8.5-2 Corrective And Preventive Action

5 Questions | By LSIadmin | Last updated: Mar 21, 2022 | Total Attempts: 156

Corrective and Preventative Action (D000368)

Questions and Answers

1.

What is the reason for initiating a CAPA?
- A.
  
  To deviate from a Work Instruction
- B.
  
  To rework a product
- C.
  
  To eliminate a nonconformity
- D.
  
  To "Run at Risk"
2.

Evaluating the Root Cause of a nonconformance happens in which stage of a CAPA:
- A.
  
  Implement and Verify
- B.
  
  Closure
- C.
  
  Submit a CAPA Request
- D.
  
  Investigate and Plan
3.

A Preventive Action is put in place to:
- A.
  
  Identify a nonconformity
- B.
  
  Make you work on a device longer
- C.
  
  Eliminate a potential cause of a nonconformity
- D.
  
  Identify the reason a nonconformity occurred
4.

Which system is used to record CAPAs?
- A.
  
  IQMS
- B.
  
  Grand Avenue Software (GAS)
- C.
  
  Excel file
5.

All CAPA requests are approved by the Quality Systems Manager.
- A.
  
  True, all CAPA requests are investigated and completed.
- B.
  
  False, the Quality System Manager may find that the problem does not require action.

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