summer '16
TRANSCRIPT
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Summer ‘161
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C.I. Team Project:
• Shadow Boards for Assembly Area - Design - Outside Resources
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Electrical Safety Documentation:
Higher Level Guidelines
• Work Area
• Testing Procedures - Hipot Testing, Ground Bond Testing, Line Leakage Testing
• Employee Training
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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
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Small Assembly Workbench Shelves:
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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
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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