Monthly Archives: July 2014

Nonconformance Versus CAPA Requests

Question: I need advice on the use of Nonconformance versus Corrective Action/Preventive Action (CAPA) Requests. I understand and have tried to communicate the low risk and high risk definitions to staff with some understanding. In reporting nonconformance’s some evolve into … Continue reading

Posted in CAPA, Other | Tagged

Employee Qualification Audit

  Question I am a Quality Assurance GxP Auditor and I am being told that I cannot perform employee qualification audit.  I am being told that CV/resumes, job descriptions, and training records are confidential and my viewing them would violate … Continue reading

Posted in Auditing | Tagged , , ,