Revision date and PLM date 1

[dman2a]

I am looking for opinions on an issue that recently came up. Our Quality department is asking that we remove the revision date from our drawing because it does not match the date in our PLM system. I would like to have some date stated on the drawing, so I have a quick reference to when the change was done. How do other companies handle this? At past companies it was understood that the revision date on the drawing might not match the revision date in the PLM. I am new to the medical device industry, and they seem to be worried about the FDA and this revision date. Really????? Does it matter that much? How can I have this date and be compliant?

Thanks

 

[PeterStock]

I think your Quality department is being a bit anal.

Would there be a problem with changing the date to the date submitted to the PLM?

One I can think of, how are your signoffs handled? The change of date from what someone in the signoff list saw could bring possibility of a change being made after he/she signed off.

Of course what your Quality dept is worried about is a change being made from the date of the revision on the drawing and the PLM date. I suggest a policy of printing the ready to release drawing to PDF and keeping these on hand as well as the CAD file.

Note, while I have worked on some medical systems, I am not familiar with the FDA rules.

Peter Stockhausen
Senior Design Analyst (Checker)
Infotech Aerospace Services

http://www.infotechpr.net

 

[dman2a]

Your first statement is totally true!!!

However our process is to create the PDF and put it in our PLM. Then the EC is sent around for Signatures, and the approvers sign off in the PLM system. You are not able to change the drawing once it is routed for approval, unless the EC is rejected. Then you go thru the whole process again. Also the date would never match because your putting the finished drawing in before anyone has signed off.

Is this crazy or is it me???

 

[PeterStock]

What comes first the EC or the changes to the drawing?

Our system (aerospace not medical) is to have an EC created that is approved before the change is made to the drawing. (One job we just did was to redraw a part from an old cad system incorporating 4 EC's).

I think a date on the drawing is a must. Any method of handling the change would have the possiblity of the date on the drawing and the date in the PLM not agree or the date seen by an approver and the date on the drawing not agree. This is just the way it is. Just make your system such that a change made without approval not possible. I.E. some way to compare a PDF after the change has been made but not approved and a PDF after the approval as filed in the PLM.

Peter Stockhausen
Senior Design Analyst (Checker)
Infotech Aerospace Services

http://www.infotechpr.net

 

[ctopher]

I have never worked at a company where the dwg and PLM dates match. They are two completely separate data.
Your quality dept needs to be a bit more educated on drawings.
If they want the dates to match, change the PLM dates to match the drawings. Tell them it would require an ECO to change the date on the dwg, which would add a newer date.

Chris
SolidWorks 09 SP4.1
ctopher's home
SolidWorks Legion

 

[fcsuper]

The date in the revision block is an internal statement within Engineering Services and is not a release date. (I assume you are talking about release because you are talking about PLM.) Some companies use automated functions within their PDM or PLM check-in system to update the revision block when the drawing is checked-in. But there is no requirement for that date to match the "PLM" date in any standards (or SOPs at your company, I'm guessing). In the old days, it used to be as a approval date. These days with paperless environments, approvals directly on drawings are not legally supported, so there is a reliance on the PDM and/or PLM. So, common practice is to use that date as a reference to revision inception by the change originator OR as the revision check-in date, but not as a release date within a PLM. (I know of only one company that uses it as a release date, and it is Quality Dept that updates the field directly, not the drafters or engineers.)

There is no true necessary correlation between the revision date and the PLM date. FDA will not look at this; and even if they did, your drafting practices SOP should already define that field as "revision initiation date" or other some-such none "release" type description. (All of your drawing fields (title block/rev block) should be defined in your drafting practices SOP already anyway.)

Additionally, knowing how to create and edit drawing content requires expertise and usually some sort of formal training within the Drafting or Engineering disciplines. Quality Dept associates are usually not qualified to assess drawing content (even if they think they are). Just because quality is employed by all associates, that doesn't mean that the Quality Dept is the first or final word in areas outside of their own dept.

That said, to make things clear for the FDA, an effectivity date (or release date) should appear on the drawing. This can be done with watermarks on the PDF or on the drawing itself. These watermarks can be added directly by some automated system, or added by Doc Control or a Quality Systems person who handles releases (for companies that run their ECO process through Quality Systems).

Matt Lorono
Lorono's SolidWorks Resources & SolidWorks Legion

http://groups.yahoo.com/group/solidworks & http://twitter.com/fcsuper

 

[fcsuper]

Just to back up what I'm saying above, I looked up this field in ASME Y14.35-1997.

"6.1.4 DATE column. The date entered in the DATE colume shall be the date the revision was incorporated on the drawing."

This shows no mandated correlation between check-in or release dates with date in the revision block. These seems to be saying "enter the day you made your change". Though it would be up to each company to determine at when "incorporated" happens. Is it when the change is initiated, completed, checked-in, released or effective? Though, I would suggest that it is impractical to use this date for release or effectivity.

Matt Lorono
Lorono's SolidWorks Resources & SolidWorks Legion

http://groups.yahoo.com/group/solidworks & http://twitter.com/fcsuper

 

[KENAT]

The 2 dates are separate. So long as your company procedures clearely state this, and probably explain what each date actually represents, I'd expect this to satisfy the ISO9001 type mindset. I can imagine medical being a bit more picky but this is silly.

We don't have PDM yet, however our procedure makes it clear that the sign off date on the drawing is the date the drawing checker gave final approval. (Don't get me started on what we do now we don't have anyone doing drawing check.)

Posting guidelines faq731-376

http://eng-tips.com/market.cfm?

(probably not aimed specifically at you)
What is Engineering anyway: faq1088-1484​