H6: investigation summary: scope of issue: the scope of issue is limited to part 344563 lot 1285770, stem cell enumeration kit (b)(4) tests.Problem statement: customer reported complaint on 20-dec-2021, kit box did not show lot number and expiration date.This happened on one qty and three qty were fine.Manufacturing defect trend: there are no quality notifications (qn-zm) for part 344563 related to the reported issue.Date range (date opened to 12 months back) is from 21-dec-2020 to 21-dec-2021.Root cause analysis: based on the investigation result, root cause was application of a label on the kit box that had not received lot specific data.Visual inspection also failed.Complaint history review: there is one complaint for this issue in part 344563, it is this complaint, parent (b)(4).Date range is from 21-dec-2020 to 21-dec-2021.Risk review: process failure mode effects analysis (pfmea) 10000525149 rev.01.Risk mitigation is sufficient.Hazard(s) identified? yes.Hazard #: not numbered; hazard : label has incomplete or illegible information; cause: dirty or worn print head, printer setup; harmful effects: wrong assay result or cannot run assay.Delay in testing.; severity:_7; probability: 2; risk index: 42; implementation: validated printers; risk control: pr003: visual inspection.Sample labels are attached to batch record.Effectiveness verification: not applicable; new hazard: no.; mitigation(s) sufficient: yes; batch history record (bhr) review: bhr for part 344563 lot 1285770 was reviewed.The materials met all the manufacturing specifications prior to release.Wi7197-03 rev.03 includes 6 copies of the kit label and those copies have correct lot number and expiration date.An inspection report dated 21-oct-2021 finds that the label has correct lot number and expiration date.Returned sample analysis: a photo is not requested because the provided powerpoint document with photos confirms the complaint.The provided powerpoint document shows 2 photos, one of a kit-box missing the required lot number and expiration date and barcodes, and one of a kit-box with the required marks.Retain sample analysis: from the retained sample of part 344563 lot 1285770, the kit label was inspected and the defect was not present.The correct lot number and expiration date were present.Labeling /packaging review: part 344563 lot 1285770 was reviewed.The materials met all the labeling / packaging specifications prior to release.Conclusion: based on the investigation result, complaint is confirmed.
|