When an OOS (Out of Specification) result is generated, it creates a lot of stress! Immediately there are many questions: Is it real? Will it prevent us from shipping the product? Why did this happen? What do we need to do next?
In most laboratories, the number of OOS incidents is relatively small. This means that the labs have relatively little experience addressing them effectively. For individual chemists, the frequency is even smaller.
On the other hand, the impact of having an OOS investigation can be huge. Let’s start with the cost. In one laboratory of a major pharmaceutical company, it was estimated that lab investigations cost a minimum of $3000 – and that was for an investigation with an obvious assignable cause which could be concluded very quickly. Worse yet, there is always the possibility that an OOS investigation cannot be resolved, even if the lot is acceptable, which could lead to a production lot being rejected, or force a recall if the lot is already in the field.
What can you do? Give your Chemists and Lab Managers the tools they need to do the job well. Develop a process for addressing OOS investigations consistently, which can help everyone involved. Use the FDA Guidance for Industry to lead you through the initial laboratory investigation, and if necessary, through the full scale laboratory and production investigations. Learn some of the techniques that help to solve investigations effectively, especially Root Cause Analysis and Effective Use of CAPA (Corrective and Preventative Actions).
By carefully designing your investigation process, and providing useful tools for these procedures, you can reduce the time and anxiety, and improve the probability of identify the true Root Cause. You can help to assure your investigation will have the appropriate outcome, and avoid having the same problem crop up again!
If you want some help in setting up this process, plan to attend the one day course, “Effective Investigation of Out of Specification, Out of Trend or Atypical Results” on May 14, 2014 in North Brunswick, NJ.