Hello there,

new to this site :bigwave: 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

Hello there,

new to this site :bigwave: 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

Hi filebase and welcome to the Cove :bigwave:

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.

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

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 :)

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

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

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 :bonk:)

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.

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


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...

Control of nonconforming product is designed to contain NC parts from leaking out to the customer.
It's also intended to prevent adding further value to nonconforming products.

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

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...


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.

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.

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.

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.


Hello Jim,

Good point! Now back to the drawing board. Trying to come up with another example...It's all about helping others.....

Stijloor.

Hello Jim,

Good point! Now back to the drawing board. Trying to come up with another example...It's all about helping others.....

Stijloor.

I think the closest we'll get is the handling of some sort of service after something has gone wrong in commission of it, but there might be situations involving equipment used in performing a service, such as calibration standards, that would invoke 8.3.

It would help to know what service your company provides,

If you are a training provider I would say that non conformances would arise if:

1. during the development you did non verify that inputs matched outputs, this could be tricky as it could be seen as subjective.

2. handling of a complaint, how you investigate, verify problem, determine if systemic (trend analysis) and how its closed, this is an area that most companies pick up a couple of observations or even non conformances.

3. Internal audits, in the service industry a process approach would identify problems (NC's maybe) with inputs, outputs, controls, resources.


Not really sure if this helps as regards definition earlier replies give this, so in addition to containment, correction, prevention (recurrence) you might want to think about how you identify them.

cheers and welcome to the Cove :bigwave:

Service is a product as defined in ISO 9001. I would suggest a review of the definition of corrective and preventive action in ISO 9000. Preventive action is not applicable to non-conmforming product since you already have a non-conformance. It is hard to prevent a non-conformance that you already have.

Example: I own a window washing service. The washers keep leaving scum on the windows. The contract states that the windows will be clean after the service is performed. I stop the window washing service until I can determine the cause of the non-conforming service and eliminate the cause.

Regards,

Dirk