Apr 27, 2010

The perception of risky process changes

Now that we have an approved device we're spending at least some time on process improvement instead of all out research and development. Unfortunately, even though everything is fairly new some of it is already difficult to change.

We have a piece of test equipment that displays pass or fail, prints out a page of results, and writes them to a database. The operator runs the test, marks pass or fail in the traveler, then staples the results to it. During a sort of related process change I suggested we take out the print out of the results. This was met with quite the uproar and doubt about how we could ever do it.

Apparently removing a redundant step that no one ever looked at was a big deal. Engineering and complaints thought it might be useful, even though they never used the printouts two years in- but someday they might. The change would save some minimal amount of money on supplies, transferring of materials into and out of the clean room and storage, along with associated labor. I was able to finally make headway when I pointed out that we do plenty of visual inspections that do not have another record and in this case we still had a record in the database. Everyone initially thought it sounded like a risky change based and we could be out of compliance, but it was all our own perception.

While this isn't the most impactful example, I think I may have learned the value of taking time up front to set this all up efficiently, but I'm not sure I'll be able to convince anyone to add extra time for these activities the next time around. "We can take care of that stuff during validation!"


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Fat Bastard said...

Less devices and more integrity!

fitgizmos said...

hi Rachelle,

I like your blog about medical devices. Very interesting topics.

I have a blog called FitGizmos talking about funny beauty and healthy gadgets around the world.

Recently, I have received 10 crystal nail files and 10 neck pain relief device from a beauty and health supplier that I know for many years.

I would like to give away one of those gifts for free.

Would you be interested?
Fit Gizmos

ranjan said...

Business intelligence healthcare
business intelligence healthcare

mark said...

It's important that with medical devices that they are built properly.