Corrective Action/Preventative Action
When taking corrective action, a company must go through the following three-step process:
Find the Issue | Assess the Risk to Patients | Contain the Issue
Noyce Quality Consulting LLC helps you find the root cause of the issue using analysis and then eliminates it by implementing corrective action plans. How an issue is contained is based on the risk level to patients. For example, it may be necessary to bring the product back for repairs, or you may be able to leave the product with the patient and simply create a correction within your manufacturing process.
Complaints need to go through levels of triage to determine if they are high-risk. We make sure every complaint is researched, recorded, and tracked. Noyce Quality Consulting LLC helps you with FDA reporting of any high-risk complaints. We will teach you how to identify worrying trends as well as how to investigate and rectify them to maintain patient safety and avoid citations.