Scrapping on production floor - Setup parts

Chrisx

Involved In Discussions
#1
We are a small contract manufacturer of orthopedic implants. Currently, we open a nonconformance for any defective product. Unfortunately, this is flooding the QMS with an unmanageable number of nonconformances. Many of these nonconformances are the setup part used to setup the mill. The operators detect these issues immediately and know the parts will be scrapped. The scrap is recorded in the ERP with a cause coding, so we are able to trend scrap rates for future quality improvement. I believe I have seen companies provide the operators with the discretion to scrap units like this on the production floor without issuing a nonconformity. I would like to do something similar, because I believe the large number of nonconformities poses an unnecessary compliance risk. I'm not trying to hide any issues, but just develop a nonconformity process that is effective. Long term, I want to improve quality and reduce scrap rates. However, I need to deal with the present issue. Does anyone know if providing discretion to the operators to scrap individual units without a nonconformity would pose an issue for FDA or other regulatory agencies? Thanks for your help.
 
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William55401

Quite Involved in Discussions
#2
You are on the right track. Put it in writing that set up samples are discarded and no NC is raised. I suspect your finance team will still want to track it somehow. Any work around can be abused and you should monitor this practice to ensure that the no NC express lane is only used for set up and not for production run material. Hope this helps.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#3
Let's try a slightly different approach: where does it say that you must "issue an NC"? And what does "issue an NC" really mean?
While it is true that there are many complexities and nuances between the many quality standards I can't remember one that says we must issue an NC. I do remember that we must identify non-conforming material such that it cannot be shipped as conforming (paraphrasing).
 

Ninja

Looking for Reality
Trusted Information Resource
#4
Not in medical...but with (I think) a comparable situation handled differently:

When I make product, it is a continuous process.
The first 50-75 feet of run-start is tweaking to get 'in the groove'...it is typically scrapped out of hand.
When run-stop is called, the line is marked immediately, the product flow is cut off, and we let the hoppers run dry (~75-100 feet).
All product after 'the mark' is typically scrapped out of hand.
For the process I run, this is normal.
There is no NC, and no NC product...because the 125-175' scrapped is not 'product'. It is lead and trail.

If we are tight to an order quantity, we may look closely at the lead and trail to see if we can grab another 10' that is good...that's a gift.

It's all in how we defined the "normal product" and we have an allowable mechanism by which we can scrutinize 'off-steady-state' material for suitability. Take care with the process definition...create yourself some freedom...(if allowed in medical).
 

Ninja

Looking for Reality
Trusted Information Resource
#5
Seems like you are doing a "one piece at a time" machining process, or similar.
I can easily see wording in the process something like:

A setup part is used to verify and determine necessary adjustments to the milling process. Any adjustments made during this step are considered "startup adjustments", not process adjustments.
Note: If, after milling setup is complete, the part used to perform the milling setup meets all final product requirements, this part may be considered the first production part. If the setup part does not meet requirements, it is handled according to process ________.

Again, I'm not in medical. I don't know if that handling is allowed...but if so, you just cut down your NC load substantially.
Up to your company if the setup part not meeting requirements is considered "scrap", or simply typical startup waste. You choose your own business metrics.
 
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