Competency Assessment
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