ECA's Analytical Quality Control Working Group (please see here for more information on the group) defined the generation of a harmonised SOP on managing analytical deviations within the laboratory including OOS, OOE, and OOT results as its first project. For that purpose the group established project task force with two project coordinators and a review team to support them.
In a first step in this project a SOP flow chart had to be developed and reviewed.
The second step comprised the development of an OOS SOP. A draft of this SOP was forwarded to the members of the OOS Review Team. About 80 members of that team provided feedback. For that reason all members were informed that it would not be possible to have two further review cycles as originally foreseen.
They were also informed that the two project coordinators, Dr Christopher Burgess and Dr Bernd Renger, would provide and present their Draft OOS SOP including the revised OOS Flow Chart during ECA's Education Course on Out-of-Specification Results in Munich from 28-29 June 2011. An additional review cycle for the OOS Draft SOP for all members of the OOS Review Team was planned for the beginning of July 2011 with a feedback time of two weeks.
Finally, the Draft OOS SOP including the revised and updated OOS Flow Chart was forwarded to ECA's OOS Review Team on 8 July 2011 - after the OOS Course in Munich. Dr Burgess also gave an introduction presentation on this Draft OOS SOP. The Review Team was also supposed to provide feedback to a few questions regarding specific details of the OOS SOP. These questions were also addressed in the presentation.
The Review Team was then asked to provide feedback and comments to this document. All answers were required by 22 July.
It is now planned to publish ECA's final OOS SOP on ECA's website in September or October 2011, which is only a slight delay compared to the originally foreseen date in July 2011.
We would like to thank all members of the Steering Committee and all members of the Review Team for their time and effort and for their great support and excellent work.
Dr Günter Brendelberger
Administration Manager of the Analytical Quality Control Working Group of the ECA Foundation