Is Soldering a Special Process?

[Al Rosen]

Okay, please excuse my ignorance.....I'm taking the above to mean that any process verified by destructive testing is considered to fall under 7.5.1. Is that correct?

Here's an example - we have a bag sealer in the plant that seals foil bags shut. Our verification of this process consists of breaking the bag; if the foil material fails, it's a pass, and if the seal splits, it's a fail.

This is a 7.5.1, then, right? But if we chose *not* to trash one bag per hour, it would fall under 7.5.2?

Sorry about the nit-picking, but I really struggled with this in another post - if this is a good way to look at it, then I think I might just get it!

Cheers - happy Friday!
-R.

IMO it is always 7.5.2.

Sealing your bags are a special process, because you cannot verify the seal without destroying it. The process requires validation IAW 7.5.2. Part of verifying/validating the process may be breaking the seals of a randomly chosen no. of bags and recording the force required to break the bags or some other parameter that might be indicative of a good seal. You should also monitor the process variables.

 

[Sam]

Okay, please excuse my ignorance.....I'm taking the above to mean that any process verified by destructive testing is considered to fall under 7.5.1. Is that correct?

Here's an example - we have a bag sealer in the plant that seals foil bags shut. Our verification of this process consists of breaking the bag; if the foil material fails, it's a pass, and if the seal splits, it's a fail.

This is a 7.5.1, then, right? But if we chose *not* to trash one bag per hour, it would fall under 7.5.2?

Sorry about the nit-picking, but I really struggled with this in another post - if this is a good way to look at it, then I think I might just get it!

Cheers - happy Friday!
-R.

IMO - All products are required to be produced in a controlled environment as described in 7.5.1, including the Bag.
Further evaluation of the bag determines it has a characteristic, sealing, that cannot be "verified by subsequent monitoring or measurement", meaning the seal strength cannot be verified during the remaining normal production run. Thereby failure would only be apparent when received by the customer, which means you have a special process. In this case you implement a seal strength test, as you did, at the sealing step to verify the strength.

 

[Rachel]

What's the sound of a lightbulb going on?

Thanks fellas...

Cheers,
-R.

 

[Cari Spears]

...You should also monitor the process variables.

Right. For example, in between your scheduled destructive testing, you can monitor the cycle time, pressure, temp. etc. of the machine that is sealing the bag.

"If you could just dooo that, that would be great" (tee hee)

 

[Fatboy]

A test on each run would be nice except we are talking about manual soldering mostly for repairs and reworks.

 

[Al Rosen]

A test on each run would be nice except we are talking about manual soldering mostly for repairs and reworks.

I guess that reverts to visual inspection of the repair and rework. You could certify your solder operators and forgo 100% inspection for periodic auditing.

 

[NewQM]

Perform a destructive test on the solder on each run.

What if we only do custom projects?

And, furthermore, what if we only *actually* solder 5-6 times a year?

Still a special process per ISO 7.5.2? How can i validate/verify?

Is something in the neighborhood of "all solderings are visually verified and performed by competent and trained personnel."

We, of course, have a final product inspection...


Half the people i talk to say exclude 7.5.2, the other half say keep it and write that we "currently do not have..."

thoughts?

 

[Jen Kirley]

What if we only do custom projects?

And, furthermore, what if we only *actually* solder 5-6 times a year?

Still a special process per ISO 7.5.2? How can i validate/verify?

Is something in the neighborhood of "all solderings are visually verified and performed by competent and trained personnel."

We, of course, have a final product inspection...


Half the people i talk to say exclude 7.5.2, the other half say keep it and write that we "currently do not have..."

thoughts?

Whether the job is custom or not, 7.5.2 applies.

It's really about validating the process's ability to produce an acceptable product. The premise is that not all things can be seen or measured for inspection after assembly or further processing. So, when that is the case, the process gets "inspected" versus the product itself. This is for critical or visual pieces - the requirement isn't necessarily for things like glove box hinges.

If a process requalification is needed for each run because you only do it 5-6 times per year, so be it.