Corrective Action and Preventative Action cover Control of Nonconformance?

Hello there,

new to this site it has been very helpful! Im currently on a work placement helping a company in the uk create a QMS. My question is does corrective and preventative action cover the area of control of non-conformance? i should add that the company is a service and does not really have a product as such.

help would be greatly appreciated

Ben

Re: corrective action and preventative action covers control of non conformance?

filebase said:

Hello there,

new to this site it has been very helpful! Im currently on a work placement helping a company in the uk create a QMS. My question is does corrective and preventative action cover the area of control of non-conformance?

help would be greatly appreciated

Ben

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Hi filebase and welcome to the Cove

In order for you to get your head around the many different opinions regarding CAPA and or NC's I suggest that you start by doing a search by using the search function at the top right of the screen. You may also benefit from reading the related threads at the bottom of this page. This will help you a lot, and if after reading these posts you still have questions relating to this issue then you will definitely be better equiped to phrase your question so precisely as to get really good feedback.

corrective action and preventative action covers control of non conformance?

Hello there,

new to this site it has been very helpful! Im currently on a work placement helping a company in the uk create a QMS and gain ISO9001. My question is does corrective and preventative action cover the area of control of non-conformance? i have been reading up and finding it a bit hard to grasp because how i am looking at it Corrective and preventative measures appear to 'control' noncomfomance. am i totally wide of the mark? i should add that the company is a service and does not really have a product as such.


help would be greatly appreciated

Ben

Re: corrective action and preventative action covers control of non conformance?

filebase, I moved your second post here to make sure that the discussion does not get to confusing. Two threads covering the same issue started by the same person is bound to be trouble

Re: corrective action and preventative action covers control of non conformance?

thank you. as this is a service company does anyone have any suggestions as how to tackle control of non conforming product?

Re: corrective action and preventative action covers control of non conformance?

filebase said:

thank you. as this is a service company does anyone have any suggestions as how to tackle control of non conforming product?

Click to expand...

I would - personally - tackle it the same way as with a production company. If I noticed any major NC's then I would raise the issue using a structured CAPA-process. With minor NC's I would simply adress the issue in the run of it.

CAPA should - in my opinion - be used to adress serious issues that can directly affect security, economy, customer satisfaction etc. It should not be used to adress if someone ordered the wrong kind of ballpen (this is if you have described the type of ballpen in the QMS. I have seen that done )

But, as you probably have guessed when you looked at the CAPA forum, there are just about as many opinions regarding this as there are QA employees around the world.... What you should describe in your QMS is - again my opinion - what will be the most efficient way of doing business and handling your serious NC's.

Re: corrective action and preventative action covers control of non conformance?

filebase said:

Hello there,

new to this site it has been very helpful! Im currently on a work placement helping a company in the uk create a QMS and gain ISO9001. My question is does corrective and preventative action cover the area of control of non-conformance? i have been reading up and finding it a bit hard to grasp because how i am looking at it Corrective and preventative measures appear to 'control' noncomfomance. am i totally wide of the mark? i should add that the company is a service and does not really have a product as such.


help would be greatly appreciated

Ben

Click to expand...

corrective action and preventative action are designed to put in place actions to prevent the occurence or reoccurence of a root cause. Control of nonconforming product is designed to contain NC parts from leaking out to the customer.

I suppose it could apply to a service operation, but I can't think of an application right now...

Re: corrective action and preventative action covers control of non conformance?

hjilling said:

Control of nonconforming product is designed to contain NC parts from leaking out to the customer.

Click to expand...

It's also intended to prevent adding further value to nonconforming products.

hjilling said:

I suppose it could apply to a service operation, but I can't think of an application right now...

Click to expand...

I can't either.

Re: corrective action and preventative action covers control of non conformance?

hjilling said:

corrective action and preventative action are designed to put in place actions to prevent the occurence or reoccurence of a root cause. Control of nonconforming product is designed to contain NC parts from leaking out to the customer.

I suppose it could apply to a service operation, but I can't think of an application right now...

Click to expand...

Hello hjilling,

Here may be an example...please tell me what you think of it.

A service organization such as a training company develops a program at the request of a Customer. After the program has been designed, developed and produced, the project-responsible person discovers errors during program validation. This would render the product (training program) nonconforming. Clause 8.3 would "kick in." It would protect the customer from receiving a nonconforming product.

Any other examples?

Stijloor.

Re: corrective action and preventative action covers control of non conformance?

Stijloor said:

Hello hjilling,

Here may be an example...please tell me what you think of it.

A service organization such as a training company develops a program at the request of a Customer. After the program has been designed, developed and produced, the project-responsible person discovers errors during program validation. This would render the product (training program) nonconforming. Clause 8.3 would "kick in." It would protect the customer from receiving a nonconforming product.

Stijloor.

Click to expand...

But it's still in the validation stage, so not considered salable, so there's no NC. In fact the validation process has done its job, and there should be no danger of the "wrong" thing reaching the customer.