ISO 9001 Clause 7.5.2 - Validation of Process for Production and Service Provision

[baynoli]

Hi all, good day everyone.

I know this question has been asked already,
Would like to know when can this clause become an exclusion to a certain product or sevice.

And when can this be included in the qms/ scope of certification.
Hope experts of this field can eblighten me about this clause.

Thanks , baynoli

 

[somashekar]

Re: ISO 9001 Clause 7.5.2 - Validation of Process for Production and Service Provisio

Hi all, good day everyone.

I know this question has been asked already,
Would like to know when can this clause become an exclusion to a certain product or sevice.

And when can this be included in the qms/ scope of certification.
Hope experts of this field can eblighten me about this clause.

Thanks , baynoli

Hii baynoli.
This question has a potential to be a long debated thread, as it has happened earlier. Below this response you will find "Similar Discussion Threads" that will be of some eye opener.
I will try giving you a tip by way of an example.
If my process is cooking rice, and I do that in a open vessel with just any flame stove and keep watch to see the water I had added to rice evaporate and check the rice grains on top to see if they are soft and cooked to my feel, I would exclude validation.
If I change my process and I now use a pressure cooker, I would include validation, for I need to decide in advance, How to set up the cooker for correct performance, what water to rice ratio gets me my desired level of cooking done for the rice grade I have , what flame level is most optimum, how many pressure whistle should I allow, what water level I have to maintain in the pressure cooker base container, how long after flame cutoff I have to open to safely get the cooked rice.....
Now again If I change my process to electric rice cooker, I have to validate and this time it may be less validation load, as I have to decide in advance just what water to rice ratio gets me my desired level of cooking done for the rice grade I have. The rest of the stuff is determined by the electric cooker.
Please note that if I change the grade or quality of rice, I may have to re-validate certain things in both the pressure and electric cooker process, to get me the desired cooked rice quality.
Hope your question is answered.....

 

[sagai]

Re: ISO 9001 Clause 7.5.2 - Validation of Process for Production and Service Provisio

Hi!
Well, I do not use a pressure cooker for rice cooking, I prefer a traditionally cooked risotto, so from the gastronomy prospective I could argue on that, however the example we have here is really great and well describes the concept.
More concrete example for you.
For a software company for example the "production" is only the activity relates to CD burning and packaging, so if they are not doing that, it is an example for exclusion.
On the other side, "service provision" can be applicable if they provide for example hot line support, so it can not be excluded.
So, sum it up, it depends on your product and service for your customer and also depends on your company structure.
Regards
Szabolcs

 

[qusys]

Re: ISO 9001 Clause 7.5.2 - Validation of Process for Production and Service Provisio

Hi all, good day everyone.

I know this question has been asked already,
Would like to know when can this clause become an exclusion to a certain product or sevice.

And when can this be included in the qms/ scope of certification.
Hope experts of this field can eblighten me about this clause.

Thanks , baynoli

I would say that only 7.3 can be excluded from the scope of a ISO 9001 certification for a QMS of an organization, but other clauses cannot be excluded. We could think that some clauses cannot be applied but not excluded, in fact in an ISO certificate only the product design clause is allowed to be excluded.

 

[Stijloor]

Re: ISO 9001 Clause 7.5.2 - Validation of Process for Production and Service Provisio

I would say that only 7.3 can be excluded from the scope of a ISO 9001 certification for a QMS of an organization, but other clauses cannot be excluded. We could think that some clauses cannot be applied but not excluded, in fact in an ISO certificate only the product design clause is allowed to be excluded.

It is possible that other clauses within section 7 can be excluded.

Stijloor.

 

[Big Jim]

Re: ISO 9001 Clause 7.5.2 - Validation of Process for Production and Service Provisio

I would say that only 7.3 can be excluded from the scope of a ISO 9001 certification for a QMS of an organization, but other clauses cannot be excluded. We could think that some clauses cannot be applied but not excluded, in fact in an ISO certificate only the product design clause is allowed to be excluded.

If it can be properly justified, anything in section 7 can be excluded. See element 1.2.

The key is in the proper justification.

 

[Big Jim]

Re: ISO 9001 Clause 7.5.2 - Validation of Process for Production and Service Provisio

Hii baynoli.
This question has a potential to be a long debated thread, as it has happened earlier. Below this response you will find "Similar Discussion Threads" that will be of some eye opener.
I will try giving you a tip by way of an example.
If my process is cooking rice, and I do that in a open vessel with just any flame stove and keep watch to see the water I had added to rice evaporate and check the rice grains on top to see if they are soft and cooked to my feel, I would exclude validation.
If I change my process and I now use a pressure cooker, I would include validation, for I need to decide in advance, How to set up the cooker for correct performance, what water to rice ratio gets me my desired level of cooking done for the rice grade I have , what flame level is most optimum, how many pressure whistle should I allow, what water level I have to maintain in the pressure cooker base container, how long after flame cutoff I have to open to safely get the cooked rice.....
Now again If I change my process to electric rice cooker, I have to validate and this time it may be less validation load, as I have to decide in advance just what water to rice ratio gets me my desired level of cooking done for the rice grade I have. The rest of the stuff is determined by the electric cooker.
Please note that if I change the grade or quality of rice, I may have to re-validate certain things in both the pressure and electric cooker process, to get me the desired cooked rice quality.
Hope your question is answered.....

I would respectfully disagree with your analogy.

The output, that is the quality of the cooked rice, can be determined by subsequent monitoring and measurement.

The red hearing here is that you use process controls to help achieve your outcome. The use of process controls in and of themselves do not determine if something is a special process that requires validation. It is when the process controls are the primary or even the only practical way to tell that the outcome is acceptable.

 

[qusys]

Re: ISO 9001 Clause 7.5.2 - Validation of Process for Production and Service Provisio

It is possible that other clauses within section 7 can be excluded.

Stijloor.

Thank you, I was wrong in the interpretation, in fact ISO 9001 clearly states what you say in par. 1.2 Application. If not applicable for an organization, other clauses within par.7 can be excluded.

 

[baynoli]

Re: ISO 9001 Clause 7.5.2 - Validation of Process for Production and Service Provisio

Those products that comes with warranty are not excluded from this clause. Since a product quality can be determined fully if its already in the hands of the customer. Is this correct?

 

[Big Jim]

Re: ISO 9001 Clause 7.5.2 - Validation of Process for Production and Service Provisio

Those products that comes with warranty are not excluded from this clause. Since a product quality can be determined fully if its already in the hands of the customer. Is this correct?

Please rephrase your question. I don't understand what you are asking.