One of the most common operational patterns we see in growing biopharma companies is what we call “busy but not aligned.” In other words, everyone’s busy but not for the right reasons.
Work is happening. Meetings are full. Teams are producing deliverables. But no one can clearly explain how the work is supposed to flow. Nothing feels efficient or consistent.
When everyone’s busy but not aligned, operational risk increases while scalability, comparability, and risk visibility decline.
What It Looks Like
What does busy but not aligned look like in practice? It means that teams spend time on tasks like:
- exporting data from multiple systems
- reconciling numbers across reports
- rebuilding deliverables from scratch
Everything varies in this environment from data collection tactics and reporting formats to report timing and assumptions. So leadership ends up making decisions on inconsistent inputs.
Why Workarounds Happen
When upstream workflows are inconsistent, team members feel frustrated by constant misalignment and miscommunication. So they come up with workarounds to improve the workflow slightly. But these workarounds usually solve the problem only for the person who created them.
People optimize for getting their work done, not improving the system.
Why does this happen? Most individuals are rewarded for delivery, not system improvement. So the behavior becomes: “I’ll just make it work.”
Where Leadership Sees Signals
When the workflow fails, certain signals regularly appear. And these signals are usually noticed first by leadership.
Signals of workflow inconsistency are:
- milestones look different across programs
- timelines are inconsistent
- teams measure things differently
Workflow inconsistency rarely fails within a single team. They happen at handoffs. For example, one team delivers to another, and the information sits because the next team doesn’t know it exists or how to use it.
The result is delays, rework, and confusion.
Process Doesn’t Equal Reality
The real problem isn’t the people or the data–it’s that the documented process doesn’t reflect reality.
In these environments, SOPs may exist but few people know where they live. And if they do exist, they aren’t updated and don’t reflect current practices.
A process not reflecting reality happens for two main reasons:
- There is no process ownership. No one is responsible for keeping the process current, and documentation becomes stale.
- Documentation is disconnected from execution. It’s either too rigid and detailed, or it’s lagging behind actual practice.
So when new people join, they aren’t aware of how work actually flows. They are told to “read and understand” outdated SOPs, rather than engage in hands-on training. Or the hands-on training is done by the people who created the workarounds.
The other issue is that too often updating a document is treated as updating behavior, rather than updating for reality.
What Process Ownership Actually Means
Document maintenance is not the same thing as process ownership. It’s literally just that–updating a document for the sake of it.
What does process ownership look like in practice? Here’s what a real process owner does:
- collects feedback
- prioritizes improvements
- filters useful insight versus noisy feedback
- ensures training reflects reality
- maintains workflow usability
One of the key ways process ownership falls short is the “suggestion box” issue. Everyone recognizes the issues and the growing number of workarounds, so they submit ideas for improvement.
These suggestions reach the process owners, but nothing happens. There is no prioritization, response, or iterations. So teams stop reporting issues and continue to default to workarounds
Part of the reason the suggestion box concept stalls is that process owners are flooded with suggestions that are merely “noise.” They are personal opinions with suggestions that benefit one team and not the others. They may be suggestions that work to alleviate symptoms and not the root cause of the issues.
The job of the process owner is to identify the “structural blockers,” which include issues that:
- prevent workflow progress
- cause delays or rework
- breaks handoffs
Process owners must identify real blockers from the noise. They must also treat each process update as version one and remember that iteration is necessary.
Identifying Core Operational Risk Areas
How can you identify if process ownership (or lack thereof) is the issue in your organization?
Take a look at these four recurring workflow risk areas and honestly answer the questions:
1. Workflow handoffs
- Is ownership clear?
- Does everyone have the same definition of “done?”
- Are workflow stakeholders aware of their role in the process?
2. Duplication and rework
- Is there repeated data entry happening?
- Are teams rebuilding reports?
- Are stakeholders reformatting deliverables?
3. Visibility and clarity
- Can leadership see real progress?
- Do teams know what leadership actually needs?
4. Tool fragmentation
- Are the various systems disconnected?
- Is manual reconciliation often the solution?
Our Perspective
At Sigma Lab Consulting, we analyze these operational signals to identify where workflows break down.
We are looking for signals like:
- handoff breakdowns
- duplication and rework
- tool fragmentation
- unclear process ownership
This is where our Operational Workflow Assessment comes in. We need to understand the reality from the people who live it.
Our goal isn’t just to fix workflows. It’s to uncover the root causes behind the broken ones..
Key Takeaway
You cannot diagnose workflow problems by reading documentation alone. You must observe how work actually flows.
Enjoy this blog? Be sure to listen to the accompanying podcast episode: https://open.spotify.com/episode/7duVSfeXgRtKB6bd2NtioW?si=-RNhlKW1SE-UlSqT31b9Mg
