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Regulatory Focus™ > News Articles > Quality & Compliance: Health Hazard Evaluation: A Useful Tool for Risk Escalation

Quality & Compliance: Health Hazard Evaluation: A Useful Tool for Risk Escalation

Posted 01 May 2010 | By

Early in my career as a medical director in the medical device industry, a young engineer approached me with a corrective and preventive action (CAPA) file and asked me to perform a health hazard evaluation (HHE) regarding a product issue. In reviewing the file, I noticed that a decision on whether an HHE was required was part of the CAPA process and one of the many boxes on the checklist required for closing this CAPA. This decision was his to make, I thanked him for getting me involved. Realizing that the CAPA was already three months old, I had a few questions:

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