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Chapter 20: C. Quality Improvement 309
The most comprehensive type of audit is the quality system audit. System audits
typically involve many areas and functions within a company or organization and
examine the suitability and effectiveness of the quality system as a whole. System
audits focus on the design and specification of specific controls and procedures,
quality system documentation and interpretation by employees, and implementation
aspects of the quality system. Reasons for initiating a system audit may range
from evaluating a potential supplier to verifying an organization’s own system.
Audits of specific elements of a system, such as processes and products/services,
are also possible but are more limited in scope than the system audit.
The process audit, while more limited in scope than a system audit, is a more
detailed audit focused on one or more processes. Russell (2005) explains that a
“. . . process audit is verification by evaluation or an operation or method against
predetermined instructions or standards, to measure conformance to these standards
and the effectiveness of the instructions.” Accordingly, a process audit
ensures the effectiveness of process controls designed, documented, and implemented
to ensure customer satisfaction with products and services.
The product/service audit, even more limited in scope than the process audit,
is conducted to ensure that finished products and services conform to customer
expectations, specifications, and tolerances. A defining characteristic of a product
or service audit is that such an audit is conducted after production or service delivery
is complete. A product or service audit typically involves the use of measurement
equipment to evaluate conformance to specifications and/or performance
tests; in this regard, a product/service audit may be confused with final inspection.
Final inspection is a normal step in production or service delivery operations
by shop floor personnel or inspectors to ensure that the product or service meets
customer expectations. Product/service audits are not a normal step in day-to-day
production or service delivery operations by shop floor or inspection personnel,
but rather are audits conducted periodically by any interested party to ensure that
the product or service meets customer expectations.
It is important to note that these classifications are not mutually exclusive and,
in practice, cross-classifications of a quality audit are possible.
The following five purposes of quality audits are listed in ANSI/ISO/ASQ
QE19011S-2004 (Guidelines for Quality and/or Environmental Management Systems
Auditing):
1. To determine the conformity or nonconformity of the quality
system elements with specified requirements
2. To determine the effectiveness of the implemented quality system
in meeting specified quality objectives
3. To provide the auditee with an opportunity to improve the quality
system
4. To meet regulatory requirements
5. To permit the listing of the audited organization’s quality system
in a register
Part IV.C.3