Meeting the Requirement of Clause 7.5.2 on Validating Special Processes

Q

qarep

Members..We are the manufacturing organization and have identified two processes as special processes, Soldering and Welding.

Can we meet the requirement of Clause 7.5.2 on validating Special processes by stating, those processes are handled by qualified trained personnel and produce training certificate as evidence.If not can anyone suggest simple validation procedure to validate Soldering process.

My apologies if similar threads are available.Thanks in advance
 

somashekar

Leader
Admin
Re: Special Processes

Hi qarep...
Kindly look through the similar discussions thread down this page.
You are considering just one out of the other parameters that are vital to the process control of soldering or welding. What you are considering is only operator qualification.
When you find out what best parameter suits your soldering (temperature, size and type of the solder, type of solder tip ...etc) and likewise for your welding, and perform several test runs to establish the optimum combination to get your desired solder join or weld join, and is tested for its strength and other parameters., you are more complete.
These parameters applied for your soldering / welding by your qualified operator is your complete validation.
 
D

DRAMMAN

The validation should then be supported by the proper data analysis and documented through control plans, rocedures, etc. Then you have a solid high quality validated process. I would think you would want to do this to prove to yourselves that your processes are optimized and validated. I am sure your team knows instictively through experience how to do the work, but how do you know for sure unless you go through the paces. You are on the right path.
 

John Broomfield

Leader
Super Moderator
Members..We are the manufacturing organization and have identified two processes as special processes, Soldering and Welding.

Can we meet the requirement of Clause 7.5.2 on validating Special processes by stating, those processes are handled by qualified trained personnel and produce training certificate as evidence.If not can anyone suggest simple validation procedure to validate Soldering process.

My apologies if similar threads are available.Thanks in advance

qarep,

You need joint acceptance criteria.

You need evidence that the mating materials, methods, jointing materials and competences result in joints that fulfill the acceptance criteria. This usually means destructive testing of samples.

You need to define the circumstances and methods for re-validation. That is what happens when any of the mating materials, methods, jointing materials and competences change or drift.

Controlling operator competence alone is not enough to validate the process.

John
 

Mikishots

Trusted Information Resource
Members..We are the manufacturing organization and have identified two processes as special processes, Soldering and Welding.

Can we meet the requirement of Clause 7.5.2 on validating Special processes by stating, those processes are handled by qualified trained personnel and produce training certificate as evidence.If not can anyone suggest simple validation procedure to validate Soldering process.

My apologies if similar threads are available.Thanks in advance

No, it is not enough. Training is an expected part, but it is only one portion of the requirements.

You would need (at a minimum):

1. Defined criteria for process approval and review
2. Defined process steps.
3. Evidence that those process steps are met consistently.
4. Approval of equipment used.
5. Qualification of personnel.
6. Use of specific methods and procedures.
7. Requirements for keeping records.
8. Revalidation.
 

AndyN

Moved On
Members..We are the manufacturing organization and have identified two processes as special processes, Soldering and Welding.

Can we meet the requirement of Clause 7.5.2 on validating Special processes by stating, those processes are handled by qualified trained personnel and produce training certificate as evidence.If not can anyone suggest simple validation procedure to validate Soldering process.

My apologies if similar threads are available.Thanks in advance

Not really. It's a bit like asking if an experienced, trained chef is the only reason why good food is produced. We know that the freshest ingredients, appropriate utensils, time, temperatures, method (possibly including a safety practice), checking (visual and taste) etc. are all factors in the production of a dish. No-one would consider it to be any other way. Same with welding and soldering...
 
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