CBA Documentation & Record Management 2

Question 1

Under FDA 21 CFR Part 820, what is the minimum retention period for Device History Records (DHRs)?

Accepted Answer

The expected life of the device or 2 years from release, whichever is longer

Answer

21 CFR 820.184 requires DHRs to be retained for the expected useful life of the device or 2 years from release date, whichever is longer.

Question 2

Which document controls activity must be completed BEFORE a revised procedure is implemented?

Accepted Answer

Approval by designated authority

Answer

Documents must be reviewed and approved by designated authorities before implementation to ensure proper authorization under ISO 13485 and FDA QSR.

Question 3

A batch record is missing a technician's initials on a critical step. Under ALCOA principles, this finding represents a failure of which attribute?

Accepted Answer

Attributable

Answer

ALCOA's 'Attributable' principle requires that each recorded entry can be traced to the individual who performed and documented it.

Question 4

When an obsolete document is retrieved from circulation, what is the BEST practice for its disposition?

Accepted Answer

Mark it as obsolete and retain per the document retention schedule

Answer

Obsolete documents should be marked clearly to prevent unintended use and retained according to the organization's record retention schedule for traceability.

Question 5

An auditor finds that a quality manual references a procedure that no longer exists. This is BEST classified as which type of finding?

Accepted Answer

Minor nonconformance

Answer

A broken cross-reference between controlled documents is a gap in document control that typically constitutes a minor nonconformance requiring corrective action.

(CBA) Certified Biomedical Auditor Practice Test

(CBA) Certified Biomedical Auditor Practice Test

CBA Documentation & Record Management 2