It’s the third day of an audit. While you’ve been enjoying the provided lunches and getting away from checking email, you’re no longer entertained by the auditors’ elaborate stories and anxiety that a haywire Teams message will appear on the screen you’re sharing.
For the last hour, he’s been locked in on one form that was not filled out properly. You’ve been scrolling through other instances of the form and haven’t found similar issues and are cursing the fact that he chose that example. But he’s not letting up, and you can feel the minor finding creeping up behind you. You’ve already drafted the CAPA in your head, and all signs point to one action. Retraining.
Stop it.
Too often, quality professionals use retraining as a crutch to solve Corrective Actions. “It’s not the process. It’s not the form. Just one more training session will fix everything”. Maybe you even know the operator and can picture their face as you present the audit finding and inform them of the training session that will result from what you see as a willful lack of attention to quality.
Well, you better be sure that the process is indeed perfect.
Retraining is an indication that a Quality department is acting as an adversary to the rest of the company (this is not the sole responsibility of Quality and may be preached by other departments). There is chaos amongst the ranks, and it is Quality’s job to reign it in, to force the employees and company into a state of order.
But there’s another way. The quality departments in regulated industries such as pharmaceuticals, medical devices, and aerospace are often seen by management as a necessary evil put in place by the government. However, the history of quality control demonstrates that the origin of the profession was to make better products and processes.
An employee didn’t fill out a form correctly. While you can hold onto the view that this was human error, it is a great opportunity to truly examine the process. Employ the tools that are in the quality handbook. Look for creative solutions to the problem that will not only fix the error but also make the process better and coworkers more satisfied with their jobs.
Quality professionals sometimes hold onto a view that a process is not the problem even if it was an inherited process, put in place years ago by a Manager they never even knew.
I’ve seen a lot of processes, and I’ve filled out a lot of forms, and I am sure that almost all of them could be improved. Quality should be seamless in the way it is integrated into day-to-day operations. When operators are constantly struggling or fighting the way processes are implemented, it’s a clear sign that something needs to give.
A lot of the time, the person performing a Corrective Action will default to listing retraining as the action. Someone messed up and didn’t fill out a form correctly. Everyone will be trained on the process and taught how to fill out the form correctly. It sounds nice and simple, but it’s the result of someone stopping at the first or second Why and not getting to the root cause.
It also opens up another can of worms for a Quality department. If you have three Corrective Actions, and the actions taken for all of them were retraining, how on earth can you say that your training program is effective?
A form being filled out incorrectly by a production employee, leading to an entire overhaul of a company’s training program, would be a more effective and honest way to solve the issue than simply retraining. And if you take this approach, good for you! This is a much better approximation of the root cause!
I will also add here that almost all CAPAs will include training or retraining as part of the actions. However people should be trained on the new, improved process, not the process that was already found to have holes.
Let me tell you, dear reader, I am not without sin regarding this issue. Recently, I was in this exact situation at my company, finding that a certain section of a form was not being completed correctly. And while it was a repeated issue, all of the mistakes were made by one person. Is this not a perfect indication that they just need to be retrained on the form?
However, I decided not to implement actions right away and took the weekend to think through the issue. And it finally dawned on me. Why the heck am I having people fill out this section of the form to begin with?
All the information is already captured elsewhere in a more appropriate place. Filling out that section of the form required an understanding of multiple unrelated processes and caused my coworkers to spend time writing the same thing over and over. My other coworkers were filling out the form correctly, but it was not adding value in any demonstrable way.
So I removed that section! Not only will the issue be impossible to repeat in the future, but it will also ease the burden of every single employee who has to fill out that form. This makes it more likely that the rest of the form is filled out correctly and that the process is completed without hitches. It also means that people can spend their time focusing on the quality of the rest of their work.
I’ll admit, this is an easy example. There will be lots of times when a form or process cannot be changed to this extent (although less than you probably think). But it’s just one example of how a mistake can lead to a better process. I believe that when you focus on what you can do to make your coworkers’ work more efficient, you will find that this leads to better and more sustainable quality.
The next time you are presented with a problem or a finding, and your first response is to retrain people on a process, don’t let yourself jump to conclusions. Take a moment, or a week, and really examine the process. You might find that even though it’s an isolated incident, there is still room to make it better.
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