QA General
Name one thing you should never do during an audit/inspection?
What is:
Volunteer information (talk too much).
Falsification/Lie/Fabricate
Promise what you cannot deliver
Argue
Name the QMS process that drive changes to the validated state of an instrument, system or process?
What is the Change Request/Control process.
What does "QMS" stand for?
What is Quality Management System.
Name the Document Control process an author/approver must train on in order to create or revise a controlled document.
What is the DCO process.
What is one of our boss's favorite drink?
What is "iced Cold Brew? (non alcoholic)
What controlled document is considered the QA Bible?
What is the Quality Manual.
The process where the lab documents issues that do not necessarily impact the product.
What is Issue Tracking.
What does "FMEA" stand for?
What is Failure Mode Effects and Analysis
Finish the famous quote "If it's not documented, _____________" (DOUBLE JEOPARDY!)
What is "it didn't happen".
What is the one thing everyone will say at least once during web/video conferencing?
What is "sorry I was on mute".
____________ is a quarterly event where departments report on metrics and KPIs for their functional area.
What is QAI or Management Review.
What is one of the qualification steps required to validate an instrument, system or process?
What is Installation Qualification, Operational Qualification, or Performance Qualification?
What does "DAR" stand for?
What is Deviation Approval Request.
SOP, form, template, work instruction, policy: these are referred to as ___________?
What are document types.
What is required on an annual basis and takes three hours to complete?
What is the sexual harassment training.
What is one of the most important jobs of QA? (DOUBLE JEOPARDY!)
What is ensuring patient safety.
What QMS process is mainly used for continuous improvement of systemic and recurring issues?
What is the CAPA process.
What does "RCA" stand for?
What is Root Cause analysis.
What must you submit with the DCO form when revising a controlled document?
What is the document redline.
In which city in California will capture both the NBA championship and the MLB World Series this year?
What is Los Angeles.
Name one the eight key sub-processes in the Quality Manual.
What is:
1. CAPA Subsystems
2. Customer-Related Processes
3. Design and Development (Design Control)
4. Documents, Records, and Change Controls
5. Equipment, Facility and Environmental Controls
6. Material Controls
7. Production and Service Provisions
8. Quality Management/ Management Controls
What QMS process is most suitable for addressing end-user/customer inquires, most often involving distributed products.
What is the Complaints process.
What does "ISO" stand for? (DOUBLE JEOPARDY!)
What is International Organization for Standardization.
Name one of the training types in QMS Training Program.
What is:
Self Guided
Classroom
Read and Acknowledge
On the Job
Name the second most awesome person QA.
Who is Richard.