Sponsored by Elite Biomedical Solutions
As a family owned and operated business, we know and value the importance of family. There have been days where our loved ones have depended on an Elite Biomedical Solutions’ part. Therefore, every replacement part, replacement assembly, production process and repair service are performed with the highest level of detail. Elite has worked diligently to build the diverse and skilled team we have today. Our experienced team works every day to ensure patient safety is met. We work hard, so your loved one is treated with Elite care. Learn how we focus upon patient safety daily.
How: Manufacturing Control
A major decision for Elite was to bring manufacturing in house! We are proud to say we use 100% USA manufactured plastic replacement parts and that we manufacture these parts in our corporate facility. This provides to you (our customer), Elite’s protection and guarantee of a high-quality replacement part. For an error-proof process, Elite manufacturing implements principles of poka-yoke. This can be as simple as pre-counting the number of labels for a specific product lot to setting alarms on the injection mold press that alert the operator of any variances in parameters.
Elite regularly evaluates their processes for improvement. We are firm believers in continual improvement at Elite. It is an ongoing effort to advance our processes, products and services in order to execute the best solution. Our team works closely in collaboration to share ideas and brainstorm improvements. Through the plan, do, check, act (PDCA) cycle, these ideas or solutions are tried and tested. If proven effective, they are then implemented.
How: Design Control
Throughout the entire process of product development, we follow a strict set of guidelines. This is accomplished by establishing a detailed Project Plan from the collaboration of department Design Reviews. The reviews foster input and discussion on the product design and the areas with special consideration. Documentation is created and maintained for each Design Review. Every product process is validated through an IQ, OQ and PQ process to ensure that the respective process will yield a product that meets the predetermined requirements. This is true regardless of how complicated or simple the process is.
Prior to releasing a product for sale, a test protocol is created and performed to ensure that Elite parts perform to the same level as OEM. Each product is composed of numerous parts that are either fastened together or included in assembly. A detailed set of assembly steps are created and validated to guarantee the assembly is correct and contains all components.
How: QMS-Risk Management
Elite Biomedical Solutions takes a risk management approach for our products and services. The risk management process includes many steps such as identifying the risk; assessing the likelihood of the risk occurring; impact of this risk; implementing risk mitigation strategies; and monitoring the effectiveness of the risk management controls. The results of the risk management process allow Elite to anticipate any error and minimize the impact. The best result of an effective risk management process is prevention.
Elite completes a risk evaluation. This allows us to determine the significance of the risk and decide to accept, minimize or prevent. During risk evaluation, each is evaluated for probability (likelihood) of it happening and the consequences. These two factors help determine if something is high, medium or low risk. By performing a risk evaluation, Elite can focus on any and all risks that impact patient safety.
After risks are evaluated and prioritized, we decide to either accept, reduce or eliminate the risk. Risks may be reduced or eliminated by introducing new gauging, new fixture equipment, poka-yokes or by changing the production/assembly process. Once the Elite team evaluates the risk mitigation plan, these plans are put in place.
Risk Management is not a one-time exercise. Continuous monitoring and review are crucial for effective risk management.
How: ISO Certifications and FDA Registered
Elite Biomedical Solutions is a registered ISO 13485:2016 and ISO 9001:2015 company. Annual audits are completed by an outside ANAB-accredited Registrar. Just as important as the Registrar audit, is the ongoing internal auditing plan. Elite has several internal auditors who also audit our processes. These audits are completed to ensure conformance to the ISO standards and operating procedures. Elite is also FDA registered and complies with 21CFR820, Quality System Regulation.
Patient safety continues to drive, challenge and propel Elite to produce the best solutions and service in the health care industry. And, we are just getting started. Be sure to follow along as we continue to develop and produce new Elite products. 2019 is a big year for product launches. You won’t want to miss this.
For more information, visit elitebiomedicalsolutions.com.
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