Attachment D.12 - Sample Pack Evaluation Checklist.pdf
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- Solicitation number
- 36C77625R0017
About this file
This document is a Custom Pack Sample Review Checklist for Solicitation 36C77624R0058, which outlines the pass/fail evaluation criteria for submitted custom sterile surgical pack samples. The checklist requires vendors to submit three sample packs, all of which must pass every requirement to receive an "Acceptable" rating for Factor 2 - Technical (d) and be eligible for award.
The checklist contains 16 specific evaluation criteria, including requirements for lot numbering, packing slips with detailed component information, TAA compliance, packaging specifications, and product-specific requirements. Key technical requirements include the use of rigid plastic or biodegradable trays, Ethylene Oxide (ETO) tape indicators, tamper-evident seals, latex-free materials, and specific gown characteristics such as non-abrasive materials, stockinet cuffs, and raglan sleeves. The checklist also specifies that cloth towels must meet National Fire Protection Regulations for flammability according to CFR Part 1610 standards.
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Text version
Custom Pack Sample - Review Checklist Solicitation 36C77624R0058
Custom Pack Sample Description:
Rating Evaluation for the submitted Sample Custom Packs Each submitted Sample Pack (3 required) will be rated using a Pass or Fail in accordance with the criteria shown below. ALL three (3) submitted Sample Packs must PASS these requirements in order to receive an “Acceptable” Rating for Factor 2 – Technical (d) to be eligible for award.
Custom Pack Requirements
Sample Pack contains individual Lot Number (SOW 6.1) Pass Fail
Sample pack contains a packing slip (SOW 6.1) Pass Fail
Packing slip includes: manufacturer, manufacturer item number, description of the component, quantity of component, Country of Origin (COO), and lot number
(SOW 6.1)
Pass Fail
Sample pack is free of debris and excessive particulates (SOW 6.1.14) Pass Fail
Sample Pack has correct components, type, and quantities as shown in the pack's Bill of Material (Attachment D.11 – Three Sample Packs – Bills of Material) Pass Fail
Sample pack components are TAA compliant (SOW 6.2.1.1) Pass Fail
Sample pack components are removed from outer packaging unless otherwise required by the customer or the component manufacturer (SOW 6.2.1.3) Pass Fail
Sample pack uses rigid plastic or biodegradable trays (SOW 6.2.1.4) Pass Fail
Sample pack has Ethylene Oxide (ETO) tape/indicator affixed to outer wrap and tray where applicable (SOW 6.2.1.4) Pass Fail
Sample pack provided in an approved packaging material with a plastic dust cover (SOW 6.2.1.4) Pass Fail
Sample pack has a sealed plastic dust cover with tamper evident seal and allows for ease of aseptic presentation (SOW 6.2.1.4) Pass Fail
Sample pack is latex free and is labeled "latex free" (SOW 6.2.1.5) Pass Fail
Sample pack gown(s) are non-abrasive, free of toxic ingredients, non-fast dyes, and noxious odors. Gown materials are non-glare and of a color that minimizes distortion from reflected light (SOW 6.2.2.3 & 6.2.2.3)
Pass Fail
Sample pack gown(s) allows for freedom of movement (SOW 6.2.2.4) Pass Fail
Sample pack gown(s) have stockinet/stockinette cuffs, raglan sleeves and welded or stitched seams (SOW 6.2.2.5) Pass Fail
Sample pack cloth towels are lint-free and meet or exceed the current requirements of the National Fire Protection Regulations for flammability in Part 1610 of the Code of Federal Regulations - Standard for the Flammability of Clothing Textiles (SOW 6.2.3)
Pass Fail
File details come from the government source that posted it. Updated .