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
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.....