For years, EPL Bio Analytical Services has operated in
compliance with the Environmental Protection Agency’s Good Laboratory Practice
(GLP) standards. Recently, we have
gained accreditation to the International Organization for Standardization
(ISO) General Requirements for the
Competence of Testing and Calibration Laboratories (ISO 17025:2005) with
additional requirements outlined in the 2010
AOAC International Guidelines for Laboratories Performing Microbiological and
Chemical Analyses of Food and Pharmaceuticals.What changes did we have to
make to meet these requirements, and why should potential customers, including
those looking to place GLP work, consider this accreditation when evaluating us
as a company?
GLP vs. ISO 17025
Currently in the US, “GLP” is basically a
self-certification. A laboratory states
that it performed a certain study in compliance with GLP standards and then may be audited after the fact by its
customer or the EPA. However, with
recent government cutbacks, there are few EPA auditors available to evaluate these
studies. Furthermore, each country sets
its own GLP standards, which means that a study conducted in compliance with US
GLP standards may not meet the requirements to be submitted in Europe. ISO 17025 is an internationally accepted
standard that is the same country to country.
EPL underwent a rigorous on-site assessment by A2LA (a non-profit
company accredited to perform these assessments) to be granted accreditation. To keep our accreditation, we will undergo a biennial
on-site assessment with a smaller, off-site review of our procedures in the off
years.
GLP standards place the emphasis for compliance on an
individual study, while ISO 17025 accreditation applies more to processes and
methodologies. Whether it is a GLP study
of 700 samples or a single sample with no regulatory requirements, our ISO
accreditation assures the customer that we have the technical and managerial
procedures in place to consistently deliver valid data that will be accepted
all over the world.
Continuous improvement
Because we are a flat company, we were already very focused
on improving our processes. We know when
a change in efficiency, cost, or turn around time has had an impact because we
can see it in the amount of work we get, how quickly we can handle that work,
and ultimately in our paychecks!
However, ISO 17025 required us to formalize that process. We developed a Corrective and Preventive Action
(CAPA) system and database to keep track of our projects. It has really helped us to improve the
effectiveness of these projects because it forced us to:
· Perform Root Cause Analysis so that we were
treating the cause of the problem rather than the symptoms,
· Break large projects down into smaller,
easier-to-tackle action items,
· Make it clear who is responsible for each action
item and by when it should be done,
· Keep records of what we did and why we did it that
institutional knowledge is not lost when an employee leaves,
,
· and Monitor changes formally to ensure that the
project did what we intended it to do.
This CAPA system is also supported by the rigorous internal
auditing we were already doing to comply with GLP standards. Expanded from our Quality Assurance Unit, our
Internal Audit Team monitors all methods and processes for adherence, conformance
to regulatory/standard requirements, and effectiveness.
When we are continually improving our processes, our
customers benefit because we can provide higher and higher quality data in less
time at the lowest cost possible!
A Focus on the Customer
ISO 17025 is much more focused on satisfying the customer
than the GLP standards. We already work
very closely with our customers to ensure that we are meeting their
requirements, so many of the ISO requirements were already in place (in fact,
it is worrisome to think that there are laboratories out there that do not
follow the best business practices outlined in this standard). As with continuous improvement, it was more
about formalizing the processes we already had in place. We have begun sending
surveys at key points in projects and keeping a log of feedback obtained
elsewhere. Any issues or complaints
brought up by our customers trigger Corrective Action as described in the
system above. Everything we do, from the
lab to the office to the boardroom, is for the customer, not for regulatory
agencies, and ISO 17025 emphasizes that.
Quality of Results
Although the GLP standards are very specific about how to perform
and document a study, they are not as detailed regarding the actual quality of
data generated. There are many
requirements of ISO 17025 that ensure the quality and consistency of results
produced by the lab:
· Training:
Initial and ongoing competence must be evaluated prior to authorization of an
analyst to begin or continue running a method.
Proof of this competence (e.g. results that meet our quality criteria,
proficiency testing) is retained in our
analysts’ training files
· Method
Validation: New methods or significant changes to current methods must meet
accuracy and precision criteria prior to use.
Other criteria determined by the method or customer may also be taken
into account.
· Measurement
Uncertainty/Traceability: Measurement uncertainty is the error inherent in
any measurement, while traceability is the ability to identify and add up all
those errors throughout a method.Because it had not been a requirement of our
customers in the past,EPL had to develop a method for estimating the
measurement uncertainty for our methods.
Also, to provide measurement traceability, we began using only ISO 17025
accredited calibration service providers and reference material producers to
support the work on our scope. Our
already rigorous equipment calibration, verification, and maintenance schedules
also help to ensure our analyses can give the level of measurement uncertainty
needed.
· Ensuring
the Quality of Test Results: Once a method is validated, it is still
important to ensure that the individual sample results are accurate and
precise:
- Internal
QC material: In most analyses a Quality Control sample is evaluated against
an internally developed control range to determine set acceptance. This chart also allows us to monitor for
biases and stop trends before they start.
Internal QC material may also be fortified to determine recovery
- Proficiency
Testing: EPL is participating in an increasing number of proficiency
testing studies. These studies allow us
to compare our results to those of other labs testing the same sample. Proficiency testing is a way to assure the
international community that we can get the same number for the same sample as
a lab in Japan, Germany, etc.
- Other
quality assurance methods: There are many other methods we employ to assure
the quality of our results, including analysis of Certified Reference Material,
running of check standards, evaluation of reagent blanks, etc.
· Scope of
Accreditation: Although our quality management system applies to the entire
business,the Scope of Accreditation is the list of the specific methods for
which A2LA has accredited EPL. Assessors
watched each method in progress or had an analyst walk them through the
procedure. They scrutinized equipment
maintenance records and reagent supplies.
We currently have 27 methods on our Scope of Accreditation, but we will
continually to add to it.
Our Commitment to Quality
Besides enrolling in proficiency testing programs and
estimating measurement uncertainty, we really didn't have to make any
substantial changes in the way that we perform our analyses because we already
employ scientific best practices in our work everyday. Changes in processes outside the lab were
similarly minor. However,preparing for
this accreditation has already made us a better company and it is gratifying to
be recognized for the quality we pursue above and beyond the regulations we
follow. This external recognition will allow us to serve new areas of the market
and should also give our current customers added confidence in the product they
receive from us.
