D000356 Control Of Production Processes

Any DR created for use with the non-qualified equipment must clearly identify the non-qualified equipment and clearly describe how this equipment is to be used.

D000324 - "Form No. 583: Non Qualified 1Alert" is to be prominently displayed on any non-qualified equipment that might be present in a production work area, and contains the following information: • EQ # and equipment name (e.g., THC Crimper, Gen 3 CK Mini Staker, …) • Purpose / function of the equipment (e.g., crimp curved handles, stake HA’s in CK Mini), • Affected product line. • Personnel responsible for the equipment • EXP # (optional)

All of the above

True

False

To ensure the devices meet approved specifications

To make the job take longer

To prevent non-conformances

Both A and C

OQ, IQ, PQ

IQ, OQ, PQ

PDQ, IQ, OQ

PDQ, PV, XYZ