Document Management Procedure Quiz

Study Notes

The purpose of this document is to define the controls to be exercised on documents, data, and records that are crucial to the operation of the quality system and for complying with regulatory requirements.
The scope of this document management procedure is the control of documented information relating to any medical device product or service development and deployment.

CCR: Change Control Record - a package of related document changes
DCO: Document Change Order - the workflow for a document item within a CCR
Deviation: Any departure from an approved policy, plan, or procedure
Management Representative: The individual (or their designee) assigned by the organisation's top management per [EN ISO 13485:2016] §5.5.2
Assignee: The individual (or their designee) assigned by the Management Representative to manage the Document or Change Control
Reviewer: The individual (or their designee) assigned by the Management Representative to review the Document or Change Control
Approver: The individual assigned with the responsibility of signing off and approving the use of new document(s) or changes
Trainee: Individuals who are to be trained prior to use of new document(s) after approval
PEMS: Programmable Electrical Medical System
SaMD: Software as a Medical Device

The document control workflow process involves creating an issue within Jira, reviewing the change control record, creating a document change order, populating, reviewing, and approving the document, and finally approving, training, and closing the DCO and CCR.
The responsibility assignment matrix (RAM) for QMS documents and records outlines the roles and responsibilities for documents and records.
Document control attributes include issue and amendment controls, with each document/record having a unique identifier, and a table showing the revision history.

Procedure metrics are outlined in section 5.### Document Management Procedure
The Document Management Procedure outlines the process for managing documents and records within the company.
The procedure applies to all employees, contractors, and third-party vendors who create, review, approve, and maintain documents and records.

The document control process involves creating, reviewing, approving, and maintaining documents and records.
The process includes:
- Creating a new document or revising an existing one
- Reviewing and approving the document
- Maintaining a record of all changes and versions
- Ensuring that only approved documents are used
- Reviewing and updating documents regularly

Documents and records must be reviewed and revised regularly to ensure they remain relevant and up-to-date.
The review process includes:
- Reviewing documents and records at a minimum interval of once every 12 months
- Reviewing documents and records more frequently if necessary
- Identifying and implementing changes
- Approving and implementing changes

The retention period for quality and regulatory documents and records is 10 years after the last product has been manufactured.
Obsolete revisions of documents shall be retained for at least 10 years.

Electronic copies of documents/records shall be kept on the company's virtual drive.
The virtual drive is regularly backed up to allow for the retrieval of documents in the event of corruption, loss of access, or loss of documents.

The deviation management process involves managing temporary deviations from the approved document or record.
The process includes:
- Recording proposed deviations in Jira
- Approving and implementing deviations
- Documenting and maintaining a record of all deviations

The change control workflow process involves managing changes to documents and records.
The process includes:
- Creating a CCR
- Reviewing and approving changes
- Implementing and verifying changes
- Validating and documenting changes
- Closing the CCR

The control of records process involves managing and maintaining records.
The process includes:
- Reviewing and updating records regularly
- Maintaining a record of all changes and versions
- Ensuring that only approved records are used
- Reviewing and approving records regularly

The procedure metrics include:
- Number and type of document/record changes conducted per year
- Time taken to open and close CCRs/DCOs
- Number of rejected CCRs and reasons for rejected CCRs