Cleanroom Contamination Risk Assessment Form
Use this form to systematically evaluate and document contamination risks in your cleanroom environment.
Assessment Date
*
-
Month
-
Day
Year
Date
Cleanroom/Area Name
*
Assessor's Full Name
*
First Name
Last Name
Purpose of Assessment
Type of Operation Being Assessed
*
Routine Cleaning
Production/Manufacturing
Maintenance
Sampling/Testing
Other
Potential Sources of Contamination (Select all that apply)
*
Personnel
Equipment
Raw Materials
Airflow/HVAC
Surfaces
Water/Utilities
Other
Gowning Compliance
*
Fully compliant
Minor deviations
Major deviations
Not applicable
Cleaning and Disinfection Procedures
*
Fully followed
Partially followed
Not followed
Not applicable
Environmental Monitoring Results
*
Rows
Pass
Fail
Not Tested
Airborne Particles
1
2
3
Surface Particles
4
5
6
Microbial Counts
7
8
9
Temperature/Humidity
10
11
12
Risk Likelihood Assessment
*
Very Low
1
2
3
4
Very High
5
1 is Very Low, 5 is Very High
Risk Impact Assessment
*
Negligible
1
2
3
4
Critical
5
1 is Negligible, 5 is Critical
Overall Contamination Risk Rating
*
1
2
3
4
5
Summary of Findings and Recommendations
Submit Assessment
Should be Empty: