Requirement for manufacturing process validation in IATF 16949

morteza

Trusted Information Resource
Hello all,

I am searching a requirement for manufacturing process validation in IATF 16949 standard.

Based on “design and development” definition in ISO 9000:2015 (clause 3.4.8), it seems that the scope of clause 8.3.4.2 (Design and development validation) includes manufacturing process validation.

Is it right?

Thanks
 

morteza

Trusted Information Resource
Do you mean ISO 9001?

Hi Marc,

I mean the definition of the term "Design and development" in ISO 9000:2015.
In clause 3.4.8 of ISO 9000:2015, it has been stated:

design and development
set of processes(3.4.1) that transform requirements(3.6.4) for an object(3.6.1) into more detailed requirements for that object.

Note 1 to entry: The requirements forming input to design and development are often the result of research and
can be expressed in a broader, more general sense than the requirements forming the output(3.7. 5) of design
and development. The requirements are generally defined in terms of characteristics(3.10.1). In a project(3.4.2)
there can be several design and development stages.

Note 2 to entry: In English the words “design” and “development” and the term “design and development” are
sometimes used synonymously and sometimes used to define different stages of the overall design and development.
In French the words “conception” and “développement” and the term “conception et développement” are sometimes
used synonymously and sometimes used to define different stages of the overall design and development.

Note 3 to entry: A qualifier can be applied to indicate the nature of what is being designed and developed
(e.g. product(3.7.6) design and development, service(3.7.7) design and development or process design and
development
).
 

Howard Atkins

Forum Administrator
Leader
Admin
The standard specifically states

4.3.1 Determining the scope of the quality management system - supplemental
The only permitted exclusion for this Automotive QMS Standard relates to the product design and development requirements within ISO 9001, Section 8.3. The exclusion shall be justified and maintained as documented information (see ISO 9001; Section 7.5).
Permitted exclusions do not include manufacturing process design.

Following this the only clauses excluded are in fact
8.3.2.2 Product design skills ....
8.3.3.1 Product design input ...
8.3.5.1 Design and development outputs - supplemental

8.3.4.2 Design and development validation
Design and development validation shall be performed in accordance with customer requirements; including any applicable industry and governmental agency-issued regulatory standards. The timing of design and development validation shall be planned in alignment with customer-specified timing; as applicable.
Applies to all for both product (if not excluded) and process for all
 

AMIT BALLAL

Super Moderator
Hello all,

I am searching a requirement for manufacturing process validation in IATF 16949 standard.

Based on “design and development” definition in ISO 9000:2015 (clause 3.4.8), it seems that the scope of clause 8.3.4.2 (Design and development validation) includes manufacturing process validation.

Is it right?

Thanks
The requirement of Process validation is addressed in 8.5.1(f) clause of IATF16949:2016 standard.

8.3.4.2 is for validation of design and development (Such as simulation).
 

morteza

Trusted Information Resource
The requirement of Process validation is addressed in 8.5.1(f) clause of IATF16949:2016 standard.

8.3.4.2 is for validation of design and development (Such as simulation).

Hi AMIT,

Do you mean that clause 8.3.4.2 is only apply to product validation?
 

Howard Atkins

Forum Administrator
Leader
Admin
There are 2 separate issues here

As there is a requirement for PRODUCT and PROCESS design both of these design functions MUST be validated as defined in 8.3
There is another requirement

8.5.1 Control of production and service provision
here there is a requirement
f ) the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement;

In TS the requirement included all manufacturing

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.


There is no longer a distinction between the standards due to the change in the manner that the requirement is written and the requirements is
8.5.1 Control of production and service provision NOT Validation of processes for production and service provision
 

AMIT BALLAL

Super Moderator
Agree. Now the requirement of process validation is only for a special process (as per IATF16949:2016).
 
Last edited:
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