Agriculture Reference
In-Depth Information
CHAPTER
3
QUALITY SYSTEMS, QUALITY CONTROL GUIDELINES
AND STANDARDS, METHOD VALIDATION, AND
ONGOING ANALYTICAL QUALITY CONTROL
DAVID GALSWORTHY and STEWART REYNOLDS
3.1
INTRODUCTION
This
first introductory section outlines the elements of a quality system that are needed
by all analytical laboratories, and not just those that are using rapid methods.
Quality systems have, in the last 20 years, become a requirement for demonstrating
the competence of an organization to carry out a speci
c task or activity. In the area of
chemical testing of food, this has been focused on the implementation of the ISO
17025 quality standard covering general requirements for the competence of testing
and calibration laboratories. This is the standard that is applied by the accreditation
body accrediting a laboratory.
Advantages of implementing a quality system include
ef
ciency improvements,
risk management,
market access,
best practice transfer, and
due diligence and legal protection.
Core elements of a quality system are presented below.
3.1.1 Quality System Design
An ef
cient quality system design is critical to the successful introduction of a quality
system and will help enormously with the maintenance of the system once it has been
applied. All quality systems have a common architecture and how this is organized is
very much down to the individual laboratory. This architecture can be described in
terms of three layers for the system. The highest level is that of policy that de
nes how
