Know your STUFF

FORMs

100

If the workmanship reconciliation log in the production record is full, what FORM do we need?

FORM-0222

200

What form can we find the "Maximum Length Calculation" for Gross Debridement?

FORM-0333

300

Steris Gamma Internal Dose Calculator

FORM-1121

400

Histology Sample submission form

FORM-1003

500

What form do we need when there's a correction request from QA if the barcode/tracking number doesn't match on FORM-1002/1003?

FORM-1034

SOP

100

what is the biologic SOP for Avance Production Record Assembly and Review Procedure?

SOP-0865

200

Avance Processing Procedure

SOP-0617

300

Nerve Debridement Process

SOP-0626

400

Sizing, Inspection, and Packaging of Avance Drug Substance

SOP-0880

500

CensiTrac C&S Review Procedure

SOP-0848

QS-0068

100

what is the acronym for "For Clarity"?

FC

200

If more than one correction is made on a page of the document, each entry must be number in the order it was recorded. True or False?

True

300

Are Processing team leads allowed to make other processing technicians correction? (Yes or No)

No

400

A _________ may be generated as electronic media or as a paper record as long as it retains all components of the original, including all the metadata for an original electronic record.

True Copy

500

what are the three "C's" of ALCOA +?

Contemporaneous, Complete and Consistent

All about deviation

100

Do we need MRB approval for Ops and QA for removing deviation reference? (True or False)

True

200

Deviation Report Work Instruction

WI-0138

300

what is the deviation procedure?

QS-0013

400

An issue or occurrence of note in which the observer cannot initially determine that a deviation is required.

Event

500

______ is the primary factor which caused the issue to occur. Correction will eliminate recurrence of the issue or decrease the likelihood of recurrence.

Root Cause

Axogen Employees

100

First shift Sr. Supervisor of Operations - Processing?  (Full name to get credit)

Kelly Peck

200

Who is the Director of Manufacturing Innovation?  (Full name to get credit)

Isaac Mabe

300

who is Manager of Cost and Accounting?  (Full name to get credit)

John Leiner

400

Who is VP of Manufacturing?  (Full name to get credit)

Mike Hoff

500

Who is the VP of Operations? (Full name to get credit)

Craig Swandal