and trend analyses are useful tools to track the performance of a method or a piece of
equipment and to detect any deviations at an early stage. Additionally, a preventive
maintenance procedure should be in place to ensure the equipment delivers reliable
results each time.
of choice. “One-stop shopping” services
help customers who would otherwise
send multiple samples to different laboratories to meet their analytical needs.
On the other hand, the portfolio offered
in a laboratory should be carefully considered, not only with respect to the
number of parameters, but also to the
matrices for which a method is vali-
Standards of Analyses
International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) 17025 is the main standard used by testing and calibration laboratories. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially
issued by the ISO in 1999. There are many
commonalities with the ISO 9000 standard, but ISO/IEC 17025 adds the concept of competence to the equation, and it
applies directly to those organizations that
produce testing and calibration results. A
second release of the ISO/IEC 17025 standard was made in 2005 to align it more
closely with the 2000 version of ISO 9001.
The most significant changes introduced
greater emphasis on the responsibilities of senior management and explicit requirements for the continual improvement of the management system itself, particularly,
communication with the customer.
There are two main sections in ISO/IEC 17025—management requirements and
technical requirements. Management requirements are primarily related to the operation and effectiveness of the quality management system within the laboratory. Technical requirements address the competence of staff, methodology and test/calibration
equipment.
Laboratories use ISO/IEC 17025 to implement quality systems aimed at improving their ability to consistently produce valid results. It is also the basis for validation
by an Accreditation Body. Since the standard is about competence, accreditation is
simply the formal recognition of a demonstration of that competence based on a documented quality management system that follows the outline of ISO/IEC 17025.
ISO 17025 accreditation should be a minimum requirement of a laboratory. However, it is not a guarantee of correct results, good service or customer satisfaction.
“Standardized practices and procedures are the backbone of a
laboratory and ensure consistent and
reliable results.”
Laboratory Proficiency
Laboratory proficiency testing is an independent, unbiased assessment of the performance of all aspects of the laboratory, both human and hardware, and is an essential element of laboratory quality assurance. With the increasing demands for
independent proof of competence from regulatory bodies and customers, proficiency
testing is relevant to all laboratories testing food for quality and safety.
In proficiency tests, the laboratory is encouraged to use its usual methods to simulate the testing of a routine laboratory sample as closely as possible. While the outcome of the analysis may be dependent upon the choice of method, it could also be
affected by the performance of the laboratory equipment or the competence of the
analyst. For this reason, it is important to involve all analysts in any proficiency test
program.
Usually, each participant receives a report that allows them to identify their own assessment. Anonymous results and assessments are also listed for all other participants,
allowing a laboratory to compare its performance with other laboratories. Reports also
contain information on methods used by participants. Laboratories that do not perform satisfactorily in a proficiency test may be required to take remedial action by
their Accreditation Body or in-house quality system.
Considerations for Consistent Service
Analytical portfolio. Whether a company operates its own laboratory or uses third-
party services, the first consideration will be the analytical portfolio of the laboratory
dated. For example, a method suitable
for the analysis of dry milk powder may
fail on a liquid dairy product. The cost
of developing, implementing, training
and maintaining a wide range of test
methods can be very high. It is advisable
to identify the core competency of the
laboratory and, before keeping any
analysis in-house, to define a minimum
number of samples to be analyzed per
week.
