1. Pharmaceutical manufacturing facility

a. Complete the graph including “X” and “Y” axis labels, lower and upper specification and control limits and data points according to the table.

b. What can you say about the relationship between “Specification limits” and the established “Control Limits”, is this a well designed process? Would you recommend tighter or wider operational control limits based on the fixed specification limits? (Note: Please consider that these are not statistical control limits and they are operational control limits arbitrarily imposed by manufacturers for operational control).

Range of the specification limits is much lower than the range of the limits defined arbitrarily (for operational control). Operational control limits should be much tighter and should be properly calculated based on the defined specification limits.

c. Is the process capable and in control throughout the year, provide explanation?

A process is said to be in control or stable, if it is in statistical control limits, which means that all special causes of variations have been removed and only common cause variation remains. If observing provided operation limits, it could be said that process is not in control throughout the year. In May it was above upper limits (6.0) and in Aug and Nov it was below the lower limits (both times 0.5).

Capability is the ability of the process to produce output that meets specifications. If observing provided specification limits, it could be said that process is not capable of meeting the required and specified % of LOD throughout the year. In May it was above, where average monthly LOD was 6%, following Aug, Sep, Nov and Dec with 0.5%, 1%, 0.5% and 1% respectively.

d. What can you say about the state of control and process capability from January until July, provide explanation?

In the period between Jan - July, it could be said

Based on the reading assignment, “Twins in Trouble II, Systems Thin...