Summer ‘161

C.I. Team Project:

• Shadow Boards for Assembly Area - Design - Outside Resources

2

Electrical Safety Documentation:

Higher Level Guidelines

• Work Area

• Testing Procedures - Hipot Testing, Ground Bond Testing, Line Leakage Testing

• Employee Training

3

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

5

Small Assembly Workbench Shelves:

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

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