Favorite Phrases
Most asked question during triage
Do we need an event if there is no impact?
What is a notification to management?
Transferred from Pfizer Rouses Point, NY to Sanford in 2015
Who is Michelle Arquiett?
Within 1 business day of awareness date (date of discovery)
When does the deviation need to be initiated in eQMS?
The departure is due to an error made by a human
What is human?
Most asked question from area manager
Can I make a comment?
This record is opened in investigation database if the root cause is endorsed as non-assignable.
What is an NTM?
This SQA supports train1 and QC triages.
Who is Jamila Davis?
Within 30 days of awareness date
What is deviation approval?
The departure is due to an issue with an SOP
What is method?
Most asked question from SQA
Is there impact?
This is search performed to understand if similar investigations have happened in last 2 years
What is a PDRR?
This SQA member supports GTX1 and Train 1, joined in June 2023, and is originally from Louisiana.
Who is Caleb?
Initial assessment must be completed.
A root cause tied to the area in which the event occurred is known as ________
What is environment?
Most asked question from investigator
Can I add this investigation to a previous record?
This is a report that is needed if Investigation can’t be approved by their original due date.
What is an Interim Report or an ISR?
This QO member holds both SQA and SIL role for the site.
Who is Niraj Bidari?
Notify SQOL of all unplanned deviations that require an NTM
What is 1 business day of discovery?
The departure is due to a problem with the measurement system - the adequacy and/or appropriateness of the measurement
What is measurement?
Is this an ER?
This is the Management review of quality performance, quality culture and metrics, which happens monthly or could be ad hoc.
What is SQRT?
This SQA started out after college as a Biology/Physical Science Teacher.
Who is Rogalene?
An extension request can be submitted to change the original due date for issues related to customer, testing or vendor.
What is 45 days?
If a root cause or substantiated root cause cannot be determined.
What is non assignable?