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Detail Mold and Manufacturing – Quality Management System to Grow
With the help of: TMAC
About
Since 1990, Detail Mold & Manufacturing has been a single source supplier for the design and fabrication of high precision plastic injection molds along with machined components and fixtures for injection molds. Located in Leander, Texas, the molds are used for plastic injections which are supplied to injection molding companies across the United States.
The Challenge
With Dan Berg – former 3M employee of 39 years – at the helm, Detail Mold & Manufacturing (DMM) made the strategic decision to expand their capabilities to better serve their current customer base along with expanding into the medical device sector such as plastic dispensing components. His vision was to be able to provide DMM’s customers with a mold that was machine independent, plant independent, and country independent. This “turn-key” mission included mold trials and production runs. Delivering customers a variety of options from FAI, IQ/OQ/PQ runs, DOE, CpK and PpK studies (which are statistical process control and quality assurance tools and techniques). Executing this vision would require a quality management system (QMS) that complied with industry recognized standards, ISO9001:2015, and the medical QMS ISO13485:2016. For help, DMM turned to TMAC, part of the MEP National Network™.
TMAC was able to help us understand the requirements of the ISO standards and to establish our quality management system so that we were able to certify to both the ISO 9001:2105 and the ISO 13485:2016 standards as required by our new medical industry customers. This provided the foundation that has allowed us to successfully add first article testing and production runs to our services while reducing the overall lead time for our clients.
MEP's Role
Detail Mold & Manufacturing worked with TMAC over a 12-month period to conduct a detailed analysis of their processes and to identify the gaps in the system where industry “best practices” could be incorporated. TMAC supported them in creating, documenting and implementing a cohesive system that could be certified to the ISO9001:2015 and ISO13485:2016 standards to ensure that DMM would deliver on their new mission.