Charles Sternberg, Assistant Editor02.19.21
Trademark Plastics Inc. (TPI), a LEAN manufacturer of medical components that specializes in custom injection molding, has partnered with MedAccred, (by 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:
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. 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 the adherence to the high standards set forth by MedAccred and its subscribers. MedAccred has 10 subscribing OEMs, 7 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, “The Team at PRI was very thorough in explaining the process and answered any questions that we had. This audit was more focused on the actual process of creating these components. It ensures that our cleanrooms are maintained and we have proper equipment with trained personnel. It also helps verify that our toolroom and maintenance departments are in tune with Production and the criteria set forth, ensuring competence of all our staff and processes.”
Chief operating officer Bryan Barrera stated, “Our goal is to continuously make our customers’ life easier. By having thorough and efficient processes, our customers can gain a confidence level to continue to work with TPI and even bring in new, difficult projects that only we can manufacture. It’s about giving them the confidence in TPI as a supplier, and the industry as a manufacturer. We want to have Six Sigma level product output, that is our goal, and we need to have regulated processes by the most prestigious certifying bodies in the world.”
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 allows Trademark’s clients to have the confidence of accurate, streamlined validations and processes to enable TPI to become the fastest and most reliable producer of medical components for OEMs in the world.
This accreditation will allow TPI clients to benefit from:
- Rigorous oversight of critical manufacturing processes
- Reduce the need for redundant onsite audits
- Increased confidence in Quality Assurance standards that align 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. 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 the adherence to the high standards set forth by MedAccred and its subscribers. MedAccred has 10 subscribing OEMs, 7 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, “The Team at PRI was very thorough in explaining the process and answered any questions that we had. This audit was more focused on the actual process of creating these components. It ensures that our cleanrooms are maintained and we have proper equipment with trained personnel. It also helps verify that our toolroom and maintenance departments are in tune with Production and the criteria set forth, ensuring competence of all our staff and processes.”
Chief operating officer Bryan Barrera stated, “Our goal is to continuously make our customers’ life easier. By having thorough and efficient processes, our customers can gain a confidence level to continue to work with TPI and even bring in new, difficult projects that only we can manufacture. It’s about giving them the confidence in TPI as a supplier, and the industry as a manufacturer. We want to have Six Sigma level product output, that is our goal, and we need to have regulated processes by the most prestigious certifying bodies in the world.”
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 allows Trademark’s clients to have the confidence of accurate, streamlined validations and processes to enable TPI to become the fastest and most reliable producer of medical components for OEMs in the world.
