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building a quality culture

Building a Quality Culture: Management Understanding QMS “State of the Union”

Building a quality culture for a firm is often a challenging task. Sustaining it can often prove to be even more challenging for upper management. For example, many Warning Letters have included a firm’s management being unaware of their Quality Management System (QMS) issues. Below are a few thoughts on how upper management can build a quality culture, and some tips to ensure they are kept current on their QMS’ “State of the Union:”

Always include your executive management in periodic updates and progress checks related to the state of Quality. Quarterly meetings with upper management is a good place to start. It is important for your upper management group to embrace quality, i.e., being involved in inspection management training, reviewing critical deviations and understanding the number of open deviations that need closure.

I’ve worked at a few firms where they learned those lessons the hard way. In fact, I consulted at a firm that was under consent decree, and one of the major concerns of FDA was that upper management didn’t have any metrics to review how their quality unit was performing. There were no periodic updates of deviations that were occurring, or the different issues that were occurring on the shop floor.

At this firm, many employees were disgruntled because of the different, possibly difficult processes that they were forced to use. Some of the equipment may have been antiquated. In order to turn situations like this around, Quality Management decided to perform weekly “walk-throughs” of these areas to gauge the level of frustration, what needed to be improved and to speak first-hand with employees. These activities helped ensure that the QMS was dialed into the pulse of the organization on the shop floor.

Organizations that foster the development of a QMS usually have less employee turnover, less employee frustration and more successful regulatory inspections. A successful QMS does not happen overnight, however. It takes a commitment from upper management, mid-line managers and shop floor employees to be able to sustain this system.

Building a Quality Culture

Setting goals by upper managment for the organization helps build a strong foundation for a quality culture. But what drives cultural quality as a key to the firm’s success”? Is it a quality motto? A monetary award for employees that have zero mistakes? All of these things are nice-to-haves, but in order to establish and sustain a solid culture of quality, there are a few elements that are needed, including:

  • Conduct a gap analysis to gauge where the firm is related to quality. A few questions to ask when beginning this analysis are:
    • Determining the status of the quality culture on the shop floor, warehouse, laboratory, even in the office areas?
    • Gauging where the organization sees itself in the future related to quality
    • Determining the outcome(s) the firm is trying to achieve

This leadership group should develop metrics of their own linked to their financial bonuses. Perhaps a walkthrough of the shop floor, talking with the employees, getting a first-hand look at the daily operations that produce the products can take place on a weekly basis. This “walk the talk” type of initiative goes far with employees, as they begin to see that their leaders are serious about quality.

The Windshire Group offers quality system-related consulting services and associated training. For further information, please contact; (+1) 844.686.5750


FDA Drug Inspection Trends and Remediation Strategies: Process Validation Live WebcastIN ADDITION…A critical component of building a quality culture for your firm is keeping current with FDA inspection trends, and learning to avoid making mistakes other firms have made. The Windshire Group is pleased to host FDA Drug Inspection Trends and Remediation Strategies: Process Validation Live Webcast, Friday October 27th. 
FDA has issued a number of process validation-related Warning Letters in 2017. This webcast will review a number of Warning Letters and provide specific remediation strategies for each situation, so that your company can be prepared for regulatory agency inspections in 2018 – Learn more and Register




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