QMS Delelgate Activity Manual LA 21-05-2021

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PR328 ISO 9001:2015; Lead Auditor
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IRCLASS/TRG/QMS/LAC/TSP/Rev 8, dtd: 21-MAY-2021 © IRCLASS Systems and Solutions Private Limited 2019 Page 1 of 40
CQI and IRCA Certified
PR328 ISO 9001:2015; Lead Auditor
(Quality Management Systems)
Training Course
Delegate Activity Manual
This material is for the personal use of a delegate attending a course presented by IRCLASS.
No part of the materials may be reproduced, stored electronically, or transmitted in any form or by any means
without the prior written consent of IRCLASS.
Course Schedule
Day 1
Time Sessions
0830~ Registration
Welcome Note & Course Introduction
Course Aim & Objectives and structure
KNOWLEDGE SESSIONS
Term & definitions as per ISO19011
Types of Audits (1’st Party, 2’nd Party and 3’rd Party Audits)
Auditing Process (Input, Process and Output)
Objectives, Scope and Criteria for (1’st Party, 2’nd Party and 3’rd Party Audits)
Auditing Resources
Roles & Responsibilities & Confidentiality of auditing resources
Audit Methods (1’st Party, 2’nd Party and 3’rd Party Audits)
Stage-1 Audit
Stage-2 Audit
Audit Plan Requirements
Work Documents for Auditing
Opening Meeting
Collecting and verifying Audit Evidences
1745~1755 Allocation Home work on specimen exam paper section-1 …. Closure for day-1
Day 2
Time Sessions
0830 Overview of Day-1
KNOWLEDGE SESSIONS
Effective communication during the audit
Audit Findings
Audit Meetings
Closing meeting
Audit Reports
Audit Follow-up
Benefits of QMS
Terms & Definitions as per ISO 9001:2015
P-D-C-A
ISO 9001:2015, structure of clauses
Role of the Auditors
Documented Information (To be maintained and to be retained)
SKILLS SESSIONS
Initiating the QMS Audit
Document Review
Audit Plan
Review of Specimen Exam Paper Section-1; Closure for day-2
1745~1800 Allocation Home work on specimen exam paper section-2
Day 3
Time Sessions
SKILLS SESSIONS
Work documents, checklist, Sampling
Opening Meeting
Plant Tour
Auditing Top Management
Auditing Context; Auditing Risk & Opportunities; Auditing ‘Objectives,
Competence and Awareness’; Auditing ‘Operation and performance evaluation’;
Auditing ‘Improvement’….
Review of Specimen Exam Paper Section 2
Allocation Home work on specimen exam paper section-3
1745~1800 Closure of Day-3
Day 4
Time Sessions
0830 Overview of Day- 3
SKILLS SESSIONS
Auditing Context; Auditing Risk & Opportunities; Auditing ‘Objectives,
Competence and Awareness’; Auditing ‘Operation and performance evaluation’;
Auditing ‘Improvement’….
Lunch
Identifying Nonconformities
Review of Specimen Exam Paper Section-3
Allocation Home work on specimen exam paper section-4
1745~1800 Closure of Day-4
Day 5
Time Sessions
Identification of Non-conformity
Closing meeting
Audit Report preparation
Audit Follow-up
Specimen examination paper (Discussion on Section-4)
Written/ONLINE Examination
1735
Activity 1: Terms & Definitions related to audit
Purpose: To understand the terms of audit as given in ISO 19011.

Duration: 5 Minutes Introduction+ 15 minutes+10 minutes feedback;
Individual Exercise, reference Slide # 32
Marks for Continuous evaluation: 1-10 (1-2: unacceptable, 3-4: poor, 5-6: acceptable, 7-8: good, 9-10: excellent.
Each delegate shall be graded as per above criteria. These marks to be linked to Continuous assessment Sheet.
Directions:
Audit related terms are given below and the definitions as per ISO 19011 are provided. You have to read
the definition and place the term which it defines against it.
Terms Answer Definition

Outcome of an audit, provided by the au-
1 Audit Criteria A dit team after consideration of the audit
objectives and all audit findings
2 Competence B Organization being audited
3 Audit Program C Extent and boundaries of an audit
Person who provides specific knowledge or ex-

4 Audit Scope D
pertise to the audit team
5 Audit Conclusion E Non-fulfilment of a requirement
6 Auditor F Set of policies, procedures, or requirements
7 Audit Client G Person with the competence to conduct an audit
Systematic, independent and documented pro-

cess for obtaining audit evidence and evaluating
8 Audit H it objectively to determine the extent to which
the audit criteria are fulfilled
Demonstrated personal attributes and demon-
9 Audit Evidence I strated ability to apply knowledge and skills
Results of the evaluation of the collected audit

10 Audit Team J
evidence against audit criteria
11 Audit Findings K Organization or person requesting an audit
Set of one or more audits planned for a specific

12 Auditee L time frame and directed towards a specific pur-
pose
One or more auditors conducting an audit, sup-
13 Non-conformance M
ported if needed by technical
Records, statement of fact or other infor-
14 Audit Plan N mation, which are relevant to the audit cri-
teria and verifiable
Description of the activities and arrangements

15 Technical Expert O
for an audit
Activity-2
Difference between 1’st party, 2’nd party and 3’rd audits;
Purpose:
Understand various types of the audits and differentiate between them into 1’st, 2’nd and 3’rd party
Audits.
Duration:
5 Minutes Introduction+ 15 minutes+10 minutes feedback; Individual Exercise
Slide # 33 to 39
Marks for Continuous evaluation: 1-10 (1-2: unacceptable, 3-4: poor, 5-6:
acceptable, 7-8: good, 9-10: excellent.
Each delegate shall be graded as per above criteria. These marks to be linked to
Continuous assessment Sheet.
Direction: Based on your understanding of audit identify key differences in 1’st, 2’nd and 3’rd party
audit. You can write your answer on the flipchart/notepad.
Activity-3 To understand the audit activities
Purpose: Understand sequence of activities related to audits.
Duration: 5 Minutes Introduction+ 15 minutes+10 minutes feedback.
Individual Exercise.
Slide # 40 to 43
Each delegate shall be graded as per above criteria. These marks to be linked to Continuous assessment
Sheet.
Direction: Fastest Finger first……….Refer the activities mentioned below with respect to typical audit,
please try and arrange these activities in chronological order.
Task-B …..Subgroup above activities into following categories
Initiating the audit; preparing the audit activities; conducting the audit activities; conducting & distrusting the
audit report
CHRONOLOGICAL Subgroup
AUDIT ACTIVITIES
ORDER (As per task-B)
Distributing the audit report
Assigning the work to the audit team
Conducting the opening meeting
Establishing the initial contact with the audi-
tee
Collection and verification of information
Prepare work document
Conducting the audit follow up
Conducting the closing meeting
Preparing the audit plan
Audit findings
Roles responsibility of guides and observer
Determining the feasibility of the audit
Audit conclusions
Communication during the audit
Document review
Preparing the audit report
Activity-4:
Difference in Methodology of 1’st Party, 2’nd Party & 3’rd party audits
Purpose:
Understand key difference amongst three types of the audit w.r.t. Duration, Methods and object-
tives.
Duration:
5 Minutes Introduction+ 15 minutes+10 minutes feedback
Individual Exercise
Slide # 44
Sheet.
Direction:
As per activity #2 you already know the difference between first party; second party and third-party
audits; now further classify them w.r.t. approach, duration, methodology, and audit objectives.
Audit Type Duration Methods Objectives
End Duration Training

Session # Day Start Time
Time method
After Activity # 1 00:15:00
1130 1145 Tea Break
4
Activity-5
Determine Audit Objectives, Scope and Criteria
Purpose:
To Outline the Audit Objectives, Scope and Criteria for 1’st 2’nd and 3’rd party audits.
Duration:
5 Minutes Introduction+ 15 minutes+10 minutes feedback.
Individual Exercise
Slide # 45 to 48
Sheet
Task-A: Refer the Activities 2 & 4. You have already understood the 1’st; 2’nd and 3’rd party audits.
Now identify the AUDIT OBJECTIVES, SCOPE AND CRITERIA laid down for each type of the audit.
Audit Type AUDIT OBJECTIVES SCOPE CRITERIA
Activity-6: Responsibility and authority of the personnel associated with audit activities
Purpose: Determine the Responsibility and Authority of Team Leaders, Auditors, Guides, Observ-
ers, Technical Expert and Auditee & Client.
Duration: 10 minutes Introduction +20 minutes+15 minutes feedback.
Group Exercise
Slide # 49 to 51
tutor will distribute the 35 statements given below; among the groups.
Sheet
Task :Read the statement given below and place them under appropriate box/es; so as to acquire
the knowledge about the responsibility & authority of audit personnel. Reference 19011:2018
1. …deny observers from taking part in certain audit activities.

2. ….assist the audit team
3. ….assisting the auditors in identifying individuals to participate in interviews and confirming tim-
ings;
4. ….ensuring that rules concerning location safety and security procedures are known and respected
by the audit team members and observers.
5. ….witnessing the audit on behalf of the auditee
6. ……..providing clarification or assisting in collecting information.
7. …….Establishing initial contact with the auditee
8. assign to each team member responsibility for auditing specific processes, activities, functions or
locations.
9. ……….collect and review the information relevant to their audit assignments and prepare work
documents,
10. ………..communicate the progress of the audit and any concerns to the auditee and audit
client,
11. ……..Any concern about an issue outside the audit scope should be noted and reported to
12. ……Conducting the closing meeting
13. ….should agree on the time frame for an action plan to address audit findings.
14. ….should advise the auditee of situations encountered during the audit that may decrease
the confidence that can be placed in the audit conclusion
15. …..report the audit results in accordance with the audit programme procedures
16. give permission and access to those parts of the audit site, to be visited in accordance with
the audit scope;
17. ….avoid any unnecessary disturbance of the operational processes
18. ……reach agreement on whether the audit should be interrupted, rescheduled or contin-
ued;
19. ……..if taking photographs or video material, ask for authorization from management in
advance and consider security and confidentiality matters and avoid taking photographs of individual
persons without their permission;
20. …..Selecting the audit team members
21. …..operate under the direction of an auditor, but should not act as auditors.
22. …..if a conflict of interest or competence issue arises, it should be discussed with…..
23. ……should develop, maintain and improve their competence through continual profes-
sional development and regular participation in audits
24. ….should exhibit professional behaviour during the performance of audit activities,
25. ….plan and organize the work effectively;
26. ….prioritize and focus on matters of significance understand and consider the experts’
opinions
27. …confirm the sufficiency and appropriateness of audit evidence to support audit findings
and conclusions
28. …use work documents to record audit activities
29. ….maintain the confidentiality and security of information, data, documents and records
30. ….preventing and resolving conflicts, as necessary;
31. ….Those documents involving confidential or proprietary information should be suitably
safeguarded at all times by the……….
32. …..sought confirmation to the agreement of all parties to the audit plan;
33. ….acknowledge the audit report…
34. …..accept the nonconformities as closed….
35. ….provide specific knowledge or expertise related to the organization, the process or ac-
tivity to be audited,or language or culture.
Program Manager Guides/Inter-

Auditee/
Team Auditors from Certification preter/Tech- Observers
Organization Client
Leaders Body nical Expert
Representative
Start End Duration

Session # Day Training method
Time Time
1300 1345 Lunch Break
6
Activity-7 Purpose: To understand different audit methods,
Duration: 5 Minutes Introduction+ 15 minutes+10 minutes feedback.
Slide # 52
Sheet
TASK: Onsite & Remote are the different methods of the audits, further it can be classified into Human Inter-
action and Non-human Interaction. List down +ve and -ve points of these different methods of an audit.
Refer ISO19011; Annex A.1 Applying audit methods; page # 35
Audit
Meth od On-site Remote
Human Interaction
Non-human Interaction
Activity-8
Purpose:
To understand the audit plan requirements,
Duration:
5 minutes Introduction + 45 Minutes Presentation + 10 minutes feedback
Group Exercise
Slide # 57 to 59
Sheet
TASK: Refer ISO19011 clause # 6.3.2; and prepare the structure for Audit Plan based on these requirements.
Also identify the risk in achieving the Audit Objectives (With respect to Objective, Scope, Criteria, locations etc.) refer
clause 6.3.2.2 Audit planning details ISO19011

Time method
1545 1600 Tea Break
8
Activity-9:
Purpose: Opening Meeting
Duration:5 minutes Introduction + 45 Minutes Presentation + 10 minutes feedback

Group Exercise
Slide # 60, 61 & 80
Sheet
TASK: Refer ISO19011 clause 6.4.3 - Conducting the opening meeting, and prepare your points for the coverage of
opening meeting presentation.
Activity-10:
Purpose: Capturing & verifying Audit Evidences
Duration:
5 minutes Introduction + 30 Minutes Presentation + 10 minutes feedback
Group Exercise
Slide # 62 & 67
Sheet
TASK: Refer ISO19011 clause 6.4.7 – methods of collecting information are INTERVIEW, OBSERVATION and REVIEW
OF DOCUMENTS & RECORDS… capture how to convert various methods of collecting the information into Audit Evi-
dence………
Methods of collecting information How to convert it into Audit evidence
INTERVIEW
OBSERVATION
REVIEW OF DOCUMENTS and

RECORDS
SOLVE SECTION-1 OF SPECIMEN EXAMINATION PAPER AS A HOME-WORK and DISCUSS THE HOME
WORK AT THE END DAY-2, likewise solve Section-2 as a home work on day-2 and discuss it at the
endof day-3……last section i.e. section-4 shall be discussed on day-4.
Session # Day Start Time End Time Duration Training method
After session 13 1 1745 ----- End of day-1
-------------------------------------------------------------------END OF DAY-1--------------------------------------------------
Activity-11:
Purpose: Questioning Technique
Duration: 05 minutes Introduction +15 Minutes+10 minutes Feedback
Group Exercise.
Slide # 68 to 71
Sheet
TASK: From the learning of various questioning technique now read following paragraph and identify the
questioning types.
Question: Do you measure customer satisfaction?

Answer; Yes! We did
Question: Are your customer satisfaction?
Yes! They are?
Question: How satisfied or dissatisfied are customers?
Answer: We send questionnaire to our customer every quarter, then we seek feedback from them. Once
feedback is received we analysis overall satisfaction and individual dissatisfaction level, if any.
Question: How many customers are satisfied?
Answer: Out of 21 customers 3 had shown strong dissatisfaction, 18 are rated us “excellent”
Question: What Actions are the opportunities improve the dissatisfied customers?
Answer: We have very less presence in that segment of Refrigerated Vans. We are hiring a person you has
got expertise in this area in all functions. This was explained to customers and they gave time frame of 3
months. Person already on board.
Question: Have you done risk analysis on newly added project “refrigerated Vans”?
Answers: Yes!
Question: what is risk of high priority”?
Answer: it was “competence” which I already explained.
Q; How many customer complaints lodged since last year?
A; 3!
Q: How many them are repetitive? How many of them are related to single customer? How many are them
related to competence and how many of them are attributable to supplier?
A: There was competence related area for which we hired a expert and that person has already on the board.
Q: What are analysis of these complaints? Do you use any specific problem-solving technique to arrive at the
root cause after analysis?
A: We use FISH-BONE diagram for root cause analysis.
Q. what is highest level concern from analysis
A. it was competence and agility.
Q. What actions are initiated to tackle this issue?
A. Trainer hired and he is on the task to align all training with respect to customers.
Activity-12:
Purpose:
Follow up audit scenario
Duration:
05 minutes Introduction +30 Minutes+10 minutes Feedback
Group Exercise
Slide # 84
Sheet
TASK: Recollect the leaning from today’s session
1. Who decides the follow up audit?
2. What could be the Objective, Scope, and duration of follow up audit?
3. Who will conduct this follow up audit?
4. Does it require audit plan?
5. Opening meeting required?
6. What will be the possible outcome from the follow-up audit?
Activity 13: Quality Management System Terms & Definitions
Purpose: Familiarization with terms and definition related to QMS ISO 9001:2015
Duration: 10 Minutes+ 5 minutes Feedback

Slide # 86
Sheet
Directions: Individually, review he terms and definitions and determine which definition belongs
to which term, Enter the correct letter of the definition next to the appropriate term in the table on the
following page. Definition of terms used in QMS ISO 9001:2015 has been provided.
Terms Definition
Set of interrelated or interacting elements of an organi-
1 Competence A zation to establish policies and objectives and processes
to achieve those objectives
Continual Im- Person or group of people that has its own functions
2 B with responsibilities, authorities and relationships to
provement
Corrective Ac- achieve
Person oritsgroup
objectives
of people who directs and controls an
3 C
tion organization at the highest level
Documented In-
4 D Results to be achieved
formation
5 Process E Ability to apply knowledge and skills to achieve intended
results
Action to eliminate the cause of a nonconformity and to
6 Interested Party F
prevent recurrence
Management
7 G Effect of uncertainty
System
Make an arrangement where an external organization
8 Measurement H
performs part of an organization’s function or process
9 Monitoring I Measurable result
10 Objective J Need or expectation that is stated, generally implied or

obligatory
Information required to be controlled and maintained
11 Organization K by an organization and the medium on which it is con-
tained
12 Outsource L Recurring activity to enhance performance
Determining the status of a system, a process or an ac-
13 Performance M
tivity
14 Requirement N Process to determine a value
Set of interrelated or interacting activities which trans-
15 Risk O
forms inputs into outputs
Top Manage- Person or organization that can affect, be affected by, or

16 P
ment perceive itself to be affected by a decision or activity
End Duration
Session # Day Start Time Training method
Time
After Activity # 13 2 1115 1130 00:15:00 Tea Break
Activity 14: Understanding EDIM (Establishment, Documentation, Implementation &
maintenance of QMS
Purpose:
Establishment of QMS ISO 9001:2015
Duration:
05 minutes Introduction +15 Minutes+10 minutes Feedback
Slide # 88
Sheet
Directions:
Fastest finger first….. Please arrange following statement in correct chronological order.
QMS objectives
Planning
External issues
Performance Evaluation
Interested parties
Management review
Risk assessment
Monitoring & measurement
Corrective action
Resource provision
Operations
Internal audit
Continual improvement
Internal issues
Strategic direction
Activity 15: Understanding audit trail
Purpose: How to generate audit trail while auditing ISO9001 2015 requirements

Individual Exercise
Slide # 88
Sheet
Directions:
You are auditing a transport service providing organization, M/s METAPHORA. You are auditing mar-
keting function. When you asked about the customer complaints; marketing manager, replied that
there are 6 customer complaints reported in the current year. He further explains that 3 customer
complaints are repetitive in nature and related to truck drivers. Customers of M/s Metafora were bit
annoyed because of delay in delivery of goods caused by the M/s Metafora’s truck drivers. Further
marketing manager states that drivers not providing correct information about the exact location of
their trucks, which causes difficulty in planning the production process, secondly; material was either
reaching late, or in damaged condition.
As an auditor how will you trace this matter further…. what all things will you verify within marketing
and all other departments of M/s Metafora to evaluate the effective implementation of QMS? List down
these items and correlate items with ISO9001:2015 clauses.
End Duration
Time
1300 1345 Lunch Break
15
Activity 16: Understanding QMS documented information
Purpose: What are the documents and records required by ISO9001 2015

Slide # 89
Sheet
Directions: Start from clause number 4 to clause number 10 of ISO 9001:2015 require-
ments, search for the phrases “documented information to be maintained – with the phrase,
“shall be available as documented information ”” and “documented information to be
retained – with the phrase, “shall be retained as documented information””. And list down
these documents, records and corresponding clause numbers.
Activity 17: Initiating the audit.
Purpose: To acquire skill for initiating the audit.

Individual Exercise
Slide # 91
Sheet
Directions:
You are working for a certification body as programme manager ….and received a request to plan
surveillance audit…..for the automotive client who has two manufacturing units one at Mumbai
and other at Chennai, head office is in Bangalore, this Bangalore office gives support both the
manufacturing sites for activities like Sales & marketing, Design Of Products, Strategic Planning,
Central purchase and Human Resource,
Previous audit was certification audit and both manufacturing sites had received 4 NCs each and
Bangalore support function 2 NCs,
What information you will seek from the and Organization Representative (Auditee Management)
and Certification Body’ Audit planning Team.
CB’s Audit planning team Auditee Mgmt./ Orgnization

Representative
Activity 18: Document Review
Purpose: Conduct document review for METAFORA (a case study)

Group Exercise
Slide # 92
Sheet
Directions: Perform a general review of the QMS Manual of the Case study – “METAFORA”
against the requriementsof the standard, focusing first and foremost on the scope of your audit. Formu-
late in writing: any non-conformances and check points during the audit.
Each team is briefly to present its findings to the whole group. Following the class discussion, each
team is required to hand-in their report for evaluation by the tutor.
Start End Duration Training

Session # Day
Time Time method
After Activity # 18 2 1600 1615 00:15:00 Tea Break
Activity 19: AUDIT PLAN
Purpose: To test the skill for preparing the ON-SITE audit plan based on the Criteria,
Scope and objectives of an audit.

Group Exercise
Slide # 93
Sheet
Directions:
Your team is required to produce an audit plan for the initial certification audit of the “METAFORA” for the
whole scope (not just the department allocated to them). (refer Activity 8 for template)
- Consider this as stage-2 initial certification audit of “METAFORA”.
- The audit is scheduled to take place on one week from today
- The duration of the audit is 4 mandays
- The audit team is to comprise a Lead Auditor and one team member
Your team is required to produce a draft audit time plan in table form describing per day; time period,
topic – controls to be verified, auditor.
Following the class discussion, each team is required to hand-in their audit-plan for evaluation by the tutor.
Refer Clause # 6.3.2.1 ISO19011:2018

After session 27 2 ---- 1745 ----- End of day-2
End of Day 2
HOME WORK: Specimen Exam paper Section 2.0 only…… this home work will be discussed in the
class at the end of day-3
Activity 20: Work Document
Purpose: TO test the skill for preparing the audit checklist for TOP MANAGEMENT
Duration: 05 minutes Introduction +40 Minutes+15 minutes Feedback.

Group Exercise
Slide # 94 to 97
Sheet
Directions: This will be group activity.

Prepare a checklist to audit top management of METAFORA (A sample case study)
Please consider clause 5 & Clause 9.2.2 and 9.3 for preparing the checklist.
Activity 21: Opening Meeting

Group Exercise
Slide # 98
Sheet.
Purpose: To practice and test the skills to conduct an opening meeting for QM audit.
Directions: This is group activity
This is group activity.

Plan and carry out the opening meeting, in accordance with your audit plan
Please refer ISO19011 section 6.4.3 for the agenda and coverage of opening meeting. Be ready
for the presenting opening meeting.
While one group is conducting the meeting, other groups will have to take notes and ready for
your comment during class discussion.

After Activity 21 3 1045 1100 00:15:00 Tea Break
Activity 22: How to conduct effective plant tour
Purpose: TO test the skill required for a site tour, and collect evidences while conducting the round.

Group Exercise
Slide # 99
Sheet
Directions: Please look at the photos in your reference material. Assume you are as
part of audit team and making these observations. Please record your observations you would
like to verify in the subsequent audit.
OR
In a group have discussion on the following points and then ready with your presentation…
1. Who all should participate in the Plant Tour?
2. Who should accompany the audit team while taking plant tour from client orgnization, what is
his/her role?
3. Any precautions with respect to Safety, Security and emergency norms?
4. How much time shall be spent on plant tour?
5. What to focus during plant tour?
6. How to take best help from Industry Expert/Technical Expert?
7. After plant tour is it necessary to have meeting amongst the audit team members?
8. How to reflect the plant tour into subsequent audits?
Activity 22: how to conduct effective plant tour…©IRCLASS SYSTEMS & SOLUTIONS PVT. LTD. IRCA AP-
PROVED ISO9001:2015 QUALITY MANAGEMENT SYSTEM AUDITOR COURSECOURSE # 1898
VEHICLE PARKING AREA VEHICLE PARKING AREA
Office Area Office Area
Working Desk Office entrance
WORK-SHOP WORK-SHOP
WORK-SHOP OFFICE DESK
MATERIAL LOADING/UNLOADING BAY WORK-SHOP
WORK-SHOP WORK-SHOP
WORK-SHOP WORK-SHOP
CARGO LOADING WORK-SHOP
WORK-SHOP DIRECTOR’S AREA
From Activity 23, Each audit team needs to interview auditee tutor during role play covering all applicable
ISO9001:2015 clauses across the specific departments assigned to the team by the tutor
Activity 23: Auditing Top management
Purpose: To test the skill required, as an auditor, to interview and audit top management of
an orgnization.

Group Exercise
Slide # 100
Sheet
Directions: This is group activity.

Interview top management of METAFORA (A sample case study ).
Tutor will play the role of top management.
Each group will have to ask questions in turn.
When you are not asking the question, please make notes and gather audit evidences. This information
may be useful for subsequent audit.
Then while class room discussion please share your information and explain to class how are you going
to use this information in the subsequent audit.
Please also discuss the attributes of Auditor as well as Auditee.
Audit Objective: Stage-2 Certification audit of METAFORA
Audit Criteria: ISO9001 2015 & Documented information of METAFORA
Scope: Entire Metafora activities.
Direction: Audit evidences gathered during this shall be used for preparation of
audit report.

After Activity 23 3 1300 1345 00:45:00 Lunch Break
From Activity 24, Each audit team needs to interview auditee tutor during role play covering all appli-
cable ISO9001 clauses across the specific departments assigned to the team by the tutor.
Activity 24: Auditing Context, Risk & opportunity, Support, Operation, Perfor-
mance evaluation and Improvement, related to various departments of case study
METAFORA.
Purpose: TO test the skill required, as an auditor, auditing ISO9001:2015 requirements.
Duration: Total time spread over 11 Hrs:30 Minutes (Spread over two days)
Group Exercise
Slide # 101 to 110
Sheet
Each team will get sufficient time to prepare checklist for their allocated department and then once
class is ready auditee tutor shall be audited, in turn.
After every department’s audit is over feedback session is planned by the Tutor.

Audit the department allocated to you by a Tutor.
Interview the tutor Auditee.
While delegates of other teams are not actively participating in the simulated audit, they should
be observing audits of other groups for offering subsequent comments on how audit could have
been done better,
Then while class room discussion please share your information and explain to class how are
you going to use this information in the subsequent audit.
Audit Objective: Stage-2 audit of METAFORA

Direction: Audit evidences gathered during this shall be used for preparation of audit report.
Process Approach
Demonstrates priority is given to questioning the organisation’s identification of processes, their se-
quence and interactions, and performance against the objectives / measures defined, with focus on the
processes which directly impact the customer
• Questioning the client’s processes, the sequence, interactions and performance against the
measures defined, with focus on the processes which directly impact the customer.
• Questioning the process objectives/targets, with focus on where targets are not being met and on
issues that have the greatest impact on the customer.
• Questioning what plans are in place to ensure targets are met, and corrective action plans are in
place where objectives are not being met. ( e.g. Customer complaints, Customer dissatisfaction, etc.)
• Following audit trails to linkages between customer concerns, performance against objectives and
relevant process documents
• Questioning the client’s process for gathering, communicating and implementing customer specific
requirements.
• Verify the identification and application of the appropriate ISO9001 2015, requirements in the con-
text of an audit of the organisation processes.
Risk based auditing:
• Demonstrates priority is given to questioning risks and opportunities identified by the orgnization
with focus on the processes which directly impact the customer.
• Prioritization of high risk area and focusing the auditing to risk mitigation, opportunities to reduce
the risk and operational control
• Monitoring of the risk by the organization’s top management; which are highest concern to business
and strategic direction.
• Identification and focusing the KEY PROCESS/PRODUCT characteristics and analysing the potential
risk associated with it.
After session 33 3 1545 1600 00:15:00 Tea Break
Session # Day Start Time End Time Duration TrainingMethod

After session 34 3 --- 1800 --- End of day-3
End of Day 3
HOME WORK: Specimen Exam paper Section 3.0 only…… this home work will be discussed in the
class at the end of day-4
Day 4
End Duration
Time
36 4 0845 1045 02:00:00 Ppts /Activity
---- 4 1045 1100 00:15:00 Tea Break
36 4 1100 1300 02:00:00 Ppts /Activity
----- 4 1300 1345 00:45:00 Lunch Break
36 4 1345 1545 02:00:00 Ppts /Activity
--- 4 1545 1600 00:15:00 Tea Break
---- 4 1600 1745 01:45:00 Ppts /Activity
End of Day 4
HOME WORK: Specimen Exam paper Section 4.0 only…… this home work will be discussed on day-5
Day 5
Activity 25: Nonconformity and closure
Purpose: TO test the skill required, as an auditor, to identify and grade the noncon-
formity based on the its impact to system and customer.
Group Activity.
Slide # 111
Sheet
Refer the scenarios allocated to you.

Each group has identified nonconformity/es during audit of their allocated department from METAFORA
case study.
Please write the nonconformity into 3 elements
1. Statement of Nonconformity.
2. Requirement of ISO9001:2015
3. Objective Evidences against the nonconformity.
Audit Criteria: ISO9001 2015 & Documented information of METAFORA Clause 10.2.1
Direction: Audit evidences gathered during this shall be used for preparation of audit report.
PLEASE REFER ACTIVITY # 28 in next pages
Activity 26: Closing meeting
Purpose: TO test the skill required, as an team leader to plan and conduct closing meeting.

Group Exercise
Slide # 112
Sheet
Directions:
Please prepare for the closing meeting based on the requirements of ISO19011.
Tutor will select one delegate as team leader.
This closing meeting is for the stage-2 certification audit of METAFORA.
All other class member will have to prepare minimum one nonconformity based on their audit
finding and be ready to present it when your team leader will prompts you for the during the
closing meeting.


After 40 5 1100 1115 00:15:00 Tea Break
Activity 27: Audit Report
Purpose: TO test the skill required, to prepare audit report, based on the conclusions
and recommendation given in the closing meeting

Group Exercise
Slide # 113
Sheet
Directions: Please prepare the audit summary report based on the Metafora’s audit.
Then hand it over to the tutor.
Please use A4/Note pad for the summary report.
Please refer ISO19011 requirements related to Audit Report.
Activity 28: Audit Follow-up
Purpose: TO test the skill required, to evaluate proposed corrective actions received
from the client Organization. To understand the various aspects of NC closure.

Group Exercise
Slide # 114
Sheet
Directions: You have conducted audit of METAFORA for stage-2 certification audit.
Refer the nonconformities ISSUED DURING STAGE-2 AUDIT along with the METAFORA’s response
in the form of Correction and corrective action. Review it to decide whether NC closure accepted
or Not.
Corrective Action Plan

Stage-2 Audit NC by
METAFORA STAGE-2 NC # :CB AD-01
a Certification Body
Date: Sept-xx
CLAUSE # 7.1.5 Department Logistics

A] Problem Statement: Lubricants are repacked in METAFORA for one of the customers. In this
activity Lubricants were filled in small packs and weighed by weighing scale. These small packs
then dispatched to the customer. The Weighing Scale (Metafora/WS-04/May-xx) was not found
calibrated during the audit. Quality In-charge stated that they do not feel the necessity of calibra-
tion
Process Owner : Logistics Supplier representative:
B] Correction: Containment Action/s. (Immediate actions taken)
Weighing scale re-calibrated Not applicable.
C] Root Cause Analysis: (Attach separate sheet for problem solving technique used to arrive at Root cause (s).
Root Cause (s):
missed one of error, M.D.’s son manufactures this weighing scale
D] Proposed Corrective Action/(s) (PCA) E] Corrective Action implemented / Initiated:

Weighing scale re-calibrated Weighing scale re-calibrated
E] Changes made in the Documents / systems (kindly attach the proof)
Document Document
F] Effectiveness of corrective action to prevent recurrence of cause of NC.

NC Reviewed and Accepted by
Stage-2 Audit NC by
STAGE-2 NC # :CB AD-02 Date: Sept-xx
METAFORA a Certification Body
CLAUSE # 7.2 Department Training
A] Problem Statement: In Metafora, drivers and cleaners were trained on “Safe driving of Tank-
ers”. Records of effectivess of training not available with HR department.
Similar training was also given by client of Metafora and they issued Identity Cards to Drivers
and Cleaners after verification of skills. When driver Mr. Sandy was being interviewed for “safe
Driving”; he hardly could explain it, HR personnel said that he was nervous because of audit.
This service was started six months back and no incident or complaint raised by client.
Supplier representative: Head
Process Owner : HR
Mkt.
Drivers ID issued by customer now All other training records are available.
retained as record of effectivess
Root Cause (s):
missed one of error,
Record of Driver ID made available Record of Driver ID made available.
Document Document
NIL

.
STAGE-2 NC # :CB Stage-2 Audit NC by Date: Sept-

METAFORA AD-03 a Certification Body xx
CLAUSE # 8.2.1 Department Procurement

A] Problem Statement: Customer “Cambridge Logistics” had given one of their trucks (Truck #
UWE 5648-SD) for cargo shipment within the 100km area. As per contract this truck was to be
used only for “Cambridge Logistics” cargo handling.
In Aug-XX there were 2 occasions, that this truck was being used for other customers as well.
This was not at all informed to “Cambridge Logistics”. Logistics in-charge said that contract is
old and we will be buying this vehicle in Dec-XX. But such contract termination or maturity doc-
uments were not available.
Supplier representative: Head
Process Owner : HR
Mkt.
Inform to customer. Customer had proposed to buy this vehicle, we are buying it
in Dec-xx
Root Cause (s):
There was no truck available to ship a cargo of “Northern Roadways”

Truck which was owned by “Cambridge Logistics” was available.
We decided to use it and it was duty of Marketing to inform to customer
Marketing in-charge failed to inform.
Lack of communication skill
D] Proposed Corrective Action/(s) (PCA) Train- E] Corrective Action implemented / Initiated:
ing on Communication Skill. Training provided on Sept-xx and verified the
effectiveness by monitoring the person.
Document Document


CLAUSE # 8.4.1 Customer Complaint CC- nil
A] Problem Statement: METAFORA had outsourced cargo transportation to “ZEBRA Trans-lines”. As part of
contract Zebra picks up the material up from client’s and deliveres to intended destination.
When quality objectives were being audited; it was evident that since last three months, 9 customer com-
plaints were reported. These customer complaints attributed to service quality of ZEBRA.
Metafora had Supplier selection process in place and one of the selection criteria of testing was psychologi-
cal mapping of drivers. This test was not being carried out through an expert agency due to exigencies.
There were 8 complaints attributable to 2 drivers who had behavioural issues.
Supplier representative: HEAD
Process Owner : PURCHASE
PURCHASE
ALL drivers are appraised of the ALL other Customer complaint reviewed and found no
corrective action and impact on cus- repetition of any other complaint. Resp., Logistics head;
tomers, Completed Sept-XX Completed – Sept-XX
Root Cause (s):

Before selection of “Zebra Trans-lines”, Metafora knew that they had shortage of drivers.
The drivers’ list approved by Metafora was not being used, because of heavy workload on the “Zebra Trans-
lines”
So “Zebra Trans-lines” hired few new drivers on contract basis, which was not informed to Metafora
Metafora accepted the things because of urgency and big order in the pipeline.
Violation of supplier selection process.
Training on
Procedure MET/SOP/01 reviewed and updated
procedure for Supplier selection not ad- dt. Sep-XX
hered to. Re-trained all process owners on Sept-XX.
Express way of psychological mapping mod- Understood the impact on business because
ule to be designed with expert- by Oct-XX of customer complaints.
Express psychological mapping model “MAP-
Intelligence” developed and results are useful.
12 drivers disqualified.
Document Document
Procedure for Supplier selection
amended.
Express psychological mapping model
“MAP-Intelligence” is part of selection of
drivers.

CLAUSE # 9.2.2 Internal Audit Process ----
A] Problem Statement: Orgnization has conducted the internal audit at the frequency of once in
six months.
While going through internal audit documents, it was evident that “risk and opportunities”
clause 6.1 not being audited. Further investigation reveals that internal auditor not trained
on “risk and opportunities”, although one of the customers had specific requirement to have
trained internal auditor on the risk and opportunity auditing. Third party auditor could able to
identify many potential risk and opportunities. Latest management review record states risk
and opportunities process is effective.
Process Owner : INTERNAL AU- Supplier representative: HEAD SYS-
DITS TEMS
Training to ALL internal auditors. NIL
Root Cause (s):

inadvertently missed the points during internal audit.
D] Proposed Corrective Action/(s) (PCA) : E] Corrective Action implemented / Initiated:
In the next internal audit ( 8’th month of next
calendar year) risk and opportunities will
have to be covered by each internal auditor Training planned in July-XY next year.
as there was nonconformity in 3’rd party au- Next internal audit – Next year Aug -XY
dit. Date of 3’rd party audit was 9’th month
of the calendar year.
Document Document

End Duration
Time
--- 5 1330 1415 00:45:00 Lunch Break
Activity 29: Specimen examination paper
Purpose: To attempt specimen exam paper for balance activities.
Duration: 15 minutes Class discussions

Slide # 115
Directions: This is individual exercise.
Attempt and complete balance part of the specimen examination paper.

Time method
After activ- 5 00:15:00
1440 1455 Tea Break
ity 29
--------------------------------------------END OF ACTIVITIES------------------------------------
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-------------------------------------------End Of Course Material------------------------------------

QMS Delelgate Activity Manual LA 21-05-2021

Uploaded by

QMS Delelgate Activity Manual LA 21-05-2021

Uploaded by

Shree Swami Samarth!!

About the CQI and IRCA

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

Delegate Activity Manual

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

Terms Answer Definition

2 Competence B Organization being audited

3 Audit Program C Extent and boundaries of an audit

Person who provides specific knowledge or ex-

5 Audit Conclusion E Non-fulfilment of a requirement

6 Auditor F Set of policies, procedures, or requirements

7 Audit Client G Person with the competence to conduct an audit

Systematic, independent and documented pro-

Results of the evaluation of the collected audit

11 Audit Findings K Organization or person requesting an audit

Set of one or more audits planned for a specific

Description of the activities and arrangements

Task-B …..Subgroup above activities into following categories

Audit Type Duration Methods Objectives

End Duration Training

Audit Type AUDIT OBJECTIVES SCOPE CRITERIA

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

Program Manager Guides/Inter-

Start End Duration

Refer ISO19011; Annex A.1 Applying audit methods; page # 35

End Duration Training

Purpose: Opening Meeting

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

Purpose: Capturing & verifying Audit Evidences

Methods of collecting information How to convert it into Audit evidence

REVIEW OF DOCUMENTS and

Session # Day Start Time End Time Duration Training method

After session 13 1 1745 ----- End of day-1

Question: Do you measure customer satisfaction?

TASK: Recollect the leaning from today’s session

1. Who decides the follow up audit?

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

3. Who will conduct this follow up audit?

4. Does it require audit plan?

5. Opening meeting required?

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

Activity 13: Quality Management System Terms & Definitions

Duration: 10 Minutes+ 5 minutes Feedback

10 Objective J Need or expectation that is stated, generally implied or

Top Manage- Person or organization that can affect, be affected by, or

Duration: 05 minutes Introduction +45 Minutes+10 minutes Feedback

Duration: 05 minutes Introduction +30 Minutes+10 minutes Feedback

Activity 17: Initiating the audit.

Purpose: To acquire skill for initiating the audit.

CB’s Audit planning team Auditee Mgmt./ Orgnization

Purpose: Conduct document review for METAFORA (a case study)

Duration: 05 minutes Introduction +45 Minutes+10 minutes Feedback

Start End Duration Training

Duration: 05 minutes Introduction +60 Minutes+25 minutes Feedback

Session # Day Start Time End Time Duration Training method

Duration: 05 minutes Introduction +40 Minutes+15 minutes Feedback.

Directions: This will be group activity.

Activity 21: Opening Meeting

Directions: This is group activity

This is group activity.

Session # Day Start Time End Time Duration Training method

Duration: 05 minutes Introduction +45 Minutes+10 minutes Feedback.

Office Area Office Area

Working Desk Office entrance

WORK-SHOP OFFICE DESK

MATERIAL LOADING/UNLOADING BAY WORK-SHOP

CARGO LOADING WORK-SHOP

Activity 23: Auditing Top management

Duration: 05 minutes Introduction +45 Minutes+10 minutes Feedback.

Directions: This is group activity.

Audit Objective: Stage-2 Certification audit of METAFORA

Audit Criteria: ISO9001 2015 & Documented information of METAFORA

Scope: Entire Metafora activities.

Session # Day Start Time End Time Duration Training method

Purpose: TO test the skill required, as an auditor, auditing ISO9001:2015 requirements.

Directions: This is group activity.