Blog # 9 is the final blog in this Redesigning Quality Systems series.
Refer to blog # 7 for an overview of the 5 Steps for GO-Live Strategy.
Go-Live: Step 4 – Triage Impacted Documents
The purpose of the triage step is to manage the impact of in-process system documents the day the new design goes live. What happens to forms that were started and not yet completed? Employees will need to know how to move forward and still be in compliance. The easiest path on Day 1 is to use the new form(s) to begin a new record. But what about the documents that were already started? The ones that were initiated. They will reflect the previous version although in effect at the time of initiation. Anticipate these questions from affected users:
- Do we process the old form?
- Do we start over with the new form and add the original started document with EOD notation for missing information?
- Do we suspend and pick up with the new form?
A good example of this situation is when paper change control requests have SOP drafts attached. The Project Manager with the guidance of the Head of Quality needs to meet prior to the launch date to carve out the decision paths based on the amount of initiated documentation stages each document contains. These decisions and individual directions are the main tenets for daily guidance from the Project Manager and/or Quality System owner during the start and end period for the transition phase. Revisit Step 2.
In addition, s/he or a small team needs to answer questions that are sent via emails, phone calls, drop by’s and drop-ins for direction on how to close the loop on initiated previous versioned documents. Anticipate additional 1-1 coaching through the new paperwork until the end of the transition period.
“What happens to forms that were started and not yet completed? ”Vivian Bringslimark, HPIS Consulting, Inc.
When Will We Be Fully Operational with The New Design?
When this design team began putting together its go-live strategy, their impact assessment (Step 1) mirrored an “End in Mind” approach. The project manager asked, “what needs to be in place in order for us to be fully compliant with this procedure”. The list of items was long. The second question – “What is the best way to accomplish this” was then asked and detailed steps were captured. The third question focused on the estimated time to complete and so on. In essence, the team was generating an implementation plan to guide its launch decisions. It became clear that they needed to launch in high priority clusters.
However, two cluster sets were competing for first place to launch. One focused on the business objective while the other focused on establishing foundational principles for the quality system. In a stunning presentation, the system owner made her compelling appeal to the site leadership team and was given the approval to begin with foundational principles despite the number of tasks and time to complete those tasks.
In order to move forward with identified tasks from the implementation plan, the team needed the high-priority procedures to be in effect in order to gain cooperation from department managers. This created a compliance dilemma of being out of compliance immediately upon launch. To mitigate this gap and not create unnecessary deviations, the system owner generated a change control packet that also included the implementation plan tracker. It gave the design team the necessary authority to invoke the changes without becoming bogged down in the compliance dilemma dialogue which derails progress.
When FDA made an unannounced visit to the site weeks later, the change control packet of documentation was not only accepted as an appropriate way to cover the obvious compliance gaps in the new procedures, but the implementation dates were moved up and execution of the plan became a site priority.
The project manager asked, “what needs to be in place in order for us to be fully compliant with this procedure”.Vivian Bringslimark, HPIS Consulting, Inc.
Go-Live Step 5: Monitor Performance and Collect Feedback.
The project ends for the consultants when the handoff is completed, and they disengage. The handoff usually includes a formal document describing the current status of the system at the point in time including deliverables, suggestions for next steps and sustainment.
Can the team celebrate that the project is over? Or should they wait until someone determines whether it is a successful adoption? Recall Step 2 of the Go-Live Strategy defined the end date of the transition period as well. Did this include the expected date for being fully operational? By the way, who is responsible for declaring success or needs improvement?
Phase Three – Successful User Adoption
One more component of the overall project plan is User Adoption aka Phase 3. In my experience, this is perhaps the most overlooked phase in redesigning quality systems. Once training is delivered and the consultants leave, “life as normal” sort of returns with pockets of progress, “learning curve” deviations and loads of suggestions for “fixing” the new design.
In this phase, the project plan expands Go-Live Step 5 into two main activities, initial user adoption results and sustaining the redesigned quality system through controlled continuous improvement feedback loops.
User Adoption: Did we succeed?
What kind of data/evidence will you use to confirm the success of the Redesigned Quality System? Will you be relying on the CAPA Effectiveness Check statements to determine User Adoption success? One word of caution here. These may be too narrowly focused on particular steps as it maps back to a single observation and does not provide enough evidence to tell a complete story just yet.
What the System Owner really needs to know is:
- Who is following the new process? Who is still dragging their feet? Who is confused about how to proceed? Who needs help remembering what the changes are?
- Do we have any early examples of how or where the new process is helping to produce positive results?
- What is the value of those results?
- How long do I have before I am forced to release the next set of “promised” revisions?
You Need a User Adoption Study
The purpose of the study is to get data both quantitative and qualitative to address the system owner’s questions. This means the study needs to focus on identifying the specific changes (removed, added, and modified) and then collecting the evidence to evaluate how well those changes have been transferred into this “life as normal” stage. Whether this means reconvening the design team or initiating a new subgroup of early adopters, user input into the tools, existing KPIs, new metrics, surveys, and who to interview is another excellent opportunity for users to be involved.
It also means keeping key stakeholders and the sponsor informed and up to date. The “project may be over” however, the adoption has only just begun. Feedback is essential to not only determine successful adoption but to also gather detailed information for continuous improvements that feed revisions.
“In my experience, [phase 3] is perhaps the most overlooked phase in redesigning quality systems.”Vivian Bringslimark, HPIS Consulting, Inc.
Managing “New Normal”
Life as new normal has begun. The quality system is fully operational and Affected Users are now performing their tasks. New normal is really about managing the new workflows and the status of the current resources to sustain the new system. Are you able to sustain the new system or are requisitions pending for more full-time employees?
What existing performance metrics can you leverage? Perhaps it is only a matter a slight tweaking here or there to accommodate your redesigned quality system. In some systems that have gone digital, brand new metrics and KPIs (key performing indicators) need to be established. Most vendors will partner with their clients and recommend industry best practices around popular metrics in use.
Anticipate periodic revisions that come from corrective actions and from the Affected User groups. Hold focus group meetings quarterly for the first year and then semi-annually the second year to stay on top of trends and possible performance challenges to prevent unexpected deviations.
Continuously Improve the Quality System
The redesigned quality system has to feed itself. Identify and continuously monitor the key linkages (handoffs) between one system interface and the other. Are they working or are they becoming the source of miscommunication between users?
How many CAPA investigations have been initiated where the handoff may have been a contributing factor? How many small or incremental changes has the quality system undergone in the course of a year? When will it be time to remap the process and identify all the tweaks that have occurred? Would anyone recognize the differences? I’m betting on savvy new hires to ring the change bell and raise our awareness. We forget just how many changes can happen to a quality system over 1 – 2 years.
- Any change we introduce into an organization must be aligned to fit the existing system or modify the system to accept the changes.
- Quality Improvement Projects/ CAPA teams are no stranger to change and all that comes with changing old ways. But managing change fatigue can wear us down and make us slow to outwardly embracing major change efforts. Include change management strategies that go beyond Awareness Training only.
- This blog series outlined why some post-implementation issues can thwart our best designs for users and provided tips and suggestions to deploy during the project phases rather than waiting until post-launch to ensure User Adoption success.
Here’s a recap of the series:
- Blog # 1 – Redesigning Quality Systems: Achieving User Adoption
- Blog # 2 – Manage Your Stakeholders and Users Expectations
- Blog # 3 – Gap Assessments are Necessary for Redesign Projects but so is the right level of support
- Blog # 4 – What to Expect When Processing Map with SMEs
- Blog # 5 – Field Testing Your Final Draft of Redesigned SOPs and Forms: Helpful or Seen as unnecessary?
- Blog # 6 – Change Management and It’s Little Cousin Training
- Blog # 7 – Do I Really Need a GO-Live Strategy?
- Blog # 8 – Is an Awareness Training Only Session Enough for Successful User Adoption?