Lynn D. Torbeck
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"The production inspectors looked at each vial three times. That is, they did three 100% inspections. How can there still
be lint, black specks, and other particulate matter in the vials?" The newly hired statistician was watching the visual-inspection
line and feeling completely stumped and at a total loss for understanding what was happening. Not only did the second 100%
inspection find rejects, but it actually found more rejects in the second round than during the first inspection. Although
the third inspection found fewer rejects, some were still present. How can this be?
100% Background
One-hundred-percent visual inspections by trained inspectors play a crucial role in biopharmaceutical quality control. Incoming
materials such as rubber stoppers, glass vials, and ampoules are visually inspected for physical defects as part of an overall
receiving plan. In-process units are visually inspected for fill levels and particulate matter. Finished units are visually
inspected for defects, stoppers with spots, bent caps, incorrect labels, and general appearance.
Despite all these reviews, 100% visual inspection by even well-trained and experienced production inspectors has been shown
to be only about 80–85% effective. It is not humanly possible to visually inspect and remove 100% of occurring defects even
in the best of conditions. Thus, second and third 100% inspections of a lot will continue to reveal defects. Individual inspectors
are often tested by reviewing a standard test set that is known to have a certain number of defects. If the inspector finds
85% of the defects, his score is considered very good.
Common practice
To complete a total inspection plan, it is common for the quality unit to follow the 100% inspections with an attribute sampling
plan with a sample size of 200 to 500, depending on the situation. This step may seem unnecessary to the uninitiated, but
it is good practice. The 100% inspection is fragile, in a sense. There are many potential sources of error and poorly controlled
variables that can affect the 100% approach. An additional sample test performed by the quality unit provides a sanity check
to demonstrate whether the 100% inspection has had a complete breakdown. If the sample passes the accept/reject criteria,
then the lot can be sent to packaging. If the lot fails the criteria test, it is 100% inspected again. Most companies do not
perform more than three 100% inspections followed by three sampling inspections. If a lot fails the third sampling test, then
it is placed on quarantine until a material review-board decision can be made.
Several factors contribute to this dilemma. First, humans are fallible and highly influenced by attitudes and day-to-day feelings
of well-being, illness, and fatigue. Supervisors' expectations affect the ability of an inspector to find defects. Furthermore,
what may be visible to one inspector may not be visible to another. Eye tests are routine and frequent rest periods are therefore
mandatory.
The physical set-up for performing 100% inspections is also crucial. The amount of lighting, background, timing, among other
factors, can affect the results. Finally, an absolute standard is needed to compare results against. Without a standard for
comparison, measurement can and does run wild.
