Work Item
ASTM WK85802

New Guide for Performing Failure Modes and Effects Analysis on Cleaning Processes

1. Scope

Pharmaceutical/biopharmaceutical cleaning processes, Medical Device cleaning processes, cosmetic cleaning processes


Cleaning; Risk Assessment; FMEA; FMECA


ASTM E3106 requires a Risk Analysis of cleaning procedures and there is no specific guidance on application of FMEA to cleaning processes. This Guide will facilitate this step in the E3106 Quality Risk Management Process

The title and scope are in draft form and are under development within this ASTM Committee.


Developed by Subcommittee: E55.13

Committee: E55

Staff Manager: Travis Murdock

Work Item Status

Date Initiated: 03-30-2023

Technical Contact: Andrew Walsh

Item: 000