GVSRAO http://www.albridgesoft.com/directors.php Whats app 0091 8076524311 Email: g2businessexcellence@gmail.com India: 1204 Regal Wood, Ananat Nagar Stage 1, MANIPAL 576104. C 905 Krishna Appra Saphire, Vaibhav Khand, Indirapuram. Ghaziabad. UP. India . No. 16, First Floor, 70 Hansraj Kamshi Building, Y M Road, Masjid Bunder, West Mumbai, India UAE: Spark International FZE, PO Box 16111, RAK FTZ, RAK-UAE. Algeria: No: 2 Etage Batimet Billayat, Cite Eyalarsa, SETIF, ALGERIA. AUDITING BASICS ISO 19011:2018 #GVSRAO 9/5/2022 2 9/5/2022 3 3 9/5/2022 4 AUDIT MANAGEMENT Audit Systematic, independent and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled. Audit Scope Extent and boundaries of an audit Auditor Person who conducts an audit Audit Criteria Set of requirements used as a reference against which objective evidence is compared Audit Evidence Records, statements of fact or other information, which are relevant to the audit criteria, and verifiable Audit Findings Results of the evaluation of the collected audit evidence against audit criteria Audit Conclusion Outcome of on audit after consideration of the audit objectives and all audit findings Audit Programme Set of one or more audits planned for a specific time frame and directed towards a specific purpose 9/5/2022 5 9/5/2022 6 AUDIT MANAGEMENT INITIATING THE AUDIT PREPARING AUDIT ACTIVITIES CONDUCTING THE AUDIT ACTIVITIES PREPARING & DISBTRI BUTING AUDIT REPORT COMPLETING THE AUDIT CONDUCTING THE AUDIT FOLLOW UP 9/5/2022 7 INITIATING AUDIT ✓Appointing the audit team leader • Lead Auditor is appointed by the cert. co -organization ✓Define audit objectives, scope and criteria • Lead auditor check scope and criteria. Objective as defined by the Audit Manager. CERTIFICATION CO ✓Determine feasibility of the audit • Adequacy of resources, time duration, other information provided are reviewed ✓Select the audit team • competences required to fulfill audit objectives. ✓Establish initial contact with the auditee • • • • communication channels(phone, email, social media..) Information on timing and audit team Request of access to relevant process/documents Arrangements of the audit including site safety rules 9/5/2022 8 DOCUMENT REVIEW ✓Performing Document Review • Part of Stage 1 audit may not require in the case of Internal Audit • Understand the auditees operations,process,functions • Take into account the context,complexity,risk & opportunites • Take into account the scope,criteria and objective • Possible confirmation to the audit criteria • May also inculde previous audit reports 9/5/2022 9 AUDIT PLANNING ✓ Audit Plan:Description of the activities and arrangements for an audit ✓ Risk-based approach to planning • Consider risk of the audit activities on the auditee’s process • Efficient scheduling and coordination to achieve objective • Composition & Competence of Audit Team • Appropriate Sampling • Improving opportunity to improve effectiveness of audit activity • Risk to achieve audit activities due to ineffective planning • Risk to auditee by perform the audit 9/5/2022 10 AUDIT PLANNING ✓ Audit Planning Details ✓ Assigning Work to team • Audit Type/Audit Objective • Consider Impartiality • Audit Criteria • Training Requirements • Audit Scope • Technical Experts • Audit Date & Time • Competence • Audit location(Physical/Virtual) ✓ Documented Information • Auditor Details • Observer/Witness Details • Auditee Representative • Checklist • Sampling Details • Audio/Visual Information • Contact Details(Auditor/Audittee) 9/5/2022 11 AUDIT PLANNING ✓ Check List • Planning Tool • Provides clarity on processes and performance measures • Aide memoire ✓ Check list Preparation • Ask for an overview of the process(es) • How do these processes interrelate with other process within the organization • How are processes controlled • How are processes monitored/measured • What evidences of continual improvement is there..? 9/5/2022 12 CONDUCTING AUDIT ✓ Conducting Opening Meeting ✓ Communicating during audit ✓ Audit Information availability and access ✓ Review of documented information while conducting Audit ✓ Collecting and Verifying information ✓ Generating Audit findings ✓ Prepare for audit conclusion ✓ Conduct the closing meeting 9/5/2022 13 OPENING MEETING ✓ Introduction ✓ Objective,Scope,Criteria ✓ Review Audit Plan ✓ Audit Method & Limitation ✓ Guides ✓ Logistics ✓ Reporting Methods/Grading of Findings ✓ Confidentiality ✓ Audit Terminations ✓ Restrictions ✓ Clarification 9/5/2022 14 ONSITE AUDIT ✓ Be well prepared ✓ Enter the area ✓ Introduction by guide ✓ Explain what you want to see ✓ Investigate to the depth necessary ✓ Interview the right people ✓ Let the interviewee relax ✓ Adjust style to suit ✓ Respond to questions ✓ No problems found move on ✓ Don’t keep on auditing until problems are found ✓ Note down audit trails(if any) 9/5/2022 15 EVIDENCE COLLECTION ✓ Interview ✓ Observation of activities and conditions ✓ Review of Documents ✓ Examination of other sources of information 9/5/2022 16 OBJECTIVE EVIDENCE ✓ Evidence that exists ✓ Can be quantitative or qualitative ✓ Data supporting the existence or verity of something ✓ May be obtained through observation,measurement,test or other means(Tools,Monitoring devices,materials,Products,documents) ✓ A statement by personnel responsible for their activity ✓ May stated or documented(Preferably) ✓ Can be verified ✓ Uninfluenced by emotion or prejudice 9/5/2022 17 AUDITOR ATTRIBUTES ▪ Open-minded ▪ Diplomatic ▪ Observant ▪ Perceptive ▪ Tenacious ▪ Decisive ▪ Self-reliant ▪ Ethical 9/5/2022 18 CHECKLISTS-BENEFITS ▪ Keeps audit objectives clear ▪ Evidence of audit planning ▪ Maintains audit pace and continuity ▪ Reduces auditor bias ▪ Reduces workload during audit 9/5/2022 19 CHECKLISTS-DRAWBACKS ▪ Checklists tend to lose value if they are ▪ Tick lists ▪ Questionnaires ▪ Prepare them as a memory aid only ▪ Auditors are not to be slave to checklist. 9/5/2022 20 AUDIT TRAILS ▪ A number of trails get revealed during the conduct of audit. Some of these could lead to considerable information. Some examples: 1. Instruments are used by inspectors but are calibrated in the laboratory 2. Personnel work in departments; their training records may be centrally controlled • If potential audit trails appear, ➢ Decide to • Disregard • Note for later • Follow up immediately ➢ Might affect the sample size ➢ Might affect the audit programme 9/5/2022 21 AUDIT NOTES • Notes taken during an audit are a record of ▪ ▪ ▪ ▪ ▪ The audit sample taken What was reported What was observed What was checked Who all were interviewed • Notes may be referenced by subsequent auditors 9/5/2022 22 RESULT EVALUATION ALL RESULTS MAJOR CONCERNS MINOR CONCERNS DO NOT REPORT ONLY TRIVIALS 9/5/2022 23 AUDIT TEAM MEETING ▪ Item on the audit programme ▪ Audit team only present ▪ Controlled by team leader ▪ Plan for closing meeting ▪ Team leader prepares audit report ▪ Finalize overall judgement on system ▪ Team completes nonconformity reports ▪ Team reviews nonconformity reports 9/5/2022 24 NONCORMITY WRITING ▪ ▪ ▪ ▪ ▪ ▪ Use auditee’s terminology Make it retrievable Must be factual Make it complete Make it concise Consider the Seriousness ▪ What could go wrong if the nonconformity remains uncorrected? ▪ What is the likelihood of such a thing going wrong? ▪ How likely is it to be detected if it did go wrong? 9/5/2022 25 NONCORMITY WRITING ▪ Area where the nonconformity has been found ▪ Evidence with source ▪ Requirement not being met with Reference to the criteria such as Company manual / Management System Standard 9/5/2022 26 NONCORMITY -1 While reviewing the Minutes of Management Reviews with the Managing Director of ABC Company, it was found that in Minutes dated 2012-0Y, there is no evidence of any incidents, nonconformities, corrective actions and continual improvement Clause 9.3 of ISO 14K requires that the organization shall include information on the trend on incidents, nonconformities, corrective actions and continual improvement for discussions 9/5/2022 27 NONCORMITY -2 • The system coordinator could not provide any documented evidence of testing of emergency preparedness(mock drill). Further the coordinator tells you that, the mock drill was conducted twice during the year 20YY • Clause 8.2 of the 14K standard that the organization shall maintain and retain documented information on the process(es) 9/5/2022 28 NONCORMITY -3 • The objective for rework for the current year has been promulgated as less than 2% in the Minutes of Review Meeting dated 23 Feb 200Y. • As per records available with Production Manager, rework has not reduced below 2.5% during the period March 0Y till date and no corrective action has been initiated. 9/5/2022 29 SCENARIO TASK- IDENTIFY THE SCENARIO AS CONFIRMITY/NONCONFIRMITY During an audit of the HR department the auditor asks how the effectiveness of safety training is monitored. The HR manager replies that only world-class trainers from reputed organizations are used by the company for safety training so monitoring of effectiveness is not required. Next9/5/2022 Ex-7 Writing NCR 30 NONCONFIRMITY - MAJOR Nonconformity that affects the capability of the management system to achieve the intended results (3.12 ISO/IEC 17021:2015) A SIGNIFICANT NONCONFORMITY WITH A 14K MANAGEMENT SYSTEM REQUIREMENT OR A FAILURE OF, OR COMPLETE OMISSION OF A 14K MANAGEMENT SYSTEM REQUIREMENT OR A SIGNIFICANT NUMBER OF MINOR NONCONFORMITIES CONCERNING THE SAME 14K MANAGEMENT SYSTEM REQUIREMENT OR CUSTOMER IS LIKELY TO GET NONCONFORMING PRODUCT 9/5/2022 31 NONCONFIRMITY - MINOR Nonconformity that does not affect the capability of the management system to achieve the intended results (3.13 ISO/IEC 17021-1:2015) AN ISOLATED INCIDENT OF A FAILURE TO COMPLY WITH A PROCEDURE OR MANAGEMENT SYSTEM REQUIREMENT 9/5/2022 32 OFI Opportunities for Improvement (OFI) Areas / processes already at good performance levels, where performance levels can be further enhanced 9/5/2022 33 CLOSING MEETING ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ Introduction Attendees Thanks Confidentiality Objective/scope Reporting system Limitations Summary of findings: Good points first Agreement on nonconformities Recommendation Clarifications 9/5/2022 34 AUDIT REPORT ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ Audit reference Auditee details Objective, scope, criteria Auditors’ names Names of auditee’s principals Audit programme Summary of findings (positive & negative) Nonconformity reports Recommendation Approval Circulation Ensure confidentiality of report 9/5/2022 35 AUDIT FOLLOW-UP ▪ Auditee receives nonconformity report ▪ Auditee determines root cause ▪ Auditee prepares Corrective action plan and submits plan (where appropriate) to auditor ▪ Auditor evaluates response ▪ Auditee implements plan ▪ Auditee evaluates effectiveness ▪ Auditee revises plan if necessary ▪ Auditee documents the changes ▪ Auditor verifies implementation and effectiveness ▪ Records made of all actions taken (by auditor and auditee) 9/5/2022 36 AUDIT FOLLOW-UP ▪ Auditee receives nonconformity report ▪ Auditee determines root cause ▪ Auditee prepares Corrective action plan and submits plan (where appropriate) to auditor ▪ Auditor evaluates response ▪ Auditee implements plan ▪ Auditee evaluates effectiveness ▪ Auditee revises plan if necessary ▪ Auditee documents the changes ▪ Auditor verifies implementation and effectiveness ▪ Records made of all actions taken (by auditor and auditee) 9/5/2022 37 AUDIT FOLLOW-UP ▪ Evaluation of submitted corrective actions ▪ Evaluation by continuing assessment visit ▪ Partial re-audit ▪ Full re-audit CORRECTION Correction is an action taken to eliminate a detected nonconformity. CORRECTIVE ACTION Corrective action is taken to eliminate the cause of a detected nonconformity. This requires understanding the root cause of the detected nonconformity and taking action to eliminate the root cause(s) to prevent recurrence of the nonconformity. 9/5/2022 38 ROOT CAUSE DETERMINATION ASK ‘WHY’ TILL YOU REACH ROOT CAUSE OOT Merry Fell down on the floor inside a warehouse Question 1 Why did she fall Answer The floor was slippery Question 2 Why the floor was slippery Answer There was water on the floor Question 3 Why there was water on the floor Answer The water as on the floor due to rain Question 4 Why the rain water happened to enter inside Answer There was leakage on the roof Question 5 Why there is a leakage on the roof..? Answer The Asbestos sheet of roof is broken The real Solution is to repair the roof instead of just cleaning the floor 9/5/2022 39 ROOT CAUSE DETERMINATION ASK ‘WHY’ TILL YOU REACH ROOT CAUSE The central heating unit stopped functioning Question 1 Why did the heating stop? Answer Because the fuse blew due to an overload. Question 2 Why was there an overload? Answer Because the bearing lubrication was inadequate Question 3 Why was the lubrication inadequate? Answer Because the lubrication pump was not functioning right. Question 4 Why wasn't the lubricating pump working right? Answer Because the pump axle was worn out. Question 5 Why was it worn out? Answer Because sludge got in. The real Solution is to attach a strainer to the lubricating pump 9/5/2022 40 We hope you enjoyed this course 9/5/2022 41 GVSRAO http://www.albridgesoft.com/directors.php Whats app 0091 8076524311 Email: g2businessexcellence@gmail.com India: 1204 Regal Wood, Ananat Nagar Stage 1, MANIPAL 576104. C 905 Krishna Appra Saphire, Vaibhav Khand, Indirapuram. Ghaziabad. UP. India . No. 16, First Floor, 70 Hansraj Kamshi Building, Y M Road, Masjid Bunder, West Mumbai, India UAE: Spark International FZE, PO Box 16111, RAK FTZ, RAK-UAE. Algeria: No: 2 Etage Batimet Billayat, Cite Eyalarsa, SETIF, ALGERIA.
