Do nonconformances always result in corrective action

S

szohar

#51
Cite one example of non-conformance without any corrective or preventive action in any field..

The company in question, Company X, had SOPs for assembling and transporting product. The SOPs were very specific about exactly what types of equipment and supplies were to be used, right down to the shipping companies and protocols. However, due to an extraordinarily unusual confluence of events, including a plant move among other things, neither of the standard shippers could pick up the product in time, and a different shipping partner had to be used.

The QA Manager reviewed the series of events, and determined that the likelihood of that particular confluence of events happening again was almost nil, so the QAM wrote an Incident Report that explained what happened, why it was unlikely to happen, and how it was essentially impossible to predict that particular series of events, let alone prevent it.

There was no corrective action needed, as the deviation did not interfere with the satisfactory delivery of the product to the buyer. There was no preventative action that could be taken, because of the inability to even predict, let alone prevent, that series of events.
 
Elsmar Forum Sponsor

Bev D

Heretical Statistician
Staff member
Super Moderator
#52
there is no non-conformance without corrective or preventive action. thats what i mean..

What if the root cause is an anomaly that cannot be prevented or mitigated, and if the result of the non-conformance is an anomalous deviation that is acceptable and that can be explained?

I grant that this is an unusual set of circumstances, but I've seen this happen, so it's not outside the realm of possibility.
well I would say that you actually have determined cause and determined a corrective action. You can't know that the occurence an "anomoly" without knowing something about it's cause - even it's just it's occurence rate and knowledge that it's an error / catastrophic event. If you know that the resulting deviation is "acceptable" then the corrective action would be to change the system to either allow the event - why is it a nonconformance fi nothing bad happens? there in lies your corrective action.

I would say that all nonconfromances have a viable corrective action - it's just that occassionally the corrective action isn't against the cause, nor does it have to be.
 

krishkaar

Involved In Discussions
#53
Our approach is:

A) for all in-house non-conformances:
a)Take 100% disposition actions at the earliest, in MANY cases immediately. (We compare this situation to giving a 'First-aid' to an injured person)

b) Record all nonconformances and assess for :
1. Repeating problems
2. Problems with very high RISK (life / Person)
3. Problems with very HIGH MAGNITUDE' (monetary loss- organisation)
If the review answer says 'yes' to any one of the three options, THEN TAKE CORRECTIVE ACTION VIA ROOT CAUSE ANALYSIS and FMEA.

We have a weekly review on in-house quality performance and also a Quality Status report every month to check for any missed actions.

----------------------------------

B) NO SUCH EXECPTIONS for:
1. Customer complaints
2. Audit Non-conformances

Not only immediate correction is required, a detailed analysis followed by several actions are required to be implemented.

Any comments please.....
 
S

szohar

#54
I'm not sure we agree about what a corrective action plan might be.

As I understand it, a corrective action plan details what actions are to be taken to fix what went wrong. In the situation I described, there was no corrective action plan created, because there was no corrective action needed.

We did a root cause analysis, and I would say categorically that all non-conformances *do* require a root cause analysis. However, under some circumstances, preventative actions might not be necessary or even possible, and corrective actions might not be required.
 

Jim Wynne

Staff member
Admin
#55
well I would say that you actually have determined cause and determined a corrective action. You can't know that the occurence an "anomoly" without knowing something about it's cause - even it's just it's occurence rate and knowledge that it's an error / catastrophic event. If you know that the resulting deviation is "acceptable" then the corrective action would be to change the system to either allow the event - why is it a nonconformance fi nothing bad happens? there in lies your corrective action.
What you're suggesting is that when a nonconforming condition is an obvious outlier--and it does happen--then some sort of correction is necessary, even if it's only to allow for the event in question. I disagree--if the cause is either understood and considered negligible or unknowable (and that happens too), it should be enough to record that fact in answer to the NC and go on with life. There's nothing to be gained from correcting things that don't need to be corrected.

I would say that all nonconfromances have a viable corrective action - it's just that occassionally the corrective action isn't against the cause, nor does it have to be.
If it's not against the cause, it's generally not worth pursuing, imo.
 
C

curryassassin

#56
Risk Assessment is a preventive action. so non-conformance doesnt exist without any corrective or preventive actions.

though u tracking the small non-conformances, altast if u take a corrective action/preventive action which is a action taken common for all those small non-conformances..

Or else , cite one example of non-conformance without any corrective or preventive action in any field..
No I disagree. Risk assessment can be performed at any time, whether nonconformance CA or PA. Also, just because you have lots of minors, if there is no common threads, and the impact assessment is minor, then there is no action needed.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#57
What you're suggesting is that when a nonconforming condition is an obvious outlier--and it does happen--then some sort of correction is necessary, even if it's only to allow for the event in question. I disagree--if the cause is either understood and considered negligible or unknowable (and that happens too), it should be enough to record that fact in answer to the NC and go on with life. There's nothing to be gained from correcting things that don't need to be corrected.


If it's not against the cause, it's generally not worth pursuing, imo.
well to clarify I was thinking primarily of internal audit NCs which require corrective action and not the general case where a product NC to a spec might have occured (the good old "use as is" or scrap it and move on).

I do agree with you that there are times when isolated events with trivial consequences can and should be stepped over.

However, when the NC is an audit finding (as was my assumption in my response) and a Corrective Action is issued (as ISO strongly implies is required) often the best thing to do is to take corrective action to eliminate the source of the nonconformance which is often a poorly written / over specified procedure.


When the NC is a product nonconformance to a spec and the cause is isolated and the effect is not harmful - we often don't get corrective actions. so those were not in my thought process. and in these cases I agree with you totally that corrective action is not warranted. There are times when the cause is not isolated or there are many unrealted causes and the effect is not harmful. These cases typically result in documentation of that fact and a "use as is" disposition. there is some value to changing the spec and gettign away from the documentation. Of course this must be weighed against all other problems...
 

Jim Wynne

Staff member
Admin
#58
well to clarify I was thinking primarily of internal audit NCs which require corrective action and not the general case where a product NC to a spec might have occured (the good old "use as is" or scrap it and move on).

I do agree with you that there are times when isolated events with trivial consequences can and should be stepped over.

However, when the NC is an audit finding (as was my assumption in my response) and a Corrective Action is issued (as ISO strongly implies is required) often the best thing to do is to take corrective action to eliminate the source of the nonconformance which is often a poorly written / over specified procedure.


When the NC is a product nonconformance to a spec and the cause is isolated and the effect is not harmful - we often don't get corrective actions. so those were not in my thought process. and in these cases I agree with you totally that corrective action is not warranted. There are times when the cause is not isolated or there are many unrealted causes and the effect is not harmful. These cases typically result in documentation of that fact and a "use as is" disposition. there is some value to changing the spec and gettign away from the documentation. Of course this must be weighed against all other problems...
In the case of an internal audit finding, I agree that there should be some form of CA. If an auditee disagrees with a finding, or thinks it's not worthy of CA, it should be worked out with the auditor or some higher authority.
 

jkuil

Quite Involved in Discussions
#59
Any non-conformance requires investigation irrespective of the source (internally identified, customer complaint, (internal) audit, product inspection, lab investigation, etc). The investigation should results in:
  • The severity of the non-conformity, especially all potential hazards to patients or users of the device;
  • The root cause;
  • The occurence rate and the likelyhood of re-occurence. The non-conformance identified may not have been the only occasion it occured, or on the other hand could have been an incident. The root cause determination may help in identifying other occurences. Especially in case of a product non-conformance, all non-conforming products must be identified.
The severity and occurance rate are input to a risk analysis to determine the risks associated to the non-conformity. The acceptability of the risks should be evaluated. In case of low severity and/or unlikely re-occurence, the risk may be acceptable and no corrective actions required. If the non-conformity has severe impact to patients safety or has a high likelyhood of reoccurence, the risk is intollerable and must be adressed by risk control measures (i.e. the corrective actions)
In case of medical devices a risk management file is associated to each product (as required per ISO 14971). The risk management file specifies which (design, process, application) risks are identified with the product, the associated hazards, the severity, the likelyhood of occurence and how they are controlled. The risk management file is generated during the design of the product, but should be maintained throughout the life cycle of the product. In other words, if the risk controls have proven ineffective by the non-conformity investigation they should be improved (i.e. the corrective action) and if needed the risk management file updated. These activities are critical in assuring only safe product are put into the market, therefore they have full attention during FDA inspections and Notified Body audits.
 
#60
I do agree with you that there are times when isolated events with trivial consequences can and should be stepped over.

However, when the NC is an audit finding (as was my assumption in my response) and a Corrective Action is issued (as ISO strongly implies is required) often the best thing to do is to take corrective action to eliminate the source of the nonconformance which is often a poorly written / over specified procedure.

...
NNoooooooooooo!

Never 'step over' an audit finding! - put it in the summary report. It may not warrant any action at the time it was found (in isolation) but if it goes unrecorded, you may be missing an opportunity to 'see' it occuring in other places, each time as 'isolated' situations. Hence, the audit manager won't be able to detect a trend and, say after 3, 4, 5 or 6 audits, focus attention on the system which is causing these not so isolated findings.......

The wording of ISO is a moot point since the 08 version allows, specifically, for corrections. I'd be very wary of jumping to the conclusion that the root cause is the procedure being too specific! That, itself, has a root cause........
 
Thread starter Similar threads Forum Replies Date
B How many nonconformances have you received on average during IATF audits? General Auditing Discussions 24
Tagin Evaluating nonconformances for escalation using Bayesian methods? Statistical Analysis Tools, Techniques and SPC 2
G Differences - Nonconformances vs CAPA, Corrections vs Corrective Actions ISO 13485:2016 - Medical Device Quality Management Systems 16
R Extension of product nonconformances - Construction project Nonconformance and Corrective Action 7
I Audit Nonconformances - Can reported corrective actions be incomplete? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
J EU ISO 13485:2016 Recertification Audit - Effect of 10 Minor Nonconformances EU Medical Device Regulations 2
W Closing of Stage 2 Audit Nonconformances AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M User Errors and Product Nonconformances Nonconformance and Corrective Action 22
K Notified Body - Minor Nonconformances - They have withheld all certificates General Auditing Discussions 3
Q Several Nonconformances with same Root Cause with just one CA ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
V 21 CFR 820 Compliant way to use Kaizen to address Nonconformances Nonconformance and Corrective Action 9
N Nonconformances in the Construction Industry Nonconformance and Corrective Action 6
T Perishable Tooling Supplier - Nonconformances and Metrics AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
H NADCAP Audit Nonconformances - Vacuum Furnace Load Sensors AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
L Internal Audit Nonconformances - Your opinion? Internal Auditing 8
M Supplier Nonconformances - Key Points to ask a Metal Stamping Supplier Supplier Quality Assurance and other Supplier Issues 7
L Insurance to cover for nonconformances ? Misc. Quality Assurance and Business Systems Related Topics 2
T Defining Nonconformances in a Service Organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
C ISO 9001 Nonconformances an how to handle them ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
N Second Registrar Visit to Confirm Major Nonconformances Fixed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
L Definitions for Minor & Major Nonconformances ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
F Response to ISO 13485 Audit Minor Nonconformances ISO 13485:2016 - Medical Device Quality Management Systems 6
M Seven Document Review Nonconformances Document Control Systems, Procedures, Forms and Templates 9
J KPI for time to close NCs (Nonconformances) Quality Manager and Management Related Issues 17
R Internal Audit Cancellation when Nonconformances are Found Quality Manager and Management Related Issues 13
J Question about GM special requirement - Open Major Nonconformances IATF 16949 - Automotive Quality Systems Standard 2
K CAPA Training for Process Nonconformances Nonconformance and Corrective Action 2
A Nonconformances and Rework in a Machine Shop Nonconformance and Corrective Action 6
Fender1 Nonconformances that do not require Corrective Action Nonconformance and Corrective Action 21
C Who does the Analysis of Nonconformances and other Data Analysis? Nonconformance and Corrective Action 23
T NonConformances as a Tool to Measure Employee Performance Nonconformance and Corrective Action 21
A Surveillance Audit Result - Multiple Audit Nonconformances ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B Suspension of ISO 9001 Certificate - Major Nonconformances Identified ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
B The Distribution that represents the Severity of Nonconformances Nonconformance and Corrective Action 2
L Non Conformance Register (aka Tracking Nonconformances and Corrective Actions) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
J How many Major Nonconformances could let the Audit be Terminated? General Auditing Discussions 9
R ISO 13485 Surveillance Audit Nonconformances and Report Help Needed ISO 13485:2016 - Medical Device Quality Management Systems 9
A ISO 14001 Surveillance Audit Nonconformances ISO 14001:2015 Specific Discussions 6
J Corrective Action Timeframe for Internal Nonconformances Nonconformance and Corrective Action 14
R Is it useful to adapt PFMEA's with nonconformances? FMEA and Control Plans 4
P Boss doesn't want Nonconformances called Nonconformances in Internal Audit Reports ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 72
C System Root Cause and CA (Corrective Action) for ISO 13485 Audit Nonconformances ISO 13485:2016 - Medical Device Quality Management Systems 3
M Can a KPI (Key Process Indicator) be created against Nonconformances? Nonconformance and Corrective Action 8
J Certification Body follow up on clearing Audit Nonconformances Registrars and Notified Bodies 4
M NCR and Cost Collection - Capturing nonconformances in the field Nonconformance and Corrective Action 1
Q CTC (Critical to Customer) vs. CTQs (Critical to Quality) Nonconformances Nonconformance and Corrective Action 6
A Escalating Minor Nonconformances into Major Nonconformances ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
D NCRs (Nonconformances) allowed during ISO 9001 Recertification Audit General Auditing Discussions 21
P Is Blaming Operators for Nonconformances correct? Quality Manager and Management Related Issues 62
C CB Client Contract Agreement - Identifying nonconformances - AS9100 Registrars and Notified Bodies 7

Similar threads

Top Bottom