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 stakeholders.
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;
- R = Responsible
- A = Accountable
- C = Consulted
- I = Informed.
So who are the stakeholders for the quality systems? In a quality system redesign, the following types of stakeholders are usually present,
- System Owner
- 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 Sponsorship is 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
Once 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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Who is Vivian Bringslimark?
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