Are Dedicated Paperwork Reviewers a good idea for your QC Lab?

In labs, testing often takes priority while the review is somewhat of an afterthought. However, it is
important to realise that until the results are reviewed and approved, we should not consider a test
to be completed. There are several reasons why review may not be completed promptly, including
volatile incoming workloads and changing/competing priorities. As there is a much better
understanding of the work involved in performing a test, it is also often easier for a manager to
schedule testing activities, as opposed to knowing how much time to schedule for the review. For
these reasons and more, we are often in the situation where review is left until the approved results
are required for batch release. If errors are found at this stage, it can then lead to delays in the
approval. In an effort to deal with this situation, many labs have dedicated specific resources to be
paperwork reviewers. It is not always clear how the number of dedicated reviewers is decided upon
and, in some labs, this can come to be seen as a ‘promotion’ off the bench into full time desk-
based review work. There is also belief that creating subject-matter experts will improve
performance and reduce errors.

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 (at best) 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.

There are, however, 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. It also means that some errors which could result in deviations or investigations can be
caught and fixed before the sample data is generated (for example using an out of date standard
or mobile phase).

A more advanced lean solution is the introduction of peer-to-peer review which completely
removes the need for dedicated reviewers. In this approach, 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 while reducing 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. It may be necessary
to update paperwork to allow for this incremental review process to be documented.

In conclusion, there may be some benefits to having dedicated paperwork reviewers but having
them desk-based reviewing completed data packets is unlikely to be the most productive use of the
time available. In contrast, BSM has developed excellent methodologies and solutions specifically
designed to tackle inefficiencies in the review process, whether through a structured process for
dedicated reviewers or for incorporating review into the day to day work of lab analysts. These
modifications reduce review lead times, increase reviewer productivity and generate consistent and
predictable performance overall.