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.
 
Elsmar Forum Sponsor

outdoorsNW

Quite Involved in Discussions
#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
Super Moderator
#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.
 

hogheavenfarm

Quite Involved in Discussions
#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.
 
Thread starter Similar threads Forum Replies Date
E AS9100 similarity to IRIS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
E International Railway Industry Standard (IRIS) Auditor Training Requirements Other ISO and International Standards and European Regulations 13
J Meaning of Business Management System in IRIS (International Rail Industry Standard)? Various Other Specifications, Standards, and related Requirements 4
M International Rail Industry Standard (IRIS) GM/RT2450 Other ISO and International Standards and European Regulations 3
hogheavenfarm ISO then International Railway Industry Standard (IRIS) Or straight to IRIS? Other ISO and International Standards and European Regulations 3
J How to get the International Railway Industry Standard (IRIS) Various Other Specifications, Standards, and related Requirements 5
T International Railway Industry Standard (IRIS) Other ISO and International Standards and European Regulations 4
M How to answer ISO9001:2015 audit finding of old revisions of documents being used? Document Control Systems, Procedures, Forms and Templates 5
B UKRP to what level should you audit Class I Technical Documentation? UK Medical Device Regulations 0
I Audit is tomorrow but I refused to participate Misc. Quality Assurance and Business Systems Related Topics 11
I ISO 17025:2017 / ANAB 3125 - Articulating / Communicating Risks vis-a-vis Audit Findings ISO 17025 related Discussions 2
D Verify Audit Trail of SaaS system Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
D Re-labeler - audit the supplier EU Medical Device Regulations 2
J Outsourced Internal Audit requirements for Aerospace Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 21
A PPAP question for audit APQP and PPAP 16
D Number of people to be interviewed during an internal audit? Internal Auditing 6
B Gamma Quarterly Audit Medical Device and FDA Regulations and Standards News 1
A Anxiety - ISO Re-registration Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 69
Ed Panek Auditor MDR (Presub audit) finding EU Medical Device Regulations 2
Q Easy CARs for Internal Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
D Question and advice for a supplier self audit questionnaire ISO 13485:2016 - Medical Device Quality Management Systems 6
S Quarterly Dose Audit Medical Device and FDA Regulations and Standards News 5
H When is a SOC 2 audit necessary? IEC 27001 - Information Security Management Systems (ISMS) 3
J NCR- Failure of contract review process - NADCAP audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
D Special IATF audit of sub-supplier IATF 16949 - Automotive Quality Systems Standard 18
A Internal audit plan and processes for ISO 14001:2015 ISO 14001:2015 Specific Discussions 3
D Question on using audit checklist ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 20
C API Q1 internal audit report Internal Auditing 3
P Filled in F48/F49 for internal audit ISO 17025:2017 Internal Auditing 2
J Internal audit random sampling methodology Internal Auditing 2
D Major NC from last audit not fixed not sure how to fix General Auditing Discussions 10
X Sample SOC2 audit report (or a redacted one) IEC 27001 - Information Security Management Systems (ISMS) 0
D Lead time to schedule an ISO 13485 audit General Auditing Discussions 2
G Organizing internal audit program for an Integrated QHSE Management System Internal Auditing 13
S Does anyone have a checklist to prepare for ISO 13485, Stage I audit? ISO 13485:2016 - Medical Device Quality Management Systems 1
W How do you phrase your internal audit questions? Internal Auditing 3
Z Steps to take before an MDSAP audit for Canada Canada Medical Device Regulations 2
V Csv, excel format - audit trail file of HPLC system ( Empower, openlab, EZchrom or any other ) Qualification and Validation (including 21 CFR Part 11) 0
G Not accepting a non conformity during an audit General Auditing Discussions 11
K IATF audit day requirements table 5.2 IATF 16949 - Automotive Quality Systems Standard 6
Q ISO 9001/IATF 16949 Audit Finding Question - Document Retention IATF 16949 - Automotive Quality Systems Standard 11
M IATF - Internal Audit 3 year span Internal Auditing 4
Q Audit report template ISO 9001/14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Q ISO 9001-2015 Internal audit finding Internal Auditing 14
lanley liao How to understand this words that the planning of internal audit shall take into consideration the results of previous audits? Oil and Gas Industry Standards and Regulations 10
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
D Supplier audit Medical Device and FDA Regulations and Standards News 2
M Go Live With New ERP System before Recertification Audit General Auditing Discussions 6
A Add MDSAP to Internal Audit Schedule Medical Device Related Regulations 0
A Define timeline for Major and Miner Audit finding General Auditing Discussions 4

Similar threads

Top Bottom