I know this subject has been discussed before, but I believe it's been awhile. I'm looking for feedback from those that are sure of the correct interpretation.

7.5.2.1 states "The requirements of 7.5.2 shall apply to all processes for production and service provision." This makes no sense to me because 7.5.2 already applies to all processes. So I suppose what they mean is that all processes must be validated, even if the resulting outputs can be verified. I don't know why one would have to validate the process if one can verify the output, and I don't want to do it if it's not required.

So is this really saying that all processes must be validated, even if their outputs can be verified? Again, if you're sure of the correct interpretation, please respond. Thanks much.

In a word, True. The requirement,7.5.2.1, which is outside the box makes it an automotive requirement. Therefore all processes, regardless of verified output must also be validated.
It's really not different then what's required by the APQP and PPAP processes.

In a word, True. The requirement,7.5.2.1, which is outside the box makes it an automotive requirement. Therefore all processes, regardless of verified output must also be validated.
It's really not different then what's required by the APQP and PPAP processes.

Absolutely! But read the requirement, John: "...shall apply to all processes for production and service provision." (emphasis mine)

Not all processes need to be validated. Only production and service processes, and as Sam has pointed out they are validated through PPAP and APQP. Reading the a) through e) in 7.5.2, you will notice that APQP handles the planning stuff, and PPAP handles the validation stuff. There should not be a whole lot of extra stuff you have to do.

I agree with you john. How can we validate the manual dependent processes (Ex. Labeling). If we validate also, what is the assurity that the process will be O.K.

But it is the standard requirement. In our company we have justified to the auditors, and not validated manual dependent processes. But we are verifying the output 100%
Sowmya

Hi sowmya

7.5.2.1 says that 7.5.2 shall be applied to all process for production and services. And coming back to 7.5.2 , it says that the Organisation shall validate any processes WHERE RESULTING PRODUCT "CANNOT BE" VERIFIED subsequently. Since your process is being verified subsequently and that too 100% .....auditors may be satisfied by the monitoring and measurement of the labelling process.

my opinion is db is correct about the planning part of APQP and Validation part of PPAP and the std do defines clearly "Where defieciencies become apparent after the product is in use"
Vasu

Thanks to all for their input!

Hi,

Can anyone let me know How write procedure for the below mention clause.

7.5.1.6 , 6.3.2 , 7.5.1, 7.5.1.3 , 7.5.2, 7.5.3, 8.2.3, 6.3, 6.4 ,6.4.2, 7.5.1.4, 7.5.1.5, 7.5.4, 7.5.4.1, 8.1.1, 8.1.2, and SPC. I need some sample for above mention clause.

thnks,

regrds,

Nathan

Mr. Nathan,

Few of the procedures mentioned (required by You) are specific to Industry. I am trying to give you an overview of the required procedures. You may ask specific clause for specific Industry.

Please find attched files of my Quality manual which address the clauses.

Regards,

Manoj

I tried to attach the files but as often it happens, there was an error. Hence What I am doing is that I am E-mailing these attachements to MARK with a request to post it.

Manoj

Hi. Manoj Mathur

Happy New Year To All,

Actually we are producing car alarm system,power window,transmitter,brake light and etc.Maybee now its easier for you to help me with the procedure.

regrds

nathan

To add to this we manufacture power steering gears. At all points of production we validate our product through inspections. All parts are inspected at each operation. We also do a full functional test on ALL steering gears after they are assembled. Would this clause even apply to us.

Dear Sowmya, I agree with you.

Though it is manual operation, you need to demonstrate the Qualification of personnel, Use specific methods and procedures for labelling operation.

During the audit / verification the above requirements has to be ensured.

Regards,

R. Senthilkumar