Delegate Workbook: CQI-IRCA Certified:-PR 328:QMS ISO 9001:2015 Lead Auditortraining Course (Course ID:17929)

 

CQI-IRCA Certified:PR 328:QMS ISO 9001:2015 LEAD AUDITORTRAINING AUDITORTRAINING COURSE (Course ID:17929)

DELEGATE WORKBOOK EXERCISES & WORKSHOPS

 

 Delegate Workbook Bureau Veritas Certification

Table of Contents

TABLE OF CONTENTS

Section

Title:

Exercise

0

Delegate Introduction-hand-out Introduction-hand-out

Exercise

1

Case Study review-hand-out

Exercise

2

Auditing Terminology-hand-out Terminology-hand-out

Exercise

3

Communication-hand Communication-hand-out -out

Exercise

4

Reviewing Corrective Action-hand-out

Workshop 1

Auditing Context, Planning and Support processes- hand-out

Workshop 2

Auditing Customer processes and Operation-hand-out Operation-hand-out

Workshop 3

Auditing perf evaluation & Improvement

Workshop 4 Workshop 5

Planning for Stage 1 Audit-hand-out Conducting Stage 1 Audit-hand-out

Workshop 6

Planning for Stage 2 audit-hand-out audit-hand-out

Workshop 7

Auditor Competence

Workshop 8

Identification and & reporting Non Conformity-hand-out Conformity-hand-out

Workshop 9

Audit plan matrix-hand-out

Workshop 10

Audit Trail Identification-hand-out Identification-hand-out

Workshop 11

Checklists- hand-out and format

Workshop 12

Conducting Opening meeting-Role Play

Workshop 13

Auditing Top Management-Role Management-Role play – Interviews

Workshop 14

Auditing Processes-Role play – Interviews

Workshop 15*

Demonstration of an acceptable audit

Workshop 16

Preparation for closing meeting

Workshop 17

Role play-Closing Meeting

*Workshop 15 is observing an actual auditing scenario to be demonstrated by the TRAINERs

Oct’18

CQI-IRCA Certified QMS ISO 9001:2015 Lead Auditor Training Course (17929)

Page 1 of 1 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification

 

EXERCISES

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 1 of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification

EXERCISE No. 0: DELEGATE INTRODUCTION- MINI INTERVIEW I NTERVIEW 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 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 t he 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.

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 2  of  of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification

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)  

Type: 1st party

Auditing experience: (Please write the numbers in respective columns)

No. of audits:

Nil Up to 5 5 – 10 10 & more

(Internal)

2nd party

3rd party

(Supplier)

(Certification)

Personal objectives in attending the course

Other information about interviewee that may be useful for auditor to know

Date: Auditor name:

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 3 of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas 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 tto o 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 and  follow instructions by the Trainers for break up Nature of the Activity

 Team work on gathering a quick overview of 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

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 4 of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification

EXERCISE No. 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 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 set of cards (differently coloured) containing printed text giving definitions of Another those terms.

Teams are required to match the terms with their definitions (there may m ay 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.

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 5  of  of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas 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 discuss the terms of a large order. On the way to that office the buy buyer er slipped on a freshly waxed waxed floor, and as a resu result lt received a badly bruis bruised ed leg. By the time Smith was notified of the accident, Jones Jones was on the way to the hospital 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 ac FACT actually tually happened. INFERENCE   = May be a tru INFERENCE truth; th; something that may or may not hav have e happened.

Statement

Fact

Inference

1. Jones was suppose supposed d 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.

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 6  of  of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification

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 Conformities reported during a /3rdpresented  party auditby organizations in response to the Non

Duration: Refer to the time table for overall time duration and follow 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 accepta acceptable, ble, what evidence will you look for accepting the propos proposed ed 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.

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 7  of  of 51  51 

 

 Exercise and Workshops

 Delegate Hand-out

Bureau Veritas Veritas Certification

CORRECTIVE ACTION REQUEST  Company:  Auditor: Non-conformity:

Date: Auditee:

NCR Number: 1

The process of documentation control is not effective eff ective Objective Evidences:While 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. Requirements:ISO 9001:2015 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: Cause & Proposed Corrective Action:

Date:

Corrective Action – Approval records will be created and added on file. Recommended by – Quality Manager Proposed Completion Date:

DATE:

SIGNATURE

Corrective Action Review:

Signed:

 Dec’19

Date:

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 8  of  of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification

CORRECTIVE ACTION REQUEST  Company:  Auditor:

Date:

NCR Number: 2

Auditee:

Non Conformity: The process of planning for the necessary documentation is not effective Objective Evidences: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. Requirements:ISO 9001:2015 4.4 requires “The organization shall maintain documented information to the extent necessary to support the operation of processes”. Signed: Cause & Proposed Corrective Action:

Date:

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

DATE:

SIGNATURE

Corrective Action Review:

Signed:

 Dec’19

 

Date:

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 9 of 51  51 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification

CORRECTIVE ACTION REQUEST  Company:  Auditor:

Date:

NCR Number: 3

Auditee:

Non Conformity: The process of evaluation and selection of suppliers is not implemented fully Objective Evidences: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’. 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.”

Requirements:ISO 9001:2015-8.4.1 The organization shall determine and apply criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements. The organization shall retain documented information of these activities and any necessary actions arising from the evaluations.

Signed: Cause & Proposed Corrective Action:

Date:

Corrective Action - From now on records will be created of all evaluations and reevaluations of suppliers, and will be maintained on file. Recommended by – Quality Manager Proposed Completion Date:

DATE:

SIGNATURE

Corrective Action Review:

Signed:

 Dec’19

Date:

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 10  of  of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification

CORRECTIVE ACTION REQUEST  Company:  Auditor:

Date:

NCR Number: 4

Auditee:

Non Conformity: The process of managing customer property is not effectively implemented Objective Evidences:Evidence of customer owned materials was found in manufacturing – valves for incorporation into the pumps – but these were not identified as customer property. Requirements:ISO 9001:2015-8.5.3 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: Cause & Proposed Corrective Action:

Date:

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:

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 11 of 11 of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification

CORRECTIVE ACTION REQUEST  Company:  Auditor:

Date:

NCR Number: 5

Auditee:

Non Conformity: The process of creating awareness among employees not implemented effectively Objective 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 Requirements:ISO 9001:2015-7.3 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: Cause & Proposed Corrective Action:

Date:

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 induc induction tion programme which will include this subject. Recommended by – Management Representative Signature

Corrective Action Review:

Signed:

 Dec’19

Date:

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 12  of  of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification

CORRECTIVE ACTION REQUEST  Company:  Auditor:

Date:

NCR Number: 6

Auditee:

Non Conformity: The process of identification identification of process outputs (products) is not implemented effectively Objective evidences:During the audit of packaging and despatch area of a pharmaceutical products, the auditor discovered that that there was no identification identification of of any unit leaving leaving the company. company. The contract requires that every unit be uniquely identified at all stages of product realization chain and records maintained. Requirements: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: Corrective Action Review:

SIGNATURE

Signed:

 Dec’19

Date:

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 13 of 13 of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification

CORRECTIVE ACTION REQUEST  Company:  Auditor:

Date:

NCR Number: 7

Auditee:

Non Conformity: The process of identifying the status of measuring equipment is not implemented effectively

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

Requirements:7.1.5.2 Measurement traceability When measurement traceability traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement measurement results, measuring equipment shall be: a) 

calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information;

b) 

identified in order to determine their status; s tatus;

Signed: Cause & Proposed Corrective Action:

Date:

Corrective Action –All items of measuring equipment will be suitably identified, identified, records raised, and their current calibration status determined. Recommended by - The Quality Manager

Proposed Completion Date:

DATE:

SIGNATURE

Corrective Action Review:

Signed:

 Dec’19

Date:

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 14 of 14 of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification

CORRECTIVE ACTION REQUEST  Company:  Auditor:

Date:

NCR Number: 8

Auditee:

Non Conformity: The process of Corrective actions has not been implemented effectively

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

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

Signed: Cause & Proposed Corrective Action:

Date:

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:

 Dec’19

Date:

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 15  of  of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification

CORRECTIVE ACTION REQUEST  Company:  Auditor:

Date:

NCR Number: 9

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: Cause & Proposed Corrective Action:

Date:

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. QMS. Proposed Completion Date:

DATE:

SIGNATURE

Corrective Action Review:

Signed:

 Dec’19

Date:

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 16  of  of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification

CORRECTIVE ACTION REQUEST  Company:  Auditor:

Date:

NCR Number: 10

Auditee:

Non Conformity: The process of maintaining the traceability of authority to release the products

Objective Evidence:During the audit it was noted the records did not indicate who the authority was, for the final release of the product. It could not be identified as to who wa was s the one who released the prod products ucts

Requirements:-

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: Cause & Proposed Corrective Action:

Date:

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. release . Recommended by – Management Representative

Proposed Completion Date:

DATE:

SIGNATURE

Corrective Action Review:

Signed:

 Dec’19

Date:

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 17  of  of 51  51 

 Delegate Hand-out  Exercise and Workshops

 

Bureau Veritas Veritas Certification

 WORKSHOPS 

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 18  of  of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification

Workshop 1- Auditing Context, Planning and Support Format:: 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 s skills kills to au audit dit particular requirements in the background of a case study organization. - To develop the s skills kills fo forr dev developing eloping audit c checklist hecklist - 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 - To enable delegates tto o appreciate the “Planning “Planning”” part (PDC (PDCA) A) of the QMS of an organization and how to audit this segment of the PDCA Cycle 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 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 implemented a quality management system based on ISO 9001:2015 standard You are scheduled for conducting an on-site 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 set of questions related to the internal and external issues encountered and all possible interested parties and their needs and expectations related to ‘Beta Training Training’in ’in the follow following ing format : Sr No

 Dec’19

External

Issues Internal

Interested parties Interested Party Needs and expectations

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 19 of 19 of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification

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 shal shalll 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 No

What to check /ask / look for

Related Related evidence to Clause No look for

Remarks/ Comments

Since 4, 6 and 7 Clauses would practically apply to all processes/ departments of Beta, delegates can make a generic checklist keeping in mind any process(es) of Beta Training.

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 20  of  of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Format:: Format

Bureau Veritas Veritas Certification Workshop 2-Auditing ‘Operation’

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 s skills kills fo forr dev developing eloping audit c checklist hecklist 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 To enable delegates to appreciate the “DO” part (PDCA) of the QMS of an organization and how to audit this segment of the PDCA Cycle

Material and Equipment Documentation of Beta Training ISO 9001:2015 Flipchart & Markers Duration: Refer to the time table for overall time duration and follow 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 imple implemented mented a quality management sys system tem 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 shal shalll prepare a detailed checklist to verify conformance of the QMS of Beta Training T raining 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:

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 21 of 21 of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification

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 No

What to check /ask / look for

remarks Related Related evidence to Clause No (Leave this look for 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.

Workshop 3-Auditing ‘performance evaluation and improvement’

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 22  of  of 51  51 

 

 Delegate Hand-out  Exercise and Workshops Bureau Veritas Veritas Certification Format:: 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 s skills kills fo forr dev developing eloping audit c checklist hecklist 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 To enable deleg delegates ates to appreciate the “CHECKING” & “ACTING” par partt (PDCA) of the QMS of an organization and how to audit these segments of the PDCA cycle.

Material and Equipment Documentation ISO 9001:2015 of Beta Training Flipchart & Markers Duration: Refer to the time table for overall time duration and follow and  follow instructions by the Trainers for break up Delegate briefing. The background scenario: Beta Training is an organization / company who is into int o design, development and delivery of training modules to industry. industry. They have implement implemented ed a quality manag management ement 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 shal shalll prepare a detailed checklist to verify conformance of the QMS of Beta Training T raining with the requirements.

The teams shall prepare the checklist in the following format

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 23 of 23 of 51  51 

 

 Delegate Hand-out  Exercise and Workshops Sr What to check /ask / look for No

Related evidence to look for

Bureau Veritas Veritas Certification Related remarks Clause No

 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.

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 24 of 24 of 51  51 

 

 Delegate Hand-out  Exercise and Workshops Bureau Veritas Veritas Certification Workshop 4 - Planning for Stage 1 Audit

Format:: Format

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

Objectives: - To prep prepare are deleg delegates ates for planning for on-site stage on one e 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 dev develop elop the ability to determine the audit scope and d determine etermine resourc resource e 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 and  follow instructions by the Trainers for break up Delegate briefing. The background: 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 inf ormed about such plans and the time scale. Delegates Tasks and Deliverables -

Based on the review of the documentation of the organization the teams shal shalll 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 th the e siz size eo off the company (No o off employ employees) ees) dele delegates gates must determine th the e 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 inclu include de the scope of the audit and identification o off the audit team.

Feedback session Teams in turn sh shall all present their conclus conclusions ions and outputs. moderates the discussion.

 Dec’19

Trainer ani animates mates an and d

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 25  of  of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification Guidelines on allocation of auditor days

1. Determine the amount of work inv involved olved and the time duratio duration n that will be req required uired – 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 require requirements ments specified by IAF for Quality Management System audits 2. It must be understood that the time req required uired for the audit dep depends ends 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 MD5:2019)

Effective Number of Personnel 1-5 6-10 11-15 16-25 26-45 46-65 66-85 86-125

Audit Time (Stage 1 + Stage 2) 1.5 2 2.5 3 4 5 6 7

Effective Number of Personnel 626-875 876-1175 1176-1550 1551-2025 2026-2675 2676-3450 3451-4350 4351-5450

Audit Time (Stage 1 + Stage 2) 12 13 14 15 16 17 18 19

126-175

8

5451-6800

20

176-275 276-425 426-625

9 10 11

6801-8500 8501-10700 >10700

21 22 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 (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:

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 26  of  of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification



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

Decreased auditor time:          

Very small site for number of employees employees (e.g., office complex only) Very Few processes, processes , Maturity of management 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 ffacilitate acilitate effective presentations and group discussions

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 27  of  of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

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

Bureau Veritas Veritas Certification AUDIT PLAN PROFORMA  PROFORMA 

Location

 Audit Criteria  Audit scope:

Day

Time

Area/Activity

Auditor

Guide

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 28  of  of 51  51 

 

 Delegate Hand-out  Exercise and Workshops Bureau Veritas Veritas Certification 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 unk unknown nown org organisation anisation 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 be between tween a Quality Manu Manual al and the appro appropriate priate 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 u understanding nderstanding o off the applic applicability ability 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 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 co contract, ntract, Bureau Veritas Certification Certification management has appointed you to audit Beta Training’s  Training’s  quality management system against the requirements of ISO 9001:2015 standard 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.

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 29 of 29 of 51  51 

 

 Delegate Hand-out  Exercise and Workshops Bureau Veritas Veritas Certification 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 s stage tage 2 audit o off an organisation. 2. To cover appropriate c clauses lauses of ISO 9001:20 9001:2015 15 with the process processes es 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 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

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

 

 Delegate Hand-out

Page 30  of  of 51  51 

 Exercise and Workshops

Bureau Veritas Veritas Certification

AUDIT PLAN PROFORMA Organisation: Date(s):

Location

Team Leader:

Specialist :

Team Members:  Audit Criteria:  Audit scope:

HOURS

 Dec’19

AUDITOR 1

HOURS

AUDITOR 2

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 31 of 31 of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification

WORKSHOP No. 7- Auditor Competence  Competence  Purpose The purpose of this workshop is to:  

Make d delegates elegates aw aware are of the know knowledge ledge and skills req required uired 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, CQI-IRCA Documents on Auditor certification (provided in pre course material) and PowerPoint Handout 10 (provided along with delegate manual) shall also be referred to. Duration: Refer to the time table for overall time duration and follow 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 flipcharts covering  covering all important elements of this clause. Trainers will ask each team to make a brief presentation on any one or more sub clauses

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 32  of  of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification

WORKSHOP No. 8- Identification and reporting ‘Non Conformity’ Conformity’   Purpose The purpose of this workshop is to:  

Develop the ability to assess the available informa information tion to determine determine if su sufficient fficient 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 and  follow instructions by the Trainers for break up THE WORKSHOP The following are descriptions of incidents observed by you during the course of an external audit. They contain descriptions of situations where a nonconformity report may may  be required. The delegates should should read the desc descriptions riptions of all incidents. incidents. The teams are th then en 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 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

Incident 1

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 33 of 33 of 51  51 

 

 Delegate Hand-out  Exercise and Workshops Bureau Veritas Veritas Certification The XYZ Ltd. is a service inspection 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 wearing jewellery. Other three operators we were re 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. 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 pressu pressure re gauge s shows hows 2.8 bar. The temperature g gauge auge show shows s 128 deg degree ree centigrade. Flow meter shows 1.2 cum/min. All instruments have have valid calibration stickers. stickers. You wish to see Process Specification for tthis his station. The operator shows the curre current nt version of specification PSC02 that stipulates the following process parameters: Pressure:

2.5  0.1 bar

Temperature: Flow:

130  2 centigrade 1.15 – 1.2 cum/min

You ask the operator operator how often the para parameters meters are checked. The operator explains th that at this normally is done every hour and recorded in process chart. chart. You check the c charts harts for past few days and notices that the parameters reading are not recorded since last shift changeover four hours ago. The operator explains th that at he was busy cleaning the reactors on another line and did not not have time to take reading readings. s. You had prev previously iously reviewed the procedure PP16 that indeed required checking and recording the process parameters every hour. Further investigation show showed ed that the whole batc batch h produced on th that at shift did not meet the requirements. Incident 3 In the Quality Manager’s office you reviewed 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. department. The procedures requ required ired auditing all departments at six six monthly intervals and this was followed strictly ever since implementation of the system. Incident 4 In the production hall you you noticed two weighing machines. Weighing machine serial no 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. Further you reviewed the documentation pertinent to a selection of ten 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 any records of desig design n validation activity activity.. Design Director explaine explained d that as every design was unique and one off kind, the requirement for design validation was not applicable to the products they were designing.

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 34 of 34 of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification

Incident 6 In theasked design department reviewed listcarried of five-quality objective for that department. You if the results ofyou planning thatthe was out to achieve these objectives were documented. The design director replie replied d that any such document was not prepared, as he believed that it would suppress the creativity. Incident 7 In the material stores you 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 identify the inspection status. The storekeeper explained th that at there was no need to use stickers or tags as all incoming material was kept in the receiving area until verified and accepted. accepted. Only accepted material was was being allowed into designa designated ted 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 Report 05 shows one corrective action outstanding Report 07 shows one corrective action outstanding There is no evidence of follow-up action.

(due ten months ago) (due six months ago) (due four month ago)

Incident 9 The hospital, XYZ XYZ plc, op operates erates emergency ambulance serv services. ices. Whilst auditing the  Ambulance Department you ask if there were any documented procedures or or instructions for paramedics covering first aid, resuscitation, etc. The head of the dep department artment explained that as all paramedics are highly competent there was no need to have any such instructions in writing.

Incident 10 XYZ plc manufactures manufactures various c cosmetics. osmetics. In the despatc despatch h 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 Incident 11

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 35  of  of 51  51 

 

 Delegate Hand-out  Exercise and Workshops Bureau Veritas Veritas Certification In the organization ABC, while auditing Purchase function for Risk Process, the Purchase Manager replied that he has only one risk identified due to the external issue related to a

single supplier forshe a key input material 6. decided When asked how they have180 planned to address this risk informed that theyPA have to always maintain days of inventory to face any potential crisis situations due to the supply chain issues arising out of this single supplier. On further investigation, it was found that during the past 12 months period after this decision was implemented, there are several occasions when the inventory levels were found to be much lower than stipulated level. When questioned, the Manager said it is always not possible to maintain this level of inventory. In fact, in the production line that you had visited earlier, it was indeed found that production had been stopped due to shortage of this key input. Incident 12 During an audit of multidiscipline engineering design, consulting and project management firm you review the project control control process. The process involv involves es number of gateway gateways s at which approvals approvals by authorised personnel are required. Gateway 3 – authorisation to submit fee proposal involves a risk assessment where number of questions related to financial, commercial, quality, OH&S, environmental and other issues need to be answered. The software then calculates the level o off risk (low (low,, medium and high). Depending on the risk, gateway approval would require authorisation at differed organisational level (Low Risk – Project Manager; Medium Risk – Regional Director; High Risk - Technical Director. Director. You reviewed a sample of ten large projects and noted the following: a) Project number 20XX/0078 – the fee pro proposal posal was issued to the client client on 16th  of June 20XX, the clients purchase order was received on 28 th of June 20XX and the work on the project work commenced on the 1st  of August 20XX. Gateway 3 th

approval was signed off on the 30  of November (ten days before the audit). b) Project number 20XX/0137 – The project control process records showed that project was classed as high risk, yet gateway 3 approval was authorised by the regional Director. c) Project number 20XX 20XX/0162 /0162 – The project co control ntrol records showed that 17 out of 42 questions included in the risk assessment questionnaire were not answered.But the project found to have been completed

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 36  of  of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification If you think there is sufficient evidence to report your findings as a nonconformity, complete

the following nonconformity report. 

Incident Number...... 

NONCONFORMITY NONCONFORMIT Y 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.

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 37  of  of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification

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

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 38  of  of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification

WORKSHOP No.9 – AUDIT PLAN MATRIX M ATRIX 

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

How to develop a workable and use useful ful audit plan to perform third party au audit dit in an auditee organisation in the context of certification process.   To c cover over appropriate c clauses lauses of ISO 9001:2015 with their proces processes. ses.

Duration:

Refer to the time table for overall time duration and follow and  follow instructions by the Trainers for break up Handouts and material Documented information of Beta Training Flip Charts and Markers Process Matrix Template giving in this handout ISO 9001:2015 Standard BACKGROUND In the previous workshops you have prepared a detailed audit plan covering all the processes of Beta Training to be audited during Stage 2 audit. Being a new auditor you may find it difficult to remember which clauses (and requirements of) ISO 9001:2015 would apply to the process being audit and at times you may be at a loss to realize as to how to approach the audit or where to start from. Therefore if you have a matrix document which identifies the applicability of various clauses of the standard to different process of the organization it would come handy to approach the audit systematically

Workshop In continuation of the preparation for the Stage 2 audit of Beta Training, the teams shall prepare an “Audit plan Matrix”. The audit plan matrix must ensure that the team will be able to 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  “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.

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 39 of 39 of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification ISO9001:2015 Process Matrix

COMPANY: Scope of audit:

Processes (Functions)

Page

of

4.1

Understanding the organization and context

4.2 4.3

Understanding the needs and expectation of interested parties 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 Design and or development of products and services Control of externally provided products and services

8.3 8.4

8.5 8.6 8.7 9.1 9.2 9.3 10.1 10.2 10.3

 Dec’19

Production and Service Provision Release of products and services Control of non conforming process outputs , products and services Monitoring, measurement, analysis and evaluation Internal Audit Management Review General Non Conformity and corrective action Continual Improvement

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 40  of  of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification

Workshop 10: Identification of Audit Trails

The objectives objectives of  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 into how to identify specific, specific, promising audit 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 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 knowledg e and that of ISO 9001 Standard, they are expected expect ed 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 know known n 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 )

 Dec’19

 

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 41 of 41 of 51  51 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification

8.2 Determinatio n of requirement for products and services

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 42  of  of 51  51 

 

 Delegate Hand-out  Exercise and Workshops

Bureau Veritas Veritas Certification

WORKSHOP No. 11- Developing an AUDIT CHECKLIST  The objectives of this workshop are to prepare the delegates to:  

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

 

To cover appropriate claus clauses es of ISO 9001:2015 w with ith their busines business s activities including processes and procedures.

Duration: Refer to the time table for overall time duration and follow 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  Plan  Matrix   the team shall use the time planned for the audit. TRAINER shall allot one process to each 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  

 Dec’19

CQI-IRCA Ce Certified rtified PR 328: QMS ISO 9001:2015 9001:2015 Lead A Auditor uditor Training C Course ourse (179 (17929) 29)

Page 43 of 43 of 51  51 

 

Checklist

Company:

Process:

Process /

Ref

Activities

Documents

ISO 9001 Cl.

Page Nº: To Check

Notes

Time

Auditor:

Date:

Signat ure:

Oct’18 CQI-IRCA Certified PR 328:QMS ISO 9001:2015 Lead Auditor Training Course (17929) P age age 43 of 43 of 51  51 

 

Delegate Hand-out  

 

 Exercises and Workshops

Bureau Veritas Veritas Certification

WORKSHOP No. 12 – CONDUCTING OPENING MEETING Purpose of this workshop: w orkshop: To prepare the delegates to understand and practice:  

How to conduct a succes successful sful 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 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  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 Meeting of Stage 2 audit shall be conducted conducted

Oct’18

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

 

Delegate Hand-out  

 

 Exercises and Workshops

Bureau Veritas Veritas Certification

Workshop 13: Auditing Top Management The objectives objectives of  of this workshop are: 1. How to approach approach the audit audit of the Top Management Management in in the context context of understanding understanding their commitment for the QMS and their overall responsibility and accountability for the QMS 2. To gain an insight insight into how to frame right questions questions and seek seek appropriate evidences evidences from Top Management to verify conformance to the requirements 3. To understand the auditors’ auditors’ attitude and skills required required to be practiced practiced while while auditing Top Management of any organization 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 of ‘auditing the Top Management’ Part 1 of the workshop - Preparation for auditing T Top op 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 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 sequential questions, relevant documents to be seen and records to be obtained while auditing Top Management of the organisation. organisation. Teams are expected to document the output of planning in either flip charts/ acetate sheets / plan papers Part 2 of the workshopw orkshop- Auditing the Top Management Each team is assigned to audit the Top Management of tthis his 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 and  follow instructions by the Trainers for break up

Oct’18

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

 

Delegate Hand-out  

 

 Exercises and Workshops

Bureau Veritas Veritas Certification

WORKSHOP No. 14 – ROLE PLAY – INTERVIEWS-Process Audits The objectives of this workshop are to be prepare the delegates to: t o:  

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 requirements   Develop the art art of of time management and prioritization prioritization during 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 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.