Let's examine a simple metric and explore the hidden unintended behavior it might encourage:
Metric: Time from completion of manufacturing to approval of batch records.
Goal: All batch records are completed in 30 days or less after manufacturing.
Realistically, not all batches will be able to be released in 30 days or less for a variety of reasons including the fact
that some complex investigations into root cause may take longer to resolve than the allotted 30 days. When considering how
to report this metric, the organization should consider all possible reasons for achievement or non-achievement of the goal.
This includes, in essence, a root-cause analysis to interpret the meaning of the metric. Evaluation of the cause and effect
relationships are necessary before determining whether or not to revise the goal. If the goal is met most of the time with
a few exceptions the data might indicate the batch release system is operating as intended. If the 30-day period is exceeded
on a regular basis, the organization needs to consider why the 30 days are exceeded. Some of the questions to be asked might
- Were there too many errors in initial submission?
- Are people unable to prioritize their work?
- Were the records too complex?
Asking and answering these questions may offer solutions that can be used to streamline the batch release process so the 30
days can be consistently achieved.
Careful thought and consideration should be exercised when determining what to measure, how often to measure, how to interpret
and communicate the data, and what the expectation is for using the data to drive positive change. Management needs to be
cognizant of the fact that whatever metrics are chosen to be reported, they must be developed, evolved, and adjusted over
time to maximize their impact on driving positive change.
When choosing a metric it is important that the architects of the metric are aware of unintended consequences that may inadvertently
drive negative behavior. Management attempting to incentivize achievement of the goal such as offering a financial award if
the goal is achieved, for instance, may lead to inappropriate behaviors that do not address the real issue. In these cases,
it is generally not the metric that will drive the behavior but rather use of behavioral rewards. Reward for achievement rather
than analysis of the real underlying causes will not lead to sustainable positive change. When managed properly, metrics are
an important tool to help drive positive change and quality process improvements.
Susan J. Schniepp is vice-president of quality and regulatory affairs at Allergy Laboratories and is a member of the BioPharm International Editorial Advisory Board.
1. J. Woodcock and M. Wosinska, Clinical Pharmacology & Therapeutics, 93 (2) (February 2013),
2. Docket No. FDA-2013-N-0124, Food and Drug Administration Drug Shortages Task Force and Strategic Plan; Request for Comments,
Federal Register, 78 (29) (February 12, 2013).