The culture of a company is what drives the organization – it can change and adapt, but ultimately, if a strong management team doesn’t drive a company’s culture – the company risks losing its identity. For medical device companies, establishing a culture around the Quality System is one effective way to set up for success. Everybody in the organization plays a part of the Quality System – so building the culture around Quality will include and impact everyone.

It is the responsibility of the Quality Manager (or Director, etc.) to ensure that executive management understands the Quality Culture and fully supports it. Meeting all Quality System regulations and compliance requirements can often be a challenge.
Here are some tips to successfully integrate your Quality System into the Culture of your company:

-Quality Products = Satisfied Customers = Repeat Business. Keeping customers happy will build a base & help grow your business. Having high quality, reliable products goes a long way. So how is quality built into products? Certainly, inspecting quality into a product isn’t sufficient – quality needs to be embedded within the design and manufacturing processes. If your processes are developed with quality in mind – inspection should catch very few mistakes.

-The Quality Team should have independence within the overall organizational structure. Members of the Quality Team aren't the “bad guys” that they are often portrayed to be – however, the organization needs to respect their role and responsibilities. Your Quality Team should report directly to executive management and be independent of manufacturing or other business functions.

-Management Reviews need to keep your Quality System well lubricated & on track. Focus on the areas that are critical to the health of the organization and to the executive management team – those are the areas to spend time reviewing data and those are the areas where change will lead to significant improvements.

-Quality need not mean complexity! If procedures become so complex that they cannot be navigated, or nobody knows how to use them – this is a recipe for failure. Procedures need to be simple enough that those doing the work can follow them. Are there key parts of an assembly that are critical to the product’s quality? The Assembly Team needs to know this! Let them know what could happen if a particular component fails. They will endeavor to prevent this failure and see to it that the product is built right.
SJG

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