2. C.I. Team Project:
• Shadow Boards for Assembly Area
- Design
- Outside Resources
2
3. Electrical Safety Documentation:
Higher Level Guidelines
• Work Area
• Testing Procedures
- Hipot Testing, Ground Bond Testing, Line
Leakage Testing
• Employee Training
3
4. Audit Procedures:
4
So far…
• Research
- FDA’s “Guide to Inspections of Medical
Device Manufacturers”
- Code of Federal Regulation, Title 21
- Quality Systems/ Good Manufacturing
Practices Regulation (QS/GMP regulation)
• Meetings
• Exhibit Log
- Overview of Audit, Checklists, Procedure
upon Arrival, Notification List (flow chart)
What’s to come…
• Revising Exhibit Log
• Establishing Staff Training
6. Astro Documentation:
• Convert documentation from binders to providex.
• Minor kinks to work out with new program.
- communicated with Amada’s Product Specialist and Software Engineer
6
7. 7
Conclusion:
• Overall…
- Project Deadlines
- Manufacturing Issues & Resolutions -> Medtronic & Zeiss Re-work
- Research -> Audit Procedures & Voltage Safety Procedures
- Problem Solving Skills
- Time Management
- Understanding Manufacturing Process
• Going Forward…
- Astro Documentation
- FDA/OSHA Official Booklet &
- School Schedule & Availability Fall ‘16
• On going…
- W.I. and time studies when requested
- Assisting in production issues
- RFC Implementation
- Fixtures, tools, and all around help in
Assembly area
