SPEC Template
AQLs
Inspections
Terminology
Deeper Knowledge
100

Where on a spec would you look to find item specific

What is *top right PCI ITEM Number* section?

100

What is always hard-coded 0-1

What is containers square root?

100

What is a VDF used for

What is verifying variable data on labels?

100

What does IQA stand for

What is Incoming Quality Assurance?

100

Why do we take a retain?

What is to keep a perfect representation of the product when it came in

200

Where would you find if label copy verification needs to be done 

Where is *page 3 or under sampling plan*?

200

What does AC and RE stand for and what do they mean

What is Accept and Reject?

What is accept number or below the lot passes and if the reject number is hit then the entire lot is rejected/NMR

200
What is the difference between Artwork and Label Copy

What is artwork is from MC and a label copy is an actual copy of a label we made?

200

What does VDF stand for

Variable Date Form

200

Why do we take a photo of lot as we get it?

What is to document how PCI/IQA received the material

300

Where would you find ink jet code placement verification if applicable

Where is bottom of first page?

300

What is the only AQL in which you go up

What is 20?

300

What do you need for a reprint

What is the original artwork, photos and VDF?

300

What is the difference between HT and Chem Free

What is heat treat IPPC stamp and a written chemical free memo?

300

Why do we sample from beginning, middle and end of lot

(Worth Double)

What is to ensure quality throughout the lot

400

This question is typically only applicable to what type of receipt?

"Verify first and last kit numbers against shipping documentation" 

What is mass receipts? 

400

Name all the AQL chart inspection types 

What is S1, S2, S3, S4, Level I, II, III?

400

What is the difference between vendor and manufacture

What is vendor is where is ships from and manufacture is who made it?

400

What does NMR stand for

What is Non-Conforming Materials Report?

400

Why do we use live labels and not dummy labels for testing?

What is to verify embedded data is correct?

500

What in the spec would clue you in that a retain(s) need to be taken?

What is dimension sampling, a signature box to take a retain, FTIR testing, Ink testing?

(Will take any variation of “any kind of testing/measuring”)

500

What would the container and unit be for a vial inside a carton inside a shipper with a UOM as KT

What is Unit carton and Container Shipper

500

Name four different products that do not require a cert

What is Amazon, Shippers, Uline, Cuvettes, Sharps, Trays, Back stoppers, Pliers, Pipettes, Empty Vials, Vial adaptors?

500

What does FTIR stand for

What is Fourier Transform Infrared Spectroscopy?

500

Why do we as inspectors, not fix or attempt to fix any defects found

What is increasing PCI's liability 

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