Slide 3 v6

PERFORMING THE AUDIT
“Using all the ‘Planning for the Audit’
that we did yesterday”

“A fool may ask more
questions in an hour than a
wise man can answer in
seven years.”
-- English
Proverb

9K2K-LAD-E-IG-D3 Ver 6
©Robere & Associates (Thailand) 2000 1

Day 3 – Audit Activities
1. Review of previous day
2. Checklists
3. Opening Meeting
4. Conducting the Audit

“It is only through the eyes of others, can
one truly know
oneself.”
- Confucius


REVIEW OF DAY-TWO:
10 minutes review
It is important that we begin each day with a review
of the previous day’s activities. Each day lays the
foundation for the upcoming subject topics.

1. Review Homework
2. What are the areas that were unclear?
3. Identify topic areas that you want
reviewed from yesterday’s activities.


CHECKLISTS


Checklist Benefits

• Ensures sample is balanced
• Assists in preparing audit team
• Helps maintain correct pace
• Provides a record of the audit for future
reference

Preparing a Checklist (1)
• General guidelines
 be conversant with the documented
quality management system
 prepare separate lists for each
function/area
 consider time allocated and key elements
to be assessed
 use the checklist as a tool
 the auditor determines the style and detail


Preparing A Checklist (2)
• References
 use the documented system

 use the Standards

 use the auditors guide

 use your experience


Preparing A Checklist (3)
• Types of checklist
 criteria
 specific questions
 Standard Checklist (Internal
Auditing)
 bullet points


Criteria Checklist

• Be Structured in accordance with
QMS Standard
QMS Standard

• Can be use for any audit


Criteria checklist example :
ISO 9001 REQUIREMENTS STATUS ACTION/COMMENTS

8.3 Control Of Nonconforming Product

Company X ensures that product which does not
conform to product requirements is identified and
controlled to prevent its unintended use or
delivery.

The controls and related responsibilities and
authorities for dealing with nonconforming are
defined in a documented procedure.


Criteria Checklist
• Advantage
– Provides ready assessment with QMS
Standard.
– Focuses auditor’s mind on measures
– Can be used time and time again

• Disadvantage
– Requires experienced auditor
– Does not identify to an inexperienced auditor
what to look for


Specific Questions Checklist

• Be structured around a discrete
department, contract,project,procedure
department, contract,project,procedure

• Can be used for every type of audit.


Specific Question checklists
Example: Calibration Department
Checklist Question Comment

1) What method are available to
control the calibration of
inspection measuring and test
equipment?
2) Does the calibration method
process identify all pieces of
measuring, inspection and test
equipment being used?
3) Is provision made for equipment
whose calibration results are

Specific Question Checklist

 Advantage
− convenient
− flexible
− good for training auditors
− tell auditor what you want

 Disadvantage

− Not provide assessment with QMS standard
− Reflex preconceived idea of person
− stereotyped audits.
− Lot of work


Standard Checklist

• Used as part of internal audit

• Could take the form of either of the
previous checklists


Standard Checklist
 Advantage
− Uniform practice
− Helps train auditors
− Economic and quick to create

 Disadvantage

− May not be suitable for all circumstances
− Inflexible
− Blinkered Stereotyped’ audits
− Does not handle changes to audit type or audit basis
very well


Standard Checklist Example
for Training company
1. How are marketing activities initiated,
and what resources are used?
2. Who are responsible for developing,
reviewing and approving the Public
Event?
3. Why would the Public Event Plan be
resubmitted?
4. What should marketing material includes
as a minimum?
5. When would you use a Registration/
Confirmation forms?
6. How long are Registration/Confirmation
slips kept for, and by whom?


Bullet Point Checklist

• Only name suggest point

• Can be deployed equally as well during
meeting and auditing alike


Bullet Point Checklist
 Advantage
− Quick and easy to prepare
− Very flexible

 Disadvantage

− Does not provide ready assessment
− Only used by experienced auditors
− Does not define what to look for
− How to record comments to objective


Bullet point Checklist Example
• Document Control
 Establish documentation procedure

Approve Document
 Updated

Identified Changes
 Versions
 Legible and readily

Control External Document
 Obsolete document


“LOOK-AT” – “LOOK-FOR”
Example: Design Control (1)
• Development plan
• Progress control
• Input to product development phases
• Output from product development
phases

• Verification of each phase


Development plan

Look at Look for

1. Project Schedule Schedule is Complete

2. Activity Assignment Assigned staff are qualified

3. Organisation Interfaces Sub-team interfaces work


Progress Control
Look at Look for

1. Progress Report Work in progress matches
with Reports and records

2. Project Schedule Project Schedule reflects
actual progress


Input to product development phases
Look at Look for

1. Requirement Specification
Clear definition of
Requirements

Authorization by issuing
2. Test criteria organization


Output from product development phases

Look at Look for

1. Requirement Specification traceability to input

2. Outputs/deliverables Requirements

3. Prototypes of product conformance with standards


Verification of each phase
Look at Look for

1. Design reviews Detailed records of reviews

2. Checkpoint review Follow-up action on problems


Summary
• Be conversant with the quality system
• Relate the checklist to the department or quality
system area to be audited
• Checklists assist the auditor in sticking to the
plan
• They can be used for subsequent audits

Checklists are optional–
but strongly encouraged !


END


Team Exercise
D3-E01:“Checklists”
Time: 60 Minutes
Feedback: 30 Minutes


Stage Three:
Conduct the Audit

• Opening Meeting
• Conduct the audit


OPENING MEETING


Opening Meeting Purpose
• Confirm the scope and
method of the audit

• Put the company at ease
• Create the "right"
atmosphere

• Give the auditors an insight
to the management's
commitment to quality


Opening Meeting Agenda - 1
1. Thanks auditee for inviting
2. Introduce assessment team
3. Note attendance
4. Confirm the full scope
5. Review the audit schedule and
responsibilities of the audit team
6. Arrange for escorts/guides
7. Explain how to assessment


8. Define the types of
non-conformance, recommendation
9. Explain the output of the audit
10. Confirm of confidentiality of audit
activities
11. Confirm and record issue status of
documentation
12. Arrange for use of office, equipment,
Logistic



13. Invite questions

14. Thank auditee organization for
time and commitment


Additional Key Points

• As appropriate
– Explain the purpose of any review meeting
– Are there any specific health and safety?
– If the required, organize a brief familiarization
tour of the facility
– Define start/stop times for the remainder of
the audit
– Is everyone aware of the audits (i.e. Unions)


Opening Meeting Conduct

• Keep it short
• Be well prepared
• Conduct meeting in a
business like manner
business like manner

• Keep a record

Summary
• Cover the details:
– confirm the scope and method of the
audit
– confirm logistical details /
arrangements

• Set the tone:
– be prepared and professional
– get off on ‘the right foot’


END


Team Exercise
D3-E02:“Opening Meeting”


CONDUCTING THE AUDIT
A “Process” Approach


Process Relationships
PROCESS PROCESS PROCESS
REWORK REWORK REWORK

PROCEDURE PROCEDURE PROCEDURE
PRODUCT(S) TO PROCEDURE PRODUCT(S) PRODUCT(S) TO PROCEDURE PRODUCT(S) PRODUCT(S) TO PROCEDURE PRODUCT(S)
DO TO DO TO DO TO
IN OUT IN OUT IN OUT
WORK CHECK WORK CHECK WORK CHECK
+ WORK + + WORK + + WORK +
ENTRY EXIT ENTRY EXIT ENTRY EXIT
CRITERIA CRITERIA CRITERIA CRITERIA CRITERIA CRITERIA
STANDARDS STANDARDS STANDARDS
TOOLBOX TOOLBOX TOOLBOX

• We are auditing a “system” that is • Examine the “interface” between
made up of “processes”. each process. Look for a logical
• Look for some “process map” that approach
indicates the relationship and • Does the “output” of one process
interaction of each activity lead to the “input” of another?


Process Auditing for ISO9000:2000
starts at the top
• More focus on Top
Management
• Start with Quality
Policy
– Does it reflect a
customer focus
– Provide for setting and
reviewing objectives
– Is there a commitment
to continual
improvement


Management Commitment
• Must show commitment to policy, objectives
• Must “focus” on the customer
• Must have a policy that “makes sense”
(strategic planning used)
• Must “Plan” for resources to accomplish the
goals and objectives
• Must be able to show that the responsibility,
authority and communication
(internal/external) is in place for everyone.
• Must have a “management review” that
shows results.

Version 2.0

A Different Audit Focus
• Everything starts with the
“Quality Policy” Quality
• The corporate “goals”
Policy
must reflect the need
stated in the Policy
Goal
• Departmental Goal Goal
“objectives” fulfill the Objectives
Objectives
Objectives
Objectives
Objectives
Objectives
goals.. Objectives
Objectives
Objectives
Objectives
Objectives
Objectives
Objectives Objectives Objectives

Version 2.0

Objectives are the “key” to
Continuous Improvement
• Must be evident at all levels
throughout the organization. They
must be:
– Measurable
– Useful (not just easy to measure)
– Contributes toward the Quality Policy
– Suitable to demonstrate effectiveness
– Monitored for trends and acted upon by
top management


Conducting Process Audit
The following items are consideration
 The purpose, input, output, control and resources applicable
to each process are clear
 Links are established between process, and high level and
local quality objectives
 The outputs of the process are compared with desired
outcomes, purpose of the process and any specific quality
objectives
 The steps in the process and responsibilities are
determined
 Process measures are identified
 Evidence of continual improvement is sought
 Need of internal and external customers are clear

Control of the Audit
• The auditor must keep control
• The auditor must manage his/her time
• Use prepared checklists
• Judgement - What is the result of the
process
• The audit team must keep in touch


Audit Objective

• To gather objective evidence
through…

• interviewing

• observation


Objective Evidence (1)

• Found in the form of:
– documents
– statements
– observations
– records


Objective Evidence (2)
• The evidence MUST
be:

– factual and exist
– accurate
– relevant to the non-
conformity identified
– significant


Recording Evidence
• A factual statement that can be verified
 not based on opinion or preference
 not based on emotion
 based on actual observations and
statements


Evidence of Documentation
• Quality Policy for the Organization

• Quality Manual referring to procedures

• Procedures covering ISO 9001

• Procedures covering processes company’s

• Instructions

• Quality objectives

• Responsibilities and authorities


Evidence of Implementation

• Records
• Activities
• Interviews
• Objects
• Understanding

Evidence of Effectiveness
• Records/results
• Measurements
• Milestones
• Management review
• Customer feedback
• Timely corrective action
• Right versions of documents in use


Interviewing (1)

• Elaboration
• Explanation
• Work status
• Basis for evidence
• Understanding
• Dialogue/rapport
• Perspective


Interviewing (2)
• Open Questions:
• where?
• who?
• when?
• why?
• how?
• what?
• Listen
• Closed question
• Please show me


Interviewing (3)
• Questions:
– suppose
– repeat, rephrase
– ‘silly’ questions may have to be asked
– silence can be useful
– remain neutral
– confirm your understanding with closed
questions


Interviewing (4)

• Remember to ask:

– the right questions

– at their workplace

– in their language


Investigating Actions (1)

• Reviews
• re-work
• re-plan
• re-review

• Minutes
• action taken
• action recorded


Investigating Actions (2)
• Inspections
• design changes

• change approval

• Establish traceability from origin
through decision and execution to
result

Investigating Plans

• Determine whether:
– they are being followed

– they are being achieved

– they are at risk

– they are up to date


Recording the Audit Trail
• Document references
• Item identification
• Job titles
• Quotations / drawings references
• Suspected problems for further
investigation in other areas


Behaviour Awareness

• Personal space

• National conventions / culture

• Disabilities / nervousness

• Distractions

• Familiarity


Auditee Reactions
• Authority
• Antagonism
• Hostility
• Diversionary tactics
• Volunteered information
• Internal conflicts
• Deception
• Stress


Diversionary Tactics
• Some tactics:
• long lunch and other breaks
• detours between interviews
• introducing other ‘interesting’ topics
• asking for your advice/opinion on an issue
• searching for records, documents etc

• Problem!
• unable to see sufficient evidence of conformance!

• Resolution
• politely insist on keeping to the schedule
• report to Lead Auditor or Quality Manager


Summary
• The Lead Auditor is responsible for overall
control of the audit but the auditor must
control their activities
• Interviewing Is the principle tool
• Use effective questioning techniques
• Record the audit trail
• Verify details of non-conformities
• Opinions and preferences should be
suppressed
• Be aware of auditee reactions and
diversionary tactics


END


Team Exercise:
D3-E03: Mock Audit


Team Homework


Slide 3 v6

Recommended

Recommended

More Related Content

What's hot

What's hot (19)

Viewers also liked

Viewers also liked (20)

Similar to Slide 3 v6

Similar to Slide 3 v6 (20)

More from Paul Robere

More from Paul Robere (20)

Recently uploaded

Recently uploaded (20)

Slide 3 v6