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

[randy04]

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

 

[morgand - 2006]

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.

 

[Statistical Steven]

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.

 

[Gert Sorensen]

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??

 

[randy04]

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.

 

[Al Rosen]

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??

Gert, how do you verify welding?

 

[morgand - 2006]

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 Sorensen]

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

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

 

[chascoffin]

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

 

[Al Rosen]

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

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

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).