ECA Analytical QC Working Group issues comprehensive OOE/OOT Guidance Document

The ECA "Analytical Quality Control" Working Group's first project was the development of an SOP for the handling of Out of Specification (OOS) Results. This OOS SOP is available as a free of charge download in the members' area of the ECA website. 

The second project is the development of a Laboratory Data Management Guidance Document for the handling of Out of Expectation (OOE) and Out of Trend (OOT) Results. Version 01 of this Guidance Document has more than 70 pages and covers the following subjects:

  • Scope and application
  • Regulatory references  
  • Overview about the data management in the laboratory and about the analytical process  
  • Responsibilities of QC and QA  
  • Overview and purpose of trend analysis 
  • The concept of control charts  
  • Detection and managing of OOE results
  • Trend analysis for Statistical Process Control (SPC) of continuous data
  • Determination of a Trend using SPC  
  • Trend analysis in the investigation of deviations for the subsequent analysis of historical data after the discovery of a problem 
  • Trend analysis for stability testing

For the trend analysis for stability testing the following subjects are covered:

General principles of the selection and evaluation of data -
a) a simplified approach by using the linear regression model 
b) a more advanced model by using the "Random Coefficient Regression"

as well as a flow chart for the evaluation of OOT results in stablility testing.

Altogether the document comprises 7 Annexes:

  • Annex 1 - Technical Glossary 
  • Annex 2 and 3 - Various examples of SPC for continuous data
  • Annex 4: Example of an investigation of continuous data by a "Post mortem CuSum Analysis"  
  • Annex 5: Example of SPC for discrete data 
  • Annexes 6 and 7: Various examples for setting stability trend limits

The current version of this OOE/OOT Guidance Management Document will be presented during the ECA Education Course Handling OOE and OOT Results from 14-15 November 2016 in Prague, Czech Republic. The presentation of the basic proposals with regard to the above mentioned subjects will be followed by discussions and interactive workshops. This way participants of the course will become familiar with the implementation.

The OOE/OOT education course will be followed by the ECA Post-Conference-OOS-Workshop on 16 November 2016. This workshop will concentrate on the (European and US) authorities' expectations relative to OOS as well as on the ECA Analytical QC Working Group's OOS SOP Version 2.

For further information on the ECA Working Group please visit the Website of the ECA Analytical QC Working Group.

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