8.8 Costs and Benefits of Analytical Quality Systems
337
viable. Unless a quality compromise is adopted, the laboratory will be
courseless. So will it if Quality Assurance does not rest on a Quality Policy. A
quality system instituted merely for exhibition (e.g. in an accreditation
process) rather than for strict development and fulfIllment will be at a risk
of failing.
(c) Implementing quality systems involves an initial investment and maintenance costs that should be considered in economic budgets. Effectively instituting Quality Assurance with a restrictive approach is virtually impossible. Some studies have estimated the additional costs to amount to
20 - 30 % of the laboratory budget.
(d) Any attempt at establishing Quality Assurance in an abrupt manner is a
serious mistake as it will raise opposition that will subsequently be difficult
to overcome. Rather, Quality Assurance should be introduced in a gradual
manner, beginning with training of staff at all levels and following with
specific aspects such as the sample custody chain, SOPs, data validation,
control charts, etc. Once these initial goals are reached, compilation of the
Quality Manual can be tackled and the laboratory subjected to internal
(creation of the Quality Assurance Unit within the framework of GLPs) and
external audits (accreditation and intercomparison exercises).
(e) The implementation of Quality Assurance should never be an excuse for the
analytical laboratory to avoid fulfilling its essential goal, viz. to generate
quality analytical reports within the scheduled deadline and at the agreed
cost. The duties implicit in the Quality Manual should be compatible with
efficiency and expeditiousness in the laboratory's routine services and never
a hindrance to them.
(f) A reliable quality system should be permanent and developed day by day,
month by month and year after year. The initial implementation should not
vanish with time. The personnel involved should be continuously assessed
and encouraged so that the initial endeavour will not be worthless. Of great
assistance in this context are audits (both internal and external). Special
emphasis should be placed on documenting and archiving operations,
which are the most costly and tedious.
(g) The literature on quality is atypical, abundant, occasionally contradictory
and packed with abbreviations, which make it rather inaccessible to beginners. Once this initial barrier is overcome, however, one realizes that the
topic is based on sensible, easily understandable premises.
Assuring the required level of quality, as a compromise between the characteristics of the results and laboratory productivity, provides a number of
benefits that are equivalent to the (basic and complementary) objectives of
Quality Assurance. The essential, most immediate benefit of Quality Assurance
is that it provides well-grounded support for the credibility of the information
supplied by the laboratory. Figure 8.13 illustrates the transparency and credibility gained by introducing an independent body in relations between
organizations via the results produced by their respective laboratories. Indirect
ternary relations, called in generic terms "third-party approval", involve mutual
337
viable. Unless a quality compromise is adopted, the laboratory will be
courseless. So will it if Quality Assurance does not rest on a Quality Policy. A
quality system instituted merely for exhibition (e.g. in an accreditation
process) rather than for strict development and fulfIllment will be at a risk
of failing.
(c) Implementing quality systems involves an initial investment and maintenance costs that should be considered in economic budgets. Effectively instituting Quality Assurance with a restrictive approach is virtually impossible. Some studies have estimated the additional costs to amount to
20 - 30 % of the laboratory budget.
(d) Any attempt at establishing Quality Assurance in an abrupt manner is a
serious mistake as it will raise opposition that will subsequently be difficult
to overcome. Rather, Quality Assurance should be introduced in a gradual
manner, beginning with training of staff at all levels and following with
specific aspects such as the sample custody chain, SOPs, data validation,
control charts, etc. Once these initial goals are reached, compilation of the
Quality Manual can be tackled and the laboratory subjected to internal
(creation of the Quality Assurance Unit within the framework of GLPs) and
external audits (accreditation and intercomparison exercises).
(e) The implementation of Quality Assurance should never be an excuse for the
analytical laboratory to avoid fulfilling its essential goal, viz. to generate
quality analytical reports within the scheduled deadline and at the agreed
cost. The duties implicit in the Quality Manual should be compatible with
efficiency and expeditiousness in the laboratory's routine services and never
a hindrance to them.
(f) A reliable quality system should be permanent and developed day by day,
month by month and year after year. The initial implementation should not
vanish with time. The personnel involved should be continuously assessed
and encouraged so that the initial endeavour will not be worthless. Of great
assistance in this context are audits (both internal and external). Special
emphasis should be placed on documenting and archiving operations,
which are the most costly and tedious.
(g) The literature on quality is atypical, abundant, occasionally contradictory
and packed with abbreviations, which make it rather inaccessible to beginners. Once this initial barrier is overcome, however, one realizes that the
topic is based on sensible, easily understandable premises.
Assuring the required level of quality, as a compromise between the characteristics of the results and laboratory productivity, provides a number of
benefits that are equivalent to the (basic and complementary) objectives of
Quality Assurance. The essential, most immediate benefit of Quality Assurance
is that it provides well-grounded support for the credibility of the information
supplied by the laboratory. Figure 8.13 illustrates the transparency and credibility gained by introducing an independent body in relations between
organizations via the results produced by their respective laboratories. Indirect
ternary relations, called in generic terms "third-party approval", involve mutual