INTRODUCTION
1.1 What is Quality?
1.2 Quality Management
1.3 Quality Assurance
1.4 Quality Control
1.5 Good Laboratory Practice (GLP)
Since this manual is aimed at improving the performance of a laboratory, the activities involved
focus on the term "quality". The quality of the product, in the present case analytical results,
should obviously be acceptable. To establish whether the product fulfils the quality requirements
these have to be defined first. Only after that it can be decided if the product is satisfactory or if
and what corrective actions need to be taken.
1.1 What is Quality?
The term "quality" has a relative meaning. This is expressed by the ISO definition: "The totality
of features and characteristics of a product or service that bear on its ability to satisfy stated or
implied needs". In simpler words, one can say that a product has good quality when it "complies
with the requirements specified by the client". When projected on analytical work, quality can be
defined as "delivery of reliable information within an agreed span of time under agreed
conditions, at agreed costs, and with necessary aftercare". The "agreed conditions" should
include a specification as to the precision and accuracy of the data which is directly related to
"fitness of use" and which may differ for different applications. Yet, in many cases the reliability
of data is not questioned and the request for specifications omitted. Many laboratories work
according to established methods and procedures which are not readily changed and have
inherent default specifications. Moreover, not all future uses of the data and reports can be
foreseen so that specifications about required precision and accuracy cannot even be given.
Consequently, this aspect of quality is usually left to the discretion of the laboratory. However,
all too often the embarrassing situation exists that a laboratory cannot evaluate and account for
its quality simply because the necessary documentation is lacking.
In the ensuing discussions numerous activities aimed at maintaining the production of quality
are dealt with. In principle, three levels of organization of these activities can be distinguished.
From the top down these levels are:
1. Quality Management (QM)
2. Quality Assurance (QA)
3. Quality Control (QC)
1.2 Quality Management
Quality Management is the assembly and management of all activities aimed at the production
of quality by organizations of various kinds. In the present case this implies the introduction and
proper running of a "Quality System" in laboratories. A statement of objectives and policy to
produce quality should be made for the organization or department concerned (by the institute's
directorate). This statement also identifies the internal organization and responsibilities for the
effective operation of the Quality System.
Quality Management can be considered a somewhat wider interpretation of the concept of
"Good Laboratory Practice" (GLP). Therefore, inevitably the basics of the present Guidelines
largely coincide with those of GLP. These are discussed below in Section 1.5.
Note. An even wider concept of quality management is presently coming into vogue: "Total
Quality Management" (TQM). This concept includes additional aspects such as leadership style,
ethics of the work, social aspects, relation to society, etc. For an introduction to TQM the reader
is referred to Parkany (1995).
1.3 Quality Assurance
Proper Quality Management implies consequent implementation of the next level: Quality
Assurance. The ISO definition reads: "the assembly of all planned and systematic actions
necessary to provide adequate confidence that a product, process, or service will satisfy given
quality requirements." The result of these actions aimed at the production of quality, should
ideally be checked by someone independent of the work: the Quality Assurance Officer. If no
QA officer is available, then usually the Head of Laboratory performs this job as part of his
quality management task. In case of special projects, customers may require special quality
assurance measures or a Quality Plan.
1.4 Quality Control
A major part of the quality assurance is the Quality Control defined by ISO as "the operational
techniques and activities that are used to satisfy quality requirements. "An important part of the
quality control is the Quality Assessment: the system of activities to verify if the quality control
activities are effective, in other words: an evaluation of the products themselves.
Quality control is primarily aimed at the prevention of errors. Yet, despite all efforts, it remains
inevitable that errors are be made. Therefore, the control system should have checks
to detect them. When errors or mistakes are suspected or discovered it is essential that the
"Five Ws" are trailed:
- what error was made?
- where was it made?
- when was it made?
- who made it?
- why was it made?
Only when all these questions are answered, proper action can be taken to correct the error and
prevent the same mistake being repeated.
The techniques and activities involved in Quality Control can be divided into four levels of
operation:
1. First-line control: Instrument performance check.
2. Second-line control: Check of calibration or standardization.
3. Third-line control: Batch control (control sample, identity check).
4. Fourth-line control: Overall check (external checks: reference samples, inter laboratory
exchange programmes).
Because the first two control levels both apply to the correct functioning of the instruments they
are often taken together and then only three levels are distinguished. This designation is used
throughout the present Guidelines:
1. First-line control: Instrument check / calibration.
2. Second-line control: Batch control
3. Third-line control: External check
It will be clear that producing quality in the laboratory is a major enterprise requiring a
continuous human effort and input of money. The rule-of-fist is that 10-20% of the total costs of
analysis should be spent on quality control. Therefore, for quality work at least four conditions
should be fulfilled:
- means are available (adequate personnel and facilities)
- efficient use of time and means (costs aspect)
- expertise is available (answering questions; aftercare)
- upholding and improving level of output (continuity)
In quality work, management aspects and technical aspects are inherently cobbled together and
for a clear insight and proper functioning of the laboratory these aspects have to be broken
down into their components.
