8.5-2 Corrective And Preventive Action

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| By Mick Snyder
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Mick Snyder
Community Contributor
Quizzes Created: 15 | Total Attempts: 9,297
| Attempts: 679
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  • 1/5 Questions

    What is the reason for initiating a CAPA?

    • To deviate from a Work Instruction
    • To rework a product
    • To eliminate a nonconformity
    • To "Run at Risk"
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About This Quiz

This quiz titled '8.5-2 Corrective and Preventive Action' assesses understanding of CAPA processes in quality management. It covers reasons for CAPA initiation, stages of investigation, preventive actions, recording systems, and approval processes, vital for ensuring compliance and quality standards.

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  • 2. 

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

    • Implement and Verify

    • Closure

    • Submit a CAPA Request

    • Investigate and Plan

    Correct Answer
    A. 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:

    • Identify a nonconformity

    • Make you work on a device longer

    • Eliminate a potential cause of a nonconformity

    • Identify the reason a nonconformity occurred

    Correct Answer
    A. 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?

    • IQMS

    • Grand Avenue Software (GAS)

    • Excel file

    Correct Answer
    A. 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.

    • True, all CAPA requests are investigated and completed.

    • False, the Quality System Manager may find that the problem does not require action.

    Correct Answer
    A. 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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Quiz Review Timeline (Updated): Mar 21, 2023 +

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  • Current Version
  • Mar 21, 2023
    Quiz Edited by
    ProProfs Editorial Team
  • Jul 13, 2015
    Quiz Created by
    Mick Snyder
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