“Audit Ready” – ClearCam’s First Regulatory Audit
Always be “Audit-ready” – we’ve lived by this mentality for a few years now, but I’ve heard it verbally more times in the past 4 months than the past 4 years combined. This is because it’s the “living motto” of our Senior Quality Engineer, Juan Hinojosa, who joined ClearCam in April. We are thrilled to have him as a leader in our team with a mind and eye built for Quality. This past week, Juan and the rest of the team proved our dedication to Quality in a stellar fashion, as we underwent our first regulatory audit for the FDA.
For those unfamiliar, in a nutshell – an auditor arrives to audit your Quality Management System (QMS/QSR) (including the physical office, lab, etc.). During the audit, they make observations, ask questions, and often discuss or debate the interpretation and clarification of internal procedures and task execution to determine company compliance as per regulations.
There are different types of FDA audits (details found online). Ours was a routine, Level 2 Baseline, QSIT Inspection. Now with the audit officially closed, we thought it might be helpful to share our takeaways for those interested in understanding the relevance and importance of a QMS (and audit) for a company like our own:
No “cookie-cutter” method or rubber stamps. Different companies have different QMS audited by different inspectors. Appreciate, internalize, and implement input from as many experienced professionals as you can speak to.
“Perfection” is unattainable. It is also, conveniently, the enemy of “good enough”. But, if you keep your QMS and team audit-ready, a strong and productive audit is well within your reach. Continuous improvement is a vital goal to maintain compliance and improve efficiency.
Live a “Quality life”. Over the years, all team members have poured countless hours into our QMS. We have “lived Quality”. This doesn’t mean everything should be perfect, mind you, but when that much focus is put into your QMS, confidence in its strength should never waiver.
Practice makes perfect. We go through 4 internal audits (kind of like a “self-audit”) every year. A high count by most industry standards. But this dedication to Quality strengthened our QMS, and the proof is in the pudding, given the results of our FDA audit.
Our friends at Q-Logic Consulting (here in Austin) helped sharpen our system through multiple internal audits. They are a 10/10 and then some. We highly recommend them to anyone needing Quality help and are happy to provide an introduction.
Iron sharpens iron. Be open to input – auditors know the regulations and have often seen multiple (if not dozens) of QMS(s). Take the opportunity to improve. At the same time, if questions arise, but you are confident that you are compliant with regulations, don’t be shy about defending your system. Just be sure to do so constructively and with strong supporting data and information. Auditors can learn from you and your team too. It should be a two-way street.
A powerful QMS is a valuable QMS. Value for a medical device company, especially a startup, doesn’t *solely* come from sales. It’s captured in growth and trajectory too. This is where the QMS value may shine brightest. At the highest level, an effective QMS de-risks the company while increasing its value.
As seen in our audit, robust Design Controls (where your Design History File resides) lay a strong foundation to assess risk for impactful and defensible post-market surveillance.
Management has to be involved, aware, and dedicate the resources needed to keep the QMS not just compliant, but effective.
If you pretend like you aren’t making mistakes, that in itself is a major mistake. Use your QMS to capture and address gaps through your CAPAs, Nonconformances, and Complaints processes. Feed those findings back into your system and product.
Production processes throughout the QMS are key, but be sure to have strong proof/documentation of critical ones, in particular (e.g., sterilization, packaging, etc.).
Supplier evaluations have to be a constant focus to ensure that products are being manufactured in a compliant and efficient manner.
Outside of “meeting the regulations”, your QMS really comes down to “The Big 3”:
Control. Prove that you have control over your product through your processes. The flexibility of procedures is valuable for day-to-day, but ambiguity can lead auditors to dig and get stuck on things. Find the balance. Sometimes it takes trial and error.
Risk. Justify decisions based on risk. Link decisions and dispositions back to your risk management documents, FMEAs, etc.
If it isn’t documented, it didn’t happen. No assumptions allowed. Get credit for the work you are doing.
So, all of these takeaways lead to the BIG question – how did ClearCam’s QMS hold up?
Honestly… We crushed it!
The auditors dug into our Management Controls, CAPA (Corrective and Preventative Actions) System, Design Controls (Design History File, etc.), and Production and Process controls, as per their “QSIT” technique. There were some very productive discussions on the performance of our system in both controls and risk analysis being integrated into decision-making. I’m proud to say that we were also given a handful of compliments for our dedication to “The Big 3” mentioned above.
All in all, it was an incredible milestone for the company to not only accomplish, but exceed expectations as compared to other companies of similar size and age – let alone in our very first FDA audit. It is a true testament to the entire team, including internal and external members, especially those with a major focus on our QMS. They have all worked their tails off and I’m proud to be able to recognize all their hard work with such a stellar audit outcome.
Just remember… “Audit-ready” - Juan Hinojosa.
Now onto the next milestone!
Chris Idelson, PhDCofounder and CTO