title: Quality Culture Survey Report.
abstract: The Parenteral Drug Association conducted an anonymous global survey of quality culture in the pharmaceutical industry to determine whether there is a relationship between certain quality behaviors and certain quality attributes, and whether these quality attributes could be used as surrogates (or proxy variables) to assess quality culture. Other studies have shown that an unhealthy quality culture is a root cause of many quality or compliance issues seen by sites and organizations. Statistical analysis of survey data suggests that certain attributes are driving good behaviors, and the demographic data suggests that this relationship holds irrespective of the geographic location of the site. Executive survey respondents had a more optimistic view of the current state of quality culture than survey respondents at large, with cross-functional vision showing the biggest gap (P-value = 0.07, F-Test). The top five quality attributes that can serve as surrogates for quality culture were (1) Management communication that quality is everyone's responsibility, (2) Site has formal quality improvement objectives and targets, (3) Clear performance criteria for feedback and coaching, (4) Quality topics included in at least half of all-hands meetings, and (5) Collecting error prevention metrics. These identified mature quality attributes are related to management responsibility, and continual improvement of the pharmaceutical quality system sections of ICH Q10, and therefore may be amenable to be incorporated in audit programs or in regulatory inspections. Additional research and discussion is required to build a coherent approach, which the pharmaceutical industry and regulators can adopt.
authors.affiliation: Pritesh Patel Consulting, LLC; ppatel0415@gmail.com.
authors.forename: Pritesh
authors.initials: P
authors.lastname: Patel
authors.affiliation: PDA;
authors.forename: Denyse
authors.initials: D
authors.lastname: Baker
authors.affiliation: Amgen, Inc.;
authors.forename: Rick
authors.initials: R
authors.lastname: Burdick
authors.affiliation: Amgen, Inc.;
authors.forename: Cylia
authors.initials: C
authors.lastname: Chen
authors.affiliation: PDA;
authors.forename: Jonathon
authors.initials: J
authors.lastname: Hill
authors.affiliation: PDA;
authors.forename: Morgan
authors.initials: M
authors.lastname: Holland
authors.affiliation: Johnson & Johnson.
authors.forename: Anil
authors.initials: A
authors.lastname: Sawant
mesh_terms: D003142:Communication; D003299:Cooperative Behavior; D004345:Drug Industry / Q000592:standards*; D006801:Humans; D007263:Infusions, Parenteral; D033183:Interdisciplinary Communication; D007398:Interpersonal Relations; D015279:Organizational Culture; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000592:standards*; D011786:Quality Control; D058996:Quality Improvement; D011795:Surveys and Questionnaires; D013678:Technology, Pharmaceutical / Q000592:standards*; D017132:Workplace / Q000523:psychology
chemical_list: D004364:Pharmaceutical Preparations