Module 1 — Quality Systems

Module quiz

5 questions on Module 1 — Quality Systems. Answer them all, then check your score before moving on. 4 correct or more is a pass. Your best score is saved on this device, and to your account when you are signed in. This is a self-check, not an accredited assessment.

1. 1. What does a control plan have to state for each check?

   Only the name of the checkThe check, the standard, the sample and frequency, and the reaction when it failsOnly who signs the formOnly the machine used

2. 2. In corrective and preventive action, what is containment?

   The permanent fixThe immediate action that stops suspect product moving onA note in the audit fileThe cost of the defect

3. 3. A defect recurs three months after a CAPA was closed. What does that indicate?

   The root cause was never removed, or the control was not sustainedThe inspector was too strictA new standard is neededNothing; recurrence is normal

4. 4. Which distinguishes quality assurance from quality control?

   Assurance builds the process that prevents defects; control detects them in productThey are the same activityControl happens before production, assurance afterAssurance only applies to laboratories

5. 5. Why must a quality manual reference the buyer's own protocol?

   To make the file longerBecause buyer protocols often set tighter limits or different test methods than the factory defaultBuyers never specify methodsTo replace the national standard