Quiz: MDSAP QMS Document Control and Approval Procedure Training

1. A regulatory authority representative identifies the need for a completely new MDSAP document. Before beginning development, what must happen first?

A The RAC Chair must provide written pre-authorization before any drafting activity begins. B The originator must immediately request a document number from the RAC Secretariat and begin drafting. C The originator must circulate a survey to all regulatory authority representatives to gauge support for the new document. D The MDSAP QMS Site Representative and/or QMS Management Representative must agree with the concept and necessity of the proposed new document.

Per Section 5.3, the MDSAP QMS Site Representative and/or QMS Management Representative must agree with the concept and necessity of the proposed new document before the originator initiates the development and approval process. Only then does the originator request a document number and begin drafting.

2. Who holds final document approval authority for a proposed revision that is determined to have a significant impact on the MDSAP?

A The MDSAP RAC Chair B The MDSAP RAC Secretariat C The document originator's regulatory authority head D The MDSAP QMS Management Representative

According to Section 4.1 and Sections 5.3–5.4, the RAC Chair maintains final document approval authority for all significant impact documents. The QMS Management Representative's approval authority is explicitly limited to non-significant impact documents or revisions.

3. When preparing a draft revision to a published MDSAP document, which technical requirement must the originator follow in Microsoft Word?

A Save the file in PDF format to ensure it is electronically searchable. B Activate the 'Track Changes' feature so all edits are visible during review. C Activate the 'Restrict Editing' feature to prevent unauthorized changes during review. D Apply password protection to the document before forwarding it for review.

Section 5.4 explicitly requires the originator to prepare the draft revision as an MS Word file with the 'Track Changes' feature activated. Additionally, Section 5.1 specifies that draft documents must not be password protected or set to read-only.

4. Under what circumstances can minor errors such as typos or grammatical mistakes in a published document be handled without immediately going through a full approval process?

A They can be saved by the Secretariat and addressed cumulatively at the next comprehensive review, or approved as a non-significant impact revision. B They can never be deferred - all changes, regardless of size, must go through the standard approval workflow immediately. C They can be corrected directly by any regulatory authority representative and re-posted to the website without review. D They must be escalated to the RAC Chair for a formal waiver before any correction is made.

Section 5.2 states that minor revisions - such as typographical, grammatical, or spelling errors - that do not impact the utility of the document can be saved by the Secretariat and addressed cumulatively at the comprehensive document review, or approved as a non-significant impact revision.

5. How frequently must a comprehensive review of MDSAP documents be conducted, and who is responsible for ensuring it takes place?

A Every 36 months, led by the RAC Secretariat and verified by the RAC Council. B Annually, led by the MDSAP QMS Site Representatives with sign-off from the RAC Chair. C Every 60 months, with the MDSAP QMS Management Representative and QMS Site Representatives responsible for ensuring it is conducted. D Every 24 months, led by the RAC Chair in collaboration with all regulatory authority representatives.

Section 5.2 specifies that a comprehensive document review must be initiated every 60 months based on the latest date of review/version. The MDSAP QMS Management Representative and QMS Site Representatives are responsible for ensuring this review is conducted and that revisions are proposed as necessary.