The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page
Go Back   The Elsmar Cove Forum > National and International Business Standards and Requirements > Food and Drug related Topics > Qualification and Validation (including 21 CFR Part 11)
Forum Username


Search the Elsmar Cove
Custom Search
Monitor the Elsmar Forum
Follow Marc & Elsmar
Elsmar Cove Forum RSS Feed  Marc Smith's Google+ Page  Marc Smith's Linked In Page   Marc Smith's Elsmar Cove YouTube Page  Marc Smith's Facebook Page  Elsmar Cove Twitter Feed
Elsmar Cove Groups
Elsmar Cove Google+ Group  Elsmar Cove LinkedIn Group  Elsmar Cove Facebook Group
Sponsor Links





Donate and $ Contributor Forum Access

Courtesy Quick Links

Links that Elsmar Cove visitors will find useful in your quest for knowledge:

Howard's
International Quality Services
Marcelo Antunes'
SQR Consulting
Bob Doering's
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook
IRCA - International Register of Certified Auditors
SAE - Society of Automotive Engineers
Quality Digest Portal
IEST - Institute of Environmental Sciences and Technology
ASQ - American Society for Quality

Related Topic Tags
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.
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  #1  
Old 17th May 2011, 07:50 AM
UweKoehler UweKoehler is offline
Shy Poster (1 to 5 Posts)

 
Registration Date: Oct 2010
 
Posts: 5
Thanks Given to Others: 0
Thanked 0 Times in 0 Posts
Karma Power: 16
Karma: 10
UweKoehler has less than 100 Karma points so far.
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

Sponsored Links
  #2  
Old 17th May 2011, 08:12 AM
harry harry is offline
Super Moderator

 
Registration Date: Sep 2005
Location: Johore/Malaysia
 
Posts: 6,277
Thanks Given to Others: 1,501
Thanked 2,978 Times in 2,066 Posts
Blog Entries: 2
Karma Power: 701
Karma: 18830
harry is appreciated, and has over 1700 Karma points.harry is appreciated, and has over 1700 Karma points.
harry is appreciated, and has over 1700 Karma points.harry is appreciated, and has over 1700 Karma points.harry is appreciated, and has over 1700 Karma points.harry is appreciated, and has over 1700 Karma points.harry is appreciated, and has over 1700 Karma points.harry is appreciated, and has over 1700 Karma points.harry is appreciated, and has over 1700 Karma points.
Re: Validation of wave solder process

Check this thread: Soldering Process Validation
Sponsored Links

  #3  
Old 17th May 2011, 09:43 AM
UweKoehler UweKoehler is offline
Shy Poster (1 to 5 Posts)

 
Registration Date: Oct 2010
 
Posts: 5
Thanks Given to Others: 0
Thanked 0 Times in 0 Posts
Karma Power: 16
Karma: 10
UweKoehler has less than 100 Karma points so far.
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 somashekar is offline
Super Moderator

 
Registration Date: Mar 2008
Location: Bangalore city, INDIA
 
Posts: 4,512
Thanks Given to Others: 1,500
Thanked 2,349 Times in 1,651 Posts
Blog Entries: 2
Karma Power: 508
Karma: 15138
somashekar is appreciated, and has over 1700 Karma points.
somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.
Send a message via Yahoo to somashekar
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.

__________________

Best Regards...
Somashekar BV, INDIA

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 Marcelo Antunes is online now
Addicted to standards

 
Registration Date: Mar 2006
Location: São Paulo, SP, Brazil
 
Posts: 2,358
Thanks Given to Others: 343
Thanked 1,770 Times in 941 Posts
Karma Power: 297
Karma: 13607
Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.
Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.Marcelo Antunes is appreciated, and has over 1700 Karma points.
Send a message via ICQ to Marcelo Antunes Send a message via MSN to Marcelo Antunes Send a message via Skype™ to Marcelo Antunes
Re: Validation of Wave Solder Process - PCBA for Medical Products

AAMI TIR 36:2007, Validation of Software for Regulated Processes might help.

__________________

I'm a moderator on the medical device forums, so if you need help with something, feel free to ask!
  #6  
Old 10th February 2012, 03:35 PM
cutsdean cutsdean is offline
Involved in Discussions

 
Registration Date: Nov 2010
Location: UK
 
Posts: 25
Thanks Given to Others: 13
Thanked 4 Times in 3 Posts
Karma Power: 18
Karma: 30
cutsdean has less than 100 Karma points so far.
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 Mikishots is offline
Appreciated Member

 
Registration Date: Jun 2011
Location: Canada
 
Posts: 830
Thanks Given to Others: 337
Thanked 486 Times in 339 Posts
Karma Power: 103
Karma: 3775
Mikishots is appreciated, and has over 1700 Karma points.
Mikishots is appreciated, and has over 1700 Karma points.Mikishots is appreciated, and has over 1700 Karma points.Mikishots is appreciated, and has over 1700 Karma points.Mikishots is appreciated, and has over 1700 Karma points.Mikishots is appreciated, and has over 1700 Karma points.Mikishots is appreciated, and has over 1700 Karma points.Mikishots is appreciated, and has over 1700 Karma points.
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 JaxQC is offline
Involved in Discussions

 
Registration Date: Apr 2009
Location: USA - OH
 
Posts: 210
Thanks Given to Others: 105
Thanked 108 Times in 82 Posts
Karma Power: 44
Karma: 550
JaxQC is appreciated, and has over 500 Karma points.JaxQC is appreciated, and has over 500 Karma points.JaxQC is appreciated, and has over 500 Karma points.JaxQC is appreciated, and has over 500 Karma points.JaxQC is appreciated, and has over 500 Karma points.JaxQC is appreciated, and has over 500 Karma points.
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
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Forum > National and International Business Standards and Requirements > Food and Drug related Topics > Qualification and Validation (including 21 CFR Part 11)

Do you find this discussion thread helpful and informational?


Bookmarks


Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
PPAP Validation for Electronic Parts (PCBA) oshoneoman APQP and PPAP 6 21st November 2011 08:46 PM
Process Validation of Lathed Products Adam S Documentation Control Systems, Procedures, Forms and Templates 3 22nd February 2008 05:50 AM
Need help on correct material composition of solder resist or solder mask in PCB for dubbie_dhoy APQP and PPAP 1 3rd April 2007 03:30 PM
Explain the process validation procedure in the manufacture of IVD products vramc ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 1 29th December 2005 01:17 PM
PCB (Printed Circuit Board) Assembly - Wave Solder Capability Chris May Statistical Analysis Tools, Techniques and SPC 6 2nd April 2002 09:38 PM



The time now is 04:26 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


   


Marc Timothy Smith - Elsmar.com
8466 LeSourdsville-West Chester Road, Olde West Chester, Ohio 45069-1929
513 341-6272