Tag Archive for Risk Analysis

How Often Should You Conduct Internal Audits?

Q: I’ve found conflicting information on how frequently to perform internal audits. The ISO standards and the Quality System Regulation don’t have any frequency recommendations, but FDA’s Quality System Inspection Technique (QSIT) Guide recommends every 12 months. I’ve been in…

Share

Risk Assessment: When is One Necessary?

Q: Can you tell me when I need to perform a risk assessment?A:  I believe a risk assessment is always necessary. For everything you produce, you should have a product risk assessment that provides you with an understanding of how your product design may impact patients…

Share

When to Open a CAPA

Q: How do I perform a risk assessment of my processes to determine when to open a CAPA project? I’ve seen various approaches, including the use of FMEAs, process monitoring coupled with “X” standard deviations of unfavorable change, three complaints of…

Share

Change Control for Software Updates

Q: We’re performing a Medra library update to our drug safety software and also considering changing a specification in our LIMS static data. In a regulated environment, do these functions require change control, or do you consider them merely maintenance issues?…

Share