Is Your Quality Training SOP Sufficient?

Is your response, “Yes!” or is it “Yea, I think so. How can I be sure?”

  • Are you trying to explain what you do for training or describe how your site handles the Quality Training System?
  • Who is your audience?
  • Who are the procedures being written for?

There shall be written procedures even for training!

Step back and take a big view of training from start to finish. There are three distinct segments: (1) preparation, (2) delivery, and (3) measuring effectiveness. To some leaders, the idea of creating more than one training procedure for these three segments is baffling.  Training isn’t that hard. Why are you making this so complicated, they ask?  The simpler the process is, the easier it is to follow and administer, is what they are really thinking.

Yet, training root cause analyses involving operator or human error often yields some contributing factors around how the individual was trained.  On the Job Training is not that simple after all and requires more than a check on someone’s to-do list.  Find out why in the e-Book, Training Root Cause Analysis. In spite of this, the level of detail in Training SOPs is always a concern for both SOP Author and Approver.    

But SMEs like KISS for Training

From an end-user perspective, I need enough detail so I can accomplish what I need to do without over-complicating my task, stay within compliance, and be effective as a qualified trainer. Since most Qualified Trainers are not full-time training professionals, the training procedures become their how-to tools not just a bunch of QA or HR rules about training. Without defining what your program includes and how to execute it, Qualified Trainers and other SMEs will conduct their training delivery assignments in a manner that is as simple as possible and may not be 100% compliant. Administrative procedures are not for them, they argue.

It takes 6 elements to make a training system robust

The big view of training may have 3 Big Blocks (preparation, delivery, and measuring effectiveness), but it takes 6 elements to execute it well.   They are:

  • GxP and Training Curricula
  • Planned OJT for Procedures
  • Use of Qualified Trainers
  • Employee Qualification and Training Effectiveness Measures
  • On-Going GxP Refresher Series
  • Training Documentation Process
6 Elements of a Robust Training System

For each of these elements, there needs to be a set of “how-to-execute” instructions. However, it is not enough to describe what these elements are. That leaves a lot of room for interpretation and inconsistent documentation or no documentation at all. For example:

  • Are you documenting on-the-job training; every time or just select sessions?
  • Does your organization complain about over-allocated curricula?
  • Do they understand the documentation requirements for your LMS?
  • Does your training document explain how to conduct OJT? You’d be surprised just how many different techniques SMEs have for conducting OJT on their watch.
  • Can anyone who has a signed training record be a department trainer? If yes, you need to upgrade your criteria and create a process around nominating and qualifying SMEs for OJT. Training is on the top 10 list for inspections.

So how is this not complicating Training?

The debate for the 1 All-Encompassing SOP (standard operating procedure) vs. multiple tailored work instructions will always bring comments after the latest version goes into effect. This includes non-QT end-user feedback criticizing how complicated and confusing the procedures are!  When pressed further for specifics, most admit that they just want to train themselves and not deal with the documentation requirements. So, addressing one set of concerns can actually create more complaints around the very changes. See the table below for pros and cons.

Screen Shot 2016-06-01 at 10.23.53 AM
Pros and Cons for One AP Training SOP vs. Smaller, Multiple Work Instructions

Remind me again who these procedures are for?

The answer to the number of SOPs argument lies in determining what is appropriate for your end-users. While addressing the ease of navigation and use concerns is laudable, it is not always realistic to satisfy all users. It comes down to a combination of appropriateness and acceptance with a little cultural history mix in. When you find yourself in the middle of this debate, ask yourself the following two questions:

  • Does the “Training SOP” contain many pages detailing steps for each of the 6 elements? This is an indicator that you need to break it up.
  • Do you have too many standalone task-focused SOPs that could be grouped into a few larger processes? Recall the 3 Big Blocks of Training (preparation, delivery, and measuring effectiveness).  Will this satisfy the end-users concerns?

Back to the opening question

You need to explain what your Training “Program” contains in a high level policy that answers “the what”.  But you also need to describe how your training is conducted.  Three “how-to execute” procedures are usually sufficient: preparation process, delivery and documentation process and measuring training effectiveness process. V-

Who is Vivian Bringslimark?

Think your Training SOP could use a makeover? How about a document review?

Interested to see how the 3 Big Blocks of Training and the 6 Elements of a Robust Training System all interface with each other? Send your email request above.

(c) HPIS Consulting, Inc.

May I See Your Implementation Plan for this Change Control?

In Part 1, we find Cara, a performance consultant has been hired to help a former client with implementing a robust training system. After waiting 3 months for the executive leadership group to get aligned around the priority for Miguel’s RTS project, Cara finally got to debrief her assessment findings. But a new development surfaced that was unexpected.

In part 2, we observe how Cara brings her inexperienced design team up to speed on how to be a team.

In part 3, we learned how Cara facilitated the design team of SMEs through various stages of working as a team to manage internal politics and a team member’s personal agenda.

In this Final Part of the Change Readiness Gap Impact Story, the design team launches and gets a surprise visit from the agency.

“But future state is being designed on the assumption that change control will be redesigned first.  We still have a lot of preparation work to do before we are even close to submitting these for change control.  And that is why change control is out of scope for this team.  We will not delay our deliverables because we decided mid-stream to go fix change control first.   There are plans for a change control project team to begin and some of you may be tapped to participate.”

After the change control rant from their distressed team mate, whenever anyone even mentioned the word change control, they joked and said: “we’re not allowed to discuss change control anymore, remember?”

Robust Training System SOPs: IMPLEMENTATION: The GO-LIVE STRATEGY

Through the efforts of Miguel negotiating behind the scenes, a new quality manager, Stuart, was hired right as the team began to work on the implementation strategy.  The timing was ideal because the team was ready to present their recommendations on how to go live and this was Stuart’s first priority.

Meet your new project leader

While Stuart got caught up to speed and completed his onboarding tasks, Cara transitioned out of the project manager role and back into external consultant mode.  The team had successfully designed their process flows and together decided the number of procedures that made sense for the organization as well as where to park the content.  They collaborated on the design of forms while leaving room for flexibility given the nature of work for each department.  The team had two proposals that competed with each other and Stuart, now fully up to speed weighed in with his decision.

Critical vs Important Focus

Critical vs. important: OJT documentation or curricula accuracy

The first proposal mapped a path forward based on OJT as the priority.  This was clearly identified in the gap assessment report and what appealed the most to the executives given their business objectives.  The second proposal was logical and made more sense to start from an overhaul of the curricula; ensuring that the training and qualifications were the right requirements for the right roles.  At the next meeting, Stuart took the lead and announced that he chose the curricula proposal and would defend this choice to Miguel and the executives as his first major task assignment.

Stuart was successful in his curricula proposal pitch with the executives.  He was able to make a compelling argument for both efficiency and effectiveness.  His next task was to finalize the implementation plan.  So he asked the team to meet once again to refine the “Go-Live Strategy”. 

“Please Pardon Our Appearance”

In order to move forward with the necessary tasks, the team needed the authorization to complete the work using the newly designed forms and process without approved Standard Operating Procedures (SOPs).   Releasing the new design before the sub-tasks were complete, would create an “out of compliance” situation at the onset of launch.  And yet, going forward without an approved procedure also put them in SOP violation status.

GMP Redesign SOP Dilemma

As part of the team’s drafted implementation plan, Stuart generated a change control package that documented the project, articulated the necessary steps, included the process flow diagrams as well as the forms.  Included in this packet, was the timeline for execution.  The effect of this documentation was to communicate that all these changes were not out of control but rather a controlled and planned change in the current procedures in order to make them standard once the subtasks were in place such as the updated position curricula.

Delivering the Qualified Trainers Workshop was a critical implementation task that needed to be timed with the SOP roll out.  The day before the Qualified Trainer’s workshop was to be delivered by Cara, Stuart called Cara and announced that a regulatory inspection was to begin on the same day.  While disappointed with the delay, Cara was optimistic that the training portion of the inspection would be favorable.   One month later, Stuart phoned her back.

“Can you deliver the workshop next week?” Stuart inquired.

“Yes, I’ll clear my calendar.  But how did training do?”

All in all, it went well.  We have some issues of course,” Stuart added.

“What about the training implementation plan? Was it accepted or challenged?” Cara asked.

“Well, we didn’t get cited for being ‘out of compliance’ so that was good.  But it was clearly stated that the plan MUST be executed ASAP! Hence, the reason for my call, today,” he answered.

Cara was pleased to hear that the Robust Training System (RTS) training project finally became a “Top Site Priority”.

END RESULT: Future State is now Current State

A few months later, Cara also delivered a GMP Basics course and qualified the site trainer to deliver it routinely as per the new training procedures. The RTS project was now officially closed and life as new normal began.   Their next follow up inspection was favorable.  A few minor issues and some verbal comments for training.  With this earned “regulatory approval”, the company was able to move forward with plans for launching their new product.

LESSONS LEARNED: Breaking down silos one meeting at a time

While the project team of SMEs learned how to collaborate in order to achieve project charter deliverables, the business units were very much still entrenched in their functional silos, defending current practices.  Deviating from approved procedures, even with a regulatory recommendation to prioritize the execution of the training plan, was not well received.  Stuart and his staff faced resistance from front-line supervision with right-sizing their curricula.  Through determination and persistent “working meetings”, the curricula sub-project finished.

Given the curricula “battle”, Stuart initially backed off from communicating the big project picture in the hopes that early accomplishments would inspire the front line to continue with the tasks and not overwhelm them with too much change at once.  

Instead, the OJT checklist sub-project was also slow, tedious, and a struggle.  Incumbent subject matter experts (SMEs)were reluctant to share their expertise or participate in the generation of the OJT Checklists, let alone be required to use them and not change the content without following the change control process.  Ironically, as new SMEs were vetted, the quality of the content improved and the checklists became a non-issue.

KEY TAKEAWAYS:

  1. The decision to delay project launch until Miguel felt confident that the executive leaders would sponsor the project and approve resources for the design team was paramount for keeping the momentum going forward after the initial launch meeting.
  2. Miguel recognized early on that the identified design team SMEs needed a specially developed curriculum to prepare them for the challenges that lay ahead.  The first four meetings as introductory lessons provided context as well as content and established the project lexicon while reinforcing team ground rules.
  3. Being prepared to defend the change control packet and explain the “Go-Live” Implementation Plan with FDA investigators not only gave credence to the project but it also elevated the importance of plan execution and made completion an urgent priority. -VB

Who is Vivian Bringslimark?

HPISC has articles, impact stories, and white papers.

Visit the Robust Training System Resource Library

(c) HPIS Consulting, Inc.

From Traditional OJT to SOJT: What else makes OJT structured?

The Evolution

First there was “Just go follow Joe around” training …

And then came “and it shall be documented” …

Next the follow up question:  “Are they trained in everything they need to know?”

So, line managers used the SOP Binder Index and “Read and Understand SOP” became a training method…

But alas, they complained that it was much too much training and errors were still occurring …

So, training requirements were created, and curricula were born.

Soon afterwards, LMS vendors showed up in our lobbies and promised us with a click and a report, we could have a training system!

But upper management called forth for METRICS! So, dashboards became a visible tool. Leader boards helped create friendly competition among colleagues while “walls of shame” made folks hang their heads and ask for leniency, exemptions and extensions  … 

Why Traditional OJT Takes So Long

Experienced SMEs are not always the best OJT Trainers
Experienced SMEs are not always the best Qualified Trainers

While the introduction to this blog poked fun at how we’ve evolved over the last 30 + years, allow me to step back in time for a brief refresher about On the Job Training.  Traditional OJT (TOJT) is not planned so for the new hire it comes across as informal almost incidental.  Monikers like “follow Joe or Jane around” or “Sink or Swim” accurately described how TOJT occurred.  My personal favorite is “trial by fire”.  It can certainly feel like that when the “trainer” albeit a SME, is not qualified to train resulting in inaccurate steps and possible bad habits like unsafe short cuts.  It causes anxiety for the new hire especially when the daily schedule dictates what will be “taught” by the technician assigned to that task. Sometimes, over-anxious new hires quit before on boarding is finished because of their chaotic OJT sessions and lack of confidence in their trainers. 

Structured OJT Defined (SOJT)

SOJT is the process in which a qualified employee (trainer) passes job knowledge and skills to another employee in an organized, personalized and thoughtfully planned manner.  It involves both learning and doing at the same time. 

For first time managers, SOJT appears to take a lot of work and time.  They would rather focus on the production schedule convincing themselves that new hires are being trained while shadowing their training buddy.  Managers are evaluated on how productive they are, not on how many new hires are being trained effectively.  They also tell themselves, that it takes 6 – 12 months to get fully up to speed, so why spend even more time planning and scheduling a new hire’s learning journey.  In spite of that impression, the Quality of OJT directly impacts:

  • time it takes to “bring someone up to speed”
  • how Employees perceive the training they receive
  • how satisfied Employees feel about their jobs and working conditions
  • how quickly Employees can be re-trained on new SOP revisions.

But Managers Find the Time to Train Twice!

Difference between TOJT and SOJT
Difference between TOJT and SOJT

Yet that is exactly what happens when the root cause of a deviation or a mistake is deemed as Human/Operator Error. The corrective action is often “repeat training”.  This training involves unlearning the first sessions and then relearning the proper way, causing more strain on the new hire’s space for learning capacity (cognitive overload).  This is why TOJT takes so long. If, SOJT had been executed instead, the error more than likely would not have happened.  It’s an argument that I have been defending for over 30 years with Senior Leaders.  Why punish the New Hire for management’s decision to make production more important than effective training?

DOES HAVING CURRICULA MAKE OJT STRUCTURED?

Just having curricula doesn’t necessarily make OJT structured.  SOJT includes a deliberate review of regulatory, departmental and positional /functional requirements.  It also includes a TRAINING SCHEDULE for the curricula requirements and an individualized learning plan for new hires; not just a matrix with their name highlighted in yellow marker. 

Isn’t The Training Matrix Enough?

Just ask an OJT Qualified Trainer that question and watch the reaction you get. Maybe a shrug and a half smile if you’re lucky. The matrix is only a listing of the requirements usually generated from the LMS or an excel spreadsheet for those who haven’t migrated to an LMS yet. In more sophisticated systems, it will include due dates. But most printouts don’t include the Qualified Trainers assigned to deliver the training or any additional information about the learner.

why isn't the training matrix enough?
QTs need more than a matrix to manage Learners training curricula

From this list, QTs are expected to manage the completion of the requirements, deliver effective training sessions, provide feedback in a safe and nurturing learning environment and qualify learners with qualification events / performance assessments.  All that from a training matrix? Wow.   

During the HPISC Qualified Trainers workshop, I present the difference between TOJT (traditional) and SOJT (structured).  When I ask the QT’s where they feel their organization is, most of them will say still in the TOJT box but closer to the middle of the range.  Why I ask?  Invariably, they’ll tell me OJT is not scheduled.  “Just because I have the list of curricula requirements doesn’t mean the training gets scheduled or that qualification events get conducted”.  But rather, it happens when someone makes it a priority, an inspection is coming or a CAPA includes it as part of corrective actions.

There Is Still A Huge Misunderstanding Regarding R&U For Sops

For years, we have been documenting that we’ve read and understood our required SOPs. I can still recall my Employee Blue Card that listed every Monthly GMP and SOP meeting/discussion I attended. When I was asked about logging every SOP that I read during an interview, I responded that it was not a practice where I worked at the time. After I accepted the new position, I realized why that was such a watershed moment for me. 

Oh, But Now We Have Curricula!

As an industry, we became obsessed about signing for our SOPs.  Then LMSes were developed to help us not only record our R & U SOP dates but to give us a mechanism for tracking what SOPs were assigned to us, reporting 100% Trained metrics and overdue requirements.  And for a short while those records were sufficient. 

But over the years, FDA Investigators began seeing a disconnect between the R & U training records and the actual performance of employees who signed that they understood the SOP.  Upon the FDA site tour, they observed departures from the written procedures.  They uncovered deviations involving Operator /Human Error, repeat deviations and even CAPAs for training fixes.  So, is it falsification of records?  Is it poorly written SOPs? Is the training ineffective? 

FDA stepped up their expectations and began asking deeper questions.  How do you know if your training is effective?  This question applies to both GxP Training sessions as well as SOPs. 

  • Who is qualified to train employees and how do they get qualified?
  • Are your employees qualified to perform their job functions and how do you know? 
  • What does that documentation look like?

SOPs Are Now Online, But It’s Still Read and Understood for SOP!

Well, I’m told we are now more compliant with ensuring that only the most current version of the SOP is used for training. LMSes and eDoc platforms have given us efficient mechanisms to document that employees have completed their training curricula. But do they understand their procedures enough to perform them correctly back on the job?

It’s still Read and Understand SOPs! Whether we access our SOPs through an eDoc system or the LMS portal, we are still only reading them. To call this eLearning is a bit of a stretch especially when compared to the design of today’s eLearning courses. Nonetheless, some new hires are still being provided with a long list of required SOPs and trained on where to find them in the LMS. “Oh, we’ve made it easier for them to manage their SOP list. They’re online now!”

I’m excited that as an industry, we are evolving with our training practices to keep up with regulators’ expectations regarding GMP and SOP Training.  But have we changed the training culture yet?  Are we just replacing attendance forms for e-signatures or are we delivering effective training?  Can we confidently say, “Yes, our employees are qualified prior to release to task”?

FD-483 Observation: “Your site has numerous instances of R & U for SOPs”

So, when there is a large number of documented R & U events for SOPs, very little OJT documentation and they are still finding repeat errors, HE/OE deviations and a host of CAPAs, FDA Investigators are going to examine what is your training process and how effective is it.

SO, WHAT ELSE MAKES OJT STRUCTURED?

SOJT is formal and it’s documented. Without the use of approved training materials, department SMEs often use different methods each time they deliver training and the training content can vary from “trainer to trainer”.  This causes confusion for the new hire during his/her onboarding phase which can then lead to Operator Error or non- compliant performance later.   

During an on-site response to an urgent performance problem, the Head of Operations expressed deep concerns about inconsistent OJT being delivered by his trainers.  During an FDA inspection, he was shown numerous examples from the Investigator, that his SMEs were teaching techniques for a critical process procedure that

  • were not written down nor were they approved (aka their secret sauce) and
  • were not at all consistent with each other. 

Naturally, this led to a FD-483 observation, a high visibility corrective action project with global impact.  As part of the CAPA (Corrective Action Preventive Action) investigation, trainers were interviewed. Their responses revealed the use of varied content; despite having an OJT checklist, the actual procedure, and knowledge of the site training SOPs. 

QT’s need to use “Quality Control Unit” approved written procedures (aka SOPs) as the main document to train with and the proper documentation to record an OJT session.  But documenting OJT sessions has been a bit of a challenge for Trainers, LMS Administrators, and QA Doc Control Staff. 

What Is Considered An OJT Session?

The hardest question to resolve isAre we required to capture every OJT session or just one?”  My favorite lament is – “Do you know what that will do to our database not to mention the amount of paperwork that would create!” A workaround to all these questions and concerns is to capture at least one session along the progression of each OJT step as per your OJT Steps Model, thus documenting adherence to the procedure. If we keep it simple and document that our learners have experienced each step, then we are complying with our OJT process and minimally documenting their OJT progression.

Even more challenging is adding the required SOJT steps to curricula.  Unfortunately, it generates almost double the requirements. So for companies who focus solely on the number of requirements, this is daunting.  What helps is differentiating between R & U step and completion of the actual OJT events.  Some organizations go one step further and also add the Qualification Event as a final requirement.

SOJT IS ALSO DELIVERED BY A DEPARTMENT SME QUALIFIED TO DELIVER OJT.  The old adage for selecting department trainers based documented R & U SOP paperwork no longer meets regulatory expectations.  The expectation today is to have a QA approved process for qualifying SMEs. I’m not talking about a mere mention in your training policy.  But a standalone process that depicts steps from start to finish.  Yes, it is necessary if you want to answer “Yes, I have a procedure for Qualifying SMEs as Department Trainers”.  Being able to present a SOP that addresses how your SMEs are qualified to sign the training records is priceless in the middle of an ongoing regulatory inspection.

What Belongs In The Qualified Trainer SOP?

Ideally, the procedure needs to include these 4 parts:

I. Eligibility

II. QT Workshop/TTT Equivalent 

III. Evaluation

IV. Performance Demonstration

I. Eligibility

In some organizations there is no difference between SMEs and Trainers.  And this is precisely why FDA has asked for clarification.  Can anyone be a Qualified Trainer (QT)?  Establishing criteria is the best way to reduce favoritism and the tendency to pick the most senior person.  SMEs need to become QTs through a formal process.   The selection criteria should be part of the qualifying documentation along with any supporting statements for eligibility selection (for example, nominated by supervisor or responded to the call for volunteers).

In this definition, everyone who is a QT is an SME in some specified area.  All nominees need to be content qualified on the subject matter they will be teaching.  This means being able to produce proper documentation confirming nominee’s eligibility. This is not always the case.  I have seen this assumption backfire horribly and cause major ripple effects on project milestones.  Find out now before an inspection, please.

II. QT Workshop/ TTT Equivalent

Sometimes known as Train-the-Trainer.  The course needs to include learning theory, training and coaching adult learning peers and agreeing to use the proper documentation.  Another key component of the OJT TTT workshop is exploring the challenges of “Life as a Qualifed Trainer”. Learning how to facilitate a live classroom event that can come later.  In fact, many QT’s are stepping up and want to expand their trainer’s toolkit for “Basic Facilitation Skills / Running a Live Classroom Event”.

III. QT Workshop Evaluation:

Simply attending this course isn’t enough.  But whether a written test is the best measure to use is open for debate.  Let’s start with the question: Why do we need an evaluation in the first place?  If you’re tempted to say because FDA wants it, I suggest re-reading CFR x211.25 again.  If you are anticipating the training effectiveness question, then you are in sync with industry practice.  But it is less about “the test” and more about how you determine the effectiveness of the training event.  Benchmarking from other certification courses, a written test usually follows the course.  So, having a written evaluation is not unreasonable.  The debate is about what format you use.

The Written Test

Most folks are familiar with taking a written test.  When informed upfront, QT’s expect the test to come at the end of the workshop.  But what is the outcome of test?  What does it really measure?  Is it a measure of their retention or comprehension?  Since SOPs are not supposed to be memorized, how can we dictate memorization of the course content? Open book is allowed in some organizations.  What then does the paper-n-pencil test accomplish?  Having the knowledge doesn’t mean that they will use the concepts “in the moment of choice”.

Consider the Action Planner

If learning transfer is what we really want and expect to achieve, then wouldn’t some kind of post workshop action planner be a more appropriate measure of effectiveness?  “Oh, but we can’t control what happens after the workshop”, you say?  “Using an action planner requires buy-in from their managers.  And commitment to follow through to host the 1-1 follow up meetings with their QTs” is what you might be thinking right now.

Let us not lose focus on the ultimate goal of the workshop.  It’s a 3-way partnership between QTs, L&D/QA Training, and Managers.  The real work happens AFTER the workshop is over.  What better way to use classroom time to discuss strategies for barriers and challenges and document their commitment for applying the concepts and procedures than a post workshop action planner?  Can the written test do all this?

IV. Performance Demonstrations

This is after all a qualification of SMEs as Trainers program and therefore, a performance demonstration is required.  What type depends on where your site is with respect to employee qualifications.  The two types are demonstrating a live OJT session in the classroom and conducting an employee qualification at the workstation. 

RECAP: WHAT IT TAKES TO MAKE OJT STRUCTURED

  1. Rigorous Curricula that includes SOJT and Qualification Events not just SOPs
  2. Methodology for OJT Steps that includes documentation
  3. Qualified Trainers who deliver SOJT curricula requirements
  4. Individualized Learning Plans and schedules for New Hire’s Learning Journey

Is that all?  No!

How Committed Is Your Organization To SOJT?

Ronald Jacobs and Michael Jones, in their 1995 groundbreaking book, Structuring On-the-Job Training, inform us that SOJT as a system functions within a larger context, namely the organization.  SOJT is not a standalone program.  Conflicts, competing priorities and mixed messages can influence the success of your SOJT program.

Do these sound familiar?

  • Business priorities and organizational change initiatives
  • Upper managements real perception of the value of OJT
  • Union shop and potential violation to use SMEs as Qualified Trainers
  • Alignment of goals for training and goals for other quality systems
  • Willingness of line leaders and staff functions to manage and maintain SOJT after launch

The Training Quality System, in my opinion, is THE most cross functional system.  It has to harmonize with other quality systems AND organizational systems in order to deliver performance improvement. 

Moving from TOJT to SOJT what it takes
Management Support is needed to make SOJT work

So, management support has to be more than lip service.  The real support is in the alignment of goals, clarifying expectations, allocating resources and budgeting time to deliver OJT using an approved OJT methodology.  This is a culture shift for many organizations but well worth the effort if management really believes in SOJT.    The “proof is in the pudding”.  Are your leaders “walking their talk”? – VB

Who is Vivian Bringslimark?

(c) HPIS Consulting, Inc.

Isn’t this still training?

To the newly minted and seasoned performance consultant, the answer is NO.  But for your client, internal customer or the VP of Quality, or whomever is your requestor, it still may look like “a training solution”, so don’t argue with them.  You do however, want to be able to explain why it is more than a classroom instructor led session or a quick and dirty PPT slide with audio recording.

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

Then it must be training, right? Not exactly, but nod your head anyway; at least they are still engaged with you!  Any one of the elements of a Robust Training System is “training-related”.  So for the less informed, this connection makes sense to them.  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, we work on raising their awareness of our early projects and successes.  Understanding and hopefully appreciation will come later.

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

Most folks will envision instruction either classroom based, virtual instructor led or even formal eLearning course.  Their reasoning is that 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?

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 an impact on the bottom line when the performance gap closes.  Is this training, you tell me?  How would you explain it to your sponsor?

Not all HPI Solutions are Classroom Based

HPI Solutions

Talk about using knowledge 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.  I applaud them.  In fact, conducting Key Performer Analyses is part of the HPI methodology and is an excellent way to gather real data from experts.  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.  Yet, it had everything to do with capturing secret sauce learned on the job.

Is this still training?  You tell me after you read the impact story.  -VB

NOTE: A more detailed version of this case –“Capturing Secret Sauce of Senior Equipment Operators?” is available. 

Next blog: “If it’s not training, then what is the right fix?”

Who is Vivian Bringslimark?

(c) HPIS Consulting, Inc.

Instructional Design: Not Just for Full Time Trainers Anymore

When I left the manufacturing shop floor and moved into training, full time trainers presented in the classroom using a host of techniques, tools, and relied on their platform skills to present content. Subject matter experts (or the most senior person) conducted technical training on the shop floor in front of a piece of equipment, at a laboratory station or a work bench.

For years, this distinction was clearly practiced where I worked. Trainers were in the classroom and SMEs delivered OJT. Occasionally a “full time” trainer would consult with a SME on content or request his/her presence in the room during delivery as a back-up or for the Q & A portion of a “presentation”. It seemed that the boundaries at the time, were so well understood, that one could determine the type of training simply by where it was delivered.

Training boundaries are limitless today

Today, that’s all changed. No longer confined to location or delivery methods, full time trainers can be found on the shop floor fully gowned delivering GMP (Good Manufacturing Practices) content for example. And SMEs are now in the classroom more each day with some of the very tools used by full time trainers! What defines a full time trainer from a SME is less important, what is imperative however is what defines effective instruction.

Instructional Design is a recognized profession

What goes into good instructional design?

Believe it or not, instruction design (ID) / instructional technology is a degreed program offered at numerous colleges and universities. Underlying the design, is a methodology for “good” course design and really good instructional designers will confess that there is a bit of an art form to it as well. Unfortunately, with shrinking budgets and downsized L&D staffs, there are less resources available to develop training materials. Not to mention, shrinking time lines for the deliverables. So it makes sense to tap SMEs for more training opportunities since many are already involved in training at their site. But, pasting their expert content into a power point slide deck is not instructional design. Nor is asking a SME to “deliver training” using a previously created power point presentation effective delivery.

What is effective design?

To me, effective design is when learners not only meet the learning objectives during training but also transfer that learning experience back on the job and achieve performance objectives / outcomes. That’s a tall order for a SME, even for full time trainers who have not had course design training. The methodology a course designer follows be that ADDIE, Agile, SAM (Successive Approximation Model), Gagne’s 9 Principles, etc., provides a process with steps to facilitate the design rationale and then development of content including implementation and evaluation of effectiveness. It ensures that key elements are not unintentionally left out or forgotten about until after the fact like evaluation/ effectiveness or needs assessment. In an attempt to expedite training, these methodology driven elements are easily skipped without fully understanding the impact the consequences can have on overall training effectiveness. There is a science to instructional design.

The “art form” occurs when a designer creates visually appealing slides and eLearning scenes as well as aligned activities and engaging exercises designed to provide exploration, practice and proficiency for the performance task back on the job. The course materials “package” is complete when a leader’s guide is also created that spells out the design rationale and vision for delivery, especially when someone else will be delivering the course such as SMEs as Classroom Facilitators.

The Leaders Guide

Speaker notes embedded at the bottom of the notes pages within power point slides is not a leader’s guide. While handy for scripting what to say for the above slide, it does not provide ample space for facilitating other aspects of the course such as visual cues, tips for “trainer only” and managing handouts, etc. A well-designed leader’s guide has the key objectives identified and the essential learning points to cover. These learning points are appropriately sequenced with developed discussion questions to be used with activities; thus removing the need for the facilitator to think on demand while facilitating the activity. This also reduces the temptation to skip over the exercise/activity if s/he is nervous or not confident with interactive activities.

A really good guide will also include how to segue to the next slide and manage seamless transitions to next topic sections. Most helpful, are additional notes about what content MUST be covered, tips about expected responses for activities and clock time duration comments for keeping to the classroom schedule. Given all the time and effort to produce the leaders guide, it is wasted if the course designer and SME as Facilitator do not have a knowledge transfer session. Emailing the guide or downloading it from a share point site will not help the SME in following the guide during delivery unless an exchange occurs in which SMEs can begin to mark up his/her copy.

Using previously developed materials

I am not criticizing previous course materials if they were effective. But replacing clip art with new images and updating the slide deck to incorporate the new company background is not going to change the effectiveness of the course unless content was revised and activities were improved. For many SMEs, having a previous slide deck is both a gift and a curse.

While they are not starting with a blank storyboard, there is a tendency to use as-is and try to embellish it with speaker notes because the original producer of the power point slide did not include them or worse, provided no leader’s guide. The SME has the burden to make content decisions such as what content is critical; what content can be cut if no time. Perhaps even more crucial is how to adapt content and activities to different learner groups or off-shift needs. SMEs who attend a HPISC. ID basics course learn how to use design checklists for previously developed materials.   These checklists allow them to confidently assess the quality of the materials and justify what needs to be removed, revised or added; thus truly upgrading previously developed materials.

What’s so special about SMEs as Course Designers?

They have expertise and experience and are expected to share it via training their peers. But now the venue is the classroom as well. It’s training on course design methodology that is needed. SMEs and most trainers do not automatically have this knowledge. Some develop it by reading A LOT, attending well-designed courses, and over time with trial and error and painful feedback. The faster way is to provide funds to get SMEs as Course Designers at least exposed to how to effectively design for learning experiences so that they can influence the outcome of the objectives. This is management support for SMEs as Trainers. -VB

Moving from Lecture to Delivering an EFFECTIVE Lecture

While lecture has its merits, today’s learners want engaging content that is timely, relevant and meaningful. Yet, most SMEs tend to suffer from the “curse of too much knowledge” and find it difficult to separate the need-to- know from the nice-to-know content.

Presenting for them takes on a lecture style format. The thought of facilitating an activity gives most SME a case of jitters and anxiety.  So, in the HPISC. “SME as Facilitator” workshop, attendees are encouraged to step away from the podium and use their eyes, hands and voice to engage with their audience. Easier said than done, yes. That’s why the course is designed to allow them to take small steps within the safety of a workshop environment.

But rather than trying to pull off a fully immersive session, SMEs as Facilitators are introduced to techniques that “liven up” the lecture. They are shown how to move back and forth from passive (sit, hear, see) to active involvement (write, construct, discuss, move, speak). This requires the ability to:

  • follow a well organized design plan
  • capture and hold attention of learners
  • use relevant examples and deviations if possible
  • show authentic enthusiasm
  • involve audience both directly and indirectly
  • respond to questions with patience and respect.

Great presentations are like great movies. They open with an attention-seeking scene, have drama and conflict in the middle so you stick around long enough to see the hero survive and they close on a memorable note. Using the movie analogy, a SME as Facilitator can open the session with something more than his/her bio. They can pick a notable career achievement that most folks aren’t aware of.  Keeping the interest alive, the SME can then draw the connection of content to the audience and address the WIIFM question on everyone’s mind. (WIIFM = What’s in it for me?)

While we don’t need to add to anyone’s stress load, overcoming conflict makes for great story telling. Case studies, major CAPAs, deviations and audit observations make it real life. Use of visuals especially diagrams is visually appealing to learners and keeps them engaged. (CAPA= Corrective Actions Preventive Action Investigations)

Thoroughness in the preparation reflects care and thoughtfulness. Learners appreciate the personal desire to deliver a more lively lecture. Therefore, I like to use the concept of a lecturette; 10 minute blocks of time to chunk up complex topics. Interspersing a 10—15 minute lecture segment with an activity whether self, small group or stand up at the flipchart, gives learners the opportunity to engage with new and/or more complex content in smaller doses.

Stepping away from the podium forces the SME to take action and allow the learners to “get up close” with the SME as Facilitator. This in turn is reflected in the learners desire to respond to questions and dialogue during a facilitated discussion. The rule of thumb for lecturing is approximately 20 minutes max. But with today’s technology buzzing away at your fingertips or on the tabletop, I’d say more like 10 or 15 minutes max if you are an engaging facilitator.

difference between a novice and wise teacher

Remember, the goal of a session is to maximize retention of the audience, not just tell them the content. Attendees learn more if the SME as Facilitator can focus their attention on the topic and deliver content that is relevant to their work situation. Involving the learners in a variety of ways is the key to effective lectures and great presentations. – VB

You might also want to get up to speed with current trend for SMEs – check out the blog post – Are your SMEs becoming duo purposed? Comments welcomed.

Moving from Presenter Controlled Training to Learner Focused Facilitation

The more trainer/instructor driven the course is, the less participation is required from the learner. For example, the instructor makes all the decisions about the course objectives and content, develops the course, delivers the course and conducts the assessment.

As you move along the Learner Participation Continuum, the
learner is required to participate more and the trainer does less “talking”. The learner acquires knowledge and skills through activities that s/he experiences with the assistance of a “facilitator”.  The facilitator is focused on helping the learners meet their needs and interests. It is through these first hand experiences and facilitated dialogue with other learners that thoughtful analysis and interpretation can become the focus of the instruction. The end result is that learners take full responsibility for decisions, actions and consequences.

Moving to a more Learner Controlled approach shifts the focus of the design from “deliver this content” to facilitate learning transfer for performance back on the job; which is after all the end goal for a training event. The new program includes opportunities for group participation, utilization of participants’ expertise and real life problem solving.

Learners are prompted to openly discuss issues and problems within the “learning lab”. Trainers become empathetic listeners as they create a climate of trust and safety. They become a Facilitator.

Of course, this shift also requires that site leadership and local management not only support the facilitated learning lab concept, but follow through on issues and concerns that surface. Failure to do so undermines not only the facilitator’s credibility but the entire training program. Wow, won’t this take longer to design, you ask?  Yes, in the sense that the design is now from the learner’s point of view. This means that the designer will need to research examples, collect data, and develop a story from an incident, a deviation or significant CAPA, etc.

The reward is that the Classroom SME stops talking and gives employees more engaging learning sessions. So learners become more accountable for participating and guess what – the SME’s session is no longer a boring podium speech. — VB

Silberman, M. (1990). Active Training: A Handbook of Techniques, Designs, Case Examples, and Tips.  Lexington Books, New York.

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 the SMEs struggle with the loss of productivity for the 2 – 3 day duration and quickly develop a “one and done” mindset.   Given the opening to “train” newly identified SMEs as Trainers, the instructional designer 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 content.

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 Trainers better trainers.  Yes, I was in love with own my content.  And then one day, that all 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 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 Workshop, 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: 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.  See 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 objectives.

How to align purpose of a course to business goals

Once there is agreement with the stated performance objectives, align the content to match these. Yes, there is still ample room in the course for learning theory, but it is tailored for the need to know only topics.

In essence, the learning objectives become evident.  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 goal for the overall program.

 

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 for compliance expectations around effectiveness and evaluation.  To meet this client need, I put on my former teacher hat and created a 10 question open book written assessment.  This proved to need 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 checklist.  Now the OJT QT Workshop is value added and management keeps asking for another round of the workshop to be scheduled.  -VB

Are you ready to update your OJT TTT Course?

 

 

 

I’ve fired my [TTT] Vendor!  

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