Questions and Answers
What action is to be taken if either refuse to sign the document due to inadequacy?
Escalated to the Management Representative or Designee who shall then return the DCO to the Drafting state again
Where should the signed PDF of DCO & CCR revision be uploaded for use?
Each document/record shall have a unique identifier, such as NNS-QP## for Procedures where ## is two numbers. For example, NNS-QP01 refers to _______.
the Quality Manual
Obsolete revisions of documents should be retained indefinitely.
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Where are technical documentation, requirements, and risk tracking created?
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What is used in Jira to analyze the impact of changes on Feature Requests and Problem Reports?
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Documents once approved in Jira should be exported to __________ for permanent secure storage.
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Validation/Verification involves conducting the Product Validation Plan (PVP) on the hardware and software.
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What is the purpose of the Document Management Procedure?
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What does 'DCO' stand for in the document?
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Define the term 'Deviation' as mentioned in the document.
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The intended audience of this document includes internal and external stakeholders concerned with Document, Record, and Change Control, including EU Notified Bodies (NBs) and UK Approved Bodies (UKABs), the USA’s Food and Drug Administration, etc.
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Study Notes
Document Management Procedure
- 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.
Definitions
- 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
Control of Documents
- 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.
Control of Records
- Disaster Recovery for Documents and Records is outlined in section 4.1.
Procedure Metrics
- 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.
Document Control
- 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
Change Control
- The change control process involves managing changes to documents and records.
- The process includes:
- Identifying and recording changes
- Assessing the impact of changes
- Creating a Change Control Record (CCR)
- Approving and implementing changes
- Verifying and validating changes
- Documenting and maintaining a record of all changes
Review and Revision
- 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
Retention Period
- 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.
Storage and Backup
- 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.
Deviation Management
- 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
Change Control Workflow Process
- 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
Control of Records
- 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
Procedure Metrics
- 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
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Test your knowledge of document management procedures, including revision history and references. Learn about effective date, revisions, and updates made to documents.
