Tag Archive for QSR

Incoming Inspection: Is Pass/Fail OK?

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…

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Design Change: How Does FDA Define It?

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…

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Management Reviews: A Checklist for Compliance

An effective and compliant Quality System must include periodic Management Reviews held at defined intervals of sufficient frequency. These reviews should include assessments of your processes, products, and customer needs. In addition, they should focus on the overall health and effectiveness…

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