Delegate Hand-out

Exercise and Workshops Bureau Veritas Certification

EXERCISES

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Exercise and Workshops Bureau Veritas Certification

EXERCISE No. 0: DELEGATE INTRODUCTION- MINI INTERVIEW

Learning Objectives:

The purpose of the exercise is:

To achieve understanding on the interview process and why it is important in the context of
process audit to obtain appropriate information and evidences, how to evaluate this
information and then present to the organization.

Duration:

Refer to the time table for overall time duration and follow instructions by the Trainers for
break up

Nature of the Activity

Delegates in team of 2 work on this exercise.

Material and Equipment

- Check list format

- Blue/ White Tack or pin board.

Delegates Tasks and Deliverables

Delegates are divided into pairs of 2 each. Each team (pair) will conduct this exercise. Initially,
one member of the team will interview the other (max time allowed is 5 minutes per delegate)
and collect all relevant information in the checklist template provided to them.

Subsequently the 2nd member of the team will repeat the exercise. After the delegate exercise
trainer will explain how to use this information.

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Delegate Introduction Checklist Template

Interviewee Name:

Employer name:

Position:

Education:

Career background:

Quality management
experience:

Knowledge of ISO 9001:2015

grade from 1 (low) to 10 (high)

Auditing experience: Type: 1st party 2nd party 3rd party

(Please tick mark the appropriate column) No. of (Internal) (Supplier) (Certification)
audits:

Nil

Up to 5

5 – 10

10 & more

Personal objectives in
attending the course

Other information about

interviewee that may be
useful for auditor to know

Date:

Auditor name:

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Exercise and Workshops Bureau Veritas Certification

EXERCISE No.1: Preparation prior to Audit - Case Study Review

The purpose of the exercise is:

1. To achieve an understanding and familiarity about the organization to be audited so that

auditors can objectively evaluate all aspects of their QMS and processes
2. To enable the students to carry out further exercises and workshops in an informed
manner

Duration:

Refer to the time table for overall time duration and follow instructions by the Trainers for
break up

Nature of the Activity

Team work on gathering a quick overview of the organization being audited, similar to
pre audit visit/discussion with a client organization before planning stage 1 & stage 2
audit

Material and Equipment

- All documentation of Beta Training.

- Note books/ plain white sheets and pens

Delegates Tasks and Deliverables

Delegates are divided into teams (see exercise 0) and expected to work in team to carry
out a quick reading of all provided documented information by Beta Training in order to
achieve familiarity about the organization.

Delegate Instructions

Read individually/or in team the documented information provided by Beta Training as

part of pre visit preparation by the audit team

The outcome of the exercise is to be written down by the team in note pad / white papers
as important information/ questions to be asked to seek further information

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Exercise and Workshops Bureau Veritas Certification

EXERCISE No. 2: Auditing Terminology

Learning Objectives:

The purpose of the exercise is:

To achieve the required understanding on and be able to explain the terminology and concepts
related to auditing a Quality Management System and apply them in real life audits

Duration:

Refer to the time table for overall time duration and follow instructions by the Trainers for
break up

Nature of the Activity

Team work on analysis of concepts and terminology related to auditing.

Material and Equipment

- Cards.
- Blue/ White Tack or pin board.

Delegates Tasks and Deliverables

Delegates are divided into teams (see exercise 0) and expected to work in team to match
correctly the cards with terms (printed on coloured card paper and cut into the shape of a card)
with their definitions (differently coloured cards).

DELEGATE INSTRUCTIONS

Delegates as a team receive packs of cards that include:

- One set of cards in one colour with printed text giving various terms related to auditing
- Another set of cards (differently coloured) containing printed text giving definitions of those
terms.

Teams are required to match the terms with their definitions (there may be more than one
definition for a term) and prepare a display by:

- Using blue (white) tack and board

- Using pin board
- Placing the cards in order on the table.

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Exercise and Workshops Bureau Veritas Certification

EXERCISE No 3.

COMMUNICATION

FACT OR INFERENCE?

“Jones, a buyer with the XYZ Company, was scheduled for a 10 o’clock meeting in Mr Smith’s
office to discuss the terms of a large order. On the way to that office the buyer slipped on a
freshly waxed floor, and as a result received a badly bruised leg. By the time Smith was
notified of the accident, Jones was on the way to the hospital for X-rays. Smith called the
hospital to enquire and no one there seemed to know anything about Jones. It’s possible that
Smith called the wrong hospital.”

Having read the above paragraph, please classify each of the following statements as “fact” or
“inference”. Use the following as descriptions:

FACT = truth; something that has actually happened.

INFERENCE = May be a truth; something that may or may not have happened.

Statement Fact Inference

1. Jones was supposed to meet with Smith.

2. Jones was scheduled for a 10 o’clock meeting.

3. The accident occurred at the XYZ Company.

4. Jones was taken to the hospital for X-rays.

5. No one at the hospital which Mr Smith called knew

anything about Jones.

6. Smith had called the wrong hospital.

7. Mr Jones is a buyer.

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EXERCISE 4.
Reviewing Corrective Actions

Format :-

Individual exercise by delegates

Purpose :

To enable delegates to understand the challenges in evaluating the corrections and corrective
actions proposed / presented by organizations in response to the Non Conformities reported
during a 3rd party audit

Duration:

Refer to the time table for overall time duration and follow instructions by the Trainers for
break up

Exercise Material

Exercise 04- Delegate hand-out

Delegate Instructions

Now that as an auditor you have issued non conformities, the organization’s representatives
submit proposed corrective action plan to you. As an auditor you are expected to review these
actions and advice the organization whether they can go ahead with implementation.

Review in team the case studies allocated by the Trainer and comment as follows:

- Are they acceptable?

- If they are not acceptable, justify why

- If they are acceptable, what evidence will you look for accepting the proposed corrective
action?

The outcome of the discussions and group work can be written on the hand-out against the
case study (NCR) allocated to you.

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CORRECTIVE ACTION REQUEST

Company: Date: NCR Number: 1
Auditor: Auditee:
Non-conformity:

Whilst auditing the Quality Department, it was discovered that three new procedures
have been released onto the intranet, but there is no evidence of prior approval.

ISO9001:2015 7.5.3.2, For the control of documented information, the organization shall
address the following activities as applicable :

a) Distribution, access, retrieval and use

Signed: Date:
Cause & Proposed Corrective Action:

Corrective Action – Approval records will be created and added on file.

Recommended by – Quality Manager

Proposed Completion Date:

DATE: SIGNATURE

Corrective Action Review:

Signed: Date:

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CORRECTIVE ACTION REQUEST

Company: Date: NCR Number: 2
Auditor: Auditee:
Non Conformity:

In the process manual established for description of the processes, there was no
description of the interaction between the processes of the quality management
system. This according to the auditee is a requirement as determined by them.

ISO9001:2015 4.4 requires “The organization shall maintain documented

information to the extent necessary to support the operation of processes”.

Signed:
Date:
Cause & Proposed Corrective Action:

The Quality Manager will, together with the Production Manager, define the processes
for the quality management system.

Proposed Completion Date:

DATE: SIGNATURE

Corrective Action Review:

Signed: Date:

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CORRECTIVE ACTION REQUEST

Company: Date: NCR Number: 3
Auditor: Auditee:
Non Conformity:

During the audit it was noted that there were no records in support of the names
of any of the organisations listed on the ‘Approved Suppliers List’.

ISO9001:2015-8.4.2 requires “The organization shall establish and implement

verification or other activities necessary to ensure the externally provided processes,
products…..

Company procedure for Purchase (QPR/PUR/001) requires that records of the results of
evaluations and any necessary actions arising from the evaluation of all suppliers shall
be maintained.”

Signed: Date:
Cause & Proposed Corrective Action:

Corrective Action - From now on records will be created of all evaluations and re-
evaluations of suppliers, and will be maintained on file.

Recommended by – Quality Manager

Proposed Completion Date:

DATE: SIGNATURE

Corrective Action Review:

Signed: Date:

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CORRECTIVE ACTION REQUEST

Company: Date: NCR Number: 4
Auditor: Auditee:
Non Conformity:

During the audit, evidence of customer owned materials was found in manufacturing –
valves for incorporation into the pumps – but these were not identified as customer
property.

ISO9001:2015-8.5.3 requires “The organization shall identify, verify, protect and

safeguard the customer’s or external provider’s property provided for use or
incorporation into the products and services

Signed: Date:
Cause & Proposed Corrective Action:

Corrective Action - All valves will be suitably identified, protected and verified.

Recommended by – Quality Manager

Proposed Completion Date:

DATE: SIGNATURE

Corrective Action Review:

Signed: Date:

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CORRECTIVE ACTION REQUEST

Company: Date: NCR Number: 5
Auditor: Auditee:
Non Conformity:

During an audit of pump assembly in the production area the auditor established that
four employees did not know the implications of not following process controls in their
equipment as laid down in their process data sheets which are part of their Quality
Management System

ISO9001:2015-7.3 requires that persons doing work under the organizations control
shall be aware of : (d) the implications of not conforming with the quality management
system requirements

Signed: Date:
Cause & Proposed Corrective Action:

Cause :

The roles, responsibilities and authorities of employees including the implications of not
conforming to QMS requirements were neither defined nor communicated within the
organisation.

Corrective action - An employee handbook defining roles, responsibilities and

authorities has been published and distributed to all employees. Training programmes
were conducted covering each employee. A test was conducted and it is now ensured
that all current employees, including the above stated four employees, are aware of
their roles. All future recruits will be routed through a formal induction programme
which will include this subject.

Recommended by – Management Representative

Signature
Corrective Action Review:

Signed: Date:

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CORRECTIVE ACTION REQUEST

Company: Date: NCR Number: 6
Auditor: Auditee:
Non Conformity:

During the audit of packaging and despatch area of a pharmaceutical products, the
auditor discovered that there was no identification of any unit leaving the company.
The contract requires that every unit be uniquely identified at all stages of product
realization chain and records maintained.

ISO 9001:2015 8.5.2 requires “Where necessary to ensure conformity of products and
services, the organization shall use suitable means to identify the process outputs:

Signed: Date:
Cause & Proposed Corrective Action:

Corrective action – The Production Manager shall ensure that a suitable identification
system is implemented for the next contract.

Proposed Completion Date:

DATE: SIGNATURE

Corrective Action Review:

Signed: Date:

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CORRECTIVE ACTION REQUEST

Company: Date: NCR Number: 7
Auditor: Auditee:
Non Conformity:

During the audit, several items of measuring equipment were discovered in use in the
production areas that were not identified by any means (e.g. micrometers, pressure
gauges etc.).

ISO 9001:2015 7.1.5 requires that measuring instruments shall be - identified in order to
determine their calibration status

Signed: Date:
Cause & Proposed Corrective Action:

Corrective Action –All items of measuring equipment will be suitably identified, records raised,
and their current calibration status determined.

Recommended by - The Quality Manager

Proposed Completion Date:

DATE: SIGNATURE

Corrective Action Review:

Signed: Date:

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CORRECTIVE ACTION REQUEST

Company: Date: NCR Number: 8
Auditor: Auditee:
Non Conformity:

During review of the internal audit programme, the auditor noted, in many cases,
actions taken in response to nonconformities only corrected the immediately identified
symptom(s) without removing the cause of the problem.

ISO 9001:2015 9.2.2 requires “The organization shall……take necessary correction and
corrective actions...”

Signed: Date:
Cause & Proposed Corrective Action:

The quality manager will review and amend the procedures for internal audits and
corrective actions to make it clear that root cause analysis is necessary and that
corrective actions must address the root causes of the problems.

She will also support implementation of the revised procedures by conducting

additional training for the audit team and department manager to cover the
nonconformity investigation, root cause analysis, developing of corrective actions and
evaluation-of-effectiveness of corrective action.

Proposed Completion Date:

DATE: SIGNATURE

Corrective Action Review:

Signed: Date:

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CORRECTIVE ACTION REQUEST

Company: Date: NCR Number: 9
Auditor: Auditee:
Non Conformity:

There was no evidence of any documented quality objective.

ISO 9001:2015 -6.2.1 requires “The organization shall retain documented information on
the quality objectives”

Signed: Date:
Cause & Proposed Corrective Action:

Cause – Lack of awareness/understanding of QMS requirements.

Correction : All identified employees and top management will undergo a detailed QMS
awareness training programme and the effectiveness of the programme will evaluated
by a third party.

Any documentation, including quality objectives, that were not included, will be added to
the QMS.

Proposed Completion Date:

DATE: SIGNATURE

Corrective Action Review:

Signed: Date:

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CORRECTIVE ACTION REQUEST

Company: Date: NCR Number: 10
Auditor: Auditee:
Non Conformity:

During the audit it was noted the records did not indicate who the authority was, for the
final release of the product.

ISO 9001:2015 8.6 requires “Documented information shall provide traceability to the
persons(s) authorizing release of products and services for delivery to the customer.”

Signed: Date:
Cause & Proposed Corrective Action:

Corrective Action – The Chief Inspector is the authority to sign for release of the
product. The final release form will be modified to allow the Chief Inspector to sign for
final release.

Recommended by – Management Representative

Proposed Completion Date:

DATE: SIGNATURE

Corrective Action Review:

Signed: Date:

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Exercise and Workshops Bureau Veritas Certification

WORKSHOPS

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Workshop 1- Auditing Context, Planning and Support

Format: Skill based Practical Evaluation - delegates will be evaluated on their ability to
meet the exercise objectives

Objectives:
- To prepare delegates for interpretation and develop skills to audit particular
requirements in the background of a case study organization.
- To develop the skills for developing audit checklist
- To enhance the understanding of process and system approach to management
and its consequences for auditing
- To be able to develop a process focused Checklist

Material and Equipment

Documentation of Beta Training

ISO 9001:2015 Standard
Flipchart & Markers

Duration:

Refer to the time table for overall time duration and follow instructions by the Trainers for
break up

Delegate briefing.

The background scenario:

Beta Training is an organization / company who is into design, development and

delivery of training modules to industry. They have implemented a quality
management system based on ISO 9001:2015 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 4, 6 & 7 of
ISO 9001 Standard.

Part 1 of Workshop

To start with, first prepare a diagrammatic model of all possible internal and external
issues encountered by Beta and all possible interested parties and their needs and
expectations in the following format :

Sr Issues Interested parties

No External Internal Interested Party Needs and
expectations

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This information is not be shared with Beta, but required for you to conduct the audit
in a systematic manner when you are on site.

Part 2 of Workshop:

Delegates Tasks and Deliverables

- Based on the review of the documentation of the organization the teams shall
prepare a detailed checklist with the information collected in part 1 of this workshop in
the background.

- You must cover the clauses 4, 6 & 7

Sr What to check /ask / look for Related Related Remarks/ Comments

No evidence to Clause
look for No

Since 4, 6 and 7 Clauses would practically apply to all processes/ departments of Beta.
Therefore, delegates can make a generic checklist keeping in mind any process, but the
questions/item/ element of checkpoint must be specific to Beta

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Exercise and Workshops Bureau Veritas Certification

Workshop 2-Auditing ‘Operation’

Format: Skill based Practical Evaluation - delegates will be evaluated on their ability to
meet the exercise objectives

Objectives:
- To prepare delegates for appropriate interpretation and developing the skills
required to audit particular requirements in the background of a case study
organization.
- To develop the skills for developing audit checklist
- To enhance the understanding of process and system approach to management
and its consequences on auditing
- To be able to develop a process focused Checklist

Material and Equipment

Documentation of Beta Training

ISO 9001:2015
Flipchart & Markers

Duration:

Refer to the time table for overall time duration and follow instructions by the Trainers for
break up

Delegate briefing.

The background scenario:

Beta Training is an organization / company who is into design, development and delivery of
training modules to industry. They have implemented a quality management system based
on ISO 9001:2015 standard

You are scheduled to conduct an onsite audit. You need to develop the knowledge and
skills sets required to carry out a detailed audit of requirements of Clause ‘8 Operation’ of
ISO 9001 Standard to verify conformance of their QMS.

Delegates Tasks and Deliverables

- Based on the review of the documentation of the organization the teams shall
prepare a detailed checklist to verify conformance of the QMS of Beta Training with the
requirements.

The teams shall prepare the checklist in the following format

Following sub clauses of ‘8.Operation’ are allocated to teams as follows:

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Team 1- Clause 8.2 Determination of requirements related to products and services &
Clause 8.7 Control of non-conforming outputs

Team 2- Clause 8.4 Control of externally provided processes, products and services

Team 3- Clause 8.3 Design of products and services

Team 4- Clause 8.5 Control of Production and Service Provision

Clause 8.6 Release of products and services

(Trainer may allocate the above sets of clauses to different teams, if they wish. However the
combination / group of clauses must not change)

Sr What to check /ask / look for Related Related remarks

No evidence to Clause No
look for (Leave this
column
blank)

All teams must produce the outputs on flip charts. All questions and check points must be
related to Beta and not generic.

Please leave the 4th column (Clause Number) blank to facilitate group work later.

Discussion and Feedback :

Please follow the trainer’s instructions after all the teams have finished their tasks.

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 Delegate Hand-out
Exercise and Workshops Bureau Veritas Certification

Workshop 3-Auditing ‘performance evaluation and improvement’

Format: Skill based Practical Evaluation - delegates will be evaluated on their ability to
meet the exercise objectives

Objectives:
- To prepare delegates for appropriate interpretation and developing the skills
required to audit particular requirements in the background of a case study
organization.
- To develop the skills for developing audit checklist
- To enhance the understanding of process and system approach to management
and its consequences on auditing
- To be able to develop a process focused Checklist

Material and Equipment

Documentation of Beta Training

ISO 9001:2015
Flipchart & Markers

Duration:

Refer to the time table for overall time duration and follow instructions by the Trainers for
break up

Delegate briefing.

The background scenario:

Beta Training is an organization / company who is into design, development and

delivery of training modules to industry. They have implemented a quality
management system based on ISO 9001:2015 standard

You are scheduled to conduct an onsite audit. You need to develop the knowledge
and skills sets required to carry out a detailed audit of requirements of Clause ‘9
Performance evaluation’ and 10.’Improvement’ of ISO 9001 Standard to verify
conformance of their QMS to these requirements

Delegates Tasks and Deliverables

- Based on the review of the documentation of the organization the teams shall
prepare a detailed checklist to verify conformance of the QMS of Beta Training with the
requirements.

The teams shall prepare the checklist in the following format

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Sr What to check /ask / look for Related Related remarks
No evidence to Clause No
look for

All teams must produce the outputs on flip charts. All questions and check points must be
related to Beta and not generic

Discussion and Feedback :

Please follow the trainers’ instructions after all the teams have finished their tasks.

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Workshop 4 - Planning for Stage 1 Audit

Format: Skill based Practical Evaluation - delegates will be evaluated on their ability to
meet the exercise objectives

Objectives:
- To prepare delegates for planning for on-site stage one audit.
- To develop the skills for audit planning
- To enhance the understanding of process and system approach to management
and its consequences for auditing
- To develop the ability to determine the audit scope and determine resource
requirements including audit day determination
- To be able to develop a process focused plan.

Material and Equipment

Material – Documentation of Beta Training

ISO 9001 & 19011 Standards.
Flipchart & Markers

Duration:

Refer to the time table for overall time duration and follow instructions by the Trainers for
break up

Delegate briefing.

The background scenario:

Delegates must remember that Certification audits are conducted in 2 stages (Stage 1
& Stage 2). But each activity involved in audit process must be adequately planned,
documented and the organisation personnel being audited must be well informed
about such plans and the time scale.

Delegates Tasks and Deliverables

- Based on the review of the documentation of the organization the teams shall
prepare an audit plan for a stage 1 audit of this organisation as part of the certification
contract signed with Bureau Veritas Certification.

- Based on the size of the company (No of employees) delegates must determine the
number of person-days required for the audit (delegates can use the table derived from
relevant IAF Mandatory Document, provided in this hand-out.)

- Audit plan must include the scope of the audit and identification of the audit team.

Feedback session

Teams in turn shall present their conclusions and outputs. Trainer animates and moderates
the discussion.

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Guidelines on allocation of auditor days

1. Determine the amount of work involved and the time duration that will be required – size
and complexity of the audit will mainly decide this – but remember, audits cost money
therefore try to keep the time as short as possible. There are requirements specified by
IAF for Quality Management System audits

2. It must be understood that the time required for the audit depends on number of factors as
outlined in the text that follows the table 1 given below

Table 1:Guide for auditor time for initial assessment (stage 1 & stage 2 together) (Derived
from IAF MD5)

Effective Number Audit Duration Stage 1 + Stage 2 (days)

of Personnel

High Complexity Medium Low Limited

Complexity Complexity Complexity

1-5 3 2.5 2.5 2.5

6-10 3.5 3 3 3
11-15 4.5 3.5 3 3
16-25 5.5 4.5 3.5 3
26-45 7 5.5 4.5 3
46-65 8 6 4.5 3.5
66-85 9 7 5 3.5
86-125 11 8 5.5 4
126-175 12 9 6 4.5
176-275 13 10 7 5
276-425 15 11 8 5.5
426-625 16 12 9 6
626-875 17 13 10 6.5
876-1175 19 15 11 7
1176-1550 20 16 12 7.5
1551-2025 21 17 12 8
2026-2675 23 18 13 8.5
2676-3450 25 19 14 9
3451-4350 27 20 15 10
4351-5450 28 21 16 11
5451-6800 30 23 17 12
6801-8500 32 25 19 13
8501-10700 34 27 20 14
>10700 Follow progression
above

Term “effective number of personnel” has been referred to in ISO 17021 as “personnel” and is
typically “person doing the work under the control of the organization”. Certain factors are to be
considered while determining the effective number of employees, viz., the number of shifts of
working where similar work is carried out or many persons doing the repetitive type of work

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(Ex: Data entry / front office work / identical products being produced on similar machines in a
manufacturing set up etc) :-

Table 1 sets out typical number of audit days to be used in an initial assessment. Experience
has shown that it is appropriate to base this upon the number of employees of the organization
and the nature, scale and complexities of operations for a typical organization in that industry
sector.

The auditors’ time should then be adjusted based on any significant factors that uniquely apply
to the organization to be audited.

The additional factors that need to be considered shall include but are not limited to:-

Increase auditor time:

 Complicated logistics involving more than one building or location where work is carried out.
e.g., a separate Design Centre must be audited;
 Staff speaking in more than one language (requiring interpreter(s) or preventing individual
auditors from working independently);
 Very large site for the number of personnel (e.g., a forest);
 High degree of regulations (e.g., food, drugs, aerospace, nuclear power etc);
 System covers highly complex processes or relatively high number of unique activities;
 Activities that require visiting temporary sites to confirm the activities of the permanent site(s)
whose management system is subject to certification.

Decreased auditor time:

 Very small site for number of employees (e.g., office complex only)
 Maturity of management system
 High percentage of employees doing the same, repetitive and simple tasks
 Work being carried out in shifts where the nature of work remains identical

Once the audit days are determined, the delegates in team shall draw out a detailed plan for
conducting Stage 1 audit of the Beta Training

Audit Plan shall be prepared on Flip Charts to facilitate effective presentations and group
discussions

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AUDIT PLAN PROFORMA

Organisation:
Date(s): Location
Team Leader:
Team Members:

Audit Criteria
Audit scope:

Day Time Area/Activity Auditor Guide

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WORKSHOP No.5 – CONDUCTING STAGE 1 AUDIT

The objectives of this workshop are to understand:

 How to prepare delegates for conducting Stage 1 audit
 How to perform stage 1 audit of an hitherto unknown organisation in order to be able to
assess their readiness with respect to all necessary documentation for a stage 2 audit
in order to verify conformance with ISO 9001:2015.
 How to find the relation between a Quality Manual and the appropriate clauses of ISO
9001:2015.
 To familiarise delegates with the background scenario for the case study and further
workshops.
 To better understand how to plan the audit in order to ensure that not only individual
processes are reviewed but also their intended results, interaction and sequence.
 To enhance the knowledge of the standard.
 To create a basic understanding of the applicability of different clauses of the standard
for different processes of an organisation and thus be ready to prepare the process
matrix.

The case study is based on a third party audit initiated by an Beta Training.

The company has signed the contract with Bureau Veritas Certification for a third
party audit next month.

As part of the third party registration process, the certification body will require the
auditee to send them a copy of the documentation that contains their intent in
respect of the standard’s requirements, in order that they can evaluate its adequacy.
Under the above mentioned contract, Bureau Veritas Certification management
appointed you to audit Beta Training’s quality system against the requirements of
ISO 9001:2015.

As a first step you will be conducting a part of the stage 1 audit of the organisation
on the basis of the documentation submitted by the organisation at site.

Each team will act as an audit team in this scenario and shall perform a part of the
stage 1 audit (documentation part) of the Organisation.

Each team is required to make a presentation on the following :

1. The team’s overall judgement about the preparedness of the organisation for a
stage 2 audit.

2. The team’s judgement on the positives and potential areas of concern.

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WORKSHOP No. 6 – PLANNING for Stage 2 audit

The objectives of this workshop are to prepare the delegates as to:

1. How to plan audit time and perform a stage 2 audit of an organisation.

2. To cover appropriate clauses of ISO 9001:2015 with the processes defined in their
system based on the outcome of documentation audit.

Material for Workshop:

Documentation of Beta Training

ISO 19011 Standard
Flip Charts and markers

Duration:

Refer to the time table for overall time duration and follow instructions by the Trainers for
break up

Workshop

Each team will act as an audit team.

Each team shall prepare plan for third party audit of Beta Training based on time
Duration and team members.

The client organization has Head office which has the following processes:

- Top Management.
- Supplier Management
- HR

Audit plan shall determine number of days and number of auditors.

Each team shall present their plan on a flip chart in the pro-forma given below

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AUDIT PLAN PROFORMA

Organisation:
Date(s): Location
Team Leader: Specialist :
Team Members:

Audit
Criteria:
Audit scope:

HOURS AUDITOR 1 HOURS AUDITOR 2

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WORKSHOP No. 7- Auditor Competence

Purpose

The purpose of this workshop is to:

 Make delegates aware of the knowledge and skills required for developing competence as
a 3rd party auditor.

Hand-outs and Material

The following material must be issued to the delegates for this exercise:

 ISO 19011:2018
 Flip Charts and marker

Additionally, PowerPoint slides on Auditor certification are also available as a hand-out

Duration:

Refer to the time table for overall time duration and follow instructions by the Trainers for
break up

THE WORKSHOP

Delegates in team should work on the Clause 7 of ISO 19011 Standard. The clause provides
guidance on technical and auditing skills as well as soft skills required for management system
auditors.

Additionally they shall refer to the PowerPoint slides on Auditor Certification given as a hand
out

The task is to read the clause 7.Competence and evaluation of auditors (of ISO 19011) of and
summarise the guidelines /their understanding on flipcharts

All teams must prepare the flipcharts covering all important elements of this clause.

Trainers will ask each team to make a brief presentation on any one or more sub clauses

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WORKSHOP No. 8- Identification and reporting ‘Non Conformity’

Purpose

The purpose of this workshop is to:

 Develop the ability to assess the available information to determine if sufficient evidence of
conformance or non-conformance has been gathered;
 Develop the ability to identify the missing information and the ways to establish this
information (audit trail);
 Develop the ability to prepare correct non-conformance report.

Hand-outs and Material

The following material must be issued to the delegates for this exercise:

 Delegate hand-outs – Workshop 8

 Flip Charts and markers

Duration:

Refer to the time table for overall time duration and follow instructions by the Trainers for
break up

THE WORKSHOP

The following are descriptions of incidents observed by the auditor during the course of an
external audit.

They contain descriptions of situations where a nonconformity report may be required. The
delegates should read the descriptions of all incidents. The teams are then required to carefully
examine the incidents allocated by the trainer, and then take one of the two following actions:
a) If you think that there is sufficient objective evidence of nonconformity then you should complete a
nonconformity report.

b) If you do not think that there is sufficient objective evidence of nonconformity then you should state
your reasons in the space below the report. You should also state what the auditor should do next i.e.
identify what must be checked before it can be determined whether or not there is any non-
conformance.

The reports should then be prepared using FLIP CHARTS OR acetate forms and markers issued
by the trainer.

The delegates must strictly present their reports in the format as given at the end of this
hand-out in either of the situations as appropriate

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Incident 1

The XYZ Ltd. is a service inspection and testing company. In the Food Analysis Laboratory
two operators were not wearing nylon caps, one operator had her laboratory coat undone and
was wearing jewellery. Other three operators were OK. Procedure FAL 002 rev.2 (which is
current version) available in area clearly describes, in clause 7, the dress code which requires
that laboratory coats must be buttoned up, nylon caps must be worn and wearing jewellery is
not permitted.

Incident 2

The XYZ Ltd. is manufacturing food products. Whilst conducting an audit in the production
area you are observing the reactor unit on the production line number 5 which is in normal
operation. The pressure gauge shows 2.8 bar. The temperature gauge shows 128 degree
centigrade. Flow meter shows 1.2 cum/min. All instruments have valid calibration stickers.
You wish to see Process Specification for this station. The operator shows the current version
of specification PSC02 that stipulates the following process parameters:

Pressure: 2.5  0.1 bar

Temperature: 130  2 centigrade
Flow: 1.15 – 1.2 cum/min

You ask the operator how often the parameters are checked. The operator explains that this
normally is done every hour and recorded in process chart. You check the charts for past few
days and notices that the parameters reading are not recorded since last shift changeover four
hours ago. The operator explains that he was busy cleaning the reactors on another line and
did not have time to take readings. You had previously reviewed the procedure PP16 that
indeed required checking and recording the process parameters every hour. Further
investigation showed that the whole batch produced on that shift did not meet the
requirements.

Incident 3

In the Quality Manager’s office you reviewed a number of internal audit reports. You notice
that regularly in all audit rounds for past two years around 70% of non-conformances were
noted in the design department. The procedures required auditing all departments at six
monthly intervals and this was followed strictly ever since implementation of the system.

Incident 4

In the production hall you noticed two weighing machines. Weighing machine serial no. 1624
had an affixed label stating due date for calibration which was over 4 months ago. Weighing
machine serial no. 1636 had no calibration label attached.

Incident 5

During the audit in the design department in XYZ Ltd., you reviewed the Design and
Development Manual and noticed that it did not contain procedures for design validation.
During the audit the you had reviewed the documentation pertinent to a selection of ten

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completed projects # 99/007, 99/010, 99/020, 99/025, 99/031, 99/042, 99/051, 99/054, 99/062
and 99/070 and were unable to find any records of design validation activity. Design Director
explained that as every design was unique and one off kind, the requirement for design
validation was not applicable to the products they were designing.

Incident 6

In the design department you reviewed the list of five-quality objective for that department.
You asked if the results of planning that was carried out to achieve these objectives were
documented. The design director replied that any such document was not prepared, as he
believed that it would suppress the creativity.

Incident 7

In the material stores auditor noticed that there were no tags or stickers to show the inspection
status of the materials. You previously visited the assembly line and noticed that tags or
stickers were being used to identify the inspection status. The storekeeper explained that
there was no need to use stickers or tags as all incoming material was kept in the receiving
area until verified and accepted. Only accepted material was being allowed into designated
areas.

Incident 8

In the Quality Manager’s office you review the internal audit reports and note the following:

Report 03 shows two corrective actions outstanding (due ten months ago)
Report 05 shows one corrective action outstanding (due six months ago)
Report 07 shows one corrective action outstanding (due four month ago)
There is no evidence of follow-up action.

Incident 9

The hospital, XYZ plc, operates emergency ambulance services. Whilst auditing the
Ambulance Department you ask if there were any documented procedures or instructions for
paramedics covering first aid, resuscitation, etc. The head of the department explained that as
all paramedics are highly competent there was no need to have any such instructions in
writing.

Incident 10

XYZ plc manufactures various cosmetics. In the despatch area you are reviewing the products
released for shipment and notice that the quantity of anti-wrinkle night cream “Gloria”
(Production Order Number 99/6802) which was kept on three pallets and marked ‘ready for
shipment’, did not have the following marked on the boxes:

 Batch number.
 Production date.
 Expiry date.

Procedure FP 001, clause 7.8 requires that the above-mentioned information must be printed on
the boxes for all creams and lotions

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If you think there is sufficient evidence to report your findings as a nonconformity, complete the
following nonconformity report.
Incident Number......

NONCONFORMITY REPORT

Description of the nonconformity:

Objective Evidence

ISO 9001:2015 clause and requirement:

OR
Give your reason(s) for thinking there is not yet sufficient evidence to report your findings as a
nonconformity.

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Describe how you would investigate further to determine conformity or nonconformity. Include
audit trails you would follow and specific examples of audit evidence you would seek and for what
purpose.

Incident Number......
Audit investigation template:
Reason why there is not yet sufficient evidence for reporting nonconformity

Audit trails you would follow, including, evidence sought and purpose
Audit Trail Evidence Sought Purpose

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WORKSHOP No.9 – AUDIT PLAN MATRIX

The objectives of this workshop are to prepare the delegates to:

 How to develop a workable and useful audit plan to perform third party audit in an
auditee organisation in the context of certification process.
 To cover appropriate clauses of ISO 9001:2015 with their processes.

Duration:

Refer to the time table for overall time duration and follow instructions by the Trainers for
break up

Handouts and material

Documented information of Beta Training

Flip Charts and Markers
Process Matrix - paper copy
ISO 9001:2015 Standard

Workshop

The case study is based on a third party audit initiated by an external organisation
which Bureau Veritas has to conduct under contract requirements and of ISO 9001.

In Continuation of the Preparation for the Stage 2 audit of the organisation for a third party
certification process, the teams shall prepare an “Audit plan Matrix”. The audit plan matrix
must ensure that the team will not only be able to assess individual processes but also
ensure the intent and depth of audit of each process by understanding the applicability of
relevant clauses of the Audit Criteria.

Based on “Workshop-Planning for Stage 2 audit” the team shall use the information to prepare
the matrix

The audit plan matrix shall indicate what elements of the standards will be looked at in various
departments / processes.

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ISO9001:2015 Process Matrix Page of

COMPANY:
Processes (Functions)
Scope of audit:

4.1 Understanding the organization and context

4.2 Understanding the needs and expectation of
interested parties
4.3 Determining the scope of the QMS
4.4 QMS and its processes
5.1 Leadership and Management commitment
5.2 Quality policy
5.3 Organizational roles, responsibilites and authorities
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented Information
8.1 Operational planning and control
8.2 Determination of requiements for products and
services
8.3 Design and or development of products and
services
8.4 Control of externally provided products and
services
8.5 Production and Service Provision
8.6 Release of products and services
8.7 Control of non conforming process outputs ,
products and services
9.1 Monitoring, measurement, analysis and
evaluation
9.2 Internal Audit
9.3 Management Review
10.1 General
10.2 Non Conformity and corrective action
10.3 Continual Improvement

Workshop 10: Identification of Audit Trails

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The objectives of this workshop are:

1. To understand the process identifying audit trails using the knowledge of interaction/ interfacing
of various requirements of clauses with each other
2. To gain an insight into how to identify specific, promising audit trails
3. To achieve an understanding on the questioning to be done, evidences to be sought and
analyse the evidences in the light of the requirements

Duration:

Refer to the time table for overall time duration and follow instructions by the Trainers for
break up

Material provided for Workshop:

Documented Information of the Beta

Flip-chart and markers

Workshop

The trainer will allocate one clause of the standard to each team. Thus each team will have different
clauses of the standard to work upon

The delegates will have studied the organisation’s documentation. However they are advised to
understand the organisation in more details.

With this knowledge and that of ISO 9001 Standard, they are expected to work in teams and identify
which other clauses of the standard interact or interface with the clause allotted to the team

Teams shall prepare their presentation in the format given below with the allocated clause shown at the
centre of the diagram (This diagram is known as Octopus Diagram)

Make reference to the relevant clauses of the standard. While presenting the information, delegates
must also depict the direction of the arrows to indicate which clause gives input to the central clause
and vice versa.

(It must have been realised by the delegates during this workshop that each clause of the standard has
one or more output(s) which become(s) input to one or more other clause(s) of the standard and vice
versa. (i.e.,output of other clauses become inputs to them )

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8.2
Determinatio
n of
requirement
for products
and services

WORKSHOP No. 11- Developing an AUDIT CHECKLIST

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The objectives of this workshop are to prepare the delegates to:

 Understand how to develop a workable and useful audit checklist to perform third party
audit in the auditee organisation.

 To cover appropriate clauses of ISO 9001:2015 with their business activities including
processes and procedures.

Duration:

Refer to the time table for overall time duration and follow instructions by the Trainers for
break up

Workshop Material:

 The Documentation of Beta Training

 Flip Charts and markers OR
 Outputs of earlier workshops

WORKSHOP

The case study is based on a third party audit contract agree between Beta Training and
Bureau Veritas Certification for conducting Stag 2 audit of the QMS and has to ensure
under contract requirements and of ISO 9001.

Based on Workshop-Stage 2 Audit Planning and Workshop-Audit Plan Matrix the team shall
use the time planned for the audit. TRAINER shall allot one process to each team to prepare
the checklist for subsequent workshop on auditing role play.

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 trainer in any
appropriate format, having at least the following headings:
 Process Activities
 Reference documents
 ISO 9001 clauses
 Items to check
 Space for notes
 Time allocation

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 Checklist

Company: Process: Page Nº:

ISO 9001 Cl.

Process / Ref To Check Notes Time
Activities Documents

Auditor: Date: Signat

ure:

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WORKSHOP No. 12 – CONDUCTING OPENING MEETING

Purpose of this workshop:

To prepare the delegates to understand and practice:

 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.

Duration:

Refer to the time table for overall time duration and follow instructions by the Trainers
for break up

Workshop Material:

Documented information of Beta Training

Plain Paper & pen/ Pencils
Stage 2 audit preparation documents (Audit Plan, Matrix & Checklist)

Workshop

The case study is based on a third party audit initiated by an external

organisation which Bureau Veritas Certification has to conduct under
contractual requirements to verify their conformance to the requirements of ISO
9001:2015.

Each team has to prepare to conduct an opening meeting with the management of the
auditee organisation in line with the recommended agenda given in ISO 19011 & Pre
course reading material

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

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Workshop 13: Auditing Top Management

The objectives of this workshop are:

1. How to approach the audit of the Top Management in the context of understanding
their commitment for the QMS and their overall responsibility and accountability for the
QMS
2. To gain an insight into how to frame right questions and seek appropriate evidences
from Top Management to verify conformance to the requirements
3. To understand the auditors’ attitude and skills required to be practiced while auditing
Top Management of any organization

This workshop is to be conducted in 2 parts.

Part 1 - is on preparing to audit and

Part 2 -is the role play of ‘auditing the Top Management’

Part 1 of the workshop - Preparation for auditing Top Management

Materials: Documentation of the Organisation provided by the trainers

Flipcharts and marker pens / acetates and pens/ plain paper

Time Allocation:

Refer to the time table for overall time duration and follow instructions by the Trainers
for break up

Workshop

Delegates in team are required to familiarize themselves with the documentation of the
organization, understand who the Top Management in the company are and their specific
roles and responsibilities within their organization and prepare for auditing Top Management.

At the end of group work they must come out of a set of logical and sequential questions,
relevant documents to be seen and records to be obtained while auditing Top Management of
the organisation.

Teams are expected to document the output of planning in either flip charts/ acetate sheets /
plan papers

Part 2 of the workshop- Auditing the Top Management

Each team is assigned to audit the Top Management of this organisation.

Each group will then act as an audit team and audit the Top Management. Here trainer(s) will
facilitate as Top Management of the Organisation.

Time Allocation:

Refer to the time table for overall time duration and follow instructions by the Trainers
for break up

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WORKSHOP No. 14 – ROLE PLAY – INTERVIEWS-Process Audits

The objectives of this workshop are to be prepare the delegates to:

 How to use a workable and developed audit checklist to perform third party ‘process
audit’ in the auditee organisation.
 To learn audit techniques, seeking appropriate audit evidences and evaluating
objectively to determine conformance or otherwise to the requirements
 Develop the art of time management and prioritization during audit
 Develop ability to decision making in difficult / unexpected situations and act
appropriately.

Duration:

Refer to the time table for overall time duration and follow instructions by the Trainers
for break up

Workshop

Part 1 preparation for the Process Audit (role play)

The case study is based on the third party audit initiated by an external
organisation which Bureau Veritas Certification has to ensure under contract
requirements and of ISO 9001:2015.

Based on results of Workshops on Stage 1 audit, Stage 2 audit planning, Process

Matrix and the learning achieved by the delegates and with the help of prepared
checklists in Workshop 7, the team will conduct interviews with the members of the
external organisation in order to verify conformity to all the relevant requirements.

Part 2 Role Play – Process audits (role play)

The trainers will provide the necessary arrangements to facilitate actual conduct of
audits of processes. There would be auditees representing the organisation and they
would provide all answers for the auditors’ queries and also relevant documents and
records.

Trainers will invite each team separately the teams have to visit the meeting venue
and conduct a formal audit. Trainers will observe the audit process and evaluate the
team and each team members on various parameters.

Time for individual group’s role play: will be decided by the trainers on the interview
spots depending on the number of teams available

Feedback and discussion

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WORKSHOP No. 15 – Observing an acceptable–through Role Play by trainers.

The Purpose of the Workshop

The purpose of the workshop is to:

 Enable delegates analyse good and bad practices in interviewing;

 Provide visual display to the delegates of the good practices followed in an actual
audit.
 Relate their own auditing experience with the auditing practice demonstrated in the
video.

Material

Not Applicable.

Duration:

Refer to the time table for overall time duration and follow instructions by the Trainers
for break up

Workshop:

Delegates are required to keenly observe the Role Play enacted by the Trainer(s) and
make notes about the whole audit process.

The delegates should bring out the following points during Video presentation

- Introduction of the auditor

- Beginning with ‘warm-up’ sentences, and generic subjects
- Conversing with the auditee and not ‘bombarding’ him with questions
- Asking open questions
- Providing positive feedback to the auditee when deserved
- Asking only relevant questions
- Clarifying questions when the auditee is in doubt
- Showing real interest in the subject while conducting the interview
- Good observation skills
- Taking notes
- Informing the auditee when non-conformities are found
- Closing the audit with summarization

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WORKSHOP No. 16 – PREPARATION FOR CLOSING MEETING

The objectives of this workshop are to prepare the delegates to:

 Write nonconformity reports/corrective action requests during /after the audit in

an ORGANIZATION.
 To practice writing an accurate summary of the audit, including positive audit
findings and opportunities for improvement.
 To enable delegates to understand the essential elements of a good audit
report and understand how the auditee organization would evaluate their audit
report and Non Conformity Reports

Hand-outs and material

CAR forms as needed (Workshop hand-out CAR forms)

Blank paper for preparing the audit summary report

Duration:

Refer to the time table for overall time duration and follow instructions by the Trainers
for break up

Workshop

Based on the findings of Role Play on auditing processes each team has to prepare to
conduct a closing meeting with the management of the auditee organisation in line
with the recommended agenda described in the pre course study material (PowerPoint
Chapter on - Audit Management) and ISO 19011 standard

Each team shall prepare and present any nonconformities that they have identified
during the role play interviews of process audits, using the forms provided (CAR
forms).

The teams shall at the end prepare a formal Audit Summary Report in line with the
recommendations described in Pre course study material (PowerPoint slides on –
Reporting) to hand over to the Top Management (maximum one page).

CORRECTIVE ACTION REQUEST

Company: Date: CAR No:

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Auditor: Auditee:
Nonconformity:

Objective Evidence:

Requirement of the ISO 9001 standard (including Clause number):

Signed: Date:
Correction:

Root Cause

Proposed Corrective Action:

Proposed Completion Date:

SIGNED DATE:

Verification of Corrective Actions :

Signed Date:

Review of effectiveness of Corrective Action:

Signed: Date:

WORKSHOP No. 17 – Role Play- CLOSING MEETING

The objectives of this workshop are to be prepare the delegates to know:

Oct’18 PR328: QMS ISO 9001:2015 Lead Auditor Training Course (17929)
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 How to conduct a successful closing meeting during a third party audit of an

auditee organisation in accordance with the requirements of ISO 19011 &
17021

Hand-outs and material

Delegates CAR’s and Audit Summary Report prepared in Workshop 16.

Duration:

Refer to the time table for overall time duration and follow instructions by the Trainers
for break up

Workshop

The case study is based on a third party audit initiated by an external

organisation which Bureau Veritas Certification has to ensure under contract
requirements to verify conformance to ISO 9001:2015.

Based on the prepared audit findings and summary report of earlier workshop, the
team will conduct closing meeting with the members of the auditee organisation in
order to clarify that third party audit is completed and the audit conclusions are
communicated to the organization in a summarized manner

Oct’18 PR328: QMS ISO 9001:2015 Lead Auditor Training Course (17929)