This week we will be talking about purchasing controls aka supplier management, but if you haven’t read the previous blogs, you might want to start there. They can be found here, here and here. Nothing worse than coming in the middle of a story.
Okay, now that you’re all caught up. Let’s talk about the importance of purchasing controls. Anyone that’s ever played a role playing game like Fallout understands the importance of vendors. They are where you can buy important stuff that will give you a much better chance of taking down that Mirelurk Queen. That means learning who has the best stuff as early as possible.
In medical devices, the FDA and other regulatory authorities expect you to understand your vendors really well. That’s because the device manufacturer has the ultimate responsibility for the quality of everything that goes into their product. Just because your vendor supplies a Certificate of Analysis, or is ISO certified, does not mean that you aren’t responsible for making sure they are up to the task of being a medical device supplier.
This is especially important for LDT manufacturers looking to bring their tests up to an IVD standard. For example, if you are like a lot of LDT manufacturers, you’re probably using Research Use Only (RUO) components in your test. If so, here are some questions you should be asking yourself and your vendor.
How are you (or they) qualifying the components? Functional testing? In-coming QC checks? Remember, if it is RUO, it’s not guaranteed to be made at IVD levels of quality, even if the supplier has an ISO cert. It is your responsibility to vouch for the quality.
Speaking of ISO certs, do they have one to either 9001 or 13485 (most common in devices)? If so, are they applying those standards to everything they make, or just their IVD products? For example, most RUO products are made under a shall we say lighter version of design control in order to speed them to market. So they may not have all the validated processes and testing procedures in place on the manufacturing floor, let alone a complete design history file. Most manufacturers are pretty candid about what they have in the way of documentation, so don’t be afraid to ask.
How are you controlling changes to those RUO components? Most manufacturers of RUO iterate their products a lot faster than IVD suppliers, because they are still improving the design. You’ll need to have supply agreements in place that - at a minimum - alert you to significant changes so you can take the appropriate actions, like verification testing or even re-validation.
Have you conducted quality audits of your key suppliers? It’s highly recommended that you take a risk-based approach to how you control your suppliers. Those that make critical reagents or instruments which can impact test performance should be visited on a regular basis, especially if there are quality issues. Other suppliers of things like buffers or pipet tips still need to be qualified either through surveys or some other means to ensure that you understand how they make and test their products.
Do you have a back-up for your key suppliers? This is as much a business risk as a regulatory one. If the company making the instrument platform you use gets bought by a competitor, you might be in trouble long-term. At the very least, you should have a back-up plan for critical components, so you can switch over to another if needed. FDA is always concerned about the risk of clinically valuable tests going on back-order because of a supply chain issue (remember the pandemic).
Finally, you should be constantly evaluating your suppliers. Just because you’ve used the same company for years doesn’t mean you don’t have to check in on them from time to time. Things change for them too, and they may be having issues with one of their key suppliers as well. So it’s a good idea to develop a relationship with them so you’ll have a better understanding of the challenges they are facing as well.
Remember, it’s best to see that Mirelurk Queen off in the distance instead of having it just pop-up unexpectedly. I hate when they do that. Jump off the couch every time.