Pharmaceutical testing laboratories face many challenges including high volatility in incoming workloads, non-optimized analyst roles and undefined testing sequences. These issues are often ‘managed’ by dedicating resources to specific tasks and creating subject-matter experts in an attempt to improve performance and reduce errors. More recently there has been a move towards dedicated reviewers, where analysts are “promoted” off the bench into full-time review roles.
Dedicating review resources might appear to be a neat way of dealing with volatile workloads because it ensures that there are trained review resources available for review work. However (because the review workloads are generally volatile in the short interval - i.e. daily / weekly) it often leads to bottlenecks in which fully tested batches are left waiting in a queue, for review by the dedicated reviewers. In response to this, batches will often get prioritized from the queue based on their requirements for release, leading to further delays for the ‘demoted’ batches. This stop-start process between the testing and the review exaggerates the impact of the volatility and leads to inconsistent and generally longer lead times.
In addition, using dedicated reviewers often means that the review does not happen until several days after testing has been completed. By that time the “trail is cold” for errors. In these circumstances, it is not unusual to find that a little ‘cottage industry’ has built up around the correction of errors.
However, there are alternative approaches which can make the review process more efficient. Applying BSM’s Real Time Review™ methodology re-engineers the review process and can significantly improve review lead times. Our Real Time Review™ approach is based on sound, carefully adapted, Lean principles in which the dedicated reviewers review test records in close to real time by touring the labs throughout the day. Employing this approach minimises the delay between testing and review, levels the review workload and simplifies and accelerates error correction.
In addition to these benefits a more advanced lean solution is to depart from dedicated reviewers completely and introduce peer-to-peer review. This approach is where analysts review each other’s work. Either continuously in ‘real time’ or at fixed intervals throughout the day. This approach further eliminates delays between testing and review and also reduces error and rework loops as review-trained analysts better understand the standards required for documentation. However, peer-to-peer review does require up-front costs in terms of training additional review capacity and developing more defined review checklists to support a more flowed process.
In conclusion, BSM has developed excellent methodologies and solutions specifically designed to tackle inefficiencies in the review process. These modifications reduce review lead times, increase reviewer productivity and generate consistent and predictable performance overall.
This blog was written by Melanie Watson, Consultant at BSM. For further information on Paperwork Review in QC Labs send an e-mail to Melanie Watson.