8.5-2 Corrective And Preventive Action

1. 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"

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.

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.

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

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.

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.

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

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.

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.

4. Which system is used to record CAPAs?

IQMS

Grand Avenue Software (GAS)

Excel file

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.

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.

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.

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.

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.