Outsourcing Processes - Supplier CofC (Certificate of Conformance)

K

Ken B.

#1
outsourcing

Being fairly new to I.S.O. 9001-2000 I am having a problem with outsourcing. I work in a box plant and a number of items are farm outs and re-tags. The problem is in preforming our verifications. It is not practical to open each unit. I understand I can have our supplier issue a certificate of quality with each shipment and that will eliminate the need for these verifications to be preformed. Does any one have a sample of this certificate? It would be very helpfull as I have never seen one before. I am also open to any other ideas. The certificate sounds like an easy way out but I would prefer to preform these verifactions if possible.
 
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C

Craig H.

#2
Hi, Ken.

It seems to me that sections 7.4.2 and 8.2.4 of 9001:2000 are the most relevant. However, there is no mention of a certificate within the standard. Some companies will accept a Certificate of Analysis (COA) or Certificate of Quality (COQ) as evidence that the item(s)in question are within spec. Weather or not this is appropriate in this situation is something you have to decide as part of the required planning.

What you need to decide is what your acceptance criteria is, and how each supplier has been doing in relation to that criteria. Then, you can decide what method of quality verification you are comfortable with.

Sorry I can't give you a straightforward answer, but you have to figure out the most effective way to control your system.

Hope this helps.

Craig
 

Mike S.

Happy to be Alive
Trusted Information Resource
#3
Welcome, Ken.

I don't wish to sound too simplistic, but ask yourself what do you think you need to give you confidence in your suppliers and what is the criticality of the product? It sounds like you've purchased from these suppliers for awhile now, true? If so, you no doubt have some history on them -- have they been reliable suppliers in the past? This, IMO, is the best and most telling determining factor as to whether they are a good supplier or not and are likely to remain so. I looked at suppliers who had a good history of supplying good quality to us as qualified to do a "ship to stock" in most cases. For new suppliers, or suppliers who had some troubles, or for super-critical supplies, I would do incoming sampling and perhaps a plant visit to work with them to develop confidence so they could go to ship-to-stock for all but the most critical of parts.

A certificate from a supplier that you speak of is typically something like this:

Acme Widget Co. Certificate of Compliance

Customer Name: ABC Company
Customer P.O. Number 12345
Date: 1-2-03
Product: Widget 34-5
Specification: ABC Company Document 789 Rev. B
Lot: 89021-51
# Shipped: 3,456

[Test Data (if applicable) can be included here.]

Acme Widget Co. hereby certifies that the above information is true and correct and that the products delivered meet all requirements put forth in the customer’s order.

Authorized Signature: Joe Sixpack Date: 1-2-03


Does this make sense? Answer your questions? If not write back!
 
K

Ken B.

#4
Thanks that helps alot. Mike are you suggesting that I may be okay because my outsource providers are on my approved supplier list? I am glad I found this forum due to the fact that I am fairly inexpieranced in I.S.O.. Your help is appreciated. Ken
 

Mike S.

Happy to be Alive
Trusted Information Resource
#5
Ken,

You can get tons of help here.

To answer your question...I'm saying you/your company needs to decide, hopefully based on data, (past experience with the supplier, audits, sampling, etc.) and based on criticality of the product (heart pacemakers might warrant more inspection than cardboard boxes) whether you feel you need to do in-house 100% inspection or in-house statistical sampling of incoming product, or whether you trust your supplier to only send good product. Having a supplier on the approved list is just one consideration. Put yourself in the end customers' shoes and consider their needs and expectations and decide how you can most efficiently meet them. Try something, your best idea for what will work, and then monitior the results carefully and make changes as necessary.

Make sense?
 

johnnybegood

Involved In Discussions
#6
I work in a manufacturing company. Recently there is a major restructuring and there are many department or operation being outsourced. The warehouse, Calibration department, some activities like Test Station Preventive Maintenance. Question is how do I satisfy ISO requirement? Where are the clauses? What will the auditor be looking for?
 

barb butrym

Quite Involved in Discussions
#7
It all falls under supplier control. Obviously outsourced processes need more control than material purchased of the shelf, you need to control them to the extend necessary to make you and your customer comfortable, as if you performed the function yourself....so to speak. So whatever was expected of you, gets passed down to the out source......

calibration....look to calibration or even ISO17025 if necessary;
warehouse look to HSPPD for guideance;
and of course process control, doc control and even customer supplied stuff....with you as the customer

You set the rules, but be realistic.
 
Last edited:

Manoj Mathur

Quite Involved in Discussions
#8
Outsourcing should be treated as Purchasing. Hence all the requirements related tp Purchasing (Section 7.4) is to be related with Outsourcing.

Regarding Certificate, I take it in this manner that Whatever the process parameters whatever the in process specifications and Final specifications, you want to achieve in the product If you would have done it in your premises The same desired Output Should come in Test Certificate. But It must be clear that As far as Final Customer is concerned, You are the processs owner and an Outsourcing agency should not be blamed for the un correct part supplied to the customer and for any defect in product or services.
We are also doing lot of Outsourcing and I have made certain rules and regulations for complete Outsourcing.
We have defined Product Specifications and rules for material reconcilation also. I feel, in QMS and in ISO , material Reconcilation is not covered , which it is supposed to be because Outsourcing becomes a major part of today's business and every aspect should be covered in QMS and in ISO.
 
Q

qsmso

#9
Outsourcing !

Dear all,
I need your input about outsource activity. We claim that we outsource calibration services and have procedure to control those activities. However, for maintenance service of some key process equipment never been considered as outsourcing even the equipment manufacture technical services team do those activities for us.
We certified QS-9000 for almost 4 years, but never had problem with CB. However, as I am the internal auditor, should I mention about this fidning in the audit report?

QSMSO
 

Manoj Mathur

Quite Involved in Discussions
#10
Dear Chatchai,

While outsourcing calibration activities one must consider the following,
The Master instruments should have tracibility to National or International certified lab calibration
NABL certification or ISO 17025 certification is required.
All the rules relating to Master and perticular instrument (Calibrated Instrument) must followed.
There must be record of Environment conditions while calibration.
The method of calibration must have some reference either from equipment maufacturer or from ISO or ASTM or DIN.
 
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