Picture this. You’re sitting in a site meeting, and the leadership team announces a renewed focus on Operational Excellence (OE). The goals sound exactly right: improve reliability, reduce delays, strengthen quality, and give people a greater voice in improving the work.
And then the next shift begins.
An operator runs into the same equipment issue. A supervisor chases information across departments. A quality reviewer sends a record back with a question everyone has seen before. People are working hard, really hard, but the same frustrations keep getting in the way.
This is the moment when a leadership promise meets everyday practice. And it raises a simple question: what is actually going to change for the people doing the work?
That question matters in pharmaceutical manufacturing. It connects directly to reliable operations, product quality, and, ultimately, the patients who depend on us. Leaders can set the direction, but people throughout the organization need the time, knowledge, and support to bring it to life.
People pay attention to what leaders do when things get difficult. When the schedule is tight, do we still make time to understand a recurring problem? When someone raises a concern, does it lead to a real conversation and a response?
Those everyday choices tell people whether improvement truly matters. They also shape whether someone will speak up the next time they see an opportunity. Not every idea can move forward, of course. But when one can’t, explain why and what would need to change. A thoughtful answer shows respect for the contribution and keeps the door open for the next one.
A good place to begin is simply to bring people together around the work they want to improve. An Operational Readiness (OR) or Operational Excellence (OE) workshop that includes leaders and people from operations, quality, engineering, maintenance, laboratories, and other relevant functions is a proven first step. With these types of workshops, it’s imperative that different shifts are represented, too. The work can look very different depending on the time of day, and you want to hear the whole story.
If it’s a new operation, talk about what must be ready for a successful startup. If it’s an established operation, ask what is getting in the way of consistent performance. Invite people to bring real examples. Where do handoffs break down? What information is difficult to find? Which problems keep coming back? Is there one person everyone relies on as the “go-to” source?
Take avoidable batch release delays, as an example. Operators may point to unclear instructions. Quality reviewers may see the same documentation questions appearing again and again. Laboratory staff may describe scheduling decisions that leave samples waiting. When everyone looks at the process together, they begin to see past their own piece to understand how all the pieces connect.
From there, leaders can help resolve competing priorities and provide resources, while the people closest to the work develop practical changes. Those changes still move through the site’s applicable quality processes, and the results are checked to make sure they work as intended.
Supervisors are central to making this real. Every day, they translate priorities into decisions while balancing staffing, schedules, and the unexpected issues that always arise. We need to give frontline leaders room to coach and solve problems with their teams. Be clear about what they can decide, what needs to be escalated, and where they can turn for help. Asking people to own improvement only works when they have the support and authority to act.
Another opportunity, and one I think we often miss, is to learn more deliberately from the work we’re already doing.
Build a moment of reflection into the end of a campaign, maintenance activity, technology transfer milestone, or improvement trial. For more significant activities, hold a formal after-action review, or AAR, with the people who planned, performed, and supported the work.
The conversation doesn’t need to be complicated. What did we expect? What actually happened? Why was there a difference? What should we keep doing, and what should we change next time? Spend time on the successes as well as the difficulties. Understanding why something went well can be just as valuable as understanding what went wrong.
Reflection becomes continuous improvement, or CI, when it changes what happens next. Capture the lesson and the context behind it. Agree on an action and give it an owner. I’ve found it’s important to have someone who owns the process being reviewed, as well as clear owners for the lessons and actions that come out of the discussion. Then carry that learning into the next pre-job brief, training session, procedure update, or planning discussion then verify whether it helped.
People also need to see what happens next. If someone raises an issue, they shouldn’t have to wonder whether it disappeared into a black hole.
A shared CI register or board can make opportunities, priorities, owners, next steps, and target dates visible. Include how you’ll know the improvement worked. Then review it in meetings that already exist, where teams and leaders can make decisions and remove barriers together.
Before closing an action, pause and look at the result. Did the delay decrease? Did the recurring question go away? Can another shift sustain the improvement? And come back to it later. Lasting improvement matters more than a quick win.
You can take that learning even further through communities of practice, whether within one site or across several. Bring together people who share a challenge: it could be equipment reliability, batch release, technology transfer, or something else that matters to the business.
Give the community a known facilitator and a regular time to connect. Ask people to bring a live problem, an opportunity, or a lesson from an AAR. Encourage them to share the circumstances around their experience, not just the answer, so others can decide what might work in their own setting.
Imagine a batch release community discovering that several sites are wrestling with the same questions. Together, members can explore the common gap, propose an improvement, and identify a team to test it through the appropriate local processes. The opportunity can be tracked in the CI register, and the results brought back to the community so everyone learns from the experience.
That kind of exchange gives people an ongoing way to surface opportunities and learn from colleagues beyond their immediate team. And don’t forget to recognize the people who share what they know, and the people who turn that knowledge into better practice somewhere else.
If you’re wondering where to start, choose one operational area and try these four things over the next few months:
- Schedule an OR/OE workshop, agree on the target condition, and identify a few priorities. (Note, a well-versed facilitator is imperative)
- Build a reflection or AAR into an upcoming activity
- Make CI opportunities, and their progress, visible
- Bring a shared challenge to a community and agree on what to try next
If you’re looking for practical ideas and tools, one resource I often recommend is the ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry. It brings together useful templates, approaches, and real-world examples to help teams capture what they know, share it more easily, and put it to work. My advice is to keep your OE approach manageable. Make time for it. Respond when people raise something. And let them see what changed because they spoke up.
Operational excellence may start at the top, because leaders shape priorities and expectations. But it grows through the people across the organization who know the work, see the opportunities, and can make it better.
That’s how a leadership promise becomes everyday practice: one honest conversation, one lesson put to use, and one improvement sustained at a time.
Paige Kane, PhD, CPIP
AVP Technical Excellence & Transformation