ISO 9001-Internal Audit-presentation to get the details

ISO

1. Sri Lanka Standards Institution Introduction to Quality Audit

2. Sri Lanka Standards Institution Audit Audit (noun) “An examination of accounts by one or more duly authorised persons”. Audit (verb) “To examine by reference to vouchers”.

3. Sri Lanka Standards Institution Audit Systematic, independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. ISO 9000:2015

4. Sri Lanka Standards Institution Auditor Person who conduct an audit ISO 9000:2015 Qualified , competent And is authorized !

5. Sri Lanka Standards Institution ISO 19011 General guidance / Code of practice AUDIT TYPES QUALIFIED AUDITORS RESPONSIBILITIES OBJECTIVES

6. Sri Lanka Standards Institution ISO 19011 A. FIRST PARTY AUDITING Audits carried out by a company on its own systems. B. SECOND PARTY AUDITING Audits carried out by one organisation on another prior to or after contract placement. C. THIRD PARTY AUDITING Audits carried out by independent accredited organisations.

7. Sri Lanka Standards Institution A. Adequacy Audit (Desk Top Audit) Review of QMS documents for their adequacy B. Trial Audit Initial verification of system activities for its effectiveness Compliance Audit The final system assessment to grant a cetification

8. Sri Lanka Standards Institution Phases of Auditing Planning & Preparation Performing Reporting & Follow up

9. Sri Lanka Standards Institution Document review Initial Preparation (Development of Audit Matrix) Development of Audit Schedule Communication PRE-ASSESSMENT ACTIVITIES “High level” check lists A personal plan of action Detailed or “low level” check lists DETAILED PLANNING Opening Meeting Performance of Audit Evaluate Results /writing NCR Closing Meeting THE ON SITE AUDIT FORMAL REPORT CORRECTIVE ACTION AUDIT FOLLOW UP AND ONGOING SURVEILLANCE

10. Sri Lanka Standards Institution Audit Life Cycle Evaluate Results Corrective Actions Audit Plan

11. Sri Lanka Standards Institution Audit Planning

12. Sri Lanka Standards Institution What is an 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. ISO 9000:2015

13. Sri Lanka Standards Institution Audit Planning Relevant ISO 9001 Standards Requirements ISO 9001:2015, clause 9.2 Internal audit 9.2.1 The organization shall conduct internal audits at planned intervals to provide information on whether the quality management system: a) Conforms to: 1) the organization’s own requirements for its quality management system; 2) the requirements of this International Standard; b) is effectively implemented and maintained.

14. Sri Lanka Standards Institution Audit Planning Relevant ISO 9001 Standards Requirements ISO 9001:2015, clause 9.2 Internal audit 9.2.2 The organization shall a) plan, establish, implement and maintain an audit programme (s) including the frequency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the importance of the processes concerned, changes affecting the organization, and the results of previous audits; b) define the audit criteria and scope for each audit; c) select auditors and conduct audits to ensure objectivity and the impartiality of the audit process; d) ensure that the results of the audits are reported to relevant management; e) take appropriate correction and corrective actions without undue delay; f) retain documented information as evidence of the implementation of the audit programme and the audit results.

15. Sri Lanka Standards Institution Quality Planning WHAT METHODS WHAT CONTROLS ? THINK BEFORE YOU DO ! WHO IS RESPONSIBLE & FOR WHAT ?

16. Sri Lanka Standards Institution DETAILED PLANNING WHAT DO I WANT TO FIND OUT? HOW DO CRITERIA APPLY? CHECK LIST (DEFINES SAMPLE) WHAT QUESTIONS SHALL I ASK? HOW SHALL I FIND THESE THINGS OUT? CRITERIA IDENTIFIED CRITERIA SATISFIED ? SAMPLE SELECTED HIGH LEVEL PLAN OF ACTION LOW LEVEL

17. Sri Lanka Standards Institution Annual Audit Plan 200Y Process Calendar Months 01 02 03 04 05 06 07 08 09 10 11 12 Cont. Review Prod. Planning Purchasing Undercoating Sanding Spray oper. Storing X X X X X X X X X X X X X X X X X X X X X

18. Sri Lanka Standards Institution THE PROCESS Information OUTPUTS Controls INPUTS Material Requirements Product Service Information Records (Evidence) Work Environment Equipment (Building, Facilities etc) Skilled People Interacting activities

19. Sri Lanka Standards Institution Process Analysis - Goods Receiving DELIVERY INDENTIFY UNPACK Input(s) Output(s) QUANTITY VERIFICATION INSPECT TO STORE TEST UPDATE RECORDS RETURN TO SUPPLIERS Activities

20. Sri Lanka Standards Institution DELIVERY INDENTIFY UNPACK Input(s) Output(s) QUANTITY VERIFICATION INSPECT TO STORE TEST UPDATE RECORDS RETURN TO SUPPLIERS ACTIVITIES Process Analysis - Goods receiving Goods Advice Notes Associated Paperwork Certificates of Conformance Drawings Specifications Inspection/Test Instructions Sample Plans Tools Test Equipment Goods Information Queries Non-conformance Reports Goods Receipt Notes Test Results Inspection Results Vendor Performance Data Scrap Quarantined Goods Goods Back to Suppliers Goods Returned Paperwork Receipt at unloading bay Identification and Booking-In Unpack Quantity Verification Select for quality verification Verification (Test, Inspection) Quality Records Stock Records Handling Movements to Stores

21. Sri Lanka Standards Institution Management System Requirements Context of the Organization 4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the Quality Management System 4.4 Quality Management System and its processes Leadership 5.1 Leadership and commitment 5.1.1 General 5.1.2 Customer Focus 5.2 Policy 5.2.1 Establishing the quality policy 5.2.2 Communicating the quality policy 5.3 Organizational roles, responsibilities and authorities Planning 6.1 Actions to address risks and opportunities 6.2 Quality Objectives and planning to achievement 6.3 Planning of changes Support 7.1 Resources 7.1.1 General 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes 7.1.5 Monitoring and measuring resources 7.1.6 Organizational Knowledge 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented Information 7.5.1 General 7.5.2 Creating and updating 7.5.3 Control of documented information Departments / Functional Areas 1 2 3 4 5 6 8 7 9 10 11 12 Management System Matrix Chart Relationship between Management System and Departments / Functional areas               

22. Sri Lanka Standards Institution Management System Requirements Operation 8.1 Operational Planning and Control 8.2 Requirements for products and services 8.2.1 Customer communication 8.2.2 Determining the requirements for products and services 8.2.3 Review of the requirements for products and services 8.2.4 Changes to requirements for products and services 8.3 Design and development of products and services 8.3.1 General 8.3.2 Design and development planning 8.3.3 Design and development inputs 8.3.4 Design and development controls 8.3.5 Design and development outputs 8.3.6 Design and development changes 8.4 Control of externally provided processes, products and services 8.4.1 General 8.4.2 type and extent of control 8.4.3 information for external providers 8.5 Production and service provision 8.5.1 Control of product and service provision 8.5.2 Identification and traceability 8.5.3 Property belonging to customers and external providers 8.5.4 preservation 8.5.5 Post – delivery activities 8.5.6 Control of changes 8.6 Release of products and services 8.7 Control of nonconforming outputs Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation 9.2 Internal audit 9.3 Management review Improvement 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement Departments / Functional Areas 1 2 3 4 5 6 8 7 9 10 11 12 Management System Matrix Chart Relationship between Management System and Departments / Functional areas               

23. Sri Lanka Standards Institution Management System Requirements Context of the Organization 4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the Quality Management System 4.4 Quality Management System and its processes Leadership 5.1 Leadership and commitment 5.1.1 General 5.1.2 Customer Focus 5.2 Policy 5.2.1 Establishing the quality policy 5.2.2 Communicating the quality policy 5.3 Organizational roles, responsibilities and authorities Planning 6.1 Actions to address risks and opportunities 6.2 Quality Objectives and planning to achievement 6.3 Planning of changes Support 7.1 Resources 7.1.1 General 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes 7.1.5 Monitoring and measuring resources 7.1.6 Organizational Knowledge 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented Information 7.5.1 General 7.5.2 Creating and updating 7.5.3 Control of documented information Departments / Functional Areas 1 2 3 4 5 6 8 7 9 10 11 12 Management System Matrix Chart Relationship between Management System and Departments / Functional areas B B A A A A A A A B B B A B Sample selected by Team Leader

24. Sri Lanka Standards Institution Process/ Department/Function Time 0930 h-1030 h 8.3.2 Design and development planning 8.3.3 Design and development inputs 8.3.4 Design and development controls 8.3.5 Design and development outputs 8.3.6 Design and development changes 7.1 Resources 7.1.1 General 7.1.2 People 7.1.3 Infrastructure GW KL Auditor Research and development Production Marketing 8.2 Requirements for products and services 8.2.1 Customer communication 8.2.2 Determining the requirements for products and services UP Tea Break 1030 h-1045 h 8.5 Production and service provision 8.5.1 Control of product and service provision 8.5.2 Identification and traceability 8.5.4 preservation 7.5 Documented Information 7.5.1 General 7.5.2 Creating and updating 7.5.3 Control of documented information ) Production Quality assuarance Marketing 8.2.3 Review of the requirements for products and services 8.2.4 Changes to requirements for products and services 1045 h-1300 h Lunch Break 1300 h-1330h UP KL Auditor GW

25. Sri Lanka Standards Institution Tea Break

26. Sri Lanka Standards Institution Development of Audit Checklist and Action Plan

27. Sri Lanka Standards Institution Phases of Auditing Planning & Preparation Performing Reporting & Follow up

28. Sri Lanka Standards Institution Document review Initial Preparation (Development of Audit Matrix) Development of Audit Schedule Communication PRE-ASSESSMENT ACTIVITIES “High level” check lists A personal plan of action Detailed or “low level” check lists DETAILED PLANNING Opening Meeting Performance of Audit Evaluate Results /writing NCR Closing Meeting THE ON SITE AUDIT FORMAL REPORT CORRECTIVE ACTION AUDIT FOLLOW UP AND ONGOING SURVEILLANCE

29. Sri Lanka Standards Institution STEP 1 Identify Management Criteria applicable STEP 2 Determine how criteria relate to activities STEP 3 Identify what the auditor must establish STEP 4 Develop high level check list STEP 5 Decide plan of action STEP 6 Develop low level check list

30. Sri Lanka Standards Institution DETAILED PLANNING WHAT DO I WANT TO FIND OUT? HOW DO CRITERIA APPLY? CHECK LIST (DEFINES SAMPLE) WHAT QUESTIONS SHALL I ASK? HOW SHALL I FIND THESE THINGS OUT? CRITERIA IDENTIFIED CRITERIA SATISFIED ? SAMPLE SELECTED HIGH LEVEL PLAN OF ACTION LOW LEVEL

31. Sri Lanka Standards Institution High Level Check List

32. Sri Lanka Standards Institution Audit Base AUDITOR’S CHECK LIST BASE CRITERIA MODIFIED BY REQTS. INTENTIONS PROCEDURES ETC.

33. Sri Lanka Standards Institution Example: Consider a company that is involved in designing and manufacturing products . Let us assume that this company receives a customer order , to design a mechanical assembly made of piece of parts some of which may be produced in-house, the remainder being purchased from external sources. Once the assembly has been manufactured it must be tested . Whilst it is tested it is also set up to function correctly. Clearly there are several stages in this overall process which may be illustrated as follows.

34. Sri Lanka Standards Institution RECEIVE ORDER DESIGN PRODUCT PURCHASE PARTS PURCHASE MATERIAL MANUFACTURE ASSEMBLE TEST

35. Sri Lanka Standards Institution This overall process is also what might be considered as a ‘ cross functional process ’ i.e. a process that ‘flows’ through the different company functional areas or departments, For this example it is assumed that the team leader requests the auditor to verify that the product test specifications are being produced and controlled in accordance with ISO 9001 7.5 within the Design department. These documents are an important output of the process. Thus, the audit ‘sample’ has been pre-determined by the audit team leader and allocated to the auditor

36. Sri Lanka Standards Institution RECEIVE REQUIREMENTS PROPOSE DESIGN DESIGN PARTS REVIEW DESIGN BUILD MODELS PRODUCE DRAWINGS PRODUCE TEST SPECS Drawing Office

37. Sri Lanka Standards Institution ARE TEST SPECIFICATIONS WRITTEN AND CONTROLLED IN ACCORDANCE WITH THE ISO 9001 REQUIREMENT OF 7.5 ?

38. 7.5 Documented information 7.5.1 General The organization’s quality management system shall include: documented information required by this International Standard; documented information determined by the organization as being necessary for the effectiveness of the quality management system.          

39. NOTE: The extent of documented information for a quality management system can differ from one organization to another due to: the size of organization and its type of activities, processes, products and services; the complexity of processes and their interactions; the competence of persons.

40. 7.5.2 Creating and updating When creating and updating documented information, the organization shall ensure appropriate: identification and description (e.g. a title, date, author or reference number); format (e.g. language, software version, graphics) and media ( e.g. paper, electronic); review and approval for suitability and adequacy 

41. 7.5.3 Control of documented information 7.5.3.1 Documented information required by the QMS and by this international Standard shall be controlled to ensure: a) it is available and suitable for use, where and when it is needed; b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity)

42. Sri Lanka Standards Institution High Level Check List DOES THE ORGANIZATION’S QMS INCLUDE DOCUMENTED INFORMATION REQUIRED BY THE INTERNATIONAL STANDARD? DOES THE ORGANIZATION’S QMS INCLUDE DOCUMENTED INFORMATION DETERMINED BY THE ORGANIZATION? DOES THE ORGANIZATION ENSURE APPROPRIATE IDENTIFICATION AND DESCRIPTION OF TEST SPECIFICATION? DOES THE ORGANIZATION ENSURE FORMAT (E.G. LANGUAGE, SOFTWARE VERSION, GRAPHICS) AND MEDIA ( E.G. PAPER, ELECTRONIC)? WHEN CREATING AND UPDATING DOCUMENTED INFORMATION, ARE TEST SPECIFICATIONS REVIEWED AND APPROVED FOR ADEQUACY PRIOR TO ISSUE ? ARE TEST SPECIFICATIONS A VAILABLE AND SUITABLE FOR USE, WHERE AND WHEN IT IS NEEDED? ARE TEST SPECIFICATIONS ADEQUATELY PROTECTED (E.G. FROM LOSS OF CONFIDENTIALITY, IMPROPER USE, OR LOSS OF INTEGRITY) ETC. ?

43. Sri Lanka Standards Institution Quality Manual Requirements The Design Manager is responsible for identifying a Co-ordinator for the writing and issue of all Specifications produced within the Design Department. The Specification Co-ordinator shall provide facilities for the processing, issue and control of specifications together with an advisory service to designers. All specifications shall use the company standard format and shall be formally reviewed for adequacy by identified technical authorities prior to issue and before and changes are incorporated. All specifications shall require the authorisation of the Design Manager prior to issue and use. THESE NEED TO BE INCORPORATED INTO THE HIGH LEVEL CHECK LIST

44. Sri Lanka Standards Institution What the auditor must find out Has a Co-ordinator been appointed ? Do designers have access to an advisory service ? Are specifications reviewed for adequacy by identified technical authorities prior to issue ? Are changes reviewed for adequacy prior to incorporation ? Are specifications authorised by the Design Manager prior to issue and use ? Do specifications use the company standard format ?

45. Sri Lanka Standards Institution Audit Base AUDITOR’S CHECK LIST BASE CRITERIA MODIFIED BY REQTS. INTENTIONS PROCEDURES ETC.

46. Sri Lanka Standards Institution High Level Check List DOES THE ORGANIZATION’S QMS INCLUDE DOCUMENTED INFORMATION REQUIRED BY THE INTERNATIONAL STANDARD? DOES THE ORGANIZATION’S QMS INCLUDE DOCUMENTED INFORMATION DETERMINED BY THE ORGANIZATION? DOES THE ORGANIZATION ENSURE APPROPRIATE IDENTIFICATION AND DESCRIPTION OF TEST SPECIFICATION? DOES THE ORGANIZATION ENSURE FORMAT (E.G. LANGUAGE, SOFTWARE VERSION, GRAPHICS) AND MEDIA ( E.G. PAPER, ELECTRONIC)? Do specifications use the company standard format ? Has a Coordinator been appointed ? Do designers have access to an advisory service ? ARE TEST SPECIFICATIONS APPROVED FOR ADEQUACY PRIOR TO ISSUE ? Are specifications authorised by the Design Manager prior to issue and use ? YES / NO         

47. Sri Lanka Standards Institution Low Level (detail) Check List Could you explain how specifications are raised? How do you ensure specifications are adequate? How do you ensure specifications are sent to those who need to have them? What happens when errors are reported? What happens to out of date specifications? May I see the appropriate procedures?

48. Sri Lanka Standards Institution Low Level (detail) Check List ALL THOSE THINGS THAT THE AUDITOR WISHES TO EXAMINE AT THE TIME OF AUDIT, TOGETHER WITH NUMBER TO BE EXAMINED AUDIT SAMPLE DOCUMENTS TO BE EXAMINED RECORDS TO BE EXAMINED TOOLS, MATERIALS, PRODUCTS, ETC.

49. Sri Lanka Standards Institution Objective Evidence EVIDENCE THAT EXISTS AND IS VERIFIABLE FACTUAL EVIDENCE OBSERVATION DOCUMENTED STATEMENTS NOT AUDITORS OPINION

50. Sri Lanka Standards Institution Collecting Evidence CONDUCTING INTERVIEWS EXAMINATION OF DOCUMENTS/PRODUCTS OBSERVATION OF ACTIVITIES OBSERVATION OF CONDITIONS/HOUSEKEEPING

51. Sri Lanka Standards Institution ACTION PLAN

52. Sri Lanka Standards Institution Audit Plan Design Manager 5 mins - Entry 15 mins - Establish Responsibilities & Intent Specification coordinator 30 mins - Establish Practice Design Engineer 15 mins - Verify Test Engineer 15 mins - Verify Drawing Office staff 30 mins - Review process Design Manager 10 mins - Exit Total time 120 mins

53. Sri Lanka Standards Institution AUDIT DURATION - FACTORS Type of business carried out by the organization Physical layout of the organization Range of products or services Complexity of processes being audited The level of automation and sophistication in operations Size of workforce employed Locations of functional units to be audited

54. Sri Lanka Standards Institution Check Lists GUIDE AIDE MEMOIRE CONTINUITY CHECK LISTS REMIND US OF THE AUDIT SAMPLE

55. Sri Lanka Standards Institution Importance of a Check List Act as a set of reminders of important/key points Act as a working document Help to keep the auditor on tract Gives confidence to the auditor

56. Sri Lanka Standards Institution Disadvantages May be followed too rigidly If the same list is used in each audit cycle, it will become a routine to the auditee

57. Sri Lanka Standards Institution QUESTIONS ?

58. Sri Lanka Standards Institution Welcome to the Day Two of workshop of ISO 9001 Standard and Internal Quality Audit

59. Sri Lanka Standards Institution Preparation of Matrix Chart Audit Check list and Action Plan Assignment

60. Sri Lanka Standards Institution Tea Break

61. Sri Lanka Standards Institution Presentations Assignment

62. Sri Lanka Standards Institution Audit Performing On Site Audit

63. Sri Lanka Standards Institution Assessment Task VERIFY THAT THE DEFINED SYSTEM ELEMENTS EXIST, ARE IMPLEMENTED AND ARE EFFECTIVE

64. Sri Lanka Standards Institution Objective Evidence EVIDENCE THAT EXISTS AND IS VERIFIABLE FACTUAL EVIDENCE OBSERVATION DOCUMENTED STATEMENTS NOT AUDITORS OPINION

65. Sri Lanka Standards Institution Collecting Evidence CONDUCTING INTERVIEWS EXAMINATION OF DOCUMENTS/PRODUCTS OBSERVATION OF ACTIVITIES/ OBSERVATION OF CONDITIONS/HOUSEKEEPING

66. Sri Lanka Standards Institution Auditor’s Task INTERVIEWS QUESTIONS EXAMINATION OBSERVATION VERIFY OBJECTIVE EVIDENCE

67. Sri Lanka Standards Institution What do we examine ? DOCUMENTATION MATERIALS PRODUCTS TOOLS PEOPLE

68. Sri Lanka Standards Institution Documentation FAILURE REPORTS DEFECT ANALYSIS DATA PURCHASE ORDERS VENDOR PERFORMANCE RECORDS PRODUCTION ROUTING DATA DELIVERY DOCUMENTATION VERIFICATION DATA SPECIFICATIONS PLANS PROCEDURES TEST / INSPECTION RESULTS AUDIT REPORTS MINUTES OF MEETINGS WORK INSTRUCTIONS CONTRACTS / ORDERS DESIGN SPECIFICATIONS ETC. Documents Records

69. Sri Lanka Standards Institution Tools CORRECT TOOLS STORAGE FACILITIES ADEQUATELY MAINTAINED CORRECTLY USED COMPANY ISSUE OPERATING INSTRUCTIONS IDENTIFIED RESPONSIBILITIES (CALIBRATION / MAINTENANCE ETC.)

70. Sri Lanka Standards Institution Materials CORRECT MATERIALS HANDLING / STORAGE FACILITIES CORRECTLY USED DISPOSAL FACILITIES SHELF LIFE REQUIREMENTS IDENTIFIED APPROPRIATE INSTRUCTIONS SAFETY INSTRUCTIONS RETURN TO STORES

71. Sri Lanka Standards Institution Products IDENTIFICATION STORAGE PACKAGING TEST RESULTS INSPECTION RESULTS HANDLING TRACEABILITY CONFORMANCE PAPERWORK

72. Sri Lanka Standards Institution People TRAINING QUALIFICATIONS FAMILIARITY WITH PROCEDURES & INSTRUCTIONS AWARENESS OF RESPONSIBILITIES AVAILABILITY PHYSICAL ABILITIES SUITABLE WORKING ENVIRONMENT

73. Sri Lanka Standards Institution Methods & Techniques AUDITORS USE A COMBINATION OF AUDIT STRATEGIES AND TECHNIQUES HORIZONTAL VERTICAL FORWARDS BACKWARDS TRAIL FOLLOWING

74. Sri Lanka Standards Institution Methods & Techniques CONTRACTS A DESIGN A PURCHASING A MANUFACTURE A TEST A B A = Horizontal audit B = Vertical audit

75. Sri Lanka Standards Institution Methods & Techniques FORWARD TRACE BACKWARDS TRACE RECEIVE GOODS INSPECT STORES

76. Sri Lanka Standards Institution Assessment Process PRE-ASSESSMENT ACTIVITIES DOCUMENT REVIEW PREPARATION FOR AUDIT DETAILED PLANNING THE ON SITE ASSESSMENT FORMAL REPORT Opening Meeting CORRECTIVE ACTION AUDIT FOLLOW UP AND ONGOING SURVEILLANCE Audit Evaluate Results Closing Meeting

77. Sri Lanka Standards Institution Audit Plan Design Manager 5 mins - Entry 15 mins - Establish Responsibilities & Intent Specification coordinator 30 mins - Establish Practice Design Engineer 15 mins - Verify Test Engineer 15 mins - Verify Drawing Office staff 30 mins - Review process Design Manager 10 mins - Exit Total time 120 mins

78. Sri Lanka Standards Institution Assessment Protocols OPENING MEETING GUIDES COMMUNICATION REPORTING OF NON-CONFORMITIES DAILY REVIEW MEETING CLOSING MEETING CONFIDENTIALITY

79. Sri Lanka Standards Institution Purpose of Guides GUIDE & INTRODUCE INTERPRETER WITNESS TO FACTS FOUND SHOULD NOT ANSWER FOR AUDITEE SHOULD NOT ACT AS AUDITOR SAFETY OF AUDITORS COMPANY CONFIDENTIALITY QUALIFICATIONS REASONABLE SENIORITY COMPANY AUDITORS UNDERSTANDING OF AUDIT PROCESS AND AUDITORS NEEDS

80. Sri Lanka Standards Institution Opening Meeting GENERAL ADMINISTRATIVE ARRANGEMENTS FEEDBACK OF RESULTS CONFIDENTIALITY CLOSING MEETING ARRANGEMENTS QUESTIONS INTRODUCTIONS OBJECTIVES AND SCOPE PROGRAMME (ASSESSMENT SCHEDULE) LIMITATIONS

81. Sri Lanka Standards Institution Key Points ARRIVE ON TIME INTRODUCTIONS RE-ITERATE PURPOSE INVITE QUESTIONS

82. Sri Lanka Standards Institution Questioning Techniques ABOUT A THEME SEEKING OPINIONS REPETITIVE HYPOTHETICAL CONFIRMATORY NON VERBAL AUDITORS MUST LEARN TO LISTEN WITH THE MIND AS WELL AS THE EARS !

83. Sri Lanka Standards Institution Questioning Techniques WHAT WHY WHEN WHERE WHO HOW OPEN QUESTIONS REQUIRE A RESPONSE THAT PROVIDES THE AUDITOR WITH INFORMATION ?

84. Sri Lanka Standards Institution Interview Techniques INTERVIEW THE RIGHT PEOPLE BE WELL PREPARED LET THE INTERVIEWEE RELAX ADJUST STYLE TO SUIT

85. Sri Lanka Standards Institution Points to remember Talk to the person who does the job. Don’t talk down. Talk the language of the auditee. Speak clearly. Re-phrase the question if not understood. Don’t confuse - pose one question at a time. Come back if information is not immediately available.

86. Sri Lanka Standards Institution Audit Etiquette To remain pleasant & polite have respect for people & their culture Remember that you are a guest in the auditees ‘house’ To remain Objective and not Subjective or "opinionated" Introductions & Thanks

87. Sri Lanka Standards Institution Taking Notes RECORD THE IMPORTANT FACTS FOR FUTURE REFERENCE WHERE THE AUDITOR HAS VISITED AUDITORS NEED TO LEARN THE ART OF GOOD NOTE TAKING WHO WAS MET & SPOKEN TO RECORD OF WHAT WAS SEEN & HEARD

88. Sri Lanka Standards Institution Nonconformity FACTUAL EVIDENCE OF A CONDITION NOT IN ACCORDANCE WITH A SPECIFIED REQUIREMENT Nonconformance Noncompliance Deficiency Discrepancy Non fulfilment of a requirement ISO 900:2015

89. Sri Lanka Standards Institution Nonconformity MANAGEMENT NEED THE FACTS ! WHAT WAS FOUND WHERE WAS IT FOUND WHY IS IT A NON-CONFORMITY (WHO WAS PRESENT)

90. Sri Lanka Standards Institution Specified Requirements LEGAL CONTRACTUAL COMPANY POLICY SPECIFICATIONS DRAWINGS QUALITY MANAGEMENT SYSTEM STANDARD

91. Sri Lanka Standards Institution Nonconformity Statement Inspection area of production unit B. Inspector undertaking inspection of Frame Assembly (GT0816) using Issue 03 of drawing. Production planning document PP86 requires Issue 04. WHAT WHERE WHY

92. Sri Lanka Standards Institution Nonconformity Statement Inspection of Frame Assembly GT 0816 was observed being performed in the inspection area of production unit B by inspector using issue 03 of drawing. Production planning document PP86 indicates that issue 04 drawing should be used.

93. Sri Lanka Standards Institution Nonconformity Statement In the inspection area of production unit B, frame assembly GT 0816 was being inspected to issue 03 of drawing instead of issue 04 as required by production planning document PP86.

94. Sri Lanka Standards Institution XYZ ASSESSMENT COMPANY Report No: Sheet No: Ref No: Company Assessed: Date:: Ref: Non-conformity Observed ISO 9001 Ref: Company Doc. Ref. Auditors Signature: Person Responsible for the Corrective action: Signature of the department head Proposed Corrective Action Verification of Corrective Action: Date of Verification: Lead Auditors Signature: Division/ Department: Correction Root cause of the Nonconformity: Proposed completion date Name of the auditor: Auditor’s Signature In the inspection area of production unit B, frame assembly GT 0816 was being inspected to issue 03 of drawing instead of issue 04 as required by production planning document PP86. Production 2016-02-25 Kanchana Kanchana Example 1 : NONCONFORMITY OBSERVED 7.5.3.1 a QP 07

95. Sri Lanka Standards Institution Nonconformity CONTRACT 5730/6 REQUIRES PRIOR CLIENT APPROVAL OF ALL CHANGES TO QUALITY PLAN 5730/QA/001 PROCEDURES HP 29, HP 38, HP 86 HAVE BEEN CHANGED WITHOUT THIS APPROVAL

96. Sri Lanka Standards Institution Nonconformity Procedure LTS 1006 paragraph 6.6.3 requires Progress Meetings to be attended by a representative of the Subcontractor Project Team. It was observed that the progress meeting for the PW305 Project, held 14/05/9y was not attended by a representative of the main subcontractors Project Team. This means that the auditor has seen this, Auditor were not told, He did not suspect, but he Saw it for thimself !

97. Sri Lanka Standards Institution XYZ ASSESSMENT COMPANY Report No: Sheet No: Ref No: Company Assessed: Date:: Ref: Non-conformity Observed ISO 9001 Ref: Company Doc. Ref. Auditors Signature: Person Responsible for the Corrective action: Signature of the department head Proposed Corrective Action Verification of Corrective Action: Date of Verification: Lead Auditors Signature: Division/ Department: Correction Root cause of the Nonconformity: Proposed completion date Name of the auditor: Auditor’s Signature Procedure LTS 1006 paragraph 6.6.3 requires Progress Meetings to be attended by a representative of the Subcontractor Project Team. It was observed that the progress meeting for the PW305 Project, held 14/05/9y was not attended by a representative of the main subcontractors Project Team. Production 2016-02-25 Kanchana Kanchana Example 1 : NONCONFORMITY OBSERVED 8.1 LTS 1006

98. Sri Lanka Standards Institution In the production department the auditor notices a batch of items, identification number 6633, which have recently been manufactured. The items are labeled “awaiting customer approval”. The production supervisor explains that these items conform to the well-known and established capability of the production department but do not conform to the customer’s specification. He explain that the color and type of the fabric are slightly different than the customer specification ( PR Note 2008/06/10- B1 ) . The supervisor shows the auditor the quality control charts for the batch. The charts show clearly that the batch 6633 items had been controlled to the known capability and were manufactured in accordance with process control procedures. The supervisor states that the contract department is currently discussing with the customer how to resolve this situation. Nonconforming Product

99. Sri Lanka Standards Institution In the production department a batch of items, identification number 6633, does not conform to the customer’s specification stated on the PR Note 2008/06/10- B1 with respect to the colour and the type of fabric due to non availability such material during the production. ISO 9001 8.2.3.1 requires that contract review shall ensure that the organization has the ability to meet the requirements contract requirements before they are accepted.

100. Sri Lanka Standards Institution School Noise In class room (X01) of the school the auditor found that high noise was coming from adjoining class rooms and due to poor lighting, the students were not able to see clearly the notes being written by the teacher on the board.Layout of class room was also not in line with local legislation.

101. Sri Lanka Standards Institution Changes to procedure In the production department procedure No PRP01 Rev01 originally approved by General Manager(GM) was found amended by handwriting by a Production Executive(PE) with his initials DGM. In response to the auditor’s query, the PE replied that these amendments were urgent and GM would not object to them. The auditor had seen in the company’s procedure that all the changes in the procedures shall be reviewed and approved by GM only. Further, in this case the GM was not aware of the changes made by PE

102. Sri Lanka Standards Institution WATER SUPPLY During interview with manager of pump house of a water supply company which supplies water to the local municipal authority, the auditor was informed that as an when water supply is disrupted, he enters the same in a register, informs his senior management, informs the municipal authority and certainly takes action to restore water supply. On a further query, the auditor was informed that no other action on this disruption other than handling the cause of disruption in the above manner is taken and neither there is any procedure for the same.

103. Sri Lanka Standards Institution Major Problems Auditors viewed as a "Police Force" Auditors believe that they are an elite group of "Quality Specialists" Auditors accuse auditees of not following procedures

104. Sri Lanka Standards Institution Control of the Audit It is the responsibility of the Lead Auditor to exercise control over the audit process at all times and to ensure that the audit objectives are met For very large audits the lead auditor may not undertake audit activity, only manage the process

105. Sri Lanka Standards Institution Responsibilities Team Leader Management & coordination Communication Resolving problems Auditors Timekeeping Audit sample Investigation Recording audit observations Auditees Access & Cooperation ISO 19011

106. Sri Lanka Standards Institution Team Meeting CHAIRED BY TEAM LEADER COLLECTIVE REVIEW OF NON-CONFORMITIES TO IDENTIFY MAJOR CONCERNS SUMMARY STATEMENT PREPARED AGENDA FOR CLOSING MEETING PREPARED NON-CONFORMITY FORMS COMPLETED ALL NON-CONFORMITIES REVIEWED

107. Sri Lanka Standards Institution Assessment Conduct AUDIT SAMPLE NON-CONFORMITY INVESTIGATION FOLLOWING TRAILS

108. Sri Lanka Standards Institution Auditor Qualities CONFIDENT DIPLOMAT INQUISITIVE GOOD LISTENER PATIENT PERSONABLE VERSATILE CONSTRUCTIVE OBJECTIVE ANALYTICAL FAMILIAR WITH QUALITY SYSTEM RESILIENT PROFFESSIONAL

109. Sri Lanka Standards Institution Auditor Qualities NEGATIVE CHARACTERISTICS POOR AT PREPARATION & PLANNING TOO RIGID JUMPS TO CONCLUSIONS ARGUMENTATIVE BAD COMMUNICATOR OPINIONATED EASILY INFLUENCED STAYS IN OFFICE POOR TIMEKEEPING AFRAID OF PASSING UNPOPULAR JUDGEMENTS

110. Sri Lanka Standards Institution Audit Rules PLANNING AVOID SIDETRACKS ALWAYS SEEK EVIDENCE AGREE FACTS FOUND CHANGE STYLE DO NOT TAKE OFFENCE DO NOT ARGUE BE CONSTRUCTIVE DO NOT RISE TO AGRESSION INNOCENT UNTIL PROVEN GUILTY FOLLOW TRAILS

111. Sri Lanka Standards Institution Major Nonconformity A SIGNIFICANT NON-CONPLIANCE WITH A QUALITY SYSTEM REQUIREMENT A FAILURE OF, OR COMPLETE OMISSION OF A QUALITY SYSTEM REQUIREMENT A SIGNIFICANT NUMBER OF MINOR NON-CONFORMITIES CONCERNING THE SAME QUALITY SYSTEM REQUIREMENT OR OR

112. Sri Lanka Standards Institution Minor Nonconformity AN ISOLATED INCIDENT OF A FAILURE TO COMPLY WITH A PROCEDURE OR QUALITY SYSTEM REQUIREMENT

113. Sri Lanka Standards Institution Observation A STATEMENT OF FACT MADE DURING AN AUDIT AND SUBSTANTIATED BY OBJECTIVE EVIDENCE ALLOWING AUDITORS TO MAKE “OBSERVATIONS” CAN LEAD TO LAZY AUDITING ! (I feel there is a problem but I cannot be bothered to find the facts) “OBSERVATIONS” CAN BE VERY SUBJECTIVE ISO 19011

114. Sri Lanka Standards Institution Closing Meeting INTRODUCTIONS RECORD OF ATTENDEES PURPOSE OF MEETING THANKS FOR COOPERATION ETC. RESTATE OBJECTIVES AND SCOPE LIMITATIONS OF AUDIT SUMMARY NON-CONFORMANCE REPORTS REPORT CORRECTIVE ACTION & FOLLOW UP QUESTIONS

115. Sri Lanka Standards Institution Lunch Break

116. Sri Lanka Standards Institution Raising and Writing NCR Assignment

117. Sri Lanka Standards Institution Presentations Assignment

118. Sri Lanka Standards Institution Tea Break

119. Sri Lanka Standards Institution Corrective Action and Follow up Action

120. Sri Lanka Standards Institution CORRECTIVE ACTION nonconformity is arisen from a are laid down in the ISO 9001 Standard Company’s own documents Contd… requirement(s) Means nonfulfillment of a

121. Sri Lanka Standards Institution CORRECTIVE ACTION nonconformity is arisen from a requirement(s) means nonfulfilment of a are laid down in the ISO 9001 Standard Company’s own documents Other documents Product specification when above is not complied when above is not complied when above is not complied Product nonconformity Is found through audits nonconformity nonconformity

122. Sri Lanka Standards Institution CORRECTIVE ACTION Action to eliminate the cause of a detected nonconformity or other undesirable situation Note 1 There can be more than one cause for a nonconformity Note 2 Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence Note 3 There is a distinction between correction and corrective action

123. Sri Lanka Standards Institution CORRECTION Action to eliminate a detected nonconformity Note 1 A correction can be made in conjunction with a corrective action Note 2 A correction can be, for example, rework or regrade

124. Sri Lanka Standard Institution ASK ‘WHY’ TILL YOU REACH ROOT CAUSE Example Question 1: Why did the machine stop? Answer 1: Because the fuse blew due to an overload. Question 2: Why was there an overload? Answer 2: Because the bearing lubrication was inadequate. Question 3: Why was the lubrication inadequate? Answer 3: Because the lubrication pump was not functioning right. Question 4: Why was’t the lubricating pump working right? Answer 4: Because the pump axle was worn out. Question 5: Why was it worn out? Answer 5: Because sludge got in. Real solution: Attaching a stainer to the lubricating pump. FINDING ROOT CAUSE

125. Sri Lanka Standards Institution Root-Cause - Examples Inadequate Training Incapable Processes Not following Procedures Instruction / Information Unclear Poor Maintenance Poor Planning Poor Work Environment Supplier Quality Problem Improper Process Steps etc.,

126. Sri Lanka Standards Institution Preventive ACTION Action to eliminate the cause of a potential nonconformity or other undesirable potential situation Note 1 There can be more than one cause for a potential nonconformity

127. Sri Lanka Standards Institution Example 1 : NONCONFORMITY OBSERVED Nonconforming products were found outside the area which was demarcated to keep nonconforming products. Procedure QP7 required to keep all nonconforming products in the demarcated area.

128. Sri Lanka Standards Institution XYZ ASSESSMENT COMPANY Report No: Sheet No: Ref No: Company Assessed: Date:: Ref: Non-conformity Observed ISO 9001 Ref: Company Doc. Ref. Auditors Signature: Person Responsible for the Corrective action: Signature of the department head Proposed Corrective Action Verification of Corrective Action: Date of Verification: Lead Auditors Signature: Division/ Department: Correction Root cause of the Nonconformity: Proposed completion date Name of the auditor: Auditor’s Signature Nonconforming products were found outside the area which was demarcated to keep nonconforming products. Procedure QP7 required to keep all nonconforming products in the demarcated area. Production 2015-02-25 Example 1 : NONCONFORMITY OBSERVED 8.3 QP 07 Kanchana Lokugeegana Kanchana

129. Sri Lanka Standards Institution CORRECTION Action to eliminate a detected nonconformity Note 1 A correction can be made in conjunction with a corrective action Note 2 A correction can be, for example, rework or regrade

130. Sri Lanka Standards Institution PROPOSED CORRECTION Nonconforming products which were found outside the demarcated area shall be placed in the demarcated area as per Procedure QP7. Proposed completion date: 2015-02-25

131. Sri Lanka Standards Institution CORRECTIVE ACTION Action to eliminate the cause of a detected nonconformity or other undesirable situation Note 1 There can be more than one cause for a nonconformity Note 2 Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence Note 3 There is a distinction between correction and corrective action

132. Sri Lanka Standards Institution PREVENTIVE ACTION Action to eliminate the cause of a potential nonconformity or other undesirable potential situation Note 1 There can be more than one cause for a potential nonconformity Note 2 Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence

133. Sri Lanka Standards Institution PROPOSED CORRECTIVE ACTION An awareness programme will be conducted to educate the staff of the production department on the procedure Proposed completion date: 2015-03-18

134. Sri Lanka Standards Institution XYZ ASSESSMENT COMPANY Report No: Sheet No: Ref No: Company Assessed: Date:: Ref: Non-conformity Observed ISO 9001 Ref: Company Doc. Ref. Auditors Signature: Person Responsible for the Corrective action: Signature of the department head Proposed Corrective Action Verification of Corrective Action: Date of Verification: Lead Auditors Signature: Division/ Department: Correction Root cause of the Nonconformity: Proposed completion date Name of the auditor: Auditor’s Signature Nonconforming products were found outside the area which was demarcated to keep nonconforming products. Procedure QP7 required to keep all nonconforming products in the demarcated area. Production 2015-02-25 Kanchana Kanchana Lokugeegana Nonconforming products which were found outside the demarcated area shall be placed in the demarcated area as per Procedure QP7. 2015-02-25 Lack of awareness of the workers of the production on the procedure QP 07 An awareness programme will be conducted to educate the staff of the production department on the procedure Samson Perera (Production Manager) 2015-03-18 8.3 QP 07 Example 1 : NONCONFORMITY OBSERVED

135. Sri Lanka Standards Institution Follow-up Action Action verified Date: 2015-04-15 An awareness programme had been conducted on 2015-03-10. Record of attendance was available. Three workers were interviewed and observed that they were aware of the contents of the procedure QP7. No nonconforming products were found outside the demarcated area. Therefore, the NCR was closed.

136. Sri Lanka Standards Institution XYZ ASSESSMENT COMPANY Report No: Sheet No: Ref No: Company Assessed: Date:: Ref: Non-conformity Observed ISO 9001 Ref: Company Doc. Ref. Auditors Signature: Person Responsible for the Corrective action: Signature of the department head Proposed Corrective Action Verification of Corrective Action: Date of Verification: Lead Auditors Signature: Division/ Department: Correction Root cause of the Nonconformity: Proposed completion date Name of the auditor: Auditor’s Signature Nonconforming products were found outside the area which was demarcated to keep nonconforming products. Procedure QP7 required to keep all nonconforming products in the demarcated area. Production 2015-02-25 Nonconforming products which were found outside the demarcated area shall be placed in the demarcated area as per Procedure QP7. 2015-02-25 Lack of awareness of the workers of the production on the procedure QP 07 An awareness programme will be conducted to educate the staff of the production department on the procedure Samson Perera (Production Manager) 2015-03-18 An awareness programme had been conducted on 2010-03-10. Record of attendance was available. Three workers were interviewed and observed that they were aware of the contents of the procedure QP7. No nonconforming products were found outside the demarcated area. Therefore, the NCR was closed. 2015-04-15 Example 1 : NONCONFORMITY OBSERVED Kanchana Kanchana Kanchana Lokugeegana Kanchana Lokugeegana

137. Sri Lanka Standards Institution Example 2 : NONCONFORMITY OBSERVED No customer satisfaction measurements are taken at the reception desk. Obtaining customer perception information at the reception desk had been identified as one of the methods of obtaining such information in the Procedure QP 06

138. Sri Lanka Standards Institution XYZ ASSESSMENT COMPANY Report No: Sheet No: Ref No: Company Assessed: Date:: Ref: Non-conformity Observed ISO 9001 Ref: Company Doc. Ref. Auditors Signature: Person Responsible for the Corrective action: Signature of the department head Proposed Corrective Action Verification of Corrective Action: Date of Verification: Lead Auditors Signature: Division/ Department: Correction Root cause of the Nonconformity: Proposed completion date Name of the auditor: Auditor’s Signature Marketing 2015-02-25 Kanchana 2015-02-25 Ruwan Ekanayake (Marketing Manager) 2015-02-28 Kanchana 2015-04-10 Example 1 : NONCONFORMITY OBSERVED No customer satisfaction measurements are taken at the reception desk. Obtaining customer perception information at the reception desk had been identified as one of the methods of obtaining such information in the Procedure QP 06 02 of 06 A structured format to record customer views will be provided to receptionists and arrangements will be made for Marketing Manager to give an awareness to receptionists on the techniques of gathering such information. Obtain customer satisfaction measurement at the reception desk according to QP 06 There’s no proper format to collect customer satisfaction measurement and receptionists are not very much aware about the procedure QP 06 A format to capture the customer's view had been introduced with effect on 2015-03-18 . Record of customer satisfaction collected as per the format was available. An awareness programme had been conducted on 2015-03-17 on the implementation of the format. Record of attendance was available. Two receptionists were interviewed and observed that they were aware of the contents of the format Therefore, the NCR was closed. Kanchana Kanchana

139. Sri Lanka Standards Institution Example 3 : NONCONFORMITY OBSERVED Audits had not been carried out according to the audit schedule (e.g. Following audits had not been carried out up to date). Purchasing - scheduled for 1 st week, January Laboratory - Scheduled for 3 rd week, January Stores - scheduled for 2 nd week, February

140. Sri Lanka Standards Institution XYZ ASSESSMENT COMPANY Report No: Sheet No: Ref No: Company Assessed: Date:: Ref: Non-conformity Observed ISO 9001 Ref: Company Doc. Ref. Auditors Signature: Person Responsible for the Corrective action: Signature of the department head Proposed Corrective Action Verification of Corrective Action: Date of Verification: Lead Auditors Signature: Division/ Department: Correction Root cause of the Nonconformity: Proposed completion date Name of the auditor: Auditor’s Signature MR’s Office 2010-02-25 K C R K Lokugeegana Before 2010-03-15 From 2010-03-10 K C R K Lokugeegana 2010-04-10 Example 1 : NONCONFORMITY OBSERVED 03 of 06 Carrying out of the audits of purchasing, laboratory, stores Since the auditors are engaged in their day to day work they forget the dates sheduled Audits had not been carried out according to the audit schedule (e.g. Following audits had not been carried out up to date). Purchasing - scheduled for 1st week, January Laboratory - scheduled for 3rd week, January Stores - scheduled for 2nd week, February A calendar of audit dates will be prepared and displayed prominently in the auditors’ cubicles. Dinesh Sahabandu ( MR / Quality Assurance Manager) K C R K Lokugeegana K C R K Lokugeegana

141. Sri Lanka Standards Institution Discussion

142. Thank you Sri Lanka Standards Instituion