7
min read
When Four Audits Hit in Ten Days: A Real Experience from the Field
Meical Device
QMS
Woburn, Massachusetts
Covaris manufactures advanced sample preparation tools based on a unique technology platform. Our goal is to empower customers to make new discoveries, develop new assays and improve bioanalytical results.
"In the span of a week and a half, I had four days' worth of auditing... No back room. No binders. No scrambling for documents. Everything was handled directly inside Orcanos." Hein Smit Sibinga, Director Quality & Regulatory at Covaris.
When Four Audits Hit in Ten Days: A Real Experience from the Field
In the span of a week and a half, Hein Smit Sibina, Director Quality & Regulatory at Covaris (a Perkin Elmer company) went through:
- One full customer audit
- Two days of ISO 13485 auditing
- A BSI audit immediately after
Four audit days. Three different organizations. Continuous pressure.
No back room. No binders. No scrambling for documents.
Everything was handled directly inside Orcanos.
“In the span of a week and a half, I had four days' worth of auditing.”
The Challenges Before and During the Audits
Hein faced real operational pressure:
- Auditors asking for immediate evidence
- Supplier documentation verification
- Traceability across parts, suppliers, and nonconformances
- Proof of purchasing controls
- Quick access to historical data
- Managing large volumes of records
In audit situations, speed and clarity matter. Delays raise questions.
Q&A: How Orcanos Performed During the Audits
Q: What changed during this round of audits?
Hein:
“All the evidence is just where it is in the Orcanos system. I have it immediately.”
Instead of searching across folders or asking others for documents, he accessed everything directly in the system.
Q: Did you still need a back room during audits?
Hein:
“I don’t really need a back room anymore. I can just type it into Orcanos. I almost always get exactly what I need.”
Real-time access replaced manual document retrieval.
Q: How did dashboards and search help?
Hein relied on:
- Custom filters (like “My Documents”)
- Dashboards for structured visibility
- Linked traceability to jump between related records
Hein:
“Good use of dashboards and keeping everything organized in the tool saved my rear end many times.” Instead of navigating disconnected systems, he moved seamlessly between records.
Q: What about traceability?
Traceability was critical, especially in:
- Supplier audits
- Purchasing reviews
- Nonconformance analysis
Hein could:
- Open a supplier record
- View linked parts
- See related NCRs
- Identify trends
“I can literally open up a supplier and go to the traceability tab and see what are all open NCRs.”
That level of connection makes audit conversations easier and more controlled.
Q: How did supplier management improve?
Hein used supplier traceability to:
- Identify inactive suppliers
- Confirm last purchase dates
- Remove unnecessary supplier files
- Reduce audit exposure
“I was able to take off another six suppliers off my list because we hadn’t paid them a single bill in five years.”
This reduced compliance burden and simplified oversight.
Q: What was the biggest difference?
Speed. Confidence. Control.
“It all ties together.”
When documents, parts, suppliers, and quality records are connected, audit preparation becomes operational discipline—not emergency response.
Conclusion
Hein didn’t describe Orcanos as a “tool.”
He described it as an environment where:
- Evidence is structured
- Relationships are visible
- Data is connected
- Answers are immediate
Under real audit pressure, that makes the difference.
And perhaps most telling:
“I love working with you guys. The collaboration with your team has always been highly effective.”
That kind of partnership is built through shared commitment to solving real operational challenges.
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