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Validation of Wave Solder Process - PCBA for Medical Products

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ghtf (global harmonization task force), medical devices (general), soldering, validation plan, validation testing, wave soldering, verification (general), printed circuit boards and assemblies (see pcb and pcba), validation of machines equipment processes design etc.
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  #1  
Old 17th May 2011, 07:50 AM
UweKoehler

 
 
Posts: 5
Please Help! Validation of Wave Solder Process - PCBA for Medical Products

Hello,

I'm urgendly looking for information and help with validating a automated wave soldering process for a PCBA.
We build a PCBA for a medical product and our customer wants us to validate the wave soldering process (the machine: starting with flux over preheat till soldering).
Before I always thougt that per GHTF it would be enough to visually check the solder joints and for hidden solder joints x-ray them. This will be verification so no validation is needed.

But our customer wants to have it validated anyway.

I now need to calculate the time, samples, manpower... needed
and I also need to write a plan, but at the moment I'm not sure what the best way is to validate it.

Is there anybody who can help me with some information, links, documents on how to validate a automated wave soldeirng process.

Thanks in Adavance

Uwe

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  #2  
Old 17th May 2011, 08:12 AM
harry

 
 
Posts: 6,277
Re: Validation of wave solder process

Check this thread: Soldering Process Validation
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  #3  
Old 17th May 2011, 09:43 AM
UweKoehler

 
 
Posts: 5
Re: Validation of wave solder process

Sorry that thread did not help.

It's about hand soldering
and the IEC document inked in it is about SMT

I need some help with WAVE soldering

Uwe
  #4  
Old 10th February 2012, 12:10 PM
somashekar's Avatar
somashekar

 
 
Posts: 4,598
Re: Validation of Wave Solder Process - PCBA for Medical Products

Quote:
In Reply to Parent Post by UweKoehler View Post

Hello,

I'm urgendly looking for information and help with validating a automated wave soldering process for a PCBA.
We build a PCBA for a medical product and our customer wants us to validate the wave soldering process (the machine: starting with flux over preheat till soldering).
Before I always thougt that per GHTF it would be enough to visually check the solder joints and for hidden solder joints x-ray them. This will be verification so no validation is needed.

But our customer wants to have it validated anyway.

I now need to calculate the time, samples, manpower... needed
and I also need to write a plan, but at the moment I'm not sure what the best way is to validate it.

Is there anybody who can help me with some information, links, documents on how to validate a automated wave soldeirng process.

Thanks in Adavance

Uwe
Forget Medical products.
How do you qualify the wave soldering process for a PCBA?
The solder used, The flux used, The bath temperature, The wave height, The zone temperatures, The chain speed,
That is about it. Are you in control of your wave soldering process ? As you answer this question you are validating.
PS: Also include operator qualification.

Last edited by somashekar; 10th February 2012 at 10:40 PM.
  #5  
Old 10th February 2012, 12:45 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Posts: 2,502
Re: Validation of Wave Solder Process - PCBA for Medical Products

AAMI TIR 36:2007, Validation of Software for Regulated Processes might help.
  #6  
Old 10th February 2012, 03:35 PM
cutsdean

 
 
Posts: 26
Re: Validation of Wave Solder Process - PCBA for Medical Products

These people have some good research about reliability of PBGA processes which may help in developing a validation process


http://www.emeraldinsight.com/journa...4404&show=html
  #7  
Old 10th February 2012, 06:54 PM
Mikishots's Avatar
Mikishots

 
 
Posts: 846
Re: Validation of Wave Solder Process - PCBA for Medical Products

Quote:
In Reply to Parent Post by UweKoehler View Post

Hello,

I'm urgendly looking for information and help with validating a automated wave soldering process for a PCBA.
We build a PCBA for a medical product and our customer wants us to validate the wave soldering process (the machine: starting with flux over preheat till soldering).
Before I always thougt that per GHTF it would be enough to visually check the solder joints and for hidden solder joints x-ray them. This will be verification so no validation is needed.

But our customer wants to have it validated anyway.

I now need to calculate the time, samples, manpower... needed
and I also need to write a plan, but at the moment I'm not sure what the best way is to validate it.

Is there anybody who can help me with some information, links, documents on how to validate a automated wave soldeirng process.

Thanks in Adavance

Uwe
Validation would include the variables you can control, as noted by Somashekar. If you decide to go the route of inspecting the final product and conducting x-ray examination, are you planning to do this for ALL PCBA's coming off the machine? By far the most effective and simplest method would be to record your process variables on a continuing basis and compare them against the process parameters that you know will produce a conforming part. it's only a pain right now because you haven't started doing it yet.

You've claimed the ability to identify a conforming part, so the metrics used in the comparison are already in place.

At my workplace (aerospace), one of the processes that falls into this area is plating of aluminum. Sure, we can check the final product (by sending out coupons to external labs), but the volume is high - by the time we get results back, many lots have been processed in that time. The only viable method is to validate the process itself - that way, we know immediately when things get out of whack, saving ourselves money and risk by being able to stop and address the issue BEFORE the customer receives the product.
Thanks to Mikishots for your informative Post and/or Attachment!
  #8  
Old 14th February 2012, 09:13 AM
JaxQC

 
 
Posts: 210
Re: Validation of Wave Solder Process - PCBA for Medical Products

One way is to always start with a PFD (Process Flow Diagram) & pFMEA to understand what factors to address in the validation.

(made up just for examples but the idea is there)

solder used – document evidence that it is the correct type, how production verifies or can’t use the wrong one

flux used – 1) document evidence that it is the correct type, how production verifies or can’t use the wrong one 2) Too much / little =adjust equipment to your process spec settings for both extremes, confirm you still get good parts

bath temperature - zone temperatures – Too hot is a negligible difference (document justification but may not need to trial) but too cold is a product recall so confirm validation trial parts with process set at worst case low still produces good product.

zone temperatures – Too hot/cold = trial at both end of the spec- confirm do you get good parts

chain speed – too fast (not enough solder) / slow (too much, puddling) = adjust equipment & trial at both end of the spec- confirm do you get good parts

operator qualification – what qualification? certification required?, training?, quality checks (manual/automatic)? etc
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