Brian Myers, Strategic Account Executive, Pilgrim Quality Solutions, an IQVIA company
The business case for quality is typically very strong, yet we still find projects mired in indecision and inaction. Spend enough time in the Quality and Compliance space working with regulated Life Sciences companies of varying size, organizational maturity, and product breadth, and you start to notice some striking similarities when it comes to reasons why really good enterprise Quality Management Systems (eQMS) projects stall or never even get started. The obvious answers are business priority, funding, and project resources. The more insidious reason is fear of, resistance to, or a complete lack of planning for an inevitable change.
When reading Spencer Johnson’s classic “Who Moved My Cheese” within the context of organizational enterprise change management, it becomes evident that every organization, department and working group has a Sniff, a Scurry, a Hem, and a Haw. As a refresher, Sniff and Scurry were the strategic planners, Hem didn’t get it at first but began catching on, and Haw just couldn’t accept this cheese-moving conundrum. In your own organization, including within the Quality and Compliance function, you know who those personas are. Unlike in the book, however, siloed action isn’t effective, so we rely on Sniff and Scurry to engage, encourage, and empower Hem and Haw.
Three Quality Facts: Eyes-Wide-Open
Let’s dig deeper and consider three Quality and Compliance system facts:
- Fact 1: Medical Device, Pharmaceutical, Biotech and other Life Sciences companies are highly regulated, including the absolute mandate of establishing a Quality Management System. Period. Do not pass go. Do not collect $200. Go directly to route 483!
- Fact 2: Companies falling under these regulations can maintain compliance AND successfully manage their Quality Management System (or subsets) in a traditional manual format consisting of e-mail, excel spreadsheets, word documents, network drives, and maybe even SharePoint or a rudimentary database. It may work. Let’s not pretend it can’t.
- Fact 3: All companies will invariably face a requirement to move these manual or siloed quality processes (all or in part) to a more robust automated, and hopefully harmonized, state. The moving cheese!
Fact 3 is why we need to pay attention to Sniff and Scurry. Hopefully, this reality is presented as natural evolution on the path of organizational maturity and growth, or perhaps as an edict to improve cost measures, operational efficiency, and patient safety. In more pressing cases, it’s a response to anticipated regulatory pressure or rule changes, or maybe even an identified systemic risk. In the worst of cases, there is scrambling to meet a regulatory body or major customer audit finding deadline, or dealing with a supplier nightmare impacting product and/or patient safety, or perhaps even reacting to a recall.
So the question is, if we know Fact 3, and we know the longer we avoid Fact 3 the higher the probability of dealing with a worst-case scenario in which bad decisions are usually made, then why aren’t companies and people doing anything about it TODAY? Change. It’s painful. It’s scary. It requires detailed planning. And not everyone is a Sniff or a Scurry.
The good news is that once we’ve accepted the importance and inevitability of this change, you can begin to reframe the question, self-reflect on the roadblocks in your organization, and set a course that resonates with Hem and begins to empower Haw. What if you could change the conversation to “We know this is going to happen, we have an opportunity to address it now, let’s get off the rock, pick a process, and at least establish a foundation”? Baby steps … one cheese crumb at a time.
So what does this acceptance journey look like? There are some major themes that broadly apply to eQMS projects, and may help Hem and Haw get past their discomfort and move towards acceptance, and possibly even action.
Avoiding the Trap in the Corner
Here are some key considerations typically discussed among new eQMS project teams to ensure everyone is on the same page and planning for success, and to help build sustainable momentum.
- Leadership Who are the executive leaders that can help establish the budget and bridge cross-departmental gaps? Think outside of Quality and Compliance as well. This applies to Manufacturing, Supply Chain, Training, Sales, Contractors, and anyone else that may be impacted by a Quality or Regulatory initiative.
- Sequence What is the Minimum Viable Disruption (MVD)? What key processes can be transitioned first, that will face the least disruption and grumbling, have the lowest risk profile, and have the greatest potential for an early win?
- Signals What are the key performance indicators (KPIs) you need to track as part of the business justification? What factors make them KPIs?
- Teamwork Who is the core project team? Before even initiating an evaluation and selection process, conduct a mock buildout of the project team members, and identify gaps early. Who can lead the project and is disciplined enough to keep everyone on task to the MVD? Who are the key subject matter experts at the process level? Who can liaise on the technology and security side? Who will become our long-term system administrator once we go live?
- Risk Have you thought about Risk? Leverage Hem and Haw. Create a two-column Risk Management spreadsheet and identify all possible project success risks down to the process level, and develop a mitigation plan for each as you continue down the project path. Important — this list is dynamic, so avoid early onset of analysis-paralysis.
- Simplicity Are you overthinking this? K.I.S.S. – Keep it Simple. Remember, you’re getting off the rock from paper/manual or siloed processes, which means there’s a good chance that whatever is implemented is an improvement. So, if anyone brings up “integrations,” thank them for the input and inform them of the plan to release system enhancements once the baseline has been established and goes live. Also, ensure that you can leverage the pre-existing, in-the-box system. Anything beyond basic configurations and initial master data setup is a no-no at this point.
- Learning Have you considered Training? It’s on the Top 5 list of important eQMS adoption factors, maybe even higher. Most systems today are designed to capture a modern user experience, which should speed adoption. However, as Change Management goes, address the Training factor early, and be sure you’ve thought about the specific user population(s) and even individuals. Also, consider the fact that not only are they learning a new software system, but in all likelihood, they are also learning new processes. This factor typically even plays into the MVD conversation. Quick learners can translate into increased project success early on.
- Vision Are you being myopic or strategic? During the eQMS evaluation, think Platform, not Process. Squash the detractors early, and ensure the selected solution is extensible, scalable, and suitable for the longer-term organizational eQMS goals. Nothing will be “perfect.” There may be a great Document Control system but can it also manage your Supplier Management, Recall, and Out of Specification processes? Also, ensure the software vendor knows the Life Sciences space, has deep domain expertise, and can demonstrate awareness and response to the requisite project elements unique to the industry.
- Continuity What’s the big picture? Plan for the long-term and keep everyone engaged. Once you prove successful in the MVD, set a course for regular release of other high-priority, low-disruption processes, or even go back and enhance the ones already released.
- Commitment What’s the start date? It’s so common to find a completely unknown planned project start date, or even worse, a project team that is completely paralyzed in an ambiguous desire to pursue never-ending information collection. Commit to change, pick a date that’s far enough out to make everyone comfortable while still infusing urgency, and then stick to it.
Johnson’s writing summarized: Change Happens, Anticipate Change, Monitor Change, Adapt to Change Quickly, Change, Enjoy Change, and Be Ready to Change Quickly and Enjoy It Again. This seems a fitting mantra for Life Sciences Quality and Compliance professionals everywhere. Change is inevitable, and it’s best to avoid managing change as a compulsory response to a hallway devoid of any cheese.
Building the Business Case for EQMS
Learn how to address the challenge of gaining executive sponsorship.