Agriculture Reference
In-Depth Information
3.1.6 Control of Records
The establishment of a comprehensive records system is critical in order to demon-
strate that the quality system is well controlled. Again, hard copy and electronic
records are acceptable. The implementation of an electronic Laboratory Information
Management System (LIMS) that allows the collection of all the sample work
ow
information from sample receipt to the
final report is critical in most laboratories.
3.1.7 Audits
The internal audit system ensures that the quality system is effectively monitored on
an ongoing basis and that staff are adhering to the requirements of the quality system.
The internal audits can also be used as a vehicle for process improvement, high-
lighting inef
ciencies and waste. Staff carrying out the audits should be trained and
external training courses are readily available through the certi
cation and accredita-
tion bodies. The annual audit plan will de
ne what aspects of the quality system will
be covered. This will include all aspects of the quality system as well as witnessing
speci
c procedures and activities being carried out by staff. Nonconformances
recorded at the audits are normally actioned through the nonconforming work
procedure and evidence of the effectiveness of these actions produced.
3.1.8 Validation of Methodology
The validation of the methodology used in terms of
fitness for purpose is a critical
component of compliance with ISO 17025. The process of producing validation data
for chemical tests has now been clearly established and includes the demonstration of
analytical speci
city, sensitivity, and repeatability/reproducibility. In order to
smoothen the accreditation process, it is strongly suggested that data from the
validation should be collated into a report that would include the purpose of the
analysis, the validation planning, the validation data, interpretation of the data
including an estimate of the uncertainty of measurement, and a
final statement of
method
fitness for purpose. Method validation is discussed in much greater detail later
in this chapter.
3.1.9 Staff Competency
Demonstration of staff competency is a critical component for compliance with ISO
17025. Wherever possible, this should be through objective measurements of staff
performance and quality control (QC) measures and pro
ciency testing, spiked
recoveries, and repeat analysis of samples are examples of these. A training
procedure should be produced and applied for training new staff as well as
established staff carrying out new duties. Training records need to be established
for all staff and these should reference the speci
c procedures staff are competent to
carry out.
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