Quality Assurance and Method Validation - Forensic Applications of Gas Chromatography - page 50

available, such as the European Pharmacopoeia (PhEur) and the Japanese
Pharmacopoeia (JP). When our packet of paracetamol (acetaminophen) is
purchased, it will have the initials of the appropriate pharmacopoeia after
it, depending upon which set of methods has been used for testing (e.g.,
paracetamol 500 mg PhEur means the preparation was testing according to
the European Pharmacopoeia). On that basis we are assured that the product
we are buying is as it should be.

5.3 Why Be Quality Assured?

Ultimately, we wish to avoid product safety issues or to ensure that our ser-
vice meets an identified specification. This in turn ensures customer trust in
our product or service provided. In forensic science laboratories or services,
quality assurance should keep miscarriages of justice to a minimum (since it
is impossible to say that no mistakes will ever be made).

5.4 Ways to Ensure Quality of Product or Service

The following points outline the steps to implement a laboratory-based qual-
ity assurance scheme that is fit for purpose:

• Quality procedures: By placing procedures in place in the laboratory
or organisation we can minimise problems or errors. Procedures will
be identified for staff training, instrument performance, validating
test methods, recording information and dealing with errors.
• Quality standards: Choosing a standard that is appropriate to our
product or service. In the UK, the ISO/IEC 17025 implemented by
the United Kingdom Accreditation Service (UKAS) is used; in the
United States the ISO/IEC 17025 standard is used but implemented
in an accreditation program through the American Association
of Crime Lab Directors Laboratory Accreditation Board (ASCLD/
LAB). In reality, ISO/IEC 17025 is a standard that provides 'general
requirements for the competence of testing and calibration labo-
ratories' and is used as the basis of accreditation in these types of
laboratories. ISO/IEC 17025 was not written specifically for forensic
science laboratories but rather for all laboratories carrying out test-
ing and calibration.
• Quality management system (QMS) : Implementing a QMS is only
the first step of the procedure of having a fully documented quality
system in place in a workplace. A QMS will be initiated and written
in accordance with the standards of an accreditation body, such as