Need to bring my engineering out of the dark ages... 2

[battleship81]

Hello-
I have to start by saying that this might not be the correct place to post this, but I couldn't find a more appropriate place in my searches.

So here's the deal:
I recently took a job as the sole mechanical engineer for a small medical device OEM, and we basically run things like we're stuck in the 1980s - meaning lots of laborious analog work, and time consuming, super inefficient, seemingly repetitive processes. We would like to modernize and we'd like to go about things the best way possible.
A few noteworthy facts:
-We use Solidworks for our design and drawing creation, but we have no document manager to keep things organized. This is all done manually in Windows explorer.
-As I said, we are a medical device company, so we are FDA regulated in our documentation of our processes.
-Currently, we still complete ERs all by hand.
-There are currently no official policies or procedures in place to guide us through the engineering design and release process.
-Although I have 5 solid years of good product development, I unfortunately have limited experience with efficient and modern systems for document and process control.
-That limited experience does include working under a "Bible" of engineering policies and procedures, which I could draw from in formulating a "Bible" here.
-I have experience with PDMWorks and I know that it's one program that we could definitely utilize for document control and ER completion, etc., but there may be better programs out there.
-We use PCMRP for our manufacturing and inventory control, and it's just terrible. Something that would play well a document control package, SolidWorks or both would be nice.

I know there's more info I could give but I think that's enough to get started.

Can anyone provide any helpful info?

Many thanks!

 

[truckandbus]

It sounds like you are heading in the right direction. Is this task being undertaken as a directive from the executive staff or is this a pet project? If you have support from on high then addressing the manufacturing and inventory control at the same time would make sense and you ought to be be able to get 'help' implementing a new system from whomever you buy the software from. If this is a pet project you will need to make sure that either your output to other departments remains unchanged even though your internal processes do change -or- that downstream departments modify their processes in step with your changes

 

[2297Rocky]

I concur with truckandbus. If you own the process and it doesn’t affect others there is a really great Open Source DMS program out there which works well with the documents which our Prime supplies us.
We too create ERs by hand and sometimes it’s a challenge to keep document revs correct. Drawings I create in CAD and Solid Works I control with a program I purchased for under a hundred dollars. This is also where I keep my current Forms and Process documents also. It creates a small mirrored directory which is where the check-out/in info is stored. Great for Configuration Management and Revision Control.

***************************************************
plan what you do, say what you do, do what you say.
Rocko

 

[ewh]

I once worked for a small company that mainly used Solidworks, while using NX for specific important customer parts. Since I was the only one familiar with NX, I was able to set up and control the related document management.
The Solidwork side did not understand how to control the data... the drawings were printed out, approved and given to Document Control to file. The actual database sat on the creators computer, and there were very frequent problems linking up the physical drawing in Document Control with the appropriate data (even though I explained several times that the databases were actually more important to control than the 8 1/2" x 11" paper "released" document).
Let's just say that I'm glad I don't have to face those issues anymore.

“Know the rules well, so you can break them effectively.”
-Dalai Lama XIV

 

[Finethread]

A few quick suggestions; first buy "Engineering Documentation Control Handbook" by Frank Watts. This will either tell you or confirm what you already suspect.
Secondly; even if I were a Cad group of (1) I would still use PDMWorks specifically for control of SolidWorks source files.
And lastly, you may want to take a look at a subscription based PLM product like Arena to manage configuration management; change control, product structure, revision control etc.