What are the rules around what you can and cant use for reference only? I would assume its whether or not its on the control plan/FMEA, but as you can imagine, there are some things that are brought up that some want to use that just seem like a waste of time if they have to be put into the calibration system. Think about pieces of plastic that have cuts in them to determine differences in length for different models. This is obviously something that is wanted in multiple areas around the plant, but seems silly to try and verify plastic annually. Are there any ways you have seen to get around this where maybe it can be used for reference only, and if it "fails", it will undergo a deeper inspection? We have something right now that is a 3d printed ring with a window in it that slides over a round ring and the QR code has to land within the window to make sure that it will not get overlapped by another part, however the part print does not indicate a location, but rather just a surface on which the QR code needs to be etched. Do you think there is an argument for not having to put this in the system for annual verification?
Rules around using things "For Reference Only"
- Thread starter Jayfaas
- Start date
Short answer is there are no rules regarding that generally (always?) poorly applied statement.
Historically, my experience has shown that when "reference only" is applied, it is done so in recognition of something that is critical to quality, yet the organization does not want to invest the necessary time/effort/cost to manage it properly.
A term I coined years ago to help my teams make determinations is "if it's WRONG or GONE, can it lead to a nonconformance?" If the answer is 'yes', then I ask "so why shouldn't we control it properly"? This statement applies to everything from documentation to measurement devices/resources.
Hope this helps.
Be well.
I think that our situation could fall under it not leading to a nonconformance because there is no spec for location on the part, just a surface. The plastic part we are using to monitor it just tells us whether or not we will have issues with assembly parts overlapping it. We had a situation where something got moved with our laser and it caused the QR code to be etched in a different spot, which then led to the part getting to the customer (I believe) and it not being able to be scanned. The knee jerk reaction was to create a 3D printed shroud to sit over the part and have an opening to show that if the QR code is in the opening when you rotate it to the QR code, it wont have issues. I am really fighting against having to manage 3D printed simple parts if we can just say that its for reference only.
EdenG
Involved In Discussions
“I think that our situation could fall under it not leading to a nonconformance because there is no spec for location on the part, just a surface.”
Seems to me like you have two choices, continue as you are now (Shrouding "GO / NOGO" check) or specify a location for it on that surface and introduce measurements...
“We had a situation where something got moved with our laser and it caused the QR code to be etched in a different spot, which then led to the part getting to the customer and it not being able to be scanned” – Non-conformance.
“The plastic part we are using to monitor it just tells us whether or not we will have issues with assembly parts overlapping it”. - Control measure.
Unless I'm understanding the situation wrong, the shroud is a control measure i.e. introduced because of the non-conformance at the suppliers you mentioned, it'll therefore be in the control plan as you hinted at originally. This will never be a reference i.e. removed from control plan until you can introduce complete assurance by some other means or some justification…
You mentioned a calibration system, what you should be doing with such a measure is validation not calibration? How would you calibrate it? I would also be validating the measure more frequently than annually.
“The knee jerk reaction was to create a 3D printed shroud to sit over the part and have an opening to show that if the QR code is in the opening when you rotate it to the QR code, it won’t have issues.”
The 'knee jerk' reaction seems appropriate.
“I am really fighting against having to manage 3D printed simple parts if we can just say that it’s for reference only.”
Look I hear you, think about what I've said above and what exactly managing the part would entail? It's not so much the part you need to manage as the measure. If you’re confident in the measure, (a validation could be introducing some bad parts and see if they’re detected), perhaps monitor the process for defects using a P chart for a few months, and if there is no defects with the position on the QR code in that time, gather up the paperwork, scan and save them somewhere and make the control measure reference only – here you have some evidence and a justification to an auditor.
Rich Shippy
Involved In Discussions
IMO, you are using the 3D printed overlay to determine acceptance, and having the operators use it to avoid a known non-conformance on final part quality, I would say it cannot be a reference only ( this overlay is being used to make a decision of acceptability on what sounds like a customer critical surface).
Of course there is. According to the customer requirements, the QR code can be anywhere on the indicated surface. You have identified the fact that there might be a visual interference if the code is not within a specific area of that surface and you developed a fixture to facilitate the proper placement of the code. That fixture is not an inspection aid. IMO it would be silly and valueless to include this fixture in a verification cycle.
Rich Shippy
Involved In Discussions
Did you use the overlay as a corrective action response to the customer? if the customer drawing did not specify a location tolerance, your part was technically in spec, and no non-conformance existed. IMO, the customer probably needs to initiate an ECN, and you company revise its process to ensure the location, and price accordingly for your added efforts.
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