“So, they want me to ask if you would do the GMP refresher for us.”
“No. I did the GMP Basics last year. It’s only been 4 months and I am not going to repeat the content or water it down or “just tell them the GMPs”.
“Well, I can’t do it by myself, not after you’ve introduced us to activities. I don’t know how to create meaningful exercises.”
“Let me think about this some more. What’s currently happening on site, other than last year’s 483? Do you have any updates we can use?”
“Oh, there was an audit done and you know they found stuff. Folks are kind of hot about it, actually.”
“Okay, now we have something to work with. I’ll do it on two conditions. 1.) That we use the audit observations and 2.) I need 90 minutes.”
“Nope, not going to happen. No way for the 90 minutes. Oh, and they want to keep the audit observations ‘confidential’. We’re not allowed to use them.”
“Then you’ll have to find another consultant to do it. After the training we did last year, I cannot go back to lecture only. I built trust with your employees. And you and I learned that we need to add time so that they can complete the quiz at the end and not feel rushed”.
“I really want you to do it. I will go back to the management team and tell them you said yes. But I need a proposal justifying the 90 minutes and describing what you will do with audit observations.”
The Quality of Previous Learning Provider Engagements
This organization is a leading manufacturer and distributor of regulated products. They received Form FD-483 observations the year before. Among the remedial actions, was a “Back to GMP Basics” training program for the entire site including indirect support and non-GMP staff.
Not only were sessions content tailored for varying roles, but employees were also introduced to interactive exercises and collaborative activities that encouraged them to share responses with their seatmates. For many of them, this was a totally different GMP learning experience. Employees were no longer grumbling about the training and management was able to produce the required paperwork to the agency.
As part of the remediation plan, the client also pledged to increase the frequency of GMP refreshers to twice a year. Given the favorable outcome from the previous GMP Training program, it was suitable that the management team extended an offer to conduct a refresher. What was a surprise, however, was that the management team wanted their old – “gloom and doom, thou shall follow these regulations” style of telling them the GMPs from the podium. Why? Was this a form of punishment? It sure felt like it.
Management Team Knew Their Priority
At the time of the above request, 4 months of the year had already transpired. During which, a follow-up audit of their GMP systems was conducted by a separate consulting group. The audit found numerous examples of recent noncompliance. The site leadership team was also reminded that the 1st GMP refresher was coming due. The head of Quality made the decision to use the GMP refresher as a corrective action for the audit.
Kudos to the Head of Quality for doing three things. First, he recognized that the c in CGMPs was the audit findings and resulting noncompliance examples. Two, he leveraged the resource of QA Training and demonstrated just how strategic the role should be to the organization by elevating the importance of this refresher. He used a systems approach when he tagged the delivery of this refresher to the corrective actions for the independent audit. This was quite novel at the time. And third, he approved the request to provide his Training Manager some help. He connected all the dots between the independent solos!
Their Decision to Outsource
Their “GMP Trainer” was also the manager of the company-wide training database. He was a department of one whose primary duty was data entry into a complicated and non-user-friendly training database. Time to develop and deliver the GMP refresher was something this manager did not have. The sooner it could be delivered, the sooner the training manager could get back to the mounting stacks of attendance records awaiting data entry.
“Just tell them the GMPs” one more time is what the management team was originally asking for. The learners were expected to sit and listen. After all, they used to be scolded for poor compliance results. One employee referred to it as “shame and blame” sessions with their heads down to avoid eye contact with the presenter; especially if it was a leader from Quality Operations.
The management team wanted to bring back their learning provider and they wanted to dictate how the refresher would be conducted. To revert to lectures only would break the trust the learners had built with the GMP Learning Provider and jeopardize any successful transfer of behavior change to the workplace.
Corrective Actions are supposed to remediate, right?
The independent audit revealed several examples of non-compliant actions taken. When categorized, these actions clustered around three main areas. If the “corrective actions training” aka the GMP refresher was going to remediate these findings, just telling them what the regs say without any discussion or collaborative processing of what these examples were showing, would have no effect on eliminating or reducing further GMP “mistakes”. What did the management team expect to happen because of the training? I imagine no more examples of GMP violations?
Aligning Business Needs with Quality Objectives Yield a Strategic Focus
Shifting the behavior towards appropriate compliance begins with shifting mindsets around compliance. Working with the three categorized areas, the management team agreed to the following three business outcomes:
- Continued commitment to comply with our GMP Work Habits
- Follow Good Documentation Practices for our controlled documents
- Perform our responsibilities for operating equipment in our work areas
While these outcomes were great goals, they were also very broad and hard for learners to put into daily practice; let alone change their behavior. Effectiveness checks for training was another commitment to the agency as part of the GMP Training program improvements.
Furthermore, measuring the effectiveness of the GMP refresher training would require more than a knowledge check if behavior change back at the workplace was their end game. What would the CAPA effectiveness checks look like for this corrective action as well? Recall, the two quality system activities were now interlinked.
In further discussions with the Head of Quality, the business outcomes were transcribed into quality themes and key messages. These then drove the decisions for specific content pieces and activities that targeted what compliant behavior should look like regarding the 3 quality themes.
To further quell any negative ramifications using audit findings, the chosen examples were approved by the Head of Quality and a courtesy copy of the refresher materials was provided to the management team in advance.
Designing, developing, and delivering the refresher course topics with even more interactive opportunities all the while ensuring that the previous GMP Basics content was refreshed, not just repeated, became the basis for the activities. It was analogous to “a Part 2” in which employees were allowed to “interact” with both the regulations and real-time scenarios (selective audit observations).
When a Learning Partnership Works
One of the advantages of working with a previous learning provider is the ability to create an ongoing learning path built upon previously delivered content; not just provide a “canned” presentation on the requested topic. There is a willingness to work with internal resources and integrate existing artifacts such as audit findings into the course design so that the organization achieves its business outcomes beyond just closing the CAPAs and getting a checkmark for delivering the first of two promised refreshers.
Value and Impact: Training Effectiveness Results
- Assembling into pairs and groups was achieved in less time than when first introduced in the GMP Basics series. The Learning Provider now had credibility and the employee’s earned trust. The relevance of the audit finding examples kept employees engaged with many of them asking private questions at the end of the sessions. This was unheard of previously, thus initiating the “transfer back to my job”. They were thinking about how these examples and the GMP content applied to them.
- A 5-question quiz was administered as part of their effectiveness training check. This is the classic tool for knowledge comprehension and their newly revised SOP now included Knowledge Checks (KCs) for GMP Training. 400+ employees completed the quiz. The mean score was 91% with several achieving 100% and a few failing scores.
Why Knowledge Checks Don’t Tell the Whole Story …
Using an item analysis can reveal a lot of information about the construction of the GMP KC questions.
As always, it is possible that some memorization and sharing the correct lettered responses happen despite that there were three versions of the KC. It is also possible that some folks do not take the time to read questions thoroughly. And some folks don’t recognize when “all of the above” choice applies. They are in a rush to exit the class.
Pay attention to incorrect responses that are clearly wrong as in they don’t make sense. It may indicate a “cheating trend” if only one version of a quiz is provided. In this case, three versions of the quiz were used.
When responses are troubling; a follow-up discussion with an SME or a “legacy” employee is needed to determine if an old, outdated, and non-GMP practice was acceptable at one time. Knowing this gives some insight into why it was chosen but disheartening that the behavior is still prevalent. If the behavior is still happening, it warrants further discussions with site leadership and the Head of Quality. It may be isolated to a few individuals and can be managed via the HR performance management system.
Sometimes verbal responses to a question in class, don’t match the chosen response in the quiz. The quiz results could be a matter of confusion with the wording of the question especially for Assessment A in which the question had a NOT worded in it, rendering the answer to be False. It’s akin to a double negative and it trips up a lot of people who are not test-savvy. So be careful with questions that can be confusing or tricky. For this client, it was worded to capture a real scenario that happens in the industry.
This client was urged to address failing scores; results below 80%. Their Training SOP had recently been revised to include formal assessments for GMP Training and Critical Task SOPs as part of their effectiveness checks for training.
- The priority for the refresher was agreed to by the site management team and communicated to everyone during the sessions. The FDA remediation plan was still a focused site objective, and this refresher was part of those activities; not something in addition to like an after-thought or add-on.
- Three outcomes were identified as the business needs and became the driver behind content and decisions for activities. The “Big Why” for this refresher was clear and compelling. Tangible work-behaviors were user-generated for peers to model as examples of complying with the GMP Work Habits.
- There was continuity with previous GMP content. The existing GMP Learning Provider connected the dots with prior content and reinforced the relevancy and importance of the GMP Work Habits. Rapport was re-established and on-going trust for an engaging and interactive session of 90 minutes was achieved. Minimal repeat of previous content; refresh enough to complete an activity.
- Learning Provider negotiated with Site Management Team on behalf of the Learners Needs: to include real workplace audit observations and an additional 30 minutes of classroom time that included the GMP quiz and debrief of the correct answers. Employees left each session with the correct responses to 5 questions; their final take away from the sessions.
- The design followed a 3-step learning model: Learn, Experience, Apply.
- Learn: Short lectures or vignettes was used to learn/refresh on content.
- Experience: Variety of ways in which the Learners engaged with the audit observations; not just a slide for each observation but small group discussion and tangible activity to complete and report back on.
- Apply: peer feedback, debriefing.
Are you thinking about outsourcing your next compliance? Why not form a training partnership with an industry GXP Learning Provider? -VB
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(c) HPIS Consulting, Inc.