A good Quality Management System should be in the DNA of a company according to Tony Wright, CEO at Exelsius Cold Chain Management Consultancy. QSM is also an essential part to healthcare logistics, and something that’s very much expected by shippers and regulators. Tony joins Pharma IQ to discuss the importance of a sound quality management system and explains how risk assessment is very much a feature of its processes.
Pharma IQ: What’s the importance of having a quality management system?
T Wright: I think, firstly, there are some really quite common and simple misconceptions about a quality management system particularly within the temperature controlled or temperature sensitive logistics process. To many people in that sector, it can sound almost like an unnecessary complication to their existing way of managing their business, and they’re perhaps a little daunted by that prospect. But in essence, it’s quite simple.
Let's look at quality management systems from three very simple principles.
- Document what you do: Put on record all the processes and procedures that are part of your business and your involvement in temperature sensitive logistics.
- Put into practice some of the things you’ve written down as your process and procedures.
- Use the system to prove what your system says:use the quality management approach as a way of improving what you do.
In my opinion, QMS is an essential part to healthcare logistics, and it’s something that’s very much expected by shippers and regulators, and they’ll expect service providers to operate within a quality management system. I also think that a quality management system is a bit like the roof of a house. It sits above the structure that is provided by all the existing regulations that we’ve got, both in Europe, and the rest of the world, and also the guidance that exists in terms of logistics. And then also, it sits above the individual pillars of process and procedures that a company has, that go towards making that business operate to good distribution practices. So I think of it like the roof of a house, really, through three very simple, basic parts.
Firstly, the quality system that you use, itself and I think you could probably think of that as the vehicle that’s going to get you towards quality management. The management process, itself, is, I guess, the driver of that vehicle, how you actually are going to get there. And the quality policy, that is also part of the quality management system, which is your declaration of how you’re going to operate, I guess you could look at that as the roadmap, or more these days perhaps, the SatNav system that will guide you towards quality.
A quality management system is very important because it ensures not only that there are some detailed procedures and that everybody’s working to them, but I think it’s also an important part of a standard approach to quality within that business. Finally, it’s important because the success of a quality management system is not, also, or should I say, not just about the structure that I’ve talked about already, but I think it’s also a part of a communication process, and it’s part of a leadership and management commitment of that company, to operate in that way.
For me, a good quality management system is one that is in the DNA of a company, meaning that, you know, they don’t have to refer to a manual to see what they do, they do it anyway.
Pharma IQ: And what happens, in your experience, when a company doesn’t have one?
T Wright: I guess the first thing I’d say is that quality seeks quality. Bio-pharma manufacturers will want to do business only with those service providers that operate a quality management system, so if you don’t have one, then don’t expect to be a preferred partner. I think companies not using a quality management system will typically be noted for having disjointed and inadequate procedures. They won’t, for example, have qualified their equipment to a high standard, and I think one other feature of companies that don’t have a quality management system is that they do spend a disproportionate amount of their time in the correction stage, correcting things that have gone wrong, and not using a quality management approach to take those learnings that have come out of the correction process back inside the business, and doing things right the first time.
Pharma IQ: What do regulators expect you to focus on regarding quality and a QMS within a pharma manufacturer company?
T Wright: I think there’s no doubt that the focus that regulators are putting upon the logistics sector is around understanding and testing, that they’ve actually got a quality management system in place. My experience is that they’ll focus a great deal upon the existence of a quality management system itself, asking to actually see the quality management system, before moving onto the more physical things of looking at their facilities. But I think the main things they’ll focus on are the existence of standard operating procedures, ensuring they are up to date; the existence of service level agreements with providers, and I think you’re going to have to look up the current revision of the EU’s guidance for good distribution practice, which focuses much more attention upon the relationships with service providers, which could mean transportation providers, for example. So having a good quality service level agreement will be an area of focus.
And then, clearly, the issues of having the right storage facilities, but also the maintenance of those storage facilities, maintenance and qualification of fridges and freezers and cool rooms. This includes whether or not a company has done temperature mapping of its facilities so that it understands how it needs to control the environment, maybe at different times of the year, different seasons, when the building is full and empty.
They’ll also look at vehicle temperature control, they’ll look at documents and records to make sure that there is only one relevant SOP, rather than any duplication. They’ll have a look at the maintenance of that quality management system. And last but not least, I think, they’ll also be very concerned about the process of correction and understanding when things go wrong, what you need to do. So, for example, using CAPA as a method of being able to look at corrective and preventative actions, so that learning is used back within the quality management system. All of those elements will be of concern.
Pharma IQ: What are the common misconceptions about risk assessment methodology, and can you discuss the best practices you’ve learned regarding assessing and mitigating risk, for example, with shipping and temperature sensitive airfreight?
T Wright: The phrase risk assessment methodologies can generate some real misconceptions about how to go about it, but in essence, it’s very simple, if you look at it from a simple process circle of being able to understand the processes that are in place, using data, flowcharts, facts and figures to be able to assemble that.
The next stage is to look at how you identify and quantify the risk, using a risk assessment matrix to be able to understand whether the risk is severe, whether it impacts the business frequently, and the costs associated with that risk.
The final step is to be able to mitigate the risk, either reducing it or eliminating that risk to a level that is consistent with good practice. To monitor the process afterwards, to see and evaluate whether the impact of the change has been sufficient, and to actually sort of implement the change and review how that change that came as a result of risk assessment has been effective in your processes. So I think there are some very common misconceptions about the complexity of risk assessment, but actually it’s a very simple and less complex process, and a good quality management system will have risk assessment very much as a feature of its processes.
Pharma IQ: Who, besides the pharma manufacturer has, or adheres to quality management systems?
T Wright: Looking at the logistics process, so all those involved need to be operating to a quality management system. And that also means training, which in itself is a requirement of a quality management system. It’s a very strong requirement for a separate chapter within a quality management system. I’ve seen many examples of someone being handed an SOP relevant to his particular job, and being told to get on with it. Well, clearly, that isn’t training.
The temperature sensitive logistics chain is complex, and we’ve seen very much that international manufacturing is continuing, so it’s likely to stay that way. It’s likely to continue and to be complex. I believe that effective end-to-end temperature assurance really starts with understanding the entire bio-pharma process, and so the training that we conduct in Exelsius takes very much an holistic approach towards that. We take students through a detailed programme, from understanding the business itself, a background business overview, looking at the drug development process, and how a drug actually gets to market, and its impact, therefore, on the logistics process; how to write SOPs and SLAs; temperature data management, and looking at the quality management system itself.
We put this training together on the basis of it being intentionally interactive with our students, for example, mapping a typical logistics supply chain and identifying where they believe the critical risk area is. We also have them undertaking an overnight packaging exercise that shows the effectiveness of various packaging systems. So it’s very much a hands-on approach to training, which I believe is an essential part of quality management. We’ve had tremendous success with this competency based approach, and it’s been remarkable that students have really recognised the value of being able to understand the collaborative nature of the supply chain process, from beginning to end, and being able to identify their particular roles in this process.
Interview by Andrea Charles
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