When Your GXP Learning Provider Becomes Your Strategic Partner

“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:

  1. Continued commitment to comply with our GMP Work Habits
  2. Follow Good Documentation Practices for our controlled documents
  3. 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

Like this blog? Tell Vivian.

HPISC eGuidebooks are available.

When to Outsource Your GMP Refresher

Tips for Writing KCs

Tips for Writing Knowledge Checks

              

About Vivian Bringslimark, President of HPIS Consulting, Inc.

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What’s Your Training Effectiveness Strategy?

It needs to be more than a survey or knowledge checks.

When every training event is delivered using the same method, it’s easy to standardize the evaluation approach and the tool. Just answer these three questions:

  • What did they learn?
  • Did it transfer back to the job?
  • Was the training effective?

In this day and age of personalized learning and engaging experiences, one-size training for all may be efficient for an organizational rollout but not the most effective for organizational impact or even change in behavior. The standard knowledge check can indicate how much they remembered. It might be able to predict what will be used back on the job. But be able to evaluate how effective the training was? That’s asking a lot from a 10 question multiple-choice/ true-false “quiz”.

Given the level of complexity of the task or the significance of improvement for the organization such as addressing a consent decree or closing a warning letter, it would seem that allocating budget for proper training evaluation techniques would not be challenged.

Do you have a procedure for that?

Perhaps the sticking point is explaining to regulators how decisions are made using what criteria. Naturally, documentation is expected and this also requires defining the process in a written procedure. It can be done. It means being in tune with training curricula, awareness of the types of training content being delivered, and recognizing the implication of the evaluation results. And of course, following the execution plan as described in the SOP.   Three central components frame a Training Effectiveness Strategy: Focus, Timing, and Tools.

TRAINING EFFECTIVENESS STRATEGY: Focus on Purpose

Our tendency is to look at the scope (the what) first. I ask that you pause long enough to consider your audience, identify your stakeholders; determine who wants to know what. This analysis shapes the span and level of your evaluation policy. For example, C-Suite stakeholders ask very different questions about training effectiveness than participants.

The all purpose standard evaluation tool weakens the results and disappoints most stakeholders. While it can provide interesting statistics, the real question is what will “they” do with the results? What are stakeholders prepared to do except cut training budget or stop sending employees to training? Identify what will be useful to whom by creating a stakeholder matrix.

Will your scope also include the training program (aka Training Quality System) especially if it is not included in the Internal Audit Quality System? Is the quality system designed efficiently to process feedback and make the necessary changes that result from the evaluation results? Assessing how efficiently the function performs is another opportunity to improve the workflow by reducing redundancies thus increasing form completion speed and humanizing the overall user experience. What is not in scope? Is it clearly articulated?

TRAINING EFFECTIVENESS STRATEGY: Timing is of course, everything

Your strategy needs to include when to administer your evaluation studies. With course feedback surveys, we are used to immediately after otherwise, the return rate drops significantly. For knowledge checks we also “test” at the end of the session. Logistically it’s easier to administer because participants are still in the event and we also increase the likelihood of higher “retention” scores.

But when does it make more sense to conduct the evaluation? Again, it depends on what the purpose is.

  • Will you be comparing before and after results? Then baseline data needs to be collected before the event begins. I.e. current set of Key Performing Indicators, Performance Metrics
  • How much time do the learners need to become proficient enough so that the evaluation is accurate? I.e. immediately after, 3 months or realistically 6 months after?
  • When are metrics calculated and reported? Quarterly?
  • When will they be expected to perform back on the job?

Measuring Training Transfer: 3, 6 and maybe 9 months later

We can observe whether a behavior occurs and record the number of people who are demonstrating the new set of expected behaviors on the job. We can evaluate the quality of a work product (such as a completed form or executed batch record) by recording the number of people whose work product satisfies the appropriate standard or target criteria. We can record the frequency with which the target audience promotes the preferred behaviors in dialogue with peers and supervisors and in their observed actions.

It is possible to do this; however, the time, people, and budget to design the tools and capture the incidents are at the core of management support for a more vigorous training effectiveness strategy. How important is it to the organization to determine if your training efforts are effectively transferring back to the job? How critical is it to mitigate the barriers that get in the way when the evaluation results show that performance improved only marginally? It is cheaper to criticize the training event(s) rather than address the real root cause(s). See Training Does Not Stand Alone (Transfer Failure Section).

TRAINING EFFECTIVENESS STRATEGY: Right tool for the right evaluation type

How will success be defined for each “training” event or category of training content? Are you using tools/techniques that meet your stakeholders’ expectations for training effectiveness? If performance improvement is the business goal, how are you going to measure it? What are the performance goals that “training” is supposed to support? Seek confirmation on what will be accepted as proof of learning, evidence of transfer to the workplace, and identification of leading indicators of organizational improvement. These become the criteria by which the evaluation has value for your stakeholders. Ideally, the choice of tool should be decided after the performance analysis is discussed and before content development begins.

Performance Analysis first; then possibly a training needs analysis

Starting with a performance analysis recognizes that performance occurs within organizational systems. The analysis provides a 3-tiered picture of what’s encouraging/blocking performance for the worker, work tasks, and/or the workplace and what must be in place for these same three levels in order to achieve sustained improvement. The “solutions” are tailored to the situation based on the collected data and not on an assumption that training is needed. Otherwise, you have a fragment of the solution with high expectations for solving “the problem” and relying on the evaluation tool to provide effective “training” results. Only when the cause analysis reveals a true lack of knowledge, will training be effective.

Why aren’t more Performance Analyses being conducted?
For starters, most managers want the quick fix of training because it’s a highly visible activity that everyone is familiar and comfortable with. The second possibility lies in the inherent nature of performance improvement work. Very often the recommended solution resides outside of the initiating department and requires the cooperation of others.   Would a request to fix someone else’s system go over well where you work? A third and most probable reason is that it takes time, resources, and a performance consulting skill set to identify the behaviors, decisions and “outputs” that are expected as a result of the solution. How important will it be for you to determine training effectiveness for strategic corrective actions?

You need an execution plan

Given the variety of training events and level of strategic importance occurring within your organization, one standard evaluation tool may no longer be suitable. Does every training event need to be evaluated at the same level of rigor? Generally speaking, the more strategic the focus is, the more tedious and timely the data collection will be. Again, review your purpose and scope for the evaluation. Refer to your stakeholder matrix and determine what evaluation tool(s) is better suited to meet their expectations.

For example, completing an after-training survey for every event is laudable; however, executive leadership values this data the least. According to Jack and Patricia Phillips (2010), they want to see the business impact the most. Tools like balanced scorecards can be customized to capture and report on key performing indicators and meaningful metrics. Develop your plan wisely, generate a representative sample size initially and seek stakeholder agreement to conduct the evaluation study.

Life after the evaluation: What are you doing with the data collected?

Did performance improve? How will the evaluation results change future behavior and/or influence design decisions? Or perhaps the results will be used for budget justification, support for additional programs or even a corporate case study? Evaluation comes at the end but in reality, it is continuous throughout. Training effectiveness means evaluating the effectiveness of your training: your process, your content and your training quality system. It’s a continuous and cyclical process that doesn’t end when the training is over. – VB

Jack J. Phillips and Patricia P. Phillips, “How Executives View Learning Metrics”, CLO, December 2010.

Recommend Reading:

Jean-Simon Leclerc and Odette Mercier, “How to Make Training Evaluation a Useful Tool for Improving L &D”, Training Industry Quarterly, May-June, 2017.

Who is the Author, Vivian Bringslimark?

Training Does Not Stand Alone |HPISC Published Article

Need some advice with developing your effectiveness strategy? Want a planning tool?

(c) HPIS Consulting, Inc.