Proof of incoming material verification - Electronic CofC's

M

Michel Saad

#1
Proof of incoming material verification

Hi folks,

We purchase material where we only compare the data supplied with our incoming material specifications, sign off the C of C, and file it. In a paper reduction effort (we have to keep stuff around for 25 years), we are looking to receive the C of C's electronically. If the C of C are received and filed electronically, how do we demonstrate that the material was verified at incoming.

Anyone out there already doing this?

thanks.
 
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SteelMaiden

Super Moderator
Super Moderator
#2
I have done this before. We started to receive all of our certs electronically and did not want to have the paper anymore. To create a record for incoming inspection i.e., does the cert match our spec, we created a spec file (our specifications for raw material) and batched all the incoming certs. We ran an edit check that passed the conforming certs and flagged the nonconforming ones. After the edit was run, it was only a matter of having someone look at the ones that did not go through and getting updated info from supplier, or initiating a rejected material process etc.

Each certification record was traceable as to when it went through the edit, if it passed, or was accepted through deviation and who did that edit step if it was not conforming etc. We still had some actual physical inspections going on at receiving, but the electronic cert stuff was really slick. I transferred before we finished the total program, but the plan was to use barcoding technology to input the rest of the receiving process automatically. i.e. read the length, check the length, if they matched you push the OK button and on it went, if not you could put it on hold in the system right from the dock without transferring a bunch of stuff to some clerk in the office.
 

E Wall

Just Me!
Super Moderator
#3
We're ISO not QS - but this might help

We receive material putting it into a designated receiving/inspection area, a month sticker is placed on pallet for FIFO and it has a sign-off block for QA Approval, QA verifies CoC or inspects part (depending on the designated criteria) then signs approval, material handler moves material to designated location, production depts know to use oldest material first and verifies QA sign-off before starting to use material on pallet (may be few or many depending on the part).

CoC's are kept for 1 year. Basically if it isn't approved by QA it isn't to be used in production. Our objective evidence is existing inventory examples - do a random check and see if anything gets through to the production machine line that isn't signed off.

Eileen
 
U

Unregistered

#4
You could state that by virtue of an electronic files location it has been reviewed and approved.

I would imagine that these certs will be received as a JPEG type image to an e-mail address. Simply create a folder with secure write access and you can say that all certs in folder C:\CERTS\APPROVED (for example) have been reviewed and approved by QA (or whoever).

The auditor need only satisfy himself that the folder is secure and he should be happy.

M Greenaway (posting from home)
 

gpainter

Quite Involved in Discussions
#5
We use C of C as most companies are starting to do this more and more. If a C of C is provided , then incoming inspection is waived and it moves to stock. We file in binders and have had no problem. If we went "e" then, we would just save them.
 
Z

Zanzi

#6
The way that I see it is that as long as you have evidence (CofC or Inspection Cert) that material used in production conforms to the specified requirements (Specification / Goods In Contol Plan) then you need only save a copy of the C of C. This becomes more process driven by virtue of material location.

Simply define in your procedures how it is completed and comply with your stated actions. This should be more than satisfactory - as long as you demonstrate the link into non-conforming product as necessary.
 
G

Greg Maggard

#7
Hey ,
That was very well stated. :lick: I actually sent the response for this treat to a friend Tim Turner also a member. They are writing a std procedure now.:smokin: great thread
 
K

keithm696 - 2008

#8
C of C or C of A for raw materials

Hi all!
We use the supplier C of C or C of A for inbound materials from our suppliers. We build first aid kits and deal with lots of over the counter meds. During a recent FDA Audit I was asked a question about processing OTC meds by passing them thru a heat shrink tunnel after being unitized. Did this exposure to heat for 15 to 20 seconds change the stability of the product? We are now sending samples back to the labs to be compared to the retained samples. I use an excel spread sheet for lot # tracking of all products but this Investigator didn't want to look at anything they didn't have full control of. Any thoughts on this?
Thanks,
Keith
 

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#9
keithm696 said:
Hi all!
We use the supplier C of C or C of A for inbound materials from our suppliers. We build first aid kits and deal with lots of over the counter meds. During a recent FDA Audit I was asked a question about processing OTC meds by passing them thru a heat shrink tunnel after being unitized. Did this exposure to heat for 15 to 20 seconds change the stability of the product? We are now sending samples back to the labs to be compared to the retained samples. I use an excel spread sheet for lot # tracking of all products but this Investigator didn't want to look at anything they didn't have full control of. Any thoughts on this?
Thanks,
Keith
Hi Keith:
Did you exceed the storage temperature of the meds? The FDA is tough although thety may have a valid point iof you exceeded the storage temp. They are regulators not your friendly ISO auditor.
 
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