Chapter 04.Performing an audit
Session Plan
Format:
Student led training & open discussion
Objectives:
Understand the methods for gathering the information and
audit evidence, and requirements of ISO 19011 & 17021
Understand the importance of observation during the audit
and in particular observation of production and service
provision processes
Understand the importance of process focus during the audit
and in particular the need to verify every time if the audited
process is producing intended outputs
Understand the concept of process mapping and its benefits
in preparation for auditing a process
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Performing an audit
How do auditors find evidence ?
• Reviewing the documentation
(ex :documents, records, procedures,
drawings, specifications etc)
• Reviewing the analyzed data /
information
• Interviewing people at all levels
• Observing practices and physical
environment / conditions/ controls
NOTE: Can/should the auditor cover all people,
documents and records during the audit?
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Performing an audit
What documents should be reviewed as part
of Document review?
►System manuals
►System / Operational
Procedures
►Work instructions
►Other documents
►Records
Should all documents be reviewed ?
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Performing an audit
Observations
► Keep observing the physical evidence:

Facilities, equipment, instruments

Infrastructure,conditions, controls

records
Observation – What to Look for
 Posted Procedures
 Structure & Organization
 Actual Operations
 Communications Postings
 Control Points
 Awareness Reminders
 Operating Logs
 Calibration Tags
 Instruments with Process
 Infrastructure
Measurements
 Inspection Logs
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Performing an audit
Auditor Proverb: “Seeing is believing”
Visit the field! See the 'real world'!!!
 production /service
lines/activities, controls,
inspections/ audits/ monitoring
 nonconforming product /service
management;
 talk to people on the field - if you
can hear them and understand !;
 watch the processes as and
where they happen;
 check what is happening and
 maintenance systems;
 storage locations and conditions;
 product segregation;
 product handling, marking,
verify against the stated/
documented version of events
and processes…
 ask what the dials and meters
are indicating about process
monitoring and measures.
packing;
 Operations such as data entry
Keen observation is one of the keys to successful audit
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Performing an audit
Spell out 3 types of approach for Auditing
 Product based approach
 Process based approach
 System based approach
What will be the different steps for each of
these approaches ?
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Performing an audit
Auditing using Process Approach
4. With What?
(Materials/Equipment/People)
3. Inputs
1.
5. With Who?
(Competence/Skills/Training)
Bid/Tender Process
(Activities)
7. How Effective?
(Measurable Objective)
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2. Outputs
6. How?
(Methods/Procedures/Techniques)
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Performing an audit
Auditing using Process Approach
4. With What?
(resources)
5. With Who?
(Competence/Skills/Training)
- Specific skill sets – product
knowledge, commercial skills, etc
- People
- Information
- Office Equipment
3. Inputs
- Customer requirements
- Legal requirements
- Organisations
requirements
1.
-
Bid/Tender Process
(Activities)
Identify customer needs
Review feasibility
Perform cost calculations
Prepare offer document
7. How Effective?
(Measurable Objective)
- Success rate
- Accuracy
- Timliness
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2. Outputs
- Approved bid
- Or a regret letter
6. How?
(Methods/Procedures/Techniques)
- Procedures, work instructions
- Price lists, forms
- Formulae for calculations
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Performing an audit – Process Approach
Planning for an audit using process approach
• Understand the nature of products / services offered
• Identify key / typical requirements of customer for products / services
• Identify the key
Customer oriented processes (COP),
Support Oriented Processes (SOP) and
Management Oriented processes (MOP)
•Schedule the audit plan to include COP’s, MOPs & then SOPs in that
order.
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Performing an audit – Process Approach
What are Customer Oriented Processes..?
What are Support Oriented Processes
What are Management Oriented Processes..?
How do you monitor & measure any process ?
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Performing an audit
Why Prepare a “Checklist” before an Audit?
► to assist memory
► to ensure covering all issues and control points
► to ensure depth & continuity of the audit
► help in time management
► organise note taking
► part of audit report
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Performing an audit
Checklist Format
► Leave space for notes
► Allow space for time control
and recording
Inquiries
Evidence and
Results
Production Area (8.1)
Interview Production
► Reference the requirements of
audit criteria
Manager about production
planning. Plan, results.
Observe equipment and
settings
► Reference the control
documents
Employee interviews (5.2.2,
7.2)
Are you aware of the quality
policy?
► Reference verifying
documents (records)
How does the policy relate to
what you do?
What type of training have
you had on QM?
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Performing an audit
Checklists should:
Checklists should NOT:
 Be specific for a given QMS.
• Narrow the vision or limit
 Be prepared using QMS
documentation.
evaluation.
• Obstruct communication.
 Be clear about evaluation criteria.
 Note documents to review.
 Identify records to sample (and
sample size).
• Be too strict or constraining.
• Be a script of exact questions.
• Restrict auditor’s inquiry.
 Identify key people to interview.
• Be yes/no lists.
 Include some key questions for
• Be completely generic.
interviews.
 Note physical evidence you
expect to see.
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Performing an audit
Follow Audit Trails
As you audit you will find
interesting opportunities for
follow-up (audit trails).
Pick promising audit trails:
►Follow it through
►Interact with team
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Interview Top Management
Obtain evidence of leadership and commitment
 Observe attendance and interest in opening, closing and
feedback meetings
 Review documents:
Quality policy
Objectives
Management reviews records
 Interview members of top management:
Do they know “their” system?
Do they monitor, analyse data, draw conclusions, define actions?
 Interview personnel at other levels:
Do they understand what top management is trying to communicate?
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Performing an audit
Always take notes
►Explain the need to take notes to auditee
►Make your notes:
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
Comprehensive

Accurate

Precise

Legible
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Performing an audit
Time management
► Time is always short
► Plan well
► Do not allow your audit to get
side-tracked
► Do not dig too much (beware
false audit trails)
► Do not focus on trivia
► Remember an audit is a
sampling
Can 3rd party auditors provide solutions as well..?....
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Performing an audit
3rd Party Auditors cannot give advice on how to
correct non-conformities. (However, auditors must
write very clear non-conformities.)
This is the finding.
It is up to you to
decide how you
want to correct this.
Ref :ISO/IEC 17021
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