Documentation & Record Management Flashcards
7 cards from real CBA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Documentation & Record Management flashcards as text
Which of the following is an example of a 'controlled document' in a biomedical QMS?
Answer: An approved and distributed standard operating procedure
Controlled documents are formally approved, distributed, and managed within the QMS, such as SOPs — external references and personal notes are uncontrolled.
A Device Master Record (DMR) for a Class II medical device should contain which of the following?
Answer: Device specifications, production processes, quality assurance procedures, and labeling
Per 21 CFR 820.181, the DMR must include device specifications, production process specifications, QA procedures, packaging/labeling specifications, and installation/maintenance procedures.
An auditor is reviewing change control records and finds that a manufacturing process change was implemented before the required risk assessment was completed. This is BEST described as:
Answer: A breakdown in the change control process requiring a nonconformance report
Implementing a change without completing required risk assessment steps is a procedural nonconformance in change control, regardless of the actual risk level of the change.
Under 21 CFR Part 820, who is responsible for ensuring that the Device History Record is maintained for each device manufactured?
Answer: Each manufacturer
21 CFR 820.184 places responsibility on 'each manufacturer' to maintain DHRs, making it an organizational rather than individual responsibility.
What is the MAIN difference between a corrective action and a preventive action in terms of documentation triggers?
Answer: Corrective actions address existing nonconformances; preventive actions address potential ones
Corrective actions (CA) are triggered by existing, identified nonconformances, while preventive actions (PA) are triggered by potential risks identified before a failure occurs.
An SOP is marked 'Rev. 3' but the training records show employees were only trained on 'Rev. 2.' What is the MOST significant risk this presents?
Answer: Personnel may be performing activities based on outdated instructions
If employees are trained only on a superseded revision, they may perform activities incorrectly or inconsistently with current approved procedures, risking product quality and safety.
Which of the following BEST describes the role of a 'document owner' in a QMS?
Answer: The individual accountable for the accuracy, currency, and periodic review of a document
A document owner is accountable for maintaining the document's accuracy, initiating periodic reviews, and ensuring it reflects current practice throughout its lifecycle.