Quality Assurance Flashcards
7 cards from real CRCST practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Quality Assurance flashcards as text
In quality management, what is a 'nonconformity'?
Answer: Failure to meet a specified requirement
A nonconformity is the failure to fulfill a specified requirement, such as a sterilization parameter falling outside its validated range.
Which quality assurance concept involves identifying and addressing potential problems before they cause failures?
Answer: Preventive action
Preventive action proactively identifies potential causes of nonconformities and implements changes to prevent them from occurring.
When performing quality checks on sterilization packaging, which characteristic indicates that a peel pouch seal is acceptable?
Answer: The seal is complete, continuous, and free of channels or gaps
An acceptable peel pouch seal must be complete and continuous with no channels, gaps, or weak areas that could allow microbial ingress.
What is the role of an internal chemical indicator (CI) placed inside a sterilization package?
Answer: To verify that sterilizing conditions were reached inside the package
An internal CI changes in response to sterilization conditions inside the package, providing evidence that sterilant penetrated to that location.
Which factor is most likely to contribute to sterilization failure in a gravity displacement steam sterilizer?
Answer: Air trapped in packs preventing steam penetration
Gravity displacement sterilizers rely on steam displacing air downward, so trapped air pockets prevent steam from reaching all surfaces and cause sterilization failure.
In quality systems, what is the purpose of trending data from biological indicator results over time?
Answer: To identify potential sterilizer performance issues before they cause failures
Trending BI data helps identify patterns that may signal deteriorating sterilizer performance, allowing corrective action before a process failure occurs.
Which standard provides guidance on event-related sterility maintenance for sterile medical device packaging in the U.S.?
Answer: ANSI/AAMI ST79
ANSI/AAMI ST79 provides comprehensive guidance on steam sterilization and sterility assurance, including event-related shelf-life principles for sterile packaging.