Quality Management Systems Flashcards
7 cards from real CRAP 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 Management Systems flashcards as text
Under 21 CFR Part 820, which type of change to a device's design requires formal design control procedures?
Answer: Changes that could affect the device's safety or effectiveness
Design changes that could affect safety or effectiveness must go through formal design control procedures including review, verification, validation, and approval.
Which of the following is a key output of the quality planning process in a QMS?
Answer: Quality objectives and processes needed to meet requirements
Quality planning produces defined quality objectives, processes, resources, and controls needed to fulfill requirements and achieve desired outcomes.
An FDA Form 483 observation during a QMS inspection indicates:
Answer: Inspectional observations of conditions that may constitute regulatory violations
FDA Form 483 lists inspectional observations of conditions that appear objectionable and may constitute violations of FDA regulations, but it is not a final agency determination.
In a QMS, document control procedures must ensure that:
Answer: Obsolete documents are removed from points of use and only current versions are available
Document control requires that obsolete documents be promptly removed or otherwise prevented from use to ensure only current, approved versions are utilized.
Which metric is most useful for evaluating the effectiveness of a CAPA system?
Answer: Recurrence rate of nonconformities after CAPA closure
The recurrence rate of nonconformities measures whether CAPAs have actually eliminated root causes, making it the most direct indicator of CAPA system effectiveness.
Under ISO 13485, which of the following is required for validation of software used in production and quality systems?
Answer: Documented procedures and validation protocols appropriate to intended use and risk
ISO 13485 requires that software used in production or quality system activities be validated with documented procedures proportionate to the risk and complexity of the software.
A quality system's effectiveness is best demonstrated through which combination of activities?
Answer: Management reviews, internal audits, CAPA closure, and customer feedback analysis
A well-functioning QMS is demonstrated by closed-loop processes including management oversight, audit findings, corrective actions, and customer satisfaction data working together.