ECA Analytical Quality Control Working Group - OOS Flow Chart Review

4 July 2011

On 24 February 2011 all members of OOS Review Team of ECA’s Analytical Quality Control Working Group received the Draft Annotated OOS flow chart. This chart was prepared by Dr. Christopher Burgess and Dr. Bernd Renger. It was also reviewed, completed and approved by the remaining members of the Steering Committee of this ECA working group (Dr. Ulrich Rose and Dr. Matthias Heuermann).

ECA was asking all members of ECA's OOS Review Team for feedback and comments to this first flow chart by the end of March 2011.

On 6 May 2011 we informed the OOS Review Team that we had received more than 80 responses and comments to our request. In a letter to the SOP Flow Chart Review Team Dr Christopher Burgess and Dr Bernd Renger wrote:

"Thank you all very much for your time and efforts in reviewing the Flow Chart and submitting various useful comments and suggestions. We are pleased to report that the more than 80 responses (including numerous slightly altered flow charts) & comments we received were in broad general agreement with the proposal. We will take all your comments and suggestions for changes and points for improvement into consideration as we generate the draft SOP.

The comments and suggestions were 4 main groups:

  1. The extent of QA involvement in laboratory deviation management
  2. The extent of the mandatory raising of CAPAs
  3. Extensions to the flow chart to cover more detailed eventualities and
  4. Requests for clarification especially regarding definitions."

By that time we also had to tell the OOS Review Team that we did not anticipate to have such a large group when we designed the process flow for the specific tasks. The two project coordinators, Dr. Christopher Burgess and Dr. Bernd Renger, were aware of this fact and decided that it would not be practical to have two further review cycles as originally foreseen. Instead we agreed on one additional review cycle for the Draft OOS SOP for all members of the OOS Review Team.


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