ISO 9001 Clause 7.5.2 - Validation of Process for Production and Service Provision

[Big Jim]

Re: ISO 9001 Clause 7.5.2 - Validation of Process for Production and Service Provisio

As an afterthought, <snip>

Without more detail, I believe you are overthinking this too. Validation for 7.5.2 applies to special processes. You have not said enough about this to show that special processes were involved. Special processes are those that the quality cannot be determined from ordinary inspection.

This appears to just be validation, not validation of special processes. It is still desirable as you have already determined.

 

[Koves]

Re: ISO 9001 Clause 7.5.2 - Validation of Process for Production and Service Provisio

Thanks Jim.

its been a few years since ive done this, so start with overthinking and work my way back

 

[somashekar]

Re: ISO 9001 Clause 7.5.2 - Validation of Process for Production and Service Provisio

We make food storage containers.

We are a injection moulder that makes and markets our own products.

How you have determined the injection molding parameters is your validation process, and what you have determined as the injection molding parameters is the validation output.

I test products to ensure they do as we say they do - dishwasher testing, microwave testing etc... I do this on new products, and existing products that have had changes such as material grade.

These are tests you conduct to verify that your validation outputs that you use in your machines are true in meeting the product requirements. Each and every product you make are not subjected through these tests certainly I guess...
Your testing when you change material grade is a correct re-validation requirement.
You are validating and rightly understanding re-validation requirements. It concerns to your product as required by the standard. You are good.
The rest is over thinking ...

 

[Marc]

Re: ISO 9001 Clause 7.5.2 - Validation of Process for Production and Service Provisio

<snip> If the product (e.g. the elevator cars) cannot be completely verified without the customer's involvement <snip>

I know this is long past when this was posted, but in the 1990's I worked with an elevator car company. You are right on? They can ONLY be validated through actual public use.

I can't tell the company name here - I never asked for permission to reference them - I can tell you that there aren't a whole lot of elevator cab companies in the *world*. I can't remember how many companies supplied elevator cars to the (then) world trade center in NY but my client was one of them. It wasn't "sole source' by any means.

 

[PaulJSmith]

Re: ISO 9001 Clause 7.5.2 - Validation of Process for Production and Service Provisio

Slightly-
There used to be an old joke about the location of a particular elevator company in St. Louis being in a one-story building...and it was (and still is) actually true.

 

[AlexanderS]

Re: ISO 9001 Clause 7.5.2 - Validation of Process for Production and Service Provisio

Hello everyone,
Can anyone please comment on 7.5.2 "output CANNOT be verified by subsequent monitoring or measurement".
Do they mean output cannot be verified in a specific company with specific production controls, or just theoretically cannot be verified, or economically does not make sense?

Imagine X-ray machine is very expensive:

a) Company A is in welding business. They have X-ray machine and they monitor each lot. Welding is not a special process for Company A.

b) Company B also welds. They don't have X-ray machine, they rely on equipment, qualification people, and well defined process. Welding is a special process for Company B. Company B now has to validate the welding process.

c) Company C also welds. They don't have X-ray machine in house, but they decided to send a small sample to 3d party for X-ray once a YEAR (I exaggerate on purpose). That's very poor way of measuring, but still technically it's the measurement of the output. Welding is not a special process for Company C any more. I save money on X-ray machine, have quite poor production controls, most likely I ship bad product to customer, but I am excluded from 7.5.2.

It that right?

 

[John Broomfield]

Re: ISO 9001 Clause 7.5.2 - Validation of Process for Production and Service Provisio

Hello everyone,
Can anyone please comment on 7.5.2 "output CANNOT be verified by subsequent monitoring or measurement".
Do they mean output cannot be verified in a specific company with specific production controls, or just theoretically cannot be verified, or economically does not make sense?

Imagine X-ray machine is very expensive:

a) Company A is in welding business. They have X-ray machine and they monitor each lot. Welding is not a special process for Company A.

b) Company B also welds. They don't have X-ray machine, they rely on equipment, qualification people, and well defined process. Welding is a special process for Company B. Company B now has to validate the welding process.

c) Company C also welds. They don't have X-ray machine in house, but they decided to send a small sample to 3d party for X-ray once a YEAR (I exaggerate on purpose). That's very poor way of measuring, but still technically it's the measurement of the output. Welding is not a special process for Company C any more. I save money on X-ray machine, have quite poor production controls, most likely I ship bad product to customer, but I am excluded from 7.5.2.

It that right?

Alexander,

X-Ray to look for flaws and inclusions is one thing but you are forgetting the strength of the welds.

Strength testing of just about any joint requires destructive testing.

Therefore we make sure the welding process is validated. We may also do NDT and we test the occasional coupon to revalidate the process.

These days many organizations design or validate their production processes to reduce the quality cost of appraisal.

John

 

[AlexanderS]

Re: ISO 9001 Clause 7.5.2 - Validation of Process for Production and Service Provisio

Thanks John,
My question was related to interpretation of the ISO/AS standard rather than your industry specific implementation.
Thanks anyway,

 

[John Broomfield]

Re: ISO 9001 Clause 7.5.2 - Validation of Process for Production and Service Provisio

Thanks John,
My question was related to interpretation of the ISO/AS standard rather than your industry specific implementation.
Thanks anyway,

Alexander,

But I did interpret clause 7.5.2 of the ISO/AS standards.

John

 

[Big Jim]

Re: ISO 9001 Clause 7.5.2 - Validation of Process for Production and Service Provisio

Hello everyone,
Can anyone please comment on 7.5.2 "output CANNOT be verified by subsequent monitoring or measurement".
Do they mean output cannot be verified in a specific company with specific production controls, or just theoretically cannot be verified, or economically does not make sense?

Imagine X-ray machine is very expensive:

a) Company A is in welding business. They have X-ray machine and they monitor each lot. Welding is not a special process for Company A.

b) Company B also welds. They don't have X-ray machine, they rely on equipment, qualification people, and well defined process. Welding is a special process for Company B. Company B now has to validate the welding process.

c) Company C also welds. They don't have X-ray machine in house, but they decided to send a small sample to 3d party for X-ray once a YEAR (I exaggerate on purpose). That's very poor way of measuring, but still technically it's the measurement of the output. Welding is not a special process for Company C any more. I save money on X-ray machine, have quite poor production controls, most likely I ship bad product to customer, but I am excluded from 7.5.2.

It that right?

To add to John's comments.

Xray is not enough of a test to confirm that a weld is good. Your assumption that Company A's welding is not a special process is incorrect. Xray is just one of the types of non-destructive tests (NDT) can can be used to help validate the weld.

Companies B & C are validating their welding. As to if what they are doing for validation is sufficient is up for discussion and depends on more variables than have been put on the table here.