By David Porter, Ph.D., Sense-Reflect-Act, LLC
It is well known that when a regulator or auditor comes to inspect your facility, your processes, your documentation, etc., part of what is expected is demonstration of compliance with applicable regulatory documents and internal documents (SOPs, protocols, etc.). One mantra of cGMP and GLP is that you should say what you do and do what you say. Otherwise, you should expect a poor outcome from the inspection/audit.
Given the importance of compliance in the pharmaceutical industry, it is not surprising that many training programs are based upon the need to comply — and demonstrate compliance — with relevant internal and external documents and procedures. The premise of this article is that training based first and foremost upon compliance does not adequately prepare people to handle the unexpected, because this mode of training does not emphasize what should always be of paramount importance to technical employees: asking scientific questions.
Common Training Methods
We have all probably sat through standard operating procedure (SOP) training that went something like this…
The trainer stands in front of the trainees with a PowerPoint presentation on the screen. If you are lucky, the trainer uses the material on the screen as talking points. If you are unlucky, the trainer reads the material on the screen to you, thereby causing “death by PowerPoint.” Often, after enduring the training, the trainees are subjected to a quiz. More often than not, the expected answers to the questions may be lifted directly out of the training material, or from the included SOP.
For example, let’s say the training pertained to an SOP related to USP <62>Microbiological Examination of Non-Sterile Products: Tests for Specified Microorganisms. The SOP includes, in part, a listing of the species of microorganisms described in the USP chapter. The quiz may ask what species of microorganisms are indicated in the chapter. The “right” answer is supposed to be the regurgitation of the listed species. It is unlikely that the quiz would ask why the particular species are indicated in the USP chapter. The first type of question requires a rote answer, the second requires thinking.
Here is another type of training you might have gone through. This form is delivered via a computer and is often based upon interactive software. The basic information is provided, often with oral material and an accompanying transcript. Sometimes you can choose the exact order of the material to be covered, sometimes not. Questions can be posed to attendees throughout, or in the form of a quiz at the end. Again, the questions asked typically require answers that can be lifted directly from the material as presented. Rarely will the questions require reflection upon what was presented in order to synthesize an answer that was not directly covered in the material.
In either of these two cases, the trainee has to sign an attendance sheet and/or submitted the quiz with an acceptable number of correct answers. This is placed in the trainee’s training file, and these files will be made available to inspectors/auditors upon request. The idea is that by having such training documented in training files, compliance with expected training requirements can be demonstrated.
Is Compliance Adequate?
Is there anything wrong with demonstrating compliance with training requirements in this manner? Through this method, you can show that each person who needed to be compliant with various SOPs/etc. did receive training and satisfied whatever quiz requirements may have existed. The problem is that training along these lines does not require obtaining a detailed understanding of, for example, why the steps in the SOPs are what they are. Why is the incubator temperature to be set at 25 +/- 0.5C? Why should the USP sterility test be conducted even though method suitability could not be demonstrated? Why is it appropriate to use dedicated glassware in an analytical chemistry laboratory involved in evaluating multiple product types? Is it appropriate to set an environmental monitoring alert level at 1colony forming unit (CFU) and an action level at 2 CFUs?
Training documents will rarely provide answers to these types of questions. However, when trainees can answer such questions, they will be in a much better position to address unexpected circumstances, and to suggest revisions to SOPs upon such reflection. For example, what should be done if an incubator temperature falls outside of the required range? If you don’t use dedicated glassware in the analytical chemistry laboratory and unusual chemical “contamination” is observed, what should you inspect in the lab as possible culprits before assuming the problem is in manufacturing? Is there scientific justification for setting an alert level at 1 CFU and an action level at 2 CFUs, given the limitation of quantitative microbiology?
Consequences of Training for Compliance Alone
Imagine this circumstance: During a regulatory inspection of the data from microbial limit testing, no indication is found, ever, of TNTC (too numerous to count) plates. It is highly unlikely that the microbiology laboratory never missed the necessary amount of dilution necessary to ensure countable numbers of colonies. When asked how this could be so, the lab employee responds, “Our SOP states that plates with too many colonies to be countable should be discarded and no data should be recorded.” The employee was, in fact, in compliance with the company SOP. Their training record confirmed that they had been satisfactorily trained. As you might guess, an inspector would not be impressed with either the SOP or the training.
If instead of merely being trained to compliance, the employee had been asked as part of the training to explain why not recording the data from the TNTC plates was appropriate, the SOP itself might have undergone revision. The fact that an SOP, compendial standard, regulatory guidance, etc. exists should not mean that reflecting and questioning is no longer required.
Given an SOP, regulatory guidance, compendial standard, etc., people may cease thinking about why they are doing what they do. Instead they use such documents as a crutch. When asked why they are doing what they do, they respond with, “That’s what the document states we should do.”
Training for Thinking
If training for compliance is prevalent, and this method is fraught with risk, what is a preferable alternative that will ensure compliance and reduce the risks? A much more effective approach, one in which the trainer can induce thinking and reflection as opposed to merely rote processes, is one employing effective questions.
This approach requires much more interaction between the trainer and trainees, and between the trainee and the material being taught. The trainer must often ask: why? The questions asked most often should not be answerable by reading text back from the documentation.
This questioning approach should be employed in practical training as well. Often the trainee is paired with a person experienced in whatever method or procedure is to be learned. In that case, the trainer must remember to not simply demonstrate, but to ask why the method is performed as shown. This requires thought by the trainee, which can help the trainer as well. A person who has been performing a procedure the same way for years may well have forgotten why a process is conducted the way it is — or they may not have been trained to ask questions, but merely to replicate what was shown. Encouraging questions during training helps avoid situations where nobody remembers why a method is done the way it is. (“We’ve always done it that way.”)
Online training can also be developed such that reflection upon the material presented is necessary to answer posed questions. Such questions should not simply be based upon rote memory (e.g. “Who is responsible for that step?”) but should require thinking (e.g. “Why is that person responsible for that step?”).
Additional Benefits of Training for Thinking
I believe it is essential for management to fully buy into the training-for-thinking versus training-for-compliance approach to achieve maximum benefit. When the company culture becomes one of questioning first the ramifications can be vast. Compliance follows naturally, because those trained under the thinking system have asked and answered enough thought-provoking questions to understand why they are doing what they do — and therefore would also understand the importance of compliance. When an inspector asks why something was done, the response is not “because that’s what the (SOP/other document/etc.) required.” Instead the answer will be based upon the underlying science behind the activity.
When the culture is one of open questioning — where people are trained under a system that emphasizes questions to the extent that they understand why the requirements are what they are — the interactions among employees will also involve more questioning than blind compliance. If people observe something unusual, something unanticipated, they will be far less likely to ignore it because documentation (internal, compendial, regulatory, etc.) did not mention it. If a trainee observes an experienced employee doing something not precisely in line with what is written, they would be quick to ask why. It may well be that the experienced person is performing in a manner they have found to be more effective. If that is true, then the improved variation should be written into the documentation. This, of course, assumes that the experienced employee can explain why the variation produces better results. If they cannot, this should elicit further questioning.
The Value of Motivation
In my experience, the way to achieve effective learning is through motivated learners. A motivated learner is one who has taken ownership of the learning process, who understands the importance and value of what is to be learned. I do not believe that such appreciation can be rammed down the learner’s figurative throat. Rather, I think the best way to motivate is by asking questions that cause the learner to understand the significance of the material. The posing of questions goes both ways — the learners must feel free to ask questions until they have satisfied themselves that what is being learned really matters, and they understand why it is performed as it is.
There are numerous modes through which training for thinking can be delivered. In-person, classroom-type settings can work, assuming the instructor understands that the environment must foster bidirectional questions and answers. The instructor must also understand that an answer of “I don’t know” can be acceptable. Electronic instruction can also be effective as long as interaction of some sort is possible, and that questions provided invoke reflection, not regurgitation.
An obvious form of training is that which often occurs in the laboratory or manufacturing floor, when an experienced employee provides instruction to an inexperienced one. Once more, the person providing the training needs to understand the importance of two-way questions and answers. By fostering such questioning, genuine understanding can develop, and compliance will flow naturally from understanding. My experience has been that if compliance is the primary goal of training, the trainee will resort to answering hard questions with “because that’s the way we do things”; if understanding is the goal, the response will be “because [technical explanation]”.
Creating the Right Environment
It is my fervent belief that the best way to achieve compliance, and more importantly high-quality products, is via the organization promoting an environment of learning. Compliance will then follow naturally. A more “dictatorial” environment may work well for a while, but sooner or later conditions change. If employees forget how to ask questions along the way, adaptability is lost, compliance eventually decreases (often substantially), and the organization fails to reach its maximum potential.
About The Author:
David Porter, Ph.D., is president of Sense-Reflect-Act, LLC. He has 28 years’ experience in compendial activities, quality assurance, medical devices, consumer products, and pharmaceutical industry research, development, and management. Combining a broad technical background in life sciences, quality control and assurance, microbiology, biostatistics, and computers, David helps develop and strengthen individuals, teams, and organizations. Prior to becoming a consultant in 2006, he held various managerial positions at Bausch & Lomb, Revlon, and the US Parmacopeia. He received his Ph.D. in zoology from the University of California, Berkeley, followed by post-doctoral experience in molecular biology and protein chemistry at the Ohio State University and Case Western Reserve University, respectively. You can contact him at firstname.lastname@example.org or connect with him on LinkedIn.