Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems. Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device. – It is appropriate to “elevate” some issues at the expense of others.Ī Preventive Action is NOT required for all situations however, a Corrective Action to prevent recurrence is required. – Not all problems require the same level of investigation and action. Should consider the risk posed by the problem. Step 1 - Define the Problem Step 2 - Risk Assessment Step 3 - Take Action While Triggering the CAPA Step 4 - Conduct Root Cause Analysis Step 5 - Plan the.Develop action plan for corrective action and/or preventive action.Identifying the action(s) needed to correct and prevent recurrence of non-conforming product and other quality problems is a critical step of CAPA process. Many manufacturers tend to overuse training as a corrective action and do not adequately address the systemic corrective action. Investigate data, process, operations and other sources of information.Graphical methods (fishbone diagrams, histograms, scatter plots, spreadsheets, etc.).A solid CAPA process is foundational and an indicator of the health of a medical device company. In fact FDA states in their QSIT guide: One of the most important quality system elements is the corrective and preventive action subsystem. Analysis of data should also include a comparison of the same problem type across different data sources.Ĭommon Statistical Techniques Used for CAPA Management As noted throughout this guide, CAPA is an important process for your medical device company. And the procedures must ensure all requirements of CAPA subsystem are met.Įnsure all quality data sources are defined and analyzed to identify existing product and quality problems. The CAPA process typically includes the following steps: 1. Each pharmaceutical manufacturer shall establish and maintain procedures for implementing corrective and preventive action (CAPA). The CAPA process is designed to identify the root cause of an issue and put in place corrective and preventive measures to mitigate the risk of reoccurrence.
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