RCMS Audit related material
It will be very easy to answer of
our Quality & Laboratories
Activities .
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, interlaboratory 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. This is done in the ensuing chapters of this manual.
1.5 Good Laboratory Practice (GLP)
Quality Management in the present context can be
considered a modem version of the hitherto much used concept "Good
Laboratory Practice" (GLP) with a somewhat wider interpretation. The OECD
Document defines GLP as follows: "Good Laboratory Practice (GLP) is
concerned with the organizational process and the conditions under which
laboratory studies are planned, performed, monitored, recorded, and
reported."
Thus, GLP prescribes a
laboratory to work according to a system of procedures and protocols. This
implies the organization of the activities and the conditions under which these
take place are controlled, reported and filed. GLP is a policy for all aspects
of the laboratory which influence the quality of the analytical work. When
properly applied, GLP should then:
- allow better
laboratory management (including quality management)
- improve efficiency
(thus reducing costs)
- minimize errors
- allow quality control
(including tracking of errors and their cause)
- stimulate and
motivate all personnel
- improve safety
- improve communication
possibilities, both internally and externally.
The result of GLP is that the performance of a
laboratory is improved and its working effectively controlled. An important
aspect is also that the standards of quality are documented and can be
demonstrated to authorities and clients. This results in an improved reputation
for the laboratory (and for the institute as a whole). In short, the message
is:
- say what you do
- do what you say
- do it better
- be able to show
what you have done
The basic rule is that all relevant plans,
activities, conditions and situations are recorded and that these records are
safely filed and can be produced or retrieved when necessary. These aspects
differ strongly in character and need to be attended to individually.
As an assembly, the involved documents constitute
a so-called Quality Manual. This comprises then all relevant information
on:
- Organization and
Personnel
- Facilities
- Equipment and
Working materials
- Analytical or
testing systems
- Quality control
- Reporting and
filing of results.
Since industries having a laboratory are of
divergent natures, there is no standard format and each has to make its own
Quality Manual. The present Guidelines contain examples of forms, protocols,
procedures and artificial situations. They need at least to be adapted and many
new ones will have to be made according to the specific needs, but all have to
fulfil the basic requirement of usefulness and verifiability. As already indicated, the guidelines for Quality Management
given here are mainly based on the principles of Good Laboratory Practice as
they are laid down in various relevant documents such as ISO and ISO/IEC
guides, ISO 9000 series, OECD and CEN (EN 45000 series) documents, national
standards (e.g. NEN standards)*, as well as a number of text books. The
consulted documents are listed in the Literature. Use is also made of documents
developed by institutes which have obtained accreditation or are working
towards this. This concerns mainly so-called Standard Operating Procedures
(SOPs) and Protocols. Sometimes these documents are hard to acquire as they are
classified information for reasons of competitiveness. The institutes
and persons which cooperated in the development of these Guidelines are listed
in the Acknowledgements.
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