PO (Purchase Order) Clauses - Entry Clause

T

The Capt - 2011

During our registration audit Tuesday the auditor sited a minor finding that we don't have an "entry clause" in our T&C on purchase orders.

I am assuming that the "entry clause" is so that we can not be denied access to a supplier if there is believed to be or is proven that there is a systemic problem or suspected problem, that is impacting our manufacturing porcess.

Yes/No?

And what section of 13485, does this relate to, I don't see any destinct verbiage in the standard.
 

howste

Thaumaturge
Trusted Information Resource
Re: PO Clauses...Entry Clause

During our registration audit Tuesday the auditor sited a minor finding that we don't have an "entry clause" in our T&C on purchase orders.

I am assuming that the "entry clause" is so that we can not be denied access to a supplier if there is believed to be or is proven that there is a systemic problem or suspected problem, that is impacting our manufacturing porcess.

Yes/No?

And what section of 13485, does this relate to, I don't see any destinct verbiage in the standard.

The auditor didn't cite a requirement? The fact that you are asking us indicates that the auditor didn't do their job. :mad:

I would ask the auditor what specific requirement they were writing the nonconformity against. If I had to guess, I'd say they were stretching this requirement in 7.4.3:
ISO 13485 said:
Where the organization or its customer intends to perform verification at the supplier’s premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.
For this to be a nonconformity, they would have to show intent on your organization's part to perform verification at a supplier’s location.
 

Stijloor

Leader
Super Moderator
Re: PO Clauses...Entry Clause

During our registration audit Tuesday the auditor sited a minor finding that we don't have an "entry clause" in our T&C on purchase orders.

I am assuming that the "entry clause" is so that we can not be denied access to a supplier if there is believed to be or is proven that there is a systemic problem or suspected problem, that is impacting our manufacturing porcess.

Yes/No?

And what section of 13485, does this relate to, I don't see any destinct verbiage in the standard.

I agree with howste. Allow me to mention that it is your responsibility to ask for clarification during the closing meeting. The auditor should never have left (assuming that the audit is finished) without clarifying this issue/concern to you.

Stijloor.
 
T

The Capt - 2011

Re: PO Clauses...Entry Clause

Section 7.4.3 is what I believed that the auditor was speaking to, just wanted to clarify with powers that be here, for my minds owns sake I guess.
 

somashekar

Leader
Admin
Re: PO Clauses...Entry Clause

During our registration audit Tuesday the auditor sited a minor finding that we don't have an "entry clause" in our T&C on purchase orders.

I am assuming that the "entry clause" is so that we can not be denied access to a supplier if there is believed to be or is proven that there is a systemic problem or suspected problem, that is impacting our manufacturing porcess.

Yes/No?

And what section of 13485, does this relate to, I don't see any destinct verbiage in the standard.
Perhaps yes and not necessarly a problem situation. If you have to assign the task of verification of product for release to next stage at the supplier plant, say to a third party inspection agency, the supplier has to be receptive to this and perhaps a good PO T&C would have this covered comprehensively. If your verification activity is of such a nature, either by your organization personnel or a third party inspection agency, perhaps he is looking for a good T&C capturing this as a stated requirement....
 

Big Jim

Admin
Perhaps the auditor is confused with a requirement from the Aerospace standard that requires you to flow down "right of entry" when the customer specifies it. This is so common in Aerospace that it is often boiler-plated onto the purchase order form.
 

Wes Bucey

Prophet of Profit
Perhaps the auditor is confused with a requirement from the Aerospace standard that requires you to flow down "right of entry" when the customer specifies it. This is so common in Aerospace that it is often boiler-plated onto the purchase order form.
This requirement of entry into downstream suppliers often caused consternation among smaller suppliers to the aerospace industry when it was invoked as an FAA mandate. It is important to note it is rarely invoked and then only when an issue of nonconformance arises. The entry clause in the FAA mandate allows not only the customer entry, but the FAA inspector as well.
 
S

Spartan Kim

Re: PO Clauses...Entry Clause

I agree with howste. Allow me to mention that it is your responsibility to ask for clarification during the closing meeting. The auditor should never have left (assuming that the audit is finished) without clarifying this issue/concern to you.

Stijloor.

I agree with both howste and Stijloor but also a properly-worded nonconformance statement should not leave you guessing about the requirement that wasn't being met. Think who, what, when, where, etc. There are auditors out there who don't seem to understand this. An issue may be perfectly understood or remembered now, but what about in a year or two when that nonconformance statement/audit report/quality record issue is reviewed? Next time ask for clarification and ask the auditor to amend their report. Also, don't be shy about asking questions during a closing meeting (remember you're their client) but avoid being combative. For example, it's generally too late to challenge an issue in a closing meeting - the time for that is when the nonconformance is first identified and the auditor is verifying the issue.
 

AndyN

Moved On
Spartan KIm:

Great first post!:applause: Thanks for that. You obviously have a great amount of expertise to share with us Covers!:agree1:

BTW _ is the 'Spartan' a reference to your favorite Michigan team...........:lol:
 
T

The Capt - 2011

Re: PO Clauses...Entry Clause

I agree with both howste and Stijloor but also a properly-worded nonconformance statement should not leave you guessing about the requirement that wasn't being met. Think who, what, when, where, etc. There are auditors out there who don't seem to understand this. An issue may be perfectly understood or remembered now, but what about in a year or two when that nonconformance statement/audit report/quality record issue is reviewed? Next time ask for clarification and ask the auditor to amend their report. Also, don't be shy about asking questions during a closing meeting (remember you're their client) but avoid being combative. For example, it's generally too late to challenge an issue in a closing meeting - the time for that is when the nonconformance is first identified and the auditor is verifying the issue.

Audits are a cool breeze for me, I've been through and done enough of them, there were other issue that we could have gotten major findings for but I was able to explain them away so I wasn't going to "rock the boat" per say, on the little things.

I figured a "entry clause" in the T&C wouldn't be a big deal to come up with, but now looking back I do think he may have been thinking of the aerospace clause requriements.
 
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