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CHARACTERISTICS
OF AUDITS
Part one of a three part
series.
The following
is an excerpt from The
Complete Guide to the CQA by Steve
Baysinger, © Quality Publishing. The
Complete Guide to the CQA may be ordered from the Quality
Publishing Order Form.
What is a quality auditor
and what is the purpose of a quality audit? Is a quality audit similar
to a financial audit? Is an audit the same as a surveillance or inspection?
These types of questions are often asked by those unfamiliar with the
quality auditing profession. As far as what a quality auditor is,
Allan J. Sayle says it best:
Auditors are
the most important of the quality professionals. They must have the best
and most thorough knowledge of business, systems, developments, etc. They
see what works, what does not work, strengths, weaknesses of standards,
codes, procedures and systems.
The purpose of a quality
audit is to assess or examine a product, the process used to produce a
particular product or line of products or the system sup-porting the product
to be produced. A quality audit is also used to determine whether or not
the subject of the audit is operating in compliance with governing source
documentation such as corporate directives, federal and state environmental
protection laws and regulations, etc. A quality audit distinguishes itself
from a financial audit in that a financial audit’s primary objective
is to verify the integrity and accuracy of the accounting methods used
within the organization. Yet, despite this basic difference, it is important
to note that many of the present-day quality audit techniques have their
traditional roots in financial audits.
System,
process, product and compliance audits
SYSTEM
AUDIT
The quality system
audit addresses the who, what, where, when and how of the organization’s
quality system used to produce its product. For example, how is the quality
system defined? Who is responsible for producing the product? Who is responsible
for assuring the quality of the product meets or exceeds customer requirements?
What is the extent of management involvement in the daily operation of
the quality system? What procedures are used to guide the organization
in its production effort? How are they maintained and updated? Who performs
that function? Where are the procedures located?
What type of processes
are used (both directly and indirectly) to produce the product? How do
current procedures support these direct and indirect processes, etc.?
A quality system audit
is characterized by its emphasis on the macro nature of the organization’s
quality management system. Think of the quality system audit in terms
of "an inch deep but a mile wide, " i.e., broad and general
in nature rather than narrow and limited in scope. A quality system audit
is defined as a "systematic and independent examination used to determine
whether quality activities and related results comply with planned arrangements
and whether these arrangements are implemented effectively and are suitable
to achieve objectives." (ISO 10011-1 (1990)) Further, it is a "documented
activity performed to verify, by examination and evaluation of objective
evidence, that applicable elements of the quality system are suitable
and have been developed, documented and effectively implemented in accordance
with specified requirements." (ANSI/ASQC A3 (1987))
PROCESS
AUDIT
Where the quality system
audit is general in nature, the process audit is much more narrowly
defined. Unlike the system audit, the process audit is "an inch wide
but a mile deep." It revolves around verification of the manner
in which: 1) people; 2) material; 3) machines, etc., mesh together to
produce a product. A process audit compares and contrasts the manner
in which the end product is produced to the written procedures, work
instructions, workman-ship standards, etc., used to guide the manufacturing
process responsible for building the product in the first place. Process
audits are appraisal and analytical in nature.
The process audit is also
concerned with the validity and overall reliability of the process itself.
For example, is the process consistently producing accept-able results?
Do non-value added steps exist in the process? Are processes cur-rent
in terms of meeting the customer’s existing and future requirements?
Bear in mind the process
audit has two active modes of operation—appraisal and analysis. While
in the appraisal mode, keep this question in the front of your mind: are
personnel involved in the production process per-forming in accordance
with company manufacturing process plans, procedures, work instructions,
workmanship standards, etc.? In the analysis mode, on the other hand,
question the procedures, work instructions, and so forth, used in support
of the process(es) being audited—are they helpful or detrimental?
Thorough or sketchy? Does duplication of effort exist between sub-functions?
Are any non-value added
steps apparent? Does the overall process complement the expressed or implied
quality objectives of the organization: short-term customer satisfaction,
long-term repeat business, continued profitability and growth?
PRODUCT
AUDIT
The word "audit"
in product audit is somewhat of a misnomer. Actually, a product
"audit" is a detailed inspection of a finished product
performed prior to delivering the product to the customer. It is
a test of both attribute and vari-able data i.e., cosmetic appearance,
dimension properties, electrical continu-ity,
etc. Results of product
audits often provide interesting bits of information regarding the reliability
and effectiveness of the overall quality system. Product audits are usually
accomplished for one or more of the following reasons:
- to estimate the outgoing
quality level of the product or group of products;
- to ascertain if the
outgoing product meets a predetermined standard level of quality for
a product or product line;
- to estimate the level
of quality originally submitted for inspection;
- to measure the ability
of the quality control inspection function to make quality decisions,
and;
- to determine the suitability
of internal process controls.
COMPLIANCE
AUDIT
During a compliance audit,
the auditor examines the auditee’s written procedures, work instructions,
contractual obligations, etc., and attempts to match them to the actions
taken by the auditee to produce the product. In essence, it’s a "say
what you do—do what you say" type of audit. Specifically, the
compliance audit centers on comparing and contrasting written source documentation
(usually the contract) to objective evidence in an attempt to prove (or
disprove) compliance with that source documentation.
The
Complete Guide to the CQA by Steve
Baysinger
Copyright © 1997
by Quality Publishing, Inc. All Rights Reserved.
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