Supplied Goods out of QMS / DtS?

Morlock

Involved In Discussions
#1
Hello all. We are currently ISO 13485:2016 certified, and we are looking for ways to slim-down our QMS and expedite some of our processes. One such process in our sights is our Supplied Good management.

Currently, just about everything that we receive in gets a Supplied Good part and lot number, and at the very least gets a paperwork inspection (i.e. packaging/labeling/packing slip against the PO). Yes, this even includes office supplies and non-manufacturing goods.

I was wondering if it is still within compliance if we scrap the part and lot number and some of the incoming inspections (move to DtS) for goods not directly related to manufacturing (i.e. supplies used exclusively for R&D), or for goods such as office supplies, generic off-the-shelf hardware, etc.

My relatively-inexperienced gut says it'd be compliant if we performed a risk-assessment for every single item within this proposal to justify *not* having part numbers for them or to justify *not* performing inspections, but figured I'd ask a group of much more experienced, much more knowledgeable individuals, in case it's just a bad idea or experience suggests it's not worth the effort.

Thanks all.
 
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Ninja

Looking for Reality
Trusted Information Resource
#2
IMO, office supplies should be reviewed only to make sure you got what you're paying for...that's just common sense.
R&D makes stuff that 'should' later go into production...I'd be nervous about waiving that one completely...but a paperwork inspection is likely enough.

All of our Dock to Stock still had paperwork inspection...but no testing. I would say it was about 30% of materials used in Mfg, and 90+% of new materials going into R&D. For Mfg, that decision was based on supplier historical performance.
You still have to know that you got the stuff you're paying for...that's not ISO, that's just good business. Skip the stuff that doesn't add value, but don't ever trust a pig in a poke.
 

yodon

Staff member
Super Moderator
#3
Your gut is right. Take a risk-based approach. Increase the controls for higher-risk things. That means, of course, that you need to organize around risk but, as your gut is telling you, it's more efficient in the long run.
 

Billy Milly

Involved In Discussions
#4
My suggestion would be to connect incoming inspection to supplier management (both should be risk-based). In our case, we require supplier approval for materials incorporated into the product. Level of incoming inspection (paperwork review / visual inspection / testing, sample size...) depends on the risk of the material. Inclusion of Ninja's suggestion - past results of supplier evaluation and incoming inspection of the specific material is also a good idea.
To do this, you have to evaluate the individual material's risk, as Yodon wrote - for example, tape for closing cardboard boxes is far less important than packaging that maintains sterility.
In our case, I found it quite challenging to promote the "risk based approach", but in the end, we managed to lower the amount of daily work when the system was set up - before, everything was "high risk", similair to your case.
 
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