Q: Section 820.5 of the Quality System Regulation says that we must establish but also “maintain” a quality system appropriate for our product. Some of the things we should maintain seem obvious, but I’m curious — from your perspective as a…
Tag Archive for CAPA
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?…
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…
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…
Latest FDA Enforcement Hot-Spots and Targets: The View from the Trenches
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Q: I’m a Quality Auditor and looking for information on the latest FDA enforcement focus. From your perspective as an ex-FDA investigator who now helps industry avoid trouble, what is FDA enforcement “going after” these days? A: Supplier management — how carefully…
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:…
Incoming Inspection: Is Pass/Fail OK?
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Q: At my company, incoming inspection includes measuring the length of a cable used in our products. The results are recorded as “pass/fail”. My colleague thinks the actual results (the measurement) should be recorded instead. I can’t recall an actual regulation…
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…
Internal Audits: Are They Really Necessary?
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Q: Question regarding internal audits: is it acceptable for a manufacturing site to NOT have an established internal audit program? In place of internal audits, the manufacturing site uses the results of external audits conducted by regulatory authorities, standards assessment organizations,…
Design Change: How Does FDA Define It?
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Q: From an FDA viewpoint and your own experience, how would you recommend we define a “design change” in our design control procedures? A: FDA has said that any change to the finished, packaged and labeled device should be considered a design…