The Cove Business Standards Discussion Forums
Welding Process Validation Plan
Please read this thread...
Software update
Welding Process Validation Plan
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Welding Process Validation Plan

Monitor the Elsmar Forum
Courtesy Quick Links


Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services


Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC



International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags
iso 13485 - medical device qms, validation of machines equipment processes design etc., validation plan, welding
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 1st March 2013, 02:08 PM
Jason S

 
 
Total Posts: 7
Please Help! Welding Process Validation Plan

Our company is trying to earn ISO 13485 certification. Along with that we have been introduced to process validation. Our company is a contract manufacturing shop specializing in welding. We do a lot of work for medical device manufacturers as a second or third tier vendor. We frequently get work from machine shops who require welding, mainly laser welding.

We keep running into problems when trying to create a validation plan specifically process performance and qualification. We have installation qualifications and operational qualifications in place. 100% of our work is on customer supplied parts. So getting parts to qualify our process performance is like trying to squeeze water from a rock. The other problem is that we have little to no defined tolerance or quantitative acceptance criteria. Inspections are typically only visual. A few customers require a tensile test or cross sectioning, but this is only about 5% or less. If they do require this, it's only when we initially weld parts. It's not done with any frequency. There are next to zero specs for the weld itself. Rarely is there a penetration requirement or weld size. Rare being <1% of our orders.

Has anyone else had similar issues? What was your explanation regarding process validation to an ISO auditor? What did you do to qualify your processes with no quantitative criteria?

Thanks for the help.

Sponsored Links
  Post Number #2  
Old 4th March 2013, 06:28 AM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,339
Re: Welding Process Validation Plan

A Quick Bump!

Can someone help Jason?

Thank you very much!!
  Post Number #3  
Old 4th March 2013, 07:13 AM
shamhaider

 
 
Total Posts: 20
Re: Welding Process Validation Plan

As welding is considered as special process..so it needs validation such as
1) Welding parameters... temperature, pressure, colling water temp etc.. must be as per defined standards..
2) The operators must be trained and skilled to do the job..
3) The destructive testing must be carried out as per defined frequency/customer rqmnt..
  Post Number #4  
Old 4th March 2013, 08:39 AM
Jen Kirley's Avatar
Jen Kirley

 
 
Total Posts: 6,143
Re: Welding Process Validation Plan

Good day Jason S,

Weld process verification, like other processes is done to ensure you and the customer can depend on outcomes.

As always, it starts with control. So the customer doesn't give requirements, but we can be sure the industry does. Welding-advisers.com has put out a web page titled Welding-validation, Definitive Approval Stamp to explain it. I am not affiliated with welding-advisors.com. That page has links to ANSI and AWS welding standards too.

The standards' criteria for welder qualification processes, destructive and nondestructive testing are generally based on the industry the welds serve. I doubt you will be held to nuclear industry weld standards, so look for differentiation. Your ISO auditor isn't looking for a full blown-out program like the nukes would have, but we do expect to see that you recognize the requirements from the industry, have met them and keep up-to-date with them.

I hope this helps!
Thank You to Jen Kirley for your informative Post and/or Attachment!
  Post Number #5  
Old 5th March 2013, 07:44 PM
Darrell B

 
 
Total Posts: 53
Re: Welding Process Validation Plan

Your final responsibility is to meet your customers expectations. If they don't give you parameters, then it can be a safe assumption that if the reject/ failure rate is low that the customer is happy.

For ISO sake, you could develop your own parameters. Red line the drawing for weld sizes, develop a WPS for weld machine settings, etc. Get rid of the "tribal knowledge" and document what you do.
  Post Number #6  
Old 18th May 2014, 09:49 AM
cosmobenz

 
 
Total Posts: 9
Re: Welding Process Validation Plan

Hello, did you ever get anywhere on this? I need to get this done asap. Any help would be appreciated.
  Post Number #7  
Old 18th May 2014, 11:16 AM
John Broomfield's Avatar
John Broomfield

 
 
Total Posts: 2,622
Lightbulb Re: Welding Process Validation Plan

Jason S and cosmobenz,

Is it reasonable for a customer to expect a contract manufacturing shop specializing in welding to be the expert in helping the customer to establish acceptance criteria (welding specifications) for their welds?

Providing your customer with a welding service and doing nothing to specify and validate the welds for yourselves exposes your firm to liability.

You could choose to manage this risk by offering the customer a choice of recommended (and validated) weld specifications.

You could also provide the customer with the option to pay for validation (destructive) testing if the joined metals belong to the customer or are specified by the customer. You would then test the coupon made strictly in accordance with the selected specification and provide the customer with the test results.

You would also revalidate the welding specification in the event of any change to the joined metals, weld materials, welders or methodology. Of course, if this is the case, your contract must oblige the customer to inform your firm of any change to the joined metals.

John
Thank You to John Broomfield for your informative Post and/or Attachment!
  Post Number #8  
Old 18th May 2014, 07:14 PM
kgott

 
 
Total Posts: 1,027
Re: Welding Process Validation Plan

Quote:
In Reply to Parent Post by Jason S View Post

Our company is trying to earn ISO 13485 certification. Along with that we have been introduced to process validation. Our company is a contract manufacturing shop specializing in welding. We do a lot of work for medical device manufacturers as a second or third tier vendor. We frequently get work from machine shops who require welding, mainly laser welding.

We keep running into problems when trying to create a validation plan specifically process performance and qualification. We have installation qualifications and operational qualifications in place. 100% of our work is on customer supplied parts. So getting parts to qualify our process performance is like trying to squeeze water from a rock. The other problem is that we have little to no defined tolerance or quantitative acceptance criteria. Inspections are typically only visual. A few customers require a tensile test or cross sectioning, but this is only about 5% or less. If they do require this, it's only when we initially weld parts. It's not done with any frequency. There are next to zero specs for the weld itself. Rarely is there a penetration requirement or weld size. Rare being <1% of our orders.

Has anyone else had similar issues? What was your explanation regarding process validation to an ISO auditor? What did you do to qualify your processes with no quantitative criteria?

Thanks for the help.
Just in case this helps;

perhaps your validation plan might consist of records of returns, failures, complaints, NCs and incident investigation reports and your own statistics about the number of parts supplied vs the number of the above you have received from customers, industry and CB auditors, end users and regulators.

I.e ratio of the above to the number of parts supplied.

Do you do radiography, ultrasound etc and any other testing on components you weld? These are also records
Thanks to kgott for your informative Post and/or Attachment!
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >

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
Emoticons 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
Justification for Not Having a Validation Plan for a Critical Process medwise ISO 13485:2016 - Medical Device Quality Management Systems 4 25th March 2015 09:45 PM
Manufacturing Process Validation Destructive Testing Sampling Plan Advice Mark Meer Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1 26th February 2014 04:42 AM
TIG Welding NG Mode Matrix for Robo Welding process praveen011281 IATF 16949 - Automotive Quality Systems Standard 1 4th December 2009 09:23 PM
Welding - Is welding always a special process per ISO9001:2000 Clause 7.5.2 Sohail ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33 7th November 2008 12:44 PM
Resistance welding process - Cold rolled and some zinc plated welding keithm696 - 2008 Various Other Specifications, Standards, and related Requirements 2 8th January 2007 11:47 AM



The time now is 11:41 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"