CLIENT: Can you come in and “teach” the basics rules (regulations) for GMPs in about an hour or two and make it, you know engaging? Oh, and give them a test so we know they got it?
HPIS: What about activities or exercises? You did say engaging.
CLIENT: Oh, we don’t have time for that! But can you also cover everything else on this 2-page list?
The organization isa leading manufacturer and distributor of multi-source topicals, antibodies and anti-fungal products.
During a routine biennial inspection, FDA investigators found several examples of non-compliance with the GMPs; 21CFR Part 211. This lead to Form 483 observation “not adequately trained on the cGMP requirements and on SOPs required to perform their duties” for all areas of production including professional staff that directly impact GMP operations.
The members of the Quality Review Board (QRB) made the commitment to review and revise their entire GMP Training Program that included Basic CGMP Training for operational employees, office staff and non-manufacturing personnel.
Problem and Perceived Solution
Site Quality Leadership believed that employees just “weren’t getting the message” and that by providing some more training a.k.a. re-training, they would surely get it this time especially if they brought in an outside expert who would “tell them the GMPs” and then test them afterwards.
Biggest Challenge- What Wasn’t Working as Expected
Members of the QRB were highly educated and many had the training mindset of “I’ve spoken therefore you’ve learned”. So, with enough repeat sessions, employees would eventually get the message. Those employees who did not “pass the test” would be remediated and if performance did not improve, would be placed on a Performance Improvement Plan. It was a very simple corrective action that was easy to execute and would close out multiple deviations in one fell swoop, or so they thought.
- Since time for instructor led training sessions was not built into the budget, deviation sponsored training sessions became crammed with “everything you need to know” in the least amount of time allowed.
- Members of the QRB did not have instructional systems design experience or education background and hence, were not familiar enough with Adult Learning Principles or experiential learning technique. Therefore, they were not able to challenge the underlying assumption behind their quick-fix remediation solution.
Human Performance Improvement (HPI) Method In Use – Cause Analysis and Modified Performance Analysis
The main difference between a training needs analysis (TNA) and a performance analysis (PA) is the starting point. TNAs begin with the assumption that the cause of the problem is a lack of knowledge and skill. And so, content is identified and developed into course material. PAs begin with looking at what’s getting in the way of employees performing as expected.
Given the specific observation from FDA, the typical corrective action that companies take is to provide remedial training of the GMP regulations. A return to “Basic GMPS” or “GMP Boot Camp” is a very typical commitment. However, assuming that the cause of non-compliance is due to a lack of knowledge only without reviewing how GMP courses are designed and delivered is likely to result in the same non-compliant behaviors. This company with their “just tell them again mindset” and lecture only mode of delivery was about to invest major budget for a strategic initiative that did not treat the root cause of their performance gap!
Upon learning how to design and deliver GMP training using active training techniques to engage modern learners, the QRB balked at the design plan. Their end goal was to be able to produce a document for FDA listing the regulations that were “discussed”, provide “evidence” that their employees attended, and took a knowledge check to prove their “understanding”. Anything more was too long, too costly and way too risky for them. Was the QRB really vested in revising their GMP training program or merely getting the check mark to close the CAPA?
HPI Solution / End Result
Of the six categories for Human Performance Improvement Solutions, the solution best matched from the causes was to improve knowledge about designing classroom compliance training sessions.
- HPISC worked with select QRB members to gradually introduce active training techniques matched to the needs of the Learners. After years of GMP training being preached to employees with no opportunity for their active participation, they passively endured the wrath especially if there was a current critical deviation or a recent audit observation. They learned to not speak up publicly in these sessions. HPISC had to overcome this learned behavior and build trust with these employees.
- With the newly designed Basics GMP Course, time was allocated for SOME active participation. Debriefing the activities became essential so that employees and QRB members could process the value of the exercise and relate it to the content and ultimately to the overall objective – GMP Compliance.
- With each session resulting in very favorable comments, more duration time was approved by the QRB for increasing the number of participant activities and depth of debriefings so that there was less focus on passing the GMP test and more qualitative responses about what compliance to the GMPs really means to each employee and for the organization.
- Sessions for critical deviations and audit observation follow-ups turned into ½ day sessions for hourlies and full-day workshops for exempts where the learners began to generate their own content and only needed a facilitator to provide some structure and guidance.
- More allocated time for active training was added to the annual budget!
Value Added to the Organization
- When GMP courses are designed with the learner’s needs in mind, including the adequate duration for exercises and activities, Learners relax. They begin to engage with the content through the skill of a qualified facilitator who can guide the experiential activities and debriefing discussions effectively.
- When learner-generated responses are immediately incorporated into the session and leveraged to enhance the debriefings, the involvement, and future application back on the job is even greater.
“Over-reliance on lecturing usually leads to boredom, lack of involvement, or limited learning from the participants”. Mel Silberman, Active Training, 1990.
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