Document Change Request Process

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Questions and Answers

What are the possible types of documents listed in the provided content?

  • Policy, Procedure, Work Instruction, Form, Flow Chart, Instruction (correct)
  • Policy, Procedure, Work Instruction, Form, Flow Chart
  • Policy, Procedure, Work Instruction, Form, Instruction
  • Policy, Procedure, Work Instruction, Form, Flow Chart, Instruction, Document

The document is routed to the QMS Manager after the Process Owner approves or rejects it.

True (A)

What is the purpose of the 'Change Requested' section?

To describe the proposed change to the document, either through a written description or by attaching a marked-up copy.

The ______ section is where the Process Owner provides their approval or rejection of the proposed change.

<p>Process Owner</p> Signup and view all the answers

Match the following roles with their corresponding sections in the document:

<p>Requester = Requester section Process Owner = Process Owner section QMS Manager = QMS Manager section Document Administrator = Document Administrator section</p> Signup and view all the answers

Flashcards

Document Change Type

Categories for modifying a document, like revision or addition.

Process Owner Responsibility

Ensure that no other document's integrity is compromised during changes.

QMS Manager Role

Assure that the Quality Management System integrity is maintained.

Document Administrator Tasks

Confirm completion of sections and mark required boxes in documentation.

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Effective Date Importance

The date when a document change or policy comes into effect.

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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
  • Created On: 9/18/24, October 17, 2024
  • Document Name: [Needed]
  • Current Revision Level: [Needed]
  • Type of document: [Needed]
  • Type of Document Change: Revision, Add, or Delete
  • Change Requested: Detailed description of the change (or a copy of the marked-up original)
  • Reason for Change: If applicable, formal identification (e.g., audit clause number or source of the requirement)
  • Requester section: Includes Requester Name/Title, Date, Work Inst., and Form/Flow
  • Process Owner section:
    • Assure no other document's integrity has been violated.
    • Approved or Rejected
  • Comments: By Process Owner(s) with initials and Effective Date
  • Route to: Document Administrator
  • QMS Manager section:
    • Assure Quality System Integrity has not been violated.
    • Yes/No boxes for QMS Manager section completion.
  • Comments: By QMS Manager(s) with signature
  • Document Administrator section:
    • Yes/No boxes for QMS Manager section and Document Revision completion.
    • Document Administrator Initials
    • Effective Date
  • Important Note: Document Administrator must mark all boxes in this section.

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