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Qualitative and Quantitative Validation of Tools with Rating Scales Aimed at Assessing the Quality of University Service-Learning
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Quality Culture Survey Report.

Pritesh Patel1, Denyse Baker2, Rick Burdick3

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Summary

A global survey identified key quality attributes that predict positive quality behaviors in the pharmaceutical industry. These attributes, like management communication and improvement objectives, can help assess quality culture effectively.

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Area of Science:

  • Pharmaceutical quality management
  • Industrial organizational psychology

Background:

  • Unhealthy quality culture is a known root cause of quality and compliance issues.
  • Assessing quality culture is crucial for pharmaceutical industry oversight.

Purpose of the Study:

  • To investigate the relationship between quality behaviors and quality attributes in the pharmaceutical industry.
  • To identify quality attributes that can serve as surrogates for assessing quality culture.
  • To determine if these relationships are geographically dependent.

Main Methods:

  • Anonymous global survey conducted by the Parenteral Drug Association.
  • Statistical analysis of survey data to identify correlations.
  • Analysis of demographic data to assess geographic influence.

Main Results:

  • Certain quality attributes were found to drive good quality behaviors.
  • The identified relationships were consistent across different geographic locations.
  • Executive respondents reported a more optimistic quality culture view than general respondents, with cross-functional vision showing the largest disparity (P-value = 0.07).
  • Top five surrogate quality attributes include management communication, formal improvement objectives, clear performance criteria, inclusion of quality topics in meetings, and error prevention metrics.

Conclusions:

  • Specific quality attributes can effectively serve as proxies for assessing pharmaceutical quality culture.
  • These attributes align with management responsibility and continual improvement principles (ICH Q10).
  • The findings suggest potential integration into audit programs and regulatory inspections, warranting further research and industry-regulator collaboration.