Moving Traditional OJT to SOJT: What does it take to make OJT structured?

Hint: It’s more than 100% complete with your curricula requirements!

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?

got curricula great! Now move forward with structuring your OJT methodology

(c) HPIS Consulting, Inc.

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 real question is to what level of detail is appropriate.  And the answer lies in the culture of the department and the company’s history with the FDA.  I once worked in an organization where the procedures were stripped to bare essentials, even the definitions were removed!  A recent warning letter left battle scars for the General Manager.

But seriously, how much is enough? Another way to answer this question is by looking at your document control hierarchy of documents.  If your site differentiates between SOPs and Work Instructions, the need for detail can be relocated into a suitable work instruction that is designed to provide detailed how-to steps.  AKA Level 3 type documents.  Refer to the diagram below.  The SOP (Level 2) can then provide a broader high-level overview addressing “the what” without getting encumbered into the “how-to execute” steps.  Some document pyramids include a Level 4 in which much detail can be used for training purposes.

A screenshot of text

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Referring to Document Pyramid determines level of appropriate detail

Back to the opening question

While addressing ease of navigation and use concerns is laudable, it is not always realistic to satisfy all users.  You need to explain what your Training “Program” contains, a high level policy that answers “the what”.  But you also need to describe how your training is conducted.  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 consider some Level 3 Work Instructions.
  • Do you have too many standalone task-focused SOPs (or Level 3 Work Instructions) that could be grouped into a few larger processes?  Recall the 3 Big Blocks of Training

From experience working with SME teams, three “how-to” procedures are usually sufficient: preparation process, delivery and documentation process, and measuring training effectiveness process.  So the next time you find yourself in the level of detail discussion, consider which of the levels (1,2,3,4) is the best place to park your “detailed” content. – VB

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.

Are all your SMEs Qualified Trainers?

I got a phone call from my Lead SME’s boss one morning. “How many more sessions do you need”, I asked him. I had already delivered 4 back-to-back workshops with class sizes of 25-30 SMEs; which was beyond optimal. So I asked him why. I needed to find out what was driving the surge in identified Qualified Trainers (QTs). I learned that a retrospective qualification needed to take place in order to close out an inspection observation. The total number of SMEs needing “proper paperwork” was well over 700. Since the redesigned training system was now in effect, these undocumented SMEs as Trainers would have to follow the new procedure. Or would they? Our discussion shifted to what type of training these SMEs will be delivering.

I then shared a related story with him. Several years prior, I got entangled with a “CAPA crisis” that involved QTs. No sooner did we launched the QT program and put the new procedure into effect, the CAPA quality system temporarily shut down shipping over a weekend. Upon return to the site, I was summoned to an emergency meeting from the security gate. Amazingly, a new practice/rule that only a Qualified Trainer can conduct training evolved from “only OJT QT’s can deliver OJT and perform Qualification Events” as per the SOP! This was clearly a case of misunderstood scope.

Does every SME need to be qualified as a Trainer?

Trainers Grid for determining QTs Scope of Training

In the Life Sciences arena, there are 5 recurring situations that require training: Self, Corrective Actions, Classroom (ILT), Structured OJT, and Qualification Events (Final Performance Demos).

Self can be achieved by the individual reading the procedure and signing the training record. This is also known as Read & Understand (R & U) for SOPs. I personally don’t think of it as training, it is reading. Yet, in some situations, reading is all that is required to gather the SOP information.  If on the other hand, you need to execute the steps of the SOP and complete required forms, then additional training with the SOP Author or a QT is the appropriate next level of training.

Deviations/ Corrective Actions stemming from a Corrective Action Preventive Action incident. Minimally an SME or the SOP Author is needed to ensure the credibility of the content. These types of training sessions have become known as Corrective Actions “Awareness” Training.  And more and more SMEs are now being required to deliver this training in a classroom setting.  They need to be qualified to deliver classroom sessions especially if the event is related to a significant CAPA or regulatory inspection observation.

Classroom (Instructor-Led Training) is preferred for knowledge-based content affecting a wide range of employees. The skillset needed is facilitation / managing the classroom and delivering content as designed by the instructional designer. Think of GMP Refresher sessions in the Training Room.

Years ago, it was a lot clearer to distinguish between classroom trainers and SMEs as OJT Trainers.  OJT was delivered 1-1 by “following Joe/Jane” around.  Classroom Trainers delivered their content in a classroom of many learners using slides, flipcharts, and handouts.  They were usually full-time dedicated training staff.  Instructor-led training requires training in learning theory design and practice in what used to be referred to as platform skills.  Today, it is more commonly known as “Running a Classroom” or “Basic Facilitation Skills”.  

Many of today’s OJT QTs are also being requested to deliver “Group Training” sessions on content found within their SOPs.  While the target audience may be the same set of peers, the scope, objectives, and tools used to deliver instructor-led training is vastly different from the OJT train the trainer course.

Group Training vs. OJT
Are your QT’s becoming Duo-Purposed?

Structured OJT is On the Job Training delivered by a Qualified OJT SME using the approved OJT Methodology. OJT QT’s attend the Qualified Trainers Workshop which focuses on the OJT Steps Model, how to perform the equipment, and complex SOPs via hands-on and the challenges of Life as a Trainer.  Should every seasoned employee become a QT based on their seniority and subject matter expertise? No, not necessarily.  Because there are some SMEs that don’t want to share their knowledge and therefore, may not make an effective OJT Trainer.  Establishing a set of nominating criteria provides an objective rationale for additional interpersonal qualities that help define a more well- rounded SME. 

Qualification Events (the Final Performance Demonstration) are formally documented observations of learners performing the procedure/task at hand in front of a Qualified OJT SME using an approved SOJT Checklist or rubric.  It is these events that set apart a Technical SME from a Qualified Trainer.  The QT workshop includes a dedicated lesson on what to look for during Q-Events and what the QT signature means for the integrity of the Employee Qualification Program.

Can having too many QTs be a problem?

It can be when there is no one else to train; to deliver OJT steps. While many of you may be wishing for this situation, it can eventually happen if staffing levels are adequate, shifts are normalized and SOPs revisions are managed via R & U only with the LMS.   How do you keep your QTs engaged and fresh if there are no opportunities for OJT sessions? I have some ideas for you to explore.

Re-examine the practice of online R & U only for SOP revisions.  I bet some of those revisions were significant enough for a face to face discussion (aka Group Training)  and there is probably at least one SOP revision in the past year that should have required a demonstration of task for optimum transfer of learning back on the job.  *Just because all employees are now qualified, doesn’t mean the program sits in hiatus waiting for new hires to join the company

When you have too many QTs who may be underutilized, it is also an appropriate time to administer the Trainer Mojo Assessment.  Based on the QTs scores, it might be time to say thank you for a job well done for the low scoring QTs.  You may be pleasantly surprised by who is ready to walk away from the training role?  Or you may have a cadre of QTs who legitimately need more training and hence, the need for some new modules is now justified.  Many of your excess SMEs were identified long before criteria was put into a place or the SOP was established.  If the Trainer Mojo Assessment doesn’t bring any discussion, perhaps it’s time to “re-nominate” them using the criteria within the SOP and offer a refresher series on the QT Workshop content. Or arrange for developmental assignments that expand their subject matter expertise or advances their training repertoire into a classroom facilitators? 

What is exciting for me is that many OJT-QTs are stepping up and volunteering to attend the SMEs as Classroom Facilitators workshop as part of expanding their QT’s toolkit.  Many of them want to learn more about teaching peers and working with adults.  A few have now become promoted to full-time trainer for L&D /QA departments.  Which of your OJT QTS are ready to step up and move into the classroom?  It’s time to find out and be part of the current trend.  -VB

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How committed to SOJT is your organization?

Are you looking for management support for the Qualified Trainers and the time needed to deliver SOJT?  If only we were required to have a procedure for that!  It may not be an SOP or even a policy document, but industry guidance documents provide a lot of references to management involvement.

ICH Q10 – Pharmaceutical Quality System

While not mandatory, management needs to seriously take notice of ICHQ10 guidance document released in April 2009 (1).  In particular to the following:

  • MANAGEMENT RESPONSIBILITY 2.3 Quality Planning 

“(d) Management should provide the appropriate resources and training to achieve the quality objectives”.

  • CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY SYSTEM

4.3 Outcomes of Management Review and Monitoring

The outcome of management review of the pharmaceutical quality system and monitoring of internal and external factors can include:

(b) Allocation or reallocation of resources and/ or personnel training.”

Under a Quality System: Managers Expectations for Training

Referencing the Sept. 2006 issue of Guidance Document for Quality Systems: IV. Management Responsibilities | B. Resources (2), we see alignment with the training CGMPs for continued training so “as to remain proficient in their operational functions and in their understanding of CGMP regulations.”  “Typical quality systems training should address the policies, processes, procedures, and written instructions related to operational activities, the product/service, the quality system, and the desired work culture (e.g., team building, communication, change, behavior).”

And my personal favorite, “When operating in a robust quality system environment, it is important that managers verify that skills gained from training are implemented in day-to-day performance.”  The responsibility for training under a quality system is not assigned to just one person or one function.  It is a shared responsibility across the entire organization.

Goals of the Train-the-Trainer Program (TTT) vs. OJT Program vs. Employee Qualification Program

In order to have qualified employees, they need to receive structured on the job training delivered by a qualified trainer who is content qualified and training process qualified via a Qualified Trainers’ workshop.   Each of the three “programs” has defined outcomes that are dependent upon each other.  Unfortunately, the term program has been a bit overused throughout the years and can have a variety of meanings for folks.  For purposes of this blog, TTT program means OJT Qualified Trainers workshop, OJT Program means OJT methodology/procedure and Qualified Employee program means having a robust quality training system beyond the newest Learning Management System (LMS).

As you can see from the diagram, Qualified Trainers are at the core of all three “programs”.  The OJT QT Workshop is designed to prepare the QT’s for the realities of life as a Qualified Trainer. It includes the pre-work of familiarizing themselves with the Quality Training System procedures and then in class: exploring basic learning theory and committing to what the QT signature means. The OJT Program is about delivering structuring on the job training consistently following the approved methodology. An Employee Qualification Program is the validation of training effectiveness of the OJT methodology and the clarity of the underlying procedures.

Readiness Factors for SOJT and an Employee Qualification Program

Let’s start with a written purpose statement for having qualified employees beyond it’s required.  What is the company’s philosophy on achieving qualified status?  Is there agreement among the leadership for the level of rigor required to demonstrate performance and achieve a pass rating?  Where are the SOJT program goals written?  Does a schedule exist for SOJT and qualification events other than an LMS printout with required due dates.  That is not a schedule for SOJT.  Do you have clearly defined objectives for the QT workshop captured in a document or perhaps a procedure?  Is there a single owner for all three programs or is responsibility and accountability assigned accordingly?

Ronald Jacobs and Michael Jones, in their 1995 ground breaking 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.  What else is going on in the organization that will compete for the same set of QTs? Remember they are also your most experienced and technical subject matter experts.  How is the overall Employee Qualification program aligned with the other quality systems? 

Recognition for QTs and Qualified Status

Most QTs are not fully dedicated to delivering training for departments.   There are pros and cons for this decision.  For now, I will leave them out.  Suffice it to say, they are tasked with both their “day” job and the responsibility for delivering training when needed.  They are at times, doing two jobs.  Whether or not they are compensated additionally for delivering SOJT, acknowledging their contribution to the department and the organization is part of management support.   It takes more than “you are doing a good job, keep it up”. 

Often supervisors and managers don’t know what else they are supposed to do to show their support, other than allow them to attend the QT workshop.  The interested ones will “pop” in during lunch and chat with their direct reports.  Others will show up at the end for the poster activity (equivalent to a written test) and some will come to learn about the parking lot issues that need follow up.  The energy in the room when this happens is amazing. 

“When operating in a robust quality system environment, it is important that managers verify that skills gained from training are implemented in day-to-day performance.

Guidance Document for Quality Systems, Sept 2006

To help ease the knowledge gap between a manager and their now Qualified Trainer, I started delivering the Leadership Briefing module prior to the QT workshop delivery.  The purpose is to provide an overview of the content highlights, alignment with initiatives / CAPAs/ agency commitments and more importantly to secure agreement for the following:

  • criteria for nominating a QT
  • roles and responsibilities of QT
  • scope of work QT’s can be assigned
  • expectations for QT’s post launch
  • what happens day one after workshop is done
  • what is the status of the SOJT checklists
  • scheduling and budget concerns.

If the organization says they support the qualification program, then what happens when employees achieve qualification status?  Nothing?  A non-event? Or is it announced in newsletters, plasma screens and other company announcements?  Is it a big deal to be able to perform independently and free up a much-needed QT for another learner?  I keep hearing over and over again about how there aren’t enough QT’s to deliver SOJT the right way.  One would think qualification status on SOPs, especially big complex processes deserves SOME kind of recognition.   Just how committed are the managers and supervisors?  QTs and employees draw their own conclusions about the level of real management support for the programs.  

Supporting QTs is more than participation in QT Workshop

If truth be told, after launching the QT workshop, many supervisors privately don’t support the program.  They lose their top performers during the workshop and the hours it takes to train someone. Forget about giving QTs adequate time to complete the paperwork properly! And then leadership wonders why good documentation practice (GDP) issues continue to be a problem? The non-distracted performance observations that QT’s are expected to conduct for the qualification demonstration drive supervisors and line managers crazy the most – what, they can’t do anything else but observe?  Hence, many QT’s are asked to multi-task just to get the work done: not enough resources they are told.  For supervisors, productivity and the workload will always trump SOJT and qualification events, until their bonuses include completion of training and qualification events.

What Real Support Is Supposed To Look Like

My key take away message is that attending the TTT program/ QT workshop is not the end of the OJT program or the Employee Qualification Program but rather the launching point.  Management support needs to go beyond just nominating QTs and allowing them to participate in the workshop.  The real support is in the alignment of goals, clarifying expectations continuously, allocating resources for training and budgeting time to deliver OJT using an approved OJT methodology that includes qualification events.  This commitment of time and sponsorship for qualified employees is a culture shift for many line managers and site leaders.  But actions do speak louder than words.  -VB

(1) Guidance for Industry Q10 Pharmaceutical Quality System | US Department of HHS | FDA
| CDER | CBER April2009 ICH

(2) Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations U.S.Department of HHS | FDA | CDER | CBER | CVM | ORA| September 2006 Pharmaceutical CGMPs

Jacobs RL, Jones MJ. Structured on-the-job training: Unleashing employee expertise in the workplace.  San Francisco: Berrett-Koehler: 1995.

How can you tell if your site is ready for SOJT?

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Employee Qualification is the Ultimate Level 3 Training Evaluation

On the Job Training is as old as some of the original apprentice-style forms of learning and ranges from very informal like follow Joe around to structured OJT that is formally documented and includes a qualification event observed by a Qualified Trainer.  While OJT means on the job training, the steps for OJT can also vary from trainer to trainer and from company to company unless the methodology is captured in an approved written procedure. 

Multiple Performance Demonstrations Occur

One of the first instances of a demonstration occurs from the trainer himself.  S/he shows the learner how to perform the technique, task, or process.  The learner observes and asks questions.  Then the roles reserve and the learner performs a mimicked rendition of what s/he observed.  The trainer provides feedback and sometimes will ask questions intended to assess the knowledge gained as well. 

Is one demonstration enough to determine OJT is done?  Sometimes it is.  When the task is simple, one time is all that most learners need.  When the task or process is complicated, it will take more than one demonstration to get the SOP steps right.  The nature of the SOP or the complexity of the task at hand determines this. 

But, how do I proceduralize that, you ask?  It starts by not arbitrarily picking the magic number 3. I have engaged in countless discussions regarding the exhaustive list of exceptions to forcing the rule of 3 times to practice.  And some QT’s will argue for more than 3 sessions especially when the procedure is so infrequently performed.  It’s not strictly about the number of times. We recognize that multiple sessions become practice sessions when the learner is still demonstrating the procedure under the supervision of his/her trainer.  But documenting the number of demonstrations and/or practice sessions is still a challenge for the Life Sciences Industry. 

At what point, is the learner going to be qualified to perform independently? As an industry, there is no standard number of times.  There are no standard learners either.  There is a range of “quick studys” to typical to slow learners.  The caveat to this is monitoring both the quick study and the slow learner.  In the QT workshops, this topic is explored using scenarios with tips and techniques that are shared during the debriefings.  Qualified Trainers know what is typical and they are empowered to evaluate the outcome of the learner’s demonstration(s).  Is the procedure being performed according to the SOP or is the learner still a bit hesitant about the next step? Is s/he relying on the QT for the assurance that the step is right?  While the steps may be performed correctly, is it also the confidence of both the QT and learner that we are assessing as well.

How many times is enough? Until both the learner and the QT are confident that s/he is not going to have an operator error deviation a week after going solo.  The QT is ultimately the one who has to assess progress and determine that “with a few more sessions”, my learner will get this or no, s/he may never get it and it’s time to have a discussion with the manager.

BTW, what does “Qualified Employee” mean?

Being SOP Qualified is the demonstrated ability of an employee to accurately perform a task or SOP independent of his OJT Qualified Trainer with consistency to meet acceptable quality standards. It satisfies the CFR ξ 211.25 (c ) regulation, “there shall be an adequate number of qualified employees to perform”.

Don’t be tempted to take the Performance Demo short-cut!

The end goal of OJT and the Qualification Event is for the employee to perform independently of his/her QT.  In order to be “released to task”, a final performance demonstration is scheduled, observed, and documented by an OJT Qualified Trainer. But don’t be fooled into taking the performance demo short cut!  The last step in the training portion of OJT is a performance demonstration to show the OJT-QT that the employee can perform the steps AND perform at the same level of proficiency as his/her peer group. If s/he can’t perform at this level, then the learner is not ready to “go solo”.

He may need more encouragement to build up confidence, correct paperwork documentation errors, and time to become proficient with his/her speed while maintaining accuracy.  That’s what practice sessions are for; time to master confidence with the steps and increase speed.  When his/her performance is on par with “business as usual” performance levels, then the employee is ready to perform the final demonstration aka the Qualification Event.  While the “readiness indicator” may not be documented, the (Q-Event) must be formally captured, assessed with the outcome being documented and communicated to both the learner and his/her supervision.  It is a separate event from the OJT demonstrations

Final Performance Demo = Qualification Event

During the final performance demonstration, the QT observes the learner’s performance.  When feedback is provided, it is evaluative and the rating result is formally documented.  Granted, when someone is watching us, we tend to follow the rules.  With enough repeated practice sessions,  learners tend to perform procedures as “business as usual”.  It’s how they learn the ebb and flow from their peers.  This is the optimum moment to determine if s/he is truly ready to perform without coaching or supervision from his QT.  If a QT has to interrupt to correct a misstep or remind the employee that his step is out of sequence, the event is terminated and documented as requires more review. 

More training practice is then scheduled until readiness is once again achieved.  And this also means the learner cannot sign for his work without his trainer’s co-signature or initials.  Do not misinterpret this as signing for the verification entry aka the second check.  In this situation, the Qualified Trainer cannot be both the co-signer and the second check person verification/reviewer.  You will need three sets of initials to properly document the supervision of a learner requiring more practice.  Otherwise you violate data integrity rules around independent verification.

Qualification events are not intended to be a rushed get ‘er done / one and done paperwork exercise.  Sufficient time for proficiency and expected department productivity levels is required to ensure knowledge has been retained and skill can be accurately repeated.  OJT demonstrations are not to be misused as the Q-Event.  This distinction is critical to ensuring a successful qualification event and the confidence of consistently performing the SOP tomorrow, next week, etc.  And not creating a deviation one day or one week after declaring the learner qualified.

It happens when QT’s are urged to “get’em done” by impatient or overly anxious supervisors consumed with productivity and not quality metrics.  With the qualification event being so recent, the QT will most certainly be interviewed as part of the investigation.  The checklist will also be examinedThis tool is supposed to help the QT be as objective as possible and consistently evaluate performance as demonstrated.  But typically, the checklist used to qualify individuals shows all Yeses; otherwise, they wouldn’t be qualified status.  And that, of course, depends on how well the critical steps and behaviors are captured in the OJT Checklist.  Yes, he was able to demonstrate the step, critical task, and/or behavior, but what we don’t know is how well?  Are we to assume that No means “No, not at all” and Yes means performed “Well” or it is “As Expected” or “Adequate” or maybe, in this case, it was “Sort of”?  The comments column would have been the ideal place to record observations and enter comments.

Validating Your SOP Effectiveness

Meeting FDA expectations for qualified employees is paramount.  But the “100% Trained on Curricula Requirements” printouts aren’t winning favor with FDA.   In the March 2015 article, Moving Beyond Read & Understand SOP Training”, I asserted that the current 100% trained reports and SOP quizzes would not be enough to satisfy the performance challenge for training effectiveness.  Are your employees qualified? How do you know? has become the training effectiveness question asked at every inspection.  The use of “100% completed” reports is a metric for completeness only; a commonly used data point from the LMS.  It does not address the transfer of learning into performance back on the job.  Neither does the 5-question multiple-choice “SOP Quiz”. The true measure of effective OJT is an observed performance demonstration of the SOP; aka the qualification event.

Employee Qualification is the ultimate Level 3 Training Effectiveness Strategy

Level 3 Behavior Change –> Transfer of Training/Learning

The focus of Employee Qualification is about the employee’s ability to apply knowledge and skill learned during OJT back on the job or in the workplace setting.  I call this Transfer of Training.  Others in the training industry refer to this as Level 3 – Behavior Change.   Actual performance is the ultimate assessment of learning transfer.   If an employee is performing the job task correctly during the final  performance demonstration (Q-Event), his performance meets the expectation for successful “OJT Required SOP”.

Yet, according to the 2009 ATD research study “The Value of Evaluation”, only 54.6% of respondents indicated that their organization conducts Level 3 evaluations.   The top technique used is follow-up surveys with participants (31%), while observation of the job was fourth (23.9%).    

If on the job assessment is the “ultimate” measure of transfer, then why isn’t it being used more frequently? “Post-training” assessments are time and labor-intensive.   But for organizations that have to meet compliance requirements (46.9% of survey respondents), documenting training effectiveness is now on FDA performance radar.

Not all SOPs require a Qualification Event

SOPs generally fall into two categories: FYI-type and OJT Required.  The more complex an SOP is, the more likely errors will occur.  Observing “critical to quality” steps is a key focus during the final performance demonstration.  However, a 1-1 documentation path for every OJT related SOP may not be needed.  Instead, batch SOPs a/o multiple SOPs of similar processes can be grouped into a “module” with documentation supporting similarity.  Where there are differences in these SOPs, then the Q Event would also require observation of these unique CTQ differences.

Two Types of SOPs
Two Types of SOPs: Only Critical Task-Based SOPs Required OJT and Qualification Events

An active Employee Qualification Program also verifies that the training content in this case the SOP, accurately describes how to execute the steps for the task at hand.  If the SOP is not correct or the qualifying documentation (checklist) is too confusing, a cause analysis needs to be conducted. Successful qualification events also validate the OJT methodology is effective. That Qualified OJT Trainers are consistently delivering OJT sessions for “OJT Required SOPs”. 

What does “Qualified Employee” mean for a company?

Qualified Employee status is not only a compliance imperative but a business driver as well. A qualified workforce means a team of well-trained employees who know how to execute their tasks accurately and with compliance in mind, own, and document their work properly.  When anyone in the organization can emphatically answer “Yes, my employees are qualified and yes, I have the OJT checklists to back that up”, then the Employee Qualification Program is not only working but is also effective at producing approved products or devices fit for use. The bonus is a renewed level of confidence in the ability of employees to deliver on performance outcomes for an organization.

*The Value of Evaluation: Making Training Evaluations More Effective. An ASTD Research Study, 2009, ASTD.

What happens when the performance demonstration becomes more of a "this is how I do it discussion" instead of an actual demonstration? Read the Impact Story - I've Fired My Vendor - to learn more.

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From training logs to OJT checklists and beyond

I can still picture my employee “blue card” that listed my department training events when I think of training records. Long before the days of LMSes, we logged events like the monthly Safety and GMP Meetings and an occasional deviation awareness session. But logging every SOP? That was unheard of until I was asked about it during an interview. After I accepted the position, I soon found out why that was such a watershed moment for the industry and me.

Note: This blog has been updated and has moved to the blog – “From TOJT to SOJT: What else makes OJT structured?” – VB.

(c) HPIS Consulting, Inc.

Is Documenting Your OJT Methodology Worth It?

The short answer is yes! 

Years ago, during the Qualified Trainers (QT) workshop, I would ask QTs the following two questions:

  • What is OJT?
  • How do you deliver OJT?

Invariably, all would answer the first question the same way: on the job training.  And then I would ask the attendees to form into groups to discuss the second question among fellow peers.  I purposely mixed the groups so that there was equal representation of manufacturing trainers and QC analytical laboratory trainers and a fascinating exchange occurred between the attendees.  During the debriefing activity, we learned that there was a lot of variability in how the trainers were conducting OJT.  How can that be when they all answered the first question so consistently? “Well”, one of them said, “we don’t have a procedure on it so I just go about it the way I think it should be done.  I’ve had success so far, so I keep on doing what I’ve done in the past.”

Declaring your OJT Model

In order to get consistent OJT, you need to define your OJT steps and you need to ensure that only approved content (i.e. SOJT checklists)  will be used to deliver OJT; not the SME’s secret sauce. I’m not proposing a cookie-cutter approach for QTs to become all the same.  But rather, I am advocating a clear distinction between each step/stage / phase so that both the learner and the QT know exactly where they are in the OJT process, what is expected of them in that step and why the OJT step is needed.  This is no longer just go follow Joe or Jane around; this is structuring the OJT sessions.  Defining your OJT steps in a methodology ensures that all QT’s consistently deliver their 1-1 sessions and document the progression through the steps.

I’m less focused on what you call these steps or how many there are.   I am looking to see how these steps move a new hire along the journey to becoming qualified prior to being released to task.  For me, this is what makes OJT really structured.  And that model needs to be captured in a standard operating procedure or embedded in a training procedure so that all employees are informed and aware of how they will receive their OJT.   

The Assess Step

What is your purpose for this step?  Is it to evaluate the learners’ knowledge and skill via a performance demonstration, the effectiveness of the OJT sessions, or to determine qualified status?  The answer matters, because the QT will be providing feedback that impacts very different outcomes.

Be clear on the purpose of the performance demonstration

 The visual on the right indicates the main difference between how QTs feedback is used during a performance demonstration for OJT vs. feedback for the Qualification Event. Despite that, the learner is asked to perform the procedure the same way.  Is it clear to the learner what the performance demonstration means?  Does your methodology articulate the difference between a practice demo, a readiness demo, a performance demo and/or a Qualification Event demonstration?

Documenting OJT sessions presents a challenge for many trainers and document control staff.  What is considered an OJT session?  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 the OJT Model, thus documenting adherence to the procedure. 

For example, the first OJT step may be READ.  It means Read the SOP first, if not already completed. We are pretty good at documenting R & U for SOPs.  Then, the next step may be DISCUSS / INTRODUCE the SOP.  Capture when that discussion occurred if it’s different from Step 1- READ.  The “trainer demonstrates” portion can also be documented.  Where it gets tricky is when we ask the learner to demonstrate and practice.  Are we required to capture every OJT session or just one? 

Why not capture the last instance when it is confirmed the learner is ready to qualify?  If we keep it simple and document that our learners have experienced at least one instance of each step /stage, then we are complying with our OJT methodology and minimally documenting their OJT progression.   It is important to describe how to document the OJT progression in the SOP.  Don’t leave that up to the QT’s to figure out.  It is in our documentation, that we also need to be consistent.

How do you know if someone is qualified to perform this SOP?

Ideally, the answer would be because:

1.) we have a structured OJT process that includes a task specific OJT Checklist and

2.) we can look up the date of completion (Qualification Event) in our LMS history. 

And that, of course, depends on how well the critical steps and behaviors are captured in the SOJT checklist. The checklist is a tool to help the QT be as objective as possible and consistently evaluate performance as demonstrated. In the article, “A Better Way to Measure Soft Skills”, author Judith Hale explains the difference between a checklist and a rubric.

            “Checklists only record whether a behavior occurred, though, and not the quality of the behavior.  Rubrics, on the other hand, measure how well the learner executed the behavior.”  p. 62.

Yes, but was it tolerable, adequate or exemplary?

What I typically see are checklists with varying levels of tasks, steps and/or behaviors with a column for Yes, No and Comments.  What I don’t see is a column to mark how well the learner performed!  Is it enough to mark Yes or No for each item since most Q Events are Pass or “needs more practice”?  Maybe. 

But consider the following situation.  A human error deviation has occurred and the LMS indicates the technician has earned qualified status.  The document used to qualify this individual shows all Yeses.  Yes s/he was able to demonstrate the step, critical task, and/or behavior, but what we don’t know is how well?  Are we to assume that No means “No, not at all” and Yes means performed “Well” or it is “As Expected” or “Adequate” or maybe in this case it was “Sort of”? 

An additional column describing what it means to score low, medium, high or in our situation: Poor, Adequate, As Expected, and even Exemplar could provide much needed insight for the root cause analysis and investigation that will follow this deviation.  It provides a level of detail about the performance that goes beyond Yes, No, or Comment.  In most checklists I’ve reviewed, the comments column is hardly ever used.

What does the QT Signature Mean?

What the signature means on the document used to qualify an employee performing the task, technique or procedure as defined in the tool is whether or not the performance matched criteria (Y/N) or to what degree if using a qualitative rubric.

  • It does not mean that said employee completed all his curricula requirements.
  • It does not mean that said employee explained how to execute the procedure without performing it.
  • It does not mean the QT is responsible for the future performance of said employee.

In fact, it means just the opposite.  It documents that on this date, said employee was capable of performing the procedure as expected and that from this date forward, said employee owns his/her own work including deviations.  The employee is no longer being supervised by the QT for this SOP.  Without this understanding and agreement, the integrity of the whole program is put into question, not just the effectiveness of SOJT.  Be sure to explain this in the QT workshop and in the Robust Training System SOPs.  – VB

Hale,JA Better Way to Measure Soft Skills, TD, ATD, August, 2018, pps. 61-64.

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Is your OJT Methodology being documented consistently?

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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

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Are you doing the Training 2 Step?

Has this situation ever happened to you? You are in a root cause meeting and the *CAPA Investigator is conducting an interview with the primary individual involved with the discrepancy. When questioned why did this happen, he shrugs first and then quietly mumbles I don’t know. When pushed further, he very slowly says I just kind of went brain dead for a moment.  And then silence.

While that may be the honest truth, the investigator must resist the temptation to label it as Operator Error and explore possible causes. One of my favorite root cause analysis tools for “I Don’t Know Why” response is to use the Fish Bone Diagram also known as the 4 M’s diagram. This tool provides a structured focus to explore many possibilities and not just stop at the first plausible cause; such as Operator Error. Aptly nicknamed, the 4 M’s are Man, Machine, Methods and Materials.   When the results of this exercise points to a training or operator related issue, don’t stop at “operator error –> retrain”.

Consider for a moment, what this retraining session would look like. Will re-reading the procedure be enough to “jog his memory”? Will repeating the procedure be a good use of precious time when s/he already knows what to do? More than likely it won’t prevent “going brain dead” from happening again. Instead, do the HPISC Training 2 Step:

Step 1 – confirm the results of the gap analysis

Ask: What task, what step(s) or actions are in question?

Step 2 – address why the original training did not transfer back to the job.

Using the 4 M’s diagram as the framework, explore Man, Machine, Methods and Materials questions with regards to the training this operator receives. See diagram below. The full set of questions can be found in the eBook Training Cause Analysis.

4msfortrca

Is this really worth it?

I think it is. Conducting these 2 steps will accomplish two objectives.   It will provide further evidence that some kind of training is needed. And it will highlight what areas are in need of revising either for the performer, the training program or course materials. Yet, there are some who will resist this added work because it’s easier to find blame than to uncover the cause. Fixing the true root cause could trigger a re-validation of the process or an FDA filing if it’s a major process change.   Why create more work? Isn’t it easier to just retrain ‘em? No, not really. Finding the true root cause is the only effective way of eliminating many of the costly, recurring problems that can plague manufacturers.

But what if

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Some folks will push back with the excuse – “this never caused a problem until now”, so it must be the operator’s fault! This may be the first time it was discovered but that does not mean the procedure is 100% accurate. Often, experienced operators know how to work around an incorrect step and don’t always report a misstep in the procedure while a less savvy operator follows the procedure and causes the non-conformance to occur. See Sidebar SOP Logic Rules. Is the procedure difficult, lengthy or requires weeks to become proficient let alone qualified? Was the qualification routine or performed as a simulation? Was the procedure written with support from a lead operator or qualified trainer? Did the draft version undergo some kind of field test or dry run prior to release? And the classic situation, are proposed changes hung up in change control awaiting effective release?

Understanding Why Human Errors Occur

Industry practice is evolving to explore why people make the decisions they do by looking at the Organization’s systems. It’s usually a poor decision made somewhere in the error chain. We must believe that the person who made the poor decision did not intend for the error to occur. As part of CAPA investigations, we need to explore their physical environment as well; the conditions under which they make those decisions. The Training Program Improvement Checklist can be requested using this link to capture your findings.

If you are going to spend time and money on training, at least identify what the gap is; fix that and then “train” or provide awareness on what was corrected to prevent the issue from re-occurring again.   That is after all, the intention of *Corrective Action Preventive Action investigations. -VB

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(c) HPIS Consulting, Inc.