Quality Assurance and Method Validation - Forensic Applications of Gas Chromatography - page 51

UKAS or ASCLD/LAB. The purpose of the QMS is to have proce-
dures to deal with organisation management, company structure,
testing procedures, and outlining how raw data should be stored and
reported, where appropriate. The documented system comprises
• Policy is defining the aims of the company relative to the struc-
ture of the organisation. The rest of the quality system will be
based on this piece of documentation.
• Manual (quality manual [QM]) outlines the policy statement,
the roles and responsibilities and the procedures involved in the
organisation.
• Procedures relate to specific activities, methods or instrumental
techniques within the organisation, giving step-by-step instruc-
tions for use. This is a collection of individual documents called
standard operating procedures (SOPs).
• Raw data are anything that you obtain from instruments, any-
thing you write, and reports that are released to customers.

In this document system, there should be procedures in place for dealing
with errors. No matter how hard we try, it is impossible to avoid errors occur-
ring; these can be instrumental or caused by human intervention.
When a laboratory is accredited, part of this accreditation means that
an organisation or laboratory should sign up to an external quality control
programme and/or proficiency testing scheme. Laboratories undertake pro-
ficiency testing as part of their accreditation program or to ensure that their
protocols and procedures work as they should. Proficiency tests will be car-
ried out as part of an intra- or interlaboratory scheme:

An intralaboratory scheme is in-house testing where known samples
will be tested and compared.
An interlaboratory scheme is signing up to a program or scheme
where a central organiser will send out samples of known origin for
comparison with other labs.

5.5 Instrument Qualification

When purchasing a new piece of equipment for a laboratory, there are four
main steps (sometimes termed the 'four Qs') involved in the implementation
of the new instrument:

• Design qualification (DQ) —the initial stage of this process is to
consider what is required of the instrument. At this point, you should
be considering such things as the sample preparation involved,