Last week, I did not publish my What Am I Missing? article. No dramatic reason. I simply missed it.
What I found interesting was what happened next.
I could see that people were checking my profile, apparently looking to see whether the article was there. It wasn’t. I also know people in my own team noticed. And nobody told me.
Nobody sent the very simple message: “Marlous, weren’t you going to publish something?” Of course, in this case, absolutely nothing serious happened. I missed a LinkedIn article. The world continued.
But it made me think.
Because what if the thing we notice is not a missing LinkedIn article? What if it is a deviation from the expected process? A strange result. Something that does not look quite right. A small abnormality. A signal that perhaps nobody else has noticed yet.
- Do we say something?
- Do we escalate?
- Do we stop?
- Or do we assume somebody else will?
A conversation I still remember
It is about a meeting that has stayed with me for years.
I was sitting with two senior executives in a large pharmaceutical company. One was responsible for manufacturing and supply chain. The other for Quality. I explained my view that Lean and Quality should not be treated as opposing forces.
They both agreed. Unfortunately, what they agreed on was that they completely disagreed with me.
- Lean, in their view, was about productivity and efficiency.
- Quality was about compliance.
Two different worlds.
I challenged that then, and I still challenge it now. Because recurring deviations are waste. Investigations that happen again and again are waste. Waiting for somebody to make a decision is waste. Searching for information after an event is waste. Repeating failures we already could have learned from is waste. And a quality system that discovers problems late is certainly not an efficient system.
Then I looked at the intelligence work we are doing now
This week I have also been reviewing the evidence we are gathering around quality events, deviations, investigations and CAPA, particularly in radiopharmaceutical operations.
And something struck me. Look at what an effective quality-event system is actually trying to achieve. Make an abnormal condition visible. Stop or contain the activity when necessary. Escalate quickly to the people who need to decide. Preserve the evidence before it disappears. Understand what happened. Learn from it. Prevent meaningful recurrence.
Does that really sound so different from Lean?
- A deviation form is not Lean.
- A CAPA database is not Lean.
- And creating more forms certainly does not make an organisation Lean.
But the behaviours behind a good quality-event system are very familiar Lean behaviours.
- See the abnormality.
- Make it visible.
- Do not knowingly pass a problem forward.
- Stop when stopping is necessary.
- Solve the problem rather than work around it.
- Learn.
- Prevent recurrence.
- Then improve the system.
In radiopharmacy, the time dimension changes everything
This becomes even more important in radiopharmaceutical manufacturing.
We do not always have the luxury of time. Products have short half-lives. Batches may be small. A dose may already be moving towards a patient. Some test results may only become available after release. Evidence can literally disappear as radioactive material decays. So when something unexpected happens, there are really two questions:
What must we decide now?
and
What must we learn completely?
Those are not the same question. Sometimes we need to stop immediately. Sometimes we need to contain. Sometimes we need to escalate to QA, QC, production, radiation protection, engineering or a clinical contact.
And then, after the immediate situation is under control, we still need to understand what happened and whether the same failure could happen again.
Speed without learning is dangerous.
But an investigation process that is so slow that nobody can make the necessary decision is not much better.
This is exactly where I believe Lean thinking and compliance need each other. Lean asks us to expose problems instead of hiding them in the process. Quality asks us to understand and control them. Both fail when people see something and remain silent.
Which brings me back to my missing article
Nobody needed to escalate my missing LinkedIn article.
There was no patient waiting. No batch at risk. No deviation to open.
But it was a wonderfully harmless example of something very human.
- We notice.
- We wonder.
- We assume.
And sometimes we do not say anything.
That is easy to laugh about when it is LinkedIn. In a radiopharmacy, I want the opposite behaviour. If you see something that does not make sense, I want you to say it. If you think we should stop, I want you to raise it. If you are unsure whether something matters, I would rather have the conversation than discover later that everybody had noticed the same thing but nobody spoke. Perhaps that is one of the places where Lean, Quality and culture meet. Not in another methodology. Not in another procedure.
But in the moment someone notices something and decides:
I should say something.
So this week my What Am I Missing? question is a very practical one:
If you notice something that others seem to have missed — something small, something unusual, something that might matter — how do you respond?
