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Root Cause on Non-Conformity Against Quality Manual

Deli88

Starting to get Involved
#1
Hi all,

I'm struggling to come up with a root cause on a non-conformity brought up during our ISO9001:2015 upgrade audit. I am new to the company and have taken on the position which was left vacant by my predecessor for 4-6 months.

I initially said that the errors were caused by an oversight by the quality manager while editing the manual to fit the new standard. However our accreditation body have said that this is incorrect. How can I determine a root cause when the error was made initially by the previous QM.

Any ideas on how I could write a meaningful root cause that doesn't surmount to human error?

Thanks
 

Deli88

Starting to get Involved
#3
a) The index covers clauses of ISO 13485:2012 only and does not include reference to ISO 9001:2015 (Note: ISO 9001:2015 is included in scope of manual however).
b) Appendices A and B which contain the company process maps were inadvertently removed during the upgrade of the Quality Manual from Revision 12 to Revision 13 and so are no longer present.
c) Although the Quality Manual was verified to include reference to procedures and work instructions, the structure of the documentation used in QMS is not included.
d) Details on the control of the work environment in the cleanroom are not included in Section 6.4 of the Quality Manual nor are reference to associated procedures.
 

JoshuaFroud

Involved In Discussions
#4
Hi Deli88,

Welcome to the Cove.

I think for anyone to be able to provide any specific assistance or guidance you may need to give a little bit more information on the nature of the non-conformance?

I can see why your notified body may have rejected human error as the root cause as there were potentially several checks or review steps for the document before it went live. A failure of the review system as opposed to the human error by the ex-employee may be more easy for the NB to accept. A corrective action can be applied to a system but not a person, especially a person no longer in the employ of your company.
 

Jim Wynne

Super Moderator
#5
a) The index covers clauses of ISO 13485:2012 only and does not include reference to ISO 9001:2015 (Note: ISO 9001:2015 is included in scope of manual however).
b) Appendices A and B which contain the company process maps were inadvertently removed during the upgrade of the Quality Manual from Revision 12 to Revision 13 and so are no longer present.
c) Although the Quality Manual was verified to include reference to procedures and work instructions, the structure of the documentation used in QMS is not included.
d) Details on the control of the work environment in the cleanroom are not included in Section 6.4 of the Quality Manual nor are reference to associated procedures.
Is that the whole NC statement? No references to requirements in the standard?
 

Deli88

Starting to get Involved
#6
Hi Jim,

It was raised against 4.2.2 of ISO 13485:2012(2003) and 7.5 of ISO 9001:2015.

That is the non-conformance in its entirety. I have made all the amendments to the manual.

Would lack of understanding due to ineffective training be an appropriate reason for this non-conformity? I do believe that my predecessor believed he was making the correct changes to the manual at the time.
 
#7
I would go with Josh's thoughts. In effective review process. While the updates where made, he should have had someone to review it, to at least make sure it made sense -- ie; no references to non-existent sections. It's still human error, just looks different. This is not an area you want to spend a lot of time on. Fix it and move on. Good luck.
 
#8
a) The index covers clauses of ISO 13485:2012 only and does not include reference to ISO 9001:2015 (Note: ISO 9001:2015 is included in scope of manual however).
This is not a non-conformity, IMO. As long as your scope and and exclusions are clearly stated, there is no requirement to maintain an "index".

b) Appendices A and B which contain the company process maps were inadvertently removed during the upgrade of the Quality Manual from Revision 12 to Revision 13 and so are no longer present.
This sounds like a problem with your change control. Go back to the change records and see if this removal was documented. Was justification given for the removal? How was the impact assessed?

c) Although the Quality Manual was verified to include reference to procedures and work instructions, the structure of the documentation used in QMS is not included.
How long was it in this state? Should this deficiency have been identified in your internal audits?

d) Details on the control of the work environment in the cleanroom are not included in Section 6.4 of the Quality Manual nor are reference to associated procedures.
Are these covered anywhere else in your documentation (e.g. Manufacturing process procedures)? If so, there is no problem. There is nothing in the standard that requires "details on the control of the work environment" to be in your quality manual (though there should be reference to the procedure).
 
#9
a) The index covers clauses of ISO 13485:2012 only and does not include reference to ISO 9001:2015 (Note: ISO 9001:2015 is included in scope of manual however).
b) Appendices A and B which contain the company process maps were inadvertently removed during the upgrade of the Quality Manual from Revision 12 to Revision 13 and so are no longer present.
c) Although the Quality Manual was verified to include reference to procedures and work instructions, the structure of the documentation used in QMS is not included.
d) Details on the control of the work environment in the cleanroom are not included in Section 6.4 of the Quality Manual nor are reference to associated procedures.
The auditor is smoking some bad stuff. Can you provide some better stuff for them to smoke? If not, suggest they point out WHERE in ISO 13485 these things are REQUIRED. Once they can't suggest they stop asking for them and move on. If they argue, call their CB's Operations management and conference them in. If all else fails, show them the door...
 

Jim Wynne

Super Moderator
#10
Hi Jim,

It was raised against 4.2.2 of ISO 13485:2012(2003) and 7.5 of ISO 9001:2015.

That is the non-conformance in its entirety. I have made all the amendments to the manual.

Would lack of understanding due to ineffective training be an appropriate reason for this non-conformity? I do believe that my predecessor believed he was making the correct changes to the manual at the time.
If that's the whole thing, you have an incompetent auditor. That's no way to write an NC statement. Nonetheless, I'll go with the others here who say that it's the review process (if there is one) that needs attention. Simply fixing what was allegedly broken doesn't explain how the broken thing was allowed to be released into the wild.
 
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