CBA Documentation & Record Management 3

Question 1

What is the PRIMARY purpose of a Master Document List (MDL) in a quality management system?

Accepted Answer

To provide a current inventory of all controlled documents and their revision status

Answer

An MDL (or document register) provides a single source of truth for all controlled documents, their current revision levels, and status within the QMS.

Question 2

A correction is made to a paper batch record by drawing a single line through the error, initialing, and dating the correction. What additional element is REQUIRED by ALCOA principles?

Accepted Answer

The reason for the change

Answer

Good documentation practice requires that corrections include the reason for the change in addition to the single strikethrough, initials, and date.

Question 3

Under ISO 13485:2016, which of the following is considered a 'quality record' rather than a 'quality document'?

Accepted Answer

Completed calibration log for a specific instrument

Answer

Quality records are completed, filled-in forms (objective evidence of activities performed), while quality documents are instructions or policies used to guide activities.

Question 4

A biomedical company uses a document numbering system that encodes department and document type. An auditor cannot determine the current revision from the document number alone. What is the MOST appropriate corrective action?

Accepted Answer

Ensure revision levels are clearly displayed on the document face and in the MDL

Answer

While revision levels need not be in the document number, they must be clearly and unambiguously displayed on the document itself and tracked in the master document list.

Question 5

Which scenario BEST demonstrates the concept of 'data integrity' in documentation?

Accepted Answer

Data is recorded directly into the batch record at the time of the activity

Answer

Data integrity requires that data be recorded contemporaneously — at the time the activity is performed — to ensure it is accurate and original.

(CBA) Certified Biomedical Auditor Practice Test

(CBA) Certified Biomedical Auditor Practice Test

CBA Documentation & Record Management 3