Supplier Quality Engineering Framework (SQEFM)
The global medical device industry is highly regulated. Medical Device manufacturers need to establish, adopt, and implement processes(purchasing) or procedures not only within their organization but also ensure that their entire Supply Chain(suppliers) meet compliance standards, across sub-component, subcontracts, raw materials, and consultancy, etc.
Some key regulations include:
- Purchasing controls: (Section 820.50) : US FDA’s expectations for Quality management systems, purchasing controls.
- ISO 13485:2016 requirements on Purchasing controls: (Clause 7.4.1)
While most Med-Tech manufacturers have dedicated supplier management teams, they continue to face significant challenges in ensuring compliance. Supplier quality management responsibility starts right from identification of suppliers, risk categorization (based on type of material /service), qualifying and onboarding to their eco-system.
LTTS has identified mandated QMS processes, driven by regulatory requirements, to enable streamlined operations, unlocking capabilities and value for new strategic initiatives and innovations.
Focus Areas
Product Development
First Article Inspections (FAI), Measurement Challenges, Supplier Corrective Actions, Qualification Checklists
Supply Base Rationalization
Addressing Component Quality, Constant monitoring
Supplier Integration
M&A Programs, Managing Demand Surge
Manufacturing
Robust and Efficient Processes, Reliable Manufacturing Methodologies
We help resolve these constraints for customers and unlock value through optimized costs, flexible workloads, better compliance, and robust processes – enabling manufacturers with the ability to focus on their core activities. LTTS’ global team of engineers, technologists, and SMEs help transform non-core regulatory and quality processes through a tailored renovation and managed services approach, to ensure a rapid deployment of team and smoot transition of suppliers. Our dedicated CoE (Centre of Excellence) for Med-Tech industry is a key enabler here, with certified global quality experts to address the focus areas.
LTTS Framework (SQEFM)
We understand the challenges faced by industry in dealing with Suppliers. Our experts in the SQE domain leverage the SQEFM framework to help you navigate the major compliance challenges.
Key Areas
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Supplier Selection and Evaluation
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Supplier Qualifications and Onboarding Process
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Supplier Performance Monitoring
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Supplier Risk Management and Disengagement
Benefits
Improved Supplier Performance
Increased Efficiency
Risk Mitigation
Cost Savings
LTTS SQEFM Offerings Enable
- Approved Supplier List (ASL), risk assessment, and mitigation
- Supplier audits (in-person and remote) and agreements
- Engagement and disengagement, NC & CAPA managements
- Revitalized supplier relationships and performance(s)
- Enhanced compliance, integration, and harmonization of varied supplier range
- Enhanced working process with RPA (Power BI dashboards) for live status reporting of deliverables /programs
Our Compliance Standards
