ISO13485 past practice labeling vs customer requirement

love02eat

Involved In Discussions
#1
I am new at this pharmaceutical plastic tubing company. My background is semi conductor manufacturing with ISO9001 internal auditor experience. To me ISO standards pretty much follow same basic clauses its just differs from what industry your working. The company I work for make plastic tubing that is not a finished product and is used in the medical industry where there customers are out of the country, but not all.I guess my company is considered a distributor. They do have there ISO13485 certificate. They are lucky that they do all desk audits when they get audited by the customer cause they are not allowed into the production area. This company I work for is NOT very knowledgeable on how to do internal audits and CAPAs among other things. Very poorly managed and its sad that certain people where the wrong hats.There procedures are so darn long winded with to much verbiage that's not necessary. A world of head spinning.Anyway sorry, just trying to give a little insight. my question that I am having issues with is a young know it all (women) new to sales vs. my experience and knowledge of meeting customer requirement's. :argue: We are trying to remove unnecessary information from our final shipping label. We are researching all our customers that we have and we are going through there master drawings and PO's. So far we are reaching the point where they have requested information they want on it. which is rev.,qty,wo#,date, sequence# and customer spec.. My goal is to barcode the label. in order to do so according to IT dept. there are item's that are on the label that has to do with dimension's example ID,OD,Wall . We still have not come across one in house document from any of the customers that states they want DIMESIONS on the label. The girl and her new appointed boss from sales is insisting we have to keep cause the customer needed it and liked. Also it is a valuable piece of information she feels. They are both insisting customers want it. We have been doing it this way for 10yrs and then I have the QC dept who is also insisting because when a customer makes a rev change she said its a way to identify the product in the shipping area. They do ship multiple parts that look similar to the same customer but I think people hate change I need to re do the label and I am trying to explain that we are not going against customer requirement's. How can I argue this with facts and awareness of something being done one way for so long..I need to push this forward. :deadhorse:






Thanks Help me deal robust personalities!!!!
Rae
 
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MIREGMGR

#2
A couple of points:

1. If you actually make the tubing, you're probably a component maker, not a distributor. Your regulatory person should have your regulatory role documented as a part of your ISO 13485 certification. Take a look at your certificate's scope statement.

2. In my experience, it's a good idea to put on your product labeling the information that the salesperson says the customer wants, even if you think that goes beyond what is regulatorily required. And, if an internal department (Shipping, etc.) also wants that information on the label, definitely put it there. Labeling should serve the needs of the other involved parties...not drive the train itself.
 

love02eat

Involved In Discussions
#3
Yes you are right we are the component maker. I alone, is not the only one who wants this to happen it actually stemmed from other dept heads who tried this and let the ball drop. we are trying to improve human error since the labels get all the information in manually the scope is to go and barcode it. That takes away from constant customer complaints because they make typos. So it is a win for the customer. My problem isn't that we are satisfying the customer and want to make a sudden change as I have just stated but in all actually its just a warm fuzzy for the inexperienced sales girl. Because her first argument was that it was a requirement and its not I checked documents nothing there. The other issue is no one can validate its relevance of having a dimension on a label when again we aren't the finished product and we are trying to make improvements
 
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