QMS Flashcards
________ is a collection of business processes focused on achieving quality while meeting customer requirements
Quality Management Systems (QMS)
\_\_\_\_\_\_ provides instructions on how to perform a task and are key to achieving consistency and control in operations. A. Process validation B. SOPs C. Contracts and agreements D. Test method validation
B. SOPs
-describes the “how”
______ is the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product
A. Process validation
B. SOPs
C. Contracts and agreements
D. Test method validation
A. Process validation
Which of the ff is a key difference of QC from validation?
A. It is repeated at a given frequency to ensure results are within acceptable ranges
B. It is done to gain assurance that a process remains at a validated state after a significant process change
C. It is repeated to gain assurance of consistency
D. It demonstrates that the process works as expected in a normal working environment
A. It is repeated at a given frequency to ensure results are within acceptable ranges
Choices B,C,D describes process validation
\_\_\_\_\_\_\_ describes the organization´s quality policy, quality objectives and overall approach to quality in all aspects of the business A. Quality manual B. SOPs C. Contracts and agreements D. Policies and proccess documents
A. Quality manual
___________ is a term that describes a wide range of approaches, tools and techniques used to uncover the causes or causes of nonconformance.
Root cause analysis (RCA)
What is the appropriate time frame for reporting fatalities related to blood collection or transfusion or to cellular therapy products to the FDA? A. Within 7 days of fatality B. ASAP C. Within 2 weeks of incident D. Within 30 days of fatality
B. ASAP
Choice A - this is for reporting/ submitting a written follow up report that includes a description of any new procedures implemented to avoid reoccurance
Which division of the FDA is the appropriate are in which fatalities related to blood collection/ transfusion or cellular therapies must be reported to?
A. CDC
B. Office of Regulatory Affairs (ORA)
C. Centers for Biologics Evaluation and Research (CEBR)
D. The Joint Commission
C. Centers for Biologics Evaluation and Research (CEBR)
________ is the testing of samples previously unknown to a laboratory that are sent by a CMS-approved program.
Profeciency Testing
A quality improvement process that (goals) focuses on eliminating non-value added steps and eliminating defects and improving the overall process. A. Quality control B. Proficiency testing C. Validation D. Lean six sigma
D. Lean six sigma
