Delegate Manual 45001

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CQI and IRCA ISO 45001 Lead Auditor

Occupational Health and Safety Management Systems (OHSMS)


Training Course

Delegate Manual

Office No 23, Building No 256A, Road No 3605, Area No 336, Manama, Bahrain
www.toveleeds.com info@toveleeds.com Phone: +973 1700 5296

Copyright © 2018
All rights reserved. No part of this delegate manual may be reproduced, distributed, or transmitted in any form or by any means, including
photocopying, recording, or other electronic or mechanical methods, without the prior written permission of the publisher, except in the case
of brief quotations embodied in critical reviews and certain other non–commercial uses permitted by copyright law.

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Table of Contents

Section Topic description

Cover Page
===========

Table of Contents
===========

Course Timetable
===========

Chapter–1 Introduction

Chapter–2 OH&SMS System in General

Chapter–3 Audit Management, roles and responsibility

Chapter–4 Approach to audit

Chapter–5 Audit Execution

Chapter–6 Non conformity reporting and Corrective action

Chapter–7 Audit Reporting

Case Study

Activities

Revision Question

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Course Time Table

Session Topic Description Start Finish

Day One (1)


Delegate Introduction, Registration and Pre course
1.1 9.00 9.45
assignment submission
1.2 Chapter :1  Introduction 9.45 11.15

1.3 Break 11.15 11.30

1.4 Chapter :2  OH&SMS System in General 11.30 13.00

1.5 Pre Course Assignment Results/Solution 13.00 13.30

1.6 Lunch 13.30 14.15

Activity 1  Auditing context of Organization,


1.7 14.15 15.30
Leadership and Planning
1.8 Break 15.30 15.45

1.9 Activity 2 Auditing support and operation 15.45 17.00


Chapter 3  Audit Management, roles and
1.10 17.00 18.30
responsibility
1.11 Day summary 18.30 18.45

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Course Time Table

Session Topic Description Start Finish

Day Two (2)


Welcome delegates, revision session by asking
2.1 questions on previous day presentation to check 9.00 9.30
knowledge
2.2 Activity 3  Auditing Hazard Identification and risk 9.30 10.30

2.3 Break 10.30 10.45


Activity 4  Auditing Performance Evaluation and
2.4 10.45 12.00
improvement
2.5 Chapter 4  Approach to audit 12.00 13.00

2.6 Lunch 13.00 13.45

Activity 5  Role and responsibilities- audit plan and


2.7 13.45 15.15
audit program

2.8 Break 15.15 15.30

2.9 Activity 6  Planning for Stage 1 audit 15.30 17.00

2.10 Chapter 5  Audit Execution 17.00 17.45

2.11 Day summary, 17.45 18.00

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Course Time Table

Session Topic Description Start Finish

Day Three (3)


Welcome delegates, revision session by asking
3.1 questions on previous day presentation to check 9.00 9.30
knowledge
3.2 Activity 7  Conducting the Stage 1 audit 9.30 11.45

3.3 Break 11.45 12.00

3.4 Activity 8  Planning stage 2 audit 12.00 13.15

3.5 Lunch 13.15 14.00


Chapter 6  Non conformity reporting and
3.6 14.00 14.45
Corrective action
3.7 Break 14.45 15.00

3.8 Activity 9  ISO 45001 Clauses 15.00 16.45

3.9 Activity 10  Audit Plan Matrix 16.45 17.45

3.10 Specimen exam paper review 17.45 18.45

3.11 Day summary, 18.45 19.00

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Course Time Table

Session Topic Description Start Finish

Day Four (4)


Welcome delegates, revision session by asking
4.1 questions on previous day presentation to check 9.00 9.30
knowledge
4.2 Chapter 7  Audit Reporting 9.30 10.00

4.3 Activity11  Audit check list 10.00 11.15

4.4 Break 11.15 11.30

4.5 Activity 12  Conducting Opening Meeting 11.30 12.00

4.6 Lunch 12.00 12.45

4.7 Specimen exam paper review 12.45 13.15

4.8 Activity 13  Auditing Top Management 13.15 14.45

4.9 Break 14.45 15.00


Activity 14  Auditing Role play, NCR Reporting and
4.10 15.00 19.00
Judgement
4.11 Day summary, 19.00 19.15

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Course Time Table

Session Topic Description Start Finish

Day Five (5)


Welcome delegates, revision session by asking
5.1 questions on previous day presentation to check 9.00 9.30
knowledge
5.2 Activity 15  Corrective action and follow up audit 9.30 11.15

5.3 Break 11.15 11.30


Activity 16  Closing meeting, preparation and role
5.4 11.30 13.00
play
5.5 Lunch 13.00 13.45

5.6 Exam revision and clarification of doubts 13.45 14.15

5.7 Break 14.15 14.45

5.8 Final examination 14.45 15.00

5.9 Course end 15.00 17.00

* Note: Where delegates take the examination in a language other than their first
language these timings are 30 minutes later.

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10/3/2018

Welcome
ISO 45001 Lead Auditor
OH& Safety Management Systems Training Course

www.quality.org/training

Tove Leeds Certification & Inspection has been independently assessed and
approved by the CQI and IRCA. This means they have the processes and
systems in place to deliver certified courses to the highest standard.

About the CQI and IRCA


The CQI is the only chartered professional body dedicated entirely to quality.
IRCA is its specialist division dedicated to management system auditors.

The CQI leads the quality profession and is dedicated to promoting excellence
through the key competencies of Governance, Assurance and Improvement.

We hope you enjoy your course

www.quality.org/training

1
Chapter – 1 Introduction

Chapter - 1
Introduction

Chapter – 1 Introduction

Course Introduction: Course Timing

DAY 1 09:00 hrs to 18:45 hrs


Refreshment Breaks:
09:00 hrs to 18:00 hrs morning & afternoon (15 min. each)
DAY 2

DAY 3 09:00 hrs to 19:15 hrs

DAY 4 09:00 hrs to 18:45 hrs


Lunch Breaks: 45 minutes

DAY 5 09:00 hrs to 17:00 hrs


Chapter – 1 Introduction

Course Introduction: Participant Introductions

► Please introduce your neighbor to everyone


► Name
► Company and what it does
► Position and what you do
► Knowledge of ISO 45001:2018
► Knowledge of the Certification System
► Auditing Experience
► Hobbies

Chapter – 1 Introduction

Course Introduction: Administration


► Start and Finish Times and ► Home Work
Time management
► Name cards
► Lunch
► Delegate Feedback Forms
► Safety rules & Evacuation
► Facilities
routes
► Local arrangements
► No external interference
(mobile phones, recording
devices )
► Availability of ISO 45001
Standards
Chapter – 1 Introduction

Course Introduction: Safety and Security Notice


 The course Directors and tutors can accept No responsibilities for
any delegates possessions and/or property
 You are advise to ensure that your personal possessions and
property are kept in a safe and secure place at all the times
 Courtesy and Copyrights
 Fire exits ? Emergency exit ? Assembly point?

Chapter – 1 Introduction

Course Introduction: Delegate Responsibility


 To qualify for certification delegates shall be required to:
► Demonstrate the ability to understand the OH&SMS
requirements
► Attain the skills necessary to conduct effective audits against
the ISO 45001:2018 ► Maintain 100% attendance
throughout the course
► Obtain an overall 70 % continual
assessment mark
► Obtain a Min. 70 % examination
mark
Chapter – 1 Introduction

Course Introduction: Course Certification Criteria

Evaluation methods P-1 P-2 P-3 P-4

Continuous
Pass Fail Pass Fail
Assessment
Not allowed to
Final Examination Pass appear Fail Fail

Overall Course Result Pass Fail1 Fail2 Fail

1. Delegate must attend the whole training course again to demonstrate satisfactory results in
continuous assessment and reappear for the Final exam in order to obtain the successful
overall result.
2. Delegate must appear for the Final exam (only one additional attempt) in order to obtain the
successful overall result.

Chapter – 1 Introduction

Course Introduction: Learning Objectives


Knowledge
 Understand the purpose of a Occupational health and safety management
system, of Occupational health and safety management systems standards, of
management system audit, of third party certification and the business benefits
of improved performance of the Occupational health and safety management
system.
 Understand the role and responsibilities of an auditor to plan, conduct, report
and follow-up a Occupational health and safety management system audit in
accordance with ISO 19011, and ISO/IEC 17021, as applicable.
Skills
 Plan, conduct, report and follow-up an
audit of a Occupational health and
safety management system to establish
conformity (or otherwise) with ISO
45001 and in accordance with ISO
19011, and ISO/IEC 17021, as
applicable.
Chapter – 1 Introduction

Enabling Objectives (Knowledge & Skill)

Explain the purpose of an occupational


health and safety management system, of
occupational health and safety
management system standards, of
management system audit, of third-party
certification, and the business benefits of
improved performance of the occupational
health and safety management system.

Chapter – 1 Introduction

Enabling Objectives (Knowledge & Skills)


Knowledge: Audit process
Explain the role of an auditor to plan, conduct, report and follow up an
occupational health and safety management system audit in accordance with
ISO 19011 and ISO/IEC 17021, as appropriate :

► Explain the purpose of an occupational health and


safety management system and the business
benefits of improving occupational health and
safety management system performance
Chapter – 1 Introduction

Enabling Objectives (Knowledge & Skill)


Knowledge: Audit process
With reference to ISO 45001:

► Explain the PDCA cycle and its application to occupational health and safety
management system processes.

► Outline the processes involved in establishing, implementing, operating,


monitoring, measuring, analysing, evaluating, reviewing, maintaining and
improving an occupational health and safety management system, including
the significance of these for OHSMS auditors.

► Explain the terms and definitions used in ISO 45001.

► State the requirements for OHSMS documented information and explain the
difference between maintaining and retaining documented information.

Chapter – 1 Introduction

Enabling Objectives (Knowledge & Skill)


Knowledge: Audit process
► Explain the purpose of and differences between first-party, second-party and
third-party certification audit of management systems.

► Explain the role of the occupational health and safety management system
auditor in evaluating an organisation’s ability to meet its legal and other
requirements, including the difference between this role and the regulatory
role of evaluating legal compliance.

► Explain the benefits of third-party accredited certification of occupational


health and safety management systems for organisations and interested
parties.

► Explain the role of an auditor to plan, conduct, report and follow up an


occupational health and safety management system audit in accordance
with ISO 19011 and ISO/IEC 17021, as appropriate
Chapter – 1 Introduction

Enabling Objectives (Knowledge & Skill)


Knowledge: Audit process
Explain the audit process, making reference to similarities and differences in the
process between first-party, second-party and third-party certification audit,
including:
► Determining audit objectives - the purpose and significance of the audit scope and
criteria,
► Identifying the appropriate personnel for the audit, the importance of auditor and audit
team competence, and the selection of team members - particularly with regard to
knowledge of the relevant management system discipline, industry sector, regulations
and legislation, and auditor training. Outline different audit methods; including on-site
and remote audits and audit activities requiring human interaction and no human
interaction.
► The purpose of a stage-1 audit, including the documented information review, and
describe a typical stage 1 audit process and outputs.
► Preparing for a stage 2 audit, including preparing an audit plan
► Conducting on-site audit activities, including preparing working documents,
conducting audit meetings, gathering and verifying audit evidence, preparing,
approving and distributing the audit report, and conducting the audit follow up.

Chapter – 1 Introduction

Enabling Objectives (Knowledge & Skills)


Skills: Audit responsibilities

 Planning the audit

 Conducting the audit

 Auditing Occupational health


and safety management
system requirements

 Generating audit findings

 Reporting the audit

 Following up the audit


Chapter – 1 Introduction

ISO 45001:2018 Lead Auditor


Occupational health and safety
management systems (OH&SMS)
Training Course

Final Examination
Rule and Format

Chapter – 1 Introduction

Course Introduction: Written Examination

► Two hours

► Extra 30 minutes if exam sat in foreign


language & for delegates with disabilities

► No electronic items in the examination room

► Reference material permitted:

►An unmarked copy of ISO 45001 standard

►A bilingual dictionary
Chapter – 1 Introduction

Course Introduction: Written Examination

1. Four sections
2. Total 90 marks available
3. Overall pass mark min. 63 marks
(70%)
4. Minimum 50% of marks for each
section
5. Specimen exam paper is provided

Chapter – 1 Introduction

Course Introduction: Written Examination

Part - 1
1. Short answers
2. Five questions
3. Ten marks available,
minimum required 5
marks
Chapter – 1 Introduction

Course Introduction: Written Examination

Part - 2
1. Short answer questions
2. Brief written answer in the space provided
3. Five marks each
4. Twenty marks available,
minimum required Ten marks

Chapter – 1 Introduction

Course Introduction: Written Examination

Part - 3
1. Long answer questions
2. Detailed written answer: use the space provided
3. Ten marks each
4. Thirty marks available,
minimum required 15 marks
Chapter – 1 Introduction

Client/ Certification Process


Organisation

Certification Body
Application
Contract Review:
 Scope
 Time-scale
Stage 1 Audit
 Audit team

Stage 2 Audit Recertification

Certification Surveillance

Chapter – 1 Introduction

Application & Review

 Application by organisation in Certification Body’s (CB) format


 Application review by CB to ensure:
1. adequacy of information about organisation
2. the CB has the necessary competence
3. differences are resolved

 CB to determine the competence


required for the audit and
 appoint audit team accordingly
Chapter – 1 Introduction

Application and Review


 Application by organisation in Certification Body’s (CB) format
 Application review by CB to ensure:
1. adequacy of information
about organisation
2. the CB has the necessary
competence
3. differences are resolved
 CB to determine the
competence required for the
audit and
 appoint audit team
accordingly

Chapter – 1 Introduction

Certification to ISO 45001 is carried out in 2 Stages

A pre-audit is optional and value added

Stage 1 Audit AND Stage 2 Audit

1 – Preparation for documentation and implementation audit


2 – Helps organization to familiarize themselves with the certification audit approach
3 – Covers all ISO 45001 requirements
4 – Optional and done at the request of the organisation
Chapter – 1 Introduction

Stage 1 – “Readiness audit”


 Recommended to be done on site
 Audit of OH&SMS Documentation
 Evaluation of location / site specific conditions
 Review of Key performances parameters
 Validation of scope
 Collection of information regarding statutory and regulatory requirements and
their compliance with respect to OH&S matters
 Review of allocation of resources for stage 2 audit, agree with client and plan for
Stage 2
 Evaluation of Internal audits and Management reviews
 Assess the overall readiness for Stage 2 audit
 Report the findings including areas of concern to the Client/Auditee

Chapter – 1 Introduction

Stage 2 - Full System Audit

Full system audit covers:


 EVERY clause of ISO 45001 for: intent, implementation and
effectiveness
 Linkages between elements of the OH&SMS

3 Key Questions:

1. Is the system adequate?


2. Is the system suitable?
3. Is the system effective?
Chapter – 1 Introduction

Audit Conclusions

 Based on both Stage 1 & Stage 2


findings
 Certification decision based on
Audit team’s findings

Chapter – 1 Introduction

Surveillance audits
 Conducted at least once per year at on-site
 Covers all functions / processes over a three year period subsequent
to certification / Re certification audits
 Audit plan based upon results of previous audits and importance and
status of processes
 Internal audits may be taken into account during surveillance audit
planning
 Assess organisations’ continued conformance to the certified standard
requirements
 What shall be checked during surveillance audits ….?
Chapter – 1 Introduction

Audit and Certification cycles


(An illustration)

Certification Cycle (3 years)


Audit Cycle (3 years)

SV 1 SV 2
27 August 19 26 August
Note: 20
Recertification Audit must be conducted well in advance so that re-certification decision is taken
before the expiry date of current certificate

Chapter – 1 Introduction

Accreditation Board Function

Accreditation Board
(e.g. ANAB, UKAS,NABCB…) ISO/ IEC 17021 and
IAF Guidelines

Certification / Registration
Body (CB)
(E.g. BV, DNV, TUV)

ISO 45001

Organization to be certified
(i.e. Client)
Chapter – 1 Introduction

End of Chapter
Chapter – 2 OH&SMS system in General

Chapter - 2
OH&SMS system in
General

Chapter – 2 OH&SMS system in General

Objectives – Occupational Health and Safety


Management System
1. To understand the Purpose of Occupational Health and Safety
Management System and
2. To understand the and outline process of ISO 45001

3. To understand the PDCA cycle of


improvement
4. To understand terms and definition
Chapter – 2 OH&SMS system in General

Purpose of Occupational Health and Safety


Management System
The Purpose of Occupational Health and Safety
Management System is to achieve the occupational
health and safety of employees in day to day work and
Continual performance improvement in the
improvement in the organization.

Chapter – 2 OH&SMS system in General

The Standard

The title of the standard is:

ISO 45001:2018
Occupational Health and Safety Management
System Requirements

The standard provides a framework to


assist organisation manage
occupational health and safety. It
provides a set of requirements that
organisations must complies.
Chapter – 2 OH&SMS system in General

What is ISO 45001


 ISO 45001 is a set of Occupational Health and safety Management
System (OH&S) standards developed by the international
organization for standardization.

ISO 45001 OH&S provide confidence to its interested parties that –

• Policies, objectives & expectations are met


• Emphasis is on prevention rather than corrective action
• It can provide further evidence of responsible care, regulatory
compliance
• System supports continual improvement

Chapter – 2 OH&SMS system in General

What is ISO 45001


 ISO 45001 is a set of
Occupation, Health & Safety
Assessment Series Standard

ISO 45001 Series


1. ISO 45001:2018 Occupational
health and safety management
systems – Requirements with
guidance for use
Chapter – 2 OH&SMS system in General

What is the goal of ISO 45001

 To develop an international standard for


OH&S management systems.
 To incorporate the OH&S in to the overall
management system of a company.
 To co-ordinate corporate functions such
as planning activities, responsibilities,
practices, procedures, processes and
resources.
 To develop, implement, achieve, review
and maintain the OH&S policy.

Chapter – 2 OH&SMS system in General

Scope of ISO 45001


 Specifies core requirements of OH&S.
 Does not state specific OH&S performance criteria
 Assure itself of its conformance with its stated OH&S policy.
 Applies to those hazards, which the organization can control
and over which it can be expected to have an influence.
 Designed to facilitate auditing of OH&S core elements and
seek certification / registration of its OH&S management
system by an external organization;
 Demonstrate conformance to others.
 Make a self–determination and declaration of conformance
with OH&SMS specification.
Chapter – 2 OH&SMS system in General

Benefits of ISO 45001


1. Increase the Acceptance From Financial Institutions, Bank, Public, Insurance
Etc.
2. Improve Industry - Government Relations.
3. Improve OH&S Performance Which in Turn Increase Productivity of Man and
Machines.
4. Meet Customer’s OH&S Expectations and Maintain Good Public Relations.
5. Government authority Benefits.
6. Ability to Meet;
● National / International Legislation
● Regional Variation in Legislation
7. Health and Safety of Workers
8. Public Image
● Consumer Opinion
● Inter-company / International Trade
● Employee Confidence

Chapter – 2 OH&SMS system in General

Advantages of ISO 45001


1. Cost
• Avoidance of fines
• Identification of possible areas which can save costs such as recycling, landfill
costs, utilities.
• Spread costs of Occupational Health and safety rather that having to be forced by
legislation to install immediately.
2. Marketing.
• Use of competitive advantage
• Improved Public relations
• Strengthened position on share market.
3. Training
• Improves Occupational, Health and safety awareness.
• Operators educate on how process may cause Occupational, Health and safety
liabilities.
• Reduced potential for Occupational Health and safety incidence through
contingency awareness
Chapter – 2 OH&SMS system in General

Advantages of ISO 45001


4. Public Perception
• Demonstrates concerns for the OH&S
• Pro-active not reactive to legislation
5. Monitoring
• Identified harmful substances outside of the process
• Improve process operation
• Enables identification of risks to be made
• Creates and builds detailed and relevant Occupational, Health and safety data
6. Management
• Provides a structured framework for management of Occupational, Health and
safety issues
• Complement other quality standards.
• Better relation with regulatory & licensing authorizations.
7. Others
• Positive response from investors, lenders, & insurers.

Chapter – 2 OH&SMS system in General

OH&SMS System
 Must be based on control of causes, not incident / reactive
 Must address all management system elements of control for
occupation, health and safety management
 Must address Normal / Abnormal / Emergency conditions
 Must have measurable parameters

 Must be goal driven


 Must be relevant to hazards and risks. The essence of
risk management is to avoid high risks, manage
medium risks and live with low risks
 Must involve all
 Must promote continual improvement
Chapter – 2 OH&SMS system in General

Typical OH&SMS Systems involve


1. Commitment of management
2. Review of current status
3. Organisation and responsibilities
4. Planning
5. Implementation
6. Measurement of performance
7. Audit & review

Chapter – 2 OH&SMS system in General

Interested Parties – Stake Holders

Management / Company
Workers employees

Insurers Financial stake


OH&S
holders

Regulatory / Society / Media


Statutory bodies
Chapter – 2 OH&SMS system in General

Evolution of a Controlled Approach

System Improvement

2000’s 2015’s

Chapter – 2 OH&SMS system in General

ISO 45001:2018 Standard Overview


0 Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Context of organization
5 Leadership
6 Planning
7 Support
8 Operations
9 Performance evaluation
10 Improvement
Chapter – 2 OH&SMS system in General

The clauses are 4 to 10 according to the High Level


Structure and their place in the PDCA Cycle. Annex SL
1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organization (P)
5. Leadership and worker
participation (P, D, C, A)
6. Planning (P)
7. Support (P,D)
8. Operation (D)
9. Performance evaluation (C)
10. Improvement (A)

Chapter – 2 OH&SMS system in General

ISO 45001:2018 OH&S Structure


PLAN DO CHECK ACT
4 Context of 5 Leadership
9 Performance
the worker 6 Planning 7 Support 8 Operation evaluation 10
organization participation Improvement

Understanding Actions to Monitoring,


the organization Leadership and address risk Operations of measurement, Incident,
and its context commitment and Resources planning and analysis and Nonconformity and
opportunity control performance corrective action
evaluation

Needs & Occupational Emergency


Health and Continual
Expectations of OH&S policy Competence preparedness Internal audit
interested parties safety improvement
and response
objectives and
planning
Org. Roles,
Scope of responsibilities Planning of Management
Management and Awareness
changes review
system authorities

Consultation
OH&S and participation Communicatio
of workers n

Documented
information
Chapter – 2 OH&SMS system in General

Structure of Standards as per ISO 45001:2017


9 Performance evaluation
• Monitoring, measurement, 10 Improvement
analysis and evaluation • General
• Internal audit • Incident, Nonconformity
• Management review and corrective action
• Continual improvement
8 Operation
• Operational planning
and control
• Emergency
preparedness and 4 Context of the organization
response • Understanding the organization
and context
• Understanding the needs and
7 Support expectations of workers and other
• Resources interested parties
• Competence • Determining the scope of the
• Awareness OH&S management system
• Communication • OH&S management system
• Documented
information
5 Leadership and worker participation
6 Planning • Leadership and commitment
• OH&S policy
• Actions to address risks
• Organizational roles, responsibilities and
and opportunities authorities
• OH&S objectives and • Consultation and participation of workers
planning to achieve them

Chapter – 2 OH&SMS system in General

Clause 1-2-3
Requirements in ISO 45001:2018
Clause 1 – This standard specifies requirements for a OH&S when an
organization -
• Use to proactively improve OH&S performance and preventing injury and ill-health.
• Seeking to manage Occupational, health and safety responsibilities in a
systematic manner to contribute to the Occupational, health and safety pillar
sustainability
• This International Standard is intended to be applicable to any organization
regardless of size, type and nature
The intended outcomes of an OH&S include:
• Enhancement of Occupational, health and safety performance;
• Fulfillment of Legal compliance obligations;
• Achievement of OH&S objectives.

Clause 2 – Normative reference


Clause 3 – Terms related to organization is given
Chapter – 2 OH&SMS system in General

4.0 Context of the organization

4.1 Understanding the organization and its context


4.2 Understanding the needs and expectations of
workers & other interested parties
4.3 Determining the scope of the Occupational
health and safety management systems
4.4 Occupational health and safety management
systems

Chapter – 2 OH&SMS system in General

5.0 Leadership and worker participation


5.1 Leadership and commitment

5.2 OH&S Policy

5.3 Organizational roles, responsibilities and


authorities

5.4 Consultation and participation of workers


Chapter – 2 OH&SMS system in General

6.0 Planning

6.1 Actions to address risks


and opportunities

6.2 OH&S objectives and


planning to achieve
them

Chapter – 2 OH&SMS system in General

Clause 7 Support

7.0 Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
Chapter – 2 OH&SMS system in General

Clause 8 Operation
8.1 Operational planning and control
8.2 Emergency Preparedness and response

The operation clause specifically looks at the organisation's


operational controls, emergency preparedness and response.

This clause is more explicit about managing


outsourcing, procurement and contractors
than ISO 45001:2018 in a move to ensure
organisations demonstrate a responsibility for
supplier health and safety management and
do not contract out risk

Chapter – 2 OH&SMS system in General

Clause 9 Performance Evaluation

9.1 Monitoring, measurement,


analysis and evaluation

9.2 Internal audit

9.3 Management review


Chapter – 2 OH&SMS system in General

Clause 10 Improvement

10 Improvement

10.1 General

10.2 Incident, nonconformity and


corrective action

10.3 Continual Improvement

Chapter – 2 OH&SMS system in General

Consequences of No control
 Damage to people, equipment, materials, property and
environment
 Prosecution, fines, legal defence
 Medical cost, compensation
 Increased insurance
 Employee confidence – lost
 Loss of production
 Loss of good will
Chapter – 2 OH&SMS system in General

Documented Information
What is a documented information ?

It is information and its supporting medium.

Documented Information : Examples Procedures,


Specification, drawing, software, graphics, and records

Formats : Example language, software version, graphics

The media of documented information could be papers,


magnetic, electronic, optical disc, photograph or a sample.

Chapter – 2 OH&SMS system in General

Purpose of Documented Information

 Internal requirements

 Regulatory requirements

 Certification requirements
Chapter – 2 OH&SMS system in General

Terms relating to Documented information

The following terms to be considered


Term Details
Documented Information and its support medium and guidelines or
information evidences
Guideline Document stating recommendations or suggestions
Record Documented information stating results achieved or
providing evidence of activities performed
Specification Documented information stating requirements
Documented Documented information
information, example Documentation, Manual, documented procedures,
record

Chapter – 2 OH&SMS system in General

Difference between maintained and Retain


documented information
The word “Documented information” is used throughout the management system
standard to show an evidence to comply with the requirements of the management
system standard.
The term “Maintained” and “Retained” have been used, the meaning of both the
terms with the example are as under;

Maintain documented information 


Means the organization has to prepare document, which
is requires to be followed on day to day implementation.
The examples of the Maintain documented information
are, OH&SMS Manual, which is prepared by
organization. Similarly the procedures, process
approaches, blank formats, work instructions / standard
operating procedures etc. are considered as “Maintain
documented information”.
Chapter – 2 OH&SMS system in General

Difference between maintained and Retain


documented information
Retain documented information 
Means the organization has to retain record, which
provides an objective evidence of the completion of
work (such as activities, processes etc.). Retain
documented information provides evidence of
conformity to requirements and of the effective
operation of management system. The word
“Retain documented information” replaces the
word “record”.

Chapter – 2 OH&SMS system in General

End of Chapter
Chapter – 3 Audit management, Roles and Responsibilities

Chapter - 3
Audit management,
Roles and
Responsibilities

Chapter – 3 Audit management, Roles and Responsibilities

Objectives:
1. Understand the importance of managing the audit in line with ISO 19011
2. Understand the various stages of the audit and their function
3. Understand the importance of effective planning and preparations for the audit including
the necessity of precise determination of audit scope
4. Understand the purpose and benefits of pre-audit contacts and their typical forms

5. Understand the process and system approach to an audit


and in particular the importance of understanding the
structure of the Occupational Health and Safety
Management System, its processes, their sequence and
interaction for planning and performance of an audit
6. Understand the requirements of ISO/ IEC 17021 on auditing
practices
7. Understand the roles and responsibility of the auditor
8. Understand the roles and responsibility of all the stake
holder included in the audit
9. Understand the need for confidentiality and effective
communication
Chapter – 3 Audit management, Roles and Responsibilities

Audits MUST be well managed


to deliver good VALUE

► The audit team leader has the overall responsibility for the
audit. Audit team members to assist the team leader

► Good audit management requires good:


 Planning and Preparation
 Communications (Client, Auditees and
Auditors)
 Accurate and Objective Fact Finding

Chapter – 3 Audit management, Roles and Responsibilities

Auditee Provides access, data,


Organisation information

Determines objectives,
Audit Client
scope,
scope,criteria
criteria

Auditor Team
1st, 2nd , 3rd Party Audit
(includes auditors,
Auditing technical experts and performance
Organisation performance
auditors in training)

Audit report
Lead Auditor
Chapter – 3 Audit management, Roles and Responsibilities

3 Types of Audits
 First Party Audit
• Self-audit (Auditor and auditees are Internal)
 Second Party Audit
• Audit by an interested body (like a customer)
 Third Party Audit
• Audit by independent body (certification / registration
body)

Chapter – 3 Audit management, Roles and Responsibilities

Different phases of an Audit

Initiating the audit

?
Document review

Preparing for on-site activities T


I
? M
Conducting on-site audit E

Audit reporting
?
Completing the audit

Audit Follow-up ?
Chapter – 3 Audit management, Roles and Responsibilities

Extent of
involvement Location of the auditor Location of the auditor
between the auditor On-site Remote
and the auditee
Human interaction - Conducting interviews Via interactive communication
- Completing checklists and means
questionnaires with auditee - conducting interviews
participation - completing checklists and
- Conducting document review questionnaires;
with auditee participation - conducting document review with
- Sampling auditee participation
No human - Conducting document review - Conducting document review (e.g.
interaction (e.g. records, data analysis) records, data analysis)
- Observation of work - Observing work performed via
performed surveillance means, considering
- Conducting on-site visit and social and legal requirements
verifying the use of PPEs - Analyzing data
- Completing checklists
- Verification of safe work
practices at plant premises

Chapter – 3 Audit management, Roles and Responsibilities

Initiating the Audit


1. Define audit objectives, scope and criteria
 Check the brief from the client and validate with auditee
2. Determine feasibility of the audit
 Is information and estimates of time and resources adequate?
3. Select the audit team
 Need competence to fulfill audit objectives
4. Establish initial contact with the auditee
 What do they do?
 How big are they?
 Complexity of operations
 Degree of readiness
Chapter – 3 Audit management, Roles and Responsibilities

Initiating the Audit


Audit Criteria Audit Scope
Reference against which Extent and boundaries of the audit
conformity is determined including:

► Standard ► Locations

► Contractual Specification ► Organisational units

► OH&SMS Documentation ► Activities and processes covered

► OH&SMS Planning

► Legislation or other
requirements related to
occupational health and safety Team Composition ?
management system

Chapter – 3 Audit management, Roles and Responsibilities

Determination of person-days based on the IAF guidelines

Audit Duration
Effective Number of personnel (Stage 1 + Stage2) – No of Days – for ISO
45001:2018 audit

1–5 1.5
6 – 10 2.0
11 – 15 2.5
16 – 25 3.0
26 – 45 4.0
46 – 65 5.0
Chapter – 3 Audit management, Roles and Responsibilities

Audit Plan Working Documents

► Scope ► Audit Checklists


► Criteria ► Forms
► Dates and duration ► Standard

► Audit team ► Guidelines


► Detailed timetable
► Matrix plan
► Audit team requirements
► Remember to cover shifts

Chapter – 3 Audit management, Roles and Responsibilities

Notify the auditee and audit team


1. Audit plan
2. Timetable
3. Matrix plan
4. What else ?
Chapter – 3 Audit management, Roles and Responsibilities

Conducting on-site Audit Activities


► Team exercise :
1. What are good meeting practices?
2. Each team to make a list.

Chapter – 3 Audit management, Roles and Responsibilities

Conducting On-site Audit Activities


► Conducting the Opening meeting

► Communication during the audit

► Collecting and verifying information

► Preparing audit Conclusions

► Conducting the Closing meeting

Also see :-
Chapter - for nonconformance
Chapter - for interviewing
Chapter - for performing an audit
Chapter - reporting
Chapter – 3 Audit management, Roles and Responsibilities

Conducting On-site Audit Activities


Meetings, Communications and Field Visits

► Opening and Closing meetings are formal


communications
► Wash-up meetings report ongoing status,
findings and progress
► Team liaison meetings help
coordinate and focus the audit team
► Regular feedback to auditees
provides ongoing communication

Chapter – 3 Audit management, Roles and Responsibilities

Opening Meeting agenda:

► Introduce the audit team ► Grading of NCR’s


► Reason, scope and criteria ► Confirm staff aware & available
► Review audit plan and ► Confirm Logistics
methods
► Confirm guides
► Explain about sampling
► Safety requirements
► Confidentiality
► Questions
► Method of reporting
Chapter – 3 Audit management, Roles and Responsibilities

Audit Team Liaison Meetings:


► To ensure smooth and effective progress of the audit

► To ensure audit scope is covered

► To review non-conformances

► To collect the findings

Intermediate and Final wash-up meetings:


► With Department Head / In charge

► To review the audit findings

► To discuss non-conformances

► To agree on corrective actions

Chapter – 3 Audit management, Roles and Responsibilities

Closing Meeting agenda:

► Thank the auditee and ► Disclaimer


reintroduce the team
► Overall summary
► Recap reason, scope & criteria
► Questions & answers
► Review audit plan and methods
► Corrective actions & time-
► Report the observations, scale
positive & negative
► Recommendation
► Follow-up
Chapter – 3 Audit management, Roles and Responsibilities

Follow-up action Documentary Evidence

1. At agreed time 1. Records


2. Training certificates
2. Review of documentary evidence
3. Amended procedures
3. Re-audit on the site
4. Photographs
4. Only review of corrective actions
5. Videos
5. Don’t start it all over again

What if they is no progress?

Chapter – 3 Audit management, Roles and Responsibilities

Role and Responsibilities of Auditor as


Team Leader
 The audit team leader has the overall responsibility for the audit.
Audit team members to assist the team leader
 Good audit management requires good:
• Planning and Preparation
• Communications (Client,
Auditees and Auditors)
• Accurate and Objective Fact
Finding
• Reporting of the audits on time
• Proper follow up of the audit
process
Chapter – 3 Audit management, Roles and Responsibilities

Role and Responsibilities of Lead


Auditor
 Determine the scope and objectives.
 Obtain background information.
 Conduct documentation Review.
 Select and assign audit team members.
 Prepare the plan including data and duration.
 Representing the team at all stages including
opening and closing meetings.
 Resolution of any problem arising.
 Evaluation of evidence and results reporting.
 Prepare and present the report, makes
recommendations, and follows up, reports and
recommends actions.

Chapter – 3 Audit management, Roles and Responsibilities

Role and Responsibilities of Auditing


Organisation

 Determines Audit scope and objectives.


 Select the team leader.
 Provides Audit Team resources.
 Determine competence of Auditors.
 Ownership of the audit report.
 Controls follow up action
Chapter – 3 Audit management, Roles and Responsibilities

Roles and Responsibilities of Auditor


 Competent to conduct the audit.  Keep within the agreed scope.
 Prepare checklists.
 Carry out assigned tasks.
 Conduct audits according to audit
plan.  Work objectively.
 Communicate with auditee’s and  Collect and analyses evidence.
team.
 Remain alert.
 Record and report observations
clearly.  Act in an ethical manner.
 Safeguard audit documents.  Support the audit team leader.
 Follow procedures and plans.
 Check on corrective actions, if  Confidentiality – code of
required. conduct.

Chapter – 3 Audit management, Roles and Responsibilities

Role and Responsibilities of Auditor

 Inform all employees about audit scope and objectives of the


audit.
 Provide resources facilities and guides.
 Provide access to all areas.
 Make themselves available for audit.
 Ensure auditee cooperation.
 Attend opening and closing meetings.
 Take corrective action.
Chapter – 3 Audit management, Roles and Responsibilities

Role and Responsibilities of Auditee’s

 Assist auditors by supplying information and documents as


requested.
 Answering questions.
 Making themselves available at the
appropriate times.
 Providing facilities as agreed.
 Guide the auditors where to go.

Chapter – 3 Audit management, Roles and Responsibilities

Role and Responsibilities of Guide

 Guide the auditors where to


go
 Assist the auditors for the
logistics
 Help the auditor to make the
auditee understand the
questions
Chapter – 3 Audit management, Roles and Responsibilities

Role and Responsibilities of Observer

 Accompany the auditors during the


audit
 Note the findings for own reference
 Verify the proceedings

Chapter – 3 Audit management, Roles and Responsibilities

Effective communication with Auditee


 Effective communication with the auditee is very important during
the audit to manage the audit timings.
 Mode of effective communications;
• Use the language understood by the auditee,
• Do not ask the questions simultaneously,
• Clarify the question to the
auditee, if not understood by
auditee,
• Ask the questions related to audit
scope and boundaries only,
Chapter – 3 Audit management, Roles and Responsibilities

Need for Assessor confidentiality


 Audit is the process where the same Assessor can come in contact
with the so many similar types of companies manufacturing the
similar products, with similar or different safety measures and hence
to maintain confidentiality by Assessor is very important.
 To maintain the Assessor confidentiality followings are done;
• Assessor has to signed confidentiality
agreement,
• Assessor need to declare the
confidentiality at the beginning of the
assessment,
• Assessor has to ensure that the notes
taken during the assessment are
submitted to Lead Assessor at the end
of assessment,

Chapter – 3 Audit management, Roles and Responsibilities

Need for Assessor confidentiality


• Lead Assessor has to submit the notes of assessment to the
Certifying Body within 3 working days.
• Assessor should not share any experience related to products,
process and system of similar types of company during the
assessment including safety related issues observed in other
company,

• Assessor will not share any


data or document of other
similar companies to the
auditee for the purpose of
reference or any other
purpose.
Chapter – 3 Audit management, Roles and Responsibilities

End of Chapter
Chapter – 4 Approach to audit

Chapter - 4
Approach to audit

Chapter – 4 Approach to audit

Objectives:
1. Understand how positive approach to be followed for any audits
2. Understand relationship between auditor and auditee
3. Understand the soft skills required for an auditor for making audit a
successful process
4. Understand and develop interviewing skills for people at various levels
of hierarchy
5. Understand various cultural, and psychological issues involved during
an audit and develop behavioural aspects during the audit
Chapter – 4 Approach to audit

Team spirit and co-operation = Successful audit,


Auditors set the “TONE” for the audit

Chapter – 4 Approach to audit

Key Success Factor: Auditor Attitude

MUST BE POSITIVE/ VALUE-ADD


 I am really here to help
 I am not here to find fault
 We are on the same team
 Together we can find
opportunities
 This benefits the business
Chapter – 4 Approach to audit

Relations between auditors and auditees are critical for a


successful audit. The auditor influences these relationships
by:

1. Understanding the communications


process
2. Minimizing barriers to communication
3. Creating the climate for good
communications
4. “LISTENING” carefully to auditees

Chapter – 4 Approach to audit

Communications Process
Sender
encodes

Message

Recipient
decodes and
interprets
Feedback
Chapter – 4 Approach to audit

Barriers to effective communication

Physical Intellectual Psychological

Find example for each of them

Chapter – 4 Approach to audit

Create a Climate for Good Communications:


1. Space (Where are you auditing?)
2. Timing (What time of day?)
3. Eye contact (How much?)
4. Body language (Watch and control)
5. Cultural sensitivities (Research if necessary)
Chapter – 4 Approach to audit

Space and Place considerations:


► Allow “personal” space

► Right location (auditees work space or conference room?)

► Seating plan

► Minimum physical distraction

► Desk between people may be a barricade

► Auditor and auditees should be one team

Chapter – 4 Approach to audit

Time Considerations:
► Leave auditees some time before you arrive

► Respect auditees’ time and stay on schedule

1. Never too far ahead of schedule


2. Never LATE
► Consider:

 Auditing timings
 Lunch timing
 Siesta
 Closing time
Chapter – 4 Approach to audit

How much eye contact?

► Western communication culture requires a lot of eye contact


► Elsewhere close eye contact may be offensive or impolite
► Lack of eye contact doesn’t have to mean attempt to hide information

Chapter – 4 Approach to audit

70% of Communication is NON-VERBAL


Body language
► Postures, gestures, facial expressions
► Communicates mass of information
► Uncontrolled messages may upset auditee
► Common meanings
► Cultural differences
Chapter – 4 Approach to audit

Cultural Sensitivities
► Audits may be carried out in multi-cultural
environment
► Be aware of cultural differences and sensitivities
► Research specific issues
► Understand how to establish
rapport with auditees

Chapter – 4 Approach to audit

Cultural Sensitivities - Examples

Do I shake hands What is the private


with everyone? space?

Beware of offensive
gestures!
Chapter – 4 Approach to audit

Good Listening is ESSENTIAL

► Eliminate distractions
► Listen for content
► Suspend judgement
► Listen for themes
► Use spare time
► Seek clarification

Chapter – 4 Approach to audit

Bad habits to avoid (i.e. not listening)


 Faking attention
 Pre-occupation
 Over-reaction
 Interrupting the speaker
 Listening without looking
 Listening only to what we want to hear
 Using listening time to collect the thought
Chapter – 4 Approach to audit

Interviewing – A CRITICAL Audit Step


Interviews provide essential objective evidence
Good communications are essential to good interviews
So, put the auditee at Ease.
 Be Friendly
 Explain why you are here
 Ask for their help
 Ask if they have questions
 Show an interest in what they do
 Explain your observations

Chapter – 4 Approach to audit

Interviewing Technique

► Interviews are not interrogations


► Ask questions in conversational
manner
► Weave questions into general
conversation
► Do not cross question
► Avoid question answer exercise
Chapter – 4 Approach to audit

Questioning Technique for Interviews


Questions should: Three Question types:
► Yield relevant information ► Open questions
► Closed and direct questions
► Not suggest answers
► Clarifying questions
► Not contain emotive words or
implications

Avoid leading questions


Don’t ask antagonising questions

Chapter – 4 Approach to audit

Open Questions - Auditor Friends

What? Why? Where? Who? When? How?

► Yield informative answer


► Limits - conversation may get side-tracked!
► One way to avoid diluting:

Show me!
Chapter – 4 Approach to audit

Closed and direct questions


► Closed questions - answer: Yes/No
► Direct questions - answer: few words
► Intended to yield very specific information
► Disadvantages:
 Do not bring much information
 If used too often may create impression of cross -examination

Chapter – 4 Approach to audit

Clarifying Questions
► Intended to clarify, retrieve full information and prevent
misunderstanding
► Allow to grasp full picture

► Disadvantages:
 If used too often may create impression that you
were not listening
 Are time-consuming
 If you are not prepared to listen in full don’t ask
them
Chapter – 4 Approach to audit

End of Chapter
Chapter – 5 Audit Execution

Chapter - 5
Audit Execution

Chapter – 5 Audit Execution

Objectives:
1. Understand the methods for gathering the information and
audit evidence, and requirements of ISO 19011 and 17021.
2. Understand the importance of observation during the audit and
in particular observation of Operational planning and control.

3. Understand the importance of


process and its safety issues and then
focus during the audit and in
particular the need to verify every
time, if the audited process is
producing intended outputs.
4. Understand the concept of process
mapping and its benefits in
preparation for auditing a process
Chapter – 5 Audit Execution

How do auditors find evidence ?

 Reviewing the documentation


(e.g.: Documents, Records, Procedures, Drawings,
Specifications etc.)

 Reviewing the analyzed data / information


 Interviewing people at all levels
 Observing practices and physical environment
/ conditions / controls
 Observing the work condition and work
practices followed,
 Use of PPEs during the work etc.

NOTE: Can / should the auditor cover all people, documents and records during the audit?

Chapter – 5 Audit Execution

What documents should be reviewed as part of Document review?

► OH&SMS manuals
► OH&SMS Procedures
► Work instructions / Operational
control procedures / Standard
operating procedures
► Other documents
► Records
Should all documents be reviewed ?
Chapter – 5 Audit Execution

Observations
► Keep observing the physical evidence:

 Facilities, equipment, instruments


 Operational planning and controls
 Records

Observation – What to Look for

 Posted Procedures  Structure and Organization


 Incident records  Consultation and participation
 Control Points  Awareness Reminders
 Emergency declaring mechanism  Emergency evacuation
 Assembly point  Medical check-up records
 Inspection Logs

Chapter – 5 Audit Execution

Auditor Proverb: “Seeing is believing”


Visit the field! See the 'real world'!!!

 Operational activities, controls,  talk to people on the field - if you


inspections / audits / monitoring can hear them and understand !;
 Incident, nonconformity and  watch the processes as and where
corrective action they happen;

 maintenance systems;  check what is happening and verify


against the stated / documented
 storage locations and conditions; version of events and processes…
 ask what the dials and meters are
 Chemical segregation based on indicating about process monitoring
compatibility; and measures.
 product handling, marking, packing;

 Operations such as data entry

Keen observation is one of the keys to successful audit


Chapter – 5 Audit Execution

Spell out 3 types of approach for Auditing

 Product based approach


 Process based approach
 System based approach

What will be the different steps for each of these


approaches ?

Chapter – 5 Audit Execution

4. With What? 5. With Who?


(Materials/Equipment/People) (Competence/Skills/Training)

3. Inputs 1. Chemical reaction 2. Outputs


(Activities)

7. How Effective? 6. How?


(Measurable Objective) (Methods/Procedures/Techniques)
Chapter – 5 Audit Execution

4. With What? 5. With Who?


(resources) (Competence/Skills/Training)
- People - Specific skill sets – product
- Information knowledge, commercial skills, etc
- Master batch processing sheet - Use of PPEs by all

3. Inputs 1. Chemical reaction 2. Outputs


- Raw materials (Activities) - Finished product
- Log sheet - Charging of raw materials - Filled log sheet
- PPEs for protection against - Heating to required temp. - No incidence related to
probable hazards - Maintaining at specified OH&S
temp.
- Filtration and drying
7. How Effective?
(Measurable Objective)
- Manufacturing in optimum 6. How?
time (Methods/Procedures/Techniques)
- Accuracy - Procedures, work instructions
- No incidence during - Yield calculation
manufacturing

Chapter – 5 Audit Execution

Why Prepare a “Checklist” before an Audit?

► To assist memory
► To ensure covering all issues and
control points
► To ensure depth and continuity of
the audit
► Help in time management
► Organise note taking
► Part of audit report
Chapter – 5 Audit Execution

Checklist Format
Evidence and
► Leave space for notes
Inquiries
Results
Production Area (8.1)
► Allow space for time control and  Interview production
personnel about the OH&S
recording matters and controls
exercised
► Reference the requirements of  Observe operation control
points controlled and
audit criteria monitored
Employee interviews (5.2, 7.2)
► Reference the control documents  Are you aware of the
OH&S policy?

► Reference verifying documents  How does the policy relate


to what you do?
(records)  What type of training have
you had on OH&S
Management system?

Chapter – 5 Audit Execution

Checklists should: Checklists should NOT:


 Be specific for a given OH&SMS  Narrow the vision or limit evaluation
 Be prepared using OH&SMS  Obstruct communication
documentation
 Be clear about evaluation criteria  Be too strict or constraining

 Note documents to review  Be a script of exact questions

 Identify records to sample (and  Restrict auditor’s inquiry


sample size)
 Be yes/no lists
 Identify key people to interview
 Be completely generic
 Include some key questions for
interviews
 Note physical evidence you expect
to see
Chapter – 5 Audit Execution

Follow Audit Trails


As you audit you will find interesting opportunities for follow-up (audit trails).
Pick promising audit trails:
 Follow it through

 Interact with team

Chapter – 5 Audit Execution

Auditing Top Management


Obtain evidence of leadership and commitment

 Observe attendance and interest in opening, closing and feedback meetings


 Review documents:
 OH&S policy
 Objectives
 Management reviews records
 Interview members of top management:
 Do they know “their” system?
 Do they monitor, analyse data, draw conclusions, define actions?
 Interview personnel at other levels:
 Do they understand what top management is trying to communicate?
Chapter – 5 Audit Execution

Always take notes

► Explain the need to take notes to auditee


► Make your notes:
 Comprehensive
 Accurate
 Precise
 Legible

Chapter – 5 Audit Execution

Time management
► Time is always short

► Plan well

► Do not allow your audit to get side-


tracked
► Do not dig too much (beware false
audit trails)
► Do not focus on trivia

► Remember an audit is a sampling

Can Auditors provide solutions as well..?....


Chapter – 5 Audit Execution

3rd Party Auditors cannot give advice on how to correct non-conformities.


(However, auditors must write very clear non-conformities.)

Chapter – 5 Audit Execution

End of Chapter
Chapter – 6 Nonconformity Reporting and
Corrective action

Chapter - 6
Nonconformity
Reporting and
Corrective action

Chapter – 6 Nonconformity Reporting and


Corrective action

Objectives:
1. Understand the nonconformity
2. Understand the need of positive approach to nonconformity
3. Understand the importance of proper reporting of nonconformity
4. Understand the roles and responsibilities for handling the nonconformity
detected during the audit
5. Understand the Corrective Action Process
6. Understand the flow of activities involved in
Corrective Action process
7. Understand the roles and responsibilities for
handling the nonconformity detected during
the audit
Chapter – 6 Nonconformity Reporting and
Corrective action

What is a Nonconformity?

ISO 45001:2018
“Non-fulfillment of a specified requirement”

Objective evidence exists showing that:


 A requirement has not been addressed
(intent)
 Practice differs from the defined system
(implementation)
 The practice is not effective
(effectiveness)

Chapter – 6 Nonconformity Reporting and


Corrective action

Communicating Findings of Nonconformity


► Do not view non-conformance in a negative way. This is NOT like a
speeding fine. It is NOT a punishment.

► Uncovering a non-conformance is a previously undiscovered


opportunity for improvement.

► Be positive, be professional, be precise.


Chapter – 6 Nonconformity Reporting and
Corrective action

Concepts relating to requirements ISO 45001:2018

ISO 19011:2011
Use with caution:
it has legal connotations
(associated with product
liabilities issues)
conformity

Fulfilment of a requirement

requirement

Need or expectation that is stated,


generally implied
or obligatory

defect nonconformity
Non-fulfilment of a requirement related Non-fulfilment of a requirement
to an intended
or specified use
Understand the difference:
Conformance
with audit Legal
As intended by the
customer criteria compliance

Chapter – 6 Nonconformity Reporting and


Corrective action

Nonconformity Report (NCR)


► There are no set rules; however an NCR shall have three parts:

1. NC Statement (An element of the system which went wrong)

2. The evidence (what actually was found)

3. The requirement (what was supposed to be)

► Different organizations have different format


Chapter – 6 Nonconformity Reporting and
Corrective action

A Nonconformity Must Also Be...


► Factual
► Precise

► Objective

► Traceable

► Concise

Will someone else be able to trace back and find the same evidence
you found, based on what you wrote?

What is an opportunity for improvement (OFI) ?

Chapter – 6 Nonconformity Reporting and


Corrective action

What examples of ‘Objective Evidence’ you can see during an


audit..?
 Factual evidence of differences between the Manual and associated
procedures
 Factual evidence of differences between procedures and working
practices
 Lack of evidence to support implementation of various standard
clauses
 Lack of evidence to show continuous implementation of various parts
of the system
 Lack of use of PPEs and emergency evacuation plan
 Lack of awareness related to safety
Chapter – 6 Nonconformity Reporting and
Corrective action

NONCONFORMITY REPORT
Description of the nonconformity:
Employees of production department are not aware related to the
NC Statement requirements of emergency preparedness and response.
Objective Evidence
Workers of production section were interviewed for the emergency
response plan, but they are not aware regarding the requirements
Evidence and response to the emergency preparedness.

ISO 45001:2018 clause and requirement:


The standard Clause 8.2, b) requires that ..
The organization shall establish, implement and maintain a process(es) needed to
prepare for and respond to potential emergency situations, as identified in 6.1.2.1,
Requirement(s) including:
(reference to Internal requirements b. providing training for the planned response
if applicable)
Process MEP/01, says that al l employees are trained for emergency preparedness
and response on quarterly basis.
Mohammed

Sign

Chapter – 6 Nonconformity Reporting and


Corrective action

A word of Caution
Be cautious, do not be over conclusive!
Don’t judge on face value!
Make sure you have complete evidence!
Make sure your evidence is objective!
When in doubt, investigate!
Identify the leads for further investigation.
Chapter – 6 Nonconformity Reporting and
Corrective action
ISO 45001:2018 Process Matrix Page No. 1 of 1
Company Name Process (Functions)

Matrix or cluster analysis


Scope of audit

Is the system
4.1 Understanding the organization and its context
 4.2
Understanding the needs and expectations of workers
and other interested parties

fundamentally sound?
4.3 Determining the scope of the OH&S management system
4.4 OH&S management system
5.1 Leadership & commitment

Are there any problem


5.2 OH&S Policy
 5.3 Organizational roles, responsibilities and authorities
5.4 Consultation and participation of workers

areas? 6.1
6.2
Action to address risks and opportunities
OH&S objectives and planning to achieve them
7.1 Resources

 Are there weak 7.2


7.3
Competence
Awareness
7.4 Communication

elements in the 7.5


8.1
Documented information
Operational planning and control

system?
8.2 Emergency preparedness and response
Monitoring, measurement, analysis and performance
9.1
evaluation
9.2 Internal audit
9.3 Management review
10.1 General
10.2 Incident, nonconformity and corrective action
10.3 Continual improvement

Chapter – 6 Nonconformity Reporting and


Corrective action

Corrections Corrective Action


“Action to remove the “Action to eliminate the cause
nonconformity and make work of a nonconformity and prevent
complies with the requirements” recurrence”

Ref : ISO 45001:2018

Don’t cure symptoms only!


Hit the cause!
Effective Corrective Action
Chapter – 6 Nonconformity Reporting and
Corrective action

Auditor Auditee
Identify, note
and communicate Agreement

Acknowledge
Prepare
PrepareNCR
NCR
& investigate

Explain Cause / Propose


Agreement Corrective Action

Review Implement,
Effectiveness and close verify and notify

Chapter – 6 Nonconformity Reporting and


Corrective action

Corrective Action Request

Example: Company: Date: NCR


Number:
Auditor: Auditee:
Standard & Clause

Nonconformity and Corrective Non Conformity

Action Request Form Objective Evidences

Requirements

Auditor: Date:
Correction :

Note area for review of Root Cause

effectiveness of corrective Proposed Corrective Action:

actions. Auditee : Date


Verification of Corrective Actions:

What should be entered here?


By whom? Auditor: Date
Review of effectiveness of corrective actions & Closure

Date: Signature
Chapter – 6 Nonconformity Reporting and
Corrective action

End of Chapter
Chapter – 7 Audit Reporting

Chapter - 7
Audit Reporting

Chapter – 7 Audit Reporting

Objectives:
1. Understand the importance of effective reporting of the audit results,
and requirements of ISO 19011
2. View the reporting as a continual process of communicating the audit
findings

3. Be able to identify the characteristics of an


audit report that bear on its quality
4. Understand the need and importance of
positively reporting the audit results
Chapter – 7 Audit Reporting

Process of communicating the outcome of the audit


► Not limited to preparation of final report
► Continual verbal and written reporting
► Report outcome completely
 Validation and confirmation of conformance and
nonconformities
► Reports should add value to OH&SMS
► Report as per the procedures of the
organisation on behalf of which the audit is
conducted

Chapter – 7 Audit Reporting

Verbal Reports are generally given to:


1. Direct auditees
2. Department / Functional Heads
3. Auditee Top management

Note: Each person (auditee) wants information related to them. Tailor


your verbal presentations to the audience’s needs.
Chapter – 7 Audit Reporting

Written ‘Audit Reports’ are sent to persons designated by the


Client and may include:
► Direct auditees

► Auditee management

► Internal auditors

► Management of the organisation on behalf of


which you are auditing
► Your fellow auditors

► Certifying body / Accreditation body

Chapter – 7 Audit Reporting

Quality characteristics of a Audit Report

Contents Form
► Informative ► Conciseness

► Factual ► Legibility

► Complete ► Transparency

► Accurate & precise ► Clarity

Reality Test: Is the Audit report easy to understand and useful ?


Chapter – 7 Audit Reporting

Tips on Writing Style

► Use simple words

► Precise wording and location, if


any
► Avoid passive voice

► Use reported speech

► Avoid abbreviations

► Avoid acronyms

Chapter – 7 Audit Reporting

Audit Report without delay!

► Normal practice = Audit report completed


on-site and presented to the Client
► Time never becomes available

► Prepare NCR’s there and then

► Timely reporting adds value


Chapter – 7 Audit Reporting

Typical Contents of Final Audit Report


► Audit scope and objectives

► Audit plan, identification of auditors and auditees

► Audit criteria

► Audit team judgement of conformance of the OH&SMS with audit criteria

► Non-conformances

► System’s ability to achieve defined objectives

► Obstacles for teams ability to arrive at conclusion

► Summary

► Distribution list

► Attachments: Completed Notes and Checklists, Non-conformance Reports,


Matrix Analysis

Chapter – 7 Audit Reporting

End of Chapter
Document No. OH&SM/01
OH&S Revision No. 00
Manual
ABC Chemical Inc. Date 01.08.2018
Page No. 1 of 40

Occupational Health and Safety Management System Manual


– OH&SM/01
Purpose: To define the compliance of ISO 45001:2018 Occupational Health and Safety
Management System requirements in the organization.

ABC Chemical Inc.


OH&S Manual
OH&S System ISO 45001:2018
Revision Number 00
Revision Date 01.08.2018
Total Pages
Copy Number
Issued To
Location address

1001, Industrial Area, GA, USA

Prepared By Approved By
Name
Designation Management Appointee Managing Director

Signature

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Manual
ABC Chemical Inc. Date 01.08.2018
Page No. 2 of 40
1.0 ABC Chemical Inc. Company profile
The Company is manufacturing Dyes. The Company has a vast experience in the
manufacturing of Synthetic Organic Dyes. Products reach to the customer after undergoing a
rigid inspection, strictly as per customer requirements in his defined application. At all stages
of the manufacturing, a proper care is taken to prevent the pollution and keep healthy
environment in and around the plant.
The Company has an efficient infrastructure and is situated at Ahmedabad (Gujarat) India. At
present, the Company has an efficient organization comprising a team of dedicated
professional personnel in all areas of management. All products released by the Company
are strictly checked as per the customer defined requirements during the entire processing.
And yes, as ABC, we never fail to match the delivery schedules and always believe in timely
supply of materials to our valued customers.
The key to our success is….
 Capacity to execute large orders.
 Quality matches customer requirements.
 Dedicated teamwork.
 Comply with all legal and statutory obligations related to Occupational, health and safety
and factory act.
 Committed to timely supply.
 Commitment to plant safety (including OHS Hazards)
 Commitment to the protection of intellectual property
 Protecting an environment
1.1 Scope of Certificate
The manual is prepared as per the guidelines of ISO 45001:2018 for Research, development,
manufacture and supply of Synthetic organic dyes. The ISO 45001:2018 system has been
implemented for;

Research, development, manufacture and supply of


Synthetic Organic Dyes
1.2 Non Applicable clauses
 All clauses are applicable to our company.
1.3 Authorization statement
Company is committed to the establishment and maintenance of OH&S Management
Systems given in this manual and implemented by the company to meet the requirements of
ISO 45001:2018.
The members of the Organization shall strictly adhere to the various OHS procedures and
Standard Operation Procedure (SOPs) as supported by the policies outlined in this manual.

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Manual
ABC Chemical Inc. Date 01.08.2018
Page No. 3 of 40
Mr. John Adam (Safety Head) has been appointed as a Management Appointee of the
Company. The Management Appointee is responsible for ensuring compliance with the
OH&S requirements stipulated in this manual. He is authorized to ensure that the OH&S
system is established, implemented, and maintained by the company. Managing Directors
and CEO need to give full support and co-operation to the Management Appointee and he is
authorized to ensure that the system is implemented. All Functional Head must implement the
system.
Authorized By

Top Management

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ABC Chemical Inc. Date 01.08.2018
Page No. 4 of 40

Chapter 2 Table of contents


Chapter
Title and clause number Page No.
No.
1. Cover page and company profile 1–3
2. Table of contents 4–5
3. Control and distribution 6–8
Context of the Organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of workers and other
4. 9 – 12
interested parties
4.3 Determining the scope of the OH&S management system
4.4 OH&S management system
Leadership and worker participation
5.1 Leadership and Commitment
5. 5.2 OH&S Policy 13 – 17
5.3 Organizational roles, responsibilities and authorities
5.4 Consultation and participation of workers
Planning
6. 6.1 Action to address risks and opportunities 18 – 22
6.2 OH&S objectives and planning to achieve them
Support
7.1 Resources
7.2 Competence
7. 23 – 28
7.3 Awareness
7.4 Communication
7.5 Documented information
Operation
8. 8.1 Operational planning and control 29 – 31
8.2 Emergency preparedness and response

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ABC Chemical Inc. Date 01.08.2018
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Chapter 2 Table of contents


Chapter
Title and clause number Page No.
No.
Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9. 32 – 35
9.2 Internal audit
9.3 Management review
Improvement
10.1 General
10. 36 – 37
10.2 Incident, nonconformity and corrective action
10.3 Continual improvement
ANX–I List of Documented information 38
ANX–II Glossary of terms 39
ANX–III Organizational structure 40

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3.0 Control and Distribution
3.1 Structure of OH&S Manual
This OH&S Manual is prepared in accordance with the table of contents. Each chapter begins
with page 1; the continuous numbering is applied within the chapter and not throughout the
manual. This numbering has been done to facilitate the future addition / deletion of pages.
The manual is supported by the documented information to establish a good OH&S
management system covering OH&S system procedures and Standard Operating Procedure
(SOPs), exhibits and Forms. In addition, a separate list of OH&S procedures and formats are
referred in this manual and it is also given in Annexure – I. The glossary of terms is given in
Annexure – II.
The manual is issued in loose-leaf and is accessible to the staff and customers.
The implementation of this manual is mandatory for all departments. The changes made in
this manual are effected through the document control and must be approved by the
Managing Director.
3.2 Responsibility
Managing Director approves Front / Cover page of the OH&S Manual. The control and
maintenance of this manual is the responsibility of Management Appointee who maintains the
master list of manual. Also, when any changes / amendment is there, the same amended
page is reviewed by the Managing Director and change note is approved before issue of such
changed / amended page to the concern copy holder.
3.3 References
 ISO 45001:2018  Occupational Health and Safety Management Systems –
Requirements with guidance for use
3.4 Distribution
OH&S Manual is distributed to the various departments on a “controlled” basis. Controlled
copies are the one, which are subject to incorporation of "revisions". Those in which the
amendment is not reflected / communicated are known as "uncontrolled" copies.
"Controlled" Copies of the OH&S Manual are stamped “Controlled Copy “on the 1st page of
manual and given a unique copy number for the maintenance purpose. The soft-copy of a
controlled copy is distributed by keeping it in common OH&S folder with a “read only” access
to HOD.
The Management Appointee maintains Master list and distribution list for the issue of OH&S
Manual; and accordingly, copies are distributed with a copy number to CopyHolders.
Amendments and revised pages of OH&S Manual are issued by the Management Appointee
through a "Change Note" to holders of controlled copies of the manual. Upon receipt of such
revisions, the recipient will replace the existing pages by the revised ones.
"Uncontrolled" Copies may be issued by the Management Appointee to the prospective
customers and others on the request of the HOD; but, the recipient shall not be issued the
amendments / revisions.
The Management Appointee is responsible to fill up amendment sheet in line with any
amendment and the entire information regarding revisions are distributed to the copyholders.
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ABC Chemical Inc. Date 01.08.2018
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If any amendment due to change in page number is done, the table of contents is amended
accordingly.
3.5 Numbering and Document Control for OH&S Manual
 The number for OH&S Manual is given as OH&SM/01, where 01 indicates the first level of
document.
 When any revision becomes necessary, only the page content that is affected is replaced
and not the entire chapter. In such case, the revision is reflected by changing suffix of
revision no. and the same is recorded in the amendment record sheet of manual. Initially
Revision no. is considered, as 00 and if total manual is revised then Revision no.00 is
changed to Revision no. 01. For any page-wise amendment, the revision number of the
page is changed to 0.1 for Page-wise revision. Total nine amendments are possible in a
single page of a single chapter. If it crosses nine amendments, the entire revision of
OH&S Manual is changed to the next no. i.e. 00 becomes 01 and so on. All such
amendments are recorded in the Amendment Record Sheet given in the paragraph 3.6.

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ABC Chemical Inc. Date 01.08.2018
Page No. 8 of 40

3.6 Amendment Record Sheet


Replace New
Amd. Chapter Page New Signature of
current Revision Reason for change
No. no. no. Rev. no. copy holder
Rev. no. Date

Note
 All the pages other than those listed above are currently in the revision Number 00. If any changes
are done, the next revision no. is given by suffix to that page (say for example 0.1) and is recorded
on the page listed above.
 To check the validity of the complete manual, confirm current revision status of this page with the
Management Appointee and cross-check with amended sheets.

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ABC Chemical Inc. Date 01.08.2018
Page No. 9 of 40
4.0 Context of the organization
4.1 Understanding the organization and its context
We are leading exporters of Dyes to more than 40 countries as well as front-runners in the
domestic market. Our purpose and strategic direction from our top management is to comply
environmental and OH&S laws, maintain our brand image in the market, maintain leading
name and increase the profit margin. By implementing the OH&S Management system, we
intend to increase our business turnover by entering into the new market and new countries,
developing new products, reducing cost of our manufacturing by process modification and
optimized use of our resources, producing environmental friendly products and complying
with legal requirements and other requirements applicable to us. Our entre intent is presented
as Quantifiable objectives given in this manual as documented information.
Considering the above intention of implementing the OH&S Management system, we have
listed our internal and external issues as furnished below.
Internal / External Issue
Type of
Description of issue
issue
 Our organization is having more than 10 years of experience and
reputed in the market for complying all obligations and environmental Internal
and OH&S friendly company
 Our value is to provide full satisfaction to the interested parties that are
Internal
committed to comply all legal requirements.
 Natural disaster like earthquake, fire, flood, cyclone etc. External
 Highly skilled, experienced, competent and knowledgeable staff as well
as HOD.
Internal
 Low employee turnover.
 Good employee welfare
 In some processes, our technology and machinery is old. Now, the
latest automated equipment is used by our competitors, which ensure Internal /
full safety of the operators. Technologies are changing at a rapid pace External
in our industry
 Good relation with all legal authorities and no defaulter-act for any legal
External
cases for either factory act or pollution control board related issues
 Considering the nature of our process, there are more chances of fire or Internal /
OHS issues External
 Now local govt. environment control authority norms are becoming tight
External
and requiring more regulatory License

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Type of
Description of issue
issue
 Compliance to the exporting country norms. In export market for
chemical products, new licenses and compliances to environment, External
health and safety and more third party audits.
 We are handling many hazardous chemicals and proper care is
External
required for handling the same considering the OH&S issues.
 Considering the nature of our products, the disposal of solid waste
generated by our process needs to be dispose off as per legal External
requirements and OH&S issue.
 The other factories in industrial area near to us are not much prepared
for emergency preparedness and we need to communicate them for our External
nature of process and chances of fire and other risks.
 Relationships with and perceptions and values of our bankers and other
interested party is more for our commitment to implement OH&S External
management system.
 Our some of the products are manufactured by our subcontractor and
External
we are depending on them for environment and OH&S issue.
 PPEs are provided to all concerned at regular intervals and all
Internal
employees use these PPEs in day-to-day work

The above tabular data is the list of some internal and external issues and
Management Appointee is updating this list to discuss it further in the management
review meeting
4.2 Understanding the needs and expectations of workers and other interested parties
The organization has determined interested parties that are relevant to the OH&S
management system. The list of all such interested parties are identified and listed
below.
1. Direct customers
2. Management
3. Workers
4. Regulators and Govt. organization and factory inspectors
5. Neighbouring factories
6. Suppliers and job work convertors
7. End-users
8. Shareholders
9. Subsidiaries companies
10. Bankers
11. Insurers
12. Pressure groups, Local villagers near our factory areas
13. Media

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ABC Chemical Inc. Date 01.08.2018
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The requirements of all these interested parties including workers relevant to OH&S
are identified in various ways as listed below.
1. Customer visits our plant for initial customer communication regarding their
requirements to OH&S issues.
2. Review requirements of PPEs and other resources for workers,
3. Review of health check–up plan for workers
4. Review of all applicable laws and updates and visit reports of govt. inspectors
at our premises for regular visit.
5. Meeting with customers and distributors, dealers and all others who are
involved in supply chain by marketing team.
6. Inviting suppliers and job work convertors in supply meet as well as regular
follow up by purchase staff.
7. Legal requirements and regular law updates
8. Other requirements as identified by organization
The Management Appointee summarizes all these needs and expectations and
prepares register of regulations for the identified requirements that are necessary to
be complied by us. Their requirements and information are reviewed and monitored
by HODs in their areas. In case any specific requirements are identified, then
communicate the same to the Management Appointee to take further actions.
4.3 Determining the scope of the OH&S management system
We have determined the boundaries and applicability of the OH&S management system and
the scope is documented as below.
Documented Information for Scope:
This scope of implementing the OH&S scope is applicable for only plant address given in this
manual covering dyes manufacturing processes.
All the requirements of ISO 45001:2018 are applicable for our activities and scope covered as
above is documented in this OH&S Manual.
4.4 OH&S management system
The organization has established the OH&S system as described in this OH&S manual. It is
implemented, and maintained and continually improved in accordance with the requirements
of the ISO 45001:2018.
The organization has defined various OH&S procedures and SOPs for OH&S management
system and their application throughout the organization is documented. It includes process
required and their interaction to implement ISO 45001:2018 requirements.
Organizations have evaluated these processes based on the feedback from HOD and
discussion in management review meeting. Based on the evaluations, the organization needs
to implement the changes, if not frequently, at least once in a year to achieve their intended
result. The criteria and method to evaluate all these processes are defined in department-

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ABC Chemical Inc. Date 01.08.2018
Page No. 12 of 40
wise functional objectives and monitored with the help of objective monitoring sheet to
improve the processes and the OH&S. Necessary resources are provided for this processes
and their job description are prepared to assign them responsibility and authority.

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ABC Chemical Inc. Date 01.08.2018
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5.0 Leadership and worker participation
5.1 Leadership & Commitment
The Managing Director attends various meetings and provides evidence of its commitment to
the development and implementation of the OH&S Management System for the continual
improvement of its effectiveness. The Managing Director demonstrates the commitment and
leadership as given below:
a) Takes overall responsibility and accountability for the prevention of work-related injury
and ill-health as well as ensures the provision of safe and healthy workplaces and
activities
b) The OH&S Policy and OH&S objectives established are kept as documented
information in this OH&S Manual and are provided for ready reference to the
employee. They are compatible with the strategic direction of the organization;
c) Ensures integration of OH&S requirements into Organization’s business processes
and preparation of all OH&S documented information including OH&S manual,
Procedures, SOP and forms.
d) Ensures that the resources needed for OH&S are available and discussed in
formal/informal meetings;
e) Communicates the importance of effective OH&S management and of conforming to
OH&S requirements during the internal meetings and management review meetings;
f) Ensures that the OH&S achieves its intended results and verifies the same with the
help of internal audits and objective reviews;
g) Engages, directs and supports persons to contribute to the effectiveness of the OH&S
management system;
h) Ensures and Promotes continual improvement;
i) Supports other relevant management roles to demonstrate leadership as it applies to
their areas of responsibility as identified in the job description of Managing Director.
j) Develops, leads and promotes a culture in the organization by Training, mock drill,
and safety meetings that support the intended outcomes of the OH&S management
system
k) Protects workers from reprisals while reporting incidents, hazards, risks and
opportunities;
l) Establishes and implements a process for consultation and participation of workers in
the organization;
m) Supports the establishment and functioning of health and safety committees;
n) Once in a Six Month, conducts a management review of our activities that is
attended by Top Management.
Organization has identified resource requirements and provided adequate in-house resources
in terms of qualified personnel, test equipment, and facility for operation and testing. The
Managing Director is responsible for providing appropriate resources and trained personnel
for effective implementation of the OH&S Management System in their respective areas.
Management Appointee reports to the Managing Director for any need of resources.
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5.2 OH&S Policy
We have defined an OH&S policy as given below in the terms of purpose and context of the
organization like nature, scale and OH&S risk of our activities, products and services. It
includes a commitment to the protection of the OH&S, provides a framework for setting
OH&S objectives. The OH&S Policy and objectives are documented and given below.

OH&S Policy
At ABC Chemical Inc., occupational health and safety of employee is our prime concern and
important objective. We are conscious of our responsibility to create; maintain and ensure safe work
practices, reduce health and safety hazards through an application of technology and safe work
practices for sustainable development.
We are committed to;
 Prevent industrial risk, rather than detect / rectify, and its adverse impact on the employee,
 Follow safe work practices and continually improve the effectiveness of the system,
 Eliminate hazards and reduce OH&S risks by HIRA exercise,
 Conserve natural resources through their responsible and efficient use in all our operations,
 Comply with all applicable legal and other requirements as well as take any additional measures
considered as necessary,
 Implement and propagate the OH&S policy through proper communication, active involvement
and participation of employees and persons working for and on behalf of the organization.
 Preserve the health and safety of the site and its neighborhood,
 Transport the products safely,
 Make this policy available to the public

1st August 2018


Top Management
OH&S Objectives
Parameters Annual Target
 Legal compliance related to OH&S and complying all identified
100 %
obligations
 Ensure OH&S compliance by supplier 100 %
 Reduce OH&S related incidents 1 Max. / 6 Months
 Reduce Nos. of cases of fire / near miss incidents 1 Max. / 6 Months
 Reduce Nos. of cases of un–safe condition / act 1 Max. / 6 Months

The OH&S policy is communicated to all the employees and are advised to undergo OH&S
Policy training on joining the company as well as made them aware of it immediately after the
preparation or modification. The Management Appointee ensures that the respective
employee understands the OH&S Policy and complies with the OH&S Management system
documented information. Also, display of the OH&S policy at prime location is done and kept

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ABC Chemical Inc. Date 01.08.2018
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in this manual in para 5.2 as documented information. The OH&S policy is kept on website
and reception as appropriate as well as given to all the interested parties like employees,
external providers, distributors etc. The OH&S policy is reviewed once in a Year to
continually improve the effectiveness of the OH&S Management System in management
review meeting.
5.3 Organizational roles, responsibilities and authorities
The Top management has assigned relevant roles as given in the organization structure. For
the entire team, the job description is prepared with authority and responsibility.
(a.) The Managing Director has defined responsibilities, authorities and their interrelation for
all the persons and communicated within the organization. All staff members are
responsible for maintaining OH&S of their own work and for informing their Respective
Heads for any conditions, which are adverse to the OH&S of the work being produced or
adverse to the protection of OH&S. A detailed Organization structure is prepared and
supported in Annexure – IV to this manual.
(b.) Personnel in Company at various level are responsible and have the authority within their
defined areas of control to:
 Implement OH&S in work carried–out.
 Initiate action to prevent the occurrence of product Non–Conformance.
 Identify and record OH&S problems.
 Initiate, recommend and provide solutions to OH&S problems.
 Verify the effectiveness of the solutions.
 Control further processing, until all conditions are satisfactory.
Roles and responsibilities at various levels of the employees
Sr.
Activity Responsibility
No.
1. Identification of OH&S Hazards and its Risks
2. Monitoring the use of earplugs, OH&S issues and number of incidents Managing Director /
Functional Heads
Carrying out necessary inspection and testing as per written procedures
3.
as well as fulfill legal compliance in their applicable areas.
Clearing the used packing materials / waste and disposing as well as Tops Management /
4.
maintain housekeeping in their areas. Functional Heads /
Management
5. Creating awareness of OH&S policy and objectives among employees Appointee
Reduction in wastes and conservation of the resources. Supervision of
Functional Heads /
the subordinates’ activities to ensure that handling and storage and
6. Management
process monitoring are done as per the recommended OH&S
Appointee
documented information.
Arrangement for the prevention of leakages as soon as they are
Supervisors /
7. detected. Ensuring safe work practices and functioning of safety
Operators
devices.

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Sr.
Activity Responsibility
No.
Follow recommended procedures for OH&S issues and are brought to Workmen /
8.
the notice of Immediate Boss Operators
Works Head /
Administration Head
9. Ensuring contract workmen are committed to OH&S protection.
/ Respective
Functional Heads

All the activities are carried out on a continuous basis and their achievements are reported in
the Management Review Meeting.
The Management Appointee is given authority and responsibility for
a. Ensuring that our OH&S conforms to the requirements of ISO 45001:2018;
b. Reporting to top management on the performance of the OH&S and on opportunities for
improvement and on the need for change or innovation;
c. Ensuring integrity of the OH&S is maintained, when changes to OH&S are planned and
implemented
(c.) Authority and responsibility for all the concerned persons is documented in job description
and communicated to them in order to facilitate effective OH&S Management System. It is
communicated and understood by all. Also, copies of job description and specifications
are given to the concerned. In case of vacancy / absenteeism, the delegation of authority
shall be upward and responsibility goes downward unless otherwise specified in the
documents.
5.4 Consultation and participation of workers
Processes for consultation and participation of workers at all applicable levels and functions
is established, implemented and maintained in organization by regular training, safety
meeting and daily on floor meeting.
In organization development, planning, implementation, performance evaluation and actions
for improvement of the OH&S management system is done through:
(a.) Providing mechanisms, time, training and resources necessary for consultation and
participation;
(b.) Providing timely access to clear, understandable and relevant information about the
OH&S management system;
(c.) Determining and removing obstacles or barriers to participation and minimize it if cannot
be removed;
(d.) Emphasizing the consultation of non-managerial workers to:
 determine the needs and expectations of interested parties
 establish the OH&S policy
 assign organizational roles, responsibilities and authorities
 determine how to fulfil legal requirements and other requirements
 establish OH&S objectives and plan to achieve them
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 determine applicable controls for outsourcing, procurement and contractors
 determine what needs to be monitored, measured and evaluated
 planning, establishing, implementing and maintaining an audit programme
 Continual improvement

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6.0 Planning
6.1 Actions to address risks and opportunities
6.1.1 General
Establish, implement and maintain the processes required to meet the requirements as given
in this chapter.
Consider during planning for OH&S:
a) The issues referred to in 4.1;
b) The requirements referred to in 4.2;
c) The scope of its OH&S management system;
Determine the risks and opportunities, related to:
 OH&S hazards;
 OH&S risks and other risks
 OH&S opportunities and other opportunities
 legal requirements and other requirements;
 Other issues and requirements, as identified in 4.1 and 4.2 that need to be addressed to;
 Give assurance that the OH&S management system can achieve its intended outcomes,
 Prevent and reduce undesired effects,
 Achieve continual improvement
We have determined potential emergency situations, including those that can have an OH&S
risk within the scope of OH&S.
The documented information is maintained in HIRA register and the identified risk is listed in
OH&S management plan for
 Risks and opportunities that need to be addressed;
 Processes and actions that are required to determine and address its risks and
opportunities to the extent necessary to have confidence that HIRA assessment is done
and necessary planning is followed
The OH&S related risk is identified for highly significant Hazard and to either reduce or
eliminate their risk, we have identified OH&S management plan and implemented the same.
The effectiveness of the action taken is reviewed by Management Appointee for risk. For
process related risk, the effectiveness is reviewed by HOD on monthly basis. Necessary
action against such risk is to reduce the risk, retain the risk or create opportunities by adding
new products, new market, new customers, new technology, or new partnership etc
6.1.2 Hazard identification and assessment of risks and opportunities
6.1.2.1 Hazard identification
The identification of OHS Hazards is an on–going process that determines the past, current
and potential risks of the activities, products and services. Procedure is documented for the
hazard identification and risk assessment. During the identification of hazards and risks, all
activities operated by the Organization as well as others are taken into consideration; like;

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 How work is organized, considered social factors (including workload, work hours,
victimization, harassment and bullying), leadership and the culture in the organization
 Routine and non–routine activities and situations, including hazards arising from:
 Infrastructure, equipment, materials, substances and the physical conditions of the
workplace
 Product and service design, research, development, testing, production, assembly,
construction, service delivery, maintenance and disposal
 Human factors;
 How the work is performed
 Past relevant incidents, internal or external to the organization, including emergencies,
and their causes
 Potential emergency situations
 The design of work areas, processes, installations, machinery/equipment, operating
procedures and work organization, including their adaptation to human capabilities
 Activities of all persons having access to the workplaces (including contractors, workers
and visitor, who are suppose to be affected by the identified work),
 Workers at a location but not under the direct control of the organization
 People in the vicinity of the workplace who can be affected by the activities of the
organization
 Situations occurring in the vicinity of the workplace caused by work-related activities
under the control of the organization,
 Situations not controlled by the organization and occurring in the vicinity of the workplace
that can cause injury and ill health to persons in the workplace
 Actual or proposed changes in the organization, operations, processes, activities and
OH&S management system
 Changes in knowledge of, and information about, hazards,
6.1.2.2 Assessment of OH&S risks and other risks to the OH&S management system
The methodology of OHS Hazards and risk assessment is defined as proactive steps for the
classification of risks and identifications of objectives and OHSMP. It is consistent with
operating experience and the capabilities of risk control measures employed. It provides input
for the determinations of facility requirements, identification of training needs and / or
development of operational controls. It provides monitoring of required actions to ensure both
the effectiveness and timeliness of the implementations. Followings are also taken in to
consideration as a methodology;
 the assessment is carried out with respect to the scope, nature and time of the Company
and is proactive rather than reactive,
Determine Hazard that have or can have a significant OH&S risk, i.e. significant OH&S
Hazard, by using established criteria given in the procedure.
Communicate our significant OH&S Hazard to various levels of employees.
Maintain documented information in HIRA sheet, procedure for criteria of evaluation of
significant Hazard and other documented information for:
 OH&S Hazard and associated OH&S risk;
 Criteria used to determine its significant OH&S Hazard;

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 Significant OH&S Hazard.
6.1.2.3 Assessment of OH&S opportunities and other opportunities to the OH&S management
system
Company has been establishing, implementing and maintaining a processes to access OH&S
opportunities & other opportunities for improving the OH&S management system.
HOD / Management Appointee access the opportunities:
a.) To enhance OH&S performance, while taking into account planned changes to the
organization, its policies, processes or its activities;
b.) To adapt work, work organization and work environment to workers
c.) To eliminate hazards and reduce OH&S risks
Significant OH&S Hazard can result in risks and opportunities
6.1.3 Determination of legal requirements and other requirements
Procedure has been established and maintained to:
a) determine and have access to the up-to-date legal requirements and other requirements
that are applicable to its hazards, OH&S risks and OH&S management system;
b) determine how these legal requirements and other requirements apply to the organization
and what needs to be communicated;
c) take these legal requirements and other requirements into account when establishing,
implementing, maintaining and continually improving its OH&S management system.
d) maintain documented information of legal requirements and other requirements.Legal
requirements and other requirements can result in risks and opportunities to company.
e) maintain and keep up-to-date document information of all legal and other requirements in
the register of regulations. The information for legal requirements is updated as well
as communication is done for the relevant information on legal and other requirements to
the employees and relevant interested parties.
A register of “OH&S Legislation” has been established and is maintained as ROR document
information.
6.2 OH&S Objectives and required Planning to Achieve Them
6.2.1 OH&S Objectives
Quantifiable OH&S Objectives are established based on OH&S Policy given and OH&S
objectives given at the relevant function. These objectives need to be consistent with the
OH&S Policy. The quantifiable criteria are dynamic and reviewed in the management review
meeting for our commitment of continual improvement.
OH&S objectives at relevant functions and levels within the Company are prepared,
documented and implemented as a performance indicator based on the OH&S Policy.
All such objectives and targets are measurable and consistent with the OH&S Policy
including consideration of applicable requirements, results of the assessment of risks and
opportunities and consultation with workers which are the basis for continual improvement.

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Along with consistency, the objectives are established and reviewed based on the OH&S
Hazard and risk, technological options, financial, operational and business requirements and
the views of interested parties, legislative requirements etc. The objectives are made for the
relevant function and level within the organization.
For achieving objectives and targets, OH&S management programme is prepared,
implemented and maintained. To achieve the defined objectives and targets, while preparing
the OH&S management programme, the following is taken into account:;
 Responsibility for achieving objectives and targets at relevant functions and levels of
Employees / organization,
 Methods / modes and time frame for achieving the objectives and targets.
The OHSMP is reviewed at regular intervals in the management review meeting and
amended in line with new development, modification, and expansion of existing activities.
The OH&S objectives are prepared based on OH&S policy; they are measurable, and
relevant to the product or service related and enhance customer satisfaction. We have define
an OH&S objectives as documented information for the company as listed below.
OH&S Objectives
Parameters Annual Target
 Legal compliance related to OH&S and complying all
100 %
identified obligations
 Ensure OH&S compliance by supplier 100 %
 Reduce OH&S related incidents 1 Max. / 6 Months
 Reduce Nos. of cases of fire / near miss accidents 1 Max. / 6 Months
 Reduce Nos. of cases of un–safe condition / act 1 Max. / 6 Months

 From the company level objectives the functional objectives are prepared and HOD
monitor the objectives status on monthly basis in objective monitoring sheet. The
objectives are communicated to all concern persons by HOD and are updated annually
based on management review meeting and discussions.
 Quantifiable OH&S Objectives are established based on documented OH&S policy given
above at relevant function and consistent with the OH&S policy. The quantifiable criteria
are dynamic and reviewed in management review meeting for our commitment to
continual improvement.
6.2.2 Planning Actions to Achieve OH&S Objectives
While planning how to achieve our OH&S objectives, objective plans are made as per exhibit
for:
a) What will be done;
b) What resources will be required;
c) Who will be responsible;
d) When it will be completed;
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e) How the results will be evaluated; including indicators for monitoring.
Consider how actions to achieve the OH&S objectives can be integrated into the
organization’s business processes.
Establish documented information and maintain OHSMP for achieving the objectives –
 Responsibility and authority for achieving at relevant level
 Means and time scale to be achieved (Plan)
 Review at regular and planned interval and updated based on progress

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7.0 Support
7.1 Resources
Company has identified resource requirements and provided timely resources in terms of
qualified personnel, test equipment, plant and machinery, facility for production, and testing
for continual improvement of OH&S management system. The resource for implementation
and maintenance of OH&S management system as well as improving its effectiveness is
provided. The adequate resources to enhance customer satisfaction by meeting customer
requirements is identified and provided by Company
Adequacies of these resources are reviewed, for example during
 Management Review
 Contract Review
 Internal safety Audit Result
 Interested party Complaint Review
Management Appointee considers the capabilities and constraints on, existing internal
resources.
In case the in-house resources are limited, services of external providers are taken.
7.2 Competence
The Management Appointee identifies competency of the employees performing activities
affecting conformity of product requirement based on the performance review. Also provides
necessary training and on-the-job training for their staff to upgrade their knowledge and
achieve the necessary Competency. The skill matrix, competency matrix and training records
are prepared an kept as documented information. In addition, during the routine work, due to
change in area of work or any other reason, the training needs are identified and provided.
Following points are considered for identification and implementation;
a.) Determining the necessary competence of the workers that affects or can affect its OH&S
performance;
b.) Ensuring that workers are competent on the basis of appropriate education, training or
experience, including the ability to identify hazards;
c.) Where applicable, taking actions to acquire the necessary competence, and evaluating
the effectiveness of the actions taken.
d.) Retaining appropriate documented information as evidence of competence
Also, we ensure that the necessary competence has been achieved and appropriate records
for the education, experience, training, and qualification are maintained in competency matrix.
The new employee is trained properly in the identified area as documented information. The
effectiveness of the training provided and action taken is evaluated as per the established
documented information. The competence and training is also evaluated and provided for
contracted employees

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7.3 Awareness
Functional Heads ensure that workers doing work under our control are aware of the
requirements of OH&S management system, including;
a) OH&S policy and OH&S objectives of Organization;
b) Their contribution to the effectiveness of the OH&S management system, including the
benefits of improved OH&S performance;
c) The implications and potential consequences of not conforming to the OH&S
management system requirements.
d) Incidents and the outcomes of investigations that are relevant to them
e) Hazards, OH&S risks and actions determined that are relevant to them
f) The ability to remove themselves from work situations that they consider present an
imminent and serious danger to their life or health, as well as the arrangements for
protecting them from undue consequences for doing so
The HOD / Management Appointee ensures that the employees are aware of all the above
requirements, including emergency awareness and how the activities affect OH&S and what
care needs to be taken for day-to-day implementation.
Suitable OH&S management system awareness programmes are arranged for all the
workers to ensure that the requirements are well understood at all level.
7.4 Communication
7.4.1 General
The organization ensures internal and external communication between Functional Heads
and at various levels of employees regarding the processes of the OH&S management
system and their effectiveness. Such communication related to OH&S includes;
a) Topic : what it will communicate;
b) Time : when to communicate;
c) Team : with whom to communicate;
i. internally among the various levels and functions of the organization
ii. among contractors and visitors to the workplace
iii. among other interested parties
d) Method: how to communicate; diversity aspects are taken into account when considering
communication needs.
Communication process is established and implemented to;
 Take into account its legal requirements and other requirements;
 Ensure that OH&S information communicated is consistent with information generated
within the OH&S management system, and is reliable.
The organization retains documented information as evidence of its communications, as
appropriate.

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7.4.2 Internal communication:
Method for internal communication is established and the HOD / Management Appointee;
a) Internally communicates the information relevant to the OH&S management system
among the various levels and functions of the organization, including changes to the
OH&S management system, as appropriate;
b) Ensures its communication process(es) enables workers doing work under the
organization’s control to contribute to continual improvement.
It is ensured that the communication process is open and the environment is created to bring
the ideas for OH&S improvement.
7.5 Documented Information
7.5.1 General
Company has established, documented, implemented, and maintained an OH&S
management system and continually improved its effectiveness in accordance with the
requirements of ISO 45001:2018. The OH&S includes;
a) Documented information required by this ISO 45001:2018 Standard;
b) Documented information determined by the Company as being necessary for the
effectiveness of the OH&S management system. The documented information are
established considering the;
 The size of company and type of activities, processes, product and services;
 The need to demonstrate fulfilment of legal requirements and other requirements;
 The complexity of processes and their interactions;
 The competence of workers.
 The critical processes, determined by the company, needed for the OH&S and their
application throughout the organisation and listed in the process flow Annexure – III
 The documented Macro level OH&S in the OH&S manual against how ISO
45001:2018 is implemented. This manual is also known as the OH&S Manual, which
outlines the scope, structure and general principles of the operation of OH&S
management system and serves as a declaration of the intentions of the top
management to satisfy various clauses of ISO 45001:2018.
 The documented standard operating procedures and exhibits as good manufacturing
practices.
 Prepared and filled up formats to retain documented information.
 The list of forms and exhibits given in Annexure–I.
7.5.2 Creating and updating
The documented information are created, implemented and updated periodically, including
the following information as minimum requirements on the documented information to ensure
followings;
a) Identification and description (e.g. title of document, date of implementation, author
means prepared by and approved by, alongwith the document number and its revision
status);
b) Format (e.g. language, software version, graphics) and media (e.g. paper, electronic);

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c) Review of document atleast once in a year and approval for suitability and adequacy by
the identified authority as per the details given on the next page.
The written documents are prepared in Company as per list given below considering the size
of organisation, type of activities, the complexity of processes and their interactions and the
competence of personnel.
 Documented statement of OH&S policy and OH&S objectives
 OH&S Manual
 Standard operating procedures and Exhibits
 OH&S records (few records are also maintained in the electronic media).
All documented information is identified by date, revision number, approved by title of
document and some identification number as per document identification and codification. All
documented information is kept in English language and it is used in either soft copy or hard
copy form.
All the documented information is reviewed and approved for the suitability and adequacy by
the authorized person/s as listed below.
Table – 1 Responsibility Matrix For Documents
Responsibility

Type of Document Document Review Maintaining document,


Modification And Master list and issuing
Approval as per distribution
1. OH&S Manual Top Management Management Appointee
2. Procedure / Standard operating Management Appointee /
Management Appointee
procedures / Exhibits / Plans Functional Heads
3. Applicable standards / customer
Management Appointee
specification, and documents of external Management Appointee
For Follow–up
origin (external)
Management Appointee /
4. Formats Management Appointee
Functional Heads

Note: – Master copy of all the documents are kept with the Management Appointee, who is
authorised to issue and distribute the same.
7.5.3 Control of documented information
All the documented information relating to the OH&S System requirements are controlled as
per details given below.
a) They are reviewed for adequacy and are approved by the authorised persons as per
table–1.
b) The documents are updated as necessary, reviewed and re–approved by the same
authority. Copies of superseded documents are identified and retained as necessary to
maintain specified / required traceability.

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c) The current revision status of the document is identified by its revision number. Also, the
latest changes are identified by suitable marking. Each document or data will have its
revision status by revision number or revised date as applicable. Such changes are
distributed to the Authorised Copy Holders of the document. Any revision is affected by
changing revision number of particular page for OH&S manual / document for all other
documented information
d) The respective Functional Heads / Management Appointee are responsible for ensuring
that the latest relevant versions of applicable documents are available at point of use
where and when it is needed. They will also ensure that documents remain legible, readily
identifiable and retrievable. Such documented information is also protected from against
the loss of confidentiality, improper use or loss of integrity
e) All the controlled documents have been identified, legible and system of preparation,
issue, distribution and maintenance of documented information.
f) The Management Appointee are responsible to ensure that all external documents those
needed for use in the OH&S are identified and proper control is established. Similar
controls shall apply to the necessary external documents for the planning and operation of
the OH&S management system. The external documents are identified and their
distribution is controlled.
g) Master list and distribution list with the current revision of documents (latest revision
number) and distribution list of all the documents is maintained for all the documented
information to prevent an unintended use of obsolete documents. If any obsolete
documents are kept for future reference, the stamp of obsolete document is put on the
document.
Company has established a system to define the control needed for identification, storage,
protection, retrieval, retention, and disposition of documented information (records).
They are kept legible, retrievable, and readily identifiable. The system is described as below;
1. For all the retained documented information, a master list of records is prepared. The
access, retrieval, and user details are provided in the master list of records.
2. Proper control is established for the storage and preservation of the documented
information to ensure that such information is available when it is needed. The hard copy
of documented information is stored in cupboard or safe places with HOD / authorized
person; it is ensured that records are legible and properly preserved during storage. The
soft copy is kept with the authorized access control by password and back up is taken on
weekly basis.
3. Control of changes (e.g. version control) is established with the help of change note. The
revision number is applied to identify the latest copy of documented information.
4. Retention and disposition; the retention period for documented information is identified
and at the end of retention period, it is either teared-off or burned out for the disposal of
hard copy of documented information. Also, the soft copy is deleted from the system.
Documented information of external origin determined by the organization to be necessary
for the planning and operation of the OH&S management system is identified as appropriate,
and listed in the master list of documents. The latest copy of such documented information is
collected and distributed to the concerned persons.

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Documented information retained as evidence of conformity is protected from the unintended
alterations by password protection or kept in cupboard with a lock.
The system is applicable for hard copy of records as well as records maintained in electronic
media. All the formats used as OH&S Records are properly identified and controlled.

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8.0 Operation
8.1 Operational planning and control
8.1.1 General
Organization has established, implemented, controlled and maintained the processes
required to meet the OH&S management system requirements, and to implement the action
plan for the actions indentified to address risks and opportunities. The OH&S objectives and
their planning are achieved by;
 Establishing operating criteria for the processes;
 Implementing control of the processes, in accordance with the identified operating criteria.
 Adapting work to workers
Documented information has been established for confidence that the processes have been
carried out as planned.
8.1.2 Elimination of hazards and Reduction of OH&S risks
Results of the assessment are kept up to date with the existing controls, proposed controls
(objectives and programmes) for the elimination of hazards and reduction of OH&S risks
considering the following hierarchy;
 Elimination,
 Substitution,
 Engineering control, signage / warnings
 Administrative controls, including
 training and
 Personal protective equipments.
All the above controls are identified and documented in the Significant OH&S Hazards list
and is made available to all employees.
A register of OHS Hazards and associated risks have been established on the basis of a
review undertaken by the Company with the assistance of an external agency to establish the
current position with regard to the occupational, health and safety using evaluation criteria
provided. This information is kept up-to-date. Also, to implement the management of change,
OH&S hazards and risks associated with the proposed changes are identified and
documented.
Further, the significant OHS Hazards are taken into account for establishing, implementing
and maintaining Occupational health and safety management system.
8.1.3 Management of change
Company controls planned changes and review the consequences of unintended changes
that impact OH&S performance, and takes action to mitigate any adverse effects, as
necessary.
Company considers the following points at the time of control of planned temporary and
permanent changes that impact OH&S performance:

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a) New products, services and processes, or changes to the existing products, services and
processes, including:
 Workplace locations and surroundings;
 Work organization;
 Working conditions;
 Equipment;
 Workforce;
b) Changes in legal and other requirements;
c) Changes in knowledge or information about HIRA;
d) Developments in knowledge and technology.
8.1.4 Procurement
8.1.4.1 General
The control for procurement of products and services is done as per both established system
controls identified by the functional heads. The documented information for process
monitoring, purchase orders, evaluation of contractors, TREM card, Related SOPs and
control plans and contracts are maintained to conform its OH&S management system.
8.1.4.2 Contractors
Organization coordinates its procurement processes with contractors, in order to identify
hazards and to assess and control the OH&S risks, arising from the:
a) contractors’ activities and operations that impact the organization;
b) organization’s activities and operations that impact the contractors’ workers;
c) contractors’ activities and operations that impact other interested parties in the workplace.
Company ensures that the requirements of its OH&S management system are met by
contractors and their workers.
OH&S criteria for the selection of contractors are defined and documented by the head of
department.
8.1.4.3 Outsourcing
The organization has to ensure that the outsourced processes are controlled. A proper
control is established at section and evaluation stage to ensure that they are committed to
implement related OH&S actions as defined in our OH&S. Also, in our purchase document
and contracts necessary care is taken by us to clearly communicate the necessary OH&S
requirements and other requirements to them.
The information about potential significant OH&S risk associated with transportation and
delivery, use or final disposal, any emergency during transportation is identified and
communicated as part of TREM card.

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8.2 Emergency preparedness (i.e. Emergency Awareness) and response
The organization has established an Emergency preparedness plan to ensure appropriate
responses to potential emergency situations and potential accidents / incidents to the OH&S
and mechanism for responding to such situation. Emergency preparedness plan is
established, implemented, and maintained and the processes are required to prepare for and
respond to potential emergency situations.
Company is;
a) Ready to respond actual emergency situations, including the provision of first aid;
b) Provide training for the planned response;
c) Review it once in a year to test and exercise the planned response capability;
d) Review and revise periodically the emergency preparedness plan and planned response
actions, in particular after the occurrence of emergency situations (mock drill);
e) communicate and provide relevant information to all workers on their duties and
responsibilities;
f) communicate relevant information to contractors, visitors, emergency response services,
government authorities and, as appropriate, the local community;
g) Review and take into account the needs and capabilities of all relevant interested parties
and ensure their involvement, as appropriate, in the development of the planned
response.
Documented information has been established to prevent and mitigate the risk of such
emergency situation, which can cause illness, injury, adverse OH&S risk etc.
Mock drill is conducted once in a year for the testing / verification of such emergency
preparedness as per documented information and retains the documented information for
evaluation of results.

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Document No. OH&SM/01
OH&S Revision No. 00
Manual
ABC Chemical Inc. Date 01.08.2018
Page No. 32 of 40
9.0 Performance Evaluation
9.1 Monitoring, measurement, analysis and performance evaluation
9.1.1 General
Documented information has been documented and implemented for monitoring and
measurement of the actual performance against the OH&S performance requirements on
regular basis. Procedure provides quantitative as well as qualitative measures to meet
company needs as well as monitor the key characteristics of operations, which have
significant OH&S risks, achievements of OH&S objectives, operational processes and the
related activities. The Documented information also includes the information for monitoring
performance, operational control points, and conformity to the objectives and targets.
Company has determined;
a) parameters need to be monitored and measured (E/OHS/02) and others processes;
b) the extent to which legal requirements and other requirements are fulfilled
c) activities and operations related to identified hazards, risks and opportunities
d) progress towards achievement of the organization’s OH&S objectives
e) effectiveness of operational and other controls
f) the methods of monitoring, measurement, analysis and performance evaluation, as
applicable, to ensure valid results;
g) the criteria (E/OHS/01 and E/OHS/02) against which the company evaluates its OH&S
performance, and appropriate indicators;
h) the frequency of monitoring and measuring to be performed;
i) the frequency for monitoring and measurement of results and its analysis and evaluation.
This includes evaluation of compliance with the relevant OH&S legislation and regulations as
per the documented procedures. The proactive measures are taken to monitor compliance
with the OH&S management programme and operational criteria. Reactive measures are
considered to monitor OH&S Hazard, its risk, accidents, incident and near miss, and other
historical evidence of deficient OH&S performance.
Equipment used for Monitoring and measuring are periodically calibrated / verified to ensure
accuracy / required precision as per the documented information and retain the calibration
reports and calibration status reports for the same.
Company evaluates its OH&S performance and the effectiveness of the OH&S management
system.
Company communicates relevant OH&S performance information both internally and
externally, as per communication process and as required by compliance obligations.
Company retains appropriate documented information as evidence of the monitoring,
measurement, analysis and evaluation results.
Results of analysis are recorded to track performance, relevant operational controls and
conformance with the OH&S objectives and targets.

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Document No. OH&SM/01
OH&S Revision No. 00
Manual
ABC Chemical Inc. Date 01.08.2018
Page No. 33 of 40
Periodic preventive maintenance is done for all equipment to ensure their fitness. Also,
machine wise breakdown history records are maintained.
9.1.2 Evaluation of compliance
Documented information, in terms of register of regulation, is maintained and implemented
periodically for the evaluation of compliance with the applicable legal requirements and other
requirements (compliance obligation). In the register of regulations, all the applicable laws are
listed and details of its implementation are given. Company ensures commitment towards
compliance with all such legal requirements consistently. Retain documented information of
such periodic evaluation are maintained in the Register of Rules and Regulation.
The company;
a) Determine the frequency and method of evaluation of compliance;
b) Evaluate the compliance and take action if needed;
c) Maintain knowledge and understanding of its compliance status with legal requirements
and other requirements.
Also, evaluation with the other requirements is done as per the ROR and documented
information is maintained in the form of control plans and SOP. The evidences of necessary
compliance records are retained as documented information for the periodic evaluation and
maintained in legal records and register of regulatory compliances.
9.2 Internal audit
9.2.1 General
Internal audit of OH&S management systems is carried–out At least once in a Six Months to:
a.) Determine whether OH&S management system
1. Conforms to the planned arrangements for OH&S management system as per details
given in relevant documented information including OH&S policy, Objective, HIRA
registers, SOP and documented exhibits, various plans and formats.
2. Is implemented and maintained in accordance with the requirements of ISO
45001:2018 OH&S management system
b.) Provide information on the results of audits to the Top Management for effective
implementation of OH&S management system.
9.2.2 Internal audit programme
The Management Appointee establishes, implements and maintains an internal audit
programme, with the details of frequency, methods, responsibilities, consultation, planning
requirements and reporting of its internal audits findings.
While programming the audit of the particular function, the consideration is given on
(i) OH&S importance of the process concerned,
(ii) changes affecting the company and
(iii) results of previous audit.
A trained auditor, independent of area being audited, is used for internal audits.

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Document No. OH&SM/01
OH&S Revision No. 00
Manual
ABC Chemical Inc. Date 01.08.2018
Page No. 34 of 40
Company:
a) Defines the audit criteria and scope for each audit;
b) Selects auditors and conducts audits to ensure objectivity and the impartiality of the audit
process;
c) Ensures that the results of the audits are reported to relevant managers; ensures that the
relevant audit results are reported to workers and where they exist, workers’
representatives, and other relevant interested parties.
d) Takes action to address nonconformities and continually improve its OH&S performance
Documented audit plan defines scope, schedule and details of the auditor. The trained
auditor follows interviewing the people, verifying the work place and processes and verifies
the documented information by competent trained auditors. After the completion of audit,
they report the results in internal audit nonconformity reports.
The documented information also addresses the followings;
 Responsibilities and requirements for planning and conducting audits, reporting results
and retaining associated records,
 Determination of audit criteria, scope of audit, frequency of audit and methods
All the audit findings and verification of audit results are reported to the top management for
review and evaluation of the system is discussed in the management review meetings. The
audit plan/schedule, audit non–conformity reports and clause-wise audit checklists are
maintained as an evidence of the implementation of audit programme and audit results.
Documented information is retained for each audit cycle.
9.3 Management review
The OH&S management system is established and systematically reviewed for its continuous
suitability and effectiveness in confirming the requirements of ISO 45001:2018 in our
company.
Top Management reviews the organization’s OH&S management system, at least once in a
Six Months, to ensure its ongoing suitability, adequacy, and effectiveness.
This review is carried–out by Top Management or his nominee by holding Management
Review Meetings, which are attended by the Management Appointee and all Functional
Heads.
Management review (Review input) includes consideration of:
a) the status of actions from previous management reviews;
b) changes in external and internal issues that are relevant to the OH&S management
system including:
1) the needs and expectations of interested parties;
2) legal requirements and other requirements;
3) risks and opportunities;
c) the extent to which the OH&S policy and the OH&S objectives have been met;
d) information on the OH&S performance, including trends in:
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Document No. OH&SM/01
OH&S Revision No. 00
Manual
ABC Chemical Inc. Date 01.08.2018
Page No. 35 of 40
1) incidents, nonconformities, corrective actions and continual improvement;
2) monitoring and measurement results;
3) results of evaluation of compliance with legal requirements and other requirements;
4) audit results;
5) consultation and participation of workers
6) risks and opportunities
e) adequacy of resources for maintaining an effective OH&S management system;
f) relevant communication(s) with/from interested parties;
g) opportunities for continual improvement.
The outputs (Review output) of the management review include consideration of:
 continuing suitability, adequacy and effectiveness of the OH&S management system in
achieving its intended outcomes;
 decision related to continual improvement opportunities;
 decisions related to any need for changes to the OH&S management system, including
resources;
 actions, if needed, when OH&S objectives have not been achieved;
 opportunities to improve integration of the OH&S management system with other
business processes, if needed;
 any implications for the strategic direction of the organization.
The Management Appointee retains documented information as evidence of the results of
management reviews in terms of minutes of the management review meeting.
As mentioned above, the review output also includes the details of action decided, person
responsible to complete the action and target completion period. And, the Management
Appointee will monitor the same to ensure timely completion of all those actions.

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Document No. OH&SM/01
OH&S Revision No. 00
Manual
ABC Chemical Inc. Date 01.08.2018
Page No. 36 of 40
10.0 Improvement
10.1 General
The Management Appointee / HOD determine and select opportunities for improvement and
implements necessary actions to achieve the intended outcomes of the OH&S management
system.
These include:
a) improving processes and products to meet requirements as well as to address future
needs and expectations to meet OH&S;
b) correcting, preventing or reducing undesired effects;
c) improving the performance and effectiveness of the environment management system.
Examples: The improvements are made in the company by:
 Correction,
 Corrective action,
 Continual improvement,
 Breakthrough change,
 Innovation and re–organization
10.2 Incident, nonconformity and corrective action
10.2.1 The company has established the system for identifying, reporting, investigating and taking
action to determine and manage incidents and nonconformities including audit results and
complaints from the interested parties. For the OH&S issues, the concerned persons are
informed for disposal of non–conformity.
When any incident or a non–conformity occurs, the concerned Functional Head;
a) reacts in a timely manner to the incident or nonconformity and, as applicable:
1) takes action to control and correct it;
2) deals with the consequences, including mitigating adverse OH&S risk;
b) evaluates, with the participation of workers and the involvement of other relevant
interested parties, the need for action to eliminate the root cause of the incident or
nonconformity, so that it does not recur or occur elsewhere, by:
1) investigating the incident or reviewing the nonconformity;
2) determining the cause of the incident or nonconformity;
3) determining similar incidents that have occurred, nonconformities that exist or could
potentially occur;
c) reviews existing assessments of OH&S risks and other risks;
d) implements any action needed;
e) assesses OH&S risks that relate to new or changed hazards, prior to taking action;
f) reviews the effectiveness of any action taken;
g) makes changes to the OH&S management system, if necessary.
Corrective action
The corrective action planning should include evaluation of the significance of problems
affecting OH&S management system. The major or repetitive non–conformities are identified
for taking corrective action in the areas as defined.
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Document No. OH&SM/01
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Manual
ABC Chemical Inc. Date 01.08.2018
Page No. 37 of 40
a. The Functional Head reviews incident or non–conformities (including customer
complaints) identified in their areas and analysed it.
b. The root cause of incident or non–conformities are identified in the area like 5M i.e. man,
machine, material, management (system), money (resources).
c. Considering the evaluation and Hazards like costs of non–conformance vs. action taken,
random failure, customer satisfaction etc., need for action is evaluated to ensure that
incident or non–conformities do not recur or occur. For non–conformities of minor nature
or random failure, it is recorded in OH&S Objectives form and no CAR is raised.
After analysing the incident / non–conformities or deficiencies for major or repetitive
problems, the corrective action is taken.
d. Based on the root cause analysis, a corrective action is initiated and implemented. If it is
applicable for other departments, a CAR Form is forwarded to the concern function to
implement the necessary corrective action.
e. The results of action taken are recorded in CAR Form and they are compared with the
results in non–conformity V/s results after action taken. If it is found not satisfactory, the
entire process is repeated.
After the completion of corrective action, a form is forwarded to the Management Appointee
to review the corrective action taken. He reviews effectiveness of the corrective action to
review the adequacy of such measures. The summary of effectiveness of corrective action is
discussed and reviewed in the management review meeting.
Functional Heads retain the documented information on incident or nonconformity identified
and the subsequent action taken in incident or nonconformity record. Management Appointee
/ Functional Head take corrective action and maintain records of corrective action taken
including effectiveness of the corrective action taken. Based on such incident or non–
conformity and corrective actions taken, the Management Appointee update the risk and
opportunity register as appropriate. The Management Appointee communicates this
documented information to the relevant workers, and, where they exist, workers’
representatives, and other relevant interested parties as required.
10.3 Continual improvement
The process is laid down for follow–up of process to ensure continual improvement of the
OH&S Management System. The Management Appointee / Functional Head continually
improve the suitability, adequacy, and effectiveness of the OH&S by;
 enhancing OH&S performance
 promoting a culture that supports an OH&S management system
 promoting the participation of workers in implementing actions
 communicating the relevant results of continual improvement to workers, and, where they
exist, workers’ representatives
The continual improvement of OH&S is facilitated through the use of OH&S policy, objectives,
and audit results, analysis of data, corrective action and output of management review to
determine the need or opportunities identified as a part of continual improvement. Maintaining
and retaining documented information serves as an evidence of continual improvement.

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Document No. OH&SM/01
OH&S Revision No. 00
Manual
ABC Chemical Inc. Date 01.08.2018
Page No. 38 of 40

Annexure–I List of Documented Information


Procedures
Sr.
Procedure numbers Title of Procedures
No.
Procedure For Hazard Identification, Risk Assessment And
1. PRO/OHS/01
Determining Controls
2. PRO/OHS/02 Procedure For Identification Of Legal And Other Requirements
3. PRO/OHS/03 Procedure For Objectives And Targets
4. PRO/OHS/04 Procedure For OHS Management Programme (OHSMP)
5. PRO/OHS/05 Procedure For Communication, Participation and communication
6. PRO/OHS/06 Procedure For Operational Control
7. PRO/OHS/07 Procedure For Emergency Preparedness And Response
8. PRO/OHS/08 Procedure For Performance Monitoring And Measurement
Procedure For Incident Investigation, Non–Conformity and Corrective
9. PRO/OHS/09
Action
10. PRO/SYS/01 Procedure for document and data control
11. PRO/SYS/02 Procedure for internal audit
12. PRO/SYS/03 Procedure for management review
13. PRO/SYS/04 Procedure for Risk Management
14. PRO/SYS/05 Procedure For Training
List of Exhibits
Sr.
Exhibit Number Title of Exhibit
No.
15. E/OHS/01 Objectives and Targets – OHS Objective Plan
16. E/OHS/02 OH&S Control Plan
17. E/HRD/01 Skill Requirements
18. E/HRD/02 Multi skill requirements
19. E/SYS/01 Exhibit for Document Identification and Codification System

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Document No. OH&SM/01
OH&S Revision No. 00
Manual
ABC Chemical Inc. Date 01.08.2018
Page No. 39 of 40

Annexure–II Glossary of Terms


Sr.
Abbreviation For
No.
1. ABC ABC Chemical Inc.
2. Top Management Managing Director / Managing Directors
Marketing Head, Purchase Head, Works Head, QC Head, Production
3. Functional Heads
Incharge, Packing Incharge, Stores Incharge, Despatch Incharge etc.
4. OH&S Occupational health & safety
5. ANX Annexure
6. NCR Non Conformity Report
7. IQANCR Internal Quality Audit Non Conformity Report
8. AEPL Approved External Provider List
9. CAR Corrective Action Report
10. PRO Procedure
11. SOP Standard Operating Procedure
12. F Format
13. E Exhibit
14. HOD Head of department/functional heads
15. DI Documented Information

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Document No. OH&SM/01
OH&S Revision No. 00
Manual
ABC Chemical Inc. Date 01.08.2018
Page No. 40 of 40

Annexure–III Organization structure

Managing Director (Top Management)

Directors

QC Legal Marketing General Manager / Purchase


Head Incharge Head Works Head Head

Plant Safety Head and


Incharges Management
Appointee

Chemists Electrical Engineering Stores Despatch


Incharge Incharge Incharge Incharge

Production
ETP
Supervisors
Operator

Electrical Mechanical
Engineers Engineers Production
Chemists

Note
 Management Appointee directly reports to Top Management (Managing Director) for effective
functioning of the system. He is given authority to execute the work for installation of ISO 45001
system and reports directly.

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Procedure for Emergency Preparedness and Response
1.0 Purpose
To establish and maintain procedures to identify potential foreseeable incidents /
emergency situation to prevent and control, mitigation of OHS associated risks and to
test effectiveness / review / revise such procedures periodically.
2.0 Scope
This procedure is applicable to any fire, explosion or other disaster leading to
emergency situation, which means any significant, non–routine situation which
endangers the personal, property and other interested parties.
3.0 Responsibility
3.1 Management Appointeeis responsible for effective implementation of disaster
management plan
3.2 Functional Headsare responsible for implementation of this procedure in emergency
situations.
4.0 Description Of Activity
4.1 Management Appointee prepares disaster management plan (emergency preparedness)
for the on–site emergency for identified potential emergency situations clearly detailing
responsibilities. While preparation of emergency plan, consider OHS Hazards and risk
associated with the activity.
4.2 Identification of potential incident and emergency situations while carrying out initial OHS
review. The potential emergencies and the areas have been identified as given below ;
Potential Emergency situation Area
 Fire and explosion,
 Natural calamity (e.g. Earthquake, Cyclone etc.) causing damages,
casualties or disruptions to work. Site area, and
 Emergency breakdown of major equipments storage area
 Work site incidents of serious nature causing multiple casualties,
labour unrest, or substantial work stoppages.
4.3 The prevention, mitigation and corrective and preventive actions are detailed below for
each type of foreseeable potential emergency.
Fire
Prevention
 Keep fire extinguishers well maintained.
 To ensure that training regarding use of fire fighting equipment to concerned
employee / security guards are provided.
Mitigation
 Any person noticing fire shall pass on the information through phone / messenger to
Security personnel at main gate and concerned supervisor.
 Use suitable fire fighting equipment. (Fire extinguishers)
 If fire cannot be put off or if fire is noticed when it has erupted in big way then take
help from Local fire fighting team.
 Cordon off the area and do not allow people to come near the fire.
 Switch off electricity near the place of fire, if necessary.

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Corrective and Preventive Action
 Analyze the causes of occurrence of the fire and prepare a report specifying
measures to be taken to prevent recurrence of the incident.
 Document corrective and preventive actions arising out of this incident in the
corresponding applicable procedures.
 Communicate about the incident to the regulatory authorities in the prescribed form
mentioned.
4.4 Occupational Incidents
 Electrical shocks
 Slips Trips, fall, and Accident. (STFA).
4.4 Management Appointee carries–out Mock Drills quarterly for each of the emergency
situations identified, where practicable and keeps records. Headcount is done by Safety
Officer during each mock drill.
4.6 Review And Disposition
 The onsite emergency plan shall be reviewed and revised Once in a Year and also
in light of findings of change shall be maintained.
 Investigation and maintenance of incidents records as per procedure
7.0 Formats / Exhibits
Sr.
Format No. Title Of formats
No.
1. ---------- Mock drill records

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Sample mock drill
1. Sr. No.  02
2. Date  09–08–2018
3. Time  10.00 AM
4. Last Done On  09–06–2018
5. Arranged By  John Adam
6. Type Of Emergency  Casualty Handling
7. Location  Near Steam Boiler
8. Outside Invitee  Nil
John Adam Management Appointee / Safety Head
9. Observers 
Smith Clare Works Head
Observations
 At sharp 10.00 AM the siren is sounded in normal mode.
 Immediately the employees are informed about accidents in site for falling down and suffered
from major injury.
 1 Employee was made ready as a casualty. He was informed that he should behave like
major injured person and is not in good condition.
 Safety members have immediately rushed towards site for handling of casualty as per the
direction given to them.
 Remaining all employees have stopped their work and become ready to provide help.
 Due to rushing towards assembly point, one employee falls down during running. No injury
was reported.
 Mr. John Adam has called immediately to the ambulance for handling of casualty towards
Hospital.
 Casualty was collected from the location and was taken to Assembly and casualty collection
1.0
point around 10.15 AM.
 Member collected causality after keeping causality on their shoulders.
 Ambulance came at 10.25 AM.
 Before reaching of ambulance at gate, Mr. John Adam has checked causality for providing
first aid treatment. However by checking him, he feels that no need of first aid treatment,
casualty can be directly sent to Hospital for further treatment.
 Casualty was collected in Ambulance after keeping him on stretcher within 3 minutes.
 Ambulance reached at Medicare Hospital at 10.55 AM and he was admitted to emergency
ward at 12:00 AM.
 Further siren sounded at 10.35 AM for informing all members for all clear messages.
 Routine work started at 10.45 AM.
 A casualty has been discharged immediately by Hospital after completion of their admission
formalities, as the Doctor knew the things, which was informed in advance.
 Everything become smoothens and regular work started at 10.45 AM.

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Security actions
2.0  Security staff was informed at 10.35 AM regarding sounding of siren for all clear.
 Immediately he has sound siren continuously for 30 seconds in blasting mode.
Post drill observations
 All employees understood regarding all clear.
3.0  Employees have started towards their work immediately on hearing all clear messages.
 All employees have taken charge of their routine work within 5 minutes.
 Further normal siren was sounded by security at 12.30 AM for lunch break.
Action for not responding as per Major Emergency Preparedness
 All safety members are called and informed for the case of falling down of one employee. All
members are strictly informed that not to rush in haphazard way. To report to the place
4.0 systematically to avoid any further accident. All members have agreed to take care of the
same in future.
 Also called that not to take / keep casualty on shoulders, casualty should be handling after
using stretcher.
Further action
5.0
 All employees were instructed findings of the mock drill for future better performance.
Conclusion
 Concluded that in general our response was satisfactory, as we have decided in Major
6.0 emergency preparedness plan.
 Numbers of personnel present in the company as per the attendance record  85
 Head Count taken by Mr. Smith Clare.

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Plant tour During the plant tours following work situation / act have been noticed. You
observati are requested to review against the ISO 45001 and identify, whether this Page 1 of 8
ons situation / act are okay or non–conformity.
Observation–1
Observation–2
Plant tour During the plant tours following work situation / act have been noticed. You
observati are requested to review against the ISO 45001 and identify, whether this Page 2 of 8
ons situation / act are okay or non–conformity.
Observation–3
Observation–4
Plant tour During the plant tours following work situation / act have been noticed. You
observati are requested to review against the ISO 45001 and identify, whether this Page 3 of 8
ons situation / act are okay or non–conformity.
Observation–5
Observation–6
Plant tour During the plant tours following work situation / act have been noticed. You
observati are requested to review against the ISO 45001 and identify, whether this Page 4 of 8
ons situation / act are okay or non–conformity.
Observation–7
Observation–8
Plant tour During the plant tours following work situation / act have been noticed. You
observati are requested to review against the ISO 45001 and identify, whether this Page 5 of 8
ons situation / act are okay or non–conformity.
Observation–9
Observation–10
Plant tour During the plant tours following work situation / act have been noticed. You
observati are requested to review against the ISO 45001 and identify, whether this Page 6 of 8
ons situation / act are okay or non–conformity.
Observation–11
Observation–12
Plant tour During the plant tours following work situation / act have been noticed. You
observati are requested to review against the ISO 45001 and identify, whether this Page 7 of 8
ons situation / act are okay or non–conformity.
Observation–13
Observation–14
Plant tour During the plant tours following work situation / act have been noticed. You
observati are requested to review against the ISO 45001 and identify, whether this Page 8 of 8
ons situation / act are okay or non–conformity.
Observation–15
Observation–16
Plant tour During the plant tours following work situation / act have been noticed. You
observati are requested to review against the ISO 45001 and identify, whether this Page 1 of 8
ons situation / act are okay or non–conformity.
Observation–1
Observation–2
Plant tour During the plant tours following work situation / act have been noticed. You
observati are requested to review against the ISO 45001 and identify, whether this Page 2 of 8
ons situation / act are okay or non–conformity.
Observation–3
Observation–4
Plant tour During the plant tours following work situation / act have been noticed. You
observati are requested to review against the ISO 45001 and identify, whether this Page 3 of 8
ons situation / act are okay or non–conformity.
Observation–5
Observation–6
Plant tour During the plant tours following work situation / act have been noticed. You
observati are requested to review against the ISO 45001 and identify, whether this Page 4 of 8
ons situation / act are okay or non–conformity.
Observation–7
Observation–8
Plant tour During the plant tours following work situation / act have been noticed. You
observati are requested to review against the ISO 45001 and identify, whether this Page 5 of 8
ons situation / act are okay or non–conformity.
Observation–9
Observation–10
Plant tour During the plant tours following work situation / act have been noticed. You
observati are requested to review against the ISO 45001 and identify, whether this Page 6 of 8
ons situation / act are okay or non–conformity.
Observation–11
Observation–12
Plant tour During the plant tours following work situation / act have been noticed. You
observati are requested to review against the ISO 45001 and identify, whether this Page 7 of 8
ons situation / act are okay or non–conformity.
Observation–13
Observation–14
Plant tour During the plant tours following work situation / act have been noticed. You
observati are requested to review against the ISO 45001 and identify, whether this Page 8 of 8
ons situation / act are okay or non–conformity.
Observation–15
Observation–16
No. PRO/OHS/06
Department
OHS Procedure Revision No. 00
OHS
Date 01–08–2018

Procedure for Operational Control


1.0 Purpose
To establish and control documented procedure and to ensure that organization’s OHS
hazards and associated risks are controlled in line with OH&S Policy including OHS
communication to suppliers / contractors and integration of OHS requirements at planning
stage.
2.0 Scope
Applicable to all OHS related activities, products and services, conditions and facilities of
Company.
3.0 Responsibility
3.1 Management Appointee is responsible for ensuring operational controls.
3.2 Functional Heads are responsible for establishing operational controls and maintain
records of it.
4.0 Description Of Activity
4.1 Identify those activities, products, operation, and services that are having OHS hazards
and associated risks, assessed and evaluated to identify significant OHS hazards / risks
where operational control is required to be established and implemented and documented
in E/OHS/02.
4.2 Those activities, products, operation and services that are having OHS hazards and
associated risks, assessed and evaluated to identify significant OHS hazards / risks where
operational control is required to be established and implemented.
4.3 Procedures, Operating criteria, or work instructions / standard operating procedure
established for the significant OHS hazards shall :
 Cover situations where their absence could lead to deviations from the site policy and
its objectives and targets;
 Include appropriate maintenance activities, operations;
 Where appropriate, communicate relevant procedures and requirements to suppliers
and contractors.
4.4 Auditable performance criteria shall be specified in SOP and related documents
4.5 Operational control procedure shall be made available at the place of work.
4.6 The SOPs / communication of relevant legal and other regulatory OHS requirements shall
be communicated to the suppliers, buyers and contractors to enable them control of
identified OHS hazards and risks.
4.7 To establish and maintain SOPs for integration of OHS requirement for design of
workplace / process / installation / machinery / operation to eliminate substitution of
chemicals or reduce OHS risks at source.
4.8 Critical equipment, machinery and other sources from the point of OHS risks shall be
maintained as per laid down procedures in order to reduce / control or prevent OHS risks.
4.9 Equipment shall be operated, monitored as per the Operational Control Parameters and
laid down criteria and records shall be maintained.
4.10 This operational control information is reviewed periodically or upon events such as
changes to the list of risks or relevant legal requirements.

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No. PRO/OHS/06
Department
OHS Procedure Revision No. 00
OHS
Date 01–08–2018
5.0 Reference
5.1 OH&S Policy
5.2 E/OHS/02 Operational Control Plan
5.3 Register Of Aspects, its impacts, Hazards and associated risks
6.0 Enclosure Nil
7.0 Formats / Exhibits
Sr.
Format No. Title Of formats
No.
1. ---------- Various operation control reports

Tove Leeds Certification & Inspection Page 2 of 2


Work permit for Un–loading of Solvent Tanker Page 1 of 1

Permit Sr. No.  Date 


Name of material  Department 
Authorised person  Shift 
Operator  Vehicle no. 
Supplier Name  Driver name 
Following instructions must be followed during un–loading of tanker, also after follow–up of
individual instruction put () mark in status column.
Sr.
Instruction Status
No.
1. Ensure that the material is approved by the Quality Control.
2. Ensure that during un–loading of tanker all PPEs are used by Operator.
3. Ensure that the spark muffler is provided at the silencer of the vehicle.
4. Ensure proper parking of the tanker at identified places only.
5. Do proper earthing of the tanker.
6. Check and ensure that all earthing joints are tightened properly.
7. Ensure that all fire fightening equipments are available.
8. Ensure that no empty container is lying in the tank area.
Ensure that all electrical accessories including engine of tanker are in closed
9.
condition.
Ensure that condition of hose is intact and clean it to prevent spillages / leakages
10.
during transfer and contamination.
11. Check level indicator of the tanker, if any and of storage tank.
12. Ensure availability of driver inside the tanker during un–loading.
13. Ensure that during un–loading, no repairing work is carried–out near by.
14. Allow to start un–loading in the identified tank.
If any leakages are found than collect the leakage materials in metal container.
15. CAUTION : Don’t drain any solvent in plastic container (Which is considered
as electric conductor)
Complete un–loading and remove hose pipe connection and ensure that the residual
16.
solvent is transferred in to the tank or tanker.
Clean the hose pipe and cover end part of hose pipe with polythene bag and store at
17.
identified places.
18. Remove earthing. Allow tanker to leave premises / tank area.
Close the yard and if any leakage is found from the tanker or any safety related
19. problem is observed than inform Safety and Maintenance department for taking
necessary actions on it.
Details of material weight
Gross weight  Tare weight 
Net weight  Supplier Net weight 
Diff. in Net weight 
Tanker receipt time  Tanker relieved time 
Remarks

Permit requested by Permit issued by Closed by

Department Representative Safety Officer / EHS Head / Authorised Person EHS Head
Vehicle check report
Sr. No. Month
Security checks Time
Vehicle Driver is
Allowed to
Type of Driver Purpose Availability Overall Security
Date registration Received from PUC Spillages, if not having enter in
vehicle name of visit of spark vehicle In Out sign.
no. Validity any alcoholic plant
muffler condition
drink
PPE Preventive Maintenance check points
Sr. No.  Year 
Frequency of check Monthly
1.0 Safety belt
Sr. Months
Check Points
No. Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar
Check condition of buckle
1.
and its functioning
2. Check usability of belt
2.0 Breathing apparatus
1. Check availability of Oxygen
Check for no leakages from
2.
the mask
Check condition and
3.
functioning of belt
Check for proper functioning
4.
of valve and meter
5. Check for usability
3.0 Mask, helmets, goggles, safety shoes etc.
1. Available in spares
2. No damages
3. Identified properly
4. Easily accessible

Checked by 
Checked on 
Fire Hydrant checklist Page 1 of 3
Report No.  Date of test 
Tested by  Day of test 
Frequency of check Monthly

1.0 Pre–checklist

Sr. Status
Check point
No. Ok / Yes Not Ok / No
1. All pumps of fire system are on manual mode.  
2. Electric motor driven hydrant pump is running.  
Electric motor driven hydrant pump re–circulation valve is partly
3.  
opened.
4. Fire hydrant header pressure @ 7.5 kg/cm2 Min.  
Fire hydrant line flushing procedure:
Open hydrant valve fully one by one for one minute and check for the followings as given in
2.0 check list.
 Do not open more than 2 valves at a time,
 If dirty water or stone appeared, continue flushing unitl clear water comes out from the
valve.
Is stone present in
Is dirty water coming After closing, if the
water coming from
Sr. Id. from the valve? valve leaking?
Location of hydrant valve the valve?
No. No.
Yes No Yes No Yes No
1.      
2.      
3.      
4.      
5.      
6.      
7.      
8.      
9.      
10.      
11.      
12.      
13.      
14.      
15.      
16.      
17.      
Fire Hydrant checklist Page 2 of 3
Report No.  Date of test 
Tested by  Day of test 
Frequency of check Monthly

3.0 Fire hydrant and hose checklist


Check point  Check condition for

No damages
Sr. Id.

Identified

Hose box
Hose box

Hose box
properly

properly
Painted
Location

Landing

Rubber
washer
No. No.

valve

glass
etc.

door
Lug

key
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
4.0 Water storage tank
No leakages Smooth functioning of
Sr. Fully filled
through pipelines outlet valve
Location
No.
Yes No Yes No Yes No
1.
2.
3.
4.
5.
Fire Hydrant checklist Page 3 of 3
Report No.  Date of test 
Tested by  Day of test 
Frequency of check Monthly

5.0 Pump
Check for
Check for Do general
Check for proper
vibration and cleaning,
proper functioning of
Sr. Id. noise free oiling and
Location and type of pump functioning bye–pass
operation greasing
No. No. valve, if any

Yes No Yes No Yes No Yes No


1.        
2.        
3.        
4.        
Overall remarks 

Checked by Reviewed and approved by

EHS Head
Fire Fightening checklist Page 1 of 1
Sr. No.  Date of checks 
Frequency of check Monthly

1.0 Fire Extinguishers


Fire Extinguisher No.
Sr.
Check Points FE– FE– FE– FE– FE– FE– FE– FE– FE– FE– FE– FE– FE– FE– FE– FE– FE– FE– FE– FE–
No.
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
1. Identified properly
2. Fully filled
3. Condition of discharge hose pipe
4. Condition of safety clip
5. Condition and legibility of sticker
6. Intact / usable condition
7. Easily accessible
8. Mounted properly
2.0 Sand bucket
Sr. Sand bucket stand no.
Check Points
No. SB–1 SB–2 SB–3 SB–4 SB–5 SB–6 SB–7 SB–8 SB–9 SB–10
1. Identified properly
2. Fully filled with dry sand
3. Condition of handle and stand which bucket
4. Condition of bucket stand
5. Intact / usable condition of bucket
6. Easily accessible
7. Mounted properly

Checked By  Safety Officer


Eye wash / shower check list
Sr. No.  Year 
Frequency of check Monthly
1.0 Eye wash
Location and status
Sr.
Check Points
No.
Yes No Yes No Yes No Yes No Yes No Yes No
Eyewash activated and
1. flushed for contaminants for            
3 minutes
Activator level remain open
2.
without holding it down            

Eyewash covers are present,


3. clean, open and close            
properly
Water flow is soft and
4. properly from both eyepiece /            
nozzles
2.0 Shower
Location and status
Sr.
Check Points
No.
Yes No Yes No Yes No Yes No Yes No Yes No
Shower activated and flow is
1.
effective and continuous            

Activator level / chain remain


2.
open without holding it down            

3.0 Eye wash and Shower


Location and status
Sr.
Check Points
No.
Yes No Yes No Yes No Yes No Yes No Yes No
1. Access is unobstructed            
2. Area is well lighted            
3. Emergency sign is posted            
Inspection tag is signed and
4.
dated            

Overall remarks 

Checked by Reviewed and approved by

EHS Head
Ambulance Review Checklist Page 1 of 1
Sr. No.  Date of check 
Frequency of check Monthly
Sr.
No.
Check Points Status Remarks

1. Check for availability of oxygen cylinder


Check for cylinder pressure on pressure
2.
gauge mounted on the cylinder
3. Check the availability of stretcher
4. Check for condition and usability of stretcher
5. Check for availability of fire extinguisher
Check for the condition of the bed inside the
6.
ambulance
Check for identification as “Ambulance” on
7.
the vehicle
Check for valid PUC registration of the
8.
ambulance
9. Check for proper blinking of the head light
Check for proper functioning of siren
10.
mounted on the ambulance
Check for tyre pressure in all wheels
11.
including spare wheel
Check for proper functioning of all utilities
12.
provided in the ambulance

Checked by Reviewed by
EHS EHS Head
Activity Index Title

Student Tutor Total


Sr. No. Title
time time Time

Auditing context of organization, leadership and


Activity_1 45 30 75
planning

Activity_2 Auditing support and operation 45 30 75

Activity_3 Auditing Hazard identification and risk 45 30 75

Auditing performance evaluation and


Activity_4 45 30 75
improvement

Activity_5 Roles and responsibility audit program 60 30 90

Activity_6 Planning for stage 1 audit 45 45 90

Activity_7 Conducting Stage 1 audit 120 30 150

Activity_8 Planning for stage 2 audit 45 30 75

Activity_9 ISO 45001 clauses 45 60 105

Activity_10 Audit Plan Matrix 60 30 90

Activity_11 Audit Check list 60 30 90

Activity_12 Conducting Opening Meeting 50 10 60

Activity_13 Auditing Top Management 60 30 90

Auditing Role Play, NCR Reporting and


Activity_14 165 75 240
Judgement

Activity_15 Corrective action and Follow Up Audit 90 30 120

Activity_16 Closing Meeting, preparation and role play 60 30 90

Tove Leeds Certification & Inspection Page 1 of 1


Activity : 01  Auditing context of organization,
leadership and planning
Format  Group exercise for the student

Purpose/ Objective 
1. To evaluate the auditee’s understanding and implementation of the relationship between
external and internal issues, the relevant requirements of workers and other relevant
interested parties, the actions to address risks and opportunities, and the occupational
health and safety management system processes needed to implement them.
2. To evaluate the boundaries, applicability and scope of the occupational health and safety
management system, taking into account external and internal issues, the relevant
requirements of workers and other relevant interested parties, planned or performed work
activities, and the products and services the organisation provides.
3. To evaluate the auditee’s determination of applicable statutory and legal requirements and
other requirements.
4. To verify that the OH&S policy, meets the specified requirements.
5. To evaluate the auditee’s process (es) for consultation and participation of workers and
workers representatives in the development, planning, implementation, performance
evaluation and actions for improvement of the occupational health and safety
management system.
6. To evaluate the auditee’s arrangements for planning process.
7. To define the scope of certificate based on the activities done by ABC Chemical Inc.
8. To develop the skills for developing audit checklist.
Time Distribution 

Participant time Tutor time Total time

45 minutes 30 minutes 75 minutes

Instruction for the Delegates 


Refer: Case study document.
ABC Chemical Inc. has implemented an occupational health and safety management system
based on ISO 45001:2018 standards.
You are selected for conducting an onsite audit. You need to develop knowledge and skills
required to carry out a detailed audit of requirements of Clauses 4, 5 & 6 of ISO 45001
Standard.
Your task
Prepare audit checklist in detail, based on review of case study, considering what will be
required as a part of objective evidence to fulfil the requirements and its effective
implementation at site.
Divide the students in 2 teams and allot the clause no. 4 and 5 to team 1 and clause no. 6 to
team 2 for developing checklist and presenting the checks/findings.

Tove Leeds Certification & Inspection Page 1 of 2


Activity : 01  Auditing context of organization,
leadership and planning

Tutor Notes
Tutor must discuss the output of each team separately with presence of all the teams
around the flip chart.
Following points must be clearly checked
Marking for continuous assessment :

5 Marks for development of checklist with key issues covered based on case study,
and
2 Marks for flow of questions in the checklist
This Exercise is meant for competency of “Interpretation of Requirements”

Tove Leeds Certification & Inspection Page 2 of 2


Activity : 02  Auditing support and operation

Format  Individual exercise for the candidate

Purpose/ Objective 
1. To evaluate support requirements relating to resources, competence and awareness;
internal and external communication and control of documented information.
2. To evaluate processes for hazard identification, assessment of OH&S risks and other risks
to the OH&S management system, assessment of OH&S opportunities and other
opportunities, and determination of legal requirements and other requirements.
3. To evaluate the process followed in the emergency preparedness and response.
4. To develop the skills for developing audit checklist.
Time Distribution 

Participant time Tutor time Total time

45 minutes 30 minutes 75 minutes

Instruction for the Delegates 


Refer: Case study document.
ABC Chemical Inc. has implemented an occupational health and safety management system
based on ISO 45001:2018 standards.
You are selected for conducting an onsite audit. You need to develop knowledge and skills
required to carry out a detailed audit of requirements of Clauses 7 & 8 of ISO 45001
Standard.
Your task
Prepare audit checklist in detail, based on review of case study, considering what will be
required as a part of objective evidence to fulfil the requirements and its effective
implementation at site.
Divide the students in 2 teams and allot the clause no. 7 to team 1 and clause no. 8 to team 2
for developing checklist and presenting their checks/findings.

Tove Leeds Certification & Inspection Page 1 of 2


Activity : 02  Auditing support and operation

Tutor Notes
Tutor must discuss the output of each team separately with presence of all the teams
around the flip chart.
Following points must be clearly checked
Marking for continuous assessment :

5 Marks for development of checklist with key issues covered based on case study,
and
2 Marks for flow of questions in the checklist
This Exercise is meant for competency of “Interpretation of Requirements”

Tove Leeds Certification & Inspection Page 2 of 2


Activity : 03  Auditing Hazard Identification
and Assessment of Risk
Format  Group exercise for the candidate

Purpose/ Objective 
1. To evaluate processes for hazard identification, assessment of OH&S risks and other risks
to the OH&S management system, assessment of OH&S opportunities and other
opportunities, and determination of legal requirements and other requirements.
2. To have a clear understanding of the process of hazard identification and risk
assessment.
3. To review the list of activities and to ensure that whether all such activities have been
taken care of during hazard identification and risk assessment or not.
4. To audit the sample hazard identification and risk assessment sheet given herewith and
identify the findings with respect to ISO 45001:2018 requirements.
5. To develop the skills for developing audit checklist.
Time Distribution 

Participant’s time Tutor’s time Total time

30 minutes 30 minutes 60 minutes

Your Tasks
1. Review all the activities and ensure that all such activities have been taken care of
or not?
2. Identify the missing information from the hazard identification and risk assessment
sheet.
3. Identify the points to be considered while preparation of hazard identification and
risk assessment.

Notes for Tutor


Tutor must discuss the output of each team separately in presence of all the teams
around the flip chart.
Following points must be clearly checked:
Marking for continuous assessment
7 Marks for identification of correct findings, and
2 Marks for presentation of the findings amongst the audience.
This exercise is meant for competency of “Interpretation of Requirements”

Tove Leeds Certification & Inspection Page 1 of 5


Activity : 03  Auditing Hazard Identification
and Assessment of Risk

Processes carried out by ABC Chemical Inc.


Following processes and situations were observed in the department during the plant
tour. Also, the Hazard Identification and Risk Assessment Sheet is given for your
review. You are requested to audit the process and identify the missing information, if
any.
Following processes were observed during the plant tour:
 Receipt of dyes intermediates (powder form – hazardous chemicals) from the stores
in 50 kg HDPE bags.
 Cutting the bag manually with the help of cutter.
 Lifting of bag manually and charging into reactor by inverting the bag into the
manhole of the reactor.
 Keeping empty bag near the reactor.
 Welding carried out near reactor, where empty bags were stored.
 Charging of Sulphuric acid (98%) and water by opening valve through pipeline.
 Checking the level inside the reactor through manhole.
 Closing of the manhole of the reactor
 Collection of sample from the reactor and transferring the sample to quality control
lab.
 Shifting of the bags to scrap yard.
Following situations were observed during the plant tour:
 One person was working to repair the rooftop, without having safety belt.
 Employees engaged in the cutting of bags were not using any personal protective
equipment.

Tove Leeds Certification & Inspection Page 2 of 5


Activity : 03  Auditing Hazard Identification
and Assessment of Risk

Significance evaluation
A Quantity / Scale (1 – 5) D Control (1 – 5)
5 Excessive / outside site area 5 Absence / No effective control
4 Very high / within site area 4 Mechanism in place but not reliable
3 High / within work station 3 Control needs human intervention
2 Moderate / within equipment area 2 Has built secondary control
1 Low / within work place 1 Available and effective control
B Occurrence (1 – 5) E Likelihood Of Detection (1 – 5)
5 Continuous 5 > 24 Hrs.
4 Several times in a day 4 12 – 24 Hrs.
3 Once in a day 3 Within 12 Hrs.
2 Once in a week 2 Within 1 Hrs.
1 Once in a month / less 1 Immediate
C Severity (1 – 5)
5 Fatal to human life 2 Causes Discomfort / Minor Injuries
4 Permanent disability
Negligible Visual Effect / First aid
Resource depletion / reportable 1
3 treatment
accidents
Significance Analysis
Significance
Rating level
Actions

0 – 100 Low Care is taken by employee during routine operation.


SOP is established for controlling the activity in the routine
101 – 250 High
operation. Need to refer the SOP no. against the activity.
OHSMP is prepared to reduce the risk and to be referred
Above 250 High
against the activity.
Legal Assess the applicability of legal concern. If the legal concern is applicable
concern is then declare the same as High Significance level, even though the
applicable rating is less than 100.

Tove Leeds Certification & Inspection Page 3 of 5


Activity : 03  Auditing Hazard Identification
and Assessment of Risk
Attributes Magnitu Present /
Sr. Risk Legal Significance
Activity OHS Hazard de of Engineering
No. Associated A B C D E concern level
risk control
Receipt of dyes
intermediates (powder
Contact Skin
form – hazardous
1. with irritation / 2 3 2 3 1 36 No Low
chemicals) from the
chemical hot burns
stores in 50 kg HDPE
bags.
Use of PPEs
Cutting the bag Contact
Cuts and during
2. manually with the help with sharp 1 4 2 3 1 24 No Low
wound cutting of
of cutter edges
bags
Lifting of bag manually Overweight Fatigue /
3. 1 4 3 3 5 180 No High
and charging into lifting Backache
reactor by inverting the
bag in the manhole of Exposure to
4. 1 4 4 3 5 240 No High
the reactor chemicals

Contact
Keeping empty bag near Skin
5. with 2 4 2 3 1 48 Low
reactor irritation
chemicals
Eye, skin
Charging of Sulphuric
Exposure to and throat
acid (98%) and water
6. acidic irritation / 1 3 3 3 5 135 Yes High
by opening the valve
vapors hot burns /
through pipeline.
lung ulcer
Eye, skin
Checking the level in the Exposure to and throat
7. reactor through acidic irritation / 1 4 2 3 1 24 No Low
manhole vapors hot burns /
Dizziness

Tove Leeds Certification & Inspection Page 4 of 5


Activity : 03  Auditing Hazard Identification
and Assessment of Risk

Attributes Magnitu Present /


Sr. Risk Legal Significance
Activity OHS Hazard de of Engineering
No. Associated A B C D E concern level
risk control
Closing the manhole of Finger Physical
8. 1 4 2 3 1 24 No Low
the reactor trapping injury
Collection of sample
Contact Skin
from the reactor and
9. with hot irritation / 1 3 2 3 1 18 No Low
transferring the sample
chemical hot burns
to quality control lab
Contact with
Shifting of the bags at chemical Skin
10. 4 3 1 3 2 72 No Low
scrap yard contaminated irritation
bags

Physical
Fall from injury /
11. Working at height 1 1 1 1 1 1 No Low
height fatal to
human

Tove Leeds Certification & Inspection Page 5 of 5


Activity : 04  Auditing operation and
performance evaluation
Format  Group exercise for the students

Purpose/ Objective 
1. To evaluate the auditee’s arrangements for monitoring, measuring, analysis and
evaluation of the occupational health and safety management system performance
against policy and planned objectives, including requirements for internal audit.
2. To evaluate management review of the suitability, adequacy and effectiveness of the
occupational health and safety management system.
3. To evaluate the auditee’s arrangements for continual improvement, including the
effectiveness of dealing with incident, nonconformity and corrective action.
4. To develop the skills for developing audit checklist.
Time Distribution 

Participant’s time Tutor’s time Total time

45 minutes 30 minutes 75 minutes

Instructions for the Delegates 


Refer to the case study document.
ABC Chemical Inc. has implemented an occupational health and safety management system
based on ISO 45001:2018 standard.
You are scheduled for conducting an onsite audit. You need to develop knowledge and skills
required to carry out a detailed audit of requirements of Clauses 8 & 9 of ISO 45001
Standard.
Your task
Prepare audit checklist in detail, based on review of case study, considering what will be
required as a part of objective evidence to fulfil the requirements and its effective
implementation at site.
Divide the students in two teams and allot the Clause no. 9 to team -1 and Clause no. 10 to
team- 2 for developing checklist and presenting their checks/findings.

Tove Leeds Certification & Inspection Page 1 of 2


Activity : 04  Auditing operation and
performance evaluation
Notes for Tutor
Tutor must discuss the output of each team separately in presence of both the teams
around the flip chart.
Following points must be clearly checked:
Marking for continuous assessment
5 Marks for development of checklist covering key issues based on case study, and
2 Marks for flow of questions in the checklist
This exercise is meant for competency of “Interpretation of Requirements”

Tove Leeds Certification & Inspection Page 2 of 2


Activity : 05  Role and Responsibilities – Audit
Plan and Audit Program
Format  Group exercise for the participants as per the Tutor’s instructions
Purpose/ Objectives 
1. To explain the roles and responsibilities of the audit client, auditors, lead
auditors, auditee, guides and observers.
2. To explain the management responsibilities of the Lead Auditor in managing the
audit and the audit team.
3. To establish that the scope, objectives, criteria, duration and resources for an
audit are appropriate.
Time Distribution
Participant’s time Tutor’s time Total time

60 minutes 30 minutes 90 minutes

Instructions for the Delegates 


The ISO 19011 guidance document explains the approach to occupational health and
safety management system auditing. In planning an audit, you need to be able to
identify the sequence of the steps, the responsibilities and the resources needed. This
exercise is aimed at understanding the tasks to be undertaken in planning, conducting
and reporting an audit. ISO 17021 identifies competence requirements,
responsibilities and resources that need to be provided to conduct the audit.
In the planning of an audit, the Lead Auditor needs to produce a plan for the audit to
ensure that all the activities that can affect quality are audited against all the
applicable clauses of the standard. The Lead Auditor must transmit this plan to the
auditors and auditee, so that interviews can be held.
You have to identify the tasks needed to conduct an audit and identify the
responsibilities of the Lead Auditor, the audit team members, auditee management
and auditee.

Notes for Tutor


For continuous marking, the total marks allotted are 4 and the markings are given
based on the correctness of the answers.
This exercise is meant for competency of “Planning of audit”

Tove Leeds Certification & Inspection Page 1 of 1


Activity : 06  Planning Stage-1 Audit

Format  Group exercise for the participants as per the Tutor’s instructions

Purpose/ Objectives 

1. To prepare delegates for planning of on-site stage-one and stage-two audit.


2. To enhance the understanding of process and system approach to management and
its consequences for auditing.
3. To develop the ability to determine the audit scope and determine resource
requirements, including determination of audit day.
Time Distribution

Participant’s time Tutor’s time Total time

45 minutes 45 minutes 90 minutes

Instructions for the Delegates 


Delegates are instructed to review the provided case study documents.
The employee strength of the company is 45.
You are given a contract for certification of ISO 45001:2018. Based on the details available, you need
to complete the following tasks:
 Based on the manpower and other details, decide the number of Man-days
required.
 Prepare the audit plan for the stage–one audit.
 Audit plan must include the scope of the audit and identification of the audit team.

Notes for Tutor

The audit plan is to be prepared considering the Man-day identified.


The audit plan is to be prepared in the format given and presented to the team.
1 mark for identification of Man-day
2 marks for stage-one audit plan
Tutor should divide the group into four teams and provide flipchart for the Man-day calculation
and format for Audit plan. The teams need to perform the task according to the instructions for
delegates and prepare the audit plan. The presentation of the audit plan is to be done, and
during the presentation, the factors related to the same need to be considered while awarding
the marks.
This exercise is meant for competency of “Interpretation of Requirements”

Tove Leeds Certification & Inspection Page 1 of 1


Activity : 07  Conducting Stage-1 Audit

Format  Group exercise for the participants as per the Tutor’s instructions

Purpose/ Objectives 
1. To conduct the stage-1 audit.
2. To establish correlation between the documents prepared by the organization and ISO
45001:2018 requirements.
3. To checking the methods of the readiness of the organization for the stage-2 audit.
4. To better understand how to execute the audit in order to ensure that not only individual
processes and activities identified are reviewed but also their intended results,
interactions, implementation and sequence, and decide for the next stage-2 audit based
on the implementation status.
5. To increase the knowledge to review major things in the organization at the stage-1 audit
Time Allocation 

Participant’s time Tutor’s time Total time

105 minutes 30 minutes 135 minutes

Total time  135 minutes


Student’s time  105 minutes
Tutor’s time  30 minutes
Instructions for the Delegates 
Kindly go through the case study documented of the ABC Chemical Inc. and familiarize
yourself with the proposed process. You are given a contract for certification of the ISO
45001:2018. As a part of that, you are selected as an auditor for conducting the stage-1 audit.
So you are required to prepare the audit teams as per the previous exercises. Each team will
act as an audit team in this process and shall perform a part of the stage-1 audit of the
organization.
Each participant is required to come with at least the following outcome:
• Findings of the audit
• Judgment of the audit
• Preparedness level of the stage-2 audit

Notes for Tutor


Tutor has to divide the group into two teams.
One team will work as auditee and the second will act as auditor.
Tutor will facilitate the teams with required documents, and also necessary arrangements
should be made.
Tutor should check the involvement of the team during the role play of the stage-1 audit.
Continuous assessment marking will be at the discretion of the Tutor. Total 5 marks will be
awarded.
This exercise is meant for competency of “Conducting audit”

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Activity : 07  Conducting Stage-1 Audit
Stage -1 audit observations
Check the photographs given in the case study and identify the same as Positive points
or NCR or observations.

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Activity : 08  Planning Stage- 2 Audit

Format  Group exercise for the participants as per the Tutor’s instructions

Purpose/ Objective 

1. To understand how to plan audit time and perform a stage-2 audit of an organization.
2. To cover appropriate clauses of ISO 45001:2018 with the processes defined in the
system, based on the outcome of documentation audit.
Time Distribution 

Participant’s time Tutor’s time Total time

45 minutes 30 minutes 75 minutes

Instructions for the Delegates 

Each team will act as an audit team.


Each team shall prepare plan for third party audit of Case Study based on the given time
duration and team members.
Audit plan shall determine number of days and number of auditors.
Each team shall present their plan on a flipchart in the Performa given below.

Notes for Tutor


Tutor should divide the teams. All the teams need to prepare the audit plan as per the case
study documents. After preparation of the audit plan by all the teams, it should be displayed
on the flipchart and discussed by the tutor in detail.
Marks should be given out of 3 marks.
Proper consideration should be given to the involvement and presentation.
This exercise is meant for competency of “Planning of audit”

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Activity : 09  ISO 45001 Clauses

Format  Group exercise for the participants as per the Tutor instructions

Purpose / Objective 

This exercise is aimed at illustrating the meaning and intent of the ISO 45001:2018 clauses
and how these relate to the requirements for the Occupational health and safety management
systems of an organization.
Time Distribution 

Participant time Tutor time Total time

45 minutes 60 minutes 105 minutes

Instruction for the Delegates 


You have to look at the clauses allocated to your team by the tutor and explain the requirement of the
clause the intent and the evidence of compliance that you would expect to see on an audit. You will
present your results as directed by the course tutor.

You’re Task

1. Read through the clauses as designated by the tutor in the ISO 45001:2018 standard.
2. Explain the meaning and intent of the clauses allocated to your team in your own words.
3. Explain what evidence you would look for in relation to each clause
4. Present your findings for discussion on the flipchart designated by the Tutor.

Tutor Notes
Tutor should divide the teams.
And all the teams/participant needs to make their understanding of the given clauses and
write on the flipchart
Marks should be given out of 5 marks
Proper consideration is to be given to the involvement and presentation.
This Exercise is meant for competency of “Interpretation of Requirements”

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Activity : 10  Audit Plan Matrix

Format  Group exercise for the participants as per the Tutor instructions

Purpose/ Objective 

1. How to develop a workable and useful audit plan to perform third party audit in an
auditee organization as a certification process.
2. To cover appropriate clauses of ISO 45001:2018 with their processes.
Time Allocation 

Participant time Tutor time Total time

60 minutes 30 minutes 90 minutes

Instruction for the Delegates 

Each team will act as an audit team.


Each team shall prepare plan for third party audit of Case Study based on time duration and
team members.
Audit plan shall determine number of days and number of auditors and clauses to be audit in
each department of organization.
Each team shall present their plan on a flip chart in the proforma given below.

Tutor Notes
For Continuous marking the total marks allotted are 5 and based on the correctness of the
answers the markings are given.
This Exercise is meant for competency of “Planning of audit ”

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Activity : 11  Audit Check list

Format  Group exercise for the participants as per the Tutor instructions

Purpose/ Objective 

1. Understand how to develop a workable and useful audit checklist to perform third party
audit in the auditee organization.
2. To cover appropriate clauses of ISO 45001:2018 with their activities including
processes, legal requirements etc.
Time Distribution 

Participant time Tutor time Total time

45 minutes 30 minutes 75 minutes

Total time  75 minutes


Student Time  45 minutes
Tutor time  30 minutes
Instruction for the Delegates 
The case study is based on a third party audit contract agree between ABC Chemical Inc. and
Certification agency for conducting Stage 2 audit of the ISO 45001:2018 Occupational health
and safety management system standard.
The audit checklist could be based on a process matrix indicating what elements of the
standards will be looked at in various departments and/or on process activities indicating the
schedule of the audit.
Then prepare the checklist for the process allotted to your team by the tutor in any
appropriate format, having at least the following headings:
 Process Activities
 Reference documents
 ISO 45001 clauses
 Items to check
 Name and signature of auditor

For Continuous marking the total marks allotted are 5 and based on the correctness of the
answers the markings are given.
This Exercise is meant for competency of “Conducting audit” and “Generating audit findings”

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Activity : 12  Conducting Opening Meeting

Format  Group exercise for the participants as per the Tutor instructions

Purpose/ Objective 

1. How to conduct a successful opening meeting as part of a third party audit of an auditee
organisation in accordance with the requirements of ISO 19011 and ISO 17021.
Time Allocation 

Participant time Tutor time Total time

50 minutes 10 minutes 60 minutes

Instruction for the Delegates 

The case study is based on a third party audit initiated by an external organisation which
Third Party Certification Body has to conduct under contractual requirements to verify their
conformance to the requirements of ISO 45001:2018.

Each team has to prepare an opening meeting with the management of the auditee
organisation in line with the recommended agenda given in ISO 19011

As directed by the tutor an Opening Meeting of Stage 2 audit shall be conducted.

Tutor Notes
Tutor must ensure that all the agenda required are covered in the meeting. So first give 10
Minutes to each team for the preparation of their agenda on the flipchart.
After that one member from each team should discuss the agenda written for 10 minutes.
(Ensure timings)
After completion of all the presentation of teams the tutor should discuss the findings, for next
10 minutes and give his feedback for the meeting conducted by all the teams.
Total 5 marks are given for the exercise.
This Exercise is meant for competency of “Conducting audit”

Tove Leeds Certification & Inspection Page 1 of 1


Activity : 13  Auditing Top Management

Format  Group exercise for the participants as per the Tutor instructions

Purpose/ Objective 

1. How to approach the audit of the Top Management in the context of understanding their
commitment for the OH&SMS and their overall responsibility and accountability for the
OH&SMS.
2. Understand skill required for top management audit.
3. Evaluate top management’s commitment to the Occupational health and safety
management systems.
4. Evaluate the OH&S Policy and OH&S Objectives.
Time Distribution 

Participant time Tutor time Total time

60 minutes 30 minutes 90 minutes

Instruction for the Delegates 

Your Task:
This activity is done by 4 teams. Two teams will be preparing the checklist for the audit and
two team is given separate task of the auditing as given below.
First group of two team
All the delegates are required to go through the case study documents and based on the
same they need to prepare the checklist for auditing the top management.
While auditing the Top Management question related to policy matters, objectives,
compliance with the legal requirements, risk and opportunities, etc. are expected and not the
record keeping related questions are to be asked. (25 Mts)
The check list will be discussed among the team and presented to the tutor and discussed
accordingly.
Second group of two team
Second team will ask the questions as per the prepared check list in above activity and tutor
will act as Top Management. (20 Mts)

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Activity : 13  Auditing Top Management

Tutor Notes

Tutor should divide the participants into 4 team and perform the exercise as per the delegate
instructions; The team are given the case study and ISO 45001 standard with flipcharts and
markers, one group of two teams needs to prepare the checklist for 15 minutes and next 15
minutes tutor will give guidance for the requirement discussed and add the missing parts, if
any.
After that the next team will do the audit of top Management for 30 minutes and ask the
questions to tutor who will act as a top Management. After completion of 30 minutes Tutor will
discuss the findings of the exercise for next 15 minutes the marks are given as per the
marking guide.
Total 5 marks is to given for the exercise,
This exercise is of 5 marks.
 For group 1, marking is given for the correct identification of the requirements, Proper
participation of the team member and presentation is noticed by the tutor and marking
is given accordingly.
 For group 2, marking is given for the correct presentation and discussion; tutor will
check the participation level of the team for the marking given.
This Exercise is meant for competency of “Conducting audit” and “Interpretation of
Requirements”

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Activity : 14  Auditing Role Play, NCR
Reporting and Judgment

Format  Group exercise for the participants as per the Tutor instructions

Purpose/ Objective 
1. Demonstrate the ability to manage meetings effectively.
2. Demonstrate the ability to implement the audit plan, use work documents and to
follow audit trails.
3. Demonstrate the ability to build rapport with the auditee during the audit,
including sensitivity to the needs and expectations of the auditee.
4. Demonstrate the ability to manage audit interviews effectively, including the
ability to formulate effective audit questions.
5. Demonstrate the ability to collect and verify appropriate audit evidence, including
appropriate sampling.
6. Write and grade nonconformity reports correctly.
7. Demonstrate the ability to evaluate audit evidence to correctly identify conformity
and nonconformity with requirements.
8. Demonstrate the ability to prepare audit conclusions, including the extent of
conformity of the management system, identification of positive audit findings in
addition to nonconformity, and identification of potential risks and opportunities
for improvement.
Time Allocation 

Participant time Tutor time Total time

165 minutes 75 minutes 240 minutes

Instruction for the Delegates 


The organisation ABC Chemical Inc. has selected you as a certifying body for
conducting the ISO 45001:2018 audit. You are a team member of the audit team.
You have information on ABC Chemical Inc. as the Stage 1 Document review audit
has been successfully completed.
The selection of the auditor based on the audit plan will be done by the tutor.
Based on the checklist prepared and updated on the previous exercise the selected
delegate has to perform the role play of the auditor.
Your Task
Delegates shall –
1. Organize teams and a team leader for each audit session.
2. Prepare checklists and audit trails to test the processes.
3. Interview required personnel as a team to evaluate each processes against the
requirements of ISO 45001:2018 standard.

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Activity : 14  Auditing Role Play, NCR
Reporting and Judgment

4. Record your observations during the interview process.


5. Review results of interview to prepare and improve the next stage interview.
6. On completion of the interviews the teams shall be required to evaluate their interview
records to identify and prepare NCRs for the next reporting exercise.
7. And if any of the cases you feel that there is not enough evidence please write further
questions to be asked,
Support Teams
During each interview the non–active audit teams shall observe the interview, but not
make any comments. Detailed notes shall be made observing the following
- Working as teams with clear direction by team leader.
- Evidence of structured questions, and development of audit trails.
- Control of interviews by the audit teams.
- Evidence of note taking.
- Evidence of attaining objective evidence.
- Auditor conduct.
Processes to be audited.
• Production
• Quality Control
• Legal requirements
• OH&S and Safety Officer

After the audit the reporting of the Non conformity is to be done by the team and also
judgement of the NCR whether sufficient evidence are available to call it as NCR is to
checked and if you feel there is a lack of evidence is any of the case please write on
the flipchart that what questions you will ask for coming to conclusion.

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Activity : 14  Auditing Role Play, NCR
Reporting and Judgment

Tutor Notes
Feedback and discussion
Tutor(s) will offer feedback after the session. Feedback will cover:
 Communication skills;
 Questioning technique;
 Use of checklists;
 Level of preparation for interview.
 Ability of the teams to pick up audit trails.
 Ability to effectively analyse the evidences provided and conclude objectively.
Marks
1 mark for proper introduction of the audit team
1 mark for communication skills
1 mark for good questioning techniques
1 mark for using checklist appropriately
1 mark for preparation and planning
1 mark for acceptable behaviour of the team
1 mark for proper summarization at the end of interview
1 mark for proper distribution of time between various members of the team
1 marks for overall performance
5 marks for the judgement and reporting of NCR
14 marks maximum available
This Exercise is meant for competency of “Conducting audit” and “Generating audit
findings” and “Reporting audit results”

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Activity : 14  Auditing Role Play, NCR
Reporting and Judgment

Observation / Finding 1
OH&S Objectives found not prepared and not available with Management Appointee.
Judgement
Clause No. and title of clause
Observation / Finding 2
Spray drying of dyes is outsourced, however no evidence of controls on such
outsourced functions and processes available.
Judgement
Clause No. and title of clause
Observation / Finding 3
Hazard identification and assessment of risks for few activities are not found.
Judgement
Clause No. and title of clause
Observation / Finding 4
Electrical trench found not covered on the top, which can lead to fall hazards.
Judgement
Clause No. and title of clause
Observation / Finding 5
Headcount found not done during the mock drill. In mock drill report the details of head
count is no where addressed
Judgement
Clause No. and title of clause
Observation / Finding 6
Competence requirements of workers engaged in the operation of chemical reaction is
not determined and documented considering the OH&S performance.
Judgement
Clause No. and title of clause

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Activity : 14  Auditing Role Play, NCR
Reporting and Judgment

NONCONFORMITY REPORT FORM


Non–conformity report
Auditee Date
Location NCR No.
Auditor Name NCR Category
Auditee Name Clause No.
Auditee Dept.
Observation/Finding

ISO 45001:2018, Clause ___,

Auditor Sign: Auditee Sign: Date:


Root cause:

Correction:

Completion Date: ______________


Auditee Sign: Lead Auditor Sign: Date:
Corrective action taken

Satisfactory : Not Satisfactory : (State Reasons)

Verified Date:
Sign

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Activity : 15  Corrective Action and Follow Up
Audit
Format  Group exercise for the participants as per the Tutor instructions

Purpose/ Objective 

1. Evaluation of the proposed correction and corrective actions.


2. Evaluation of the evidences provided for the closure of the non-conformities.
Time Distribution 

Participant time Tutor time Total time

75 minutes 30 minutes 105 minutes

Instruction for the Delegates 

Exercise
You have completed the audit and closing meeting. Your task is to follow up and close out the
NCR’s reported at the closing meeting in a follow up visit to ABC Chemical Inc., establish
evidence of conformance with the ISO 45001 standard, effective evidence of the root cause
corrective action and evidence of application of continual improvement, customer satisfaction
objectives in the areas audited in order to close out the NCR’s.
You’re Task
1. Review the evidence of the corrective actions presented to you by the company. Look
at the evidence of the corrective action and decide if the activity now complies with the
ISO 45001 standard for closing out the NCRs.
2. Decide if the root cause has been addressed and clause 10.2 has been fully
implemented.

This is a group exercise, with all teams to take an active part in the discussion.

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Activity : 15  Corrective Action and Follow Up
Audit

Tutor Notes

 Team in turn present their comments.


 Encourage discussion.
Tutor(s) must remember that some of the terms are very complex to understand such as
‘Correction’ v/s ‘Corrective Action’. It must be ensured that tall delegates have the correct
understanding of these terms at the end of this exercise. Tutor(s) must provide adequate
examples and make delegates challenge their own understanding of terms.
Tutor(s) must not give ready answers to all questions, but mostly throw the questions back to
class or other delegates and try and get the correct answers from delegates.

Total 7 marks is to given for the exercise,


This exercise is of 7 marks.
- Root cause: 3 marks
- Correction: 2 marks
- Corrective action: 2 marks

This Exercise is meant for competency of “Reporting audit results”

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Activity : 16  Closing Meeting Role Play

Format  Group exercise for the participants as per the Tutor instructions
Purpose/ Objective 
1. Demonstrate the ability to prepare audit conclusions, including the extent of conformity
of the management system, identification of positive audit findings in addition to
nonconformity, and identification of potential risks and opportunities for improvement.
2. Write and grade nonconformity reports correctly
3. Present audit conclusions and recommendations clearly to the auditee at a closing
meeting.
Time Distribution 
Participant time Tutor time Total time
60 minutes 30 minutes 90 minutes

Instruction for the Delegates 


Background
You have completed your audit interviews and now need to collect together all the findings of
your team and present them to management in a closing meeting. The objective is to present
your findings being able to give detail and support them with objective evidence.
Management know their system has recently been developed and know that there are some
deficiencies that you have found. Management are anxious regarding certification or rejection
of their quality management system.
Your Task
1. Prepare an agenda for the closing meeting.
2. Prepare to present your findings concisely to Management.
3. Ensure that you have sufficient evidence of a deficiency with objective evidence if you
are going to report it.
4. Write out non-conformance.
5. You must get agreement of management on your NCR findings and obtain
commitment for corrective action during the meeting. (As per previous Exercise )
6. Review the adequacy of the nominated corrective actions. (As per previous Exercise )
7. Reject any inadequate planned action for corrective actions.
8. Be prepared to answer any questions regarding your findings with objective evidence.
9. Elect a Team Leader.
10. Conduct the Closing Meeting.

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Activity : 16  Closing Meeting Role Play

Tutor Notes
Closing Meeting – Agenda
A formal closing meeting, where attendance shall be recorded, shall be held with the client's
management and, where appropriate, those responsible for the functions or processes
audited. The purpose of the closing meeting, which shall normally be conducted by the audit
team leader, is to present the audit conclusions, including the recommendation regarding
certification. Any nonconformity shall be presented in such a manner that they are
understood, and the timeframe for responding shall be agreed. “Understood” does not
necessarily mean that the nonconformities have been accepted by the client.
The closing meeting shall also include the following elements. The degree of detail shall be
consistent with the familiarity of the client with the audit process:
a) Advising the client that the audit evidence collected was based on a sample of the
information; thereby introducing an element of uncertainty;
b) The method and timeframe of reporting, including any grading of audit findings;
c) Process for handling nonconformities including any consequences relating to the
status of the client's certification;
d) The timeframe for the client to present a plan for correction and corrective action for
any nonconformities identified during the audit;
e) Post audit activities;
f) Information about the complaint handling and appeal processes.
For continuous marking the total marks allotted are 09 and based on the correctness of the
answers the markings are given.
Also focus is given on the involvement and presentation of the participants.
This Exercise is meant for competency of “Reporting audit results” and “Conducting
audit”

Tove Leeds Certification & Inspection Page 2 of 2


Revision session

ISO 45001 Lead Auditor


(Occupational health and safety management systems –
Requirements with guidance
for use) Training course Revision questions – Day 2

Copyright © 2018
All rights reserved. No part of this document may be reproduced, distributed, or transmitted in any form or by any means, including
photocopying, recording, or other electronic or mechanical methods, without the prior written permission of the publisher, except in the case
of brief quotations embodied in critical reviews and certain other non–commercial uses permitted by copyright law.

Tove Leeds Certification & Inspection Page 1 of 2


Revision session

Model Questions
Sr.
Question
No.

1. What are the course certification criteria?

2. What is the auditing standard?

What is the certification process? What is accreditation board or body and


3.
what is certifying body?

What is the meaning of PDCA and how the clauses are distributed in
4.
PDCA?

What do you mean by documented information? Where the documented


5.
information is required?

6. What are the points to be covered in the opening and closing meeting?

Tove Leeds Certification & Inspection Page 2 of 2


Revision session

ISO 45001 Lead Auditor


(Occupational health and safety management systems –
Requirements with guidance
for use) Training course Revision questions – Day 3

Copyright © 2018
All rights reserved. No part of this document may be reproduced, distributed, or transmitted in any form or by any means, including
photocopying, recording, or other electronic or mechanical methods, without the prior written permission of the publisher, except in the case
of brief quotations embodied in critical reviews and certain other non–commercial uses permitted by copyright law.

Tove Leeds Certification & Inspection Page 1 of 2


Revision session

Model questions
Sr.
Question
No.

1. What are the factors or climate for good communication?

2. Which are the interviewing techniques?

3. What are the key success factors for Auditor Attitude?

4. What are the critical steps in interviewing?

5. Which are the questioning techniques for interview?

Tove Leeds Certification & Inspection Page 2 of 2


Revision session

ISO 45001 Lead Auditor


(Occupational health and safety management systems –
Requirements with guidance
for use) Training course Revision questions – Day 4

Copyright © 2018
All rights reserved. No part of this document may be reproduced, distributed, or transmitted in any form or by any means, including
photocopying, recording, or other electronic or mechanical methods, without the prior written permission of the publisher, except in the case
of brief quotations embodied in critical reviews and certain other non–commercial uses permitted by copyright law.

Tove Leeds Certification & Inspection Page 1 of 2


Revision session

Model questions
Sr.
Question
No.

1. What needs to be taken care during conducting stage 1 audit?

What do you mean by defect, requirements, conformity and non-


2.
conformity?

3. What needs to be taken care during planning of stage 2 audit?

4. How to write non-conformity statement?

5. What are the difference between correction and corrective action?

Tove Leeds Certification & Inspection Page 2 of 2


Revision session

ISO 45001 Lead Auditor


(Occupational health and safety management systems –
Requirements with guidance
for use) Training course Revision questions – Day 5

Copyright © 2018
All rights reserved. No part of this document may be reproduced, distributed, or transmitted in any form or by any means, including
photocopying, recording, or other electronic or mechanical methods, without the prior written permission of the publisher, except in the case
of brief quotations embodied in critical reviews and certain other non–commercial uses permitted by copyright law.

Tove Leeds Certification & Inspection Page 1 of 2


Revision session

Model questions
Sr.
Question
No.

1. What are the bare minimum requirements as a part of audit reporting?

2. What are the contents of final audit report?

3. What is the care to be taken during auditing top management?

4. How to judge the audit finding as non-conformity?

5. What are the deliverables at the end of audit?

Tove Leeds Certification & Inspection Page 2 of 2

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