understand (What do I do?)” Suggestion: ALWAYS state three items in Corrective Action Requests (CARs): The requirement violated (doc/para/text) The nonconformity (text related to req’t) The objective evidence (what, where, when) If you can’t cite the requirement, you shouldn’t write a CAR ! (Maybe an OFI?)

140. Closing the Audit “Our corrective actions don’t work. The problems keep coming back” Suggestion: Conduct formal Root Cause Analysis and Effective Corrective Action training for all managers/supervisors CAR respondees must fully comprehend the difference between correction and corrective action and understand that there is a system cause to the nonconformity, not just “operator error”

141. Containment ( aka Correction ) In some cases, swift action needs to be taken to contain the problem and prevent any consequences of the problem (“escapes”) from affecting customers This containment action includes the immediate fixing of the problem at hand, which is referenced in ISO 9000 as correction , which should not be confused with corrective action

142. Correction vs. Corrective Action ISO 9000:2005 defines these as: Correction: Action to eliminate a detected nonconformity (3.6.6) Corrective action: Action to eliminate the cause of a detected nonconformity or other undesirable situation(3.6.5) Note 1 There can be more than one cause for a nonconformity Note 2 Corrective action is taken to prevent recurrence Bold = My emphasis

143. Some More Advice Recognize that there are at least two causes for each quality problem: A technical cause (and there may be more than one !!!) such as a bearing failure or an operator error and A system cause such as an ineffective preventive maintenance program or incomplete employee training program or incorrect procedure or work instruction You Must Fix Both (ALL)

144. Even More Advice Utilize all appropriate quality tools to get at the root cause, such as: Ishikawa fishbone cause/effect diagram with the seven M’s as the branches, Man, Machine, Method, Materials, Measure- ments, Mother Nature, Management “Five Why’s” fault tree analysis diagram, looking for common “grandfathers” as high priority items to fix Kepner-Tregoe Cause Analysis

145. Assuring Effectiveness Don’t forget to prevent recurrence by changing the system as appropriate: Revise procedures, policies, QA Manual Train/retrain employees, adjust training needs matrix Inform all who “touch” the process Look at other processes/products. Can or should the fix(es) be used on them?

146. Closing the Audit “Our CARs seem to hang open forever” Suggestion: Monitor CAR action item timing/commitments, remind owners, only accept corrective action plans that address true root causes, are appropriate actions Audit the process to verify that ALL actions have been effectively implemented, other processes have been considered, there has been NO RECURRENCE since the corrective action has been implemented Only then can you close the CAR

147. Based on the information given, if you think the situation represents a nonconformity, then write a non conformity statement that includes the following information: Situation #; area/process being audited; applicable ISO 9001 clause #; whether the nonconformity is major or minor; a clear description of the specific requirement that the situation is nonconforming against; a clear description (finding) of the nonconformity itself, supported by relevant objective evidence. OR, based on the information given, if you do not think there is a nonconformity, then clearly state your reason(s), and also provide at least 3 further actions you would take to gather additional evidence of conformity or nonconformity (had you been there performing the audit).

148. Case study 1 In the purchasing department, the auditor notes that the staff are placing orders over the phone with suppliers using a computerized purchasing system. On inquiry, the auditor is told that the staff has been fully trained and the database holds details of all supplier contract specifications and, therefore, there is no need for an independent review of individual orders.

149. Case Study 2 In the quality manager’s office, the auditor asks to see the schedule for internal audits. This schedule shows that each of the eight QMS processes are audited every six months. The auditor asks the quality manager how the frequency of audits was decided. The manager says that when the system was set up three years ago, 6-month intervals were specified for all processes. The company has kept to this original schedule. The auditor asks to see the file containing corrective action requests (CARs). It lists 85 CARs for the past two rounds of internal audits. Of these, 65 CARs are in the production department and the remainder are spread evenly over five other departments. Two departments received no CARs.

150. Case Study 3 In the shipping area, the auditor stops to look at six finished products, serial numbers X245 to X250, in individual cardboard cartons. The auditor asked the shipper why the items are packed in corrugated cardboard instead of plastic containers as required by packaging work instruction PWI 6, revision 2. The shipper replied that the shipping supervisor had instructed them to use corrugated cardboard when they ran out of plastic containers three weeks ago .

151. Any Questions? Thanks