Validation of Processess

[Manoj Mathur]

Manoj Mathur Manoj Mathur

According to 9K2K clause 7.5.2, Org. shall validate for processss, where the resulting output can not be varified by subsequent monitoring and measurement.
What are the examples of such type of processess and conditions.
Heat Treatment is such type or other.
Pl. Share your view to eloborate the topic.

Manoj Mathur

 

[M Greenaway]

Monoj

Any process that cannot be verified by subsequent inspection would be what is commonly termed a 'special process'. You cannot really produce a definitive list of manufacturing processes that are special, because it also depends on any inspection processes available to the organisation.

Your example of heat treatment might be a special process if you have no hardness testing capability for example. In such instances you would need to qualify a set of process parameter settings, such as oven temperature, quench media, quench times, etc to prove that a material subjected to this process will produce the desired outcome.

Electro-plating is also often a special process as thickness measuring equipment is often very expensive, and adhesion testing is also often beyond most companies, however if you had these tests in house it would no longer be a special process.

Welding is often considered a special process also, and often defined by weld preparation geometry, filler material, weld geometry, etc.

 

[Roger Eastin]

I agree with what Martin has said. It is interesting to note that with TS-2002 it doesn't matter whether your process is "special" or not, you have to follow the steps in 7.5.2 for any process.

 

[Supich]

Manoj
For me, yarn spinning process would be under cl. 7.5.2, where the results will be shown fabric weaving process

supich

 

[PeterL]

7.5.2 Validation

I would like to pose this question related to TS2 7.5.2.1. -Supplemental, which states: the requirements of 7.5.2 shall apply to all processes for production and service provision.

Does this mean that the "where" clause exclusion in 7.5.2 line one does not apply and therefore ALL processes for production and service provision need to be validated?

If not, what is the intent of the supplemental?

Peter

 

[Sam]

Peter said;
"Does this mean that the "where" clause exclusion in 7.5.2 line one does not apply"

No. The word "any" in 7.5.2 is replaced by the word "all"


"and therefore ALL processes for production and service provision need to be validated?"

Validation of only those processes where the resulting output cannot be verified.

Verification methods are defined on the control plan. If you have an operation and no verification then you would need to show evidence of validation.