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Exam CMQ-OE topic 1 question 123 discussion

Actual exam question from ASQ's CMQ-OE
Question #: 123
Topic #: 1
[All CMQ-OE Questions]

In medical device manufacturing and in pharmaceutical production, strict traceability is mandated by regulation. What type of actions may draw upon this requirement?
I: Fulfillment of an unconditional guarantee
II: Replacement of failed product under warranty
III: A product recall that is needed to safeguard product users
IV: Analysis of problems leads to process improvement

  • A. II, III, and IV only
  • B. III and IV only
  • C. I, II, and III only
  • D. I, II, III, and IV
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Suggested Answer: B 🗳️
by gemazyni at April 5, 2025, 5:55 p.m.

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4f400d2
1 week, 4 days ago
Selected Answer: A
It is debatable whether 'I' does not require traceability. If a product fails, one of the first questions is about the serial number of the product to start the investigation and identify the date of manufacturing, the potential batch/lot, and whether other products may be impacted. This may trigger a product recall. In my opinion, answer 'A' is the correct choice.
upvoted 1 times
4f400d2
1 week ago
Update: All actions require traceability. D is the correct answer.
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