Q: I’ve been assigned to do a product risk assessment on a new device we’re developing. My background is not in risk management, so any advice you can offer would be very much appreciated. I’m especially concerned about how often we…
Tag Archive for Denise Dion
What are Considered “Work Operations” under FDA’s CAPA Rules?
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Q: 21 CFR Part 820.100(1) says we should establish and maintain CAPA procedures with requirements for “analyzing processes, work operations…” Does “work operations” mean operations of processes? Should we determine criteria and methods to ensure that our “work operations” are effective?…
FDA Rules for Tracking Exchanged Parts: Are You Servicing, Remanufacturing, or Refurbishing?
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Q: Are there any FDA regulations or requirements that cover the tracking and recording of exchanged parts used in equipment such as medical devices? A: The current answer depends on whether you are servicing the device, remanufacturing it, or refurbishing it. If…
Design Validation: More than Just User Testing
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Q: Really, in the final analysis, isn’t design validation just user testing? A: I’ve heard that a lot lately. But it’s not true. The Quality System Regulation (21 CFR Part 820) includes requirements for design controls. The regulation requires design validation…
Guidelines for Making Quality System Changes
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Q: I think we understand what’s required for changes to a product design or manufacturing process. But when it comes to making changes to a quality system procedure or work instruction, we’re not clear on what’s needed prior to implementing such quality…
FDA Outsourcing Rules: Do They Cover More than Contract Manufacturers?
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Q: Question about FDA outsourcing rules: ISO 13485 requires that when an organization chooses to outsource a process that affects product conformity with requirements, the organization must ensure control over such processes. It also says that control of outsourced processes should…
Complaint Investigation: When You Don’t Have to Investigate Every Complaint
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Q: Does every complaint require some kind of complaint investigation? A: Yes, but with some qualifications. For each complaint you receive, you should determine the extent of the problem, its impact (risk) to the user, patient or by-stander, and its validity. Why…
Determining What’s “Production Equivalent” with a New Product Design
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Q: I’m dealing with a design contract house responsible for product design of a medical device. They are responsible for all of the documentation needed for design control, etc. If we produce the first 100 units via the contract house, those units will be…
ER Analogy: When to See the CAPA “Specialist”
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Q: My company continues to struggle with deciding when to elevate a complaint to the level of a CAPA. And at times we disagree about how to differentiate complaints, non-conformances, and CAPAs. Can you help us sort it all out? A:…
CAPA Data Sources; What Makes a Compliant CAPA System
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Q: My question is about what makes a compliant CAPA system, including appropriate CAPA data sources. We recently received a 483 notice citing inadequacies in our CAPA system. Could you review for me FDA’s basic requirements for CAPA? Moreover, what are…