8.5-2 Corrective And Preventive Action

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| By Mick Snyder

Mick Snyder

Community Contributor

Quizzes Created: 15 | Total Attempts: 7,668

Questions: 5 | Attempts: 399 | Updated: Mar 21, 2023

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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"
Correct Answer
C. To eliminate a nonconformity

Explanation
The reason for initiating a CAPA (Corrective and Preventive Action) is to eliminate a nonconformity. CAPA is a systematic approach to identify, investigate, and address the root cause of a nonconformity or deviation from a desired outcome. By implementing CAPA, organizations can take corrective actions to address the nonconformity and prevent its recurrence in the future. This helps in improving quality, ensuring compliance with standards, and enhancing customer satisfaction.

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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
Correct Answer
D. Investigate and Plan

Explanation
The stage of CAPA where the root cause of a nonconformance is evaluated is the "Investigate and Plan" stage. In this stage, a thorough investigation is conducted to identify the underlying cause of the nonconformance. Once the root cause is determined, a plan is developed to address and correct the issue. This stage is crucial in ensuring that the corrective and preventive actions implemented in subsequent stages are effective in preventing future occurrences of the nonconformance.

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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
Correct Answer
C. Eliminate a potential cause of a nonconformity

Explanation
A Preventive Action is put in place to eliminate a potential cause of a nonconformity. This means that it is implemented to address and resolve any factors or conditions that could potentially lead to a nonconformity or deviation from the desired standards or requirements. By identifying and eliminating these potential causes, the organization can proactively prevent nonconformities from occurring in the first place, ensuring that processes and products meet the required standards and specifications.

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4.

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

Explanation
Grand Avenue Software (GAS) is the system used to record CAPAs. This implies that GAS has the necessary features and functionality to effectively record and manage Corrective and Preventive Actions (CAPAs). IQMS and Excel file are not mentioned as the systems used for this purpose, suggesting that they may not have the required capabilities for recording CAPAs.

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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.
Correct Answer
B. False, the Quality System Manager may find that the problem does not require action.

Explanation
The correct answer is False because the statement mentions that all CAPA requests are approved by the Quality Systems Manager. However, this is not accurate as the Quality Systems Manager may determine that the problem does not necessitate any action. Therefore, not all CAPA requests are necessarily approved by the Quality Systems Manager.

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8.5-2 Corrective And Preventive Action

What is the reason for initiating a CAPA?

Evaluating the Root Cause of a nonconformance happens in which stage of a CAPA:

A Preventive Action is put in place to:

Which system is used to record CAPAs?

All CAPA requests are approved by the Quality Systems Manager.