Tag Archive for Failure Investigation

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…


CAPA Definitions as Used by FDA and ISO

CAPA definitions and terms can sometimes be confusing. Nearly everyone stumbles over the proper use and application of the CAPA terms of corrections, corrective actions, and preventive actions. The following CAPA definitions clarify the differences and are consistent with interpretations…