Dear All,
I am trying to apply SPC to a filling line in order to control fill
weight and some container dimensions. One problem area is the way to
handle erroneous data entered into the system. It could happen one day,
for instance, that the operator controlling the process measures
diameter instead of height. Some say that value is to be kept and the
documentation amended by handwriting when reviewing the batch
record. In
this case, no tampering or any mistake will take place, but the
statistics will not be valid. Others say there should be some controlled
means of changing that value, provided only certain people, e.g.
supervisors, have access to this routine via a password. Is there any
regulation directing the procedure in this case? What is your experience
in this area?
Thank you for your comments.
Charles Goldenzon
Glaxo Wellcome
Golden@unikey.com.br
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