Validation of Processes for Production - How are doing it? Clause 7.5.2

[Statistical Steven]

Re: Handling 7.5.2 Validation of processes for production - How are doing it?

You can't verify a weld(strength) without destroying it, just like sterility in a medical device. That is why it's necessary to validate the process. When there is a manual element such as an operator, it is important to have a trained competent individual(read that certified).

I think we are talking around the issue of the OP. Since you cannot directly measure a weld, you need to validate the process. How one validates the process is to perform the special process and destructively test the output and measure it. Based on the measurement (pass/fail or measurement), you can validate the process. If it is a manual process, then you have some training that must be verified for each operator before they can perform the special process. It is tedious and costly, but if the weld is considered critical, you need to validate the using certain settings and conditions, you will produce acceptable welds with high confidence.

 

[Sidney Vianna]

Re: Handling 7.5.2 Validation of processes for production - How are doing it?

Since you cannot directly measure a weld, you need to validate the process.

You can inspect weldments using a number of non-destructive techniques, including visual and dimensional inspection, x-ray, magnetic particle, ultrasound, dye penetrant, acoustic emissions, etc...
Not every welding process needs validation. Depending on the criticality of the weld and the application of the equipment being welded (pressure containing, structural, nuclear, etc), certain regulatory and other codes (ASME, API, AWS, etc...) might dictate how much "validation" is required, such as welding procedure qualifications, welder certification, equipment calibrations, etc...
For a chance to be able to assist the OP, one would need to know what exactly is being welded and it's application.

 

[apestate]

Re: Handling 7.5.2 Validation of processes for production - How are doing it?

I think chascoffin is on track with this particular circumstance...

If you are not required to certify your welding staff or anything else per customer, and only per ISO 9001:2000, why not treat it just like anything else you've defined the requirements of?

Have the welders perform the different types of welds on coupons of the material of the product, and inspect them for pinholes and slag inclusions. You can do this by grinding a weld flat. Once the weld is flat, try to bust the weld in a brake press.

What works for you?

 

[randy04]

Re: Handling 7.5.2 Validation of processes for production - How are doing it?

Randy, what product are you welding? If your customers require certification of the weld then you will probably have to validate the 'special process'. If certification of the weld is not a requirement, and your not in a high reliability situation (e.g. aerospace), then you may not have to declare your welding as a special process, the decision is yours, not your auditors. I have a similar situation and hope to get by with training and the fact that our customers don't require certified welds/welders.

Chas

We are welding fittings for a company in the steel industry. Our customer uses the fittings to inject argon into molten steel to clean the impurities. They do not have any requirements for welding/brazeing. We discussed with the auditor about training, and the fact that the customer does not state any requirements, she just wouldn't buy into it.

 

[chascoffin]

If I understand you correctly, you are welding on a peice that is submerged into molten metal and used as a disfuser to 'clean' the metal, or drive the impurities to the top as slag. I assume the life of this disfuser is very limited, and would guess that the weld quality is not critical. It doesn't sound like your welds need to be validated, reference ISO handbook 4th edition page 369, audit note. If you have not had problems or customer complaints about the welds, I would try to reason with the auditor again. Good luck.

Chas

 

[Nicco]

Sorry, I cannot answer anything and give you any sugggestion. it's different field for me.

 

[Kevin Mader]

Some more for the mix:

It seems that the auditor was satisfied with the verification activity. It seems that her challenge was that this was also insufficient. While verification might be useful in detecting some attributes or variables, it may not be for others.

So have the requirements been specified? For instance, is weld strength a critical quality characteristic? How would you know? More importantly, how would she know?

Have the critical, major, minor quality characteristics been determined from the requirements? How are these controlled? Is there an FMEA for example? How about a Control Plan?

To demonstrate adequate control, you may have to perform a process validation and subject the PV replicates to a study (inspection and test). If your PV was successful and you could also demonstrate the product quality met the requirements in a summary of the study (design records), you may in the end rely on the PV records, established process controls, and verification activities.

What pieces do you currently have?

Regards,

Kevin

 

[Sebastian]

May I start my welding story?

1. We get metal bracket (automotive part) drawing with weld characteristics (lenght, penetration) defined on it.
2. Production start to define machine welding program for all part welds. Generally it is based on welding arm moves (position, angle, speed), together with amperage used. So they make 5 samples for each weld and give it to QA for checking - outer lenght and penetration determined after weld cutting.
3. Production continue trials depend on QA check results.
4. When trial is finished, program is stored.
5. Mass production trial is made and parts are submited to customer for trials.
6. After customer approval, at the beginning of every welding lot Production submit to QA initial sample(s) for checking of weld(s) characteristics.

End of story and now could you help me find 7.3.5, 7.3.6 and 7.5.2?

 

[Louis Reimer]

We are welding fittings for a company in the steel industry. Our customer uses the fittings to inject argon into molten steel to clean the impurities. They do not have any requirements for welding/brazeing. We discussed with the auditor about training, and the fact that the customer does not state any requirements, she just wouldn't buy into it.

Question? if the weld is not performed correctly, what would happen? If the specifications of the fittings can all be inspected without destructive testing then the process does not require validation.

If the weld process has a specification quality that can only be verified by destructive means, vaildation is required. this can be performed by creating a work instruction procedure that when followed using equipment with known performance parameters (Calibration) with personnel that have been trained will yield an acceptable product that is proven my testing samples at the initial validation and then setting up sample testing schedule.

 

[mwccwi]

Re: Handling 7.5.2 Validation of processes for production - How are doing it?

Validation of welding processes can be defined by many organisations like ISO3834, ASME sections 6 & 9, AWS. Basiclly identify the critical variables- like filler metal, base metal, shielding medium, the electrical parameters- volts / amps, travle speed. calibrate the measuring devices, test the sample coupons record the data - test at more multiple ranges. or reference published standards that use prequalified welding procedures specifications (WPS). Qualify/certify the welding operator using these WPS's and your on your way. Good luck.