D. Summers Chap 15 Audit Slides

Auditing
Chapter 15
Audit
 An effective measurement system links actions and
plans to the goals and objectives.
 Audits measure performance against objectives.
 An audit is a systematic and independent examination
to determine whether quality activities and related
results comply with planned arrangements and
whether these arrangements are implemented
effectively and suitable to achieve objectives” (ISO –
8402)
Quality, 5th ed. © 2010 Pearson Higher Education,

Donna C. S. Summers Upper Saddle River, NJ 07458. • All Rights Reserved.
2
Audit
 An effective measurement system answers the

question:
 How do we know?

3
Audit
 An effective measurement system enables an organization to:
 determine if the activities occurring within the company support the
achievement of company goals and objectives

 determine whether or not those goals and objectives move the
organization closer to the stated vision

 see where the organization is and where it is going.
Other
 The documentation meets the defined quality objective of the
organization.
 The activities performed are in conformity with the documented system.
 The quality system is effective with respect to documentation and its
implementation, in meeting the defined quality objectives, and

 Statutory and safety requirements are being fulfilled.

4
Audit
 When developing measures consider:

 What are we measuring now?
 How is this information being captured?
 Is the information currently being captured useful?
 Is the information currently being captured being used?
 Are these measurements being captured over time?
 What do we need to know?

5
Audit
 What is an audit?
 Audits appraise the activities, practices, records,
or policies of an organization.

6
Audit
 Audits are designed to determine whether

deficiencies exist between actual performance
and desired standards.
 Remember one definition of Quality? –
“Conformance to specification?”
 Therefore, Audits assure quality!

7
Audit
 Audits help organizations determine the

answers to:
 Is the company achieving its objectives?
 Have value-driven improvements been made?
 Have costs of quality been reduced?
 Have lead times been reduced?
 How do the measures of performance measure up?

8
Audit
 Audits help organizations determine the
answers to:
 Are correct procedures being followed?
 Are new/more applicable method of performance
documented and used where applicable?
 Are records being properly retained and used to solve
problems?
 Are preventive maintenance schedules being followed?
 Etc.

9
Audit
 Where do Audits focus?

 Can cover an entire company, a division, or any
portion of the processes that provide a product or
service
 Can be focused on product development and design
or material procurement or billing or order taking
or production…

10
Audit
 What types of Audits Exist?

 Internal process audits
 ISO audits
 Financial audits
 Customer specific audits
 In fact, Regulatory “inspections” now becoming audits

of processes
 UL, OSHA, etc

11
Audit
Quality Audit Categories:
1. System Audits are looking at a particular system which includes multiple processes and
can spread across several employees and departments. The audit of your calibration
system can be consider a system audit. Your interaction chart lists your systems.
2. Conformance Audits are audits to define system requirements. These are global in
nature. For example a 3rd party audit of your ISO 9001 SYSTEM is a conformance
audit.
3. Compliance Audit is an audit to regulatory requirements. This includes government
agency audits.
4. Process Audit is a focused audit on a set of processes within your organization. It
examines adherence to procedures and specifications during production or service
activities.
5. Product Audit is a focus audit on the product itself. This may be an inspection activity
or an out of the box audit.
6. Department Audit is a focus audit on one department that looks at the processes,
specifications, and systems in one department only. It will look at the different
operations with in that department. It will also examine department organization and
training
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Types of Quality Audit:
1) First party quality audit (Internal audit): when an organization conducts an audit on its
own quality system using its own staff / external consultants, the audit is known as first
part quality audit or internal quality audit. Important points are: auditing staff must be
trained for conducting this exercise and should not bias against the functional department
being audited
2) Second party quality audit (external quality audit): The second party quality audit is
performed by the purchasing organization upon the supplier organization. The idea here
is to have an assessment of the supplier’s processes in order to have confidence that the
supplier would be able to supply goods or services of an agreed quality level on a
sustained basis. Important point is these audits can be performed by the trained
personnel of the purchasing organization or an outside agency hired by them.
3) Third party quality audit (extrinsic audit): this audit is performed by the certification
bodies (ISO registered bodies) on the applicant organization seeking such certification. If
these, auditors, after conducting the quality audit on the organization with respect to a
standard, find the organization to be worthy enough, the certification is granted to the
organization. Third party audits normally results in the disruption of day-to-day activities
of the organization being audited during the duration of the audit. Apart from the
registered certification bodies, the third part audit may also be conducted by some
government departments dealing with environment and pollution, health and safety,
atomic energy etc.

13
Audit
 Facilitated meetings  Interviewing

 Observation and  Scanning
Inspection
 Reconciliation
 Documentation Review
 Confirmation or
 Analytical review
Representation
 Data Analysis
 Questioning
 Process mapping
 Process tracing  Vouching & Verifying
 Recalculation &  Surveys
Valuation
14
Audit
 Auditor –give the audit

 Gather sufficient evidence to assure conformance
and report status
 Auditee – receive the audit
 Provide just enough evidence to assure
conformance
 “Do you know what time it is?”
 Respond to report status
 BOTH sides require training
15
Audit
 Conducting an Audit is as simple as
Plan-Do-Study-Act

16
Audit
 Plan:
 Who is to be audited?
 Who is to perform the audit?
 What does the audit hope to accomplish?
 What are the performance measures?
 Where will the audit be conducted?
 When will the audit be conducted?
 How will the audit be conducted?
 Why is the audit being conducted?

17
Audit
 This is important:
 Why will the audit be conducted?
 What do we expect to or hope to learn
from the audit?

18
Audit
 Do
 Conduct the audit

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Audit
 Study
 Study the information and look for strengths,
weaknesses, and areas for improvement.
 Create an action plan to deal with the issues
 Specify the actions
 Assign responsibilities
 Provide a time frame

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Audit
 Act
 Implement the action plan to strengthen the
strengths, eliminate the weaknesses, and make
improvements
 FOLLOW UP!
 Audits are costly and time consuming, do something
with the information!

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D. Summers Chap 15 Audit Slides

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Auditing

Quality, 5th ed. © 2010 Pearson Higher Education,

 An effective measurement system answers the

Quality, 5th ed. © 2010 Pearson Higher Education,

achievement of company goals and objectives

organization closer to the stated vision

 The quality system is effective with respect to documentation and its

implementation, in meeting the defined quality objectives, and

Quality, 5th ed. © 2010 Pearson Higher Education,

 When developing measures consider:

Quality, 5th ed. © 2010 Pearson Higher Education,

Quality, 5th ed. © 2010 Pearson Higher Education,

 Audits are designed to determine whether

Quality, 5th ed. © 2010 Pearson Higher Education,

 Audits help organizations determine the

Quality, 5th ed. © 2010 Pearson Higher Education,

Quality, 5th ed. © 2010 Pearson Higher Education,

 Where do Audits focus?

Quality, 5th ed. © 2010 Pearson Higher Education,

 What types of Audits Exist?

 In fact, Regulatory “inspections” now becoming audits

Quality, 5th ed. © 2010 Pearson Higher Education,

Quality, 5th ed. © 2010 Pearson Higher Education,

 Facilitated meetings  Interviewing

 Auditor –give the audit

Quality, 5th ed. © 2010 Pearson Higher Education,

Quality, 5th ed. © 2010 Pearson Higher Education,

Quality, 5th ed. © 2010 Pearson Higher Education,

Quality, 5th ed. © 2010 Pearson Higher Education,

Quality, 5th ed. © 2010 Pearson Higher Education,

Quality, 5th ed. © 2010 Pearson Higher Education,

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