Next Step of the ECA QC Working Group: SOP for OOE and OOT Results
1 November 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.
Meanwhile, the ECA SOP on Out of Specification (OOS) results has been finalised
and is 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 one SOP. Therefore, the ECA QC Working Group is planning
the creation of a separate SOP on OOE and OOT. This SOP will have the following
priorities and will thus be structured accordingly:
1. Methods and approaches for detecting out of expectation (OOE) data within
an analytical sequence which could be based on the process capability of
the analytical procedure.
2. Methods and approaches for detecting
out of trend (OOT) data between analytical sequences where no trend is expected,
for example a variety of statistical process control approaches.
3. Methods and approaches for detecting out of trend (OOT) data between
analytical sequences where a trend is expected as is the case for stability
The first draft of this SOP will be presented during the OOT
Forum 2014 from 22-23 October 2014 in Prague, Czech Republic. Following the
presentations of the basic proposals for the three issues mentioned above there
will be discussions, allowing delegates to get actively involved and to define
what regulations with regard to OOE and OOT especially need to be considered
from their perspective.
For more details please take a look at the OOT Forum
Dr GŁnter Brendelberger
Manager of the Analytical Quality Control Working Group of the ECA Foundation
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