An urgent request to fix a broken training system is typically the point of entry for my Robust Training System (RTS) makeovers. When I join the conversations, I discover that a lot of “work” has already begun. So, I take a deep dive into the documentation to “hit the ground running and get caught up to speed” as quickly as I can. By this time, the agency response letter has already been sent with commitments to correct observations and promises to fix system issues. And immediately, CAPAs are opened to track these activities. Sigh. [CAPA = Corrective Action Preventive Action]
So often, immediate fix CAPAs are generated so quickly and only focused on the fast fix of the observation, that the short-term benefit becomes a major barrier for the long-term prevention of a systems upgrade. The advice that is given to a CAPA owner is “don’t fixate on the big picture right now, we can always revise it later…”. “We’ve only got 15 days to respond to the agency”. While revisions are part of our SOP management system, revising the CAPA fix to something else in the next revision can appear to look like it was only for the FD-483 observation or the Warning Letter response.
And a lot of the time, those CAPA fast-fixes conflict with a proposed future state. It can become a huge obstacle to redesigning an effective and efficient quality training system. There is a belief that it takes too long to map out the proposed future state and pinpoint exactly where the observation or citation gets corrected. Given how some redesign projects are managed, there is a lot of truth to that belief. So, the rule of thumb is to correct first, then come back and “improve” later when site employees have a moment to catch their breath. But closing out those fast-fix CAPAs in record time prevents redesign projects from moving forward because available SMEs are busy executing the corrective actions. What’s really frustrating is realizing that the fast fix is incompatible with the proposed future state. Sigh again.
Little CAPAs and Big CAPAs
By little CAPAs I am referring to the immediate fix corrective actions and in no way am I minimizing their importance. Their scopes tend to be single focused and short term. By comparison, big CAPAs are created when many of the little CAPAs are rolled into one big CAPA. The scope is expanded to include the related little CAPAs because the corrective actions relate to each other, impact each other, and may produce repetitive paperwork. So, all the CAPAs get bundled together in an overall CAPA aka, the big CAPA.
When this occurs, be careful that little CAPA commitments to the agency via response letters don’t get lost in translation. By that I mean, the fast fixes need to remain visible or traceable in the deliverables of the project. If by chance those steps were removed or changed, be prepared with heavily documented justification with appropriate approved signatures like Department Heads. Take note, merging little CAPAs into one big overarching CAPA usually changes the completion timeline given that the scope of the big CAPA is bigger. For most projects, this is a welcomed relief. It can also change the timelines of the little CAPAs. Be mindful of the commitments made to the agency.
But We’ll Be Out Of Compliance The Second The SOPs Go Into Effect!
One way to keep multiple CAPAs visible is to create subprojects that are also managed within the overall future state project. Sometimes these projects have completion dates projected to be 6 – 9 months out. Yet, the future state quality system procedures need to be operational before these subprojects can come to fruition. In essence, the day the SOPs go 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 (the Big CAPA) can be generated to allow the organization to meet agency milestones and move forward with the new process while working on the subprojects. The key to this approach is ensuring that the implementation plan is written, approved, up to date, and indicating progress forward.
During the development of the last set of redesigned SOPs for a client, FDA conducted a follow-up visit for the original FD-483 inspection. One of the little 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.
As part of their Go-Live strategy, a decision was made to schedule the release of the revised procedures all at once when the final set of SOPs was ready to go to Change Control. It was determined 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.
Unfortunately, this incomplete CAPA created a hold for product to be released. As a result, the priority to complete a retrospective qualification of 700(+) SMEs as Trainers derailed the Training Quality System project for close to 4 months. Painfully, additional immediate fix CAPAs were also generated. Ironically, these CAPAs could have been avoided if the design team chose to release each SOP as it was ready instead of waiting for all of the SOPs to go into effect all at once.
Be Mindful Of The Quest For The Perfect SOP
The most typical corrective actions involve revising procedures to include a changed step, a form revision, or in some cases, a completely overhauled process that includes multiple work instructions or SOPs. Standard Operating Procedures mean a description of the approved steps for the task at hand to be followed repeatedly without exception or deviation. But SOPs are not static, they change frequently which is a good thing for folks who seek improvement and a source of exasperation for the end users assigned to keep current with their procedure revisions.
Change fatigue is real and can often be the root cause of SOP deviations. CAPA owners need to be made aware of the learning curve for major revisions. Hence, awareness training and primary end-user workshops are integral for implementation strategies. However, the antidote for SOP change fatigue is not waiting for the perfect SOP that will never change again! But knowing in advance that a procedure is going to revise multiple times is also frustrating. Just when end users get used to the change(s), the SOP changes again and quite possibly re-introduces a host of deviations almost suggesting that the changes are a waste of time and energy.
There Is No Such Thing As The Perfect SOP; Don’t Delay CAPAs Unnecessarily
What then is the remedy? Conducting impact assessments of the change(s) and then managing the go-live strategy for awareness training, triage support, and FAQ type communications depending on how big the change gap is. And this is exactly the approach that one Quality System L & D Manager implemented as part of the go-live strategy for a major overhaul of her training system.
With 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 monitored and project tracked as well. This information shaped a pragmatic and timed sequence of events that lead to the conclusion that releasing one SOP at a time was the most effective way to transition into future state with minimal disruption despite that the overall quality system policy document would have to be revised multiple times during the transition period. The project lead volunteered to be the task master on those subsequent policy changes and updates for the stakeholder briefings.
Agile Approach Enables SOP Change Resilience
The timed sequencing of these revised SOPs addressed potential version confusion and change fatigue. By managing smaller rollouts, there was less impact on the organization. The Training Manager was able to introduce the employees to SOP change resilience by combining awareness training, project briefings and end user feedback for the “next SOP revision”. Rather than dread the next release, end users discovered that their feedback was taken into consideration. And in most SOPs, the next release didn’t really change anything but rather added another component or element of the future state that they were now ready to implement.
The iterative design and roll out expedited a continuous improvement cycle that kept the project moving forward to meet FDA commitments, milestones, and stakeholder expectations. -VB
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Who is the Author, Vivian Bringslimark?