IRIS audit - Discussion about Special Processes

#1
Hi,

During our current external audit in ISO 9001 and IRIS we ended up having a rather weird discussion about the term "Special Process".

We're in the cable industry and has pointed out specific processes in a list which we review yearly with solusions considering special processes as we has interpreted the standards. This list considers processes where we can't guarantee or control the end-result without breaking the product.

During the audit in our production the auditor was absolutely 100% sure all of our different "lines" (machines) are all special processes, so he wrote a non-conformaty regarding our handling of special processes.

Could anybody explain this to me (cause the auditor just pointed at IRIS segment 6 but I can't get a hold of it atm) and if I'm wrong; how do I solve this? We have separate worksheets with all testing included for each product in each individual machine.
 
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#2
We do some cable work, and I doubt 100% of your machines are special processes. For instance, if a part needs to be able to withstand 10 pounds of pulling force, you can put it in a tester and see if it passes. We have some customers who ask us to 100% test at the rated max force. Your customers may have different requirements.

Special processes are things that can not be adequately inspected. So anything you could inspect but choose not to (perhaps because you had no failures in a 5 year period) is not a special process.
 
#4
How can you expect to comply with a requirement if you don't have access to it?

The following comes from ISO/TS 22163:2017

Thank you for this. We do have the IRIS-standard at site but I don't hold the main responsibility in this, I was just curious since we haven't gotten a NC about this since like 15 years back, which we solved by creating this list of our special processes and do yearly internal audits regarding this list.

We do some cable work, and I doubt 100% of your machines are special processes. For instance, if a part needs to be able to withstand 10 pounds of pulling force, you can put it in a tester and see if it passes. We have some customers who ask us to 100% test at the rated max force. Your customers may have different requirements.

Special processes are things that can not be adequately inspected. So anything you could inspect but choose not to (perhaps because you had no failures in a 5 year period) is not a special process.
We have some of those testings aswell, like HOT-SET and aging tests, which are made in our labratory, but still in relation to the current order.

I don't know, we will have a discussion and most likely refuse the NC, just wanted som input from others.
 

somashekar

Staff member
Admin
#5
During the audit in our production the auditor was absolutely 100% sure all of our different "lines" (machines) are all special processes, so he wrote a non-conformaty regarding our handling of special processes.
It is not the auditor who decides what are your special processes.... That said, the note in the post #3 display are most typical special processes. I have seen that crimping for example is not a special process in some cable industries, and has been justified based on the process control, tool maintenance and monitoring, and the batch release system based on batch starting and ending records of inspection (FAI and LAI) The same has also been well documented in the risk management.
I don't know, we will have a discussion and most likely refuse the NC, just wanted som input from others
Your records of risk management and process must support your NC refusal, as well as your internal complaints or customer complaints.
 

John Broomfield

Staff member
Super Moderator
#6
Also, consider the cost benefits of treating processes as if they are special.

Such processes are designed to result in products that reliably conform to specifications without any need for further testing or inspection.
 
#7
IRIS goes way above and beyond 9001, so I sympathize there. I dont have the current IRIS standard, so without knowing what it states, I can't help much, we decided to avoid IRIS entirely after researching it in depth, its another case of a large customer setting the requirements, sort of like Boeing in the AS9100 world. If you could post segment 6 wording, or what the auditor said exactly, that would help.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#8
ISO/TS 22163 is the global standard for quality management systems in the rail industry. It is based on the ISO 9001 quality management standard, with the addition of rail-specific requirements. Released in May 2017, it replaced the previous quality standard IRIS Rev. 02
 
#9
IRIS goes way above and beyond 9001, so I sympathize there. I dont have the current IRIS standard, so without knowing what it states, I can't help much, we decided to avoid IRIS entirely after researching it in depth, its another case of a large customer setting the requirements, sort of like Boeing in the AS9100 world. If you could post segment 6 wording, or what the auditor said exactly, that would help.
I have it on my computer at work now so I'll share it tomorrow when I'm stationed. The segment on special processes was a full 6 pages addition and explanation about what a special process is. We kind of solved this today tho after an hour of intense studying of this segment. We cover all of The requirements, but we were a document short showing how we deal with this standard. So I just collected and put together a few different documents and the auditor was very pleased again.
 
#10
For you who are interested, this is the full explanation according to IRIS what a special process is, moderators hopefully will post my link (since I'm not trusted YET).

This was changed in 2014, but the former auditor never pointed this out. Hard to keep up if the auditor doens't mention this is not fullfilled.
 
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