In my last blog I discussed how implementing 3 simple strategies would help you get the funding you need to implement a 21st century PLM solution – a solution that will let you move faster than your competition. In this blog, I will provide you with the first strategy that is essential for medical device companies: focus on quality.

I’m guessing that in your company, the focus is on quality – and providing quality-driven operations. If that is the case, then compliance automatically follows. So, let’s talk about both quality and compliance. The time to think about both of these is at the very beginning of the product creation process.

Remember, you can’t test quality into a product – your entire product operation process should be all about enforcing quality in your company. And companies utilizing systemic quality processes and designing quality into a product are unlikely to experience compliance issues. So what does this type of quality design process look like? It involves setting up and effectively running all of the following for product development and operations:

  • Design control
  • Document control
  • Change management
  • Corrective action
  • Compliance management

Keep in mind that these processes need to be implemented early AND constant, accurate sharing of product/part information between R&D, procurement, manufacturing, engineering, quality departments and suppliers is required. A company-wide, systemic approach is needed to ensure quality and compliance.

Remember — a company that fixes compliance issues on a piecemeal basis is likely to experience recurring problems. Does this sound like your company? If it does, you need to solve that problem. And the first step is to go back to the beginning — focus on quality.

To learn more about RitePro and how it will help you achieve operations excellence, click here.

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