Investigation summary: samples received from the customer (41 pieces of batch 7319660) and retention samples (20 pieces per batch) are evaluated for the length test of the opening tab, in all the functional tests there are conformity results.So the claim is not confirmed and it is attributed that the event is presented by an inadequate opening of the packaging.The lots were manufactured in line 6 in 2 days during which the production is monitored through the frequency rit0225ctis01-04 rev.17, where characteristics were evaluated in the packing stage such as: blister cut suitable to the catalog (visual method vs drawing), perimeter seal less than 3 mm and continuous (measurement method with calibrated rule), correct longitudinal cut (visual method), packaging with peel apart (visual method), integrity of the primary packaging: blister without perforations, seal not open or seal without wrinkles (visual method), during the frequency take 40 pieces per hour, completing a total sample size of 1,120 pieces with an acceptance limit of 0 and rejection of 1.Additional process parameters are reviewed all are within of the operation window and almost in the middle of it.The final batch was inspected by quality control, taking a sample of 120 pieces with an acceptance criterion with 1 rejection and with 0 obtaining conforming results within an aql = 0.25%, for which the batch was approved and inspected according to the current work instruction with satisfactory results for the characteristics required for its approval including functional tests.Investigation conclusion: unconfirmed.It is attributed to an inadequate opening of the packaging.
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