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
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/procedureand 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
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.
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?
HPISC has created a 2 part checklist of questions and attributes to explore. The checklist is available gratis when you become a HPISC mailing list member. Just be sure to include that are you interested in receiving the SOJT Readiness Checklist.
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.
The Client Request –”Can you help us upgrade our Trainer Qualification process?”
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
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!
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.
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
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 is “Are 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:
II. QT Workshop/TTT Equivalent
IV. Performance Demonstration
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
Rigorous Curricula that includes SOJT and Qualification Events not just SOPs
Methodology for OJT Steps that includes documentation
Qualified Trainers who deliver SOJT curricula requirements
Individualized Learning Plans and schedules for New Hire’s Learning Journey
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.
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
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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Develop Your Go-Live Strategy Before Opening up a Change Control Request
Don’t underestimate what Go-Live will look like the day the new SOPs go into effect. The overall project plan may reflect one lined task – [Go-Live] and the date, but who is responsible for making it happen? Doc Control administration hits a button and the eDoc system sends out a notification or perhaps folks find out about the revisions and effectiveness date from their LMS notification. What else needs to be done, you ask? Actually, a lot of things and without a detailed plan of assigned tasks or a set of instructions, the first week of Go-Live could be disastrous if not managed well. Whether it is broken down further in the project plan or contained in the communication strategy, the plan needs to drill down into specifying how tasks and activities will be managed, by whom and by when.
Step 1 – Transition Options
Most quality system redesigns include more than one SOP. Sometimes the project includes multiple work instructions that are designed to work in tandem. Releasing one without the other automatically creates a departure from the new SOP. One approach design teams take is to release the package all at once. Other teams decide to release serially, one after the other with timed intervals to manage the learning curve. Other approaches include pairs or high priority clusters similar to a wave or a phased tactic. All have their advantages and disadvantages.
And all need an impact assessment that examines the details about what will change, how that change will be handled and how many users will be involved. In other words, how many tasks could be out of compliance when the procedure(s) goes into effect? Will the release shut down the organization on Day 1?
vs. Later – Timing is Everything!
A few years ago, a client received a pretty involved FD-483. One of the corrective actions was to enhance the Training Quality System. So, a project team was deployed, process maps verbally approved, and the revised SOPs were in various stages of being ready for a field test. The design team was concerned that SOP decisions for in-process drafts could impact the final drafted SOPs significantly. The team needed to be able to update a final draft SOP immediately without getting bogged down in their change control process. Not to mention managing a new round of awareness training that could change a week later!
as part of the Go-Live strategy, a decision was made to schedule the release of
the procedures all at once when the final set of SOPs were ready to go to
Change Control. It was determined
(assessed), that too many little changes for the Training System would result
in confusion, retention issues, and a paperwork nightmare controlling which
version of the form was correct. This is
a popular option for design teams because the coordination of new changes
happens on the same day and is much easier to track. Albeit the learning curve
can be high as the site works on closing the size of their change gap.
During the development of the last set of SOPs, FDA conducted a follow-up visit for the FD-483. One of the training CAPAs was not yet completed. It was waiting for the redesigned set of procedures to go into effect. The new version would encompass this observation and essentially close it out. Unfortunately, this incomplete CAPA created a hold for product to be released. As a result, the priority to complete a retrospective qualification of 700(+) “trainers” derailed the Training Quality System project for close to 4 months. Additional immediate fix CAPAs were also generated. Ironically, these CAPAs could have been avoided if the design team chose the serial release option.
Step 2 – Who Will Do What, When?
Establish roles, responsibilities, and priorities for the transition period. This means identifying the beginning and end date for the transition from what we used to do to what we will do by what date. When do we anticipate being fully operational with the new procedures? Is the end date automatically the day the procedures go into effect? Or is there a sequence of tasks that need to be executed before the Go-Live date? Have those tasks been assigned to individuals with clear expectations and due dates?
Still Open During Our Construction Phase!
One client began their Go-Live Strategy with Step 2 to help assess the impact of the changes to her organization which dictated the decision to release each SOP serially; one at a time. Using a worksheet, each targeted SOP was listed vertically while impact criteria were listed horizontally. The team need to “see” associated form numbers, cross-referenced SOPs, the actual impact, mitigation steps, how to transition, other impacted documents, disposition status and dates of those other documents and of course next steps.
careful examination of what tasks, forms, and steps were actually changing, the
Project Lead was able to realistically determine how much time it would take to
mitigate the impact. Subtasks such as
final form revisions and revisions to other documents were being monitored and
project tracked as well.
This information shaped a pragmatic and timed sequence of events. Resulting in the conclusion that releasing one SOP at a time was the most effective way to transition into the future state with minimal disruption despite that the overall policy document would have to be revised multiple times during the transition period. The project lead volunteered to be the taskmaster on those subsequent policy changes and updates for the stakeholder briefings.
What else needs to be done, you ask? Actually, a lot of things and without a detailed plan of assigned tasks or a set of instructions, the first week of Go-Live could be disastrous if not managed well.
Vivian Bringslimark, HPIS Consulting, Inc.
Included in this impact assessment were numerous immediate response CAPA corrective actions. It was vital to ensure that future state procedures did not eliminate commitments that were made to the agency. These CAPAs resulted in subprojects that also needed to be managed within the overall quality system redesign project. Given the scope of these projects, completion dates were projected to be 6 – 9 months out. Yet, the future state quality system procedures were expected to be operational way before these subprojects came to fruition.
In essence, the day the SOPs went into effect, the site would automatically be out of compliance and numerous deviations would have to be initiated. To manage the SOP change gap, an overarching CAPA was approved to allow the organization to meet agency milestones and move forward with the new process while working on the subprojects. With each planned release of a future state SOP, the impact assessment worksheet was updated with feedback including future release notes.
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Catch up on the previous redesigned Quality Systems blogs here.
Training can be considered a change in what the learner knows now | can do now and what s/he knows and does afterward. Training can close these gaps when knowledge and skill are lacking. Thus, a trainer has a dual role: trainer and change agent. While on the surface, the actions a trainer takes looks like change management, it is a sub-part of the larger change management plan. The scope is narrower. It is focused only on the training content. But the expectations for successful transfer back to the job and improved organizational results remain the same. One allocated and approved session designed and delivered by the training department is supposed to shift years of a mindset, alter behaviors and change the company’s culture. Amazing!
This expectancy or shall I say management assumption is very real and prevalent in fast-moving start-up companies whose leaders claim to have a limited budget for “training” and no time to sit in frivolous meetings planning “the people side” of change. I’m supposed to be grateful that I get an hour session. What happens next also amazes me. Training on the proposed system changes is reduced to an hour-long awareness session on the SOPs that have already gone into effect and folks are told – “Go with the flow. Change is part of our everyday life around here. Get with it or get out”. And here’s the rub for me, errors rise, deviations spike, users are annoyed, pissed off or disenfranchised and management blames the trainer for a failed change effort. Wow! Is this the management support that was promised to folks at the town hall meetings?
The bigger the redesigned quality system changes are, the more you need to consider beyond just training awareness on the SOPs. Assess the size of the change gap and the impact the new design will have on the culture; “the way we normally handle changes around here”. Training rollout sessions are already time-crunched. There is not enough time “allowable” to manage all the other non-training change issues like feelings, job security concerns, why the need for change retorts, lack of supervisory support post-training, etc. that actually get in the way of a successful learning transfer. And later create hurdles for improvement results.
Let’s look at the HPISC 5 Step Change Management Plan and apply it to quality system redesign projects. (See the sidebar below.)
Management Plan Considerations
1. Why is
the change needed?
This may be really obvious when the site receives a Warning Letter. But an explanation of how this became a driving force for the needed changes will do wonders for your employees to feel the urgency about the change.
is really changing?
Will the changes be incremental or a huge transformational change such as “changing the quality culture”?
How are these SOP changes part of the GMP culture?
are the pros and cons of the change?
Who benefits and who loses?
Are customers hurt or helped?
What are the stakeholder’s benefits from the change?
What about the benefits for the primary users?
does success look like?
will the outcomes of the change look like?
will you and others know if the change has been successful?
benchmarks will help you track progress?
is the day or timepoint we get to declare success?
other initiatives are we competing with?
how will adding the new change requirements impact already heavy workloads?
Will Awareness Training be the only
vehicle for announcing the new changes?
Are the answers to the change management questions sitting with the trainer/training department or with the site leadership team? Perhaps the answers can be found within the steering committee members? Is the trainer supposed to address all of these questions in a 60-minute awareness session that also includes the SOP changes? If successful user adoption is paramount to your strategic action plan, warning letter remediation plan, or CRL commitment response, you need to ensure that change management messages regarding these changes are included in the overall communication plan. Don’t just rely on the design team members to deliver these messages casually at huddle updates. That is not a communication plan.
“The bigger the redesigned quality system changes are, the more you need to consider beyond just training awareness on the SOPs”.
Vivian Bringslimark, HPIS Consulting, Inc.
The design team with the aid of the project manager needs to schedule special change management sessions where the Affected Users are briefed on the status of the project and the answers to the questions listed above addressed. Some leaders do not want to “waste time” on these sessions. They are concerned that it will become a gripe session. Instead, they think it’s better to just present the users with the revised procedures. There’s less time to fret and grumble over it.
There is a false belief that once the Affected Users see the changes in a QA-locked down version, they will follow them “because it’s now in the approved SOP”.Forced acceptance is not a change management strategy despite rampant practice in our industry. If awareness training will be the first time affected users are learning about significant system changes and the “Go-Live” date, be prepared to receive A LOT OF FEEDBACK FROM UPPER MANAGEMENT regarding how awful the awareness training sessions went.
“Change is disturbing when it is done to us, exhilarating when it is done by us”.
procedures impact all personnel, temporary employees, consultants, and
contractors involved in the manufacture of GMP drug products. However, inviting all affected users to
review the proposed changes is not practical; nor efficient. Neither is skipping the advanced review while
hoping that the draft SOPs will be approved quickly. This is a surefire way to derail the
project. And just might add to the
resistance for changed behavior these procedures are seeking.
I’m amazed at all the feedback that surfaces after the procedures go into effect. A field test is an effective vehicle to generate user feedback that is constructive, timely and can be used to evaluate concerns before the procedures go live. It can be as simple as an “Open House” with silent feedback forms to a full-fledged Pilot Program with formal feedback.
pilot would be ideal. What better way to
gauge the impact of the desired state than to pilot it in the workflow? But,
this would require two processes (the current one and the proposed one) to be
executed simultaneously. What a documentation nightmare this would cause; not
to mention the lack of approval for the plan.
An alternative approach is to invite impacted department heads, business
unit leaders and a handful of affected SMEs to briefing meetings.
The scope of the meeting is focused on one task.
The project manager (PM) controls the copies of draft SOPs and Forms.
The PM provides a forum for discussion by providing the updates in advance and still has development time to consider the feedback before submitting to Change Control/ Document Control.
Invited folks are “now in the know”.
Expedites change control review and approval workflow later on.
Open House Invitation to Field Test the Process Redesign
The goal of this Field Test was to provide targeted feedback sessions with identified internal customers before new procedures became effective. Three feedback rounds were delivered each designed to achieve targeted stakeholder and user feedback.
Session # 1 – Formal Project Update and sharing of Communication Plan for the Project. The first feedback form was developed to capture participants’ observations in general.
Session # 2 – Simulated Scenarios that challenged the future state process. Scenarios included routine processes and new situations such as major changes to an SOP for example. Two feedback forms were used: one for procedural steps and a second one for the proposed forms.
Session # 3 – Silent Feedback where users provided their comments, questions, concerns and overall experience. Similar to a “brown paper exercise”, the entire process was pasted on the wall showing actual steps, decision points, documentation, and interfaces with other systems. The exercise got users involved and they commented on strengths, weaknesses and further opportunities. By enlarging the process maps to wall size, users literally walked through the process and used a feedback form specifically for this activity.
The rounds were scheduled in advance to allow the design team to leverage the feedback from each round and make changes before the next round of feedback began. Participation in the previous round was a prerequisite for attending the next round to minimize having to brief new participants on the project; thus, keeping the sessions short and focused.
This is the 3rd blog in the on-going Redesign Quality Systems: Achieving Successful User Adoption series. Visit Blog 1 and 2 here.
Assessments – “Truth Be Told”
Assessing the current state of the targeted quality system is analogous to collecting the “voice of the customer” input. Discovering what is and is not working is vital to ensuring a successful redesign and ultimately user adoption. This is more than a review of the SOPs and forms; however. Interviews are key to this phase of the project. From the system owner to primary users, QA staff and even the LMS or the eDoc administrator are essential. The more cross functional the input, the better the confirmation of the “data” and the “evidence”. Which in turn, provides a truer gap assessment.
Most interviewees know the system’s weaknesses and they know how to fix it. But they are frustrated with ignored attempts to change it. Many simply give up trying to get it changed on their own or within their circle of responsibility. So, when quality systems interviews are being conducted with an external consultant, some are eager to share the “dirt” on just how broken the system really is. And some of the “fixes” are political and can only be handled when trust has been earned or when the sponsor deems it so.
recognize Training is important but …
A small vitamin and supplements company set out to become a commercial manufacturer of pharmaceutical drug products. Naturally, their quality systems were not robust enough to meet 21CFR 211 code of regulations. So, assessments were conducted for the major quality systems. The Training Quality System assessment revealed several positive activities that were enabling current success and a lot of gaps that would need to be addressed to meet regulatory expectations for today’s pharmaceuticals companies.
The sponsor explained that without top leadership support (meaning physically show up and attend this debriefing meeting), no one else would show up nor take the project seriously.
The sponsor routed the Training Gap Assessment Report to his peers and the CEO with an invitation to attend the first in-person briefing. No one showed up except the sponsor, his direct reports and the consultant. The meeting was rescheduled for a month later when all executives’ schedules showed availability. One month later, the sponsor learned that key executives would be out of office during the meeting, so he postponed the briefing indefinitely.
The sponsor then arranged for a one-on-one follow-up session with the CEO and explained that without top leadership support (meaning physically show up and attend this debriefing meeting), no one else would show up nor take the project seriously. He also reiterated that in order to grow the business as intended, resources needed to be hired and the quality systems including Training needed immediate prioritization. Or else the company would not receive approval to manufacture and could further impact its current relationship with the agency.
Three months later the meeting was scheduled. However, the agenda took on a different focus. Particularly, the collaboration benefits of working cross-functionally with department managers and the shared ownership for the Training Quality System. More specifically, the training project was not just a QA program, but a robust training system that impacts all employees. This time the meeting occurred and was fully attended by all invitees.
Readiness for the Design Team
the briefing finally conducted, the sponsor explained to the consultant, that the
“Design Team of SMEs” had very limited experience working cross-functionally or
as a team. They knew even less about project management concepts like scope and
project charters and they lacked fundamental concepts like quality systems and
systems-based inspections. And they did not
know how to process map. They had been silo’d far too long.
The consultant’s background included curricula building, instructional design, and quality systems redesign experience. She sketched a brief outline of the mini-curriculum for the Design Team of SMEs and the Sponsor agreed. Over the next few weeks, they used their meeting time to work through the 4 introductory lessons. And as a team, they used the “live” aspects of the project work to illustrate the concept and apply its principles to the progress and development of their team. In essence, they were taught just what they needed to know at the moment the project needed it, similar to learning in the flow of work. Four weeks later, the team was ready to begin their process mapping sessions together.
Engage Users from the Beginning and Throughout the Redesign Project
When Quality System
redesign CAPAs are project managed using the 5 typical phases (see diagram),
the progression of the project is easier to track and report status updates to
Tapping into the different types of users for their input from the start of the project advances their engagement with the project along with the phases.
For example, during the Initiate Phase, an assessment of the current procedures, processes, and practices can include a variety of users, not necessarily the SMEs or system owners only.
But without an organized and approved communication plan for each of these phases /stages, rumors evolve, misinformation circulates and the success of the new system being adopted is put into jeopardy.
Managing Stakeholders Expectations
A popular activity from the project management toolbox is to conduct a stakeholder analysis whereby a list of affected folks is captured. And their role with the project team is clarified. A handy acronym called PARIS can be followed: Participant, Accountable/Owner, Reviewer, Input Required, Sign-off required before proceeding. Also popular is a RACI matrix chart where;
So who are the stakeholders for the quality systems? In a
quality system redesign, the following types of stakeholders are usually
QA, HR, IT if it includes technology platform or upgrades
All affected Users.
Additionally, team members can identify their stakeholders’
relationship to the project which can be very helpful when the project hits
barriers and is sent derailing off timelines.
Executive Sponsorshipis a Key Success Factor
Quality systems by their nature are interdependent and
frequently cross into boundaries of other departments’ workflow. Sponsorship is
needed especially if the changes are significant, there are multiple quality
system projects happening at the same time and other site initiatives all vying
for the same resources. Every quality
system redesign project needs an executive sponsor:
To approve resource requests
To become aware of the impact of the changes being proposed
To be informed with the most current status
Thus, naming the sponsor holds this person accountable for
the expected results. Thereby endorsing the project and becoming an advocate
for the team’s work.
The Communication Strategy
the stakeholders have been identified and categorized, the next activity is to
determine what level of involvement is necessary. Ask them directly. Ask them how often and in what format do they
prefer. If you think one size fits all stakeholders, think again. Many a project has derailed, missed its goal
or became defunct as a result of miscommunication and misunderstandings. Often stakeholders do not interact directly
with the team. It’s the Project
Manager’s responsibility to be the interface.
One way to achieve this is to conduct briefings.
Briefings as a Communication Medium
The purpose of briefings is to provide updates on
the project regarding timelines, milestones, deliverables and unresolved
issues. The expected results for a
redesigned quality system are not always clearly understood because of confusing
priorities and diluted focus.
Not all briefings have to be conducted in person via meeting time and conference room space. Storyboard updates can be routed electronically. Weekly updates, interim reports, and even significant project meeting minutes can be useful for briefing the stakeholders. Make sure you match the type with the frequency as per your stakeholder analysis and communications strategy. As the project progresses through its phases, stakeholders’ roles can change. Use these briefings to continuously check-in for feedback and adjustment with frequency and format.
Routine Stakeholder Briefings: An
example in practice
One client of mine decided to leverage the cadence
of their standing update meetings and used the proposed system changes as the
focus of the agenda. As each procedure
progressed to working-draft status, the Project Manager invited the key stakeholders
and guest users to the meeting.
She diligently took notes in the drafts, captured
their concerns on the parking lot flipchart and brought up issues from the
design team for further exploration and discussion among the system owners.
Then she invited them back to the next briefing to review the newest SOP drafts
and secured a verbal approval for the draft so that the draft did not get hung
up in disagreements among the approvers during formal change control.
They used the briefings to work through their issues and concerns. She would point to where the previous discussion was now resolved and often, she would provide an explanation as to why a concern or an issue did not get acknowledged in the procedures as discussed. Participation in these meetings was generally good; a few key leaders were absent from time to time. So, occasionally one-on-one meetings were scheduled for critical approvers.
In the next blog, I will walk through assessments in more detail. – VB
Feeling a bit lost with the sequence of this blog? It is second in the Redesigned Quality Systems series. Check out the kick-off blog here.
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