A radiopharmaceutical production process can be stopped by something that costs only a few euros. It might be a missing cassette, a particular filter, a vial or stopper that is no longer available, or a reagent with an unexpected change in specification.
None of these necessarily indicates poor quality. The supplier may be perfectly capable, the material may meet its specification, and all the relevant documentation may be available. And yet, production cannot continue.
We have qualified our suppliers, approved our materials, established specifications, purchasing procedures and incoming goods controls. So, what are we missing?
The supply chain is bigger than the supplier list
When we talk about the radiopharmaceutical supply chain, our attention often goes to radionuclides, isotope producers and specialised technologies. Understandably, because without the radionuclide, there is no radiopharmaceutical.
But think about everything else that is needed before a patient dose can be prepared. Chemicals and precursors, synthesis cassettes, tubing, filters, vials, stoppers, cleaning materials, packaging components and labels. Some come from suppliers specialising in radiopharmaceutical applications, while others are purchased from companies serving many different industries.
For some of these suppliers, our production might represent only a very small part of their business. Something that is relatively ordinary to them can be absolutely critical to us.
And this makes me wonder: does the supplier actually know how important that component is to our process? And have we ever explained it?
Qualification is important. Understanding is something else.
Supplier qualification helps us establish whether a supplier is suitable and capable of meeting our defined requirements. Depending on the associated risks, we may evaluate quality systems, technical capabilities, regulatory compliance, change management and previous performance. All important, and certainly not something I would suggest doing less thoroughly.
But qualifying a supplier does not automatically mean we understand each other.
A supplier may know our specifications without understanding why certain characteristics are so important. They may have an established change notification process, but not realise how much time we need to assess and implement a particular change. Or they may offer an alternative product that appears technically equivalent, without knowing what that substitution means for a validated manufacturing process.
And, of course, it also works the other way around.
We may expect short lead times without understanding their manufacturing schedules, request flexibility while providing unreliable forecasts, or expect them to maintain the availability of a specific product without appreciating the commercial and operational challenges involved.
The supplier has responsibilities, but so do we. We cannot expect suppliers to understand requirements that we have never properly explained. And equally, we cannot expect reliable supply without making the effort to understand their constraints.
What I learned at the interface
Looking back, I have spent a considerable part of my career working at the interface between suppliers, technical teams, Quality and Operations. And one thing I have learned over those years is that understanding does not always come naturally, even when everyone involved is competent and genuinely trying to do a good job.
Some suppliers know their customers' processes exceptionally well. They understand the regulatory environment, the consequences of delays or changes, and sometimes recognise potential problems before we do. Others may be far less familiar with our particular applications, especially when they serve many different industries.
But what I have experienced repeatedly is that a lack of understanding certainly does not have to mean a lack of interest.
I have seen suppliers who initially knew very little about the specific demands of our processes become genuinely engaged once somebody took the time to explain. Why a particular material characteristic matters, why a seemingly small change can require extensive assessment, why delivery on Tuesday rather than Wednesday might be much more than an inconvenience, or why a component costing only a few euros can determine whether a much more expensive production process can take place.
And I have learned just as much by listening to the other side. Understanding why a supplier cannot simply change their production schedule, why a particular material is difficult to source, why minimum order quantities exist, or why our apparently straightforward request might create considerable complexity for them.
Sometimes those conversations led to solutions we had not even considered before. Other times, they simply helped both sides understand why certain things were not possible. And that is valuable too, because understanding a limitation is often the first step towards finding a workable alternative.
Good communication does not automatically solve every problem, but it certainly changes the quality of the decisions we make together.
Communication is more than exchanging information
We communicate with suppliers all the time. Purchase orders, specifications, quality agreements, audit reports, change notifications and delivery confirmations. There is usually no shortage of information being exchanged.
But exchanging information is not necessarily the same as creating understanding.
A specification tells a supplier what we require, but not always why. A purchase order tells them when we need something, but not necessarily what happens if it arrives too late. And a quality agreement may define responsibilities very clearly on paper, while the people involved still have quite different expectations of how those responsibilities work in practice.
This is where I believe the interface becomes particularly important.
Being the interface is not simply about forwarding questions and answers between departments or organisations. It is about understanding enough of both sides to recognise when something is missing, when people are using the same words but mean different things, or when a decision that makes perfect sense from one perspective might create problems somewhere else.
It means connecting the technical, quality, operational and commercial perspectives, and sometimes asking questions that initially seem unnecessary because everyone assumes the answer is obvious.
And perhaps that is one of the most important lessons I have taken from working at those interfaces: what is obvious to one person is not necessarily obvious to another.
That is not a lack of competence. It is often simply a difference in perspective, experience or knowledge.
The challenge is recognising that difference before it becomes a problem.
Five perspectives. One supply chain.
When looking at processes and operational decisions, I often use five connected perspectives: Safety, Quality, Delivery, Cost and People. SQDCP.
Supplier relationships are a very good example of why these perspectives cannot be managed independently.
Take the decision to introduce a second supplier for a critical consumable. From a delivery perspective, it might reduce our dependency on a single source. From a quality perspective, however, we may need to evaluate material differences, perform additional qualification activities or reassess parts of our process. We also need to understand whether those differences could have consequences for product or personnel safety.
Then there is the cost perspective, which involves much more than the price we pay for the component. Qualification efforts, inventory, administration and the consequences of potential production interruptions all need to be considered.
And finally, there are the people involved. The colleagues who understand the material, those who know the production process, those responsible for quality, and the supplier who understands how the component is actually manufactured and delivered.
Each brings knowledge that the others may not have.
The question is whether we manage to bring those perspectives together before making the decision.
Having two suppliers is not automatically better than having one. Keeping larger inventories does not always improve resilience, and choosing the least expensive material does not necessarily result in the lowest overall cost.
There is no universal answer, because the answer depends on the process, the materials, the risks and the circumstances.
But there is a difference between making a decision based on the information available within one department and making it with an understanding of the consequences across the entire chain.
Reliability is a shared responsibility
When supply becomes unreliable, our first reaction may be to look at the supplier. Did they deliver on time? Did they communicate the change? Did they meet the agreement?
And those are perfectly legitimate questions.
But I think we should be just as willing to look at ourselves. Were our forecasts realistic? Did we communicate changes in demand early enough? Did we explain which materials were particularly critical to our process? Did we involve the supplier in relevant planning discussions, and did we actually listen when they raised concerns?
Of course, there are situations where suppliers fail to meet their commitments despite clear communication and reasonable planning. Mutual understanding does not remove accountability, nor does it replace the need to manage supplier performance.
What it does help us understand is whether we are dealing with a performance problem, a misunderstanding, unrealistic expectations or a combination of several factors.
And that distinction matters, because the solution to a supplier performance problem may be very different from the solution to a communication problem.
If we respond to every difficulty with additional requirements, audits or performance indicators without understanding the underlying cause, we may create more work for everyone without making the supply chain any more reliable.
Sometimes a different control is needed. Sometimes an agreement needs to be reconsidered. And sometimes we simply need to talk to each other earlier, or differently.
The chain does not end at our factory door
In radiopharmaceutical production, these dependencies can become particularly visible. Production schedules may be closely connected to radionuclide availability, products may have short useful lives, and delivery windows can be narrow, leaving limited opportunities to recover from delays.
An interruption upstream can therefore have consequences much further downstream, potentially reaching the hospital and ultimately the patient.
That does not mean every delayed consumable creates a patient safety issue, or that every supply interruption can be prevented. But it does mean we need to understand which dependencies are truly critical, so we can focus our attention and efforts where they actually make a difference.
And that understanding is not something we establish once during supplier qualification and then simply maintain through periodic reviews.
It develops as processes change, suppliers change, technologies evolve and people gain experience. It requires us to keep asking questions, sharing knowledge and making sure that the people involved understand not only what is expected of them, but also why it matters.
What am I missing?
We need qualified suppliers, specifications, agreements, controls and documented evidence. These are essential parts of a reliable and compliant supply chain.
But what I have learned over the years is that the real value often comes from what happens between those formal arrangements.
From people who take the time to explain their needs rather than assuming the other party already understands them. From suppliers who share their knowledge and limitations openly. And from colleagues who recognise that understanding a process means looking beyond their own department or responsibility.
Good communication does not guarantee reliable supply, and it certainly does not replace formal controls. But without mutual understanding, even capable suppliers and well-designed systems can struggle to manage their dependencies effectively.
Sometimes the most valuable improvement does not start with another audit, procedure or performance indicator. It starts with a conversation in which both sides are genuinely interested in understanding each other.
So perhaps the question is not only whether our supplier is qualified.
Do we understand each other's needs, requirements and constraints well enough to build a reliable supply chain together?
And are we having those conversations before something goes wrong?
What am I missing?
