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Supplier Development

 

 

 

Freije Quality Engineering, LLC can work with your current suppliers to help improve product quality, reduce scrap with process improvement techniques, and other quality tools like CAPA, SPC, FMEA, Control Plans, RCA, etc.  For new or potential suppliers we can work with you in planning, controlling, and ensuring product and process quality requirements are flowed down including process validation (IQ, OQ, PQ) as well as Quality and or Manufacturing Requirements Documents.  Freije Quality Engineering, LLC can also work with you for pre assessment audits for ISO 9001:2000, ISO 13485:2003, and 21 CFR Part 820 - Quality System Regulation.

Key Benefits

bulletLower your operating cost due to fewer quality issues
bulletImprove the quality of your product
bulletGain better understanding of supplier's process and quality system
bulletStandardization across all processes

Results

bulletWork with critical suppliers to a major medical device company to help improve quality of products as well as improve supplier's CAPA
bulletWorked with key medical device supplier for a major medical device company to improve product quality by reducing a major complaint 40% by implementing and validating (IQ, OQ, PQ) changes to an insulin pen-injector that resulted from a DOE
bulletWorked with key medical device supplier for a major medical device company to increase outgoing quality of product 50% by reducing deviations from functional and cosmetic missed opportunities
bulletWorked with plastic injection supplier to a major defense contractor to help them understand process and measurement variation

 

 

 

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