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Chapter 20: C. Quality Improvement 307
Process
For purposes of this book, and for the Certified Quality Inspector Body of Knowledge,
a process is set of interrelated steps used to produce a product or deliver a
service. A process may or may not require the use of tools and equipment.
The Interrelatedness of Products and Processes
Products and the processes used to produce them are integrally connected. Under
a concept called “concurrent engineering,” customer expectations, product and/
or service delivery designs, materials and procurement, process designs, packaging
and distribution, and disposal are all considered simultaneously in acknowledgement
of their interrelatedness.
3. QUALITY AUDITS
Define and describe various types of
audits, including internal, external, system,
product, process, etc., and describe how
corrective action requests (CARs) from
audits can support quality improvement.
(Comprehension)
Body of Knowledge IV.C.3
Quality auditing is an important topic for the ASQ Certified Quality Inspector
(ASQ CQI). While quality auditing is a career field in and of itself, and while there
are three ASQ professional certifications pertaining to various aspects of quality
auditing (ASQ Certified Quality Auditor, ASQ Certified Biomedical Auditor, and
the ASQ Certified HACCP Auditor) we will focus here only on the depth of content
required for the ASQ CQI. Accordingly, in this section we will cover basic terms and
definitions, types of audits, roles and responsibilities in audits, audit planning
and implementation, audit outcomes, and audit reporting and follow-up.
A quality audit is defined by ANSI/ISO/ASQ QE19011S-2004 (Guidelines for
Quality and/or Environmental Management Systems Auditing) as follows:
. . . a systematic, independent and documented process for obtaining audit evidence
and evaluating it objectively to determine the extent to which audit criteria are
fulfilled.
A quality audit is a fact-finding process that compares actual results with specified
standards and plans. The audit provides feedback for improvement and
differs from inspection, which emphasizes acceptance or rejection, and surveillance,
which is ongoing continuous monitoring. There are several key terms and
definitions that apply specifically to the preparation, conduct, and reporting of
quality audits.
Part IV.C.3