Compliance Architects® Quality Culture Assessment – A Robust Methodology for Rapid Organizational Change

Quality culture is one of FDA-regulated industry’s most discussed topics.  Understanding the drivers of behavior behind quality and compliance outcomes can be frustrating and challenging.   Stated Corporate intent and policy can be disconnected from actual employee conduct.   Pockets of information can lead to lack of transparency, and to personnel not working together as a team towards common goals, and with common understandings.FDA quality culture graphic

Compliance Architects® has developed industry’s first plant-floor and staff-focused innovative methodology, based on proven cultural survey science, to assess staff and line employee perceptions of quality culture – and its potential impact – by assessing and measuring individual and aggregate employee responses to fact-based questions scenarios simulating actual business situations.

Quality culture trumps quality systems when evaluating the key drivers of quality and compliance performance and outcomes.

Assessment categories include:

  • Training
  • Awareness
  • Knowledge
  • Intent
  • Culture
  • Capability
Where survey questions are used, they are specifically designed to not lead respondents – there is generally no “right” answer to the questions, and responses yield a determination of overall cultural maturity. Expert consultants supplement personnel perspectives with objective analysis based on years of plant-floor experience.

Other assessment focus areas include:

  • Staffing levels adequacy
  • Document adequacy
  • Quality systems’ adequacy
  • IT/IS support availability & adequacy
  • Leadership support for decisions
  • Training, technical knowledge of regulatory / compliance
  • Etc.

Score reporting helps drive remediation approaches that collectively create cultural improvements to specific areas of deficiency, reducing executive leadership concern.

Bad quality culture is like a cancer – it can spread and quickly overwhelm your organization quickly.  If you are concerned about your quality culture, call us before FDA shows up at your door and identifies the negative outcomes that can occur from bad quality culture.

The Quality Culture Assessment Methodology was developed by and is offered exclusively through Compliance Architects®.   For further information on the Quality Culture Behavioral Assessment Model, or for help on how to improve your organization’s quality and compliance culture, please fill in the form below, or, contact Jack Garvey or Teresa Gorecki at info@compliancearchitects.com or at 888-734-9778.