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Being prepared to describe your response to a significant quality issue is an important part of inspection readiness, and corrective and preventative actions (CAPAs) are the heart of that response. These terms are commonly misunderstood. A quick explainer:
Quality issue: You forget your friend's birthday.
Correction: "Happy belated birthday!"
Corrective Action: You write your friend's birthday in your calendar, recurring annually, so that you never forget it again.
Preventative Action: You write ALL your friends' birthdays in your calendar so you never forget anyone's birthday.
Two aspects that trip us up: First, both the "corrective" and "preventative" actions are essentially preventative. "Corrective" actions prevent the exact same issue from recurring; "preventative" actions prevent a new issue from occurring. Second, when we're working on a clinical study, many quality issues are unique to the study, thus many actions are "corrective," or applicable to that study, rather than "preventative."
When addressing quality issues, don't worry too much about the difference between "corrective" and "preventative" actions, but do think about the best way to address the root cause of an issue (a whole other blog post), and whether it should be applied at the clinical study level or the organizational level.
Denise DeRenzo Lacey, RQAP-GCP, has over twenty years’ experience in clinical Quality Assurance and clinical development operations. Her practice focuses on application of quality risk management techniques for clinical studies, including risk-based approaches to auditing, data quality and integrity, and SOP development. She has provided consulting services to a wide range of pharmaceutical, medical device, biotech and CRO clients in the US and Europe and has held senior positions at Vertex Pharmaceuticals and Radius Health.