CAPAs and NCs
Identify, document, and resolve non-conformities; implement corrective/preventive actions.
Product & Raw Material Specifications
Collaborate on drawings, work instructions, material & process specs, test specs, regulatory requirements and other docs
Identify and discuss failure modes, causes, effects, severity, detection, risk priorities of your product, design & process
Ensure all ITAR controlled docs & data are stored in compliant locations and retrieved only by authorised individuals.
Integration & Collaboration
Integrate with other systems and tools, such as ERP systems, CRM systems, and collaboration platforms to facilitate seamless information exchange and workflow management.
Manage the qualification, evaluation, and monitoring of suppliers, including conducting supplier audits, tracking supplier performance, and maintaining supplier documentation.
Plan, schedule, and conduct internal, layered and external audits for compliance verification.
Control, track and manage documents required for compliance with AS 9100, 9110, 9120, ISO 9001
Performance Metrics and Reporting
Generate reports, dashboards, and analytics on key quality metrics, performance indicators, and trends to enable data-driven decision-making.
First Article Inspection
Validate that product design and production processes produce items meeting specified design requirements.
Implement approval workflows within the QMS that allow for electronic signatures.
Controlled management of changes to device design or production process with proper review and approval.
Regulatory & Compliance
Ensure adherence to relevant regulatory requirements, such as ITAR, AS 9100, AS 9110, AS 9120 and other applicable standards.
Security & Access Controls
Implement robust security measures to protect sensitive data, ensure user access controls, and maintain audit trails for system activities.
Environment, Health & Safety (EHS)
Track and manage safety incidents, risks, EH&S audits, regulatory compliance, environmental protection, etc.
Electronic Batch Records
Capture critical batch info such as materials used, manufacturing steps, calibration, QC tests, batch releases.
Identify and mitigate risks during product design and production stages
Capture, document, and track customer complaints, initiate investigations, implement corrective actions, and analyze complaint trends.
Ensure employees are trained on safety practices and quality procedures, including when controlled docs are revised.
Ensure all docs and specs have proper documentation, review, and approval of changes & revisions by the right people.
Calibration & Maintenance
Manage the calibration and maintenance schedules for equipment, track maintenance activities, and ensure compliance with calibration requirements.