Process Validation - Hand soldering of components & wires on PCB - Special Process?

[Kumuda]

We are ISO 9001: 2000 certified, In our company we do hand soldering of components / wires on PCB. Is it a special process??? Should we validate this process???

 

[AllanJ]

We are ISO 9001: 2000 certified, In our company we do hand soldering of components / wires on PCB. Is it a special process??? Should we validate this process???

This is a curious question. If you are "certified" one would presume your registrar has satisfied itself whether or not you should validate your soldering process. If your registrar feels you must validate your soldering process, because presently you do not (I assume you do not, hence your question) why then did he/ she certify you? One either complies with the standard or one does not.

If your registrar has no opinion on the matter, I would suggest you decide whether or not validating the soldering process is of benefit to your business. If it was my company, I would certainly qualify the solderers by first training them in soldering, then by training them in the particular soildering proocess to be used and then by examining/ testing a test piece of their work, record the results of the test and also save (space permitting) the test pieces made if there is a safety related or legal risk associated with the soldering done.

To validate the process I would, of course, also examine/ test the resultant solder joints. Perhaps an appropriate sample would suffice, according to the volume of solder work to be done.

I hope this is of some use to you.

 

[Kumuda]

Validation of process

Thx for ur input Allan.
We have been following all the steps that u hv mentioned for validating the soldering process as of now (except for giving PCB's for test soldering & maintaining the same.) Our qualification methodology for personnel on soldering job is only a written test. All that is fine
But what exactly Iam still not able to comprehend is, Does soldering require validation at all when subsequent inspection can identify the product conformity to the requirements??

Can somebody throw some light on this

 

[AllanJ]

Thx for ur input Allan.
We have been following all the steps that u hv mentioned for validating the soldering process as of now (except for giving PCB's for test soldering & maintaining the same.) Our qualification methodology for personnel on soldering job is only a written test. All that is fine
But what exactly Iam still not able to comprehend is, Does soldering require validation at all when subsequent inspection can identify the product conformity to the requirements??

Can somebody throw some light on this

You originally asked whether or not your soldering is a "special process". That expression appeared some years ago in the early quality standards, such as ANSI N45. Indeed, soldering was often listed as one such.

The expression eventually appeared in the 1987 edition of ISO as clause 4.9.2. But, the definition of a "special process" was always silly. As I explained in the first edition of my book "Meeting ISO 9000 in a TQM World", page 198, "I have not encountered any product that cannot be verified by one means or another, including putting it into trial use. There is always an test/ inspection that can fully verify the product - after all that is precisely what one's customers do."

So, I would not think your soldering would need validation at all by any additional means to those you seem to be currently undertaking.

But I would still be uneasy about only requiring a written test for your process owners. It is my view that theory and practice are two entirely different matters. When it comes to a process, I believe in hands-on demonstration by the individual they can do the job correctly.

I hope this also helps.

 

[Kumuda]

Validation of process

Okay,
Then can I show cl-7.5.2 as exclusion??? & if so, under which clause should I show testing personnel for soldering?

 

[Paul Simpson]

Why claim an exclusion?

Okay,
Then can I show cl-7.5.2 as exclusion??? & if so, under which clause should I show testing personnel for soldering?

I have to ask why you are starting off trying to get an exclusion for clause 7.5.2. Even though some people will argue the point each element of ISO 9001 is there for a purpose. For 7.5.2 it is there because people realize there are processes out there that you cannot inspect once they are complete. Soldering is one of them.

So the principle is that if you cannot readily inspect the quality of a solder joint you should validate the soldering process.

But, the definition of a "special process" was always silly.

The wording might be "silly" but the idea is not.

"I have not encountered any product that cannot be verified by one means or another, including putting it into trial use. There is always an test/ inspection that can fully verify the product - after all that is precisely what one's customers do."?

I think this misses the point. The new standard uses the terms "monitor" and "measure" related to the process output (solder joint). The implication is that it is something to be carried out within the organisation. The idea is that if the products from a process are not able to be inspected or measured readily then the company needs to take steps to ensure the process is working well and is robust so as to ensure products that get as far as the customer do work and they aren't filtering out the poor quality products and returning them.

So, I would not think your soldering would need validation at all by any additional means to those you seem to be currently undertaking.

Perhaps Kumuda you need to consider the application and the risk of poor quality joints getting out to the market place and then decide what level of validation you need in parallel with internal product monitoring and process measuring.

 

[AllanJ]

I think this misses the point. The new standard uses the terms "monitor" and "measure" related to the process output (solder joint). The implication is that it is something to be carried out within the organisation. The idea is that if the products from a process are not able to be inspected or measured readily then the company needs to take steps to ensure the process is working well and is robust so as to ensure products that get as far as the customer do work and they aren't filtering out the poor quality products and returning them.
.

Exactly so. Considering the use abuse and misuse to which a product might be subjected as well as determining the capability of an item to withstand inter alia, the actual usage conditions is an essential part of the R&D and design functions. Once that is done, one can prescribe whatever in-house tests/ inspections/ checks and so forth that would mimic/ simulate/ reproduce the type of usage/ environment etc to which the end user (a subtle but important distinction from the customer) may put that product. It is something that is not new: in fact has been rather well established for decades. My post was not suggesting the firm should do what (for example) certain well-known elements of the software industry tend to do: i.e. outsource the product verification to the customer.