8.5-2 Corrective And Preventive Action

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.

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.

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.

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.

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.