title: The critical phase inspection process: a benchmarking study in search of industries' best practices.
abstract: Benchmarking is the orderly process of measuring one's own products, services, and practices against those of companies recognized as leaders. Eli Lilly and Company's Quality Assurance Department formed the Critical Phase Inspection Team to benchmark the processes for selecting and conducting critical phase inspections and reporting inspection findings. The team developed a telephone survey that was conducted with 33 other quality assurance units across the country. Analysis of the phone survey responses resulted in the identification of 5 quality assurance units that we felt could provide valuable information to us on these activities. Site visits to these companies were arranged and information was shared. We present here the analysis and results of our benchmarking endeavor. Through the information sharing involved in the benchmarking process, namely, the telephone surveys and the site visits, fresh ideas emerged and new acquaintances were made. Comparisons and adaptations of our methods with others in the quality assurance business will lead us to breakthrough improvements that will allow us to improve our current processes.
authors.affiliation: Environmental Affairs/Quality Control/Quality Assurance, Eli Lilly and Company, Greenfield, Indiana.
authors.forename: D R
authors.initials: DR
authors.lastname: Herman
authors.forename: T L
authors.initials: TL
authors.lastname: Dangler
authors.forename: D A
authors.initials: DA
authors.lastname: Houser
authors.forename: T G
authors.initials: TG
authors.lastname: Lewis
authors.forename: J L
authors.initials: JL
authors.lastname: Masten
authors.forename: I E
authors.initials: IE
authors.lastname: Taylor
mesh_terms: D003625:Data Collection; D004345:Drug Industry; D005161:Facility Regulation and Control / Q000458:organization & administration*; D017146:Models, Organizational; D009937:Organizational Objectives; D010934:Planning Techniques; D011785:Quality Assurance, Health Care / Q000458:organization & administration*