CAPA is acronym of Corrective Action and Preventive Action. The CAPA process is one of the center cycles that exist inside the quality arrangement of every medical device organization. The FDA mandates that medical device organizations break down quality review reports, work activities, returned items, administration records, concessions, processes and work on the root cause of non-conforming products. We team of Operon strategist help our clients to manage CAPA documentation; CAPA creates a huge amount of paperwork , information from processes, work tasks, quality review reports, client grumblings and administration records, meeting notes, CAPA structures, main driver examination archives, and then some. Our team keep documents organized ,open for endorsement and survey as you explore potential CAPA occasions.
- Operon Strategist is ISO 13485 Medical Device Consultant helps to create the documents for ISO 13485 certification. for more details and services contact us or whatsapp us
CAPA- Risk base approach
There should be a strong correlation between the CAPA and risk management in your organization. Before taking the CAPA of the problem you should check whether the same problem is already captured in your risk management document or not, If not then it’s time to update the documents.
It’s also important to remember that starting a CAPA is a risk management activity. Risk is formed by combining the likelihood of injury and the severity of the harm. As we have seen, CAPAs are typically initiated when a problem is systemic, implying that it has a higher probability of occurring. Nonetheless, due to the seriousness of adverse events involving a patient’s injury, a CAPA may be required.
Read More - Trigger a CAPA
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