The general requirements of an SPC system shall encompass, but are not limited to, the following elements:

a. Overall quality system

b. Management commitment

c. SPC system documentation

d. Critical process nodes

e. Gage characterization and capability

f. Process characterization and capability

g. Control system documentation

h. On-line/off-line control

i. Training

j. Supplier SPC systems

k. Calibration

l. Prevention maintenance

m. Self audit