Your Process is Your Product

Monday, February 23, 2009

If I've learned anything about product development over the last 15+ years, it is that making good, safe, reliable, robust products that meet the customer and the companies needs is all about the process by which it happens.

What does good process bring to the table?

  • Sets expectations for all involved, this ultimately leads to better communication in the organization within the team and between the team and management.
  • Consistency for all, no matter who is doing the work.  This can be at the project level, design level, or at the experiment level. 
  • Better recorded history of what happen and why, leading to better implementation of those things that worked and more importantly fixing those things that caused failure.   

In addition to the above, valuing process can lead to new approaches to dealing with a problem or design challenge.    At one of my previous companies, the use of DOE (Design of Experiments) processes by a colleague, not only found the optimum buffer formulation for the product that we were working on, the same buffer has since then been found to be beneficial for other products, saving the company time and money.   

While it is understandable that companies can't spend all the time on process, a balance should be struck.  It is clear that having associates only work on process is not the right approach, but neither is ignoring how the work gets done.  While it is true that small companies are focused on the science (getting that first product out the door is important), if you are working in the IVD world, thinking about how things are done is valuable to the company in terms of compliance and sustainability.  For medium and large companies, sustainability over multiple simultaneous projects presents a different set of challenges and having good processes in place will increase the chances that nothing will slip through the cracks.    

Here are some suggestions for implementing process:

  • Keep it simple
  • Make sure the work is relevant, don't create something for the sake of checking it off a list.  Make sure it makes sense to everyone.
  • If you have someone in your organization that is good at thinking about process, let them be involved, those that can't be bothered should not be.
  • If you are management, lead by example.  No one else will take it serious if you don't.    

Tags: Best Practices, Design Control, Documentation

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