7.5.2 Validaton of processes for production and service provision

A

Angelika

#1
Thanks for this great forum. I wished we had something similar at such a high level here in Germany. Otherwise the Cove helps me to fresh up my English and I really enjoy reading your threads. Lately it has given me some new ideas, especially as to process mapping. Thanks a lot.

Today I have a question regarding "Special processes" and I hope that one of you can help me.

One of the companies I am working for has had an EN 9100-audit. The inspector requested procedures for the validation of special processes (audit finding). Before the audit took place, the company was sure not to have any special processes. Now they learnt that varnishing, laminating and riveting are special processess.

The company is relatively small and does not want to integrate complicated procedures in their quality management system.

Does anyone of you have an idea how to handle this in an easy way?

Thanks a lot and kind regards,
Angelika
 
Elsmar Forum Sponsor
D

Don Palmer

#2
Hi Angelika,
I do not have an answer for you. I hope some of our most knowledgable AS/EN9100 people will see your post and offer some ideas. Good day to you.:)
 
A

Angelika

#3
Muleskinner said:
Hi Angelika,
I do not have an answer for you. I hope some of our most knowledgable AS/EN9100 people will see your post and offer some ideas. Good day to you.:)





Thank you, Muleskinner, for your kind words – apparently none of the specialists of this forum has had an answer for me. I am not sure if I did not describe my problem clear enough or if none of them has ever had to do with this matter.

In the meantime, I (hopefully) have found a solution how to handle this matter and I would like to share it with you all, at the same time asking you for your opinion and your criticism.

Just a few introducing words to make you more familiar with my problem.

The whole matter came up, when one of my customers had a second-party-audit by a member of ASD (former AECMA) i.a.w. EN 9100.

The auditors found that the company had special processes, i.e., processes that cannot be verified by subsequent monitoring or measurement – including processes where deficiencies become apparent only after the product is in use or the service has been delivered (9100/7.5.2). Painting, laminating, welding, riveting, electroplating are some examples for such special processes which require special procedures to show conformity with the requirements.

Here is my proposal for a procedure:

1. Determine all the special processes
2. Determine product specification and pass/fail criteria.
3. Determine the required qualification of personnel involved in special
processes and make sure that special processes are performed only by
sufficiently qualified personnel
4. Determine suitable equipment and make sure that only approved
equipment is used when performing special processes
5. Determine and control procedures for performing and inspecting special
processes, including additional in-process-verification points.
6. Determine the required records.
7. Ensure qualification and approval of special processes prior to use (e.g.
by destructing testing of a sample)
8. Compare results from destructive testing with product specification.
9. In case of pass: Release of product
10. In case of fail: error analysis and corrective action

The auditors explained that special processes will be more and more important in the future - this is why I still try to learn more about it.

Looking forward to your comments:)

Best regards,
Angelika
 

Douglas E. Purdy

Quite Involved in Discussions
#4
I'm not Muleskinner and I'm No Specialist Either

Angelika said:
Thank you, Muleskinner, for your kind words – apparently none of the specialists of this forum has had an answer for me. I am not sure if I did not describe my problem clear enough or if none of them has ever had to do with this matter.

In the meantime, I (hopefully) have found a solution how to handle this matter and I would like to share it with you all, at the same time asking you for your opinion and your criticism.

Just a few introducing words to make you more familiar with my problem.

The whole matter came up, when one of my customers had a second-party-audit by a member of ASD (former AECMA) i.a.w. EN 9100.

The auditors found that the company had special processes, i.e., processes that cannot be verified by subsequent monitoring or measurement – including processes where deficiencies become apparent only after the product is in use or the service has been delivered (9100/7.5.2). Painting, laminating, welding, riveting, electroplating are some examples for such special processes which require special procedures to show conformity with the requirements.

Here is my proposal for a procedure:

1. Determine all the special processes
2. Determine product specification and pass/fail criteria.
3. Determine the required qualification of personnel involved in special
processes and make sure that special processes are performed only by
sufficiently qualified personnel
4. Determine suitable equipment and make sure that only approved
equipment is used when performing special processes
5. Determine and control procedures for performing and inspecting special
processes, including additional in-process-verification points.
6. Determine the required records.
7. Ensure qualification and approval of special processes prior to use (e.g.
by destructing testing of a sample)
8. Compare results from destructive testing with product specification.
9. In case of pass: Release of product
10. In case of fail: error analysis and corrective action

The auditors explained that special processes will be more and more important in the future - this is why I still try to learn more about it.

Looking forward to your comments:)

Best regards,
Angelika
Angelika,

It seems to me that you have the right plan. I was going to respond the other day as to the company not wanting to integrate complicated procedures into their Quality Management System. It should not be complicated if they have these processes under control. They just needed to document them. But it sounds as though they may not have had the processes validated. That is an important element that you are addressing in your plan.

I could see varnishing and lamination as special control processes, but do not understand why riveting is special. Is there some specification for the roll-over onto the mating matierial that makes this special - or could it be fastened or not fastened? Just wondering.

I have a situation here concerning the brazing of carbide tips onto steel for twist drills. Besides having all the required brazing materials, temperatures, and other controls, the company no longer performs a destructive test of tools that have failed some other characteristic of the tools (it was called a Braze Check). The manufacturing supervisor of that area is stating that the wetting of the braze joint is the critical criterion to determine if the braze operation was satisfactorily performed or not. We do not need to perform a destructive test to validate the brazing action (according to him). I am not an engineer and I do not know how to deal with this situation. We see some voids and/or nonfills between the carbide tip and the steel (along the edge - can not confirm visually how deep they are), but there are no criteria as to if any amount of these voids / nonfills is acceptable or rejectable. So how you validate is important - if you know how to validate the process. I just do not know how to validate this brazing process (any suggestions or recommendations would be appreciated).

Doug
 
D

Don Palmer

#5
Doug, thanks for lending an assist to Angelika

Hopefully, your comments help Angelika with her concern. :)

Douglas E. Purdy said:
Angelika,

It seems to me that you have the right plan. I was going to respond the other day as to the company not wanting to integrate complicated procedures into their Quality Management System. It should not be complicated if they have these processes under control. They just needed to document them. But it sounds as though they may not have had the processes validated. That is an important element that you are addressing in your plan.

I could see varnishing and lamination as special control processes, but do not understand why riveting is special. Is there some specification for the roll-over onto the mating matierial that makes this special - or could it be fastened or not fastened? Just wondering.

I have a situation here concerning the brazing of carbide tips onto steel for twist drills. Besides having all the required brazing materials, temperatures, and other controls, the company no longer performs a destructive test of tools that have failed some other characteristic of the tools (it was called a Braze Check). The manufacturing supervisor of that area is stating that the wetting of the braze joint is the critical criterion to determine if the braze operation was satisfactorily performed or not. We do not need to perform a destructive test to validate the brazing action (according to him). I am not an engineer and I do not know how to deal with this situation. We see some voids and/or nonfills between the carbide tip and the steel (along the edge - can not confirm visually how deep they are), but there are no criteria as to if any amount of these voids / nonfills is acceptable or rejectable. So how you validate is important - if you know how to validate the process. I just do not know how to validate this brazing process (any suggestions or recommendations would be appreciated).

Doug
 
A

Angelika

#6
Douglas E. Purdy said:
Angelika,

It seems to me that you have the right plan. I was going to respond the other day as to the company not wanting to integrate complicated procedures into their Quality Management System. It should not be complicated if they have these processes under control. They just needed to document them. But it sounds as though they may not have had the processes validated. That is an important element that you are addressing in your plan.

I could see varnishing and lamination as special control processes, but do not understand why riveting is special. Is there some specification for the roll-over onto the mating matierial that makes this special - or could it be fastened or not fastened? Just wondering.

I have a situation here concerning the brazing of carbide tips onto steel for twist drills. Besides having all the required brazing materials, temperatures, and other controls, the company no longer performs a destructive test of tools that have failed some other characteristic of the tools (it was called a Braze Check). The manufacturing supervisor of that area is stating that the wetting of the braze joint is the critical criterion to determine if the braze operation was satisfactorily performed or not. We do not need to perform a destructive test to validate the brazing action (according to him). I am not an engineer and I do not know how to deal with this situation. We see some voids and/or nonfills between the carbide tip and the steel (along the edge - can not confirm visually how deep they are), but there are no criteria as to if any amount of these voids / nonfills is acceptable or rejectable. So how you validate is important - if you know how to validate the process. I just do not know how to validate this brazing process (any suggestions or recommendations would be appreciated).

Doug

Thank you for your explanations, Doug.

By and by I get a better understanding for the whole matter. I am not an engineer either and that is why sometimes I am really "fighting" with all that technical stuff.

Thank you once again and sorry that I cannot assist you with a suggestion for your validating problem...........

Angelika
 
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