Quality Risk Management Findings: Can Regulators Ask to See Them?

Q: Are our quality risk management findings accessible to regulatory agencies? Or are they considered private and confidential company information?

A: All quality risk management activities and documentation are accessible to the regulatory authorities.

Your company should base its findings on the risks of the decisions it makes — decisions about product design, product recalls, complaint investigations, and system validation, among others.

“When a regulatory agency looks at any of these areas, it likely will want to see your decision-making process.”

When a regulatory agency looks at any of these areas, it likely will want to see your decision-making process, which includes the quality risk management decisions you make about assessing, mitigating, and managing risks.

Answered by Janis Olson, Vice President of Regulatory and Quality Services for EduQuest, who served 22 years at the U.S. FDA as an expert field investigator and also as regional director of information management resources. Jan is the developer of EduQuest’s 12-hour training class on Quality Risk Management for FDA, ISO, and ICH Compliance. The class is available as an on-demand, on-site training course that can be delivered when and where you need it. Email EduQuest for a quote.

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