Earlier this year, TCG published a white paper about “Human Error” and how it relates directly to the top reasons for FDA 483s. Training was listed as a way to reduce the opportunity for error. Indeed, successful performance of compliant work relies on job knowledge and skill development. A solid training program that offers frequent refreshment on key topics, and shares important performance metrics (KPIs, KQIs, CTQs) remains an effective method for creating and maintaining a firm foundation of technical skills.

Don't Change to Reach your goalMore and more frequently, however, employee training or re-training is listed as a corrective action for deviation or non-conformance investigations. If retraining were indeed a common need, a savvy auditor who reads these CAPAs would begin to question the effectiveness of the overall training program. He may wonder if the root cause analysis was sufficient and the investigation thorough. This might lead him to further exploration of the overall deviation or non-conformance program and metrics. The auditor might also question the content and quality of other process governance (Risk Management, Change Control, Complaints) and the integrity of batch documentation previously completed by these “qualified” personnel. You can imagine how easily the Quality System sweater can unravel when this little thread is pulled.

Let’s take a step back for a moment and consider the facts. A CAPA is a corrective and/or preventive action. It is generally one or more actions that you take in order to address the root cause of a problem that you’ve somehow discovered in your process. The corrective action fixes what you observed – the reason the problem occurred. The preventive action addresses any possibility that this problem could occur elsewhere in your process or at some future point – the potential for it to recur.

Re-training may be one of many actions taken as part of an investigation, but it shouldn’t be the only action. Assuming that your training program is effective in developing the necessary technical skills, communicating compliance needs and expectations, and ensuring operators are qualified and competent prior to task execution, what is the likelihood that retraining really is a good CAPA? If I had to guess, I’d say slim to none.

Another question to consider is, what have you done to engineer your process in order to mitigate the impact of human error or poor job performance? If you still believe re-training of an operator is an appropriate corrective action, then what preventive action are you going to take with your training program so that this problem doesn’t repeat? Also, are there any other aspects of the current training program that need remediation before they create a non-conformance or deviation?

Be cautious when assigning training as a CAPA for a deviation or non-conformance. If this is an approach you’ve taken in the past, but you’re now having second thoughts, TCG is happy to help you make effective changes and start down a different path. If an agency or auditor has already taken exception with your CAPA or Training programs and you need assistance with remediation, we have skilled resources available and are happy to partner with you.

As always, I welcome any comments you might have regarding this post. If you have other topics you’d like to discuss or questions you’d like to ask, please contact me directly at abarefoot@catalystcompliancegroup.com.