Supplier quality management is a foundational activity for any medical device manufacturer. This is especially true for medical device companies focused on achieving true quality. But even for those with the best intentions, supplier management can be a major pain point.
With the spirit of True Quality in the air, three medical device experts outlined what you need to know about evaluating, qualifying, and monitoring suppliers.
Start qualifying suppliers early, but be prepared for delays
Qualifying suppliers isn’t something that happens overnight. This is a lengthy process that begins with establishing criteria, evaluating suppliers, and implementing purchasing controls. It’s imperative to risk management and ensuring quality in devices and deserves plenty of time and attention.
But manufacturers can often try to rush through the steps or getting upset. Jon Speer, founder of Greenlight Guru, says building an approved supplier list (ASL) can be a headache for any company, regardless of size or experience.
“It doesn’t matter if you’re a start-up or a large company,” he says. “The whole supplier selection process is super time consuming and can be very frustrating.”
Getting started means working through ISO 13485, which requires:
- An established criteria for the evaluation and selection of suppliers
- Objective methods for documenting the performance of the supplier
- Documented effects a purchased product may have on the quality of the medical device
- Supplier assessment and monitoring proportionate to the device risk
Even with regulatory requirements fulfilled, there’s still a scarcity component to worry about. The unique needs of the medical device industry means manufacturers may be competing for the attention of a small number of known, niche service providers, explains Bassil Akra, CEO and co-owner of QUNIQUE.
“If you are searching on Google for a biocompatibility testing lab, you may get just one name. If you are looking for a sterilisation service provider, you will find one or two names. Then you call them, and they don’t have time for you at this moment because they’re full. And then you’re like, ‘Okay, I’m lost.’”
Disheartened by this lack of visibility, Akra recently launched QUNIQUE’s Quality Engine (QE) solution for supplier management, which helps manufacturers find compliant solutions to fulfil obligations and achieve continuity that puts medical devices on the market.
Supplier and quality agreements are critical
You’ve managed to choose an ideal and available supplier. Now it’s time to articulate the expectations around communication, roles, and responsibilities — for both you and your supplier.
To do so, we’ll need to use formal documented quality agreements that outline the manufacturer-supplier relationship. These agreements are not legally required by FDA. However they are required for ISO 13485 compliance — the same standard harmonised with in FDA 21 CFR 820.
Kyle Rose, president of Rook Quality Systems, says that some companies land in regulatory hot water when failing to properly use supplier agreements for QMS documentation.
“Quality agreements should not just be about pricing figures, and sales,” says Rose. “You need to cover quality, as well. That’s really the focus of what the ISO standard is looking for.”
The most used agreements are supplier agreements and quality agreements.
- A supplier agreement defines logistics of how the supplier plans to deliver the required goods or services, and covers business terms and conditions, cost, ownership of mold and tooling, and liability concerns.
- A quality agreement defines the manufacturer’s quality requirements that must be fulfilled by the supplier. It focuses on the Current Good Manufacturing Practices (CGMP), and establishes regulatory requirements, acceptable design changes, and communication directions for corrective and preventive action (CAPA).
By using both, or a combination of the two, you can rest a lot more easily knowing both hands know what the other is doing.
Supplier quality management is not a one-time deal
The requirements set forth in ISO 13485 are more than regulatory red tape — they’re a defining staple of the standard’s risk-based approach for managing quality. But even for seasoned medical device professionals the risk-based perspective has proven hard for them to wrap their heads around.
Speer says some of this may be attributed to the language and references used in the standard’s text.
“I think the risk-based approach and reference to ISO 14971 creates confusion for many companies because 14971 is product-based risk management,” Speer says. “What 13485 is saying is that your risk-based approach is more about methodology – that is, risk management plan, risk assessment and risk controls. You can and should apply this type of methodology when qualifying your suppliers.”
That’s why the standard places such emphasis on supplier monitoring and validation, says Rose.
“You can’t just sign up a supplier one time and say that you’re done with it,” Rose says. “You need to continually monitor your suppliers, too, and make sure that they’re continuing to meet your requirements.”
The connection between supplier management and the true quality mindset runs deep. The same goes for everyone coming to True Quality 2022 in San Diego June 6-8. This is the can’t miss event of the year for medical device professionals. Ready to learn more? Check out the event info here and be sure to secure your seat at the ultimate gathering for True Quality.