5.

1 Process capability is carried out for the critical analytical parameters to be

calculated as follows.
CpK= USL-X or X-LSL

3* SD is 3 sigma

USL= Average + 3Sigma

LSL= Average -3sigma

Where USL= Upper specification Limit.

LSL= Lower specification Limit.

X= mean

SD= standard Deviation

This calculation helps to understand how close the process is producing out
comes compared to what the specification is.

Interpretation:

Cpk< 1.0 i.e. Not capable

Cpk 1.00 to 1.33 i.e. product is barely manufactured

Cpk 1.34 to 3.00 i.e. process is good

Cpk > 3.00 i.e. process is excellent

Note: Minimum 10 batches are required to calculate the process capability.