ISO/TS 16949 - 7.5.2 - Validation of Processes And 7.5.2.1 All Processes

S

sgbhat

#1
Hi all,

This is on ISO/TS 16949 , Clause 7.5.2.1,says " Validation of Processes as one of the Process for all processes..." .

I agree that it is required 100 % for all Special processes (Eg. Heat treatment , Plating ).(again , Is it enough ; while establishing(APQP /PPAP stage) or against any change OR need to be done periodically (Eg. - yearly once !)are the hard questions !!)

But

the question is , Why and How the same is applicable for the Processes other than Special Processes !!!!

Because,

These (otherthan special processes) are ;-

a) Set-Checked-Confirmed-Monitored-Controlled-Recorded at Set up stage(7.5.1.3) and also during (mass ) production against set/established/validated (may be during APQP/PPAP/Change Management stage/cases) Standards which covers both Process (machine etc) controls and Part (parameters) controls. Basically out put is / can be or need to be measured.
These are standardised as process it self.
Eg. Machine setting~set up Instructions / SOPs,Process monitoring instructions /SOPs and SOFs.
b) Manufacturing Process Audits (8.2.2.2) and Product audit (8.2.2.3) and system audit (8.2.2.1) are in place.
c) Calibration~MSA (7.6 ~ 7.6.1) is in Place
d) Skill matrix ( 6.2.2) is in place
e) Machine maintenance (7.5.1.4) and Tool Maintenance ( 7.5.1.5) are in place.

Need a clarification on intent of " Validation & (7.5.2.1) All processes " combination and it's deployment method.
 
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#2
Hi all,

This is on ISO/TS 16949 , Clause 7.5.2.1,says " Validation of Processes as one of the Process for all processes..." .

I agree that it is required 100 % for all Special processes (Eg. Heat treatment , Plating ).(again , Is it enough ; while establishing(APQP /PPAP stage) or against any change OR need to be done periodically (Eg. - yearly once !)are the hard questions !!)

But

the question is , Why and How the same is applicable for the Processes other than Special Processes !!!!

Because,

These (otherthan special processes) are ;-

a) Set-Checked-Confirmed-Monitored-Controlled-Recorded at Set up stage(7.5.1.3) and also during (mass ) production against set/established/validated (may be during APQP/PPAP/Change Management stage/cases) Standards which covers both Process (machine etc) controls and Part (parameters) controls. Basically out put is / can be or need to be measured.
These are standardised as process it self.
Eg. Machine setting~set up Instructions / SOPs,Process monitoring instructions /SOPs and SOFs.
b) Manufacturing Process Audits (8.2.2.2) and Product audit (8.2.2.3) and system audit (8.2.2.1) are in place.
c) Calibration~MSA (7.6 ~ 7.6.1) is in Place
d) Skill matrix ( 6.2.2) is in place
e) Machine maintenance (7.5.1.4) and Tool Maintenance ( 7.5.1.5) are in place.

Need a clarification on intent of " Validation & (7.5.2.1) All processes " combination and it's deployment method.

It is required because the standard says so!!

By your reasoning why do we need it for "special processes" as we do so many other actions!

The emphasis of the standard is process control

In my mind the constant exclusion in ISO 9000 is unreasonable

What does the standard say:
The organization shall establish arrangements for these processes including, as applicable
a) defined criteria for review and approval of the processes,
How can you work in any different manner
b) approval of equipment and qualification of personnel,
You already have a skills matrix
c) use of specific methods and procedures,
AGAIN How can you work in any different manner
d) requirements for records (see 4.2.4)
AGAIN How can you work in any different manner, and
e) revalidation.
You have said that you are doing this

Whats the problem!!!
 
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