I have encountered more resistance to the quality system, currently the procedures call for all drawings to be released as a formal drawing with title block, rev status, and approvals, etc. We recently had an issue where the engineer did not take into account a change to the drawing and put in an incorrect depth for drilling and taping holes which broke through material. All issues taken care, we came up with a fix and now it's time to come up with a way to make sure the fix worked. Any way a test piece was needed, and was actually done up on solidworks, but the engineer decided to say to heck with procedure and tried to get the piece made without it going through the release procedure because this test piece would basically be a throw away piece. He argued the point with the Pres. and here I am trying to see if anyone has ever been posed with this type of thing. It's really just a a way to say oh we need this now let's throw quality to the wind and do it. Personally I think it's crap. But I was told to see if there was a good way to do this.

Any thoughts anyone? Sorry so Long winded

I have encountered more resistance to the quality system, currently the procedures call for all drawings to be released as a formal drawing with title block, rev status, and approvals, etc. We recently had an issue where the engineer did not take into account a change to the drawing and put in an incorrect depth for drilling and taping holes which broke through material. All issues taken care, we came up with a fix and now it's time to come up with a way to make sure the fix worked. Any way a test piece was needed, and was actually done up on solidworks, but the engineer decided to say to heck with procedure and tried to get the piece made without it going through the release procedure because this test piece would basically be a throw away piece. He argued the point with the Pres. and here I am trying to see if anyone has ever been posed with this type of thing. It's really just a a way to say oh we need this now let's throw quality to the wind and do it. Personally I think it's crap. But I was told to see if there was a good way to do this.

Any thoughts anyone? Sorry so Long winded

If all that was needed was a single piece for test purposes, why do you feel that a formal, fully-vetted print was needed? I presume that if the test piece proved out, the necessary changes would have been formally incorporated, no? It sounds to me like maybe your written procedure calls for something that might not be necessary, unless I'm missing something.

I have encountered more resistance to the quality system, currently the procedures call for all drawings to be released as a formal drawing with title block, rev status, and approvals, etc. We recently had an issue where the engineer did not take into account a change to the drawing and put in an incorrect depth for drilling and taping holes which broke through material. All issues taken care, we came up with a fix and now it's time to come up with a way to make sure the fix worked. Any way a test piece was needed, and was actually done up on solidworks, but the engineer decided to say to heck with procedure and tried to get the piece made without it going through the release procedure because this test piece would basically be a throw away piece. He argued the point with the Pres. and here I am trying to see if anyone has ever been posed with this type of thing. It's really just a a way to say oh we need this now let's throw quality to the wind and do it. Personally I think it's crap. But I was told to see if there was a good way to do this.

Any thoughts anyone? Sorry so Long winded

If all that was needed was a single piece for test purposes, why do you feel that a formal, fully-vetted print was needed? I presume that if the test piece proved out, the necessary changes would have been formally incorporated, no? It sounds to me like maybe your written procedure calls for something that might not be necessary, unless I'm missing something.
Actually, you describe a relatively common situation. In "document terms" here is what is really taking place:
Despite FMEA (Failure Mode & Effects Analysis), the drawing was allowed to proceed to the next stage, PPAP (Production Part Approval Process)
The design flaw was discovered/detected in the PPAP stage, at which point, production was suspended while a root cause analysis and a tentative Corrective Action were proposed.
The designer made a "temporary" change to the initial design for a prototype "research" piece to be manufactured and evaluated for suitability to function according to the design.
If the prototype research piece passes function evaluation, designer will "redline" the drawing as a new revision, getting approvals of the redline changes from the entire list of approvers normally used for ANY revision.
(redline is ONLY used in lieu of formal revision when time to prepare complete new drawings and go through formal approval process would create economic hardship for supplier or customer or both.)
Production may continue with redline drawing while designer works up complete new revision drawing which goes through formal revision/approval process.
When new revision is ready, redline drawing is superseded with new revision, but there is no change in production which continues.With modern computer drafting and combined manufacturing direct from computer assisted drawing, the concept of redline (once using actual red ink on the engineering drawings) may not be necessary because the computer can generate complete drawings incorporating design changes faster than a human can add red ink changes to a paper drawing. The same technology allows geographically scattered approvers to view changes on a computer screen via internet and add electronic approvals so formal revision could actually happen faster than formerly using redline approvals on paper drawings.

The important factor is a prototype research piece may be manufactured WITHOUT a formal drawing or approval process. I am reminded of the days when design models of cars used to be made in clay with various folks tinkering with the design by adding or removing clay and then the final drawings "reverse-engineered" from the final clay model to build the sheet metal tooling for the production design. In concept, tinkering with the depth of tapping holes in a machined piece is the same process.

Actually, you describe a relatively common situation. In "document terms" here is what is really taking place:
Despite FMEA (Failure Mode & Effects Analysis), the drawing was allowed to proceed to the next stage, PPAP (Production Part Approval Process)
The design flaw was discovered/detected in the PPAP stage, at which point, production was suspended while a root cause analysis and a tentative Corrective Action were proposed.
The designer made a "temporary" change to the initial design for a prototype "research" piece to be manufactured and evaluated for suitability to function according to the design.
If the prototype research piece passes function evaluation, designer will "redline" the drawing as a new revision, getting approvals of the redline changes from the entire list of approvers normally used for ANY revision.
(redline is ONLY used in lieu of formal revision when time to prepare complete new drawings and go through formal approval process would create economic hardship for supplier or customer or both.)
Production may continue with redline drawing while designer works up complete new revision drawing which goes through formal revision/approval process.
When new revision is ready, redline drawing is superseded with new revision, but there is no change in production which continues.With modern computer drafting and combined manufacturing direct from computer assisted drawing, the concept of redline (once using actual red ink on the engineering drawings) may not be necessary because the computer can generate complete drawings incorporating design changes faster than a human can add red ink changes to a paper drawing. The same technology allows geographically scattered approvers to view changes on a computer screen via internet and add electronic approvals so formal revision could actually happen faster than formerly using redline approvals on paper drawings.

The important factor is a prototype research piece may be manufactured WITHOUT a formal drawing or approval process. I am reminded of the days when design models of cars used to be made in clay with various folks tinkering with the design by adding or removing clay and then the final drawings "reverse-engineered" from the final clay model to build the sheet metal tooling for the production design. In concept, tinkering with the depth of tapping holes in a machined piece is the same process.

Well not exactly Wes, although most of what you described is correct, the drawing I speak of is a bolt with a hole through the middle to apply air pressure to the tapped hole to see if the "Redline Drawing" fix did the trick. Engineering had to design a bolt that would thread into the hole at torque specs, but also would accept a hige pressure air fitting. As I said they did this in solid works, and are putting it through the system to have it manufactured.

If as part of a corrective action it states that the fix has to be tested, shouldn't I expect that the proper procedures be followed in order to test the fix. I mean if an auditor comes in and sees this corrective action, and obviously there will be a lot of direction with it,and part of that fix is this testing fixture, he certainly could go through to see if that testing fixture was made in accordance with the quality system, No?:confused:

I quess what I may be looking for, is there a good way to side step processes such as formal drawings released to the floor, so that a one off part can be made but it will also fall with in a process so that it's covered in the case of an audit.

Well not exactly Wes, although most of what you described is correct, the drawing I speak of is a bolt with a hole through the middle to apply air pressure to the tapped hole to see if the "Redline Drawing" fix did the trick. Engineering had to design a bolt that would thread into the hole at torque specs, but also would accept a hige pressure air fitting. As I said they did this in solid works, and are putting it through the system to have it manufactured.

If as part of a corrective action it states that the fix has to be tested, shouldn't I expect that the proper procedures be followed in order to test the fix. I mean if an auditor comes in and sees this corrective action, and obviously there will be a lot of direction with it,and part of that fix is this testing fixture, he certainly could go through to see if that testing fixture was made in accordance with the quality system, No?:confused:

I quess what I may be looking for, is there a good way to side step processes such as formal drawings released to the floor, so that a one off part can be made but it will also fall with in a process so that it's covered in the case of an audit.

Well, as I see it, the bolt with the hole through it is not a "part". It is not something that is deliverable to the customer. If you feel it must be documented, the CA plan can state "prototype fix will be tested by using a suitable fastner with a hole and fixture for applying air pressure to validate fix." The document control system exists to make sure that the right information is available, and the wrong or outdated information is not. If a sketch existed, it could be appended to the CA documentation with a statement "test fixture fabricated per attached sketch" so you have a record of the validation setup. Don't overcomplicate things. Document control exists to protect the organization and its customers from the use of incorrect information. I don't see that as a danger here.

Geoff Withnell

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I quess what I may be looking for, is there a good way to side step processes such as formal drawings released to the floor, so that a one off part can be made but it will also fall with in a process so that it's covered in the case of an audit.


Why not just have the engineer sign and date the print/drawing/sketch, and ask that the part be made and tested.

Note: the ISO standards do not require drawings to be "formally released with title blocks and cad files," etc. They simply require that information (data, docs) be controlled [to ensure the information is correct, current and approve]. You decide the method(s) that can be employed. Many progressive companies have several different methods described and allowed in their doc control procedure.