Advanced Molding Technologies Recent growth and increased regulation in the Medical Device industry are continuing to drive the need for additional resources in the Quality Department at Advanced Molding Technologies.
Led by FDA and ISO 13485:2003 requirements, we have seen a big push toward more and more validation and control of our processes. To do so means the need for inspection, protocol authoring, data analysis and reporting before we are able to begin production. Advanced has responded to these needs by recently adding a Metrologist, two Quality Engineers and additional staff on the off-shifts with more personnel in the inspection department.
At the start of a new project, our Metrologist works with our Engineering and Quality team as well as the customer to evaluate what will be the best measurement method for the parts. This includes recommending new equipment needing to be purchased, designing fixtures and advising print updates/interpretations. Once we are in the development phase and making sample parts he can begin the Measurement Systems Analysis: taking representative parts from the process and making sure that our measurement system is not introducing an unacceptable amount of error and is repeatable and reproducible. Once that method is defined, he works with the customer to align measurement methods. After the measurement system has been approved he creates work instructions and trains the in-process inspectors on the techniques to be used during production.
The addition of two new Quality Engineers is a direct response to the need to provide the services for our customers for part and process development as well as ongoing process monitoring. The Quality Engineer will author IQ, OQ, PQ protocols to validate the plastic injection molding process, sonic welding, gluing or other assembly processes where validation is required. Those protocols are reviewed and approved by the customer. Along with the Project Manager the Quality Engineer will manage the validation process incorporating: the measurement systems analysis with the Metrologist, Design of Experiments (DOEs), Process Failure Modes Effects Analysis (PFMEA), control charts, data distribution identification (normality), capability studies, First Article Inspection Reports, and measurement correlation with the customer. All of this work goes in to developing a process to produce parts to meet customer specifications for the long term.
With continued growth and expanded capabilities in inspection, we have also added staff to our off shifts. Advanced operates 24/7. If production is running then the quality lab is staffed. The recent hires come with years of industry experience and are able to work independently to monitor the production process. They take samples defined by the control plan throughout production to verify the process is still meeting customer specifications. In addition to the inprocess inspection, we have the capability to do our First Article Inspections, capability studies and measurement systems analysis on the off shifts as well. This means quicker turnaround time through the development phase.
Industry demands, customer needs and our exciting growth will continue to lead us to adding more talent in the Quality Department. Our commitment to our strategic partners as well as the confidence to stand behind what we make gives us the opportunity to pursue candidates who fit in with our culture and provide a skill set to continue to improve us.
