$1)(1$ point each$)$ For the past $2$ years, QC has been inspecting incoming lots of vials and has never had to reject a batch. Last September, Lot #$2024-35$ was received. Following the company$$s inspection rules, identify the following regarding acceptance or rejection of this lot:

Total Lot Size of vials to be sampled:

Sample Size Code Letter to Use:

Sampling Plan to Use $($Tightened$,$ Normal, Reduced$)$: Minimum Required # Vials to be sampled:

Minimum # Non$-$Conforming Vials to Reject Lot: Maximum # Non$-$Conforming Vials to Accept Lot:

$2)(1$ point each$)$ For Lot #$2024-35,$ QC found $1$ cracked vial among the samples. Following their master plan, what will this mean for accepting or rejecting the next Lot #$2024-36?$

Sampling Plan to Use $($Tightened$,$ Normal, Reduced$)$: Minimum Required # Vials to be sampled:

Minimum # Non$-$Conforming Vials to Reject Lot: Maximum # Non$-$Conforming Vials to Accept Lot:

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PhEn$604$: Validation & Regulatory Issues Distance Learning, Spring $2024$ Instructor: Paul A$.$ Melamud FINAL EXAM

QA continues to monitor incoming shipments over the next quarter, following the AQL guidelines, and identify the following # of defects in each of the next $10$ consecutive lots #$2024-37$ through $2024-46$: $1,0,0,2,0,1,2,3,1,0.$

$3)(1$pointtotal$)$YourcompanychangeSamplingPlans$($fromthatusedinQuestion$2)$atsome point during the above inspections.

a$)(1/2$ point$)$ What Inspection Plan did they change to$,$ and why $($provide full details$)?$

b$)(1/2$ point$)$ If each lot # was tested in numerical order, yielding the above results, for which Lot #$($s$)$ did the Sampling Plan change?

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PhEn$604$: Validation & Regulatory Issues Distance Learning, Spring $2024$ Instructor: Paul A$.$ Melamud FINAL EXAM

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 company$$s QA and Operations authorize receipt of a new batch of new vials $($Lot $2024-53).$

$4)(1$pointeach$)$Followingthecompany$$sinspectionrules$,$identifythefollowingregarding acceptance or rejection of the incoming vial lot:

Sampling Plan to Use $($Tightened$,$ Normal, Reduced$)$:

Minimum Required # Vials to be sampled:

Minimum # Non$-$Conforming Vials to Reject Lot:

Maximum # Non$-$Conforming Vials to Accept Lot: