title: Increasing Product Confidence-Shifting Paradigms.
abstract: Leaders in the pharmaceutical, medical device, and food industries expressed a unilateral concern over product confidence throughout the total product lifecycle, an unsettling fact for these leaders to manage given that their products affect the lives of millions of people each year. Fueled by the heparin incident of intentional adulteration in 2008, initial efforts for increasing product confidence were focused on improving the confidence of incoming materials, with a belief that supplier performance must be the root cause. As in the heparin case, concern over supplier performance extended deep into the supply chain to include suppliers of the suppliers-which is often a blind spot for pharmaceutical, device, and food manufacturers. Resolved to address the perceived lack of supplier performance, these U.S. Food and Drug Administration (FDA)-regulated industries began to adopt the supplier relationship management strategy, developed by the automotive industry, that emphasizes "management" of suppliers for the betterment of the manufacturers. Current product and supplier management strategies, however, have not led to a significant improvement in product confidence. As a result of the enduring concern by industry leaders over the lack of product confidence, Xavier University launched the Integrity of Supply Initiative in 2012 with a team of industry leaders and FDA officials. Through a methodical research approach, data generated by the pharmaceutical, medical device, and food manufacturers surprisingly pointed to themselves as a source of the lack of product confidence, and revealed that manufacturers either unknowingly increase the potential for error or can control/prevent many aspects of product confidence failure. It is only through this paradigm shift that manufacturers can work collaboratively with their suppliers as equal partners, instead of viewing their suppliers as "lesser" entities needing to be controlled. The basis of this shift provides manufacturers with a newfound respect for their suppliers, and it will allow manufacturers to finally address true root causes that can lead to a marked increase in product confidence.
  
  
  
  In the past decade, pharmaceutical, medical device, and food manufacturers have increased their focus on controlling and managing the performance of their suppliers in an effort to improve the confidence of the materials going into the final marketed products and to improve patient and customer confidence in final product reliability and safety. Concerned that product confidence has not improved, Xavier University launched the Integrity of Supply Initiative in 2012 with a team of industry leaders and U.S. Food and Drug Administration officials. Through this initiative, data generated has revealed that manufacturers either unknowingly increase the potential for error or can control/prevent many aspects of product confidence failure. Product confidence can be improved by shifting the focus from controlling supplier practices to controlling the practices of the manufacturers themselves.
authors.affiliation: Xavier University Cincinnati, OH, USA; and phillipsm4@xavier.edu.
authors.forename: Marla
authors.initials: M
authors.lastname: Phillips
authors.affiliation: University of Graz, Graz, Austria.
authors.forename: Vishal
authors.initials: V
authors.lastname: Kashyap
authors.affiliation: Xavier University Cincinnati, OH, USA; and.
authors.forename: Mee-Shew
authors.initials: MS
authors.lastname: Cheung
mesh_terms: D004345:Drug Industry / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005502:Food / Q000592:standards; D019649:Food Industry / Q000592:standards*; D007221:Industry / Q000592:standards*; D004364:Pharmaceutical Preparations / Q000592:standards; D015203:Reproducibility of Results; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations
keywords: Product risk; Supplier relationship management; Supply reliability