WHAT DOES A DOCUMENT CONTROL SUPERVISOR DO?
Published: Dec 17, 2024 – The Document Control Supervisor oversees the final documentation process, ensuring customer approval is obtained after order fulfillment and addressing any post-shipment issues. This position maintains constant communication with the customer, ensuring clarity in the interpretation and management of the project ITP while supporting the After Sales team with necessary documents and information. The supervisor analyzes contracts, verifies requirements, and enters order details into the system to ensure project execution aligns with agreed terms.
A Review of Professional Skills and Functions for Document Control Supervisor
1. Document Control Supervisor Responsibilities
- QMS Compliance: Supports QMS compliance with current FDA QSR, ISO 13485:2016, MDD, and other standards as applicable.
- Routine Assignments: Complete routine daily assignments using established procedures and work instructions consistently and accurately.
- ECO Management: Process Engineering Change Notices (ECOs) and other Quality Management System documentation in a timely, efficient, and effective manner.
- ECO Review: Review ECOs for completeness and accuracy.
- Feedback: Provide feedback to the initiator.
- Data Entry and Notification: Perform data entry and notification of approved ECOs and distribution of released documentation.
- Audit Support: Provide support for audits (internal and external) by collecting and preparing process and procedural audit data as directed by the department manager.
- File Management: Coordinate with department personnel for filing, indexing, scanning, storage, and updating of department files/logs/records (e.g., DHF, DMR, ECNs, Training Matrix).
- Continuous Improvement: Drive continuous system, process, and product improvements throughout the organization.
- Nonconformance Control: Support Nonconformance Control and CAPA activities.
- Timely Resolution: Assure NCMRs and CAPAs are identified and addressed on time according to procedure requirements.
- QMS Assurance: Assure that the company’s QMS is compliant with current FDA QSR, ISO 13485:2016, MDD, and other standards as applicable.
2. Document Control Supervisor Accountabilities
- Training Delivery: Conduct Training for Quality System related procedures, for current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDP), and ISO 13485 standards.
- CAPA Program Management: Supervises, administers, and coordinates the CAPA program including tracking follow-up and effectiveness checks.
- Complaint Investigation: Supervises, administers, and coordinates investigations and closing of complaints.
- NCMR Program Management: Supervises, administers, and coordinates the NCMR program.
- MRB Coordination: Act as Lead MRB coordinator of non-conforming products and provide input on corrective actions related to NCMRs.
- Internal Audits: Lead, initiate, organize, and execute Internal Audits and reports to appropriate internal procedures and 21 CFR Quality Regulations and ISO 13485 Medical Device Quality System Standards.
- Supplier Qualifications: Participate in Supplier Qualifications for critical suppliers and as related to Root Cause Analysis of supplier non-conformities.
- Training Program Management: Supervises, administers, and coordinates the Training Program, as related to processes covered by the Quality Management System.
- Training Coordination: Coordinates with the appropriate personnel to facilitate and document the training activities.
- Policy Development: Develop and review policies and procedures to ensure that the appropriate checks and balances are included to ensure a quality output.
3. Document Control Supervisor Functions
- Document Maintenance: Maintenance of documents and revisions to ensure a complete and up-to-date repository of information.
- Document Review Management: Manage and monitor the document review and assurance process.
- Approval Workflow Management: Take responsibility for managing approval workflows.
- Documentation Organization: Manage classification, sorting, indexing, filing, archiving, and retrieval activities of all documentation.
- Compliance Assurance: Ensure compliance across all information in line with standards, protocols, and security measures.
- Document Management Systems: Assist in the development, maintenance, and rollout of document management processes and systems.
- General Administration Support: Assist the teams with general administration.
- Quality Assurance Checks: Take responsibility for QA checks on information to company standards.
- Recruitment and Training: Interview applicants and train new hires.
- Performance Management: Conduct performance reviews, including setting and tracking goals.
4. Document Control Supervisor Overview
- Specification Production: Assist with the production of specifications and associated Project Documentation.
- Site Documentation: Produce site documentation from Production Office Copies.
- Scanned Documentation Handling: Assist with scanned documentation to produce sets of design documentation required to be transferred between different engineering sites.
- Issue Control Management: Produce documentation for Issue Control Logs.
- Document Register Maintenance: Assist with the production and upkeep of the Project Document Register and related correspondence and engineering documents.
- Design Approval Collation: Collate and submit the approval design on the NR platform.
- Transmittal Documentation: Produce transmittal documentation.
- Document Release and Distribution: Formal release and distribution of controlled documents.
- Liaison and Support: Effective liaison and support to both internal and external Project/Functional teams.
- Quality Data Analysis: Performs regular detailed Quality Data Analysis and Communicates Results to Senior Management via QA Reporting.
5. Document Control Supervisor Tasks
- Meeting Coordination: Attend meetings with the PM and the client if information is requested regarding the scheduling/issuance of the final documentation and/or the applicability of discussed penalties and/or the payment schedule.
- Final Documentation Management: Manages the final documentation to obtain customer approval after order fulfillment, collecting the deliveries of the PMs.
- Data Book Issuance: Issues Data Books on customer requests and corporate interests.
- After Sales Support: Supports the After Sales staff by providing all information, clarifications, and documents required for the resolution of post-shipment problems.
- Customer Relationship Management: Maintains constant contact with the customer to ensure a relationship of continuous collaboration, without ambiguity as regards the interpretation and management of the project ITP.
- Report Management: Filling out and updating reports as requested by the Project Management Manager.
- Customer Relations: Keeping good relations with customers and always guaranteeing a response timely, even in the absence of the PM.
- Customer Support: Ensuring professional support to customers to ensure the satisfaction of their expectations that translate into commercial returns for the company.
- Contract Analysis: Complete the detailed analysis of the contract (Terms and Conditions, presence of signatures and congruence dates, Scope of Supply - quantity and prices, and basic configuration).
- System Entry Validation: Check that all the necessary and mandatory requirements are present and complete system entry and booking entry.
- Order Entry: Enter the order into the system and then create the internal order/project internally, according to all information made available by the seller.