Process Mapping the Redesign of a Quality System
While there is value in mapping the current state of the quality system, teams can often get bogged down in disagreements over the level of detail and the sequence of explicit steps. They miss the point that a future state design is our desired outcome from this stage. The danger lies in members becoming so entrenched in the current state, that they have difficulty envisioning any other possibilities including a better future process for the named quality system. The gap assessment interviews and report findings were the opportunity to focus on the current state of affairs. The Project Manager can either suggest that they refresh on the gap assessment report or take 5 minutes to let design team members work out which “state” they are operating out of.
To keep the project moving forward and team members engaged, begin the process mapping sessions with a marked-up, “proposed” future state model and have the design team members identify what needs to change, be eliminated or added using the gap assessment report. During these discussions, another layer of discovery is often revealed. The project manager frequently learns that recommended steps suggested forms, etc. were previously included in the SOPs only to have been removed in later change control requests with limited or no rationale provided.
Occasionally, one or two members will find themselves stuck in “the way we do it here” mindset and cannot embrace the change(s) being proposed. This is when the project manager needs to switch roles and become a facilitator (or hire one) to put into practice the training concepts from team-building like staying open-minded, respecting different viewpoints, actively listening to each other and reaching consensus.
Change is a process. As a project manager, I could just come in and tell the design team “this is the future state and these are the SOPs and new forms you will be following. Now, will someone help me get this packet of documents into the change control queue? We have FDA due dates to meet”. I don’t envision any of my team will raise their hand. Would you? And yet, most Quality Systems redesign projects are executed this way under the guise of the SME team. If the design team isn’t buying the need for changes, how can I expect the rest of the users to embrace it, let alone comply with the new design?
“This Will Never Work Here!”
Another barrier to staying focused on future state mindset is succumbing to the fear that “management will never buy into any of this”. A good project manager will maintain a project issues log that becomes the agenda for weekly check-ins with the sponsor. This is why it so crucial to keep the sponsor up to date with anticipated barriers and challenges sooner rather than later during the implementation stage. It is also wise to reflect the tracking of these items in the written project status updates. It is the responsibility of the project manager to track resolution and report back to the team in order to keep momentum, encouragement and continued trust within the team.
If the design team isn’t buying the need for changes, how can I expect the rest of the users to embrace it, let alone comply with the new design?Vivian Bringslimark, HPIS Consulting, Inc.
“But we’ve already got our process in place!”
Once in a while, I am presented with a range of progress on implementing a Robust Training System, where some departments are very far along with their executed tasks and some departments haven’t even begun. It’s like a race to see who crosses the finish line first. Being first allows the department to carve its way as the best practice and the process for the rest of the organization to follow. AKA – they like to think they can influence the policy and/or SOPs with little regard for the nuances of other department’s unique processes. So, be mindful of resistance to adapt, adjust, or even participate in design team meetings, when one group is heavily entrenched in their departmental training practices, especially the unwritten ones.
Spend the team’s meeting time wisely and focus on the process maps first. Get a consensus on the flow diagrams before proceeding to the SOPs. This accomplishes a number of benefits. Having a process flow diagram keeps the discussion centered on the process conceptually and not hung up in SOP semantics. Word-smithing comes after an agreement for the future state has been achieved.
Another barrier to staying focused on future state mindset is succumbing to the fear that “management will never buy into any of this”.Vivian Bringslimark, HPIS Consulting, Inc.
Include your sponsor and select executive stakeholders on the update. This is the opportunity to inform them about major changes and anticipated impact on the organization. Be sure to speak about eliminated redundancies and/or any anticipated efficiencies gained from the future state. Keep the discussion at the conceptual level for now. But also be prepared to field specific or detailed concerns i.e. will this result in a change of headcount? Note: If your sponsor or key executive stakeholder prefers “seeing” the process via printed SOP steps, accommodate this preference and have a good working draft prepared.
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(c) HPIS Consulting, Inc.