Lubrizol Life Science Health Quality Management Process
Quality isn’t something you only start to care about after the CAD rendering or once production begins. It’s always your top priority — beginning with the medical device design and continuing throughout the life of your product. With our quality management process, we deliver performance, compliance and repeatability from concept through shipping. We create processes, validate them, test them, improve them and validate them again. All so you can rest easy knowing that your products are providing excellence and strengthening your brand.
LLS Health’s commitment to quality begins at the point of project inception. Our engineers collaborate with you and make recommendations on materials, tools or design modifications to improve manufacturability. We source only the highest quality materials from our list of approved suppliers. And we work with the industry’s most skilled toolmakers to ensure the most precise tool for the project. Our suppliers and partners are routinely audited and qualified. Then, we take great measures to manufacture products that meet the highest standards possible. And our commitment to quality doesn't end at the production line. Every component LLS Health makes is carefully packaged to maintain product integrity.
From start to finish, LLS Health cares for the life of your product.
LLS Health’s Quality Management Systems
All LLS Health systems are designed to support compliance. LLS Health is ISO registered and a certified supplier to many of the top medical device manufacturers in the global healthcare industry.
Each step of LLS Health's process is validated. Beginning with pre-production, LLS Health validation includes reviewing design attributes, establishing process parameters, tooling validation, prototyping, testing and inspection. Our quality management system is compliant to QSR 21 CFR Part 820 and uses industry-standard population statistics, Hi / Lo grouping, pass / fail and capability methods.
Lean Six Sigma
LLS Health incorporates Lean Six Sigma quality management principles at every level of our operation to verify that quality standards are being met, and to identify areas in need of improvement. We have Six Sigma black belts — with more in training — driving Six Sigma guidelines throughout the organization. And we’re committed to helping qualified individuals obtain black belt certification.
Analytics and Reporting
We conduct Gauge Reproducibility and Repeatability Studies. And our running validation includes a first article inspection report, qualification data collection and statistical analysis. We continually analyze the results and use them as guides for refinement of the process.