It is no understatement to say that the pharmaceutical industry is currently undergoing a sea change in attitude and approach
to reducing errors caused by personnel, particularly in the operational areas. This area is broadly known as human error reduction
(HER). Human errors can be expensive, lead to accidents, and risk product quality. Historically, there have been too many
of them in the industry and the emerging approach for responding to them is promising to be fundamental and far reaching.
Simon Chalk
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When something goes wrong in our bioprocess supply chains that could have an impact on product quality, the business is obliged
to record and investigate the incident. This is required by industry regulators and accepted by the industry. Current practice
is for a manufacturing deviation report to be issued and effective corrective and preventative measures to be implemented.
Failure to see this process through (within a reasonable timeframe) can result in regulatory concerns and, in the worst cases,
regulatory observations and Warning Letters.
Analysis of the root causes of deviations is most commonly traced back to human error (more than 50% according to a recent
survey of BioPhorum member companies). Where human error is the root cause, the most common corrective action set is to retrain
the people involved. In most cases, training involves having staff read the relevant SOP and then having a supervisor or trainer
validate that training by checking that the procedure is correctly understood by the staff. Unfortunately, evidence suggests
that this approach does not eradicate the problem and the errors are repeated (47% of the time, in fact according to the same
BioPhorum survey).
Given the pressure to close corrective and preventive actions within a reasonable timeframe and the consequences of not doing
so, it is tempting to think that the primary motivation is to get people working in compliance within quality policies and
SOPs rather than to develop effective learning processes. These two motivations are not necessarily mutually exclusive, but
there is a risk that our GMP compliance culture is preventing us from getting to true root causes. In other words, the corrective
part is easier to do rather than the preventive part.
When properly investigated, the incidence of human error is actually lower than normally cited. Is an ambiguous SOP that can
easily be misinterpreted an operator error or a document error (written by another human)? One scenario might lead to the
operator being retrained (expect a repeat) while another scenario might lead to the SOP being rewritten.
Although this is the status quo today, there are two drivers changing the landscape. First, there is pressure to improve operational
performance, which means it is no longer acceptable to bear the cost of repeated errors that can sometimes run into millions
of dollars. Second, regulators are realizing that there is a better way to respond to human error. One only has to look to
the aerospace and nuclear industries to learn that errors can be driven down to levels that the biopharmaceutical industry
can only dream of. For examples closer to home, one can turn to the medical device and chemical manufacturing sectors.
Dissatisfaction with current practice is clearly building. HER is relatively new to our industry despite the extent of manual
intervention in the biomanufacturing process, but it is rapidly gaining boardroom attention. But if the current Retrain–Read
SOP–Check cycle is not fit for purpose, what are the essential elements of this new landscape? And how should the transition
be managed?
