Avoiding common pitfalls
For several years now our training Human Error Reduction has been a well-attended seminar. Even though human errors aren’t a new phenomena!
The GMP expects you to properly investigate human failure. You might be wondering why many people still like to follow a training seminar on such an established principle in the GMP’s; one of the reasons is that many participants still encounter a major challenge when dealing with human errors. All too often they conclude a human error investigation with the following CAPA’s;
- Write more procedures,
- Include more details in the procedures,
That’s it! We’re done. Just a few training sessions on the procedures and we have successfully prevented this human error from occurring again, ever!
Reporting takes time, but it’s worth it!
Deviation reporting consumes a great deal of resources; time, money, patience!
As such, many investigators tend to implement quick-fixes. Unfortunately, quick-fixes aren’t effective and can even be damaging to the company. At some point you’re going to have to stop using duct-tape to keep that car window in place and start repairing. When you’re done you won’t only have a working window but you’ll feel much better having actually fixed that annoying and recurring problem for a long time to come.
Why shouldn’t I write more GMP procedures?
Because applying more duct-tape on top of the already applied duct-tape won’t fix the underlying problem. You probably have over a thousand controlled documents already, of which a major part is to be used on the work floor. Just adding an additional procedure may increase the confusion about what to do and when.
Instead of having one recall procedure, a pharmaceutical company had four separate recall procedures, each procedure separately detailing the responsibilities and actions for the involved departments.
The company had about 5000 controlled documents. They had a nice digital documentation system making it easy to search for documents (in theory). In practice, people were not aware of overlapping procedures with contradictive instructions, or they assumed the other department was taking care of the responsibility to inform key-personnel.
Why shouldn’t I include more details in my GMP procedures?
Adding details to an existing procedure may seem like a good strategy at first, explaining how things should be done in detail.
By adding more details to your procedures you are going to lose sight of what’s GMP critical and what is not. There are too many pharmaceutical organizations which haven’t properly mapped out their process on a high-level using block flow diagrams, indicating the key-activities and key-decisions.
So many details are presented as if they are equally important in documents and procedures that there is no way to distinguish between critical GMP steps and insignificant steps or GMP data in documents and procedures.
Why is re-training employees after a human error not always a good idea?
Re-training on a procedure when someone has made a mistake makes me wonder how the education system of this company is set-up in the first place.
Do you usually train personnel by giving them a reading list with a number of procedures to sign-off when read on their first working day? And then some practical activities are learned on the job?
And once training is finalized, you expect them to know how the procedures and your processes work? Does your company have a different approach?; that’s great! If not, there is some work to do here.
Solving human errors, the right way
When you’re going to solve human errors, as with any deviation, you need to perform a thorough investigation first in an open and blame-free environment, to get to the most likely cause of the incident. Following modern insights on Human Error, you should not assign blame, the incident merely being a symptom of an imperfect system.
At PCS we have developed a process guiding you through the required steps for solving human errors the right way. It comes down to putting yourself in the other person’s shoes; truly understanding why a mistake was made, given the available information at that time. Only then can you identify the real corrective action.
The root cause is usually far more complex than incomplete (or missing) procedures.
Human Error Reduction in the pharmaceutical industry is about;
- The fact that errors are symptoms, not the actual cause,
- Having a basic understanding of the human psychology; why do we make mistakes?
- Designing error-proof systems.
Mastering these three principles allows for robust processes, increasing quality and a decrease in (personal) frustration. Try it!