As quality professionals, we are always looking for ways to improve the quality of products, and reduce the cost of quality mishaps. But how do you actually climb to the top of that mountain of high quality while still maintaining a marketable product?

Recently, many device manufacturers have been criticized for their ‘reactionary’ nature to quality issues. The truth is, when everyone is out there fighting fires, it becomes really hard to catch up. Quality issues become a big problem once the product is in production: they cost more money to fix, they create risk to patients and users, and they consume a lot of time. If you are able to catch problems in the design and development stages it can save you in the long run. But due various influencing factors, spending more time and money during development is not always possible.

So how exactly do you achieve the perfect balance? It turns out that one of the most important things is to create a culture of quality within your organization. Your quality engineers should not be the only ones concerned or knowledgeable about it, but it should be engrained in everyone – the top managers, the R&D engineers, the marketing representatives, and so on.

I recently read an article from Qmed and MPMN where they interviewed Vipul Sheth, the VP of Quality for Coronary Cardio Vascular at Medtronic that really resonated with me. He discussed many of the challenges that quality professionals face, and some good tips on how to achieve high quality products. He emphasized the importance of creating a culture of quality. He says, “Improving compliance and quality requires everyone in the company to understand their role in the quality system and to follow the procedures every time, be “audit ready every day”.

I highly recommend giving this one a read. Sheth offers a lot of good advice from his own experiences, and I think we can all apply to our daily jobs – even if you aren’t a quality professional. What do you do to maintain the culture of quality at your organization? I’d love to hear your thoughts!

- Sherri

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