Below is a top-10 list of best practices gleaned from a recent BioPhorum collaboration event in which 14 of the top biopharmaceutical
manufacturing companies came together to benchmark their approaches and experience for handling human error.
1. Change the perspective and the message. Advanced practitioners talk about increasing human performance and creating a high reliability workforce as opposed to reducing
human error. But developing a positive, as opposed to removing a negative, is a subtle yet important difference. The development
of these capabilities in a systematic and programmed way is underway in 75% of the top 20 biopharmaceutical companies.
2. Educate people in the science of HER. The nature and causal factors of human error are largely behavioral and psychological. Only when these factors are understood
can effective tools and techniques be developed and adopted. There is some great reference material available and specialists
are now working in the industry.
3. Encourage a climate of revealing errors as opposed to hiding them. This best practice means removing a blame culture if one exists in the company and replacing it with an open culture that
focuses instead on transparency of exactly what happened. This means getting the operators, engineers, whoever was around
to recall their observations as the error occurred.
4. Track human errors in a way that underlying trends can be identified and analyzed. Record near misses as an additional source of useful information and to help prevention.
5. Adopt effective investigation techniques, thereby establishing the true causalities. This practice may require the internal Quality organization to change the way it manages and measures some investigations.
The 30-day rule-of-thumb target for closing investigations may not be sufficient if an issue is complex and difficult. However,
an average closure time well below 30-days across all manufacturing deviations can be easily achieved.
6. Use internal specialists and experts in root-cause analysis. These experts need to be viewed as independent and should be trusted so there is no fear of a comeback. The approach needs
to have a light touch, recognizing that middle managers may be defensive about discussing mistakes made in their plants.
7. Create effective lesson-learned processes and feed them across communities of practices. Companies are now leveraging their knowledge-management systems to capture single point lessons as well as broad lessons-learned
case studies. In one case, "operations alerts" are formally written up and signed off by a vice-president. The implementation
of the learning across the network of facilities is mandatory.
8. Transform the role of trainers from tactical focus to business focus. Trainers need to think more about performance improvement overall than pure skills training. The emphasis must be to developing
capabilities that make a real difference.
9. Invert the pyramid, so that there is a "servant leadership" philosophy to support operators and the people at all levels.
Senior managers need to ensure everything around operational staff is in place to enable them to get it right the first time.
For example, procedures need to be fit for purpose, the work environment needs to be free from distractions, and the operating
approach needs to be well thought through.
10. Establish a vision and goals that help move the organization and culture away from reactive HER to active human error
prevention. Many of the companies involved in the collaboration event boiled down the above top-10 list to three supporting pillars. They
are: better training, open reporting, and rigorous root-cause investigation.
The industry is at the beginning of its long journey to be able to claim it has human errors driven down to a level comparable
with other safety critical industries. The early signs are encouraging. The BioPhorum members who gathered recently to share
best practices are reporting greater than 50% reduction in human errors following implementation. Of course, statistics need
to be used carefully. Tracking human errors through the lens of HER usually leads to more errors being counted because not
all are picked up by the traditional means. Counter to this, many errors are recategorized when properly investigated because
they are revealed to be system, equipment or organizational issues rather than human errors.
From the HER practices being developed in the leading companies, the industry should be expecting and seeing a fundamental
change in over the next two years. New best practices will change the landscape so completely that lagging companies will
not be able to rely on Retrain–Read SOP–Check any longer. Time to fetch out the sea-sickness tablets. ?
Simon Chalk is director of the BioPhorum Operations Group, simon@biophorum.com
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