When SMEs have too much “secret sauce”

Many QA/ L&D Training Managers are tasked with improving their “training program”. An integral component of a robust quality training system is the Qualified Trainers (QT). Having a cadre of existing department Subject Matter Experts (SMEs) as Trainers can be very helpful when implementing the rollout of the new quality redesign to meet regulatory commitments and expected timelines. But, sometimes it can also lead to sustainability issues after the launch is over and the next big project becomes the new site priority.

During my on-site response to an urgent performance problem, the Head of Operations expressed deep concerns about inconsistent OJT being delivered by his trainers. A series of significant non-conformances occurred in his area. As part of the CAPA (Corrective Action Preventive Action) investigation, trainers were interviewed to uncover how they trained the identified employee(s) and what was said specifically for each step of the procedure. Their responses revealed a lack of consistent process and the use of varied content; despite having an OJT checklist, the procedure, and approved Training SOPs.

Once a Trainer; Forever a Trainer

I was then invited into a conversation with the Training Operations Manager (My Performer), regarding her desire to upgrade the existing department SMEs as Trainers. Responsible for the effectiveness check of the CAPA corrective action and the overall quality of Operations OJT sessions, she complained that many of the trainers should no longer be considered Dept. Trainers. While she had position title influence, she was frustrated by the lack of support for her “improvement suggestion”. I became her catalyst to help her push through the fixed barrier regarding SMEs.

The site followed a cultural assumption regarding department SMEs: once a Trainer; always a Trainer; regardless of feedback and informal impressions of their ability. Without any tangible criteria and lack of assessment tools, my Performer had no authority to remove the underperforming Dept. Trainers. Granted these SMEs were long ago chosen when the widely accepted practice of being proficient as a technician after a year earned them the designation of subject matter expert and automatically, a Dept. Trainer. Today, the Life Sciences Industry, with FDA investigators’ observations, has evolved their understanding that it takes more than seniority and R & U SOP training to become an OJT QT. Unfortunately, the environment where my Performer worked, the mindset about acquired expertise still held.

Significant CAPAs can be Drivers for Change

Undaunted, my Performer seized the CAPA as an opportunity for change. Leveraging suggested criteria and the use a form to document justification for each Dept. Trainer, she now had a process (SOP with form) that she could “educate” her colleagues on what it takes to become a Qualified Trainer. The focus of her message dramatically changed. She became strategic in her communications, using the effectiveness check portion of the CAPA as her “Why / WIIFM for Operations Managers”. In order to close out the CAPA, Managers had to complete their portion of the form.

The long-term success of my Performer depended on her owning her solution. She never lost of her original desire; she was patient and waited for her colleagues to accept today’s best practices for OJT QTs.   In the meantime, we brainstormed on a variety of feedback options that could be used to evaluate the current status of each SME at the same time the Managers completed the new form. My Performer chose a rating system and arranged for a 1-1 sessions with Operations Managers to discuss what rating they would use for each criteria if they got challenged during a CAPA investigation or a regulatory inspection.

While the results were not formally documented, my Performer was effective with the assessment rating exercise.   The Managers reconsidered who they wanted to nominate based on the new formal criteria and the informal ratings discussions. They did not automatically submit the form for all existing Dept. Trainers. A constructive dialogue then ensued regarding skills remediation support for those SMEs deemed as potentials. At last, my Performer achieved her desired outcome. “As catalysts, we build a bridge, light the path, and give [ ] our hand to help [ ] demolish or jump over obstacles”, (Haneberg, 2010, p.96). I was privileged to be part of a dramatic shift in their training culture.

An alternate alignment exercise

For many, adding ratings suggests a formal performance assessment and this can raise HR issues if not fully supported by the organization. In addition, many Operations Managers do not have the luxury of “weeding out undesirables”. They simply do not have enough SMEs to complete the training curricula generated requirements. Yet, there needs to be mutual consent between manager and identified SME in order to effectively deliver the OJT Methodology and to ensure a successful learner experience.

For those situations where automatically re-nominating existing SMEs is raising a red flag, I created the Trainer Mojo Assessment.  Nominated SMEs and existing SMEs as Trainers rate themselves on 10 attributes that align with the characteristics of an effective OJT Trainer.   Low scoring SMEs/QTs are encouraged to have a discussion with their management regarding continuation in the program and possible action steps. For SMEs/QT’s that score in the On-Target range, this is both validation of the nomination and confirmation that manager and QT are in sync. For high scoring QTs, this is also confirmation and an early indicator for potential QT Rock Stars!

Haneberg, L. Coaching up and down the generations. Alexandria, Virgina:ASTD, 2010.

You might be interested in the Impact Story – From Dept. SME to QT.

From Dept. SME to QT

The Client Request –”Can you help us upgrade our Trainer Qualification process?”

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.

Calling ALL User Generated Tools Home

What do I mean?  You know, job aids, tools users have created, and SME cheat sheets.  I’ve even seen task instruction sheets, quick reference guides for completing forms, and process flow diagrams.  But I’m not talking about posters on the wall describing how to turn on the projector in the conference room.  In this 3rd issue of Making It Work for Compliance Trainers series, I blog about why creating and openly sharing user-generated tools may not be a good thing in a regulated environment.

The Dilemma

As a Performance Consultant (PC) or HPT specialist, works with SMEs, Key Performers, or STAR employees, s/he invariably uncovers or discovers that their SMEs have “other” tools they’ve developed that help them be so good at what they do.  While these are helpful to the key performers, it presents a dilemma for the PC who is also a Compliance Trainer or a QA Manager.  “If I expose the source of their secret sauce, will I break trust and create a barrier to the relationship?  On the other hand, if I don’t speak up about this tool, what assurance do I have that the content is approved by the Quality Control Unit (per GMP) and is version controlled?

Why create them in the first place?

To get grounded, the PC/Compliance Trainer needs to perform a quick cause analysis upon the discovery of the tool.  Why was it created in the first place?  Is there information or steps missing from the standard operating procedure (SOP)?  Was this tool created to “chunk up” the steps or create bite-sized training materials that evolved into a job aid?  Or is it a maneuver to bypass the change control system?  The answers to the questions could provide the basis for a more user-friendly revision or at least be officially approved as a supporting tool to the SOP upon the next version release.

What’s the big deal?

Rejection of product, deviation from approved written instruction that could result in adulterated product, additional follow up testing, and rework are all forms of waste to the organization.  Not to mention that consistency is the key to compliance and assuring public confidence in approved marketed products.  If folks are not using the approved procedure, then there’s an issue somewhere.

To what level of control is needed?

That is the most sought after question regarding job aids and user tools.  The answer lies in each company’s level of risk and its document hierarchy.  I’ve seen extreme cases where “NO Paper” on the floor means not even an SOP is allowed to be in hand.  I do believe that some level of control is needed to ensure that the content is valid, is in sync with the current procedure and users have the most current version of the tool.  Can your organization defend the level of control?  Are you sure about that?  Or do you use a “don’t tell and we won’t ask policy”?  Are folks making errors because they followed an uncontrolled worksheet vs. the approved procedure?

Tips for Establishing Level of Control

  • If the tool /job aid is tied to a procedure, it needs to become a required tool and included in the SOP.
  • Job aids should not be a standalone orphan.  It needs to have a procedure that it supports.  The use of the job aid is included in the hands-on training so folks know how to use it properly and where to access it if it is not “attached” to the SOP.

o   For example, some companies have a separate numbering system for these exhibits and the storage location may not be in the same folder directory as the parent SOP.

  • If more than one tool / job aid / worksheet exists per procedure, then an appendix or reference section needs to highlight the existence of these “tools in use”.
  • Establish an amnesty initiative to raise awareness for the quality and compliance consequences of using uncontrolled tools.

Calling all User Generated Tools Home

The purpose of the initiative is to allow users to admit that they have these tools and that no performance consequences will follow when they surrender them.  The second focus of the program is to find a proper home for these tools once they are deemed valuable.  They need proper care and nourishment.  In other words, content is valid, accurate, up to date and approved for use.  The PC/Compliance Trainer is the ideal conduit to make this happen.

One company that I visited did just that and more.  Once it was discovered that a series of mistakes were coming from an old tool that had been downloaded and copied to their desktop, a team of auditors was dispatched to observe the removal of all tools from employee’s desktops.  The 2nd phase of their program was the identification of an owner for the share-point site who now manages access and content revisions.  The 3rd phase includes a content/tool submission process that is vetted by a designated users group of SMEs.

Is it time for a Job Aid/Users Tool Amnesty Project where you work? – VB