Question: Sure at this point that there must be a problem, QA sends all rejected lots and those pending inspection back to the supplier, demanding an
Sure at this point that there must be a problem, QA sends all rejected lots and those pending
inspection back to the supplier, demanding an investigation. Within a week, the supplier has
identified a subtle but significant problem with a batch of glass they purchased from their vendor,
which can occasionally cause vials to crack during shipping and handling. They soon resolve the
issue with their supplier, test a new batch of glass, and provide evidence that several batches of vials
made from the new glass do not reflect the error.
Given the likelihood that the problem has been corrected, your companys QA and Operations
authorize receipt of a new batch of new vials Lot
point each Following the companys inspection rules, identify the following regarding
acceptance or rejection of the incoming vial lot:
Sampling Plan to Use Tightened Normal,
Reduced:
Minimum Required # Vials to be sampled:
Minimum # NonConforming Vials to Reject
Lot:
Maximum # NonConforming Vials to
Accept Lot:
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