"Special Production Process" Validation and TS16949 Clause 7.5.2.1

[Daniele Italy]

Hallo friends,

I need a clarification: are the former special process classification mentioned in the old ISO 9001 standard ( the ones than cannot be fully verified by subsequent inspections...) also valid for the ISO TS? Better, have I to distinguish for the validation of the production process between special and not special production processes using different validation methodology? Someone is telling me that also in ISO TS the validation of the non special process doesn't require any planning for re validation or doesn't require the qualification of the working personnell by using suitable check lists or exams.

Thank you for the help

daniele

 

[Stijloor]

Re: "Special production process " and 7.5.2.1

Hallo friends,

I need a clarification: are the former special process classification mentioned in the old ISO 9001 standard ( the ones than cannot be fully verified by subsequent inspections...) also valid for the ISO TS? Better, have I to distinguish for the validation of the production process between special and not special production processes using different validation methodology? Someone is telling me that also in ISO TS the validation of the non special process doesn't require any planning for re validation or doesn't require the qualification of the working personnel by using suitable check lists or exams.


Thank you for the help

daniele

Daniele,

From ISO/TS 16949:2002:

7.5.2 Validation of processes for production and service provision

ISO 9001:2000, Quality management systems — Requirements

7.5.2 Validation of processes for production and service provision
The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered.
Validation shall demonstrate the ability of these processes to achieve planned results.
The organization shall establish arrangements for these processes including, as applicable
a) defined criteria for review and approval of the processes,
b) approval of equipment and qualification of personnel,
c) use of specific methods and procedures,
d) requirements for records (see 4.2.4), and
e) revalidation.

7.5.2.1 Validation of processes for production and service provision — Supplemental
The requirements of 7.5.2 shall apply to all processes for production and service provision.

7.5.2 in ISO 9001 (boxed text, blue in the quote) requires validation: where the resulting output cannot be verified by subsequent monitoring or measurement.

7.5.2.1 (automotive addition, red in the quote) eliminates that option and requires ALL processes for production and service provision to be validated. You must be able to demonstrate that these processes are able to deliver the intended outcome.

Hope this helps.

Stijloor.

 

[Caster]

Re: "Special production process " and 7.5.2.1

If you are TS 16949 and supply the "old" big 3 there are also requirements for special process assessments in the customer specific requirements documents.

These cover heat treat, painting and chroming so far.

The requirements are significant indeed.

My favorite is the very first question in the heat treat audit "name the degreed metallurgist in charge of heat treat"

Nothing went away in the change from QS to TS, the numbers just got changed and the requirements got more specific.

 

[wak125]

Could you please explain with examples( besides commonly used example of Welding)?

 

[Daniele Italy]

In my side the hot potato is the crimping process where some metallic crimps are fixed on a continuous metallic wire. It is impossible to check the pulling force of the crimps during the process because of the requested integrity of the wire where the crimp are fixed ( the products are sold winded on a 2 km long spool) We are testing the last pieces of each spool and by these test the spool is validated. Is this process considered special even for the ISO 9000 ? I don't think so because some, even if few, samples are always checked... what do you think?

Is it the spot welding considered special process ?

daniele

 

[Stijloor]

In my side the hot potato is the crimping process where some metallic crimps are fixed on a continuous metallic wire. It is impossible to check the pulling force of the crimps during the process because of the requested integrity of the wire where the crimp are fixed ( the products are sold winded on a 2 km long spool) We are testing the last pieces of each spool and by these test the spool is validated. Is this process considered special even for the ISO 9000 ? I don't think so because some, even if few, samples are always checked... what do you think?

Is it the spot welding considered special process ?

daniele

Daniele,

I am not a crimping expert, so you'll have to see how others respond.

I would consider spot welding a "special process" because the integrity of the weld can only be checked through a destructive test. So yes, this process should be validated.

Stijloor.