Cannon Quality Group announces 2 new shared supplier audits for Steri-Tek and Nelson Labs!

Posted on: February 18, 2020

Cannon Quality Group has pioneered the concept of the Shared Supplier Audit. CQG founder Nicolle Cannon had the idea some years back when she noticed that so many of her client companies were auditing the same suppliers. Especially for start-ups and emerging medical device companies, sending scarce resources out to a supplier for an audit is hard to do.

Why not consolidate multiple audit days from multiple customers into one audit to save everyone time and money?

We’re excited to announce two new Shared Supplier Audits for spring 2020: Steri-Tek in Fremont, CA and Nelson Labs in Salt Lake City, UT, both to be conducted in May.

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 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.”

For clients of a shared audit the results are no different from a solo audit other than it is much more cost-effective. Clients do not know who the other participating companies are, and no confidential information is shared between clients.

If you’d like to get on board either the Steri-Tek or Nelson Labs audits this May, please get in touch at www.cannonqualitygroup.com/contact-us/ or by phone at (925) 944-9468.

If you need other suppliers audited or if you are a supplier and would like to explore the possibility of hosting a shared audit of your facility, we’d love to hear from you!

Testimonials

"I am working on aging and packaging which they specifically said was assigned based on my experience at Cannon. Your internship program is literally the gift that keeps on giving."

-Maggie Baker/R&D engineer intern, former CQG intern from California Polytechnic State University, San Luis Obispo, CA, now at a major medical device manufacturer.

"I just wanted to drop a quick note to thank you all for your support over these past several months. We had a very successful audit this week. Both auditors were very complimentary of the progress we have made since the last audit and that is really a testament to…"

-Zachary Woodson/Vice President of Regulatory Affairs & Quality, LimFlow SA, Santa Clara, CA and Paris, France

"Look what you have done!  Profusa has a functional QS thanks in large part to you. The GMED auditor has conducted over 700 audits and said we have an extremely good QS and a lot of that credit goes to you… I just wanted to let you know that Profusa…"

-David Hesting/QA Director, Profusa, Inc., Emeryville, CA

"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, Marlborough, MA

"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., Los Altos, CA

"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., Hayward, CA

"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., Sunnyvale, CA

"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, Seattle, WA

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

-Robert Angelopoulos/Sr. Engineering Manager, Powervision, Inc., San Mateo, CA

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

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

"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, Fremont, CA

"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, Mountain View, CA

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

-Kyle Dion/Quality Specialist, BlueLine Sterilization Services, Novato, CA

"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, San Francisco, CA

"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, San Francisco, CA

"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, Irvine, CA, Leeds, U.K. and Munich, Germany

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

-Mark Adler/Senior Director of R&D JenaValve, Irvine, CA, Leeds, U.K. and Munich, Germany

"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., Emeryville, CA

"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, San Ramon, CA

"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, Menlo Park, CA

"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, San Mateo, CA

"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., Los Altos, CA

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

-Kityee Au-Yeung/Profusa, Emeryville, CA

"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, Palo Alto, CA
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