AUDIT PREPARATION
Checklist Questions
+ Based on Quality Documentation used by
the Dept.to be Audited.
+ From the documentation Identify all the
key things involved / to be done
+ Record the key things on the checklist
as things to be checked.
+ Include references to all forms and other
documentation, i.e. other procedures / W.I.
AUDIT CHECKLIST
Job Ref : NDB
Procedure: QP008 / Issue B / Rev.1 Auditor : P.C. Chan
Sheet No. 1 of 4
Item
No.
Requirement Comments/
Remarks
Activity Compliance
Yes/No
Receiving Check
For small packet, By Foreman
- Visual check
- Identified & Marked off against the P.O.
- Until required (what does it means?), unpacked/
inspected / put into store
For Plant / Equipment, By Foreman
- Quantity check against Engineers order
- Damage check
- For specialised equipment, need to sign DN,
may be by Chargehand
- Equipment Acceptance Cert send to Contract Engineer
By Foreman for all items:
- Check DN about Order No.,
Quantity or Weight
Suppliers name & her Order No.
Description
4.01
4.02
4.01
AUDIT CHECKLIST
Job Ref. : NDB
Procedure : QP008 / Issue B / Rev 1 Auditor: P.C. Chan
Sheet No. 2 of 4
Item
No.
Requirement Comments/
Remarks
Activity Compliance
Yes/No
- Check DN against PO
- Send test Cert to site eng.
If all Ok, sign Material Received Copy, send to Engg:
Dept with D.N.
IF Non-conformity found
Inform Contract Engineer
Indicated with Red Label with defects detail, separately
located
Disposition by Site Engineer
Fill Non-conforming item input sheet (Distribution
required?)
If found after stored, remedial work.
Record on either one
- Non-Conforming Item Report Sheet
- Non-Conforming Workmanship Report Sheet
4.01
4.06
4.11
4.09
SECTION
AUDIT Conduction
AUDITEE AUDITOR
Non-conformance Statements
N Audit objectives
N Audit Schedule
N Notification of Audit
N Selection of Audit Team
N Prepare Checklist
N Audit Plan
N Audit team
N Auditee
N Audit team
N
N
CAR (s) / Audit Report
N
CAR Status Log
N Team Leader
N Team Leader
N QMR
Planning
Preparation
Conduct Audit
Complete Audit /
Discuss Findings
Audit Report Back
and Recording
Follow - up
Close - out
-investigate cause of non-
conformance
-return complete CAR
-implement necessary
corrective / preventive
action and monitor for
effectiveness.
Auditor
Auditee
PERSONAL CONDUCT
positive, professional, constructive approach
co-operative, open, honest
People
Processes
Equipment / tools / materials
Documentation
AN AUDITOR "VERIFIES" BY
OBTAINING OBJECTIVE EVIDENCE
Sampling
Scope
Duration of Audit
Requirements of the
standard
Complexity of the
process
Considerations:
Previous Problems
Important aspects
Auditor skills /
knowledge
Sample size and its
significance
Support from management
Trained auditors
Independence of audit function
Timely access to facilities, documents,
personnel
Access to all levels of management
Defined audit procedures
FUNDAMENTAL REQUIREMENTS FOR
EFFECTIVE AUDITING
Record
Past implementation
Examined / Observed
Current implementation
Method Stated
Staff knowledge & understanding
OBJECTIVE EVIDENCE
meet the area representative first
always talk to those performing the task
explain the purpose of the visit
be calm, polite, reassuring
never talk down
speak clearly and carefully
THE AUDITOR'S APPROACH
examine objective evidence
ask open-ended questions
refer to checklists
make notes
consider impact on other activities
examine physical conditions
CONDUCTING THE AUDIT
ASK
LOOK
LISTEN
How
Where
When
What
Why
Who
QUESTIONING TECHNIQUES
6 important
words
be side-tracked
be led or misled
get "bogged down"
let the auditee dictate the pace
make assumptions or presumptions
CONTROL THE AUDIT
DO NOT
aggressive auditees
missing people
missing documents
pre-prepared samples (choose your own !)
BE AWARE OF
Be prepared
Be punctual
Insist on auditee answering questions
As little talking as possible
Avoid misunderstandings
Keep questions clear and concise
Polite and calm
CONTROL THE AUDIT
DO
good listener
open-minded
diplomatic
unbiased
honest
patient
self-disciplined
SELECTING AUDITORS
DESIRABLE TRAITS
opinionated
self-important
lazy
argumentative
shy
SELECTING AUDITORS
UNDESIRABLE TRAITS
stay within audit scope
communicate audit requirements
collate objective evidence
document CARs
report audit findings
verify effectiveness of corrective actions
retain and safeguard documents
AUDITORS SHOULD
Audit Techniques
Forward Trace
Background Trace
Vertical Audit
Horizantal Audit
comply with the Standard
implement quality manual, procedures or
other documented requirements
implement a code of practice, regulation
or contract
_______________
no requirement = no nonconformance
A NONCONFORMANCE MAY BE A FAILURE
TO:
Noncompliance Reporting
What is the Problem ?
describe clearly, concisely and
factually
Why is it a noncompliance ?
i.e. against what requirement
Where did it occur ?
i.e. which department or activity
Who ? - avoid apportioning blame
(i.e. naming individuals)
Noncompliance Reporting
Information to be recorded
Identification /Serial number
The nature of the noncompliance Where, What,Why
Reference numbers of Documents/ Materials etc.
Auditee/ contact
Clause of the standard or specification applicable
Category of noncompliance (if applicable)
Agreed corrective action and timescale
Follow up action
See Noncompliance Report Form
Standard: ISO 9001:2000
Procedure: QP6 Issue 2
Area: Purchasing Dept.
1. The procedure is not being implemented in full in
that not all purchase orders are being fully
completed. For example; Pos 1234 and 1235
do not contain prices or delivery dates.
2. All Purchase Orders must be completed in
accordance with Procedure QP6.
EXAMPLE OF
NON-COMPLIANCE STATEMENT
LAC 09.08 / 05
EXAMPLE OF CORRECTIVE ACTION REQUEST
Company:
Job No:
Assessor:
Company Representative:
Procedure No:
Issue:
Details of Non-Conformance:
Signed:
Company
Representative:
Corrective Action taken to prevent recurrence:
Signed:
Company Representative
Acceptance of Corrective Action/Comments
Visit No:
Assessment Date:
Area/Dept/Function:
CAR No.: of
ISO 9001/2/3/REF
Clause
Major CAR
Proposed
Close out date:
Signed:
Assessor:
Date:
:
NON-CONFORMANCE
STATEMENTS
L/C 341-6787 for a customer under credit grade of #
8 for the amount of USD 400,000 FOB, there was no
evidence of any insurance provided.
The procedure requires that for the issue of L/Cs to
customers under credit grade 7-10 over USD 325,000
under FOB and C&F terms evidence of insurance is
required.
NON-CONFORMANCE STATEMENTS
Customer complaint from the ABC company had not
been followed up and no action had been carried out
whatsoever.
According to the procedure QP 13 paragraph 4.6 all
customer complaints are to be followed up in the
Quality Improvement Committee.
SECTION
Audit Follow Up & Close Out
AUDITEE AUDITOR
Non-conformance Statements
N Audit objectives
N Audit Schedule
N Notification of Audit
N Selection of Audit Team
N Prepare Checklist
N Audit Plan
N Audit team
N Auditee
N Audit team
N
N
CAR (s) / Audit Report
N
CAR Status Log
N Team Leader
N Team Leader
N QMR
Planning
Preparation
Conduct Audit
Complete Audit /
Discuss Findings
Audit Report Back
and Recording
Follow - up
Close - out
-investigate cause of non-
conformance
-return complete CAR
-implement necessary
corrective / preventive
action and monitor for
effectiveness.
RESPONSIBILITY OF MANAGERS
RECEIVING A CAR
1. Investigate the problem