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
The 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
Is 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 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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