Page 227 - The Handbook for Quality Management a Complete Guide to Operational Excellence

214 P r o c e s s C o n t r o l Q u a l i t y A u d i t s 215

Process Audits
Process audits focus on specific activities or organizational units. Examples
include engineering, marketing, calibration, inspection, discrepant mate-
rials control, corrective action, etc. Processes are organized, value-added
manipulations of inputs that result in the creation of a product or service.
Process audits compare the actual operations with the documented require-
ments of the operations. Process audits should begin with an understand-
ing of how the process is supposed to operate. A process flowchart is a
useful tool in helping to reach this understanding.
It has been said that a good reporter determines the answer to six
questions: who? what? when? where? why? and how? This approach also
works for the process auditor. For each important process task, ask:

• Who is supposed to do the job? (Are any credentials required?)
• What is supposed to be done?
• When is it supposed to be done?
• Where is it supposed to be done?
• Why is this task done?
• How is this task supposed to be done?

The documentation should contain the answers to every one of these
questions. If it doesn’t, the auditor should suspect that the process isn’t
properly documented. Of course, the actual process should be operated in
conformance to documented requirements.

Systems Audits
Systems are arrangements of processes: a group of interacting, interre-
lated, or interdependent elements forming a complex whole. Systems
audits differ from process audits primarily in their scope. Whereas pro-
cess audits focus on an isolated aspect of the system, systems audits
concentrate on the relationships between the various processes in the
system. In the case of quality audits, the concern is with the quality sys-
tem. The quality system is the set of all activities designed to ensure that
all important quality requirements are determined, documented, and
followed.
The level of requirements for quality systems varies with the type
of organization being audited and, perhaps, with the size of the orga-
nization. Organizations that produce, distribute, and support a prod-
uct have greater needs than organizations that sell a service. The
changes made to the ISO 9000 series in 2000 delineated the require-
ments in broader terms that were more clearly applicable to most or all
organizations.

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