Turning 10 Compliance Rules Into Everyday Behavior

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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

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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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(c) HPIS Consulting, Inc.

I’m in love with my own content!

Many QA /HR Training Managers have the responsibility for providing a train-the-trainer course for their designated trainers.  While some companies send their folks to public workshop offerings, many chose to keep the program in-house.   And then an interesting phenomenon occurs.  The course content grows with an exciting and overwhelming list of learning objectives.

The supervisors of these SMEs struggle with the loss of productivity for the 2 – 3 day duration and quickly develop a “one and done” mindset.   Given the invitation to “train” newly identified SMEs as Trainers, the QA Trainer gets one opportunity to teach them how to be trainers.  So s/he tends to add “a lot of really cool stuff” to the course in the genuine spirit of sharing, all justifiable in the eyes of the designer.  However, there is no hope in breaking this adversarial cycle if the Training Manager doesn’t know how to cut his/her own content.

From 16 to 8 to two 4hr blocks of time

I used to deliver a two-day (16 hour) workshop for OJT Trainers. I included all my favorite topics.  Yes, the workshop was long.  Yes, I loved teaching these concepts.  I honestly believed that knowing these “extra” learning theory concepts would make my OJT SMEs better trainers.  Yes, I was in love with own my content.  And then one day, all that changed.

Do they really need to know Maslow’s Hierarchy of Needs?

During a rapid design session I was leading, I got questioned on the need to know Maslow’s Hierarchy of Needs.  As I began to deliver my auto-explanation, I stopped mid-sentence.  I had an epiphany.  My challenger was right.  Before I continued with my response, I feverishly racked my brain thinking about the training Standard Operating Procedures (SOPs) we revised, the forms we created, and reminded myself of the overall goal of the S-OJT Program.  I was searching for that one moment during an OJT session when Maslow was really needed.  When would an OJT Qualified Trainer use this information back on the job, if ever I asked myself?

It belongs in the Intermediate Qualified Trainers Curriculum, I said out loud.  In that moment, that one-question exercise was like a laser beam cutting out all nice-to-know content.  I eventually removed up to 50% of the content from the workshop!

Oh, but what content do we keep?

Begin with the overall goal of the training program, not just the TTT course: a defendable and reproducible methodology for OJT.  The process is captured in the redesigned SOPs and does not need to be repeated in the workshop. 

Have you flipped your OJT TTT Classroom yet?

Seek agreement with key stakeholders on what the OJT QTs are expected to do after the workshop is completed.  If these responsibilities are not strategic or high priority, then the course will not add any business value.  Participation remains simply a means to check the compliance box.  Capture these expectations as performance outcomes.

How to align the purpose of a course to business goals

Once there is an agreement with the stated performance outcomes, align the learning objectives to match these.

Performance outcomes are not the same thing as learning objectives

Some folks might say that I’m mincing words, but I beg to differ.  The expectations for training delivery are that participants learn the content, aka learning objectives, and then use or apply them back on the job thus improving departmental /organizational performance.  Are you providing the training and then keeping your fingers crossed that they can deliver on their performance outcomes? Are you including practice activities within the workshop? This ensures that learners have an opportunity to begin the transfer process. And the facilitator is able to complete formative assessments in real-time while providing immediate feedback where needed.

Yes, there is still ample room in the course for learning theory, but it is tailored for the need to know only topics. When challenged to add certain topics, the instructional designer now refers to the performance objectives and ranks the consequences of not including the content in the workshop against the objectives and business goals for the overall program.

What happens when the Instructor is over-ruled by their boss? Read Robert’s learning journey here.

What is the value of the written assessment?

With the growing demand for training effectiveness, the addition of a written test was supposed to illustrate the commitment to compliance expectations around effectiveness and evaluation.  To meet this client’s need, I put on my former teacher hat and created a 10 question open book written assessment.  This addition resulted in needing additional time to execute and hence, more content was cut to accommodate the classroom duration.

My second epiphany occurred during the same rapid design project, albeit a few weeks later.   What is the purpose of the classroom written assessment when back on the job the OJT QTs are expected to deliver (perform) OJT; not just know it from memory?

The true measure of effectiveness for the workshop is whether they can deliver OJT according to the methodology, not whether they retained 100% of the course content!   So I removed the knowledge test and created a qualification activity for the OJT QTs to demonstrate their retained knowledge in a simulated demonstration using their newly redesigned OJT checklistIf I’m asking for 8 hours of time to deliver a workshop, it must be value-added.  -VB

Find out what happens when the most critical aspect of a course is “accidentally” left out.

I’ve fired my vendor! Can you help me? |HPISC Impact Story

Are you ready to flip your OJT TTT Course?

Who is Vivian Bringslimark?

Comments are welcomed here.

(c) HPIS Consulting, Inc.

Reframing a Training Request

When you hear we need a training course on … pay attention!  It is by far the most opportune time a Performance Consultant (PC) has to get an HPI (Human Performance Improvement) project going.  But a word of caution is in order.  Please don’t launch into a 15-minute dissertation on the HPI methodology if all they want is a training fix. 

A Typical Training Request

Begins with an assumption that a lack of knowledge is somehow missing, and that “training” is the right solution.  Next, the requestor launches into a list of “required content” and without taking a breath, asks when can you complete the classroom training. Rather than attempting to explain when training is the right answer, stay calm and in your best professional tone use the following phrases:

  • Okay, have they been trained before?
  • What was that like?
  • I see.  So more of the “same” training will change the results? In what way?

If they continue to insist, then use my favorite one: Okay, but what will they be doing differently as a result of this training session? 

Say Yes and …

Never say no to a training request until you know more.  The key is to get more time without actually saying you need more time!  You do this by conducting a performance cause analysis to determine the nature of the discrepancy.  Evidence can be collected from document review examples, deviations, audit observations, and follow-up “interviews”.   Even if a solution begins to form in your mind, stay on the HPI methodology path and let the data show you the proper answer.  It’s this data that grants a PC a little bit more time.

Analyses Du Jour: Isn’t It Really All The Same Things?

There’s root cause analysis and gap analysis and now performance cause analysis? 

Is there a difference?

Do they use different tools? 

It can be overwhelming to decipher through the jargon, no doubt.  I think it depends on which industry you come from and whether your focus is a regulatory/quality system point of view or performance consulting perspective.  To me, it doesn’t change the outcome.  I still want to know why the deviation occurred, how the mistake was made, and /or what allowed the discrepancy to happen.  Mix and matching the tools allows me to leverage the best techniques from all.

Why We Love Root Cause Analysis

For starters, it’s FDA friendly and we get to document our compliance with CAPA requirements.  It allows us to use tools and feel confident that our “data doesn’t lie”.  This bodes well for our credibility with management.  And it provides the strategic connection between our solution (as a corrective action) and site quality initiatives thus elevating the importance and quite possibly the priority for completing the corrective action on time.

But You Have To Ask The Right Questions

The consequence?  Jumping to the wrong conclusion that automatic re-training or refresher training is the needed solution.  Done, checkmark.  On to the next problem that needs a root cause analysis. But when the problem repeats or returns with a more serious consequence, management questions why the training did not transfer, or we wonder what’s wrong with the employee – why is s/he not getting this yet?

Given the constant pressure to shrink budgets and improve the bottom line, managers don’t usually allow themselves the luxury of being proactive especially when it comes to knowledge transfer and performance gaps. 

So, they tend to fall back on quick-fix solutions that give them a checkmark and “clear their desk” momentarily.  For the few times this strategy works, there are twice as many times when those fixes backfire and the unintended consequences are worse. 

No Time To Do It Right, But Time To Do It Twice!

Solving the problem quickly and rapidly closing the CAPA allows us to get back to our other pressing tasks.  Unfortunately, “band-aids” fall off.  The symptom was only “covered up and temporarily put out of sight”, but the original problem wasn’t solved.  So now, we must investigate again (spend more time) and dig a little deeper.  We have no time to do it right but, we find the time to do it twice.  Madness!

Tired Of Repeat Errors – Ask A Performance Consultant To Help You Design A Better Corrective Action

In the article, “Why the Band-Aids Keep Falling Off”, I provide an alternate strategy that emphasizes moving away from events-only focus to exploring the three levels of interaction that influence performance: individual performer, task/process, organizational quality systems.  These same three levels are where performance consultants can carry out their best work when supported by their internal customers.  The good news is that the first step is the same; it begins with a cause analysis. 

The difference is that the corrective action is not a reactive quick fix but a systems approach to correcting the issue and preventing it from showing up again.  System-based solutions are the foundation of many HPI/HPT projects that require cross-functional support and collaborative participation across the site/organization.  And this is where a PC needs support from senior leaders and/or a sponsor.

I Need Training for 800 Employees ASAP

A corporate auditor discovered a lack of training records for newly developed Job Aids during a Mock Inspection.  So, the easy fix would be to re-train everyone and then produce the records, right? Notice, however, that the solution is biased towards retraining without discovering why the training was missed in the first place.  Reframing the request allowed the Performance Consultant to not only find the root cause but to provide both immediate resolution and long-term prevention.  The PC never said no to the training request, only that they “wanted to provide the most effective training possible”.   The PC’s part was to expedite a Cause Analysis and solution recommendations as quickly as possible. 

Short Term Value vs. Bottom Line Impact

This situation presented a very real dilemma for the PC.  Provide short term value for the VP of Quality (Requestor) and satisfy the goal to close out the audit observation or find the real root cause to determine what the appropriate solution SHOULD be. In theory, there is no dilemma. The choice is obvious. But in practice, for organizations under intense pressure to take immediate action, short term value can be quite attractive.

This is exactly where performance analysis provides a balanced approach.  If the PC proceeded as requested (directed), the training for 800 employees would not have prevented the deviation from occurring again, leaving the possibility of an FDA investigator discovering the same discrepancy! In the end, the HPI approach delivered the solution far quicker than the traditional training approach was originally planned for and the audit observation was closed before the due date.

Isn’t this what HPI is all about – impacting the bottom line? – VB

Like this blog?

READ: “Just Get the Audit Observation Closed Already, Will You?” to learn what the PC discovered, how she was able to calculate the wasted cost of continuing with the request for training, and what steps were recommended to prevent a recurrence. 

Performance Analysis: the lean approach to solving performance problems

Who is Vivian Bringslimark?

Interested in learning how to flip a training request into a performance consulting project?

(c) HPIS Consulting, Inc.

Wanted: Seeking a business partner who has performance needs

Alan Weiss in his book, Organizational Consulting: How to be an effective internal change agent, recommends that internal consultants avoid what he calls the IRS syndrome – “I’m from the IRS and I’m here to help you”.  Just because you may be an expert in training and are “schooled” in HPI/HPT (Human Performance Technology); you don’t need to alienate your internal customers. 

You want to gain credibility in order to be accepted as a peer and earn their trust.  It’s easy to play it safe and agree with their current point of view when seeking acceptance with a new internal customer.  Contrary to how to win and keep friends, you may need to take an unpopular viewpoint on an issue you feel strongly about.  But don’t just show up only when there is a problem and declare “gotcha” or “I told you so”. 

10 Ways to Earn Trust with Your Client

First You Need To Make Friends With Line Management

One of the best ways to establish a business partner working relationship is to start with line management while you are waiting for your first HPI (Human Performance Improvement) project or during project downtimes.  Spend some time getting to know the folks you are most likely to be engaging with for a future project.   

While the relationship is forming, both parties can begin to share information about each other’s area of responsibilities.  The Performance Consultant (PC) learns more about the manager’s department: work processes that are not robust; performance needs that are both urgent and ongoing and tied to “important” performance requirements.  These could be ideas for improvement. 

During the dialogue, listen for internal challenges such as:

  • supplier snafus,
  • resource-constrained hick-ups,
  • conflicting policies and procedures and
  • other projects that are resulting in more to-do’s. 

Find out if they are also managing regulatory commitments and working on closing out CAPAs and deviations related to training, performance issues, or “Operator Error” mistakes.  These are possible sources of entry points that can move the relationship to potential partner status.  However, be mindful of finding the right balance between suggesting ideas and showcasing your “brilliant” concepts.

Partnering Implies A Two Way Exchange

The PC also shares information about HPI/ HPT (Human Performance Improvement/Technology) at a level of depth that matches the individual’s interest and needs at the time.  Remember, while your goal is to educate them about HPI, you don’t want to lecture to them or overwhelm them with even more tasks for their workload.  According to Mary Board, author of Beyond Transfer of Training: Engaging Systems to Improve Performance; the PC is striving to build a close working relationship that over time can lead to more strategic performance improvement work.  It is not only about getting projects. 

Moving the Relationship to Partner Status

Requests for help/support are bound to surface. To demonstrate support and strengthen the desire to partner, a PC can follow up on discussions by sending additional literary sources such as articles, white papers, and blogs from industry thought leaders.  Another popular activity is to pitch in to help meet a deadline or rebalance their workload.  Mini-projects are certain to follow, next.  It is an excellent way to move the relationship to partner status. 

Keep in mind; however, that it is a JOINT undertaking and not a delegation of tasks to a direct report or a hired temporary employee.  This is where the consulting side of the partnership can begin; leading him/her through decisions and actions using the HPI methodology says Broad. Early conversations around partnering should include:

  • purpose of working together
  • benefits of shared tasks shared outcomes
  • role clarification
  • partnering process explanation and agreement.

Three Consulting Styles

Let’s start with the Pair of HandsThis style of consulting resembles more or less the contractor for hire or long-term temporary employee; sometimes referred to as the permanent temp much to the chagrin of those who hold those positions.  Here the client (or internal customer) retains control of the project from problem identification to solution deployment.  The consultant implements those decisions as if s/he were an extension of the client’s staff.  Hence the expression, an extra pair of hands to delegate the work to.

Three Types of Consulting Styles

There’s the Expert.  Here the consultant assumes most of the control for the project.  The client can still make suggestions while the consultant makes recommendations for the best solution selection.  Ultimately, the expert-consultant decides on the course of action and tells the client what the best path forward.  In this type of consulting relationship, the client wants the expertise of the consultant. 

The third is Collaborator.  This is where the consultant utilizes his/her specialized knowledge and field experience and leverages the client’s knowledge of the operations, including processes and procedures, and the cultural factors.  In this relationship style,  1 + 1 = 3, representing a more synergistic approach to problem solving.  Decisions and implementation plans become shared responsibilities.  This style is often referred to as a business partnership and it is really the only one that changes performance.

The Best Time to Initiate

Ideally, the best time to initiate a relationship is during a current assignment especially when the shared project is going well.   A “project client” is no less important than a business partner, the difference is in the intensity during the life of the project.  A project client is the one who is ultimately accountable for the project results and may not be the one who initiates the project discussion, explains Dana Gaines Robinson and James C. Robinson in their book, Strategic Business Partner: Aligning people strategies with business goals

Before you can get access to strategic work, a PC has to prove s/he can deliver on tactical projects that are solution-oriented.  Gaining access starts with cultivating a relationship with project clients.  The secret is not to ignore or bypass the project contact person but to work with him/her to gain access to the project client. 

Suggest that the contact/lead attends meetings with you regarding issues that need to be resolved at the higher level or collaborate on joint update briefings to the leadership team.  By establishing good relations with the contact, access to the project client is less adversarial and demonstrates an authentic approach to getting answers/ direction that was not previously available. 

Project clients can become business partners; one that provides access to strategic initiatives.  Or they can provide introductions to true clients.  If possible, volunteer for activities that will give you visibility with this person while supporting him/her on the assigned project.  They will begin to learn more about your “other” capabilities and your ability to handle more than “assignment at a time” will be confirmed.  And in all your interactions, ensure that they are truly value-added conversations; else you will be perceived as wasting a busy executive’s time.   

Internal vs. External Consultant

I’ve been both and have had success in implementing HPI projects in both environments.  There are pros and cons and tradeoffs.  Whether you are internal to the organization or external (an outsider), Compliance Trainers need to expand their skills sets if they are going to move from a “pair of hands” to expert and eventually to trusted business partner. 

Technical Trainer or Performance Consultant Wanna-be?

As the traditional role of technical trainer evolves into Performance Consultant, the skills needed are evolving as well to keep up with management expectations for alignment with business needs.  To that end, Beverly Scott, author of Consulting on the Inside: An internal consultant’s guide to living and working inside organizations, suggests that internal consultants re-tool with some new skill sets:

  1. Know the business.  Tie solutions and align results to real business issues that add value. Get to know finances.
  2. Identify performance gaps before management does or becomes the focus of a CAPA corrective action.
  3. Become a systems thinker.  HPI is all about systematic performance improvement.
  4. Build skills for the multiple roles a PC performs.  Become known as a change agent, systems thinker, learning strategist.
  5. Pay attention to trends; talk about them.  Watch for relevance for the organization. –VB.

“The ability to give advice as a consultant comes from trust and respect, which are rooted in the relationship”. (Beverly Scott, p.61, 2000).

  • Beverly Scott Consulting on the Inside: An internal consultant’s guide to living and working inside organizations.
  • Dana Gaines Robinson and James C. Robinson in their book, Strategic Business Partner: Aligning people strategies with business goals
  • Alan WeissOrganizational Consulting: How to be an effective internal change agent.

Who is the Author, Vivian Bringslimark?

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(c) HPIS Consulting, Inc.

If the only tool is a hammer …

A hammer is the right tool to drive a nail into wood or dry wall, etc. supporting the adage “right tool for the right job”. Until the closet you installed comes off the wall and you realize that perhaps you needed screws instead or an additional widget to support the anticipated load.

It isn’t until “in-use” performance feedback is collected that the realization of a different tool and additional support mediums are needed. Providing training (as in formal instruction) as the solution to a performance issue is analogous to using a hammer for every job.

Site leaders want business partners who can help them succeed with organizational goals, yearly objectives and solve those pesky performance issues. The more valuable the “trainer-now-known-as-performance-consultant is in that desire, the more access to strategic initiatives. So, the more a trainer wants to be recognized as a business partner to site leaders, the trainer needs to continue to build their “solutions toolbox” that includes more than delivering a training event or LMS completion report.

But I Already Do All That!

A trainer with strong instructional design skills could argue that s/he has loads of experience with 3 of the 4 roles sans solution specialist.  To that end, ADDIE has been the methodology and the foundation for successful training events for years.  A sound training design analyzes needs first. Incorporates change management elements. And includes evaluation activities for level 1 (reaction) and level 2 (learning) of the Kirkpatrick Evaluation Model.  So how hard could it be to master the role of Performance Consultant? 

HPI roles for Perf Consult
A performance consultant wears all these hats.

Does your current trainer have the necessary competencies to tackle the additional performance solutions?  A logical next step is to review the literature that has been published on the multiple roles for a Performance Consultant.  These include Analyst, Change Manager, Solutions Specialist, and Evaluator.  There are more, but let’s start with an overview of these four.    

The PC wears the hat of Analyst when working the business analysis and performance analysis portion of the HPI methodology by honing in with the skill of asking the right questions and being able to analyze all of the contributing factors for performance causes.   This is more than a needs analysis for designing a course. 

I Need Training for 800 Employees ASAP

A corporate auditor discovered a lack of training records for newly developed Job Aids during a Mock Inspection.  So, the easy fix would be to re-train everyone and then produce the records, right? Notice however, that the solution is biased towards retraining without discovering why the training was missed in the first place. 

Reframing the request allowed the Performance Consultant to not only find the root cause but to provide both immediate resolution and long-term prevention.  In the end, the HPI approach delivered the solution far quicker than the traditional training approach was originally planned for and the audit observation was closed before the due date! 

Read:  “Just Get the Audit Observation Closed Already, Will You?”  for a more in-depth description of how a cause analysis provided the true root cause and how the originally proposed training request would not have prevented repeat errors. 

The Solution Specialist role relies heavily upon systems thinking skills and is way beyond the power point training solution.  As a problem solver working the probable causes from the Performance Cause Analysis, s/he opens the toolbox and can look past the “training design tray” into other alternative performance solutions. 

The ATD HPI methodology adapted 6 categories of learning solutions from the work of Dean, Dean, and Rebalsky. Their *1996 study focused on analyzing employee perceptions about which workplace factors would most improve their performance. They categorized these factors into 6 key areas:

This is much more than a hammer in their toolbox. Implementation experience grows with each executed solution and a skilled PC also develops good project management skills.

Capturing SME Secret Sauce to improve KPIs for a business unit

A team of site leaders met to discuss (problem solve) what to do about lagging metrics for a business unit.  The idea of studying SMEs (aka key performers) to learn what they needed to do to meet or beat the numbers was brought up.  However, the outcome was already biased with a set of “knowledge based” assumptions unbeknownst to the Performance Consultant (PC). 

During the Key Performer Interviews, it turned out that those assumptions were brutally flawed and put this HPI project and another highly visible project in serious jeopardy.    The PC was able to uncover the right knowledge from the SMEs and successfully deliver a solution.  However, it was far from a traditional classroom training session or even an OJT session.  Yet, it had everything to do with capturing secret sauce learned on the job. 

Read  “Capturing Secret Sauce of Senior Equipment Operators?” to learn more about the revised project solution and the final outcome.

During implementation, the PC may also have to wear a dual hat of Change Manager.  Process changes, culture change and more require strong facilitation skills and process consultation techniques to manage the different phases of change depending on the nature of the solution and the size of the change impact. 

When Borrowing A Best Practice From Another Department Can Backfire

If having one department of qualified operators is good, then why not duplicate the best practice?  Hmm, sounds reasonable enough, right?  This is exactly what one manager thought after a department re-organization. 

So, she set out to cut-n-paste curricula from manufacturing operators and use for her staff of technicians.  But after months of reminding, little progress was made towards completion of the “cross-training requirements” project. She contacted the PC, and a performance cause analysis was conducted.  The results revealed a few surprises.  In an effort to expedite the cross-training program and hit the ground running, decisions about what to include in the cross training curriculum were done without input of the technicians. 

Read the more detailed version of “I’ve Been Re-org’d. What’s in it for me?” to learn more about those surprises and how this HPI Project was refocused on wellness and motivation as the right fix instead of completing borrowed training curricula.

And the Evaluator role begins to surface with understanding the cultural impact of performance solutions as the solution goes live.  Feedback collection, standards-setting, and re-assessing the performance gap to determine success or additional gap analysis are additional examples of what to expect from this role.

When an FDA Inspection Reveals a Performance Gap with Training on SOPs

During an inspection, FDA Investigators observed multiple departures from SOPs. When they inquired about the training, training records were produced. The investigators then asked, “How do you know your training was effective”? They had witnessed firsthand the performance gap between the set of written instructions and the signed training records. “What then did the operators sign for, the reading of the SOP or that I’m trained to do the task as written?” 

The client could not defend the effectiveness of their training “program” during an extensive FDA inspection.  Clearly the performance solution was going to be more than the mandate to use evaluation sheets or quizzes at the end of SOP Training.  They were routinely performing tasks that did not match the procedures they signed for.  After a thorough performance cause analysis and a comprehensive evaluation of the culture supporting the causes,the solution best matched to the causes was to improve structure and process for an Effective Training Quality System.

Read – Impact Story – “You Changed Our Training Culture” to learn more about what was allowing the performance gap to continue. 

A Word Caution: The Silver Bullet For Performance Problems Doesn’t Exist!

Oh, but if it did, life for a supervisor would be easier, right?  Let’s face it, “people” problems are a big deal for management.  Working with humans does present its challenges, such as miscommunications between staff, data entry errors, or rushing verification checks.  Sometimes, the task at hand is so repetitive that the result is assumed to be okay and gets “a pass”.  Add constant interruptions to the list and it becomes even harder not to get distracted and lose focus or attention to the detail.

Actual Behavior Vs. Performing As Expected

In their book, Performance Consulting: Moving Beyond Training, Dana Gaines Robinson and James C. Robinson describe performance as what the performer should be able to do.  A performance problem occurs when the actual behavior does not meet expectations (as it should have been able to do).   Why don’t employees perform as expected?  Root cause analysis helps problem solvers and investigators uncover a myriad of possible reasons.   For Life Sciences companies, correcting mistakes and preventing them from occurring again is at the heart of CAPA systems (Corrective Actions Preventive Actions).

A closer look at performance gaps

Dana and James Robinson conducted research regarding performer actions and sorted their results into three categories of obstacles:

  • Conditions of performers
  • Conditions of the immediate managers
  • Conditions of the organization

A checklist for common Performance Causes is available to mailing list subscribers. 

But weren’t they trained and qualified?

Hopefully, employees are trained using an approved OJT Methodology in which they are shown how to execute the task and then given opportunities to practice multiple times to become proficient.  During these sessions, they are coached by Qualified Trainers and given feedback on what’s right (as expected) and given specific instructions to correct what’s not right with suggestions for tweaking their performance so that their final performance demonstration is on par with their peer group.   At the conclusion of the qualification event, employees must accept that they now own their deviations (mistakes) from this point forward.  So, what’s getting in the way of performing “as they should” or in compliance speak – according to the procedure? We need to find out.

Is it a lack of knowledge, skill or is it something else?

The Robinson’s explain that performance is more than the training event.  It’s a combination of the overall learning experience and the workplace environment that yields performance results.  Breaking that down into a formula per se, they suggest the following: learning experience x workplace environment = performance results.

The root cause investigation will include a review of training and the qualification event as well as a discussion with the performer. 

  • Is it a lack of frequency; not a task often performed?
  • Is it a lack of feedback or delayed feedback in which the deviation occurred without their awareness?  
  • Is it task interference?

The work environment includes organizational systems and business unit processes that together enable the performer to produce the outcomes as “expected”.   These workplace factors don’t always work in perfect harmony resulting in obstacles that get in the way of “expected” performance:

  • Lack of authority -> unclear roles, confusing responsibilities
  • Lack of time ->schedule conflicts; multi-tasking
  • Lack of tools -> reduced budgets
  • Lack of poorly stored equipment/tools -> lost time searching

Isn’t it just human nature?

Once the root cause investigation takes on a human element attention, it’s easy to focus on the performer and stop there.   If it’s the first time for the performer or first instance related to the task, it’s tempting to label the event as an isolated incident.  But when it comes back around again, it becomes apparent there was a “failure to conduct an in-depth investigation” to correct and prevent.  Not surprisingly, a push back of “Operator Error as Root Cause” has forced organizations to look deeper into the root causes involving Humans.

Who’s human nature?

Recall that one of the categories of Robinsons’ researched obstacles was “conditions of the immediate managers”.  This makes managers uncomfortable.  With so much on their plates, managing a people performance problem is not what they want to see.  A silver bullet like re-training event is a nice activity that gives a big red checkmark on their to-do list.  However, Robert Mager and Peter Pipe, in their book, Analyzing Performance Problems, provide insights to managing direct reports that may lead to unintended consequences.  (It’s not always the performer’s fault.)

When It’s Not a Skill Deficiency

Examine these four general causes of non-performance triggers:

1. It is punishing to perform as desired.

2. It is rewarding to perform other than as desired.

3. It simply doesn’t matter whether performance is as desired.

4. There are obstacles to performing.

Want to learn more about strategies for these four triggers?

It takes all three to correct a performance problem

The third category of researched obstacles clustered around “conditions of the organization”.  I’ve already discussed task interference above.  To suggest that organizations are setting up their employees to fail is pushing it just a bit too far.   So, I won’t go there, but it is painful for some leaders to come to terms with the implication.  In order to prevent issues from reoccurring, an examination of the incidents and quite possibly a restructuring of systems have to occur, because automatic re-training is not the only solution to a “people performance problem”.

The role of Performance Consultant requires more variety of skills and depth of project experiences.  While training solutions are part of the PC toolkit, a training manager’s toolbox typically does not offer other performance solutions.   It’s usually a hammer when a swiss army knife is what’s needed. – VB 

Dean, PJ,Dean,MR,Rebalsky,RM. (1996) Performance Improvement Quarterly, 9(2), 75-89.

Mager R, Pipe P.  Analyzing performance problems. Belmont: Lake Publishing; 1984.

Robinson DG, Robinson JC. Performance Consulting: Moving beyond training. San Francisco: Berrett-Koehler; 1995.

Rothwell, WJ. Editor, ASTD Models for Human Performance Improvement: Roles, Competencies, Outputs. 2nd Ed, 1999.

Weiss, A. Organizational Consulting: How to be an effective internal change agent, USA, Wiley, 2003.  

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What’s the difference between Trainers and Performance Consultants?

Aren’t they one and the same?

 Since the original release of this blog in 2014, it continues to be the # 1 blog viewed on the Theory vs. Practice blog spot.  Thank you to all the viewers and future viewers.  This tells me that the question is still relevant today in 2021. 

Just another fancy title?

Some leaders think there is no difference; that we’ve just added one more title into the crowded lexicon of L&D jargon.  And others believe that performance consultants (PCs) want to expand their scope, budget and timelines.  And some simply hear excuses about why the requested training “course” is not immediately being embraced. 

Dana Gaines Robinson in her seminal book, Performance Consulting, provides 6 items to use when comparing a Trainer/Training event and a PC/performance-based solution.  Allow me to expand upon the 6 elements to illustrate the difference between the two and the depth of impact one has over the other.  

FOCUS

Training addresses the learning needs of employees.  Various definitions include closing the knowledge and skill gap of what they know now and what they know afterward.  It’s built on the assumption that the cause of the gap is a lack of knowledge and skill.  Performance Consulting addresses the business goals and performance needs of the affected employees.  Instructor-led training is just one of the possible solutions that can be used; not the only one. See HPI 6 “boxes” of performance solutions. 

OUTPUTS

A training solution delivers a structured learning event.  Whether it is a classroom or virtual or self-led, the event itself is the end goal. The assumption is that learning occurred and knowledge gained so, therefore, a change in behavior or in the learners’ performance should occur as well.  

Performance Consulting or Human Performance Improvement (HPI) projects are implemented to improve performance.  The end goal is not about the solution such as the specific HPI Project, but rather a positive change in performance that leads to the achievement of the business goal.  The endpoint is “further down the road”.  So it takes longer to produce the results. This frustrates site leadership.  They would rather check off the box that a learning event was delivered because it’s more tangible and occurs faster than quarterly metrics. 

ACCOUNTABILITY

With training, the Trainer is held accountable for the event.  In a lot of organizations, there is an implied but not spoken accountability for the results back on the job despite that Trainers lack the authority to direct their learners’ actions back in the workspace.  Without the proper systems and support mechanisms in place, many Trainers get “blamed” for training transfer failure.  Here’s the big difference for me. 

Performance Consultants (PCs) partner with their internal customers, system owners, and business leaders in support of the business goals.  The accountability for improved performance becomes shared across the relationships.

Differences between Training and Performance Consultants
ASSESSMENTS

Trainers typically conduct a needs analysis to design the best learning “program” or course possible.  Again, the assumption is that a learning course will close the training gap. When the directive comes from a senior leader in the organization, it is hard to initiate a dialogue about human performance improvement.  That is probably the least successful time to educate the leader.

PCs conduct performance gaps to assess causes that can go beyond knowledge and skills.  It’s called a performance cause analysis and often reveals other contributing factors that a training course cannot and will not fix. To a compliance trainer or quality systems professional, this sounds a lot like root cause analysis. 

Why we love root cause analysis

We get to document our compliance with CAPA requirements.  It allows us to use tools and feel confident that our “data doesn’t lie”.  This bodes well for our credibility with management.  And it provides the strategic connection between our HPI solution (as a corrective action) and the business goal.  This collected data can become the baseline for measuring the effectiveness of the chosen solution later on.   CAPA= Corrective Actions Preventive Actions.

The outcome of a performance analysis produces a 3 tiered picture of what’s encouraging or blocking performance for the worker, work tasks, and/or the workplace. And what must be done about it at these same three levels.  The solutions then become tailored to the situation, coordinated across the organization, and executed consistently over time.

MEASURES

Trainers very often use course evaluation sheets as a form of measurement.  In the Compliance Training arena, knowledge checks and quizzes have also become the norm.  Caution.  A learner can achieve 100% of the learning objectives and still fail to perform the skills necessary to achieve the business outcomes.  This is also known as a failure to transfer training or the learning objectives. PCs measure the effect on performance improvement and achievement of business objectives.

ORGANIZATIONAL GOALS

This is another key differentiator.  Training is viewed as a cost typically.  Compliance Trainers are all too familiar with the phrase, “GMP Training is a necessary evil”.  And more recently, compliance training has become synonymous with check the box training and “just get ‘er done”. PCs become business partners in solving performance gaps and accomplishing organizational goals.

But isn’t this still training?

Managers and leaders really all the benefits that come from performance consulting, but they don’t have the patience for it especially when many of the solutions end up looking like a “training event”.

If it looks like, smells like, and tastes like training …

Then it must be training, right? Not exactly. But nod your head anyway; at least they are still engaged with you!  If your client/sponsor/requestor is more comfortable with calling it training, let them do so.  Don’t push the HPI label at this point.  First, work on raising their awareness with your early projects and successes.  From your success, you can bridge to an explanation about HPI and gain more support for HPI projects. 

What’s your company’s definition of training, anyway?

Most folks will envision instructor-led classrooms, virtual instructor-led, and formal eLearning courses. Their frame of reference is the gap must be a lack of knowledge and training is used to close that gap.  Is closing a skill-based gap also considered training?  Most companies would define that as OJT.  What about “awareness training” and communication “training” sessions; are these considered training?  It is a form of closing a knowledge gap, the depth of the gap and the degree of required proficiency is the differentiator.  Again, what’s your company’s definition of training?  You may have several examples of differentiating levels of depth.

What’s your organization’s definition of training?

Closing Performance Gaps with the Right Solutions

The essence of HPI methodology is all about the right solution based on the data (evidence) and making a worthy impact on the bottom line when the performance gap closes.  Is this training, you tell me?

 I believe that this is what training is supposed to provide when you perform the proper cause analysis and identify what the business wants to achieve by resolving the performance gap. How would you explain it to your requestor?

Wait a minute. What is worthy performance?

Thomas Gilbert described it as engineering worthy performance in his groundbreaking book, Human Competence: Engineering worthy performance.   It’s when the cost of doing the task is less than the value of the results generated.  When they are the same or greater, we have a performance gap.  The eBook, “Triggering the Shift to Performance Improvement” is a short primer that explains human performance to management.

After the business analysis is conducted, the performance analysis (PA) follows next.  PA recognizes that performance occurs within organizational systems.  It is not a training needs analysis.  The emphasis during a PA is on first recognizing the drivers and barriers that get in the way of worthy performance.  The method gathers multiple perspectives on the problem, not just content for a training course. 

Human Performance Improvement Solutions is like opening up Pandora’s Box

Very often the recommended HPI solution(s) involves integration of linkages outside of the initiating department but within those same “organizational and quality systems” in order to ensure sustainable performance improvement. Otherwise, you have a fragment of the solution with high expectations for solving “the problem” which often falls short of performance improvement.

This requires cooperation of others

How solid are these relationships?  Would a request to fix someone else’s system go over well?   Or would you be reproached of starting a turf battle?  HPI projects have the potential of opening up unsettling issues similar to Pandora’s Box.  Image, perception, pending promotions, can all be impacted by what the Performance Analysis reveals, including the fear of losing one’s job.  And yet, this very opportunity to engineer worthy performance is what makes these projects so valuable for impactful results. 

HPI Project vs. a Training Event

Conclusion

A training solution closes a knowledge and skill gap, wonderful.  Rarely is lack of knowledge the only factor contributing to poor performance.  A performance solution may include a training piece, but it also closes a gap in Job Performance which in turn can close a gap in a Process Performance and resolve a gap in Business Results. That’s what an HPI project/solution does differently than a training solution. Being able to show this kind of impact on the business as a result of the work a Performance Consultant does go a long way to earning business leaders’ trust.  –VB

References:

Robinson DG, Robinson JC. Performance Consulting: Moving beyond training. San Francisco: Berrett-Koehler; 1995.

Gilbert T Human Competence: Engineering Worthy Performance. San Francisco: ISPI, Pfeiffer; Tribute Edition, 2007.

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Taking the Agile Learning Plunge

When Rapid Design for eLearning found its way into my vocabulary, I loved it and all the derivatives like rapid prototyping, etc.  And soon, I started seeing agile this and agile that.  It seemed that agile was everywhere I looked.  When Michael Allen published his book, LEAVING ADDIE for SAM, I was intrigued and participated in an ATD sponsored webinar.  It made a lot of sense to me and “I bought into the concept”.  Or so I thought …

I joined a project that was already in-progress and had to “hit the ground running to get caught up to speed”.  The element of urgency was the anticipation of a post FDA visit following a consent decree.   If you’ve experienced this “scene” before, you can relate to the notion of expedited time.   As part of remediation efforts, training events needed to be conducted.  I learned during a meeting sometime my first week, I was to be the trainer.  Okay, given my instructional design background and classroom facilitation experience, that made sense.  Sure, in a few weeks when we have the new procedure in place, I’d be happy to put the training materials together, is what I was thinking.  Wait, what, in two weeks?  Are you kidding me?  I’m not the SME and I don’t even have the software loaded on my laptop yet.  Well, some cleaned up version of those words was my response.

My biggest challenge was to get out of my own design way

I’m classically schooled in *ADDIE with 30+ years as an instructional designer and very comfortable with how to design, develop and deliver training.  All I needed was more time; more than two weeks, for a process that was changing daily!   And then I found myself thinking about all the buzz for rapid design and prototyping I had been reading about.  

*ADDIE = Analysis, Design, Develop, Implement, Evaluate: a project management approach to training projects.

In theory, I totally bought into it. But this is different I argued with myself.  This is compliance with a quality system for a company that is undergoing transformative change as a result of a consent decree!  Furthermore, I teach GMP Basics and conduct Annual GMP Refreshers several times a year. My GMP dilemma challenged the very essence of my “learned” compliance beliefs about following the 1st basic GMP Work Habit – “thou shall follow written procedures” otherwise, it’s a deviation. 

Are we really planning to deviate from the SOP while under a consent decree?

While it was the intention of the business unit leader to deviate from the approved set of work instructions, a planned deviation would not be appropriate in this case.  I mean we were talking about a corrective action for a consent decree item.  Were we really considering a PLANNED DEVIATION to intentionally teach unapproved procedures and then submit the documentation as a completed corrective action for the CAPA to the agency?  I was truly baffled by how I was going to pull this off in two weeks.  I’m not a magician, I can’t pull this rabbit out of my laptop is what I was thinking when I left the VP’s office.

Yet on the other hand, how could I teach a work instruction that was known to be broken; was being re-designed and not yet finalized?  The instructional designer side of me screamed – how can you teach flawed content?  That’s wasted training that results in scrap learning. How is that training going to be effective not to mention having to explain a failed effectiveness check during the post inspection?

And then, it hit me!  I was so focused on WHAT I NEEDED, that I was missing the urgency of the learners’ needs. Julia Lewis Satov refers to this situation as ‘agility by fire’ – “the ability to move quickly but not easily, and still excel”, (p. 50, 2020). It was time to put theory into practice and take the agile learning plunge into the realm of the unknown.  If I could come up with a way to document what we were doing and get it approved, then I could reconcile my GMP dilemma and satisfy my instructional designer. 

 With a little help from my validation colleagues – the training implementation plan

Validation engineers use protocols to capture their “change in process” work.  Whether it’s experimental batches, 3 batches for process validation or **IQ-OQ-PQ protocols for equipment qualifications.  They are validating the procedure or the new process before it can become the standard operating procedure by developing the plan, developing acceptance criteria, managing deviations and capturing the results.  So why couldn’t I borrow the concept and adapt it to my situation?

**Installation Qualification, Operational Qualification, Performance Qualification

The purpose of the initial training session was to test the new sequence of steps and confirm the robustness of the software responses for each field entry and then make correct decisions where needed.  The learners were still in compliance with the quality policy for complaint handling and were still meeting the intention for Medical Device Reporting requirements.  They were essentially testing the future “how-to steps” for the proposed new work instructions.

Agile QT’s processing their learning experience

I did not copy and paste the validation protocol template. I did, however, include a please pardon our appearance while we are under construction” paragraph in the training plan to document the departure from the current set of work instructions.  This protocol-like section also included our intentions for the outcomes of the sessions. We also stipulated that required SOP training of all affected users including the Qualified Trainers, would be mandatory once the finalized set of work instructions were approved.

Anybody want to play in the sand-box?

By shifting the prioritization away from perfectly designed classes with pristine training materials, I was able to diagnose that the need was to get the learners into a live classroom. But first I needed a small group of super users who wanted to see the database software in action and “play in the sandbox”; the training materials could follow afterwards. 

It didn’t take long for them to find me.  These “learning-agile individuals” wanted the challenge of not only learning something new but seemed to thrive on the idea that they would be managing their part of the training implementation plan.  They were not at all worried about the lack of available training materials for themselves.  They allowed the learning experience to occur spontaneously.  Their ability to learn new knowledge and skills did not get in the way of previously learned skills. They embraced the changes rather than resist them.

A new breed of SMEs as Agile Qualified Trainers?

I shifted my role to facilitator and allowed these learning agile SMEs to navigate the software screens and then work out the explanation of how to complete field transactions.  In the Center for Creative Leadership “Learning Agility” white paper, authors Adam Mitchinson and Robert Morris explain that learning-agile individuals understand that experience alone does not guarantee learning; they take time to reflect, seeking to understand why things happen, in addition to what happened”, p. 2.

“SMEs are true front-line and onsite educators” says Satov.  Every organization has employees who are brimming with intelligent and diverse ideas and are eager to share their talent producing work deliverables. “[…] Our focus must shift to finding and developing individuals who are continually able to give up skills, perspectives, and ideas that are no longer relevant, and learn new ones that are”, (Mitchinson and Morris, 2014, p.1).

We documented these sessions as training because we all learned how to navigate the screens; albeit it was learning on the fly.  We recognized that learning the software was the goal.  Developing the process steps and eventually the work instructions was the secondary goal.  This training documentation became the qualifying evidence for their train-the-trainer knowledge transfer.  And collectively they decided what choices end users were to pick from the drop down tables.  

Is this “learning on the fly” or agile learning in practice? You decide.

1 + 1+ 1 is more than 3

I shifted my role again to become a scribe and worked on sequencing these pages for the next round of end-users. To my surprise and delight, my new breed of Agile QTs volunteered to paste screen shots into participant worksheets so their “students” could take additional notes.  Together, we all collaborated to meet the urgent need of the end-users. Each of us in our niche roles experienced first-hand the value the others brought with them to that room.  And in that time away from our regular job tasks, we became more valuable to the organization.

The learners were paired up with their Agile QT for guided instruction of real entry into the live system.  The following week, the department was able to go live with a project plan that focused on a series of interim roles, changed roles and transitioning responsibilities within established roles.  The project launched on time to meet commitments promised to the agency.

Why are they thanking me?

It was an energizing and empowering learning experience for the super-users. A truly collaborative experience for the SMEs and the biggest surprise of all was that they thanked me.  Me?  I did not deliver the training; I was not the SME, nor did I provide perfect training materials.   If I had pursued my classically trained ADDIE approach, we would have waited for the perfect SOP to deliver those sessions and woefully miss FDA committed timelines. While I’m not ready to throw ADDIE overboard yet, Satov makes a compelling plea, “move aside elite and long-standing establishments of formal education”. 

My lesson learned was this: when the demand is for speed and the content design is not the key focus, I need to give up control to the true onsite educators and focus on facilitating the best learning experience given the daily change challenges and system constraints. Satov would agree, “the role of learning is to capitalize and create the architecture of the hybrid-mind”.  Is this “learning on the fly” or agile learning in practice?  You decide. But agile instructional design is here to stay if QA L&D is going to keep up with the fast-paced, often reactive, and regulated world of the Life Sciences Industries. – VB

  • Allen, M. Leaving ADDIE for SAM: An Agile Model for Developing the Best Learning Experiences. ASTD, 2012.
  • Mitchinson, A & Morris, R. Learning Agility. Center for Creative Leadership white paper, 2014.
  • Satov, JML. “Agile by Fire”, Chief Learning Office, July/ August, 2020, p. 50.
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