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Manufacturing without a Formal Drawing

#1
Good afternoon,

In our production facility, We make some parts without formal drawing because of either time crunch or too old parts. In our ISO procedure, it says that manufacturing collects drawings prior to starting work. Can I tweak the procedure that Computer programmed files like AutoCAD files are also valid for manufacturing? or do we have to have formal drawings for every part we make? I would highly appreciate any suggestions on this topic.
 

Pancho

wikineer
Super Moderator
#2
Hello Vihar,

You get to write or edit your own procedures to whatever it is that allows you to produce quality parts. The standard does not proscribe tweaking your procedures to say whatever allows you to produce quality parts, including saying "Autocad files are valid for manufacturing". You just have to make sure that the design outputs are "adequate for the subsequent processes", per Section 8.3.5 b of the standard. If the files are adequate in this sense, tweak away!
 
#4
Be careful not to write yourself into a corner. Instead of using 'Auto Cad', you may want to say "Auto Cad or other electronic formats". This allows formats like DFX or solid works to be used (now or in the future) without violating your procedure. If you say 'Auto CAD', and you have a solid works file, some auditors may say you are in violation because you do not say that. I personally disagree with these auditors as the intent is pretty clear and requires procedures to be written with wiggle room and double talk that allows for things that should not be (i.e. in my opinion, procedures should be written clearly with easy to understand processes/instructions and not a bunch of double talk to keep auditors happy).
 
#6
Put this in your procedure:
Approved engineering drawings in hard copy and/or electronic formats are acceptable for part manufacturing and inspection purposes.
Thank you .
Be careful not to write yourself into a corner. Instead of using 'Auto Cad', you may want to say "Auto Cad or other electronic formats". This allows formats like DFX or solid works to be used (now or in the future) without violating your procedure. If you say 'Auto CAD', and you have a solid works file, some auditors may say you are in violation because you do not say that. I personally disagree with these auditors as the intent is pretty clear and requires procedures to be written with wiggle room and double talk that allows for things that should not be (i.e. in my opinion, procedures should be written clearly with easy to understand processes/instructions and not a bunch of double talk to keep auditors happy).
Thank you
 
#8
The issue concerns the space between "A) what you intended to create" and "B) did we actually create what we intended to create". Your quality system should show that A=B with any and all tests/verification that took place to ensure that you reached your goal or tweaked the design along the way.
The auditor will be looking for any documentation to show that you intended to create A to begin with, and any specifications therein including why A needed to be changed. Otherwise, B just showed up and was introduced into the production line mysteriously.
 
#9
Be careful not to write yourself into a corner. Instead of using 'Auto Cad', you may want to say "Auto Cad or other electronic formats". This allows formats like DFX or solid works to be used (now or in the future) without violating your procedure. If you say 'Auto CAD', and you have a solid works file, some auditors may say you are in violation because you do not say that. I personally disagree with these auditors as the intent is pretty clear and requires procedures to be written with wiggle room and double talk that allows for things that should not be (i.e. in my opinion, procedures should be written clearly with easy to understand processes/instructions and not a bunch of double talk to keep auditors happy).
And this is why ISO qms systems fail to get management support. We spend our time on legalese to get us out of an potential audit issue rather than doing the important stuff.
 
#10
Good afternoon,

In our production facility, We make some parts without formal drawing because of either time crunch or too old parts. In our ISO procedure, it says that manufacturing collects drawings prior to starting work. Can I tweak the procedure that Computer programmed files like AutoCAD files are also valid for manufacturing? or do we have to have formal drawings for every part we make? I would highly appreciate any suggestions on this topic.
I would go broad -- "collects applicable documents, drawings, samples, etc. prior to starting work." Heck there may be times when a guy will make something from his "head" based on a conversation with a customer.
 
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