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.

HPIS Means Human Performance Improvement Solutions

Welcome to the “official” HPIS C. Blogspot.  

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

HPIS C uses 6 boxes of solutions
HPIS C uses 6 boxes of solutions

References:

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

Gilbert, T.  Engineering Worthy Behavior,

Wilmoth, Prigmore, Bray “HPT Models”, Performance improvement 41(8), 16-23.

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.

Curricula Creation and Maintenance are NOT a “one and done event”!

Allow me to have a blog about the need for keeping curricula up to date.  I realize the work is tedious even painful at times.  That’s why donuts show up for meetings scheduled in the morning, pizza bribes if it’s lunchtime and quite possibly even cookies for a late afternoon discussion.  So I get it when folks don’t want to look at their curricula again or even have a conversation about them. 

Once a year curricula upkeep?

It’s like having a fichus hedge on your property.  If you keep it trimmed, pruning is easier than hacking off the major overgrowth that’s gone awry a year later.  And yet, I continue to get push back when I recommend quarterly curricula updates.  Even semi-annual intervals are met with disdain.  In the end we settle for once a year and I cringe on the inside.  Why?  Because once a year review can be like starting all over again.

Don’t all databases know the difference between new and revised SOPs?

Consider for a moment the number of revisions your procedures go through in a year.  If your learning management system (LMS) is mature enough to manage revisions with a click to revise and auto-update all affected curricula, then once a year may be the right time span for your company. 

Others in our industry don’t have that functionality within their training database.  For these administrators, revisions mean manual creation into the “course catalog” each time with a deactivation/retirement of the previous version; some may be able to perform batch uploads with a confirmation activity post submission.  And then, the manual search for all curricula so that the old SOP number can be removed and replaced with the next revision.  Followed by a manual notification to all employees assigned to either that SOP or to the curricula depending on how the database is configured.  I’m exhausted just thinking about this workload.  

Over the course of a year, how many corrective actions have resulted in major SOP revisions that require a new OJT session and quite possibly a new qualification event?  What impact do all these changes have on the accuracy of your curricula? Can your administrator click the revision button for these as well?   And then there’s the periodic review of SOPs, which in most companies is two years.  What is the impact of SOP’s that become deleted as a result of the review?  Can your LMS / training database search for affected curricula and automatically remove these SOPs as well? 

The Real Purpose for Curricula

Let’s not lose sight of why we have curricula in the first place.  So that folks are trained in the “particular operations that the employee performs” (21CFR§211.25).  And “each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities” (21CFR§820.25).  Today’s LMSes perform reconciliation of training completion against curricula requirements.  So I’m grateful that this task is now automated.  But it depends on the level of functionality of the database in use.  Imagine having to manually reconcile each individual in your company against their curricula requirements.  There are not enough hours in a normal workday for one person to keep this up to date!  And yet in some organizations, this is the only way they know who is trained.  Their database is woefully limited in functionality.

The quality system regulation for training is quite clear regarding a procedure for identifying training needs.  To meet that expectation, industry practice is to have a process for creating curricula and maintaining the accuracy and completeness of curricula requirements.  Yes, it feels like a lot of paperwork.  §820.25 also states “Training shall be documented”.   For me, it’s not just the completion of the Read & Understood for SOPs.  It includes the OJT process, the qualification event AND the ownership for curricula creation and maintenance.

Whose responsibility is it, anyway?

Who owns curricula in your company?  Who has the responsibility to ensure that curricula are accurate and up to date?  What does your procedure include?  Interestingly enough, I have seen companies who get cited with training observations often have outdated and inaccurate curricula!  Their documentation for curricula frequently shows reviews overdue by 2 – 3 years, not performed since original creation and in some places, no specialized curricula at all!   “They were set up wrong.”  “The system doesn’t allow us to differentiate enough.”  “Oh, we were in the process of redoing them, but then the project was put on the back burner.”  Are you waiting to be cited by an agency investigator during biennial GMP inspection or Pre-Approval Inspection?

The longer we wait to conduct a curricula review, the bigger the training gap becomes.  And that can snowball into missing training requirements, which leads to employees performing duties without being trained and qualified.  Next thing you know, you have a bunch of Training CAPA notifications sitting in your inbox.  Not to mention a FD-483 and quite possibly a warning letter.  How sophisticated is your training database?  Will once a year result in a “light trim” of curricula requirements or a “hack job” of removing outdated requirements and inaccurate revision numbers? Will you be rebuilding curricula all over again?  Better bring on the donuts and coffee!  -VB

How many procedures does it take to describe a training program?

Who is Vivian Bringslimark?

(c) HPIS Consulting, Inc.

Remember, we are not allowed to talk about 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 see how Cara facilitates the design team of SMEs through various stages of being of team.

“Please tell me, how you think YOU are going to train us on OUR procedures when you do not work here nor do you have any background in the science part of what we do here?”  she spewed.

“But, who are you?  I mean you just can’t walk in here and change our procedures!” she retorted.

“Ah, yes, I have been vetted by Miguel, you know, the VP of Quality and have already met several of his peers during the assessment debriefing meeting.  They have all read the assessment report and agreed for these SMEs to be the design team.  You can look me up in Linked-In later if you want to.  But for now, would you like to take a seat or will you stand for the rest of the lesson?” she asked.

The timing and sequencing for the last lesson, “Foundations of Teamwork” was not accidental.  Cara set up the curriculum to build knowledge first with an immediate need to apply in order to close their knowledge and experience gap and prepare them for the much-needed discussions without getting bogged down in terminology.  This last lesson introduced them to stages of team development and what to expect as the honeymoon phase of the project faded and the real work began.  A key piece of this lesson was to emphasize how to offer a different perspective while maintaining respect to team members (their peers) rather than remaining silent when not in agreement.

(Re)-DESIGNING A SYSTEM: FUTURE STATE VISION

With these 4 lessons delivered, Cara returned to the previous assignment of marked up process flows.  Cara anticipated that most of the team might have difficulty envisioning a future state that would be different from their current state.

Design Team Readiness Curriculum

“Thank you for your time and participation in the last four meetings and special thanks for those of you who have already been trained on these concepts.  The temptation to skip it and finish other pressing work was very real and your enthusiasm to show up and attend speaks volumes to your commitment to the team and for the project,” said Cara.

But that’s not how we do it here!

“Before we delve back into these marked-up process flows, I ask that you remain open to ideas and suggestions not only from me but from your colleagues who have come from other similar companies.  It may be difficult to envision a future state that looks different from today, but please don’t let that become a barrier for you.  If you find yourself thinking or saying ‘that’s not how we do it’, then you need to ‘fess up and ask for patience’ while you recognize what state you’re in.  Can you all do this?” Cara asked.

To quiet fears that this was all a big waste of time or that “management will never buy into any of this” Cara initiated a project issues log.  She assured them that this list would be on the agenda for each weekly check-in with Miguel.  And the updates would be reflected in the weekly project status updates.  Teams often stall or lose momentum when issues and concerns go unresolved, so Cara told the team that this was also part of her role as interim project manager.

“Remember, we are not allowed to talk about change control!”

Each week the team met to redesign one process flow at a time from the training policy to curricula management to qualified trainers, training delivery, and effectiveness measures.  Cara monitored how the team shared their differing points of view and how receptive they were to work on a joint process that could be implemented across the functions not just for Operations or for the QC lab. 

Without fail, the energy and momentum would derail when the discussion found its way to the current state of their change control quality system.  Once again, the role of Cara as interim project manager was to get them back on track, future-focused, and not get mired in current barriers.  For the most outspoken member of the team, this nearly shut her down.  It was a real barrier and nearly threatened to compromise the team’s future success.

“Yes, there is no denying that change control needs to be fixed.  That what we are proposing will not fly with how it is defined today,” said Cara. 

“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.”

And then Cara directed the next question to the member in distress.

“Can you proceed with us knowing that change control is out of scope for us?” she asked.

“No.  This is the wrong priority and all this work will have to be redone because it will be rejected by the Change Control Manager when it’s all said and done!” she retorted. 

“What if you were to be the Change Control Manager, would this change your viewpoint?” asked Cara.

“No, I don’t want to be the Change Control Manager.  I just want change control fixed now,” she snapped and then shared a litany of items that were being delayed because of the backlog in change control.

“Can you proceed with us or shall we find a replacement for you?” Cara asked again.

“Let’s continue and I’ll make a decision before our next meeting,” she mumbled.

The rest of the team sat still and watched the volley back and forth.  Apparently, this was not the first time the team experienced their peer’s change control rant.  This time, however, the team was mesmerized by how Cara maintained respect while letting their peer air her frustration; truly modeling team rules and getting to the heart of the matter.  Cara practiced what she taught in the earlier lessons.  After this episode, whenever anyone even said the word change control, they joked and said: “we’re not allowed to discuss change control anymore, remember?”

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Who is Vivian Bringslimark?

(c) HPIS Consulting, Inc.

Interested in Robust Training System resources?

You might find the Redesigning Quality Systems blog series insightful. Read the series here.

Congratulations, you have been selected to be on the Design Team

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.

Miguel then went on to explain, “they don’t know how to be a team. They know even less about project management concepts like scope and project charters and they lack fundamental concepts like quality systems and systems based inspections. And they certainly don’t know about process mapping. It’s not their fault, many of them never worked anywhere else but here. They have been siloed far too long.”

In part 2, we pick up with Cara meeting the design team for the first time.

“Do you know why you are here?” asked Cara.  As expected, most of the SMEs shrugged sheepishly.  To that end, Cara provided a brief explanation of the request and then presented a high-level view of the assessment gaps to the SMEs as the basis for the project scope.

For some of you, being on a team and working with process maps is quite familiar.  Yet, there are others here today, where this will be their first project as a team of SMEs.  I’ve been asked to provide a few short introductory ‘lessons’ to help orient us around a set of ground team rules and establish a common lexicon for this project.

SME Design Team Readiness Curricula

Cara continued.  “Over the next few weeks, we will begin our time together with one of these lessons.  As a team, we will use ‘live’ aspects of our project work to illustrate the concept and apply its principles to our progress and development of a team. Let’s begin with ‘Six Elements of Robust Training System’ .”

After the lesson was presented, Cara asked the SME design team to locate the assessment report and match the gaps to the six elements.  This exercise helped the team achieve one of the learning objectives and at the same time rendered the report more meaningful for their project kick-off. 

Miguel then went on to explain, “your ‘Design Team of SMEs’ has very limited experience working cross-functionally or as a team.”

The next lesson “Launching a Project Team” introduced the team to project management 101 terms and the concept of a project charter.  The application exercise became the completion of their project charter and familiarize themselves with the project management terms being used for the RTS project. In preparation for the third lesson, the team was asked to review a set of generic training process maps and mark up their copies with comments and questions.

“Excuse Me, Who are You?”

At the beginning of the next lesson, a nominated SME stepped into the room just as Cara finished the opening of their third lesson “Process Mapping Quality System Documents”.

“Hello, are you joining us today or only staying for the presentation?” asked Cara.

“Well that depends on how you answer my question,” she replied. 

“Please sit down and I’ll do my best to answer it,” Cara responded.

But she stood in the doorway anyway and continued. 

“Please tell me, how you think YOU are going to train us on OUR procedures when you do not work here nor do you have any background in the science part of what we do here?”  she spewed.

“As I explained during the kickoff and then again during the first two lessons that you were absent from, I am not here to train you on your procedures.  These folks here are the experts on that.  I am here to work with them on your training process.  Training is a quality system and your process needs to be robust enough to handle all of the training elements within that system.  The assessment I conducted revealed many areas that are not up to today’s standards nor FDA expectations,” Cara replied.

“But, who are you?  I mean you just can’t walk in here and change our procedures!” she retorted.

“Ah, yes, I have been vetted by Miguel, you know, the VP of Quality and have already met several of his peers during the assessment debriefing meeting.  They have all read the assessment report and agreed for these SMEs to be the design team.  You can look me up on Linked-In later if you want to.  But for now, would you like to take a seat or will you stand for the rest of the lesson?” she asked.

Reluctantly, she stepped into the room and found a seat.  This third lesson oriented the team on process mapping diagram shapes and commonly used terms, as well as a balanced discussion on vertical process flows vs. horizontal “swim” lanes.  Using their marked-up copies, Cara facilitated a question and answer exercise on project management terms, concepts and flow only. 

The team was asked to continue reviewing the process flow diagrams as their homework task but this time to focus only on content within the shapes and was told that after the next lesson, the collaboration of ideas and suggestions would begin.

Please tell me, how you think YOU are going to train us on OUR procedures when you do not work here nor do you have any background in the science part of what we do here?”  she spewed.

The timing and sequencing for the last lesson, “Foundations of Teamwork” was not accidental.  Cara set up the curriculum to build knowledge first with an immediate need to apply in order to close their knowledge and experience gap and prepare them for the much-needed discussions without getting bogged down in terminology. 

This last lesson introduced them to stages of team development and what to expect as the honeymoon phase of the project faded and the real work began.  A key piece of this lesson was to emphasize how to offer a different perspective while maintaining respect to team members (their peers) rather than remaining silent when not in agreement.

Stay tuned for Part 3, where Cara works with the Design Team to envision the future state for their robust training system.

Sign up at the left side bar to automatically received this and future blogs from theory vs practice.

Who is Vivian Bringslimark?

(c) HPIS Consulting, Inc.

Learn more about Robust Training Systems here.

How Big is the Change Readiness Gap – Part 1

This blog is Part 1 of an impact story about recognizing what a robust training system (RTS) meant for the future of a small vitamin and supplements company.  But first, they needed to build their change foundation in order to sustain their desired state.

First comes awareness: discovering where the gaps are

Miguel finished his preliminary assessment of the company’s quality systems as part of his first 90 days task list.  The Training Quality System was the last one on his list.  He sighed.  This is not going to be easy, he said to himself.  With so many systems needing to be updated, I cannot do this alone, he concluded.  So, he clicked on his laptop and located a recent congratulations email from a LinkedIn contact who happened to be a performance consultant (PC).  In the subject line, he typed, “I need your help, got time to chat?“.

Miguel explained to Cara the PC, that he was recently hired as VP of Quality.  His first major initiative was to get the organization ready for a comprehensive systems-based inspection.  They had been successfully producing products with sales above forecasted targets for several years now.  Previous regulatory inspections were favorable and did not indicate GMP compliance issues that couldn’t be mitigated with a few minor procedure updates.  “So, the Board of Directors decided it was time to launch a new product line and become a commercial manufacturer”.  He took a breath and continued.

“What I am finding is that they have very basic rudimentary systems for making OTC supplements, but without upgrading the quality systems, they (we) will not pass a full-blown inspection, I’m afraid,” Miguel said.

To which, Cara asked, “What about training?  What’s in place?”

Nothing, really.  I mean they have a procedure and all, but it’s not like what you did for me last time.  It’s nowhere close to today’s standards or FDA’s expectations.

Current State of Affairs

Miguel then went on to describe the small QA Training staff, their reporting structure and then asked when Cara could be on site.  She refreshed Miguel on her approach and reiterated that an assessment of the current state was in order.  He gave her the contact information for his Quality System Manager and ended the call relieved that his PC was available and interested in helping him succeed with his initiative. 

After two days of back-to-back interviews and a review of the requested documents, Cara wrote the report with recommendations and arranged for a conference call with Miguel and his site trainer.  With observations confirmed, the remainder of the discussion focused on a review of the project phases in which the recommendations would be implemented.  Cara requested an on-site meeting with the primary stakeholders to debrief the findings and provide an overview of the Robust Training System (RTS) project.  Together they were going to be asking for a team of cross-functional resources.  Miguel agreed it was a good idea and they set a date and time. 

“… but without upgrading the quality systems, they (we) will not pass a full-blown inspection, I’m afraid,” Miguel said.

Is training really a priority?

The day before the meeting, Miguel learned that his boss would not be on-site and therefore unable to attend the meeting.  He called his PC and together they picked a new date; one month out.  Once again the meeting was canceled due to the unavailability of Miguel’s boss and his peers to attend a 60-minute briefing on what they all deemed was a critical and important project for the company’s future state.  This time, Miguel did not automatically re-schedule.  Instead, he postponed the meeting indefinitely.

Three months later, he contacted Cara.  “I apologize for the delay.  I believe we are now ready to have you come back on-site,” he said.

“Okay, this is great news.  What happened?”

“After I canceled your meeting for the second time, I had a heart-to-heart ‘chat’ with my boss.  Believe me, it was not an easy conversation to have with him.  I told him that without his support and I meant physically show up and attend this debriefing meeting, no one else will show up nor take this project seriously.”

“Wow!  That was a bold move for you just being hired and all,” Cara exclaimed.

“Oh, I already told them in my interview that I was going to shake things up and that if this isn’t what they wanted, don’t hire me.  But if you are serious about growing your business, I’m the quality guy to make that happen for you,” he replied.

“So how did you leave it with him?  Is he going to attend the meeting?” Cara asked.

“No.  A lot has changed since you were here.  All good and in the right direction.  I mean with the leadership and with funding.  We are finally getting job requisitions approved and attracting experienced candidates for interviews,” he explained.

“This is good news; we are going to need those people to help implement many of the quality system improvements,” Cara responded.

(Re)-DESIGNING A SYSTEM: PROJECT LAUNCH

They switched gears and focused on the agenda for the debriefing meeting.  Miguel asked Cara to emphasize certain slides in her presentation; namely, the collaboration benefits and the shared ownership of the quality training system.  More specifically, he wanted to hone in on the message that this 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.  

After the executive briefing meeting, Miguel asked Cara to join him in his office. 

“Okay, that went better than expected, don’t you think?” asked Cara.

“Yes, there was a lot of discussions last week about the importance of this (your) RTS project,” he replied.

“Oh good.  I’m glad we waited three months.  The project would have floundered and then died on the vine,” Cara replied.

Seriously, yes, but now we have another problem.  Let’s call it a challenge; a training and development challenge that I believe is right up your alley,” he said.

Miguel then went on to explain, “your ‘Design Team of SMEs’ has very limited experience working cross-functionally or as a team.”

He explained further. “They don’t know how to be a team.  They know even less about project management concepts like scope and project charters and they lack fundamental concepts like quality systems and systems based inspections.  And they certainly don’t know about process mapping. It’s not their fault, many of them never worked anywhere else but here.  They have been siloed far too long.”

“Oh, okay.  This does change things a bit”, Cara replied.

“I was thinking about your curricula building background and quality systems work.  You could work with them and provide the necessary training that they need” he suggested.

“Yes, it means more time on-site and I need to push out the due dates for the deliverables.  But I’m concerned about content overload.  Why don’t I teach them what they need to know in the moment the project needs it, you know like just in time training?”  she said aloud.

Miguel nodded his approval and Cara left his office with a sketched outline of a mini-curriculum for the Design Team of SMEs.  Two weeks later the team met for the Project Kickoff meeting.

Part Two: Cara has to teach and coach her design team of SMEs on how to be a team, introduce them to quality systems, project management concepts and how to process map a quality system.

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Who is Vivian Bringslimark?

(c) HPIS Consulting, Inc.

So, we went LIVE, what happens next?

Blog # 9 is the final blog in this Redesigning Quality Systems series. Refer to blog # 7 for an overview of the 5 Steps for GO-Live Strategy.

Go-Live: Step 4 – Triage Impacted Documents

The purpose of the triage step is to manage the impact of in-process system documents the day the new design goes live.  What happens to forms that were started and not yet completed?  Employees will need to know how to move forward and still be in compliance.   The easiest path on Day 1 is to use the new form(s) to begin a new record.  But what about the documents that were already started?  The ones that were initiated.  They will reflect the previous version although in effect at the time of initiation. Anticipate these questions from affected users:

  • Do we process the old form?
  • Do we start over with the new form and add the original started document with EOD notation for missing information?
  • Do we suspend and pick up with the new form?

A good example of this situation is when paper change control requests have SOP drafts attached. The Project Manager with the guidance of the Head of Quality needs to meet prior to the launch date to carve out the decision paths based on the amount of initiated documentation stages each document contains.  These decisions and individual directions are the main tenets for daily guidance from the Project Manager and/or Quality System owner during the start and end period for the transition phase.  Revisit Step 2. 

In addition, s/he or a small team needs to answer questions that are sent via emails, phone calls, drop by’s and drop-ins for direction on how to close the loop on initiated previous versioned documents. Anticipate additional 1-1 coaching through the new paperwork until the end of the transition period. 

“What happens to forms that were started and not yet completed? ”

Vivian Bringslimark, HPIS Consulting, Inc.

When Will We Be Fully Operational with The New Design?

When this design team began putting together its go-live strategy, their impact assessment (Step 1) mirrored an “End in Mind” approach.  The project manager asked, “what needs to be in place in order for us to be fully compliant with this procedure”.  The list of items was long.  The second question – “What is the best way to accomplish this” was then asked and detailed steps were captured.  The third question focused on the estimated time to complete and so on.  In essence, the team was generating an implementation plan to guide its launch decisions.  It became clear that they needed to launch in high priority clusters

However, two cluster sets were competing for first place to launch.  One focused on the business objective while the other focused on establishing foundational principles for the quality system.  In a stunning presentation, the system owner made her compelling appeal to the site leadership team and was given the approval to begin with foundational principles despite the number of tasks and time to complete those tasks. 

In order to move forward with identified tasks from the implementation plan, the team needed the high-priority procedures to be in effect in order to gain cooperation from department managers.  This created a compliance dilemma of being out of compliance immediately upon launch.  To mitigate this gap and not create unnecessary deviations, the system owner generated a change control packet that also included the implementation plan tracker.  It gave the design team the necessary authority to invoke the changes without becoming bogged down in the compliance dilemma dialogue which derails progress. 

When FDA made an unannounced visit to the site weeks later, the change control packet of documentation was not only accepted as an appropriate way to cover the obvious compliance gaps in the new procedures, but the implementation dates were moved up and execution of the plan became a site priority. 

The project manager asked, “what needs to be in place in order for us to be fully compliant with this procedure”

Vivian Bringslimark, HPIS Consulting, Inc.

Go-Live Step 5: Monitor Performance and Collect Feedback.

The project ends for the consultants when the handoff is completed, and they disengage. The handoff usually includes a formal document describing the current status of the system at the point in time including deliverables, suggestions for next steps and sustainment. 

Can the team celebrate that the project is over? Or should they wait until someone determines whether it is a successful adoption? Recall Step 2 of the Go-Live Strategy defined the end date of the transition period as well.  Did this include the expected date for being fully operational? By the way, who is responsible for declaring success or needs improvement?

Phase Three – Successful User Adoption

One more component of the overall project plan is User Adoption aka Phase 3.  In my experience, this is perhaps the most overlooked phase in redesigning quality systems.  Once training is delivered and the consultants leave, “life as normal” sort of returns with pockets of progress, “learning curve” deviations and loads of suggestions for “fixing” the new design. 

In this phase, the project plan expands Go-Live Step 5 into two main activities, initial user adoption results and sustaining the redesigned quality system through controlled continuous improvement feedback loops.

User Adoption: Did we succeed?

What kind of data/evidence will you use to confirm the success of the Redesigned Quality System?  Will you be relying on the CAPA Effectiveness Check statements to determine User Adoption success?  One word of caution here. These may be too narrowly focused on particular steps as it maps back to a single observation and does not provide enough evidence to tell a complete story just yet.  

What the System Owner really needs to know is:

  • Who is following the new process?  Who is still dragging their feet? Who is confused about how to proceed? Who needs help remembering what the changes are?
  • Do we have any early examples of how or where the new process is helping to produce positive results?
  • What is the value of those results?
  • How long do I have before I am forced to release the next set of “promised” revisions?

You Need a User Adoption Study

The purpose of the study is to get data both quantitative and qualitative to address the system owner’s questions.  This means the study needs to focus on identifying the specific changes (removed, added, and modified) and then collecting the evidence to evaluate how well those changes have been transferred into this “life as normal” stage.   Whether this means reconvening the design team or initiating a new subgroup of early adopters, user input into the tools, existing KPIs, new metrics, surveys, and who to interview is another excellent opportunity for users to be involved.

It also means keeping key stakeholders and the sponsor informed and up to date.  The “project may be over” however, the adoption has only just begun.  Feedback is essential to not only determine successful adoption but to also gather detailed information for continuous improvements that feed revisions.

“In my experience, [phase 3] is perhaps the most overlooked phase in redesigning quality systems.”

Vivian Bringslimark, HPIS Consulting, Inc.

Managing “New Normal”

Life as new normal has begun. The quality system is fully operational and Affected Users are now performing their tasks.  New normal is really about managing the new workflows and the status of the current resources to sustain the new system.  Are you able to sustain the new system or are requisitions pending for more full-time employees?

A screenshot of a cell phone

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why redesigned SOPs are more than a set of revised procedures

What existing performance metrics can you leverage? Perhaps it is only a matter a slight tweaking here or there to accommodate your redesigned quality system.  In some systems that have gone digital, brand new metrics and KPIs (key performing indicators) need to be established.  Most vendors will partner with their clients and recommend industry best practices around popular metrics in use.

Anticipate periodic revisions that come from corrective actions and from the Affected User groups.  Hold focus group meetings quarterly for the first year and then semi-annually the second year to stay on top of trends and possible performance challenges to prevent unexpected deviations.

Continuously Improve the Quality System

The redesigned quality system has to feed itself.  Identify and continuously monitor the key linkages (handoffs) between one system interface and the other.  Are they working or are they becoming the source of miscommunication between users? 

How many CAPA investigations have been initiated where the handoff may have been a contributing factor?  How many small or incremental changes has the quality system undergone in the course of a year?  When will it be time to remap the process and identify all the tweaks that have occurred? Would anyone recognize the differences?  I’m betting on savvy new hires to ring the change bell and raise our awareness.  We forget just how many changes can happen to a quality system over 1 – 2 years.

Summary

  • Any change we introduce into an organization must be aligned to fit the existing system or modify the system to accept the changes.
  • Quality Improvement Projects/ CAPA teams are no stranger to change and all that comes with changing old ways.  But managing change fatigue can wear us down and make us slow to outwardly embracing major change efforts. Include change management strategies that go beyond Awareness Training only.
  • This blog series outlined why some post-implementation issues can thwart our best designs for users and provided tips and suggestions to deploy during the project phases rather than waiting until post-launch to ensure User Adoption success. 

Here’s a recap of the series:

  • 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 Testing Your Final Draft of Redesigned SOPs and Forms: Helpful or Seen as unnecessary?
  • Blog # 6 – Change Management and It’s Little Cousin Training
  • Blog # 7 – Do I Really Need a GO-Live Strategy?
  • Blog # 8 – Is an Awareness Training Only Session Enough for Successful User Adoption?
  • Blog # 9 – So, We Went Live, What Happens Next?

Who is Vivian Bringslimark?

© HPIS Consulting, Inc.

Is an Awareness Training Session enough for successful User Adoption?

Note: This blog is part of an ongoing series. Blog # 7 – Go-Live Strategy introduces the 5 Steps.

Go-Live: Step 3 – Develop the Rollout Timeline and Training Schedules.

A redesign of the quality system SOPs more than likely resulted in significant changes in routine tasks.  What changed, what was removed, what was added that is truly new and what stayed the same? Simply reading the newest version in an e-document platform will not suffice as effective training.  Nor will reading the change history page or reviewing a marked-up version of SOP for the highlighted changes.  When your previously delivered change management sessions include this level of detail, then the content of your training session can focus more on the new process.  If successful user adoption is tied to the effectiveness check of your CAPAs, then the project team needs to discuss what the training rollout will look like.  

Identifying Critical Users

From the stakeholders’ analysis for Affected Users, consider who is directly affected and indirectly affected by the change in responsibilities. Which users are most critical to ensure success with adhering to the new steps and forms? I refer to them as the Primary Users who are directly affected. They are usually more functional in their responsibility rather by department titles or business units.  Another way to determine this is to review the responsibilities section of the new SOPs.  Who in your organization are these people? In this review, are there supporting and ancillary responsibilities with the steps and forms?  I call this group the Secondary Users that are indirectly affected.  Both sets of users need to be fully trained in their tasks and responsibilities in order to ensure that the new system will function per the SOPs. 

The Training Rollout

Training Roll Outs need to meet three different levels of Users needs.

The overarching question to address is whether or not everyone has to attend the training.  One awareness training session for both groups is extremely efficient but not nearly as effective if the training sessions were tailored based on the level of user need.  See figure at the right.  Within the indirectly affected group are the senior leadership team members. 

An executive briefing is more likely to be attended by these folks when it provides a summary of what they need to know only.  What does the general population need to know about these changes?   Keep this short and to the point. It’s the Primary Group of Users who need to not only be made aware of the changes but to also know how to execute the new forms.  Yes, this session is a bit longer in duration than Awareness Training and it should be.  These Users have more responsibilities for correct execution. 

Simply reading the newest version in an e-document platform will not suffice as effective training. Nor will reading the change history page or reviewing a marked-up version of SOP for the highlighted changes.

Vivian Bringslimark, HPIS Consulting, Inc.

Who is the Trainer?

Depending on the level of involvement of the Design Team members, the following minimal questions need to be addressed:

  • Should the Project Manager deliver any sessions?
  • Will we use Train the Trainer approach?
    • Where each design team member is assigned to deliver Awareness Training for their area of remit.
    • Do these members have platform skills to lead this session?
    • Will they be provided with a slide deck already prepared for them?
  • Solely the responsibility of the QA Training Department
    • Provided s/he was a member of the Design Team
  • What kind of Training schedule will we need?
    • Will we provide three different tiers to meet the needs of our Affected Users?

Did the Training Roll Out Meet the Learning Needs of Primary Users?

While the revised SOPs were in the change control queue, the design team for this client met to discuss the difference between Awareness Training and Primary Users Training. Briefly, the differences were:

Difference between Awareness Training and Primary Users Training Content

Awareness Training is more knowledge-based.  It tends to be information sharing and very passive until the Q & A session.  A knowledge check at the end is no assurance that there will not be any deviations.  Primary Users Training is intended to focus on the behavioral changes that will be needed for adoption back in the department. The session can be a workshop with real examples that are generated from the users as part of their concerns and questions. 

The design team concluded that the differences were significant enough to warrant two different classes based on the type of user.  The risk of deviations was too great and would send a negative message to the site leadership team about the new process design.  Early adopters were not at risk because they were already trained via their participation in the design team. 

The task of developing the Awareness Training and Primary Users materials was assigned to the instructional designer on the team.   Attending the Awareness Training would not be a substitute for participating in the Primary Users class.  However, attending the Primary Users class would automatically credit the Awareness Training requirement for users if they attended.

Given that condition, the Primary Users materials also included similar content from the Awareness Training and then expanded the level of detail to include the sequence of steps for executing associated new and revised forms.  The Primary Users class was designed to provide more in-depth discussion of the changes and to provide adequate time to become familiar enough with their responsibilities to minimize disruption on the day the procedures and forms go into effect. 

The system owner then scheduled all users to attend the Awareness Training.  He concluded that there would be too much confusion between which class to attend. Since Awareness Training was being delivered first due to a very short Go-Live window, it would be better that they received the same training or so he thought.  In addition, the system owner felt that all employees were actually Primary Users and would not attend the training session if it went past 60 minutes.  As a result, Primary Users were never identified, and no learner matrix was generated.   No one asked for more training until weeks after the SOPs and forms went into effect. 

A knowledge check at the end is no assurance that there will not be any deviations.

Vivian Bringslimark, HPIS Consulting, Inc.

But rather than schedule the Primary User class, Users who had questions or concerns stopped by the department for 1-1 help instead.  For weeks, the staff was interrupted from their daily tasks and was expected to conduct impromptu help sessions.  The intent of the Primary Users class was to provide a hands-on training workshop for their impacted documents and not have to stop and go find someone for help.  The slide deck for Primary Users was eventually uploaded to a shared drive.  When the department got tired of being interrupted, the system owner put out a general email with the link and redirected late adopters to the website link.  The slide deck was not designed to be a substitute manual. 

Had the design team followed through with identifying lead champions, the Primary Users training workshop would have been delivered to a small group of users who then could have fielded questions from their colleagues.  The original design team members did not agree to be change champions nor trainers for their departments.  They complained about their workload already being heavy and had no time to address implementation questions.  That was for the training department to deliver, they concluded.  And then reported back to management that their direct reports could not attend a second session on the revised procedures.

Stay tuned.  Next blog includes Steps 4 and 5 of the Go Live Strategy and wraps up this series.  Become a subscriber so you don’t miss any more blogs. 

Who is Vivian Bringslimark?

© HPIS Consulting, Inc.