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 processesKeywords
Cleaning; Risk Assessment; FMEA; FMECARationale
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
Work Item Status
Date Initiated: 03-30-2023
Technical Contact: Andrew Walsh
Item: 001
Ballot: E55.13 (24-01)
Status: Will Reballot Item
Item: 006
Ballot: E55 (24-06)
Status: Negative Votes Need Resolution