Quality within an organization is everyone’s responsibility. From the highest-level executive to the intern who just had their first day. Everyone needs to work to reach the quality goals of the organization. However, it is the responsibility of the leaders within the organization to pave the way. In order to create a culture of quality, the leaders need to demonstrate their commitment to quality. If they do not, there will be serious repercussions for the entire organization and the organization will likely never meet the requirements of regulatory bodies, let alone their own internal quality goals.

Leaders are not only the upper management of an organization, but they are also those who wish for, and work towards, the success of an organization. High-level executives are leaders within an organization but there are also divisional leaders and front-line leaders who work directly with the staff.[1] These leaders must all participate in the quality initiatives of the organization in order to inspire the rest of the people to pursue those goals as well. If even one leader shows apathy or completely rejects a quality initiative, then others will be likely to follow, and the initiative will fail.

If an organization does not pursue quality improvement or even consider quality when creating processes and procedures there will be inevitable problems that occur. For example, a process may be created that does not meet the quality standards set by the FDA. If that is the case and the FDA performs an audit and discovers the process, they will mark that on the audit and, depending on the severity of the issue, use an enforcement action against the organization. The first action taken will likely be a warning letter or a 483. However, even if the organization attempts to fix the mistake it can be incredibly difficult since the workers and staff do not care about quality since their leaders did not. This difficulty to fix the issue will reveal the systemic issue of lack of quality in the organization. Eventually being unable to fix the issue will result in further actions being taken by the FDA.

Lack of quality improvement in an organization is an easy trap to fall into and often starts from the top. Leaders who believe that quality should be the focus of others and not themselves will cause systemic problems to occur. EMMA International can help create and grow a culture of quality. By not only creating a quality system that is compliant with regulations but providing training to staff and knowledge to leaders EMMA International helps demonstrate what it means to be a quality-driven organization. EMMA International provides Full Circle Consulting services, give us a call at 248-987-4497 or email us at info@emmainternational.com to get in touch with our team of experts today.


[1] Quality Progress (June 2020) Transfer to Transform, Retrieved 02/26/2022 from https://asq.org/quality-progress/articles/transfer-to-transform?id=497ef359a7e4499c9f77d0a8f7102110

Gabe Kadoo

Gabe Kadoo

Mr. Kadoo is a Quality Engineer at EMMA International. He has experience in statistical analysis, performance improvement, quality assurance, and value stream mapping in the clinical setting. Mr. Kadoo also has experience as a clinical researcher and medical technologist. Mr. Kadoo holds a Bachelor of Science in Biology and a Master of Public Administration with a concentration in Healthcare Administration. He is also a Six Sigma Green Belt.

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