Document change order is significant because it lies in its role in ensuring the integrity, accuracy, and compliance of organizational documentation. It is also significant because it ensures compliance with regulatory bodies, audit trail, communication and transparency, and risk management.
What is a DCO Document Change Order
Document Change Order (DCO) is the process of filling out and submitting for approval, will list the documents which are being initiated or revised, a brief description and reason of the change for each document, the “old” and “new” version number for each document, the regulatory impact of the change, a disposition of any existing inventory (if applicable), and the required approvals.
Why are DCO important in the medical device industry
DCOs ensure a higher level of safety and effectiveness. It creates a higher barrier of entry for design changes and documentation. It builds in an independent reviewer into the system to create an extra layer of quality control.
Regulatory Requirements
- ISO 9001-
- FDA- 21 CFR Part 11
- ISO 13485
- EU MDR
These regulations give the criteria for documentation and the reviewing system for the process of approving and changing documents
FDA regulations for medical device manufacturers
Document approval and distribution-Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented. Documents established to meet the requirements of this part shall be available at all locations for which they are designated, used, or otherwise necessary, and all obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use.
Document changes- Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise. Approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective.
Compliance with ISO standards for documentation changes
- General Requirements: The standard mandates that records shall remain legible, readily identifiable, and retrievable.
- Retention Time: It specifies the required retention time for records, which should be defined within your organization’s quality management system.
- Handling and Protection: Records should be stored and maintained in a manner that ensures their protection against damage, deterioration, or loss.
- Disposition: Procedures should be in place for the disposition of records, including identification, retrieval, and retention time, as well as the authority responsible for their disposition.
- Availability: Records must be made available and accessible to those who need them, including relevant regulatory authorities.
- Requirements for Quality Records: This may include but is not limited to records of product realization, monitoring, and measurement activities, as well as records necessary to demonstrate conformity to specified requirements.
What is the purpose of DCO
The purpose of this procedure is to document the activities associated with initiating, processing, and controlling a company device design changes and manufacturing/ quality system process changes in accordance with 21 CFR 820.40, ISO 13485:2016 section 4.2.4, and EU MDR
Streamlining the change process for medical devices
With an in place document control hierarchy and naming convention helps with reduced error rates, improved traceability, faster turnaround times, enhanced collaboration, and less training.
Ensuring quality control and product safety
- Supporting continuous improvement of medical devices
- Promotes accountability with version controls and signing off of documents
- Facilitating training and awareness
- Standardizing process changing and controlling the safety of the medical devices
- Ensuring Compliance with guidelines and regulations
What are the stages of the DCO Process
- Using a Quality Document template create the document with correct formatting and document number- version, description, category, authored by, effective date, and status
- Record in a document master list
- Good documentation practice
- Change order initiation to release the document
- CO approval and training
- Record maintenance
- Sign off of records
Identification of the need for a change
Describe how the need for a change is typically identified within the context of medical device manufacturing. Discuss who might be responsible for recognizing this need and what signals or data might trigger the initiation of a DCO. Emphasize the importance of this step in ensuring the appropriateness and timeliness of changes.