Quiz: MDSAP QMS Control of Quality Records Procedure
Test your understanding. Select the best answer for each question.
1. According to the MDSAP QMS procedure, which of the following best describes the required characteristics of all quality records?
The procedure explicitly states that all records are required to be legible, accurate, readily identifiable, and appropriately retrievable to ensure effective QMS operation.
2. A staff member needs to discard a data entry recorded on an electronic MDSAP document. What is the correct procedure?
The procedure requires that discarded data be crossed out, initialed, dated, and accompanied by a reason using the MS Word 'Track Change' feature - ensuring an auditable record of the correction.
3. Which of the following is NOT considered an MDSAP quality record under this procedure?
The procedure explicitly states that personal papers - documentary materials belonging to an individual not used to conduct government business - are not government/agency owned and are not considered MDSAP records.
4. What is the minimum record retention period specified in this procedure?
The procedure states that the retention period will not be less than five years, or as governed by specific regulation and/or policy applicable to a given MDSAP site.
5. Where should audit and assessment reports specifically be filed and stored according to the electronic records maintenance requirements?
The procedure specifies that audit and assessment reports are to be filed and stored using the MDSAP Regulatory Exchange Platform-secure (REPs), while other documents are stored in MDSAP Box.