GMP Risk Assessment Checklist
GMP Risk Assessment Checklist
Process or activity being assessed
*
Assessment date
*
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
GMP risk areas to assess
*
Personnel practices
Facilities and equipment
Materials and suppliers
Manufacturing process
Cleaning and sanitation
Documentation and records
Storage and handling
Other
Describe the potential GMP hazard or failure mode
*
Likelihood of occurrence
*
Unlikely
1
2
3
4
Likely
5
1 is Unlikely, 5 is Likely
Potential impact on product quality or process compliance
*
Minor
1
2
3
4
Major
5
1 is Minor, 5 is Major
Existing controls in place
*
How effective are the existing controls?
*
Effective
Partially effective
Ineffective
Not yet assessed
Required corrective or preventive actions
*
Residual risk after planned controls
*
Low
Medium
High
Not yet assessed
Submit Assessment
Should be Empty: