CBA Documentation & Record Management 4

Question 1

Which of the following is an example of a 'controlled document' in a biomedical QMS?

Accepted Answer

An approved and distributed standard operating procedure

Answer

Controlled documents are formally approved, distributed, and managed within the QMS, such as SOPs — external references and personal notes are uncontrolled.

Question 2

A Device Master Record (DMR) for a Class II medical device should contain which of the following?

Accepted Answer

Device specifications, production processes, quality assurance procedures, and labeling

Answer

Per 21 CFR 820.181, the DMR must include device specifications, production process specifications, QA procedures, packaging/labeling specifications, and installation/maintenance procedures.

Question 3

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:

Accepted Answer

A breakdown in the change control process requiring a nonconformance report

Answer

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.

Question 4

Under 21 CFR Part 820, who is responsible for ensuring that the Device History Record is maintained for each device manufactured?

Accepted Answer

Each manufacturer

Answer

21 CFR 820.184 places responsibility on 'each manufacturer' to maintain DHRs, making it an organizational rather than individual responsibility.

Question 5

What is the MAIN difference between a corrective action and a preventive action in terms of documentation triggers?

Accepted Answer

Corrective actions address existing nonconformances; preventive actions address potential ones

Answer

Corrective actions (CA) are triggered by existing, identified nonconformances, while preventive actions (PA) are triggered by potential risks identified before a failure occurs.

(CBA) Certified Biomedical Auditor Practice Test

(CBA) Certified Biomedical Auditor Practice Test

CBA Documentation & Record Management 4