General Quality Assurance
CAP Audit Preparation
100
Number of Continuing Education Credits laboratory personnel must earn in one year.
What is 12.
100
Name of document that provides an overview of how Metabolon adheres to each of the Quality System Essentials.
What is Metabolon's Quality Manual.
200
Location of all controlled copies of SOPs.
What is the Master SOP Binder.
200
When answering an auditors questions, you should answer all questions, including questions about areas that do not pertain to your current job responsibilities. (True or False)
What is False.
300
The name of two documents that get revised when an individual has a change in job description or title. (need both)
What is CV and job description.
300
Finish this statement: “If you didn’t document it, …”
What is “ you didn’t do it.”
400
How to fill in blank sections of a document that are not applicable to the situation.
What is draw a diagonal line through any blank fields or empty spaces and write 'N/A' along with your initials and date.
400
Two locations where you can find the Quality Policy statement. (need both answers)
What is in the Quality Manual & posted in the laboratories.
500
The timeframe by which all SOPs should be read by performing employees.
What is "Before the effective date".
500
Name two things you should do to prepare for the CAP inspection.
What is review relevant SOPs, clean up the labs, have goggles and lab coats ready for the inspectors, discard of expired reagents, ensure logbooks and all documents are filled out correctly, be familiar with location of signs in the labs, and ensure equipment is maintained and calibrated (and documented).
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