Can this Nonconformance have suitable CAPA (Corrective and Preventive Action)

Can this NCR have suitable CAPA

  • Yes

    Votes: 0 0.0%

  • No

    Votes: 0 0.0%
  • Total voters
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  • Poll closed .
M

moonlight - 2011

in our recent audit we got an ncr that "wehave not a inhouse capablity of manufacturing product" but as per our design the the approved supplier has made product and we have a procedure how to produce it .

wat would be the possible actions(cause and CAPA) to the closure of it .
 
Howard Atkins

Howard Atkins

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moonlight said:
in our recent audit we got an ncr that "wehave not a inhouse capablity of manufacturing product" but as per our design the the approved supplier has made product and we have a procedure how to produce it .

wat would be the possible actions(cause and CAPA) to the closure of it .
Click to expand...

To help please give some more info
What is the standard?
What is your scope?
What clause is the NC refering to?

With this info we should be able to help more
 
Randy

Randy

Super Moderator
Your problem isn't with making the product and your solution will not be preventive. Your problem lies with meeting this requirement and your solution has to reside here.

7.2.2 Review of requirements related to the product
The organization shall review the requirements related to the product. This review shall be conducted prior to the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of
contracts or orders, acceptance of changes to contracts or orders) and shall ensure that
a) product requirements are defined,
b) contract or order requirements differing from those previously expressed are resolved, and
c) the organization has the ability to meet the defined requirements.
Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4).
 
Last edited by a moderator:
Jim Wynne

Jim Wynne

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Admin
Randy said:
Your problem isn'twith making the product and your solution will not be preventive. Your problem lies with meeting this requirement and your solution has to reside here.

7.2.2 Review of requirements related to the product
The organization shall review the requirements related to the product. This review shall be conducted prior to the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of
contracts or orders, acceptance of changes to contracts or orders) and shall ensure that
a) product requirements are defined,
b) contract or order requirements differing from those previously expressed are resolved, and
c) the organization has the ability to meet the defined requirements.
Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4).
Click to expand...

I think this is on the right track--"ability to meet the defined requirements" can exist as internal capability or meeting the requirements through use of contracted work. What I'm wondering, and what the OP hasn't explained, is how the auditor came to believe that the capability is internal. Is there a documented procedure that makes it appear that the work is done internally? More information is needed.
 
RoxaneB

RoxaneB

Change Agent and Data Storyteller
Super Moderator
My first take on this was not under 7.2.2. but under the organization's ability to demonstrate that they have a controlled manufacutring process that results in product which meets requirements.

My reasoning for this thought is that we almost received a finding on our cpk charts that were showing some pretty bizarre numbers and product was still going into the warehouse. But then we showed that we looked at the numbers, anlayzed the situation, made modifications and adjusted the line so that our product was back in spec...and we had records showing how we dispositioned the out-of-spec product.
 
Sidney Vianna

Sidney Vianna

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moonlight said:
wat would be the possible actions(cause and CAPA) to the closure of it .
Click to expand...
Until the auditor CLEARLY IDENTIFIES what is the requirement being violated, this NC is suspect, at best. If the auditor can not identify a REQUIREMENT associated with this NC, it must be voided.

The NC is poorly phrased.
 
A

AndyN

Moved On
moonlight said:
in our recent audit we got an ncr that "wehave not a inhouse capablity of manufacturing product" but as per our design the the approved supplier has made product and we have a procedure how to produce it .

wat would be the possible actions(cause and CAPA) to the closure of it .
Click to expand...

Seriously?

Find another auditor! If this was a CB auditor, then appeal the finding. If this is all they wrote, then reject it for the reasons Sidney stated.

If it was an internal auditor, find another one who knows how to audit and report effectively. Those are your corrective and preventive actions.

And I'm being very serious!:cool:
 
J

JaneB

Yes, I agree with what's been said.

(And BTW it's not possible to vote in a poll like this until there is adequate information on which to make a reasonable assessment.)
 
P

Pudge

Do you have a waiver from the customer saying that your parts although not capable are acceptable...this could be a route to look into if I am understanding this correctly
 
Howard Atkins

Howard Atkins

Forum Administrator
Leader
Admin
I suggest that until we get input from the OP we stop guessing to what he means.
This is like playing 20 questions with no one answering
 
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