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.
Go-Live: 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?
Now 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!
So, 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.
Go-Live: 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?
We’re 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.
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 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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