Who Owns Quality?

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When it comes to the healthcare industry (e.g. pharmaceuticals, medical devices, dietary supplements, etc.), who owns a company’s quality assurance practices? Without a doubt, the quality organization has had the burden, if you will, for their business’s quality practices. And Quality Assurance (QA) has its hands full “assuring” that they continue to change to meet the ongoing challenges before them. Here are a few challenges that QA is up against:

Mindsets Throughout The Organization

  •  Changing from a “they” to a “we” approach of ownership of quality
  •  Changing from a problem-solver to a preventer approach of investigations
  •  Changing from an enforcer to an advocate approach of practices
  •  Changing from a results to a purpose driven approach of orientation
  •  Changing from a conformity to a continuous improvement approach of inspections
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