Company back ground.
We are a small class 1 medical device company with limited resources. The problem I have is the sewing department works without B/P’s or very few and they are outdated (they use wood patterns/templates).
Unfortunately the company’s owners have let this go on for years. Every time I start to tackle this I hit roadblocks, Engineering is too busy to make drawings for all of these (what we call soft goods) the person that does all the actual designing, how should I put this??? Is a “Primadonna” and when ever I ask for help in coming up with some type of system he runs to one of the owners and complains he has to much work etc :mad: etc. So then I am forced to back off.

So my latest idea is to control the patterns/templates. But this would have to be done without drawings.

Setup a logbook with Pattern/Template Part#, rev, description, change description, date, changed by and approved by & date.
Then write and SOP to cover it.
1) Designer creates a new or revised pattern/template
2) Enters the above information in the log box
3) Sewing Supervisor has product made to new Pattern/template
4) The 1st. part is presented to QA to check for form fit and function.
5) QA verifies the pattern/template P/N & rev.
6) QA signs off in the log box

Would this type of a system be acceptable to the FDA? If not I don’t want to waste my time. :bonk:

If anyone has other ideas I would appreciate them. Other than quit can’t do it at the moment.

I have made a lot of changes since I started :nopity: (QA manual and SOP’s hadn’t been updated since the mid to late 90’s, no calibration, final inspection was performed by production personnel and so on) and still have a long way to go. As the consultant said recently our procedures look good, but they are not being followed.
They probably never will until after the FDA actually comes in and audits us. I will hate to see that day/s.
But I am determined to get this place in compliance or get fired trying.

:thanks:
DG

In a past life, I had a similar problem with templates at a sewing facility. Our solution was audited by our registrar to the ISO9001:2000 and was approved. We simply used a permanent marker to write the part number, revision, date approved, and approval initials on each template. If a part had a revision but didn't require the template to be changed we added that revision to the approval. Finally, if the template was changed for a revision, we would cross off the initial approval with one line, and write the new approval under it.

We didn't use a log because the templates were verified each time a job was set up (ready to be cut). As long as the template was approved by an engineering signature and the part number and revision matched the job packet, we were all set.

Thanks for the info.
I’ve been thinking about a few different methods.
One would be to issue an ECO for the P/N and rev.
and on the drawing it would just say see template.
That way we would be controlling something.
The template would be identified either with some type of sticker or
As you said, written on the template itself.

The other method was the logbook idea (in place of doing ECO’s) recording the P/N rev. description of the change.
And same as above, the template would be identified either with a sticker or
written on the template.