CAPA for Nonconformities
An overview of the key concepts and terminologies associated with nonconformities, and the CAPA methodology used to address them as part of a company’s Quality System. The concept of risk and categorization of nonconformities as minor, major, or critical is also covered as are regulatory expectations surrounding nonconformities and CAPA.
Duration: 30 Mins
Description
The module uses a scenario-rich design to introduce the user to the key concepts and terminologies of CAPA. Using various industry-based scenarios, the user will be taken through the key steps of a CAPA process from identifying a problem to verifying the effectiveness of the solutions implemented to resolve it. In doing so, users will be better equipped to distinguish between key concepts such as corrections, corrective actions, and preventive actions. They will also work through the concept of risk, categorization of nonconformities as minor, major, or critical, and subsequent decision-making regarding CAPA implementation. The regulatory expectations surrounding nonconformities and CAPA will also be stressed.
Learning Objectives:
- Explain the term ‘nonconformity’.
- Define CAPA
- Explain the purpose of a CAPA system.
- Explain the difference between minor, major, and critical nonconformities.
- Distinguish betvveen corrections, corrective actions, and preventive actions.
- Describe the different elements of a ‘SMART ‘CAPA plan.
- Describe the correct way of verifying the effectiveness of
