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
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”.
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:
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
partnering process explanation and agreement.
Three Consulting Styles
Let’s start with the Pair of Hands. This 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.
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:
Know the business. Tie solutions and align results to real business issues that add value. Get to know finances.
Identify performance gaps before management does or becomes the focus of a CAPA corrective action.
Become a systems thinker. HPI is all about systematic performance improvement.
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?
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!
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.
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.
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:
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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
Back in March of 2008, I was completing my second course in the ATD Human Performance Improvement Certificate series in Alexandria, VA. ATD had recently moved into their new HQ home and the building was filled with a lot of excitement, energy, and promise. Having been a national member since 1990, I was kind of in awe with being at the center of such a publicly accredited resource center.
The course did not disappoint. Somewhere on the morning of the 1st day, I had an epiphany that changed the path of my career. Actually, it was when we were knee-deep into cause analysis of performance problems that I declared that I wanted to do this full time.
The HPI approach is much more than a fancy training fix, or an excuse to buy more time. Yes, it’s true that often the solution has a training component to it, but often the focus has evolved into something much more appropriate. What appeals to me with Human Performance Improvement, is that a trainer’s toolbox of solutions is so much bigger. The old expression, “when the only tool you have is a hammer, you tend to see everything as a nail” couldn’t be truer for trainers who deliver only courses. The cause analysis step in the HPI Methodology gives credence to conducting a root cause analysis specifically for humans and their work environment. The results of the analysis then provide insight as to how to resolve the gap(s). Notice I didn’t say that it provides the learning objectives for the course that management wants delivered. It is solution-agnostic until the end of the analysis period.
The HPI toolbox has 6 categories from which learning solutions typically are derived from. Not to be confused with Carl Binder’s 6 boxes, the ATD HPI Model adapted these categories from the 1996 work of Dean, Dean, and Rebalsky; albeit, both have strong origins to the father of human performance improvement, Thomas Gilbert who first captured the concept as Engineering Worthy Behavior. I highly recommend reading his work. See reference at the end.
The *1996 study focused on analyzing employee perceptions about which workplace factors would most improve their performance. They categorized these factors into 6 key areas:
1.) PHYSICAL RESOURCES (the tangible tools and resources)
2.) STRUCTURE & PROCESS (Workflow factors of who and how)
3.) INFORMATION (effectiveness of data exchange between people a/o machines)
4.) KNOWLEDGE (skill related)
5.) MOTIVES (intrinsic to the performer; may or may not affect performance)
6.) WELLNESS (physical or emotional factors affecting performance)
HPIS Consulting was created on the basis of the HPI methodology. Using a structured process to uncover what gets in the way of employees performing their jobs, a true “training” root cause analysis can be conducted. The solutions are then project managed to fruition and evaluated for impact results.
So how does HPISC’s Robust Training Systems and HPI mesh?
The following diagram illustrates just how expansive today’s Performance Consultants toolbox can be. It was this vision back in March 2008 that got me so excited about where the Learning and Performance field can go. I say bring it on! -VB
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 detail.
Training can be considered a change in what the learner knows now | can do now and what s/he knows and does afterward. Training can close these gaps when knowledge and skill are lacking. Thus, a trainer has a dual role: trainer and change agent.
While on the surface, the actions a trainer takes looks like change management, it is a sub-part of the larger change management plan. The scope is narrower. It is focused only on the training content. But the expectations for successful transfer back to the job and improved organizational results remain the same. One allocated and approved session designed and delivered by the training department is supposed to shift years of a mindset, alter behaviors and change the company’s culture. Amazing!
This expectancy or shall I say management assumption is very real and prevalent in fast-moving start-up companies whose leaders claim to have a limited budget for “training” and no time to sit in frivolous meetings planning “the people side” of change. I’m supposed to be grateful that I get an hour session.
What happens next also amazes me. Training on the proposed system changes is reduced to an hour-long awareness session on the SOPs that have already gone into effect and folks are told – “Go with the flow. Change is part of our everyday life around here. Get with it or get out”. And here’s the rub for me, errors rise, deviations spike, users are annoyed, pissed off or disenfranchised and management blames the trainer for a failed change effort. Wow! Is this the management support that was promised to folks at the town hall meetings?
The bigger the redesigned quality system changes are, the more you need to consider beyond just training awareness on the SOPs. Assess the size of the change gap and the impact the new design will have on the culture; “the way we normally handle changes around here”. Training rollout sessions are already time-crunched. There is not enough time “allowable” to manage all the other non-training change issues like feelings, job security concerns, why the need for change retorts, lack of supervisory support post-training, etc. that actually get in the way of a successful learning transfer. And later create hurdles for improvement results.
Let’s look at the HPISC 5 Step Change Management Plan and apply it to quality system redesign projects. (See the sidebar below.)
Management Plan Considerations
1. Why is
the change needed?
This may be really obvious when the site receives a Warning Letter. But an explanation of how this became a driving force for the needed changes will do wonders for your employees to feel the urgency about the change.
is really changing?
Will the changes be incremental or a huge transformational change such as “changing the quality culture”?
How are these SOP changes part of the GMP culture?
are the pros and cons of the change?
Who benefits and who loses?
Are customers hurt or helped?
What are the stakeholder’s benefits from the change?
What about the benefits for the primary users?
does success look like?
will the outcomes of the change look like?
will you and others know if the change has been successful?
benchmarks will help you track progress?
is the day or timepoint we get to declare success?
other initiatives are we competing with?
how will adding the new change requirements impact already heavy workloads?
Will Awareness Training be the only
vehicle for announcing the new changes?
Are the answers to the change management questions sitting with the trainer/training department or with the site leadership team? Perhaps the answers can be found within the steering committee members? Is the trainer supposed to address all of these questions in a 60-minute awareness session that also includes the SOP changes? If successful user adoption is paramount to your strategic action plan, warning letter remediation plan, or CRL commitment response, you need to ensure that change management messages regarding these changes are included in the overall communication plan. Don’t just rely on the design team members to deliver these messages casually at huddle updates. That is not a communication plan.
“The bigger the redesigned quality system changes are, the more you need to consider beyond just training awareness on the SOPs”.
Vivian Bringslimark, HPIS Consulting, Inc.
The design team with the aid of the project manager needs to schedule special change management sessions where the Affected Users are briefed on the status of the project and the answers to the questions listed above addressed. Some leaders do not want to “waste time” on these sessions. They are concerned that it will become a gripe session. Instead, they think it’s better to just present the users with the revised procedures. There’s less time to fret and grumble over it.
There is a false belief that once the Affected Users see the changes in a QA-locked down version, they will follow them “because it’s now in the approved SOP”.Forced acceptance is not a change management strategy despite rampant practice in our industry. If awareness training will be the first time affected users are learning about significant system changes and the “Go-Live” date, be prepared to receive A LOT OF FEEDBACK FROM UPPER MANAGEMENT regarding how awful the awareness training sessions went.
“Change is disturbing when it is done to us, exhilarating when it is done by us”.
Rosabeth Kanter, 1984, p. 64.
Camp, RR, Blanchard, PN. & Huszczo. Toward a More Organizationally Effective Training Strategy & Practice. New Jersey: Prentice-Hall, 1986.
Kanter, RM. The Change Masters. New York: Simon and Schuster, 1984, 64.
The rest of the series can be found below:
Blog # 1 – Redesigning Quality Systems: Achieving User Adoption
Blog # 2 – Manage Your Stakeholders and Users Expectations
Blog # 3 – Gap Assessments are Necessary for Redesign Projects but so is the right level of support
Blog # 4 – What to Expect When Processing Map with SMEs
Blog # 5 – Field Test Your SOPs before they go into effect
This is the 3rd blog in the on-going Redesign Quality Systems: Achieving Successful User Adoption series. Visit Blog 1 and 2 here.
Assessments – “Truth Be Told”
Assessing the current state of the targeted quality system is analogous to collecting the “voice of the customer” input. Discovering what is and is not working is vital to ensuring a successful redesign and ultimately user adoption. This is more than a review of the SOPs and forms; however. Interviews are key to this phase of the project. From the system owner to primary users, QA staff and even the LMS or the eDoc administrator are essential. The more cross functional the input, the better the confirmation of the “data” and the “evidence”. Which in turn, provides a truer gap assessment.
Most interviewees know the system’s weaknesses and they know how to fix it. But they are frustrated with ignored attempts to change it. Many simply give up trying to get it changed on their own or within their circle of responsibility. So, when quality systems interviews are being conducted with an external consultant, some are eager to share the “dirt” on just how broken the system really is. And some of the “fixes” are political and can only be handled when trust has been earned or when the sponsor deems it so.
recognize Training is important but …
A small vitamin and supplements company set out to become a commercial manufacturer of pharmaceutical drug products. Naturally, their quality systems were not robust enough to meet 21CFR 211 code of regulations. So, assessments were conducted for the major quality systems. The Training Quality System assessment revealed several positive activities that were enabling current success and a lot of gaps that would need to be addressed to meet regulatory expectations for today’s pharmaceuticals companies.
The sponsor explained that without top leadership support (meaning physically show up and attend this debriefing meeting), no one else would show up nor take the project seriously.
The sponsor routed the Training Gap Assessment Report to his peers and the CEO with an invitation to attend the first in-person briefing. No one showed up except the sponsor, his direct reports and the consultant. The meeting was rescheduled for a month later when all executives’ schedules showed availability. One month later, the sponsor learned that key executives would be out of office during the meeting, so he postponed the briefing indefinitely.
The sponsor then arranged for a one-on-one follow-up session with the CEO and explained that without top leadership support (meaning physically show up and attend this debriefing meeting), no one else would show up nor take the project seriously. He also reiterated that in order to grow the business as intended, resources needed to be hired and the quality systems including Training needed immediate prioritization. Or else the company would not receive approval to manufacture and could further impact its current relationship with the agency.
Three months later the meeting was scheduled. However, the agenda took on a different focus. Particularly, the collaboration benefits of working cross-functionally with department managers and the shared ownership for the Training Quality System. More specifically, the training project was not just a QA program, but a robust training system that impacts all employees. This time the meeting occurred and was fully attended by all invitees.
Readiness for the Design Team
the briefing finally conducted, the sponsor explained to the consultant, that the
“Design Team of SMEs” had very limited experience working cross-functionally or
as a team. They knew even less about project management concepts like scope and
project charters and they lacked fundamental concepts like quality systems and
systems-based inspections. And they did not
know how to process map. They had been silo’d far too long.
The consultant’s background included curricula building, instructional design, and quality systems redesign experience. She sketched a brief outline of the mini-curriculum for the Design Team of SMEs and the Sponsor agreed. Over the next few weeks, they used their meeting time to work through the 4 introductory lessons. And as a team, they used the “live” aspects of the project work to illustrate the concept and apply its principles to the progress and development of their team. In essence, they were taught just what they needed to know at the moment the project needed it, similar to learning in the flow of work. Four weeks later, the team was ready to begin their process mapping sessions together.
So the event description is clarified and updated. The assigned investigator is up to speed on the details of “the story”. What happens next? What is supposed to happen? In most organizations, there is rush to find the root cause and get on with the investigation. A novice investigator will be anxious to conduct the root cause analysis (RCA). S/he can easily make early root cause mistakes like grabbing the first contributing factor as the root cause without being disciplined to explore all possible causes first.
Thus it makes sense to get the Investigators trained in root cause analysis. Unfortunately for many, this is the ONLY training they receive and it is not nearly enough. RCA is a subset of the investigation process and the training agenda is heavy on the tools, which is perfectly appropriate. But when do they receive training on the rest of the investigation stages like determining CAPA significance and writing the report? Given the amount of FD-483 observations and warning letter citations for inadequate investigations that continue to be captured, I’d say we need more training beyond RCA tools. As a result, we are starting to see FDA “recommendations” for trained and QUALIFIED Investigators. This means not only in how to conduct a root cause analysis, but also the Deviation and CAPA Process.
This goes beyond e-sign the Read and Understand procedures in your LMS
E-Doc systems are a great repository for storing controlled
documents. Searching for SOPs has
become very efficient. In terms of
documenting “I’ve read the procedure”, very proficient and there’s no lost
paperwork anymore! But learning isn’t
complete if we’ve merely read through the steps. We also need to remember it. At best, we remember that we read it and we
know where to find it when we need to look something up. Does that translate to understood? Maybe for some.
To help us remember the actual steps, we need to do something with the knowledge gained. This is where the responsibilities section of the procedure tells us who is to do what and when. But the LMS doesn’t include structured and guided practice as part of the assigned curricula. Unless your equipment and complex procedures are also flagged for Structured OJT and possible Qualification Events as in most Operations groups, practice happens incidentally as part of on the job experience. Feedback is typically provided when there’s a discrepancy or a deviation. This is reactionary learning and not deliberate practice.
If we want Deviation Investigators to understand and remember their tasks (procedures) so they can conduct investigations and write reports that get approved quickly, then we need to design learning experiences that build those skills and ensures accurate execution of assigned roles and responsibilities for Deviations and CAPAs. They need an interactive facilitated learner centered qualification program.
More than just studying a set of procedures and filling out related
It’s about putting the learners; the assigned SMEs as Investigators and QA Reviewers, at the center of the whole learning experience. It’s about empowering them to take charge of their own learning by enabling them to experience real work deviations / CAPA investigations and to deliberately practice new skills in a safe environment with the assistance of adult learning facilitator(s) and coaches. Thereby bridging the “R & U Only Knowledge Gap”.
The look and feel of the program follows a Learn By Doing approach with customized learning content, using interactive techniques and offering more hands-on opportunities for them to engage with real work application that ensures learners are immediately using the knowledge and tools in class and for their homework assignments thus increasing the connections for knowledge transfer.
This requires a shift from the traditional mindset of a classroom course where the emphasis is on the expertise of the instructor and the content. The learners and their learning experience becomes the priority. The instructor’s task isn’t to deliver the content, it’s to help their learners acquire knowledge and skill.
Qualifying SMEs as Deviation Investigators Program
This unique curriculum uses a variety of teaching methods fostering more balanced and meaningful instruction over the duration of the program. It is not a single course or 2-day training event. It is delivered in modules, with weekly “homework” assignments consisting of active deviations and open investigations.
“Spaced learning works, in part, because the brain needs resting time to process information, create pathways to related information, and finally place the new information into long-term memory – the main objective of learning.” (Singleton, Feb 2018, p.71).
Each module revisits the Investigation Stages and builds on the prior lessons by reviewing and debriefing the homework. Then, expanding on that content and including new lessons with increasing intensity of the activities and assignments.
By design, the program provides time and space to interact with the content as opposed to delivering content dumps and overwhelming the newbies; short-term memory gets maxed out and learning shuts down. The collaborative participation and contributions from the Investigators and Program Facilitator(s) result in better overall engagement. Everyone is focused on accomplishing the goal of the program; not just checking the box for root cause analysis tools.
The goal of the program is to prepare subject matter experts to conduct, write and defend investigations for deviations and CAPAs. The program also includes QA reviewers who will review, provide consistent critique and approve deviations, investigations, CAPAs. Attending together establishes relationships with peers and mutual agreement of the content. The learning objectives describe what the learners need from the Deviation and CAPA quality system procedures while the exercises and assignments verify comprehension and appropriate application.
“Learning happens when learners fire their neurons, not when the trainer gives a presentation or shows a set of Power-Point slides.” (Halls, Feb 2019, p.71).
Qualified, really? Isn’t
the training enough?
Achieving “Qualified” status is the ultimate measure of the training program effectiveness. For newly assigned Investigators, it means the company is providing support with a program that builds their skills and confidence and possible optional career paths. Being QUALIFIED means that Investigators have undergone the rigor of an intensely focused investigations curriculum that aligns with the task and site challenges. That after completing additional qualification activities, Investigators have experienced a range of investigations and are now deemed competent to conduct proper investigations.
For the organization, this means two things. Yes, someone gets to check the FDA commitment box. And it also means strategically solving the issues. Better investigations lead to CAPAs that don’t fail their effectiveness checks. Now that’s significant performance improvement worthy of qualifying Investigators! -VB
Campos,J. The Learner Centered Classroom. TD@Work, August, 2014, Issue 1408.
Chopra,P. “give them what they WANT”, TD, May, 2016, p.36 – 40.
Halls,J. “Move Beyond Words to Experience”, TD, February, 2019, p. 69 – 72 DL.
Parker, A. “Built to Last: Interview with Mary Slaughter”, TD, May, 2016, p. 57.
Singleton, K. “Incorporating a Spiral Curriculum Into L&D”, TD, February, 2018, 70 – 71.