How Supplier-Friendly Shared Audits are Creating a Win-Win for the Medical Device Industry
With popular ride-sharing apps, you can often save money going from A to B by joining up with other passengers who are going in the same direction. If various parties are going to the same place, can they save money by riding together?
With supplier audits, the answer is “yes”. Especially for start-ups and emerging medical device companies, sending scarce resources out to a supplier for an audit is hard to do. That’s why Cannon Quality Group has pioneered the concept of the “Shared Supplier Audit”.
In a shared audit, Cannon Quality Group pools together a number of companies who need to audit a particular supplier and performs the audit at one time on the behalf of the participating clients. Clients are consulted beforehand on the agenda, and each participant gets a customized report at the end.
We’re dedicated to lowering the cost of innovation in the medical device world, and creating a shared audit day at a key industry supplier is just one way to make the hurdles a start-up faces more manageable. A big advantage to the shared audit is that suppliers have started embracing them as well.
Jeff Sauter at Steri-Tek (https://steri-tek.com/) in Fremont, CA, has experience hosting both solo audits as well as shared audits performed by Cannon. Steri-Tek is a high-volume E-beam/X-ray contract sterilizer and the requests for audits are significant in terms of the support burden.
“For us as a supplier, it saves an incredible amount of time to consolidate multiple customer audits into one,” says Sauter, “but from a customer perspective we also know that their resources are being well spent by participating in a Shared Supplier Audit. I can’t emphasize enough that for many customers, especially smaller companies, joining a shared audit is a wise use of limited resources.”
Steri-Tek’s experience during the audit has been positive: “With any audit, being ready to answer any question is key. Cannon is known for the quality and thoroughness of their audits, so as a supplier you know it’s not going to be an ‘easy’ desktop type of audit. Any findings they have are constructive and allow us to improve upon our own QMS. It’s really no different procedurally from a solo audit, or from an FDA or notified body audit for that matter.”
Internally at Cannon, it’s audit coordinator Amanda Harbarth that makes the program work. “I juggle dates between the supplier and the group of audit clients” says Amanda. “ I keep track of audit agreements, and set up pre-audit discussions between our auditors and the clients on board. Our goal is to make sure the audit meets all our clients’ regulatory and internal procedure requirements. ”
“I also manage the auditors’ calendars and coordinate the delivery of the audit reports once completed. I try to get both supplier and clients locked in for the following year to make it as smooth as possible for our clients.”
For clients of a shared audit the results are no different from a solo audit other than it’s much more cost-effective. Clients do not know who the other participating companies are, and no confidential information is shared between clients.
Cannon Quality Group’s auditors are known for their experience and thoroughness. If you’d like to explore the possibility of hosting a shared audit of your facility, please feel free to get in touch at www.cannonqualitygroup.com/contact-us/ or by phone at (925) 944-9468.