Podcast
Questions and Answers
What is the primary role of the Process Owner in the document change process?
What is the primary role of the Process Owner in the document change process?
Which of the following sections requires the QMS Manager to confirm the integrity of the Quality System?
Which of the following sections requires the QMS Manager to confirm the integrity of the Quality System?
In the Requester section, what must be included if applicable when stating the reason for a change?
In the Requester section, what must be included if applicable when stating the reason for a change?
What is required of the Document Administrator after marking boxes in their section?
What is required of the Document Administrator after marking boxes in their section?
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Which document type does NOT appear in the Requester section?
Which document type does NOT appear in the Requester section?
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Flashcards
Document Change Types
Document Change Types
Categories indicating how a document is modified: revision, addition, deletion.
Process Owner Responsibilities
Process Owner Responsibilities
Ensure no other document's integrity has been violated during changes.
QMS Manager Role
QMS Manager Role
Assures that the Quality Management System's integrity remains intact.
Document Administrator Duties
Document Administrator Duties
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Effective Date
Effective Date
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Study Notes
Document Change Request Form
- Document Title: Document Change Request Form
- Document Number: 520
- Revision Level: B
- Last Revision Update: 9/18/24
- Process Owner: Responsible for ensuring change requests adhere to procedures.
- Requester: Individual initiating the change request
- Document Name: Name of the document being changed
- Current Revision Level: Current version of the document
- Type of Document: Category of the document (e.g., Policy, Instruction, Chart)
- Change Requested: Description of the modification
- Reason for Change: Explanation for the needed change, potentially including audit clause numbers or source requirements.
- Date: Date of request
- Requester Information: Name, title of the requester
- Process Owner Section: Section for the process owner's verification
- Process Owner Approval/Rejection: Confirmation that the process owner has verified the change
- Comments: Space for additional remarks by the process owner
- Effective Date: Date the change becomes applicable.
- QMS Manager Section: QMS manager assures changes do not compromise quality system integrity
- QMS Manager Approval/Rejection: Confirmation that QMS manager has approved/rejected the change
- QMS Manager Comments: QMS manager comments on the change.
- Document Administrator section: Lastly, verification by the document administrator.
- Document Administrator Approval/Rejection: Document administrator's approval/rejection of change.
- Document Revision Completion: Confirmation the revision is completed.
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Description
This quiz tests your understanding of the Document Change Request Form. You will explore key components such as the roles of the requester and process owner, types of documents, and change request details. Learn how to effectively manage and document changes within an organization.
