Documented Information
What type of documented information describes what to do in a process?
Maintained Documented Information / Document
Who is accountable for the document's content and lifecycle and keeps it accurate, current, and fit for purpose?
Document Owner
Give two examples of information used to identify a document during creation.
What should be updated when a controlled document is revised to ensure users can identify the current version?
The document's revision/version information and other applicable identification information.
A completed form, log, report, or meeting minutes generally falls under what type of documented information?
Retained Documented Information / Record
Who checks the document for technical accuracy, completeness, clarity, and compliance?
Document Reviewer
What is the difference between document review and document approval?
Review checks the document for accuracy, clarity, completeness, and compliance.
Approval is the formal authorization for the document to be issued and used.
A document is no longer valid for operational use. What is this condition called?
Document obsolescence.
is a Training Attendance Sheet classified as Maintained or Retained?
Retained
Who formally authorizes a document for release or implementation?
Document Approver
A document has been drafted and reviewed, but the authorized approver has not yet approved it. Can it already be formally issued as an approved controlled document?
No. It needs formal approval before it is issued and used as an approved controlled document.
An obsolete document is still needed for historical, legal, or audit purposes. Should it automatically be destroyed?
No. It may be archived and protected, such as in read-only form, according to the retention requirements
Name three different media that can contain documented information.
This role manages activities such as version control, revision history, distribution, retrieval, archiving, and document access. Who is it?
Document Controller
According to creation requirements, identify the three areas that must be appropriately controlled when creating documented information.
The Master List shows Rev. 04 as the current version, but Rev. 03 is still available at the point of use. Name three actions that should be taken.