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 testing.

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 website.

Dr G√ľnter Brendelberger
Administration Manager of the Analytical Quality Control Working Group of the ECA Foundation


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