Control of Product Drawings - Engineers don't follow the same protocol

[Cari Spears]

Ah - I see. Well - if you've made them aware of the possibility of a nonconformance and they choose to not act on it - then you've done all you can. Make sure you document your internal findings to CYA.

As has been mentioned - if you receive a nonconformance, it gets fixed and all will be well.

Good Luck!!

 

[Ted Schmitt]

I see a much bigger problem... not just 4.2.3 and 4.2.4...you mentioned various times in your posts "the lack of resources"....

In what other areas is the lack of resources affecting?

Your management can´t have an effective QMS if they don´t provide the resources.

See :
5.1 c), 6.1 and 6.3

 

[jsn80]

I see a much bigger problem... not just 4.2.3 and 4.2.4...you mentioned various times in your posts "the lack of resources"....

In what other areas is the lack of resources affecting?

Your management can´t have an effective QMS if they don´t provide the resources.

See :
5.1 c), 6.1 and 6.3

This has really been the only problem during the implementation that there has been the lack of resources. That's mostly due the manager of the department leaving the company.

 

[LexieB]

That whole thing about the paths not being connected in the computer can be a major problem. Assuming I understand the problem, would your company be willing to hire an IT guy to fix and put them all on one server? You may just have to pay for a couple days of work, and then make sure the engineers are all on the same page.

 

[jsn80]

We have come together with a solution for our product drawings. The engineers have started to place pdf's of the drawings in a single server location. Once we are ready to start the process we will quarantine all printed drawings. When an employee needs to reference a drawing they will look in that location for the drawing they need. If the drawing is not there they will contact the designated engineer in charge of the process and request that drawing. That engineer will then be tasked with the assurance that the current revision will be placed in the drawing location and contact the requester when it's ready. This will help prioritize the work and prevent resources being spent on a drawing that is not needed until our permanent solution is in place.

Does anyone see a problem with this process?

Also, another question I have is in regards to handwritten changes. He have some product drawings that due to timeline restraints the engineer didn't have time to create a new drawing so he noted the changes, initialed them and then scanned it onto the server as a pdf. This has been a big discussion in my group whether or not this would be acceptable. So I figured I would post the question here and get some feedback.

 

[ddunn]

Also, another question I have is in regards to handwritten changes. He have some product drawings that due to timeline restraints the engineer didn't have time to create a new drawing so he noted the changes, initialed them and then scanned it onto the server as a pdf. This has been a big discussion in my group whether or not this would be acceptable. So I figured I would post the question here and get some feedback.

We have done this as an Advanced Change Order (ACO). The ACO goes through the same approval process as an ECO only with authorization to work from the approved ACO rather than the revised drawing. The revised drawing is required prior to QC inspection.

 

[jsn80]

We have done this as an Advanced Change Order (ACO). The ACO goes through the same approval process as an ECO only with authorization to work from the approved ACO rather than the revised drawing. The revised drawing is required prior to QC inspection.

This is interesting. In our situation though the handwritten changes were done for the QC inspection of incoming goods.

 

[JaneB]

We have come together with a solution for our product drawings.... This will help prioritize the work and prevent resources being spent on a drawing that is not needed until our permanent solution is in place.

Sounds like a good and practical solution. Well done. Naturally you (the company I mean) will need to keep working through and gradually get them all fixed, which will presumably get a lot easier when you have the new manager/new resource etc.

But in the meantime, you're managing it which is the point. And making sure there's only one true copy and that it's available to the person/people who needs it and that unauthorised copies are not.

Also, another question I have is in regards to handwritten changes. He have some product drawings that due to timeline restraints the engineer didn't have time to create a new drawing so he noted the changes, initialed them and then scanned it onto the server as a pdf. This has been a big discussion in my group whether or not this would be acceptable.

Sounds like another practical solution to the problem. Just make sure that it doesn't conflict with your written procedure - ie, make sure that allows for it.

As an auditor, I'd also expect to see evidence that this whole issue of control of engineering drawings was known to management and being actively monitored (eg, agenda item, meeting action/minutes etc).

 

[ddunn]

This is interesting. In our situation though the handwritten changes were done for the QC inspection of incoming goods.

The reason for requiring the revised drawing prior to QC inspection was to set a deadline for getting the drawing done. Otherwise it could sit for a long time without the change being incorporated. I strongly recommend the ACO process include some deadline for the drawing revision.

 

[JaneB]

I strongly recommend the ACO process include some deadline for the drawing revision.

If you mean 'write deadlines into the procedure', I disagree. I'm not disagreeing with a desire not to have something sitting around for ages, BUT putting deadlines into a procedure might be too inflexible. One size doesn't fit all.

But there's other ways of achieving the end desired - eg, assign the task of setting a priority to suitable role(s) and/or build them into a form (if a form is used) etc.