Quiz: MDSAP QMS Document Control and Approval Procedure Training
Test your understanding. Select the best answer for each question.
1. A regulatory authority representative identifies the need for a completely new MDSAP document. Before beginning development, what must happen first?
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?
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?
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?
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?
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.