Hi Everyone!

As I've noted before, my company makes audio equipment - for these purposes, think receivers or amplifiers.

Does the welding process of the metal housings need to be validated? The majority of the metal is just bent; however, some of the joints and junctions are welded to ensure the housing doesn't fall apart.

We have made this exact housing for the past 5 years with no customer complaints or feedback of the housings ever failing due to anything let alone welding (we are not yet certified but are looking to become ISO 9001 cert.). I would think we could make an argument that we can analyze all the data that we have to provide evidence that the welding process satisfies its intended use. I know in the medical industry, we would use the data and a risk assessment to justify not validating this process.

Is this justifiable? I cannot see a reason to validate a process when we have evidence to show that it has never been a problem. On the flip side, if we had not made this exact housing for the past 5 years with no problems, or if we begin to encounter problems, or if we change the process, it will have to be validated.

Any information would be greatly appreciated! :thanx:

Hi Everyone!

As I've noted before, my company makes audio equipment - for these purposes, think receivers or amplifiers.

Does the welding process of the metal housings need to be validated? The majority of the metal is just bent; however, some of the joints and junctions are welded to ensure the housing doesn't fall apart.

We have made this exact housing for the past 5 years with no customer complaints or feedback of the housings ever failing due to anything let alone welding (we are not yet certified but are looking to become ISO 9001 cert.). I would think we could make an argument that we can analyze all the data that we have to provide evidence that the welding process satisfies its intended use. I know in the medical industry, we would use the data and a risk assessment to justify not validating this process.

Is this justifiable? I cannot see a reason to validate a process when we have evidence to show that it has never been a problem. On the flip side, if we had not made this exact housing for the past 5 years with no problems, or if we begin to encounter problems, or if we change the process, it will have to be validated.

Any information would be greatly appreciated! :thanx:

IMO, yes it should be a controlled process and needs validation.... you mention that by anlyzing all the data (I understand this as past data) you can justify that you don´t need validation... fine and dandy, but not always will a customer complain... and he may just not complain about a faulty weld on your speaker.. he might just repair it himself...

.... however, some of the joints and junctions are welded to ensure the housing doesn't fall apart.
Sorry to disagree with Ted. IMHO the welding process doesn't need to be validated as there is no engineering requirement for the weld.

What's the risk of not validating it? History isn't a predictor of the future, however, if you did encounter a number of welded joints which popped open, what would be the effect on the customer and your reputation, recall/replacement costs? My guess is that for the effects and volume of problems likely, you'll just shrug your shoulders and replace them!

In a simple welded structure like you describe, the quality of the weld can be determined by looking at the spot weld 'nugget' in the metalwork. I'd set some criteria for that and some basic preventive maintenance on the weld tips/current/dwell settings and leave it at that..............until I noticed a problem in QC.