The ANSI ASQ Z1.4 and Z1.9 tables are great for picking validation acceptance criteria, but they are commonly used for normal operations as well. Here's one example.

Your packaging department orders glass vials once per month for packaging 4 of the company's liquid products, a 2-shift / 5-day operation per week. Each shipment lot consists of 6 pallets, each pallet containing 32 stacked, shrink-wrapped cases, each packed with 250 vials. Your QC Department requires the vendor to supply a Certificate of Conformity with each shipment, indicating that the vials were produced and tested as meeting a number of specifications set forth in the quality agreement and supply contract.

QC's master plan requires that they sample and inspect all incoming packaging component lots following ANSI/ASQ Z1.4-2003 R2018 plans and switching rules (identical to the 2008 revision you received in class), and their SOP for vial inspection requires them to sample and inspect for cracks and other imperfections considered critical quality risks (AQL = 0.065%). This company's QA has an average risk appetite, employing General Inspection Level II and single sampling plans for AQLbased inspections, unless specifically required to do otherwise by an SOP or contractual obligation.

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 #2021-35 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 #2021-35, QC found 1 cracked vial among the samples. Following their master plan, what will this mean for accepting or rejecting the next Lot #2021-36? 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