For companies who are required to have standard operating procedures (SOPs), managing changes and ensuring affected employees are up to date is a constant challenge. Especially for companies whose weekly revision churn rate is from 10 to 150+ revisions. The standard approach is to “get ‘em done” in the fastest amount of time. The end goal for most people is the proverbial (√) and lots of records claiming “read and understood” the procedure.
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.
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.
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
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
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?”
I say no, not at all. Ask an Operations Manager and he’ll acknowledge that what it’s called is less important than getting the “assignment” done and entered into the LMS. He’s usually more concerned about the loss of productivity during the training than the effectiveness of the training at that time. It isn’t until later when the training may have to be delivered again (repeated), that the comment “training doesn’t really work” is heard.
Retraining is typically delivered as repeat training. Corrective Actions from *CAPAs usually trigger these types of required training events. In the context of the specific CAPA, we uncover the error, mistake, non-conformance, or what I like to call performance discrepancy from the expected outcome. It is believed that by delivering the training again, the cause of the discrepancy will be resolved. That is if the root cause was determined to be a lack of knowledge, skill, or not enough practice.
Some folks believe that more is better and that with several repeated training sessions, employees will eventually get it right. It always amazes me that we find time to do repeat training over and over again but complain very loudly for refresher training, significant **SOP revision training or even new content training. (*Corrective Actions Preventive Actions, **Standard Operating Procedures).
Refresher Training implies that training was already provided at least once. The intention here is to review on that content. A lot of regulatory training requirements are generated to satisfy this need. Common examples are Annual GMP Refreshers and several OSHA standards such as Blood Borne Pathogens training. While the aim is to refresh on the content, it is not necessarily meant to just repeat the training. Also included is the part – “so as to remain current” with current practice, trends and new updates. Hence, refresher training needs to include new material based on familiar content.
Upon Biennial SOP Review
There are some folks who would like to use this required SOP activity to coincide with the need to “refresh” on SOPs already read and/or trained. The rationale being that if the SOP hasn’t revved in 2 or 3 years time, more than likely the training hasn’t been repeated either. So, it sounds like a good idea to require that SOPs be “refreshed” upon using the same SOP cycle. One could argue for the prevention of errors; thus, in theory, this sounds very proactive.
But donning my Instructional Designer Hat, I ask you, what is the definition of training – to close a knowledge gap or skill gap. What value is there for forcing a mandatory “refresher reading” on SOPs just because the procedure is due for technical review? In practice, this becomes one huge check mark exercise leading to a paper work /LMS backlog and might actually increase errors due to “information overload”! Again, what gap are you trying to solve? In the above refresher scenario, we are avoiding a compliance gap by satisfying regulatory requirements.
Defending Your Training Process
For those of you who have fielded questions from regulators, you can appreciate how the very training record produced generates follow up questions. How you describe the conditions under which the training occurred or is “labeled” can impact the message you are sending as well. Calling it retraining instead of refresher training implies that training had to be repeated as a result of a performance problem not meeting expectations or standards. Whereas refresher training occurs at a defined cycle to ensure that the forgetting curve or lack of practice is not a factor of poor performance. It is a routine activity for satisfying regulatory expectations.
For end-users, clarifying the difference between refresher training and “repeat” training in your Policy/SOP not only defines the purpose of the training session but also provides the proper sequence of steps to follow to ensure maximum effectiveness of the training. There’s a difference between training content that is new /updated vs. delivered as a repeat of the same materials. Yes, a new and/or updated design takes resources and time. How many times do you want to sit through the same old same old and get nothing new from it? Recall the definition of insanity – doing more of the same while hoping for change. You just might want to review your Training SOP right about now. – VB
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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What really happens to “change initiatives” after the CAPA due dates are met? Is the project done because the consultants leave? Or is it when the new priority has been re-directed to another pressing issue? What kind of post-implementation support is there for the leader charged with the ultimate responsibility for the improved performance of the redesigned quality system(s)?
But how did we get here?
The Compliance Situation
Whether it was a Warning Letter, a series of problematic 483 Inspections, or an OAI letter from FDA, you are now facing a compliance situation that has become your #1 priority. If you are like most companies in this situation, Quality Improvement (QIP) Teams or CAPA groups are formed and are typically managed with an outside Compliance Consulting firm that is leading the overall compliance strategy using a popular 5 phased project plan. See the visual example below.
Congratulations on taking action to quickly rectify your status with the agency. In most cases, the redesign of one of more quality systems is part of the commitments made to the FDA, sometimes with very aggressive due dates.
CAPA Teams Produce Good Work
individuals assigned to these teams collaborate on the necessary decisions to
redesign current procedures and produce streamlined processes that link the
inputs and outputs of key critical quality systems. Team members trace and re-trace the process several
times to challenge their thinking and include steps for non-routine situations
that are known to happen occasionally.
They examine how the current forms will be used to ensure that the right
information is captured and forwarded on to the next system when required. For some system redesigns, new forms need to
be created or undergo significant modifications that result in better
compliance to form requirements.
When Due Dates Are Met
there a collective sigh of relief? Is
the project now completed? It might
appear that way since the consultants have left and the new SOPs are in
effect. The mindset at this point may be
akin to: “So long as we met the due dates
and everyone has been trained, the new system redesign should run smoothly,
right?” Ideally yes, but the reality
is no. I often hear comments like these:
“even though we trained everyone and sent out GO-LIVE emails, there is still a
lot of confusion.” Another classic one is “the learning curve for new system
changes is expected to be high initially considering how many changes we made.”
So what happened? Was there a rush to complete the awareness training and collect knowledge checks as evidence of effective training? It is no surprise that training on the new procedures follows the redesign. But what is a surprise is when the Training Group is notified to make it all happen just days before the due date.
When is the Training Group invited to
the project meetings?
Often the Training Group is late to the planning conversations and sometimes very late to the rollout discussions. There’s never enough time to deliver a proper training session, so in 60 minutes or less, folks are supposed to have all their concerns addressed and get “trained” on all the changes.
Suggestions and new ideas are captured for the “next revision” because it’s “kind of too late” to revise the procedures at this point. And when the deviations start racking up, we sigh, shrug our shoulders and check the box for human error/learning curve. There is a better way to manage the rollout.
This new blog series will examine why “training only roll-outs” are not enough to gain 100% participation and compliance with changes associated with Quality Improvement Plans (QIP) / Continuous Improvement Plans / Strategic Action Plans.
I often hear comments like these: “even though we trained everyone and sent out GO-LIVE emails, there is still a lot of confusion.”
I will include descriptions of additional project tasks/actions that need to be designed, planned for and incorporated into the overall QIP that are often left out or neglected. One such area is Affected Users.
In this blog series, I will also identify several opportunities for the inclusion of Affected Users and how best to include them throughout the project phases. The series will wrap up with additional blogs on suggestions for maintaining the new changes for sustained performance improvement.
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BONUS Material available
You might be interested in reading this BioPharma article about Quality Systems.
Looking for Remediation support? Check out these items in the HPISC library.