Imagine a cascade of events; a lackluster push around novel drug offerings, questionable department performance, lack of Continuous Improvement Methodology, and the list keeps expanding…

A Road Map To Improve
Quality Culture

First presented at SQA 2022 FDAQRC’s Project Manager, Amanda White examines how poor-quality culture can take a toll on your organization.

THE IMPORTANCE

Imagine a cascade of events; a lackluster push around novel drug offerings, questionable department performance, lack of Continuous Improvement Methodology, and the list keeps expanding…

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Forbes examines these omens of poor Quality Culture within the aptly name article ’10 warning signs of Quality Culture¹.’ Perhaps the most jarring for this writer would be a missing-in-action Quality Vision or one that bears zero linkage to established Business Strategy. Even more concerning is where Quality isn’t a problem until it becomes -wait for it- problematic.

A study by Harvard Business Review² also concludes that poor Quality Culture impacts the bottom line and suggest Departments/Leaders/Managers examine the following:

Cost accumulated while determining the degree of conformity to quality specifications
Internal failures discovered before the product reaches the customer
External failures detected after the services reach the consumer

Turning the ship around before a collision with the metaphorical Poor Quality Culture iceberg is possible, but not without concerted deliberate action. Re-centering the Quality Mission in alignment with your Business Goals will put momentum behind the Cultural shift while driving customer loyalty and shoring up any financial losses.

FOLLOW THE DATA

Introducing the Plan-Do-Study-Act (PDSA)

Assessing your current state serves as a baseline with which to inform intended and future strategies. Collecting objective evidence also serves to minimize antidotal, nebulous gut-feelings; while these subjective views may be indicative of problem points, groups stand to maximize impact by using empirical data.

The initial phase of the Plan-Do-Study-Act (PDSA) model³guides users to begin any Quality Improvement intervention with Planning. Data collection can be applied to a number of scenarios, such as: driving increases around Client/Customer surveys, achieving certain product specifications or modifying processes. The Plan, Do, Study, Act (PDSA) model plays an important continuous role in creating a strong and successful Quality Culture.

Per your established procedures, ensure that the data are analyzed for patterns, shifts and trends. Transparency also shares an equally relevant role; communicating outcomes as driven by evidence supports goal-achievement and group cohesion.

RESOURCES

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In this poster, titled A Road Map to Improve Quality Culture, Amanda simplifies this process by walking you through critical thinking and things to consider when in the process of improving your Quality Culture.

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