Trademark Plastics, Inc. (TPI), Riverside, California, is a LEAN manufacturer of medical components, specializing in custom injection molding. TPI has partnered with MedAccred (by PRI, the Performance Review Institute), an industry-managed certifying body committed to ensuring critical manufacturing process quality throughout the medical device supply chain. This accreditation will allow TPI clients to benefit from:
- Rigorous oversight of critical manufacturing processes
- Reduced need for redundant onsite audits
- Increased confidence in quality assurance standards aligning with FDA’s Case for Quality (CfQ)
- Controlled and audited production processes, policies and procedures
- Robust quality management system
In medical device manufacturing, the ability to prevent output deficiencies is critical. OEM manufacturers place an emphasis on quality processes to ensure products are validated during manufacturing and rely on audits to satisfy regulatory and client requirements.
“The audit criteria incorporate industry-accepted performance standards and manufacturer specifications that meet the requirements of the regulator.” – (https://p-r-i.org/medaccred/) MedAccred helps prevent output deficiencies by properly detailing criteria for validation protocols in regard to critical processes and products. Conducted by industry subject matter experts, in-depth process audits are performed in compliance with industry/technical standards on a consistent and standardized basis. Yearly audits are performed to show adherence to the high standards set forth by MedAccred and its subscribers. MedAccred has 10 subscribing OEMs, seven of which are ranked in the top 25 in the world for medical device manufacturing. Obtaining this accreditation leads to “process discipline and greater operational efficiency and continuous improvement resulting in higher quality and lower overall cost.”
TPI’s Quality Director Aaron Clement explained the importance of obtaining the MedAccred accreditation, stating that the team at PRI was very thorough in explaining the process and answered any questions that TPI had. The audit was more focused on the actual process of creating these components. It ensures that the company’s cleanrooms are maintained and that is has proper equipment with trained personnel. It also helps verify that the company’s toolroom and maintenance departments are in tune with production and the criteria set forth, ensuring competence of all of its staff and processes.
With the MedAccred accreditation, Trademark’s commitment to implementing Six Sigma manufacturing methodology is reinforced. TPI can perform medical-level validations for original equipment manufacturers with an increased rate of confidence and reliability. Investments made in gaining the MedAccred Accreditation allow Trademark’s clients to have the confidence of accurate, streamlined validations and processes to enable TPI to become one of the fastest and most reliable producers of medical components for OEMs in the world.
For more information, visit www.trademarkplastics.com.
