Kevin O’Donnell: A Good QMS is an Essential Part of Cold Chain Success

Kevin O'Donnell Senior Partner at Exelsius Cold Chain Management and Cold Chain IQ Advisor, joins us to talk about quality management systems, specifically what regulatory inspectors focus on regarding quality and a quality management system, and how a good QMS is an essential part of the big picture of cold chain success.

Cold Chain IQ: Can you tell us what is the importance of having a quality management system?

K O'Donnell: Well, in terms of pharmaceutical supply chain, from a shipper's standpoint and from a service provider standpoint, it's pretty much a regulatory expectation globally. Nearly all new regulations that are coming out from regulatory bodies and those who have pretty high influence in the industry, such as the United States Pharmacopeia, all make reference to having a quality management system.

For instance, the USP, or the US Pharmacopeia in the general information chapter, 1079, Good Storage and Distribution Practices, there's a new draft of this document that will become effective in 2012, and it specifically states that the increase in global processes, coupled with products requiring special environmental controls, highlights the need for a strong quality management system. So it is becoming more and more of a regulatory expectation.

And really, it's just a great kind of universal framework that can be applied across the supply chain that allows you to have a definition of how you're going to act responsibly, and what the quality aspects are going to include and what they're not going to include, and the standards that you're going to follow.

So basically, how quality management systems work, or the overall quality system is. If you want to think of it in terms of driving down the road, a quality system is the vehicle that's going to take you to whatever you determine to be quality, and quality could be defined as many things depending on its application. So the vehicle is the quality system. The driver of the vehicle is the actual management of the quality system, and that's what's going to take you to whatever you define as quality. And then you have a roadmap, or you have a Garmin GPS, and that's going to be your guide as to what gets you to where you need to go, and that's essentially what your overall quality policy is.

Cold Chain IQ: And in your experience, what happens when a company doesn't have one?

K O'Donnell: It's not a good thing. Any successful company worth their salt has some form of a quality management system. It's just whether or not it is detailed enough and robust enough to pass the scrutiny of, let's say, in the case of a shipper or a licence holder of a drug, a regulatory body such as the FDA or some other regulatory body, Health Canada for example, come in to conduct an audit, the first thing they're going to want to take a look at is the overall validation master plan for the company and what the company's corporate policy is. So the quality management system contains all those things.

So every company has some level, or some degree of a quality management system. It's just a matter of whether or not it's good enough to pass muster for the pharmaceutical industry regulatory bodies and for their scrutiny.

And also, the shippers who have a responsibility to the drug throughout the supply chain, they need to make sure that their suppliers downstream in the supply chain also have quality management systems that are in place that can protect the quality of the drug product adequately through their portion of the supply chain. So every member of the downstream process also needs to have a quality management system in place.

Cold Chain IQ: Speaking of regulatory inspectors, what do they focus on regarding quality in a QMS within a pharmaceutical manufacturing company?

K O'Donnell: Broadly speaking, it's being able to document what you do, do what you document, and then being able to prove that you've operated to that standard, and also to improve what you're doing. So there's this constant progression towards continuous improvement. It isn't just a kind of a static thing.

In essence, it creates and encourages effective and active leadership, it defines roles and responsibilities, it ensures consistency in a process, it empowers the people who actually contribute to it, and it allows for focus on root cause of problems so you can manage problems and also include corrective and preventive actions when problems arise. It allows for having internal audit programmes to make sure that you're staying the course, to develop quality metrics, measurable KPIs and how to improve the process. And it allows you to manage any deviations and document any deviations that you may have as a result.

Cold Chain IQ: And can you give us some examples of best practices you've learned regarding assessing and mitigating risk; for example, with regards to shipping time and temperature sensitive airfreight?

K O'Donnell: The International Air Transport Association, or IATA, has a regulation called the Perishable Cargo Regulation, and within that Perishable Cargo Regulation, there's something called Chapter 17. And Chapter 17 specifically addresses logistics for time and temperature sensitive healthcare products that are shipped by air. And they have an entire section within Chapter 17 that is devoted to quality management systems, and it's actually laid out quite well.

It doesn't necessarily have to specifically to air carriers. I could be a trucking company or I could be a ground handling agent; I could be a freight forwarder, and I can look at the outline for this quality management system within the airline industry and adapt it to my applications. And it contains a lot of really great elements. It defines that it should include, for instance, appropriate organisational structure; that the processes and the resources are in place that are necessary to meet specific requirements of time and temperature sensitive healthcare products as opposed to other products. And at the very least, it has quality requirements that provide a high degree of assurance that within the transportation system, following these procedures, the quality of the drug is maintained and that the processes are effective and that they're consistent.

So they include some of the typical things; having approved written procedures, specifications; defining roles and responsibilities; escalation procedures in the event something goes wrong; having a CAPA programme which is a corrective and preventive action programme; having documented training, which is all important; having calibration programmes that are accurate and maintained, again delivering quality metrics, having some sort of KPIs to show improvement and show growth; an auditing programme; deviation management; change controls procedures, those types of things.

And these are all the types of things that healthcare companies look for in their service providers, so it really would behove anybody in the supply chain to look at a quality management system outline such as what's in the IATA Chapter 17 Regulations of the Perishable Cargo Regulations, and adapt them to their processes.

There's a great example of that, for instance, in the trucking industry in the United States. There's a company called Panther Life Science Logistics, and they have developed a 31-page guidebook called Life Science Good Distribution Practices. And essentially, what it is is an overview of what their quality policy is, and they provide this document to their customers and others in the supply chain to say, hey, look, here's the standards by which we operate. And it's a really good thing to have, and as far as I know, they're the only service provider within the industry that is willing to share this kind of information with their internal and external customers.

Cold Chain IQ: Let's talk about who besides the pharma manufacturer has or adheres to a QMS.

K O'Donnell: Yes; it's like I just mentioned. Everyone in the supply chain according to regulators has a responsibility to the drug. No one is exempt. So anyone touching that drug has to make sure that the quality is maintained. And for instance, in Canada, the GUI-0069, which are guidelines for temperature control of drug products during storage and transportation, states that all persons and companies involved in the storage and transportation of drug products have a responsibility for ensuring that appropriate storage and transportation conditions are maintained from the point of manufacture up to the delivery of the drug product to the final distribution point.

And specifically, they say that the maintenance of the chain of storage and transportation conditions should be supported by written agreements among distributors, importers, wholesalers, transportation and service providers, that sort of thing. So the shippers of the drugs, because they're having their feet held to the fire by regulatory authorities, they delegate that responsibility to others in the supply chain who move their drugs.

So if I'm a drug manufacturing company and I have to abide by this quality management system, which includes having service level agreements with my supply chain partners, then my supply chain partners better have those service level agreements in place with their supply chain partners.

For instance, I'm shipping a drug from Montreal to Germany aboard Air Canada, let's say, I as a drug manufacturer, I don't deal directly with the airlines, I have a freight forwarder, my intermediary who serves on my behalf for making sure that that cargo gets to where it needs to go in Germany. So I have a check to make sure that my quality management system with my freight forwarder is robust, and I audit them, and make sure that I have a service level agreement in place with them for terms of expected service and what happens if you don't get that service.

And then in turn, that freight forwarder would have a service level agreement in place with the air carrier that they use or that they choose, in this case Air Canada, for example. And Air Canada would perhaps have a service level agreement in place with whoever does the ground handling for their freight on the airport premises, because it's generally not owned by the airlines. That's contracted out.

So anything that's contracted out needs to make sure that there are service level agreements in place, and that should expend throughout the supply chain. So who besides pharma has to adhere to a QMS? Essentially, everyone in the supply chain has to.

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