How Supplier-Friendly Shared Audits are Creating a Win-Win for the Medical Device Industry

Posted on: November 1, 2018

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.

Testimonials

"My Manager reviewed and approved this validation, and he called me to say it would be the gold standard for spreadsheet validations for all Nordson Medical D&D sites from this point forward!"

-Kim Trottier/Quality Information Systems Manager, Nordson Medical

"Our notified body commented that he was impressed with the focus and professionalism of the Emboline team during a recent audit. This is largely a credit to the Cannon Quality Group team. Your team, as always, was extremely organized, well-prepared and professional. Thank you!"

-Scott Russell/President and CEO at Emboline, Inc.

"Everything about the audit process including scheduling, the audit itself, and results & follow-up were seamless and enabled LamaMed Solutions, Inc. to fulfill its requirements for Internal Audit and assessment of QMS conformance with ISO 13485:2016 in advance of our Notified Body audit."

-Lloyd Griese/Quality and Regulatory Consultant, LamaMed Solutions, Inc.

"Our SVP of QA/RA performs mock-FDA audits across all our global facilities. So it was huge compliment for us when, after reviewing all aspects of a software validation authored by Cannon Quality Group, he said it was as good a validation as he had ever seen."

-Ron Koronkowski/Director of Quality & Regulatory, Vention Medical, Inc.

"Cannon Quality Group's staff was highly engaged and responsive to our needs. They were easy to work with and provided a high-quality work product."

-Caroline Jewett/Consultant for PvP Biotech

"It was by far the best QSR/GMP training – high caliber content and engaging delivery."

-Robert Angelopoulos/Sr. Engineering Manager, Powervision, Inc.

"Don’t stress. Call Cannon Quality Group for great project support."

-David Freed/Sr. Quality Director, AcelRx Pharmaceuticals, Inc.

"My 3rd party ISO 13485:2016 audit was extremely beneficial to my company. The auditor was very knowledgeable about the standard and current trends that notified bodies are looking for."

-Tom Mason/Director QA, Vactronix Scientific

"When strategic partners were doing due diligence, I think they expected to find an empty drawer where the Quality Management System would be. We started showing them the procedures and design files that Cannon Quality Group helped us establish, and they were pleasantly surprised to get just what they wanted…The ability of…"

-Don Bogue/President/CEO, Compact Imaging

"Our [CQG] auditor provided findings with value-based explanations and implementation ideas."

-Kyle Dion/Quality Specialist, BlueLine Sterilization Services

"CQG has been with my organization from the nascent stages of our QMS.  Their team of experts coached us on the ISO standards, provided training classes, furnished sample QMS documentation, and were always quick to respond to our endless questions.  Most importantly they were present at our crucial certification and customer audits. …"

-Kathleen Perry/Twist Biosciences

"Working with Cannon was a pleasure. They helped us create our first formalized Quality Management System with just the right balance of rigor, detail-orientation, and practicality. I would definitely work with Cannon again in the future on quality management projects."

-Gideon Wald/CTO Welkin Health

"JenaValve would like to extend a very appreciated “Thank You” to the whole Cannon Group team in supporting us, JenaValve, through the quality system improvements and associated activities. Your organization has been exceptional in supporting the chaotic schedule and the Cannon Group team members have performed above and beyond the…"

-Peter Wulff/CFO JenaValve

"Your team is great, love the maturity level. Great respect from Quality & Regulatory."

-Mark Adler/Senior Director of R&D JenaValve

"CQG has really shattered my preconceptions of what contracted support can do for a quality system. They are true professionals from the advice they provide, work they produce, and the integrity of actions. From complicated design control issues, to Process Validation, to Doc Control, they have been a huge resource…"

-David Hesting/QA Director, Profusa, Inc.

"Amy has done an amazing job here and we appreciate all her help. Communication with everyone/doc control is good/responsive, and we especially appreciate the quick turnaround on hot DCO’s – they find everything."

-Bijesh Chandran/VP of Quality, R2 Dermatology

"Cannon Quality Group is an absolute pleasure. For our startup, CQG made QSR development and compliance enjoyable and easy. Their unique style and system has allowed us to work at the fast pace required by the market, while still maintaining regulatory compliance."

-Andrew Hosford/Director of Engineering, Gauss Surgical

"Our startup was working with a skeleton quality system and struggling to apply QSR standards, when we brought in the Cannon Quality Group. They overhauled and sharpened our quality system so that it complied with the QSR, in only a few months, which allowed us to have a flawless audit.…"

-CQG client/

"When a key employee quit just as the load on my QA group exploded because of a clinical build, CQG stepped in immediately with the resources we needed to keep us going. I hope nothing like this ever happens to us again but, if it does, I’ll know exactly whom…"

-Ari Zak/Sr. VP, Clinical, Regulatory & Quality and Corporate Counsel, PowerVision

"Prior to CQG, our startup worked with another company which made quality slow, very expensive, and highly frustrating. Comparatively, CQG has been a game changer for our company. They have made QSR development and compliance enjoyable and easy, which has allowed us to work at the fast pace required by…"

-CQG Client/

"Kudos to the Cannon Quality Group for helping us get through our FDA audit with zero 483s and just a few CAPAs.Their expertise in quickly turning our bare bones QMS into a robust system is exactly what was needed."

-Shaun R. Bagai/CEO – RenovoRx, Inc.

"Pete is awesome, I appreciate the help he provides to our team and his assistance in various quality needs."

-Kityee Au-Yeung/Profusa

"As a new Quality Director at a young start-up company, I am happy to leave a recommendation for Cannon Quality Group. Cannon Quality Group has an innovative and efficient process in place to bring a working Quality System to a start-up company in a short amount of time. Cannon retains…"

-Delane Dale/Quality Director – BioInspire Technologies
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