Medical Device Assembly Line Changeover Safety Checklist

Line/Area:
Date:
Performed by:
Pre-Changeover Preparation
Checklist Item Yes No N/A Comments
All machinery and equipment are turned off and locked out/tagged out as required.
Area is clean and free of unnecessary materials/tools.
PPE is available and being worn by all involved personnel.
During Changeover
Checklist Item Yes No N/A Comments
Personnel are following correct changeover procedures.
Hazardous energy sources are identified and controlled.
Tools and parts used are accounted for and stored safely.
Post-Changeover
Checklist Item Yes No N/A Comments
Guards and safety devices are re-installed and checked.
All tools, parts, and unused materials are removed from the line.
The area is clean and ready for operation.
Lockout/tagout devices are removed as per procedure.