INTERNAL
QUALITY AUDIT
ISO 9001:2015
7 JUNE 2021
HJ FAIZAL HJ MOHAMMAD
B . E N G I N ME C H A N I C A L ( U T M, S K U D A I J B )
C E R T I F I E D L E A D A U D I T O R Q MS I S O 9 0 0 1
C E R T I F I E D L E A D A U D I T O R I S MS I S O 2 7 0 0 1
C E R T I F I E D L E A D A U D I T O R E MS I S O 1 4 0 0 1
REGISTERED ENGINEER BEM
ME MB E R S O F I E M ( G 4 1 2 0 4 )
REGISTERED ASEAN ENGINEER (AAE3809)
COURSE OBJECTIVES
!
To understand the principle and
concept of internal audit for ISO
9001:2015
!
To understand how to plan an
audit
!
To understand how to prepare
audit check list
!
To understand how to perform an
audit
!
To understand how to write audit
report
!
To understand how to conduct
corrective action and follow up
COURSE AGENDA
9:30 AM – 10:30 AM
10:45 AM – 12:30 PM
1:30 PM – 2:45 PM
Introduction to
Auditing
Review on
ISO9001:2015
requirements
Audit process (plan,
prepare, execute,
report and follow-up)
Continue audit process
Break
Break
Q&A
10:30 AM – 10:45 AM
12:30 PM – 1:30 PM
2:45 PM – 4:00 PM
INTRODUCTION TO
INTERNAL AUDITING
SECTION
1
SCOPE
NORMATIVE REFERENCES
THE HIGH
LEVEL
STRUCTURE
‘HLS’
TERMS AND DEFINITIONS
CONTEXT OF ORGANIZATION
LEADERSHIP
PLANNING
SUPPORT
OPERATION
PERFORMANCE EVALUATION
IMPROVEMENT
PLAN
4 Context of
the
organization
4.1 Understanding
the organization
and its context
5 Leadership
DO
6 Planning
5.1 Leadership
and commitment
6.1 Actions to
address risks and
opportunities
4.2 Needs and
expectations of
interested parties
5.2 Quality policy
6.2 Quality
objectives and
planning to
achieve them
4.3 Scope of QMS
5.3 Roles,
responsibilities
and authorities
6.3 Planning of
changes
4.4 QMS and its
processes
CHECK
7 Support
8 Operation
7.1 Resources
8.1 Operational
planning and
control
New!!!
10
Improvement
9.1 Monitoring,
measurement,
analysis and
evaluation
10.1 General
7.2 Competence
8.2 Determination
of requirements
for products and
services
9.2 Internal audit
10.2
Nonconformity
and corrective
action
7.3 Awareness
8.3 Design and
development of
products and
services
9.3 Management
review
10.3 Continual
improvement
7.4
Communications
8.4 Control of
externally
provided products
and services
7.5 Documented
information
8.5 Production
and service
provision
8.6 Release of
products and
services
HIGH LEVEL STRUCTURE
9 Performance
Evaluation
ACT
8.7 Control of
Nonconforming
process outputs,
products and
services
WHAT IS QUALITY AUDIT
A systematic, independent and
documented process for obtaining audit
evidence and evaluating it objectively to
determine the extend to which the audit
criteria are fulfilled
Source: ISO 19011
WHAT IS QUALITY AUDIT
Audit
Criteria
Audit
Evidence
Audit Findings
Conformity
Audit
Conclusion
Non-Conformity
Minor
Certification
Re-Audit
Major
OFI
Reasons for Audits
• ISO 9001:2015 requires them (Clause 9.2) - to
determine the system meets the standard
requirements
• To determine the system is effectively implemented
• To determine the system is properly maintained
• A control mechanism Used by Management
• Tool for continuous improvement
• To implement corrective action in the systems
Audit is NOT
• A police force
• Inspection of product
• An interrogation task
force
Audit is an information gathering activity.
There is no element of a fault finding or blame for problems
• 9.2.1The organization shall conduct internal
audits at planned intervals to provide information
whether the quality management system:
• Conforms to:
• The organization’s own requirements
for its quality management system;
• The requirements of this
International Standard;
Clause 9.2
Internal Audit
• Is effectively implemented and maintained.
• 9.2.2 The organization shall:
• Plan, establish, implement and maintain an
audit programme(s) including the frequency,
methods, responsibilities, planning
requirements and reporting, which shall take
into consideration of importance of the
processes concerned, changes affecting the
organization and the results of previous audits;
•
define the audit criteria and scope for each
audit;
• Select auditors and conduct audits
to ensure objectivity and the
impartiality of the audit process;
Clause 9.2
Internal Audit
• Ensure that the results of the
audits are reported to relevant
management;
• Take appropriate correction and
corrective actions without undue
delay;
• Retain documented information as
evidence of the implementation of
the audit programme and the
audit results.
AUDIT PLANNING
SECTION
2
AUDIT PROCESS
6.2 Initiating the audit
6.3 Preparing audit
activities
Clause 6 of
ISO 19011:2011
6.4 Conducting the audit
activities
Pre-audit
activity
Site-audit
activity
6.5 Preparing & distributing
the audit report
6.6 Completing the audit
6.7 Conducting audit
follow-up
Post-audit
activity
Audit
Program
•
Output of audit program
– Audit scope
– Resources
– Auditor competency
– Audit plan
• Annual plan
• Detail plan
Annual Audit Plan (Example)
No.
Process
1
Management
2
Maintenance
3
Purchasing
4
Delivery
5
Product Development
6
Customer Satisfaction
7
Training
8
Calibration
9
Production
10
Contract Review
Jan
Feb
Mac
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
Details of Audit Plan
# Date: Mon 28/6
Activities
Auditor Auditee
Time:
1
2
9.00 - 9.30 am
Opening meeting
9.30 - 10.30 am
Management support
( Quality policy, quality objective determination,
management review, internal communication)
3
4
5
Request For Quotation
(costing, proposal preparation, customer
specific requirements and customer communication)
10.30 - 12.30 am
Manufacturing
( Daily planning, production control, in-process/final
inspection, calibration, identification and traceability,
control of nonconforming, corrective and preventive
action, analysis of data)
All
Adam
Thomas
Adam
Annie
Daniel
Tan
Human Resource Management
Marissa
(Training Plan, Training record, Training evaluation OJT)
May
Notify The
Auditee:
Purposes
• Confirm the authority to
conduct the audit
• Provide information on
proposed audit timing and
audit team composition
• Request access to relevant
information , including
records
• Determine applicable site
safety rules
• Make arrangements for the
audits
PREPARING AUDIT CHECKLIST
• Use 5W 1H approach
• Know the “gist” of the standard requirements
• Let’s try shall we?
WITH WHAT ?(Materials / Equipment)
WITH WHO ? (Competence/Skills/Training)
Maintenance of production
and test equipment and tooling
Computer system,
Materials, child parts
Trained and competence of
Personnel(all levels),
Housekeeping, safety
requirements
INPUT (What should we received)
Production
planning, P/Order,
Delivery Instruction
OUTPUT (What we should deliver)
Process : Stamping,
welding, plating,
assembly
Work instruction, inspection
instruction, packaging,
calibration, MSA, FMEA,
Process control
HOW ? (Method/Procedures/Techniques)
Brake system
Delivered to customer
Conforming and
on-time
Delivery performance,
response time, time for returned
product test/analysis and
problem solving, quality cost,
Corrective & preventive action.
WITH WHAT Key Criteria ?( Measurements/ Indicators)
Dangers With Checklists
• Relying too much on checklist and ignoring what
is going around
• As checklists are prepared in advance, may not
address critical issues
• Tendency is to follow checklist too closely - audit
flows according to checklist not auditee response
The purpose of checklist is as an aide memoir
and itshould no. It is the servant not the master
PERFORMINGAUDIT
SECTION
3
AUDITING TOOLS
ü Checklist
ü Standards / Procedures / Work Instructions etc.
ü Pen / Pencil / Clip File
ü Auditor’s eyes, ear, mouth, nose etc.
ü Auditor’s Best Friend
§
§
§
§
§
§
What
Where
When
Who
Why
How
Please show me ….
PERFORMING AUDIT
Opening Meeting
Interview
Gather
information
Closing Meeting
Opening MeetingGuideline
•
•
•
•
•
•
•
•
•
•
Introduction of team, if deem necessary
Confirm Objective and Scope
Confirm Audit program
Explaining the audit method
Resources and Facilities
Matters relating to confidentiality
Availability of any guides
The audit is taken on a sample basis
Confirm time of closing meeting
Questions
How to gather information
Interview/Question
Observe/demonstration
Examine/Check
Interview
• Main source of information
gathered during the audit is by
interviewing people
• Interviewing people is a critical
skill that all auditors must strive to
master
• communication skill required questioning, listening, reading and
writing
DURING INTERVIEWS
QUESTIONS
LISTEN
RECORD
READ
VERIFY
Listening…the most important skill!!!
How to start interviews:
!
Start with some ‘small-talk’
!
Interviews can be initiated by asking the
persons to describe their work.
!
Explain clearly the purpose of the audit
!
Express your interest in his/her work
!
Interviews the “right’ persons.
!
Be polite and sincere, and have empathy,
i.e. to put one in another person’s place, to
understand the problems and pressure.
AUDIT IN VIEW OF RISK-BASED THINKING
Machines
(with what)
Method (How)
Environment
(conditions)
Suppliers
Process
Customers
Materials
(with what)
Measures
(Trend charts,
metrics)
Manpower
(competence,
knowledge)
= RISK = WHAT CAN GO WRONG ?
Type of questions
3 Type of Questions
• Open Ended
• Focus
• Closed Ended
Open Ended Questions
Please explain ?
• Purpose
What ?
– Encourage auditee to speak
– To get a wide range of answer
– Require several sentences (or action) to reply
• No specific answer expected
• Need to be alert to the answer
that out of context or
irrelevant
When ?
How ?
Who ?
Tell me ?
Where ?
Can you describes ?
Why ?
Open ended questions (Examples)
w
w
w
w
w
w
Can you describe the procedure briefly?
Why did you affix the sticker?
So, how was the document change done?
How did this come about
What type of models do you built?
Please tell me, who else has the authority to release the
specifications?
Focus Questions
• Purpose
– Follow up on activities highlighted
during answer to open question
– Go deeper into the understanding
• May use auditee words as leads to
focus questions
Focus Questions
• Focus Question
– Example
• As you’d explained about….just
now, would you please explain
more in detail?
• As explained earlier, how about
situation like this…?
Closed Ended Questions
• Closed Ended Question
– Purpose
• To gather specific information
• Reduce misunderstanding of what is
required.
– Guide the discussion towards a
specific issue/problem
– Should minimize using this type of
questions
Closed Ended Questions (Example)
w
w
w
w
w
w
w
Were this the right material?
Is this the way you do?
Are you responsible for updating the data?
No authorized signature was seen on this report?
Are these materials that belonged to your customer?
Is this an approved supplier?
Did you say that the concentration of the tank was
checked two weeks ago?
AUDITOR’S BEST FRIEND
Please Show Me !
Don’t forget !
Active Listening
• Active listening encourage auditee go deeper for
further communication. Some of “door opener”:
–
–
–
–
–
–
–
Interesting !
Tell me about it
Tell me more
Would you like to talk about it
Let’s discuss it
You have something on your mind
Your thoughts are important to me
Effective Listening
Effective listening is an active listening:
– Listen to the auditee says
– Listen for the way the auditee says
– Carefully observe all non-verbal communication
• You must listen for three types of information:
– Facts
– Feelings
– Non-verbal sign
Non-verbal Sign
• Sociologists tell us that much of our communication
occurs through non-verbal messages
!55% Nonverbal communication
!38% Tone of voice
! 7% Only through the words themselves
Non-verbal communication includes . . .
! Body language
! Space
! Time
BODY LANGUAGE
BODY LANGUAGE
BODY LANGUAGE
LISTENING SKILLS
When listening, try to avoid the following
behaviors…
•
•
•
•
•
Making judgments
Mentally rehearsing what you are going to say in
response
Interrupting or completing sentences
Assuming you already know what the speaker is
going to say
Offering advice or solutions
Poor Ethic of
Auditor
• Poor At Preparation & Planning
• Too Rigid
• Fault Finding
• Jumps To Conclusions
• Argumentative
• Bad Communicator
• Easily Influenced
• Stays In Office
• Arrogant
• Poor Timekeeping
• Afraid Of Passing Unpopular
Judgements
Taking Notes As Reference
ry! ou go
o
em as y
m
ur tails
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y
st e de
u
r
t t n th
o
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o
D te d
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Please, Please Take Notes !!!
" For Investigation Now
" For Investigation Later
" For Use During Report Writing
" For Use By Other Auditor
Audit Note
Before start to take note, pls record the following :
" Auditee’s name
" Date
" Process/ department
" Other necessary information
While auditing, please record
" Auditee’s statements
" Audit evidence/Reference
" Verification Result
AUDIT REPORTING
SECTION
4
What is Audit report
•
•
•
•
•
Audit report is the final product of
audit process
The evidence of the audit was
conducted
Must be factual
Tone must be be courteous and
professional
Should be verifiable (track down the
evidence)
Audit Findings
Audit evidence should be evaluated against audit criteria to
generate audit findings. Audit findings can indicate either:
Non Conformances
Conformances
OFI*
*Opportunity for further improvement
Nonconformance Exists Because
•
•
•
The system does not comply
with the standard, procedure
or other requirements
Performance does not comply
with the system
Performance is not effective
Minor Nonconformance
•
•
Single incident observed that a requirement of
procedure or system or standard not being
conform to.
It may be one of the followings :– A failure in some part of the organization’s document QMS
relative to ISO 9001:2015
– A single observed lapse in fulfilling one of a company’s QMS.
Major Nonconformity
- The absence of or total breakdown of a system
to meet a requirement.
- Any noncompliance that would result in the
probable shipment of nonconforming product.
- A number of minor nonconformities against
one requirement can represent a total
breakdown of the system
OFI (Observation)
•
•
•
An observed situation where there was not
enough objective evidence to classify the
situation as nonconformance
An observed situation which is NOT a major or
minor nonconformity, but where results
achieved, based upon the auditor’s judgement
and experience in that commodity, are not
optimal.
These opportunities shall be recorded in the final
audit report for benefit of the supplier.
EXAMPLE OF MINOR NONCONFORMANCE
• Isolated examples of deficient record keeping on Contract
Reviews of design review
• Isolated examples of instruments or test equipment not
calibrated or out of calibration
• Isolated examples of obsolete documents retained in
quality manual, procedures, manual or work instruction
• Isolated examples of drawings unchecked
EXAMPLE OF MAJOR NONCONFORMANCE
• Management review was not conducted at all for the last
one year.
• No internal audit carried out within one year cycle.
• No evidence of corrective action taken to all complaints
received from customer for the last one year.
• Nonconforming were mix with conforming product which
is ready for shipment to customer.
Closing Meeting
• Opening Remarks & thanks
• Attendee list - Pass around for signatures
• Review audit objective and scope
• Restrictions/ limitation
• Tell of GOOD things you saw
• Review of findings
• Clarification
• Agreement and Q & A
• Closing and Thank you
• Save audit finding as Quality Records
CORRECTIVE ACTION AND
FOLLOW UP
SECTION
5
NCR or CAR
Raised
CORRECTIVE
ACTION
PROCESS
Record
Investigate root cause of a
problem and identify
Corrective Action
Implement Corrective
Action and Update
documentation
No
Corrective Action
Effective
Management
Review
Yes
END
TREY
research
NON-CONFORMITY REPORT or
CORRECTIVE ACTION REPORT (ISO 9001:2015)
Details of Nonconformance
Auditor: _______
Auditee: _________
Root Cause:
Root Cause:
Correction :
Corrective Action :
Auditee: _______
Accepted by: _________
Completion Date : _________
Verification :
Verified by: _______ NCR Close Out: Yes/No
TREY
research
NCR/CAR Statement
• Findings of nonconformance
• Statement of nonconformance that deviated against
requirements or system
• Evidence
• Something you found and confirm by authorize
personnel
• Be specific, where, what name, what number
• Make it retrievable
• Correct - check your fact
• Requirement - cite the specific requirements
• Reference Standard, Auditee QMS,Management
requirement, Customer contract, Gov. regulations,
codes of practice
TREY
research
How to start writing
• It was found that…….
• It was noted that……
• It was observed that …….
• There is no evidence ……
• During the audit …….
TREY
research
NCR example 1
During the audit it was found that products kept in
finished goods store were not preserved adequately.
(objective evidence: Several on-hold pipe elbows
were found mixed with other acceptable pipe
elbows).
ISO 9001:2015 Clause 8.5.4 (Preservation)
TREY
research
NCR example 2
Although several customer complaint letters were
seen in both the Sales and Marketing Department,
there was no evidence that the complaints had been
analyzed and investigated.
(objective evidence: Complaint from ‘En. Faris’ dated
30/4/2018),
ISO 9001:2015 Clause 10.2 (Nonconformity and Corrective Action)
TREY
research
NCR example 3
• There is no evidence that the measuring equipment had been calibrated against measurement standard.
(objective evidence: Vernier caliper - VC001 was found not calibrated since 2017)
ISO 9001:2015 Clause 7.1.5 (Monitoring and measuring
resources).
TREY
research
Fundamental Components of Corrective
Action
IDENTIFY
NONCONFORMANCE
IF EFFECTIVE
CLOSE OUT
ROOT CAUSE
ANALYSIS
CORRECTIVE
ACTION
PROCESS
FOLLOW-UP
APPLY
CORRECTIVE ACTION
NON-CONFORMITY REPORT (NCR)
Responsibility
Details of Nonconformance
Auditor
Auditor: _______
Auditee: _________
Root Cause:
Root Cause:
Correction :
Auditee
Corrective Action :
Auditee: _______
Accepted by: _________
Completion Date : _________
Verification :
Verified by: _______ NCR Close Out: Yes/No
Auditor
5-Why Fundamentals
Problem
Why
If done correctly, you should
be able to trace the root
cause back to the problem
using “there fore”
Therefore
Cause
Why
Ask “Why” until you
reach a logical root
cause
Therefore
Cause
Why
Therefore
Cause
Why
Therefore
Cause
Why
Therefore
Root Cause
CAUSE ANALYSIS (example)
5 WHY(example)
Questions 1: What happen to cooling water ?
Answer 1: Cooling water cannot reduce temperature
Question 2: Why cannot reduce temperature ?
Answer 2: Because inadequate of water flow
Question 3: Why inadequate of water flow ?
Answer 3: Because pump insufficient pressure
Question 4: Why pump insufficient pressure ?
Answer 4: Because the pump axle was worn out
Question 5: Why pump axle worn out ?
Answer 5 : Lubrication not done according to schedule
Follow-up and check results. Ask:
• Is the solution working?
• How do I know?
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