Can Non-conforming outputs & Non-conformity & Corrective Action procedures be merged

#1
Hi,
I am developing procedures addressing Non-conforming Outputs and Non-conformity & Corrective Action.
My manager indicated that we should be able to merge these two procedures. My reservation was that non-conforming outputs clause 8.7 of the ISO9001 Standard is based on processes outputs such as assembly outputs, supplier non-conformance etc whilst Non-conformity & Corrective Action clause 10.2 refers to the overall non-conformity Detected within the Quality Management System.
Results from procedure addressing Non-conformity Outputs can then be fed into Non-conformity & Corrective action which can be discussed at the Quality Management Review meeting.
Any thoughts and help on the above is appreciated.
Regards
Hari Varma
 
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Zero_yield

"You can observe a lot by just watching."
#2
Hello Hari,

I'm not sure I understand how you're defining "non-conforming outputs". I don't necessarily see a distinction between a "nonconforming output" and a nonconformance.
 
#3
Hi,
Non-conforming outputs (clause 8.7 of ISO9001 Standard) - these non-conformities that are detected in a process and correction is made to rectify the non-conformity. Hence, no further investigation is performed.
Non-conformity & Corrective action ( clause 10.2 of ISO9001 Standard) - this process reviews trends of similar nature within the Quality Management System that would require investigation and determine the root cause(s). In addition , the effectiveness of the solution is assessed to ensure the non-conformity is eliminated.
Non-conformance is both cases has the same meaning. The distinction between the two clauses of the Standard is that 8.7 makes the correction to the non-conformity but 10.2 goes further to review trends of similar nature and investigates.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#4
Possibly. A failure to meet specifications is documented, the root cause is determined, a correction is identified, implemented, and verified its effective, and continuance of monitoring for that failure bucket.
 

Enghabashy

Quite Involved in Discussions
#5
*The integrated process to merge NC & corrective action in one process is applicable’ although it's maybe more complex rather than the separation ; because also the findings & Ncs are the inputs of coreective action process

**regarding the standardized company form / formal report; it' more effective if the NC &CA report contain atleast 3 parts :

1-1st part for NCs. found , the relevant objective evidences & the relevant reference / clause number of company requirement / standard clause # " -- this issue should be recorded by the auditor /the responsible inspector "

2- 2nd part are reflecting the causes / root causes ; the actions /action plan taken "all should be recorded by the process owner "—the details should contain :
-the correction " controls/repair" related products findings / /--etc. & - the corrective actions " to prevent the re- occurrences" -- the actions should be nominated within time frame for the completion by date & signature
3-the follow up & verification for the effectiveness of actions taken " it's responsibility of the auditor / inspector / Q mgr " whatever the statement in organization process
*** in many cases of NCs/ findings ; the relevant risk assessment / FMEA/control plan, -- could be submitted for reviewing accordingly and for addressing new threats / additional controls
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#6
Another thought, combining external and internal failures (NC) could create a problem. We handle failures in a customer complaint very differently from a risk perspective than a production failure. The risks are vastly different. We have regulatory reporting requirements for customer complaints (Possibly) while that would not happen for production failures.
 

malasuerte

Quite Involved in Discussions
#8
Hi,
I am developing procedures addressing Non-conforming Outputs and Non-conformity & Corrective Action.
My manager indicated that we should be able to merge these two procedures. My reservation was that non-conforming outputs clause 8.7 of the ISO9001 Standard is based on processes outputs such as assembly outputs, supplier non-conformance etc whilst Non-conformity & Corrective Action clause 10.2 refers to the overall non-conformity Detected within the Quality Management System.
Results from procedure addressing Non-conformity Outputs can then be fed into Non-conformity & Corrective action which can be discussed at the Quality Management Review meeting.
Any thoughts and help on the above is appreciated.
Regards
Hari Varma
Yes. We call this Issue Management. We then build off that for all the topics in a single document.
 

Enghabashy

Quite Involved in Discussions
#9
This could be defer from company to company also, it's depend on the complex & sophisticated degree of activities & processes ; manufacturing activities including automotives ; metal forming /cutting/--- maybe more complex rather than one or two process of total final assembly or limited commercial activities , the numbers of processes & relevant inputs & outputs , the risks issues , the measuring issues , the track of people competences ; the heritage of maturity , the Quality culture, the track of repeated deviations & NCs discovered , --etc, -- all could be considered when we merge or separate the processes & the relevant forms
 
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