3 3 3-OHSMS-LAC - Delelgate Activity Manual-20-JULY-2020

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PR357 ISO 45001:2018

Lead Auditor
(Occupational Health & Safety Management Systems)
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IRCLASS/TRG/ISO45001/LAC/DAM/Rev 0.4, dtd: 16/05/2019 © IRCLASS Systems and Solutions Private Limited 2019 Page 1 of 33
Occupational Health & safety (OH&S) Management
System Lead Auditor
Training Course
Delegate Activity Manual
This material is for the personal use of a delegate attending a course presented by IRCLASS.
No part of the materials may be reproduced, stored electronically, or transmitted in any form or by any
means without the prior written consent of IRCLASS.
CQI-IRCA Accreditation No. 2122
Activity-1: Terms & Definitions related to audit
Purpose: To understand the terms of audit as given in ISO 19011.
Duration: 5 Minutes Introduction+ 15 minutes+10 minutes feedback.This is individual exercise.

Slide # 31
Marks for Continuous evaluation: 1-10 (1-2: unacceptable, 3-4: poor, 5-6: acceptable, 7-8: good, 9-10: excellent.
Each delegate shall be graded as per above criteria. These marks to be linked to Continuous assessment Sheet.
Directions:
Audit related terms are given below and the definitions as per ISO 19011 are provided. You have to read the
definition and place the term which it defines against it.
Terms Answer Definition
Audit outcome of an audit, after consideration of the audit objectives
1 A
Criteria and all audit findings
2 Competence B organization as a whole or parts thereof being audited

Audit
3 C Extent and boundaries of an audit
Program
Person who provides specific knowledge or expertise to the audit
4 Audit Scope D
team
Audit
5 E Non-fulfilment of a requirement
Conclusion
set of requirements used as a reference against which objective

6 Auditor F
evidence is compared. Set of policies, procedures, or requirements
7 Audit Client G person who conducts an audit

Systematic, independent and documented process for obtaining
8 Audit H audit evidence and evaluating it objectively to determine the extent
to which the audit criteria are fulfilled
Audit
9 I ability to apply knowledge and skills to achieve intended results
Evidence
Results of the evaluation of the collected audit evidence against

10 Audit Team J
audit criteria
Audit
11 K Organization or person requesting an audit
Findings
arrangements for set of one or more audits planned for a specific
12 Auditee L
time frame and directed towards a specific purpose
Non- one or more persons conducting an audit, supported if needed by
13 M
conformance technical experts
14 data supporting the existence or verity of something i.e. Records,
Audit Plan N statement of fact or other information, which are relevant to
the audit criteria and verifiable
Technical
15 O Description of the activities and arrangements for an audit
Expert
Activity-2: Difference between first party, second party and third-party audits;
Purpose: Understand various types of the audits and differentiate between them into 1’st, 2’nd and
3’rd party Audits.
Duration: 5 Minutes Introducion+ 15 minutes+10 minutes feedback, This is individual exercise.

Slide # Slide no 32 TO 38
Each delegate shall be graded as per above criteria. These marks to be linked to Continuous
assessment Sheet.
Direction: Based on your understanding of an audit identify key differences in 1’st, 2’nd and 3’rd party
audits. You can write your answer on the flipchart/notepad.
Activity-3 To understand the audit activities
Purpose: Understand sequence of activities related to audits.
Duration: 5 Minutes Introduction+ 15 minutes+10 minutes feedback, This is individual exercise.

Slide # 39 to 42
Each delegate shall be graded as per above criteria. These marks to be linked to Continuous
assessment Sheet.
Direction: TASK-A: Fastest Finger first………. Refer the activities mentioned below with respect to typical
audit, please try and arrange these activities in chronological order.
AUDIT ACTIVITIES CHRONOLOGICAL ORDER Subgroup (As per task-B)

Distributing the audit report
Assigning the work to the audit team
Conducting the opening meeting
Establishing the initial contact with the auditee
Collection and verification of information
Prepare work document
Conducting the audit follow up
Conducting the closing meeting
Preparing the audit plan
Audit findings
Roles responsibility of guides and observer
Determining the feasibility of the audit
Audit conclusions
Communication during the audit
Document review
Preparing the audit report
Task-B …. Subgroup above activities into following categories
Initiating the audit; preparing the audit activities; conducting the audit activities; conducting & distributing
the audit report
Activity-4: Difference in Methodology of 1’st Party, 2’nd Party & 3’rd party audits
Purpose: Understand key difference amongst three types of the audit w.r.t. approach, time,
methodology, and objectives
Slide # 43
Marks for Continuous evaluation: 1-10 (1-2: unacceptable, 3-4: poor, 5-6: acceptable, 7-8: good, 9-10:
excellent.
Each delegate shall be graded as per above criteria. These marks to be linked to Continuous assessment
Sheet.
Direction: As per activity #2 you already know the difference between first party; second party
and third-party audits; now further classify them w.r.t. approach, time, methodology,
and objectives.
Activity-5: Determine Audit Objectives, Scope and Criteria

Purpose: To Outline the Audit Objectives, Scope and Criteria for 1’st 2’nd and 3’rd party audits.
Slide # 44 to 47
excellent.
Sheet
Direction: Refer the Activities 2 & 4. You have already understood the 1’st; 2’nd and 3’rd party audits.
Now identify the AUDIT OBJECTIVES, SCOPE AND CRITERIA laid down for each type of the audit.
AUDIT OBJECTIVES SCOPE CRITERIA
1’st party
2’nd party
3’rd party
Activity-6: Responsibility and authority of the personnel associated with audit

activities
Purpose: Determine the Responsibility and Authority of Team Leaders, Auditors, Guides, Observers,
and Auditee & Client.
Duration: 10 minutes Introduction +20 minutes+15 minutes feedback; This is GROUP exercise.
Slide # 48 to 50
Sheet
Task: Read the statement given below and place them under appropriate box/es; so as to acquire
the knowledge about the responsibility & authority of audit personnel. Reference
19011:2018
1. …deny observers from taking part in certain audit activities.

2. …. assist the audit team
3. …. assisting the auditors in identifying individuals to participate in interviews and confirming timings;
4. …. ensuring that rules concerning location safety and security procedures are known and respected by
the audit team members and observers.
5. …. witnessing the audit on behalf of the auditee
6. ……. providing clarification or assisting in collecting information.
7. ……. Establishing initial contact with the auditee
8. assign to each team member responsibility for auditing specific processes, activities, functions or
locations.
9. ………. collect and review the information relevant to their audit assignments and prepare work
documents,
10. ………. communicate the progress of the audit and any concerns to the auditee and audit client,
11. ……. Any concern about an issue outside the audit scope should be noted and reported to
12. ……Conducting the closing meeting
13. …. should agree on the time frame for an action plan to address audit findings.
14. …. should advise the auditee of situations encountered during the audit that may decrease the
confidence that can be placed in the audit conclusion
15. …. report the audit results in accordance with the audit programme procedures
16. give permission and access to those parts of the audit site, to be visited in accordance with the audit
scope;
17. …. avoid any unnecessary disturbance of the operational processes
18. ……reach agreement on whether the audit should be interrupted, rescheduled or continued;
19. ……. if taking photographs or video material, ask for authorization from management in advance and
consider security and confidentiality matters and avoid taking photographs of individual persons
without their permission;
20. …. Selecting the audit team members
21. …. operate under the direction of an auditor, but should not act as auditors.
22. …. if a conflict of interest or competence issue arises, it should be discussed with….
23. ……should develop, maintain and improve their competence through continual professional
development and regular participation in audits
24. …. should exhibit professional behaviour during the performance of audit activities,
25. …. plan and organize the work effectively;
26. …. prioritize and focus on matters of significance understand and consider the experts’ opinions
27. …confirm the sufficiency and appropriateness of audit evidence to support audit findings and
conclusions
28. …use work documents to record audit activities
29. …. maintain the confidentiality and security of information, data, documents and records
30. …. preventing and resolving conflicts, as necessary;
31. …. Those documents involving confidential or proprietary information should be suitably safeguarded
at all times by the……….
32. …. sought confirmation to the agreement of all parties to the audit plan;
33. …. acknowledge the audit report…
34. …. accept the nonconformities as closed….
35. …. provide specific knowledge or expertise related to the organization, the process or activity to be
audited, or language or culture.
Team
Auditors, Guides Observers, Technical Expert Auditee Client.
Leaders,
Activity-7: To understand different audit methods,
Duration: : 5 Minutes Introduction+ 15 minutes+10 minutes feedback; This is individual exercise.
Slide # 51 & 52
excellent.
Sheet
Direction to Delegates: Study the previous Activity-2 & 4 and identify what method were used by the
various auditors…also list down +ve and -ve points of these methods.
Audit
Method On-site Remote
Human Interaction
Non-human Interaction
Activity-8: To understand the audit plan requirements,

Duration: 5 minutes Introduction + 45 Minutes Presentation + 10 minutes feedback This is GROUP exercise.
Slide # 56
excellent.
Sheet
Direction to Delegates: Refer ISO19011 clause # 6.3.2; and prepare the structure for Audit Plan based on
these requirements.
Also identify the risk in achieving the Audit Objectives (With respect to Objective, Scope, Criteria, locations
etc.) refer clause 6.3.2.2 Audit planning details ISO19011
Activity-9: Opening Meeting
Duration: 5 minutes Introduction + 45 Minutes Presentation + 10 minutes feedback This is

GROUP exercise.
Slide # 59 to 60
excellent.
Sheet
Direction to Delegates: Refer ISO19011 clause 6.4.3 - Conducting the opening meeting, and prepare your
points for the coverage of opening meeting presentation.
Activity-10: Capturing & verifying Audit Evidences
Duration: 5 minutes Introduction + 30 Minutes Presentation + 10 minutes feedback; This is

GROUP exercise.
Slide # 61 to 66
excellent.
Each delegate shall be graded as per above criteria. These marks to be linked to Continuous assessment Sheet
Direction to Delegates: Refer ISO19011 clause 6.4.7 – methods of collecting information are INTERVIEW,
OBSERVATION and REVIEW OF DOCUMENTS & RECORDS… capture how to convert various methods of
collecting the information into Audit Evidence………
methods of collecting
How to convert it into Audit evidence
information
INTERVIEW
OBSERVATION
REVIEW OF DOCUMENTS and

RECORDS
SOLVE SECTION-1 OF SPECIMEN EXAMINATION PAPER AS A HOME-WORK and DISCUSS THE HOME WORK
AT THE END DAY-2, likewise solve Section-2 as a home work on day-2 and discuss it at the end of day-
3……last section i.e. section-4 shall be discussed on day-4.
DAY-2
Activity-11: Questioning Technique
Duration: 05 minutes Introduction +15 Minutes+10 minutes Feedback; ; This is GROUP exercise.
Slide # 67
excellent.
TASK:
Role play will be there
One team will ask questions to their auditee (selected from another team)
From the learning of various questioning technique now be ready for the interview of the person, tutor will
ask you to pose various types of question (Open, closed, probing, leading etc.) to your auditee….
Scenario –
1. Incident Investigation.
2. Operation was manual; company has installed equipment for the operation, now operation is semi-
automatic.
3. There are 10 nonconformities in internal audit.
4. Training to workmen.
Activity-12: Follow up audit scenario

Duration: 05 minutes Introduction +30 Minutes+10 minutes Feedback; This is GROUP
exercise
Slide # 83
excellent.
Sheet
Direction to Delegates: Recollect the leaning from today’s session and answer the questions as follows;
student can note down their answer in the flipchart/notepad. This is group exercise
1. Who decides the follow up audit?
2. What could be the Objective, Scope, and duration of follow up audit?
3. Who will conduct this follow up audit?
4. Does it require audit plan?
5. Opening meeting required?
6. What will be the possible outcome from the follow-up audit?
Activity 13: OH&S Management System Terms & Definitions

Duration: 10 Minutes+ 5 minutes Feedback; This is INDIVIDUAL exercise
Slide # 85
Directions:
Individually, review he terms and definitions and determine which definition belongs to which term, Enter
the correct letter of the definition next to the appropriate term in the table on the following page. Definition
of terms used in OH&S ISO 45001:2018 has been provided.
Worker management system or part of a management system used to achieve the
1 A
OH&S policy
Participation 2 B -making seeking views before making a decision
Consultation 3 C involvement in decision
Workplace extent to which planned activities are realized and planned results
4 D
achieved
Contractor person performing work or work-related activities that are under the
5 E
control of the organization
Requirement legal requirements that an organization has to comply with and other
6 F
requirements that an organization has to or chooses to comply with
legal requirements external organization providing services to the organization in accordance
and other 7 G with agreed specifications, terms and conditions
requirements
OH&S management need or expectation that is stated, generally implied or obligatory
8 H
system
Effectiveness policy to prevent work-related injury and ill health to workers and to
9 I
provide a safe and healthy workplace
OH&S policy objective set by the organization to achieve specific results consistent with
10 J
the OH&S policy
OH&S objective place under the control of the organization where a person needs to be or
11 K
to go for work purposes
Audit 12 L specified way to carry out an activity or a process
injury and ill health occurrence arising out of, or in the course of, work that could or does
13 M
result in injury and ill health
Hazard 14 N adverse effect on the physical, mental or cognitive condition of a person
OH&S risk circumstance or set of circumstances that can lead to improvement of
15 O
OH&S performance
OH&S opportunity combination of the likelihood of occurrence of a work-related hazardous
16 P event or exposure(s) and the severity of injury and ill health that can be
caused by the event or exposure(s)
Procedure 17 Q measurable result
Performance performance related to the effectiveness of the prevention of injury and ill
18 R
health to workers and the provision of safe and healthy workplaces
Incident 19 S source with a potential to cause injury and ill health
OH&S performance systematic, independent and documented process for obtaining audit
20 T evidence and evaluating it objectively to determine the extent to which the
audit criteria are fulfilled
Activity-14: Understanding EDIM (Establishment, Documentation, Implementation
& maintenance of OH&S
Purpose:
Establishment of OH&S ISO45001:2018
Duration: 05 minutes Introduction +15 Minutes+10 minutes Feedback; This is INDIVIDUAL exercise
Slide # 87
Directions to Delegates:
Fastest finger first…. Please arrange following statement in correct chronological way
OH&S objectives
Planning
External issues
Evaluation of Data
Interested parties
Management review
Risk assessment
Monitoring & measurement
Corrective action
Resource provision
Operations
Internal audit
Continual improvement
Internal issues
Strategic direction
Activity 15: Understanding audit trail
Purpose: How to generate audit trail while auditing ISO45001 2018 requirements
Duration: 05 minutes Introduction +45 Minutes+10 minutes Feedback; This is INDIVIDUAL

exercise
Slide # 87
excellent.
Direction to delegate:
You are auditing top management of an orgnization engaged in the manufacturing of automotive items, during
interview with top management you came to know that as part of Corporate Social Responsibility; the
orgnization has decided to employ 5% physically challenged personnel for the office work. Another policy of the
orgnization is to empower local women so they employed 80% women employees. Now you went to audit of
manufacturing cell, few workmen from physically challenged working in the production. Production supervisor
told you that he is working here because of heavy absenteeism in the production because of health issues. You
also noticed that illumination Level in the manufacturing cell is low. Manufacturing cell works in two shifts; up to
12 ‘o clock in the night. You also noticed that lot of fumes are getting generated in the production cell. There is
no effective exhaust for the fumes.
Now try to link this situation to maximum number of ISO45001:2018 clauses, which you would like to verify as a
OH&S auditor.
Activity 16: Understanding OHSMS documented information
Purpose: What are the documents and records required by ISO45001 2018
Duration: 05 minutes Introduction +30 Minutes+10 minutes Feedback; This is GROUP ACTIVITY.
Slide # 88
excellent.
Sheet
Direction to Delegate:
Start from clause number 4 to clause number 10 of ISO45001 2018 requirements, search for the phrases,
“the organization shall establish, implement and maintain a process”; “documented information to be
maintained” and “documented information to be retained.”. And list down these processes, documents,
records and corresponding clause number
Clause Number establish, implement and documented information documented information

maintain a process to be maintained to be maintained
Activity 17: Initiating the audit.
Purpose: To acquire skill for initiating the audit.
Duration: 05 minutes Introduction +20 Minutes+05 minutes Feedback; This is INDIVIDUAL

exercise
Slide # 89 & 90
excellent.
Directions:
You are working for a certification body as programme manager ….and received a request to plan surveillance
audit…. for the automotive client who has two manufacturing units one at Mumbai and other at Chennai,
head office is in Bangalore, this office gives support to both the manufacturing sites for activities like Sales &
marketing, Design Centre, Strategic Planning, Central purchase and corporate Human Resource department,
Previous audit was certification audit and both manufacturing sites had received 4 NC s each and Bangalore
support function 2 NCs,
What information you will seek from the and Auditee Management, Audit Client, Design and Development
centre….
Design and Development

Auditee Management, Audit Client
centre
Activity 18: Document Review

Purpose: Conduct document review for Auto exile (A sample case study)
Slide # 91
excellent.
Directions: Refer Autozen Exile Global Products case study document and conduct document
review
Activity 19: AUDIT PLAN

Purpose:
To test the skill for preparing the ON-SITE audit plan based on the Criteria, Scope and objectives of an audit.
Slide # 92
excellent.
Directions:
Refer Autozen Exile Global Products documents, use template made in the activity number 8 and prepare
the audit plan. This is for Stage-2 certification audit, consider two auditors two days.
Also Highlight Risks to achieving the audit objectives because of poor audit planning.
And Risks to the auditee created by performing the audit.
Refer Clause # 6.3.2.1 ISO19011:2018
Activity 20: Work Document

Purpose: TO test the skill for preparing the audit checklist for TOP MANAGEMENT
Duration: 05 minutes Introduction +40 Minutes+15 minutes Feedback. ; This is GROUP ACTIVITY.
Slide # 93 to 96
Sheet
Directions:
This will be group activity.
Prepare a checklist to audit top management of Autozen Exile Global Products (A sample case study)
Please consider clause 5 & Clause 9.2.2 and 9.2.3 of ISO45001:2018 for preparing the checklist.
Activity 21: Opening Meeting

Duration: 05 minutes Introduction +40 Minutes+15 minutes Feedback; This is GROUP ACTIVITY
Slide # 97
Purpose:
To practice and test the skills to conduct an opening meeting for OH&S Management System ISO45001 2018
audit for stage-2 audit.
Directions:
This is group activity
Plan and carry out the opening meeting.
In accordance with your audit plan
Please refer the ISO19011 section 6.4.2 for the agenda and coverage of opening meeting.
Be ready for the presenting opening meeting.
While one group is conducting the meeting, other groups will have to take notes and ready for your
comment during class discussion.
Activity 22: How to conduct effective plant tour

Purpose:
TO test the skill required for a site tour and collect evidences while conducting the round.
Duration: 05 minutes Introduction +45 Minutes+10 minutes Feedback. This is INDIVIDUAL

Slide # 98
Sheet
Directions:
Please look at the photos in your reference material. Assume you are as part of audit team and making
these observations. Please record your observations you would like to verify in the subsequent audit.
OR
1. In a group have discussion on the following points and then ready with your presentation…
2. Who all should participate in the Plant Tour?
3. Who should accompany the audit team while taking plant tour from client orgnization, what is
his/her role?
4. Any precautions with respect to Safety, Security and emergency norms?
5. How much time shall be spent on plant tour?
6. What to focus during plant tour?
7. How to take best help from Industry Expert/Technical Expert?
8. After plant tour is it necessary to have meeting amongst the team members?
9. How to reflect the plant tour into subsequent audits?
Activity 23: Auditing Top management

Purpose: TO test the skill required, as an auditor, to interview and audit top management of
an orgnization.
Duration: 05 minutes Introduction +45 Minutes+10 minutes Feedback. This is GROUP ACTIVITY
Slide # 99
Sheet
Directions:
This is group activity.
Interview top management of Autozen Exile Global Products (A sample case study).
Tutor will play the role of top management.
Each group will have to ask questions in turn.
When you are not asking the question please make notes and gather audit evidences. This information may
be useful for subsequent audit.
Then while class room discussion please share your information and explain to class how are you going to
use this information in the subsequent audit.
Please also discuss the attributes of Auditor as well as Auditee.
Audit Objective: Stage-2 audit of Autozen Exile Global Products
Audit Criteria: ISO45001 2018 & Documented information of Autozen Exile Global Products
Scope: Entire “Autozen Exile Global Products” activities.
Direction: Audit evidences gathered during this shall be used for preparation of audit report.
From Activity 24, Each audit team needs to interview auditee tutor during role play covering all applicable
ISO45001 clauses across the specific departments assigned to the team by the tutor.
Activity 24: Auditing Context, Risk & opportunity, Support, Operation,

Performance evaluation and Improvement, related to various departments of case
study “Autozen Exile Global Products”.
Purpose: TO test the skill required, as an auditor, auditing Context.
Duration: Total time spread over 11 Hrs and 30 Minutes (Spread over 2 days)
Slide # 100 to 108
Sheet
Each team will get sufficient time to prepare checklist for their allocated department and then once class is
ready auditee tutor shall be audited, one after the other team
After every department’s audit is over feedback session is planned by the Tutor.
Directions:
Audit the department allocated to you by a Tutor.
Interview the tutor Auditee.
While delegates of other teams are not actively participating in the simulated audit, they should be
observing audits of other groups for offering subsequent comments on how audit could have been done
better,
Then while class room discussion please share your information and explain to class how are you going to
use this information in the subsequent audit.
Audit Objective: Stage-2 audit of Autozen Exile Global Products

Audit Criteria: ISO45001 2018 & Documented information of Autozen Exile Global Products Scope: Entire
“Autozen Exile Global Products “activities.
Direction:
Audit evidences gathered during this shall be used for preparation of audit report.
Risk based auditing:

• Demonstrates priority is given to questioning risks and opportunities identified by the orgnization
with focus on the processes which directly impact the safety of the workers
• Prioritization of high-risk area and focusing the auditing to risk mitigation, opportunities to reduce
the risk and operational control
• Monitoring of the risks; which are highest concern to business and strategic direction; by the
organization’s top management;
• Identification and focusing the operational control commensurate with the risk rating.
Activity 25: Nonconformity and closure
Purpose: To test the skill required, as an auditor, to identify and grade the nonconformity
based on the its impact to system and customer.
Slide # 109
excellent.
Sheet
Directions:
Refer the scenarios allocated to you.
Each group has identified nonconformity/es during audit of their allocated department from “Autozen Exile
Global Products” case study.
Please write the nonconformity into 3 elements
1. Statement of Nonconformity.
2. Requirement of ISO45001:2018
3. Objective Evidences against the nonconformity.
Audit Objective: Stage-2 audit of “Autozen Exile Global Products”

Audit Criteria: ISO45001 2018 & Documented information of “Autozen Exile Global Products”
Scope: Entire “Autozen Exile Global Products” activities.
Direction: Audit evidences gathered during this shall be used for preparation of audit report.
Delegate may attempt additional scenarios given below if time permits, else it can be attempted as a home
work and can be discussed in the course of time
Scenario-1
Consequences of deviation from established Operational Control Procedure for “Entry into confined Space
(Vessel Entry) has not been communicated to workers. You also notice workmen carrying out work; are
from different linguistic background.
Correction: Procedure displayed at the work station.

Root Cause: Inadvertently missed out to display the procedure
Corrective action: Procedure displayed at the work station.
Auditor – verified the procedure (English version) displayed at confined space entry.
Scenario-2
During the audit of Press shop auditor observed that 2 out of 10 workmen working in the shop since last 10
years, had shown the mild NILS (Noise Induced Hearing Loss). This is a notified disease as per the local
factory rules. This was understood from their 6 monthly medical surveillance reports for last 6 years.
Although they were using ear bud. It was of little use.
Correction:
1. Workmen are made aware of the Health Hazard arising out of workplace environment.
2. Similarly, all the other workmen are made aware of their workplace hazards.
3. Root Cause: Participation of workmen were weak in identifying the workplace hazards.
4. Medical surveillance report of are not monitored as a trend.
5. Similarly, workplace injuries and health data not monitored as a trend.
6. Poor implementation of factory rules
7. HIRA reviewed and updated covering Health as well injury and emergency situations
Corrective action:
1. Training to all workmen; HIRA development was weak
2. Participation procedure made more robust.
3. All Health and injury related data now monitored by using historic data.
4. New software developed and implemented for this.
5. These two workmen are moved out of Press shop and they have allocated office work.
6. Ear muffs provided instead of ear buds, engineering control initiated to suppress the noise level.
7. Quarterly, Management review now review all the monitoring trends
Auditor – Verified the monitoring methods of data monitoring, verified the workmen are transferred to
new department. Verified the HIRA, verified training record of workmen, verified workmen are now
involved for development of the workplace hazard.
NC-3
Assembly shop had painting booth to the automotive parts. Most of the job was done by the contract
labourers. During the audit auditor notice that the periodic Maintaince of this paint-booth is carried by out
by an external agency (Outsourced Activity). There was no work permit system established to carry out the
Maintaince work in a paint booth. As per HIRA this activity is no-routine and requires work permit system.
Correction: - External party trained, and henceforth work permit to be issued
Root cause: - Forgot to issue Work Permit system, as external agency is quite familiar with the job and
performing the task every year.
Corrective actions –Work permit to be issued regularly.
Auditor verification – Verified the Correction and corrective action, found satisfactory NC CLOSED.
NC-4
Emergency preparedness carried out in the month May-XX does not include visitors, who were present in
the premises. Verified for fire mock drill carried out in the month of May-xx, Purchase people invited the
supplier representatives for safety training. Purchase in-charge told that. Everybody in the training heard
the emergency siren, but because of training, we said we will complete the training.
Correction: - NIL.
Root cause: - This training was related to important project work; hence visitors did not follow the
emergency preparedness drill.
Corrective actions –NIL
Auditor verification – This NC cannot be closed, as Root cause and corrective action not complete. NC
response rejected.
NC-5
Orgnization has conducted the internal audit at the frequency of once in six months.
While going the through internal audit documents, third party auditor noticed that risk and opportunities
not audited. Further investigation reveals that internal auditor not trained on risk and opportunities,
although one of the customers had specific requirement to trained internal auditor on the risk and
opportunity auditing.
Third party auditor could able to identify many a potential risk and opportunities.
A management review record says risk and opportunities are effective.
Correction: - Internal auditors advised to focus on risk and opportunities
Root cause: - inadvertently missed the points during internal audit.
Corrective actions –in the next internal (8’th month of current calendar year) audit risk and opportunities
will be covered by each internal auditor as there was nonconformity on this aspect in the third-party audit
conducted in the 2’nd month of the calendar year.
Auditor verification – proposed action is accepted, effectiveness to be verified in the next surveillance
audit.
BASED ON THE AUTOZEN EXILE CASE STUDY FOLLOWING 5 NONCONFORMITIES WERE ISSUED BY THIRD
PARTY AUDITOR AND CORRECTIVE ACTION RESPONSE WAS OUTLINED THEREOF BY CLIENT; AS A THIRD-
PARTY AUDITOR REVIEW THE CORRECTIVE ACTION RESPONSE AND STATE WHETHER CORRECTIVE ACTION
PROPOSED BY AUTO-EXILE IS MEETING REQUIREMENTS OF ISO19011 OR NOT.
Tutor will distribute the NCs amongst the various group.
Corrective Action Plan
Stage-2 Audit NC by
STAGE-2 NC #: CB AD-01 Date: XX-YY
AUTO-EXILE a Certification Body
CLAUSE # Clause 10.2 INCIDENT INVESTIGATION
Manual handling operation in Assembly section shows monitoring of the

A] Problem Statement:
Workplace upper limb disorders and slip trip and fall no action is taken on these hazards.
Process Owner: Assembly Supplier representative:
B] Correction: Containment Action/s. (Immediate actions taken)
Supervisor informed to take a meeting of all the This shall also be communicating to other departments as well
workmen and warn them if they report false injury
their salary will be deducted.
C] Root Cause Analysis: (Attach separate sheet for problem solving technique used to arrive at Root cause (s).
Root Cause (s):
Warning issued to workmen as they are reporting false injuries.
Notice to be displayed stating the actions initiated by top management.
D] Proposed Corrective Action/(s) (PCA) E] Corrective Action implemented / Initiated:
Notice put up on the prominent places in the factory Notice put up on the prominent places in the factory
E] Changes made in the Documents / systems (kindly attach the proof)
Document Document
1 NIL 3
2 4
F] Effectiveness of corrective action to prevent recurrence of cause of NC.

NC Reviewed and Accepted by
Stage-2 Audit NC by
STAGE-2 NC #: CB AD-02 Date: xx-yy
Auto exile a Certification Body
CLAUSE # Clause 7.2 Not applicable Logistics CC- nil
A] Problem Statement: Effectivess of training of workers are not verified for the training on “safe evacuation of
individuals”. Training was tested the skill of workers and then only issued a “SAFETY-MARSHAL” to them.
When asked question about the “safe evacuation of individuals” worker Mr. Dany could not able to explain
save evacuation procedure and how will he help others to rescue being a safety-marshal. No safe evacuation
drills were carried out.
Assembly Manager said that Mr. Dany, was nervous because auditor was asking a question to them. There is
no incident of such type, so it cannot be demonstrated. When asked for methods of verifying the effectivess of
training not available process owner.
Process Owner: Logistics Supplier representative: Head Logistics
This was worker issue as they could not explain the safe As per training records they have understood everything,
evacuation procedure. signature was sought from each worker.
Root Cause (s):
Classroom training given on emergency preparedness.
Workers are not able to re-collect the learning in trainings.
More classroom training before next audit Training plan revised as per that.
Document Document
1 NIL 3
2 4

.
Stage-2 Audit NC by
STAGE-2 NC #: CB AD-03 Date: XX-YY
Auto Exile a Certification Body
CLAUSE # 8.2.1 Customer Complaint CC- nil

A] Problem Statement: Lifting tool Auto Exile/Assembly/LT/Chain Pulley Block/01 to 05; not found teste
periodically as per the sated frequency in the legal register. As per Legal register the frequency of the testing
was once per six months.
Process Owner: Assembly Supplier representative: Assembly.

Lifting tool Auto Exile/Assembly/LT/Chain
Pulley Block/01 to 05 tested by competent Risk and opportunity register updated to considering the impact of
authority. Certificate available testing the chain pulley blocks. All other Legal requirements are found
complied after review by top management along with workmen
Root Cause (s):
Why-1 – Verification of compliance to legal requirements not full proof.

WHY-2 – there is no method available to know when is legal requirement is due for renewal, for testing for calibration
etc.
Why-3 – There was inadequate review by top management.
D] Proposed Corrective Action/(s) (PCA). E] Corrective Action implemented / Initiated:
Software LEGAL TRACKER to be installed, with auto Software LEGAL TRACKER to be installed, with auto
reminder facility. reminder facility.
Top management review and safety committee meeting Top management review and safety committee meeting
agenda to be modified to incorporate Status on Legal agenda modified to incorporate Status on Legal
compliance. compliance.
Separate annual budget to be made available for legal Separate annual budget made available for legal
compliance. compliance.
Training to be provided on Legal requirements Last two months review from MRM and Safety meeting
indicate no further violation on legal.
Trained all workmen
Document Document
1 LEGAL TRACKER reference made in safety manual 3
2 MRM and Safety Meeting Agenda. 4


Stage-2 Audit NC by
Auto Exile STAGE-2 NC #: CB AD-04
a Certification Body
Date: XX-YY
CLAUSE # 8.1 Purchase CC- nil

A] Problem Statement: Contract workers of “SriLanka Traders” found working at height without any safety
measures, when requested for Work permit system workmen could not able to show that.
Process Owner: PURCHASE Supplier representative: HEAD PURCHASE

Strict Warning to Contractors. This is one of incident. Because of audit Purchase head could not able
to issue Work Permit System.
Root Cause (s):

Letter issued to all contractors that they shall follow safety in Auto Exile premises.

Strict warning to all subcontractors Strict warning letter dt. XX-YY
Document Document
1 Procedure for Contractor selection amended. 3
2 4

Stage-2 Audit NC by
AUTO EXILE STAGE-2 NC #: CB AD-05
a Certification Body
Date: xx-YY
CLAUSE # 8.4.1 INTERNAL AUDIT CC- nil

A] Problem Statement: Orgnization has conducted the internal audit at the frequency of once in six months.
While going the through internal audit documents, third party auditor noticed that there are risk and
opportunities not audited. Further investigation reveals that internal auditor not trained on risk and
opportunities, third party auditor could able to identify many a potential risk and opportunities. A
management review record says risk and opportunities are effective.
Process Owner: INTERNAL AUDITS Supplier representative: HEAD SYSTEMS

Training to ALL internal auditors. NIL
Root Cause (s):

inadvertently missed the points during internal audit.
D] Proposed Corrective Action/(s) (PCA) : In the next E] Corrective Action implemented / Initiated:
internal ( 8’th month of next calendar year) audit risk Training planned in July-XY next year.
and opportunities will have to be covered by each Next internal audit – Next year Aug -XY
internal auditor as there was nonconformity on this
aspect in the third party audit conducted in the 9’th
month of the calendar year.
Document Document
1 3
2 4
Activity 26: Closing meeting

Purpose:
TO test the skill required, as a team leader to plan and conduct closing meeting.
Duration: 05 minutes Introduction +45 Minutes+10 minutes Feedback.; This is GROUP ACTIVITY
Slide # 110
Sheet
Directions:
Please prepare for the closing meeting based on the requirements of ISO19011.
Tutor will select one delegate as team leader.
This closing meeting is for the stage-2 certification audit of AutoZEN Exile
All other class member will have to prepare minimum one nonconformity based on their audit finding and
be ready to present it when your team leader will prompt you for the during the closing meeting.
Audit Objective: Stage-2 audit of AutoZEN Exile

Audit Criteria: ISO45001 2018 & Documented information of AutoZEN Exile
Scope: Entire AutoZEN Exile activities.
Activity 27: Audit Report

Purpose: To test the skill required, to prepare audit report, based on the conclusions and
recommendation given in the closing meeting
Duration: 05 minutes Introduction +45 Minutes+10 minutes Feedback. .; This is GROUP ACTIVITY
Slide # 111
Sheet
Directions:
Please prepare the audit summary report based on the AutoZEN Exile’s audit.
Then hand it over to the tutor.
Please use A4/Note pad for the summary report.
Please refer ISO19011 requirements related to Audit Report.
Activity 28: Audit Follow-up

Purpose: To test the skill required, to evaluate proposed corrective actions received from the
client Orgnization, as part of your recent audit on them.
To understand the various aspects of NC closure.
Slide # 112
Continue and ATTEMPT additional scenarios given in Activity-25.

Additional time as follows allocated.
45 minutes.
15 minutes Class discussions
Directions:
You have conducted audit of AUTOZEN EXILE for stage-2 certification audit.
Refer the nonconformities raised by a team on AUTOZEN EXILE along with the AUTOZEN Exile’s response in
the form of Correction and corrective action.
Refer NC scenarios/NCs given in the Activity-25, now review the Response given by the client.
Your response shall be specific whether you as an Auditor accept the Action plan, why/why-not?
Activity 29: Specimen examination paper

Purpose:
To attempt specimen exam paper for balance activities.
Duration: 15 minutes Class discussions
Directions:
This is individual exercise.
SOLVE SECTION-1 OF SPECIMEN EXAMINATION PAPER AS A HOME-WORK and DISCUSS THE HOME WORK
AT THE END DAY-2, likewise solve Section-2 as a home work on day-2 and discuss it at the end of day-
3……last section i.e. section-4 shall be discussed on day-4.
Attempt and complete balance part of the specimen examination paper.

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What is the purpose of the training course?

What is the purpose of the training course?

What are the different types of audits discussed in the material?

What are the different types of audits discussed in the material?

Welcome to your CQI and IRCA Certified

PR357 ISO 45001:2018

About the CQI and IRCA

Find out more about the CQI and IRCA at www.quality.org

Delegate Activity Manual

CQI-IRCA Accreditation No. 2122

Purpose: To understand the terms of audit as given in ISO 19011.

Duration: 5 Minutes Introduction+ 15 minutes+10 minutes feedback.This is individual exercise.

2 Competence B organization as a whole or parts thereof being audited

set of requirements used as a reference against which objective

7 Audit Client G person who conducts an audit

Results of the evaluation of the collected audit evidence against

Duration: 5 Minutes Introducion+ 15 minutes+10 minutes feedback, This is individual exercise.

Duration: 5 Minutes Introduction+ 15 minutes+10 minutes feedback, This is individual exercise.

AUDIT ACTIVITIES CHRONOLOGICAL ORDER Subgroup (As per task-B)

Task-B …. Subgroup above activities into following categories

Activity-5: Determine Audit Objectives, Scope and Criteria

AUDIT OBJECTIVES SCOPE CRITERIA

Activity-6: Responsibility and authority of the personnel associated with audit

1. …deny observers from taking part in certain audit activities.

Activity-8: To understand the audit plan requirements,

Activity-9: Opening Meeting

Duration: 5 minutes Introduction + 45 Minutes Presentation + 10 minutes feedback This is

Activity-10: Capturing & verifying Audit Evidences

Duration: 5 minutes Introduction + 30 Minutes Presentation + 10 minutes feedback; This is

REVIEW OF DOCUMENTS and

Role play will be there

Activity-12: Follow up audit scenario

1. Who decides the follow up audit?

2. What could be the Objective, Scope, and duration of follow up audit?

3. Who will conduct this follow up audit?

4. Does it require audit plan?

5. Opening meeting required?

6. What will be the possible outcome from the follow-up audit?

Activity 13: OH&S Management System Terms & Definitions

Duration: 05 minutes Introduction +45 Minutes+10 minutes Feedback; This is INDIVIDUAL

Clause Number establish, implement and documented information documented information

Duration: 05 minutes Introduction +20 Minutes+05 minutes Feedback; This is INDIVIDUAL

Design and Development

Activity 18: Document Review

Activity 19: AUDIT PLAN

Refer Clause # 6.3.2.1 ISO19011:2018

Activity 20: Work Document

Activity 21: Opening Meeting

Activity 22: How to conduct effective plant tour

Duration: 05 minutes Introduction +45 Minutes+10 minutes Feedback. This is INDIVIDUAL

Activity 23: Auditing Top management

Please also discuss the attributes of Auditor as well as Auditee.

Audit Objective: Stage-2 audit of Autozen Exile Global Products

Scope: Entire “Autozen Exile Global Products” activities.

Activity 24: Auditing Context, Risk & opportunity, Support, Operation,

Interview the tutor Auditee.

Audit Objective: Stage-2 audit of Autozen Exile Global Products

Risk based auditing:

Audit Objective: Stage-2 audit of “Autozen Exile Global Products”