How are some of you handling Validation of welding processes? We don't do much welding here but what we do we do not validate. Just something to cover the standard. Nothing to elaborate.


Thanks

If your welders are certified, keep copies if their certificates or certifications. This proves that they are skilled, trained, and hopefully competent to perform the special process that can't be "validated" in the normal way at the time of completetion.

How are some of you handling Validation of welding processes? We don't do much welding here but what we do we do not validate. Just something to cover the standard. Nothing to elaborate.


Thanks
Unfortunatley, in many situations like validation of welding, it requires that samples be subjected to levels of testing that would not ordinarily be performed during routine production. For example. send samples to a lab for x-ray evaluation of the weld, chemical testing, etc.

Validation is not a cheap process, but most companies see it as just running production for a few lots and doing inspection of the output.

How are some of you handling Validation of welding processes? We don't do much welding here but what we do we do not validate. Just something to cover the standard. Nothing to elaborate.


Thanks


I don't know what business you are in, but in my part of the validation-world you choose whether the process needs to be validated or verified. Is it a possibility for you to make that choice?? :notme:

Unfortunately I don't have that choice. The auditor was happy with our verification, and we argued that, but she still wanted some type of validation for the welding process.

I don't know what business you are in, but in my part of the validation-world you choose whether the process needs to be validated or verified. Is it a possibility for you to make that choice?? :notme:Gert, how do you verify welding?

Verification: Confirmation, through the provision of objective evidence that specified requirements have been met

Validation: Confirmation, through the provision of objective evidence that requirements for a specific use or application have been fulfilled

7.5.2 The organization must validate any production or service provision where subsequent monitoring or measurement cannot verify the output.
This validation includes processes where deficiencies may become apparent only after product use or service delivery. The validation must demonstrate the ability of processes to achieve the planned results.
The organization must establish validation arrangements including, as applicable:
7.5.2.a Criteria for process review and approval
7.5.2.b Qualification of personnel
7.5.2.c Use of defined methods and procedures
7.5.2.d Requirements for records
7.5.2.e Re-validation


professional certifications can be a helpful validation artifact/objective evidence.

Gert, how do you verify welding?

As I said, I don't know if it is an option. The question in my little universe is the reverse: How do you validate welding?? If it is possible to verify the result somehow you may be able to validate the process, but what do you do when can't validate the result?? Lets say if you build a ship or a house and the welding is being done as a manual process how do you validate that? So, what is my point. If you can validate it, then I believe you must somehow be able to produce objective evidence that the welding is as specified. If you can produce that evidence, and there is a good reason for the decision, then you can use the same kind of evidence to verify your welding.

When you choose - in the medical device industry - whether you need to validate a process, there is a number of considerations:
Is it possible to just verify the process?
Is it economically acceptable to just verify the process?
Does the output of the process pose a danger to the end user?
Is there a salespitch to validation vs. verification?

So, if it is possible to verify the output, and there is an economic or safety reason not to validate then you can choose just to verify.

I don't know if this makes sense, but if it doesn't please respond, and I will try to do better :rolleyes:

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

As I said, I don't know if it is an option. The question in my little universe is the reverse: How do you validate welding?? If it is possible to verify the result somehow you may be able to validate the process, but what do you do when can't validate the result?? Lets say if you build a ship or a house and the welding is being done as a manual process how do you validate that? So, what is my point. If you can validate it, then I believe you must somehow be able to produce objective evidence that the welding is as specified. If you can produce that evidence, and there is a good reason for the decision, then you can use the same kind of evidence to verify your welding.

When you choose - in the medical device industry - whether you need to validate a process, there is a number of considerations:
Is it possible to just verify the process?
Is it economically acceptable to just verify the process?
Does the output of the process pose a danger to the end user?
Is there a salespitch to validation vs. verification?

So, if it is possible to verify the output, and there is an economic or safety reason not to validate then you can choose just to verify.

I don't know if this makes sense, but if it doesn't please respond, and I will try to do better :rolleyes: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).

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.

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.

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?

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.

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

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

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

May I start my welding story? :D

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?
:thanx:

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.

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.

Hello, mwccwi! Welcome to the discussion board!

Thank you very much for the informative post. This one was a little older, so I don't remember seeing it. It is interesting, though. It would never occurred to me to validate a welding process. I would have thought that certifying the welders would have been sufficient.

I learn something new everyday. Again, thanks!

Hi i m Ahsan
Can some one eleborate for me what is difference between process varification and process validation ?

If i m considered i m of the view that process varifaction means to varify all inputs(theri characteristics or attribute,compositions etc) of the process are right while process validation means to varify that product(outcome) is according to your desire or upto mark.

Can somone provide us information about procedures involved in varifation and validation of process.

Regards

Ahsan

If ?you? are required to weld, and the weld is a specification of the product then the process and product are required to be inspected and validated. Not elaborate on the validation but just state that the process is in control through different forms of documentation. Being training, inspection, quality control, customer satisfaction, etc. Non of the less you must show that the welding process is in control because your company is offering this service... namely welding; even if its minimal welding.

First, if you have process validation you will have process verification. ISO 9001; 7.5.2. To have a process be able to deliver the requirements for the full working range of parameters is process validation. Only when this is confirmed we get into the business of controlling individual run and this is called process verification or process control.:bigwave:

Again, Elsmar Cove saved my day. As I sit here rewriting our Quality Manual on clause 7.5.2, the inputs I gain from this site have saved many, many hours of wandering the Web and finding nothing. It's all here. :thanx:

Again, Elsmar Cove saved my day. As I sit here rewriting our Quality Manual on clause 7.5.2, the inputs I gain from this site have saved many, many hours of wandering the Web and finding nothing. It's all here. :thanx:

Thank you for the very nice comments! :agree1: :agree1:

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