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QMS Internal Audit - 1 Day Trainng

This document provides an overview and agenda for a training on conducting internal audits according to ISO standards. It discusses the objectives of the training which are to understand the basic principles and process of internal auditing, how to audit ISO requirements using a process approach and risk-based thinking, and how to appropriately document audit findings. It also outlines prerequisite knowledge, the contents to be covered including introduction to auditing, the audit process, workshops and exercises, and expected post-training activities. Finally, it lists references to relevant ISO standards that will be discussed.

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Fleur Robles
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100% found this document useful (2 votes)
604 views104 pages

QMS Internal Audit - 1 Day Trainng

This document provides an overview and agenda for a training on conducting internal audits according to ISO standards. It discusses the objectives of the training which are to understand the basic principles and process of internal auditing, how to audit ISO requirements using a process approach and risk-based thinking, and how to appropriately document audit findings. It also outlines prerequisite knowledge, the contents to be covered including introduction to auditing, the audit process, workshops and exercises, and expected post-training activities. Finally, it lists references to relevant ISO standards that will be discussed.

Uploaded by

Fleur Robles
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
You are on page 1/ 104

Presented by:

Jayzer L. Aquino
1
Welcome Participants!
House Rules:
-Mobile phones in silent mode

-Participants are encouraged to interact

-Feel free to ask questions relevant to the topic/ may interrupt the
speaker so we could immediately address the questions.
1. To know the basic principles and activities in conducting
Internal Audit.
2. To know how to audit the ISO 9001 & 14001:2015
requirements by using the principle of PDCA (Plan-Do-
Check-Act) and IPO (Input-Process-Output), Risk-Based
Thinking (QMS) and Life Cycle perspective (EMS)
3. Reference to the ISO 19011:2011 – employ the knowledge
and skills in conducting IA into your organization.
4. To appropriately report the audit findings – Good Practices,
Opportunities for Improvement and Nonconformities

Management System Internal Audit


Training 3
PREREQUISITE / Course Requirements
•Knowledge of ISO 9001/14001:2015 basic requirements
•Engaged in the implementation of QEMS

PURPOSE
•To check the conformity of the organization to the
requirements of the ISO 9001/14001

•To contribute for Continual Improvement of the


organization
POST TRAINING ACTIVITIES
• All trainees need to be engaged in the next audit

•Trainees need to further read the ISO 9001/14001:2015


and ISO 19011:2011 standards
Contents
 Introduction to the Audit
 Audit Principles
 Overview of the ISO 9001/14001:2015 standards
 The Audit Process
 Workshops (Process Approach Audit) / PDCA / IPO /
Exercise / Role Play
 Workshop on How to Write Audit Findings
Course References

ISO 9000 : 2015


QMS - Fundamentals and vocabulary

ISO 9001 : 2015


QMS - Requirements

ISO 14001:2015
EMS – Requirements

ISO 19011 : Guidelines of Auditing


ISO 9001:2015 and ISO
14001:2015 Overview

8
1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organisation
5. Leadership
6. Planning for the quality
management system
7. Support
8. Operation
9. Performance evaluation
10. Improvement

9
P-D-C-A Methodology applied by ISO

“Plan-Do-Check-Act” (PDCA)
Plan: establish the objectives and processes necessary to deliver
results in accordance with customer requirements and the
organization's policies.
Do: implement the processes.
Check: monitor and measure processes and service against
policies, objectives and requirements for the service and report the
results.
Act: take actions to continually improve process performance.

10
(Source: ISO/ 9001:2015)

11 12.07.2015
The standard follows the Plan – Do – Check – Act cycle i.e.
DO CHECK
Develop and Implement the The effectiveness of the
Management Structure and Planning and Action stages
Control Mechanisms against established criteria
necessary to eliminate and for performance and, as
reduce the QEMS Issues necessary, take action
against weaknesses to
improve the management
and control measures
involved
PLAN
The approach to
Management of QEMS ACT
Issues now and in the Demonstrate and operate
future Top Management
commitment by initiating
continual improvement
against actual and potential
areas of need
AUDIT –
Its Principles and Process

13
AUDIT

The word audit is derived from a Latin word


"audire" which means "to hear". During the
medieval times when manual book-keeping was
prevalent, auditors in Britain used to hear the
accounts read out for them and checked that the
organization's personnel were not negligent or
fraudulent

Source: Wikepedia
AUDIT
- A systematic, independent and documented
process for obtaining audit evidence and
evaluating it objectively to determine the
extent to which audit criteria are fulfilled.

Management System Internal Audit


Training 16
-Systematic - Planned, Process approach,
organized

-Independent – Auditors cannot audit their


own work

-Documented – audit findings /evidences are


recorded

-Objective Evaluation – audit findings are clear,


information is confirmed and validated

17
Identification of Self-Evaluation
Nonconformity and Future Plan

Plan
Analysis of Act Standardization
present system

Root Cause Evaluation of


Analysis
Check Result

Do
Selection of best Solution
alternative Implementation
solutions

18
ISO 9001/14001:2015
 Clause: 9.2.1 Internal audit

 The organization shall conduct internal audits at


planned intervals to provide information on whether
the environmental management system:
 a) conforms to:
 1) the organization’s own requirements for its
environmental management system;
 2) the requirements of this International

 b) is effectively implemented and maintained.


 Ethical conduct-
◦ the foundation of professionalism
 Fair presentation-
◦ the obligation to report truthfully and accurately
 Due professional care-
◦ application of diligence and judgment in auditing
 Independence-
◦ the basis for the impartiality of the audit and objectivity of the
audit conclusions
 Evidence based approach-
◦ the rational method of reaching reliable and reproducible
audit conclusions in a systematic audit process

Management System Internal Audit


Training 20
Key Definition of Terms in Auditing:

Audit criteria - set of policies, procedures or


requirements used as a reference against which
audit evidence is compared
Note: If audit criteria are legal requirements –
the term “compliant”/non-compliant is used

Audit evidence – records, statements of fact or


other information which are relevant to the
audit criteria and verifiable
Note: Audit evidence can be qualitative or
quantitative.
Audit findings – results of the evaluation of the
collected audit evidence against audit criteria

Note 1 Audit findings indicate conformity or


nonconformity.
Note 2 Audit findings can lead to the
identification of opportunities for improvement or
recording good practices.
Note 3 If the audit criteria are selected from legal or
other requirements, the audit finding is termed
compliance or non-compliance.
Audit conclusion – outcome of an audit, after
consideration of the audit objectives and all audit
findings

Auditee – organization being audited

Auditor – person who conducts an audit

Audit team –one or more auditors conducting an


audit, supported if needed by technical experts

Technical expert – person who provides specific


knowledge or expertise to the audit
Observer – person who accompanies the audit
team but does not audit

Audit programme - arrangements for a set of


one or more audits planned for a specific time
frame and directed towards a specific purpose

Audit scope - extent and boundaries of an


audit
Note: The audit scope generally includes a description of the
physical locations, organizational units, activities and
processes, as well as the time period covered.
Audit plan – description of the activities and
arrangements for an audit

Conformity – fulfillment of a requirement

Management system – system to establish


policy and objectives and to achieve those
objectives
Principles of Auditing
& Purpose

26
SIX PRINCIPLES OF AUDITING:

-Help to make the audit an effective tool – for


improvement of QMS
-As guidance to the auditors to reach clear
audit conclusions with objectivity

1. Integrity
2. Fair Presentation
3. Due Professional Care
4. Confidentiality
5. Independence
6. Evidence-based Approach
AUDIT PLAYERS

Client
- party requesting the audit
Auditor
- conducting the audit /collects evidence and
findings
Auditee
- recipient of audit (entity/person)
TYPES OF AUDIT

First Party
- internal audit – own system
Second Party
- audit done by the organization to its external
(supplier/service) provider
Third Party
- audit done by an independent party of both
organization & supplier
“Plan-Do-Check-Act” (PDCA)

Plan: establish the objectives and processes necessary to deliver


results in accordance with customer requirements and the
organization's policies.
Do: implement the processes.
Check: monitor and measure processes and service against
policies, objectives and requirements for the service and report the
results.
Act: take actions to continually improve process performance.

30
PDCA Cycle – Internal Audit Application

Plan
(5.3) Establishing the Do
AUDIT PROGRAMME
(5.4) Implementing the
Audit Programme:
(5.6) - Competence & Evaluation of Auditors
Reviewing & Improving - Performing the Audit
the Audit Programme

Action (5.5) Monitoring the


Audit Programme

Check
31
32
Audit Criteria

-set of policies,
-procedures or
-requirements used as a reference against which audit evidence is
compared
ISO Standard, i.e. ISO 9001/14001

•Conformity Assessment

Statutory and Regulatory

•Compliance Audit

Others

•Contractual Agreements
33
Verify the implementation of – How?

Through a SYSTEMATIC PROCESS-APPROACH AUDIT

34
PRODUCT AUDIT – concentrates on the outcome – final
product/service (as received by the
customer/interested parties)

PROCESS AUDIT – focus on processes (both core and


support process) – Ref. to SIPOR (Source – Inputs –
Process – Outputs – Receiver)

*** RISK-BASED / LIFE CYCLE PERSPECTIVE AUDIT – Based


on the priorities/impacts of risk as identified in the
organization

35
VERTICAL Audit
-An in depth look at a specific department/section
and verify the implementation of the step by step
procedures
-Common practice in Internal audit

HORIZONTAL Audit
-Focus on the inter-related processes /
interfaces
-Commonly used in 3rd party audit

36
37
IMPROVEMENT requirements of ISO
9001/14001:2015, clause 8.5

38
Regardless of the nature / type of audit
findings…(including Non-conformance)
All are intended for CONTINUAL
IMPROVEMENT of “”

39
PERFORMING
FIRST PARTY AUDITS

* Short Introduction {formal or informal}


* Perform Audit
- Examination/ interview of staff, inspection of
documents, observation of activities and conditions
of the area concerned.
* Conclusion of deviation/ observation of the Auditor
* Wrap-up meeting, confirmation of deviation
* Preparation of audit summary/ rating system
* Maintenance of Audit
Guidelines for Auditing
ISO 19011

1] Initiating the audit


2] Conducting document review
3] Preparing for the on-site audit activities
4] Conducting on-site audit activities
5] Preparing, approving and distributing the
audit report
6] Completing the audit
7] Conducting audit follow-up
Guidelines for Auditing
ISO 19011:

7. Conducting audit follow-up

 The conclusions of the audit may indicate the


need for correction, corrective, preventive or
improvement actions

 Such actions are usually decided and undertaken


by the auditee within an agreed timeframe and
are not considered to be part of the audit.
Implementation Phase

FOUR METHODS OF OBTAINING INFORMATION:


1. Observation- if auditee’s work matches with the
procedure
2. Asking question- if auditee knows what he is doing
3. Verifying records kept- completeness of record
maintained
4. Selecting records- examination of records

Quality Management System Internal


Audit Training 46
Implementation Phase
o OBTAINING INFORMATION:
 is the center of audit process,
 An effective auditor must ask the right question
and behave in a manner which encourages the
flow of information.

Quality Management System Internal


Audit Training 47
Audit methods are dependent on the defined audit
objectives, scope, criteria, as well as the duration of
audit in the area.

1.Desktop Audit / Document audit


2.Sampling approach on documented information (no
specific rule in sampling)
3.Interview of auditees
4.Process approach

48
Audit Trail can be TRACED in one of combination of
the following:

-Traced forward
Follow the chronological progress of the process

-Traced backward
Auditor audits the final product then re-trace it
backwards to preceding process

-Random Selection
The auditor selects the any point in the process path
then makes use of flowchart
49
Ask what they do

Question

See what they What the


actually do audit criteria
(requirement
s) says they
should do
Observe Check

50
What key things to look for and where?

•Task - work procedures, efficiency, productivity


•Objectives / Targets, e.g. KRAs,
•People – training, skills, competence
•Equipment / Work Environment
- maintenance, identification, capability, condition

•Documented Information
-identification, issue, content, adequateness, and
distribution
-Retention, archiving, preservation, legibility, accessibility
51
QUESTIONING TECHNIQUE

 THREE TYPES OF QUESTIONING


TECHNIQUES

 Open Question
 Probing Question
 Closed Question

52
QUESTIONING TECHNIQUE

 OPEN QUESTION
is useful for starting an audit, allows the
auditee to give general explanation,
e.g “what is the context /
“what are the identified risks…..?
“What are the processes ….?

53
QUESTIONING TECHNIQUE

 PROBING QUESTIONS
- Digging deeper on the area /process
“ Can you explain the…?
“How do you determine the context /
risks….?

54
QUESTIONING TECHNIQUE

 CLOSED QUESTIONS
- Answerable by Yes or No.
“Do you have a documented information related
to…?”
“ Do you have job description…?”

55
Follow-up Phase

• Verification of effectiveness of corrective action


taken.
• Clear NCR- if nonconformity has been corrected.
• Follow-up shall be done within specified time.
• Assigned auditor will make the follow-up audit.

56
Follow-up Phase
Corrective and preventive action
1. The auditor is only responsible for identifying the
nonconformity.
2. The auditee is responsible for correcting
nonconformance.
3. Corrective action (s) should be implemented within the
time period agreed on during the closing meeting.
4. An action plan should be submitted to the management
representative and/or the team leader by the concerned
auditee.
57
Follow-up Phase
Corrective and preventive action

5. Follow-up shall be made as per agreed time table


of corrective action.
6. Corrective and preventive shall be reviewed and
approved prior to implementation.
7. Corrective action shall be verified according to the
documented procedure.

58
Types of Audit findings
1. Good Points / Best Practices
2. Observation / Opportunities for Improvement
3. Potential NCs
4. Non-Conformance
Note: Classification of Audit findings / classifications may vary
in the organization
Basic Audit Questions

a) Are the processes identified & established?


b) Are the processes effective in providing the
required results?
c) Are the processes approximately describe in
procedures?
d) Are the interactions between processes defined,
controlled, and managed?
Quality of documentation
• identify the purpose of process
• identify the inputs
• identify the intended outputs
• establish the flow / sequence of activities
• Identify resources used
• identify what controls are in place ( procedure, instructions,
specifications, etc.)
• identify what planned monitoring arrangements are required
POINTS TO CONSIDER IN THE CONDUCT OF AUDIT /
FINDINGS:

Evidence of audit shall be collected through the interviews,


examination of documents, observation of activities and condition of
the area being audited.

1. At the end, we will call for a wrap-up meeting to finalize


the findings. We may sometimes give recommendations for such.

2. Audit is sampling and therefore further deviations not


detected during the audit may exist. The findings and conclusions of
the Auditors do not release the company from its responsibility to
ensure compliance with and constant observance of the requirements
of the standards.
3. Audit Report need to be finalized as soon as possible.

4. If we find a deviation, we shall expect for a corrective action to be


set at a given period of time, which may be completed on or before
that given time or can be extended to.

5. Conduct follow-up Audit to close such issues.


DOCUMENTATION
OF AUDITS

AUDIT
Reasons for writing down all audit observations:

* To avoid misunderstanding
* To avoid omissions
* To assert how the process is demonstrated
* To sustain clarity
RELATED DOCUMENTS
FOR AUDIT

1. Auditee - QMS & EMS Documentation


2. International Standards, e.g. ISO 9001/14001:2015
3. Audit Plan
4. Audit Notes / Audit Checklist (optional)
5. Deviation Report(s) / CAR / PAR
6. Audit Summary Report (optional)
REQUIREMENTS
FOR AUDITORS

ROLES & RESPONSIBILITIES


*LEAD AUDITORS
- Overall in-charge of audit
- Represent audit team to auditee
management

*AUDITORS
- Cooperate and support the lead auditor
AUDITOR’S
Qualification

Candidates for Auditor should have completed at least


ISO 9001 & 14001:2015 IQA Training, pass the exam,
and evaluation

Candidates should have demonstrated competence in


clear and fluent expression of concepts and ideas -
orally and in writing
AUDITOR’S TRAINING

* Knowledge and understanding of the standards against which


QMS & EMS audits will be performed.

* Assessment techniques on examining, questioning, evaluating


and reporting.

* Additional skills required for managing an audit, such as


planning, organizing, communicating and directing.

{Reference: (ISO 19011)}


ATTRIBUTES OF A GOOD
AUDITOR
1. Objective
- must base observation from facts

2. Steadfast
- must achieve audit objectives fairly

3. Polite
- for everyone’s concern: an Auditor is a guest or a visitor

4. Professional
- report findings exactly as they are found without
fear or favor
ATTRIBUTES OF A GOOD
AUDITOR
5. Progressive
- technology changes constantly, so auditors must be
kept abreast with such developments

6. Precise but practical


- bear in mind that you are working with human
beings and it is a natural state not to be perfect

7. Punctual
- stick to the plan and be on time
ATTRIBUTES OF A GOOD
AUDITOR

8. Principled
- be completely open about concerns; handle the
confidential information appropriately, thus, keeping trust intact

9. Optimistic
- auditor’s task should not be regarded as a negative
undertaking that audit could become a search for
failure; instead should be viewed as an opportunity for
improvement
ATTRIBUTES OF A GOOD
AUDITOR

10. Practical
- treat each thing from a practical point of view that
audit is not a waste of time and money

11. Prepared
- time spent in planning and preparation of audit
should be worthwhile
REASON FOR APPLYING THE
AUDITOR’S PERSONAL ATTRIBUTES
 To obtain and assess objective evidence fairly.
 To remain true to the purpose of the audit without fear or favour.
 To evaluate constantly the effect of audit observations.
 To treat concerned personnel in away that will best achieve the audit
purpose.
 To react with sensitivity to the national conventions.
 To perform the audit process without deviating due to destruction.
 To commit full attention and support to audit process.
 To react effectively in stressful situations.
 To arrive at generally acceptable conclusions based on audit
observations.
 To remain true to a conclusion despite pressure to change that is not
based on evidence.
(ISO 19011)
FOUNDATION
OF TRUST FOR AN AUDITOR
1.0 Has an Improved Communication
1.1 Know thyself
1.2 Listen more than talking (75% listening)
1.3 Paraphrase to clear ideas
2.0 Must be Prepared
2.1 Know the procedure
2.3 Choose a convenient audit time
3.0 Must be Empathic
3.1 Be genuine and enthusiastic
3.2 Be sensible
3.3 Maintain eye contact
3.4 Exercise good humor
3.5 Boost morale
FOUNDATION
OF TRUST FOR AN AUDITOR
4.0 Has an Objective Criteria
4.1 Agree on a standard to be followed
5.0 Focus on problem, not on people
5.1 Refrain from blaming others
6.0 Consult before deciding
6.1 Understand views before considering deviation
7.0 Agree or disagree if necessary
7.1 Refrain from inevitable argument
7.2 Elevate unresolved issue
8.0 Build a working relationship
8.1 No to conventional audit, instead give recommendations
8.2 Understand the auditee’s limitations
8.3 Consider common courtesy; “thanks”, etc.
Internal Auditor’s Note:
1) Analyze data, don’t just accept, show where to improve solve
problem, identify risk
2) An auditor decision must be more substantive and value added
3) Increase competence of auditors like educating them to other
related trainings
4) Cannot audit if process was not fully understood. Team skill is a
mandate including understanding of legislative and how transfer of
information are made.
5) Audit is lots of analyzing, evaluating, asking complete objective
evidence and verification, so do 3rd party.
MECHANICS
OF INTERNAL AUDIT
I. PREPARATION STAGE

1. Make an audit plan and audit notice.


2. Sign on the audit notice prior to distribution of notice & plan.
Ensure that all affected personnel were informed especially the
top management
3. If request for changes in plan exist, revise the notice & distribute
again to supersede the former.
4. Prepare the audit question list.
5. Brainstorm the questions with the team.
6. If time doesn’t permit, questions may not be asked completely
during the audit. On this effect, make a footnote on the question list.
MECHANICS
OF INTERNAL AUDIT
7. A brief meeting among auditors prior to the actual conduct of audit
is important.
8. Other individual / trainee may act as observer, but not allowed to
interfere / answer the questions.
9. As the team complete their audit, they should sit down together to
discuss and evaluate their findings. Figure out the deviations/
observations / CAR / PAR / NCR.
MECHANICS
OF INTERNAL AUDIT
II. AUDIT PROPER
1. Open and close the audit with courtesy.
{Formal or informal will do, which also depends on the situation.}
2. Require the representative of the auditee to come along with the
team throughout the audit.
3. Remember the method of collecting audit data, which are as
follows:
a} interview
b} document check
c} observation
Note: Remember to dig deeper, if necessary, on the situation.
MECHANICS
OF INTERNAL AUDIT
4. Better start with asking the changes / improvements in the
area/process
5. Ask about the performance based on the KPIs, then ask for
documentation
6. Don’t take too much time during the audit.
MECHANICS
OF INTERNAL AUDIT
8. There should be a concrete basis for deviation. Gather facts or
evidences to support such.

9. Show maturity. Don’t be displeased because few or nothing has


been found.

10. Show courage and politeness to either upper or lower level.


MECHANICS
OF INTERNAL AUDIT
III. WRAP UP MEETING
1. Audit wrap up meeting is suggested to be attended by top
management and all concerned parties.
2. Open the meeting and allow each team-lead auditors to present their
report.
3. When presenting deviation it is assumed that the findings were
discussed with concerned personnel for confirmation (and elevated, as
necessary to the heads)
4. If argument still exist … Pacify… Elevate problem if needed.
5. Signed original deviation report shall be returned for reproduction
and endorse the original copy to the auditee for corrective actions.
6. Close the wrap up by asking the top management for closing
remarks
MECHANICS
OF INTERNAL AUDIT
.

IV. OTHER ISSUES


1. Immediate action is required within a week but the actual
completion of corrective action may extend depending on the
situation.
2. Auditors should thoroughly evaluate the corrective action.
3. Suggestions for corrective action may come from the
auditors but this does not bind the auditee.
4. Evaluate issues thoroughly, determine if there should be a
necessity for a follow up audit to resolve such issues.
MECHANICS
OF INTERNAL AUDIT
5. Close the deviation if the action assures non-recurrence of
the same failure.
6. Establish Audit Summary Report and update it as necessary
(on development of actions or next audit highlights).
Distribute this to all concerned including top management.
7. Document the internal/ external audit system including
needed form sheets.
8. Make a good filing system.
9. Make an advance audit plan.
10. Internal Audit shall be scheduled on the basis of audit
status or importance of activity.
Reporting of
Audit Findings

85
Objective
Evidence

Audit
Findings
Audit
Cirteria

86
Types of Audit Findings:
-POSITIVE - exemplary conformance / best practices
-OPPORTUNITIES FOR IMPROVEMENT – e.g. suggestions /
recommendations
-POTENTIAL NON-CONFORMANCE – on the edge to be
NC, if not address
-NON-CONFORMANCE - non-conformance to a
specific requirement/s and/or based on risk or impact

87
Three (3) Components of NCs:

Requirement Evidence Deviation

88
1.Requirement (e.g. Standards)
 Ref. ISO 9001:2015 clause/s
 Ref. applicable statutory / regulatory requirement
 Ref. documented information / specifications

2.Evidence (Audit Evidence)


 What was found?
 Where it was found?
 Who is accountable / responsible?

3. Deviation (Description of Failure)


- Answers the question – What was deviated? / extent of failure
89
Need to cite the exact / specific reference:
 ISO 9001 / 14001:2015 clause / sub-clause/s
 State the whole requirement/phrase, e.g.
Regulatory Requirements
 If the NC is based on procedure – state the
 Document No. , Title, Section, …

Note: You need to be objective in raising NC


90
Record the EVIDENCE based from …
- What you’ve checked
- What you’ve heard
- Where it was found (location/area)
- Who is responsible / accountable

Note: As appropriate, be specific.

91
Normally stated in one sentence as to WHY the evidence
deviated the requirement/s
Description of Failure

STATE the problem…CLEAR / CONCISE

K.I.S.S – Keep It Short and Simple

92
Purpose:
-To serve as evidence of problem noted “as of the
time of the audit”

-To provide the information, in order for the auditee to


properly address the problem

93
Nonconformity (NC):

Deviation of product/service or process from specified


requirements, or the absence of, or failure to implement
system elements, or a situation which would, on the basis
of available objective evidence, raise significant doubt
as to the conformity of what the supplier is supplying /
what the organization/functional unit is supplying to the
customers.

94
-Extent of conformity of quality
management system based on the audit
criteria and effectiveness

-Effective implementation, maintenance


and improvement of

95
-Audit evidence gathered was based on samples

-Method of reporting / Classification of Findings

-Process of handling audit findings

-Post audit activities

96
- Comments / opinions should be discussed
related to findings…. if possible resolved
immediately

- If not resolved, comments/suggestions/opinions


should be recorded

97
The Audit Report, should be:

- Dated

- Reviewed and approved by concerned personnel

- Distributed to appropriate recipients within agreed


completion date

98
Guides on Writing
Audit Findings…

99
Note: the type/classification of audit findings may vary in
different organization
Type of Audit Nature How to handle
Findings
Opportunities for -No bearing if the auditee Auditees are
Improvement / will consider or not encourage to
Observation -For improvement “consider “ / Optional
purposes with the auditee if
action is necessary.
Potential NCs -Audit evidence are not Auditees need to take
clear; action – to PREVENT
-Audit criteria not clearly from NC to OCCUR
specified
Nonconformities -Clear deviation from Auditees need to take
requirements action – to PREVENT
-Significant impact / RISK RECURRENCE of the
in the system if not raise problem. 10
as NC 0
- Insufficient knowledge with the Audit Criteria
-Thinking of the “implication” of raising audit findings – or
the impact of the findings
- Not familiar with the structure of stating OFIs / Potential
NCs and NCs
- Choice of words / inappropriate

-Participants…. to share own experiences


10
1
1. OFI (Opportunities for Improvement):
Statements need to start with or include:

- “May consider…”’
- “Consider to…”
- “It was observed that…consider to ….”
- “It would be better if…”
- “Consider to improve…”
- “Consider to review…”
- “Review the ….”
- “Consider to revisit”
- Note: Don’t use words like .. “shall”, “must”, “should”10
2
2. PNC (Potential Non-conformity):
Statements need to start with or include:
-“Ensure that the…
-“There’s a need to consider….otherwise (site the
possible consequences / impacts)
-“It is strongly suggest that…
-“It was observed that… however, it is strongly suggest
that action need to be taken… in order to prevent…
Note:
Depends on the context … the statement
should always imply…the potential
impact/consequences
10
3
3. NC (Non-conformity):
Statements need to start with or include:
-“The requirement of…was deviated…based on the
audit evidence…
-“It was found out that there are inconsistencies on the
compliance to the requirements…
-Based on the evidence gathered…such as (bullets
can be included)….the requirement of …was
deviated.
-“The following items….are not in accordance with the
criteria of …”
-Note: Outline of stating NC can be enumerated as
(RED):
-Requirement?
-Evidence? 10
4
-Deviation?
3. NC (Non-conformity):
Additional…

“The ISO 9001 clause (…) requires that…., however,


based on the sample/s taken….(…), the said
requirement was not complied / or not evident”

“As of the time of the audit, there were no


objective evidence / record presented as required
by….(….”state the requirement/s)…

“Section … of the procedure (“ref. Doc. No.,


rev.)…states that…, however,…”
10
5
Question and Answer

10
6
Thank you for Participation
QUESTIONS?

107

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