4.2-2 Control Of Records

1. A Device Master Record (DMR) reflects:

Deviation Requests for a device

The entire manufacturing process of a device

All nonconformances associated with a device

2. Who maintains the Quality Record Matrix?

Receptionist

Training Manager

Sales Department

Quality System Administrator

3. You should always use whiteout when making corrections.

True

False

4. When completing forms by hand, what color ink should be used?

Red

Black

Blue

Both B & C, but Blue is preferred

5. How long is LSI required to keep records for implantable devices?

2 years

5 years

7 years

15 years