Final OOS SOP
20 August 2014
The ECA Working Group "Analytical Quality Control" was founded in 2010. Its
first project was the development of a single SOP for the handling of analytical
deviations within the laboratory - including OOS, OOE and OOT results.
In the first step of this project, an SOP flowchart was developed which was
then evaluated by the ECA OOS review team with over 100 ECA members. In the
second step, a draft of the OOS SOP was developed using the already coordinated
flowcharts. To this OOS SOP draft the review team members submitted
approximately 25 responses - comprising many detailed suggestions and comments
for the final OOS SOP.
This OOS SOP was presented and discussed during the OOS Forum in Prague,
Czech Republic, in June 2012. One of the main objectives of the OOS Forum was to
introduce the ECA OOS SOP to a wider audience and to discuss other alternative
approaches of a GMP-compliant handling of OOS results.
At the OOS Forum members of the review team presented opinions and
approaches, which deviated from the process described in the ECA OOS SOP. These
notes were still considered in the final revision of the OOS SOP.
Meanwhile, the final version 2.1 of this SOP is now available as a free
download in the ECA members' area.
During the development phase of the OOS SOP it showed that the handling of
Out of Expectation (OOE) and Out of Trend (OOT) results can not be covered in
the same document as the subjects OOE and OOT are much too complex, to address
all relevant aspects in an SOP.
Therefore, the ECA QC Working Group is planning the creation of a separate
SOP on OOE and OOT. The first draft of this SOP will be presented at the OOT
Forum 2014 from 22-23 October 2014, again in Prague. For more details please
take a look at the OOT Forum website.
Dr GŁnter Brendelberger
Manager of the Analytical Quality Control Working Group of the ECA
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