Risk management and CAPA that hold up in an audit
I build or improve your risk management under ISO 14971 and your CAPA process, so risks are followed through the product's life and corrective actions reach the real cause.
Three situations where this works best
It was prepared for the submission and hasn't been updated since, while the product and the field data moved on.
Corrective actions sit past their due date, or close without evidence that they worked.
Nonconformities repeat because the root cause was never found.
Your risk file was written once
CAPAs stay open
The same problems keep coming back
Your risk management file doesn't reflect complaints and post-market data.
Auditors raised findings on your risk management or CAPA process.
Your team isn't sure when a nonconformity needs a CAPA.
Root cause analyses stop at human error, and the problem returns.
CAPAs are closed without checking that they worked.
You probably need this if one of these sounds familiar
Risks followed through, and actions that close
A risk process that links design, production and post-market data.
Clear criteria for opening a CAPA, a real root cause, and an effectiveness check before closure.
Overdue CAPAs reviewed and closed with the evidence an auditor expects.
Your people know how to run the process without me.
Risk management under ISO 14971
A CAPA process that closes
Open items under control
A team that can carry it
From a first conversation to the work itself
You tell me about the device, the market you are aiming for and your timelines. I tell you what I would do first.
When needed, I go through your procedures, your technical file or your most recent audit reports.
The scope of work, estimated hours and a timeline. I work by the hour.
I work with your team on what the company needs at that stage, and we meet regularly for updates.
A first conversation
Looking at what you have
A clear proposal
The work itself
I handle CAPAs at several of the companies I work with, including a dental navigation company I support on an ongoing basis. I take each one from the investigation and the root cause through to checking that the action worked. Risk management is a subject close to my heart: I wrote an 18-part series on qualitypulse. that walks through ISO 14971 step by step.
CAPA that gets to the cause
I analyze the findings, build the corrective action plan and the documentation that supports it, and help you respond on time. For a 483 or a warning letter, I map the gaps and lead the remediation plan.
Both are possible. Many clients start with a project and continue with a few hours a month of ongoing support. I work by the hour, and offer a fixed price only when the scope is closed and known in advance.
It depends on the scope. I work by the hour, and after a first conversation, and sometimes a look at what you already have, I send a proposal with the scope, estimated hours and timeline.
What happens after an audit finding or an FDA warning letter?
How do engagements typically work – project-based or ongoing?
How much does it cost?
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A 30-minute call. You tell me where you are, I tell you what I'd do first and whether I'm the right fit.