Striving for perfection dates back as far as time. The founders of our country sought for a “More Perfect Union” in the preamble of the Constitution.
However, despite our best efforts, human error is impossible to completely avoid in almost every situation. In the pharmaceutical manufacturing industry specifically, human error can have dire consequences, as every product produced ultimately ends up in a patient.
While many issues may require a simple solution, sometimes that isn’t always the case. One of the most important things is to identify all aspects of your manufacturing process so that any problems that do arise can be easily addressed, and do not infiltrate other areas of the manufacturing process.
Psychology professor, James Reason, of the University of Manchester in England came up with the “Swiss Cheese” model to help explain accident causation.
Put simply, it refers to an undesired outcome. Each step in the process to get to the outcome is its own slice of swiss cheese. The holes represent different errors, some being accidental while others can be the effect of cutting corners. Usually when operating with as many safeguards as possible, these holes do not align. Therefore, if you were to look through a hole in one slice, you would only see the next slice. When they do align, you get to your undesired outcome.
This is usually applied to healthcare, aviation safety, and engineering risk analysis, but has relevance anywhere. “Reason’s Swiss Cheese Model,” a video by Clinical Leadership Solutions Ltd on YouTube, uses a simple trip to the airport as an example to discuss active failures and latent conditions.
Reason describes active failures as “slips, lapses, mistakes, and violations.” These tend to be the choices made by an employee or the accidents they’ve unintentionally caused. Referring to the video, a slip would be the accident; forgetting to set an alarm can make you wake up late and miss your flight. A violation is intentional; speeding to get to the airport is something you knew to be wrong, but you did it anyway and were pulled over. How is this applied to a 503B outsourcer? If an employee neglects to write an event in a logbook or batch record that occurred during the production process, they’ve taken the integrity of that product into their hands. This slip may lead to inaccurate quality review and release of a batch due to missing information. The chances that the product may not fall within the approved specifications have increased, i.e. A new hole in your cheese.
Latent conditions within an organization can go unnoticed until a significant event occurs that sheds light on it, often creating the “fire-drills” many of us find ourselves in frequently. Latent conditions commonly occur as a result of poor communication, improper training, being under or overstaffed, or other oversight made when considering the environment for the employees and equipment. To use an example pulled directly from a recent 483: when a failure is made visible by media fill, there is a likelihood that your staff is inadequately trained on the aseptic techniques.
It is important to try and identify these conditions before they escalate and cause an issue, or interfere with another process, effectively lining up the holes in your swiss cheese.
If you notice something that does not seem correct, communicate with your manager, or seek additional training so that it doesn’t permeate into other facets of your business.
Companies already know they want as few mistakes as possible and investigate the causes of shortcomings, but if they can relay the importance of the main goal, it is possible that employees will be more proactive to help resolve and eliminate shortcomings. If everyone is working towards the same goals, properly communicating, and identifying holes, you can avoid major problems.
 Published on March 14th, 2019