Nonconformity Caused by Human Error - How to make a Corrective Action?

Bev D

Heretical Statistician
Staff member
Super Moderator
#41
I think the confusion here is the mis-use of the operational definitions of common cause and assignable/special cause. We must remember that these are operatational definitions, limited in scope and useful for a very special situation: responding to process fluctuations with actions that are looking for something that changed or did not. The definition does not apply to "inside" or "outside" the process. It refers to normal levels of all input factors. A factor that suddenly changes levels is still part of the process, it's just that the factor ahs gone to a level not normally seen. All processes can improved regardless of common or special causes of variation. or whether or not the 'defect' is a result of variation or error as in this case.

we really don't have that situation going on and the standard doesn't overtly recognize the applicablility of "SPC thinking" when identifying and requiring action on nonconformities. This particular event is not a NC to the standard but to internal procedures. it is relatively trivial. can corrective action to prevent re occurence be taken. Absolutely. from changing the process to eliminate teh need for dual records to automating the process so that a single entry can be reported multiple ways: by operation, operator or department etc.

It is interesting that the standard requires correction as to cause for internal audits but not for registration or other second or third party audits.
 
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Marcelo

Inactive Registered Visitor
#42
Is this line of reasoning really sound? I question it in the light of this real-life situation:

Process - change hydraulic fluid
Nonconformity - spill 600 gallons
Cause - employee forgot to close drain valve
Correction - clean up mess
Corrective action - ????

The quoted reasoning seems to say corrective action is not possible here. It is, after all, a "spike" in the process. The employee forgot to close the drain valve just as the HR manager in the parent post forgot to make an entry in the training database.

But I don't think it follows that acting on the system won't reduce the chances of this happening again. How better visual signals? Or error proofing the drain valve with a dead-man switch? These are actions within the boundary of the system, and would qualify as corrective action, I believe.
Hello CliffK
I don´t see things as you put it. In my opinion:

Process - change hydraulic fluid
Nonconformity - employee forgot to close drain valve (because the requirement, which wasn´t fulfilled, was to close the drain valve)
Cause - why did the forget? The cause is the cause of his forgetfullnes
Correction - clean up mess
Corrective action - this depends on why the employee forgot to drain the valve.

Altough the reasons for the forgetfullnes could be difficult to discern, let´s focus on another side of the problem, the situation of the process at the time of the problem.

If there´s no controls or not enough control (as in your examples, there´s not enough visual signals, or there´s no switch), then the process could be acted upon, but keep in mind that if the process is in this poor condition, the probability that this situation happen would be high. And again, in my opinion, if it happened once, there´s no way i would say it´s a NC in an auditing. Surely the auditee would need to investigate, and even make an corrective action if he found that the controls are not enough.

But what i was thinking in my example was the situation when the process already has enough controls (which seems to be the case on the example that started this discussion). There´s visual signs. Theres a control switch. And even then the employee forgot to close the drain valve. What can be done?

Well, i don´t think anything could be done to the process. More controls in this situation is not a guarantee that the problem would not happen again.

As always, the point is "does it add value"?

I know that this line of thinking is not the usual one, but i try to stick to it as a counterpoint to auditors that give a NC for every event that´s a NC in the system (i think it would be a really improvement if people tried to differentiate system NCs from audit NCs).

Cheers :)
 
P

pinpin - 2009

#43
Dear mmantunes,

I know what you mean. Auditor should only raise NC when it is good for the auditee and aims at customer satisfaction for the auditee.

But I think Cliffk is right that "spill 600 gallons" is a Nonconformity, not "employee forgot to close drain valve". I think "employee forgot to close drain valve" is the cause for "spill 600 gallons". And, "his forgetfullnes" could be the "root" cause for "employee forgot to close drain valve".

Anyway, I agree, we may not need to raise it as an NC that require Corrective Action as a quality management system auditor, because it is an isolated incidence and if it does not cause quality issue.

However, I think, as we all agree here, as an auditor, we may not be sure of its impact and may not have time to explore further, we should just raise it as an Observation for the auditee to take note. But the auditee may initiate an action to prevent it from recurrence as "spill 600 gallons" is very costly and adversely impact the environment. Is this Corrective Action as there is not nonconformity but just an Observation from the auditor? Or just a Preventive Action because there isn't a nonconformity yet? Yes, it doesn't matter, most importantly is to solve the problem.

You know that the purpose of Error-proof or so-called idiot-proof is to prevent human error? It could be used to prevent us from forgetting to close the drain valve!
 

Marcelo

Inactive Registered Visitor
#44
Heloo Pinpin

Good points!

Still, i do not agree with the interpretation of what is the NC.

As Stijloor remembered some posts ago

From ISO 9000:2005

3.6.2
nonconformity
non-fulfilment of a requirement (3.1.2)
So if what you and CliffKsay is correct ("spill 600 gallons" is the NC - and i´m pretty sure a lot of poeple thinks that way) then the requirement would be "do not spill 600 gallons" or "do not spill anything"? This seems to me more of a commercial issue than a requirement for an auditor to check (as you yourself know when you said "spill 600 gallons is very costly and adversely impact the environment"). I do know it´s very costly and all, but these are not really QMS requirements, they´re commercial issues that came from QMS requirements. In my opinion, as they´re different to each manufacturer (it might be that 600 gallons are not this costly to some, and even that they may not impact the environment) they should not be included in the audit criteria, simply because the the opinion of it´s impact depends on the auditee, not on the auditor.

That´s why i still think the NC here, from a QMS auditor perspective, would be that someone forget to follow a procedure.

I know that a lot of people would say that the NC is "spill 600 gallons" simply because it´s the action that´s easy to see. And it´s easy to point as a NC and to request a corrective action. But this is just one of the cases i was talking about, a mistakenly identified NC with a mistakenly requested corrective action that will add no value to the process (keep in mind that this situation has to have the boundaries i mentioned before, i.e., the process already have enough controls).
 
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Marcelo

Inactive Registered Visitor
#45
Hello Bev D

...the standard doesn't overtly recognize the applicablility of "SPC thinking" when identifying and requiring action on nonconformities
You´re correct, the standard does not asks for this SPC thinking.

But, as in all standards, just because it doen´t say it doen´s mean you should not use ( i always think that a standard cannot explain all the past research on the subject because it would become a bible - so this depends on the knowledge of the reader about the subject)

There´s 3 fact i always try to remember in this case:

1 - QMS standards were born based on these quality control thinking

2 - the standards are based on the "process approach" so why should we not use process tools (the SPC thinking for example) to apply the standard?

3- not having a clear, technical and sound approach to identifying and requiring action on NCs leave this decision up to the auditor, which means that it´s real easy to go beyond what is required by an audit. And this happens a lot.
 

eternal_atlas

Involved In Discussions
#46
I agree with caster statements. But, registrar shall consider the severity of the error and impact on the QMS before defining it as a NCR. But, we cant define it as an NC but as an observation.

Suresh kumar
 
P

pinpin - 2009

#47
I agree with caster statements. But, registrar shall consider the severity of the error and impact on the QMS before defining it as a NCR. But, we cant define it as an NC but as an observation.

Suresh kumar
Can you be sure that when there is an NC there must be a CA? Anywhere in ISO/TS or Certification Bodies' definition say so?

Some posts here already pointed out that:
1) A NC is a nonfulfillment....
2) CA shall be commensurate ....

So why can't a NC be raised as an Observation for auditee to take note to prevent?
 
P

pinpin - 2009

#48
Heloo Pinpin

Good points!

Still, i do not agree with the interpretation of what is the NC.....

That´s why i still think the NC here, from a QMS auditor perspective, would be that someone forget to follow a procedure.

.....
Actually, Cliffk just simply quoted an example without putting a lot of attention in the description about the requirement of "Process - change hydralic fluid". Let's treat it to include not to spill ok?:D

Anyway, as per what you said that the NC is "someone forget to follow a procedure", then you actually mean the requirement shall be "SHALL NOT FORGET to follow the procedure"! Is this correct?;):)

Again, anywhere in ISO/TS or Certification Bodies' definition say that when there is a NC there must be a CA? Why can't a NC be raised as an Observation for auditee to take note to prevent rather than saying it must be resulted in CA?

Does the audit involved in verifying the differentiation between an Observation and a NC?
 
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Marcelo

Inactive Registered Visitor
#49
Anyway, as per what you said that the NC is "someone forget to follow a procedure", then you actually mean the requirement shall be "SHALL NOT FORGET to follow the procedure"! Is this correct?
Haha, you got me...in fact, the requirement would be to follow the procedure and the NC that the procedure wasn´t followed. But the cause would still be "why it wasn´t followed", and, in my example, as the employee forgot, the real root cause would be "why did he forget?".

Again, anywhere in ISO/TS or Certification Bodies' definition say that when there is a NC there must be a CA? Why can't a NC be raised as an Observation for auditee to take note to prevent rather than saying it must be resulted in CA?
Well, to me this is the problem, because (using the generic ISO 9001) the standard requires that every NC needs a correction and corrective action.

See, for example, in the ISO 9001 auditing practices group webpage the document "Guidance for reviewing and closing nonconformities"

So, if the auditor gives a NC, therem must be a correction and corrective action. My point in this discussion is that there are some situations which cannot have further controls, and no corrective action, so they should not be given as an NC in an audit.
 
P

pinpin - 2009

#50
Dear mmantunes,

These were extracted from the document you mentioned:

Nonconformity: non-fulfillment of a requirement (ISO 9000:2000, clause 3.6.2)

Correction: action to eliminate a detected nonconformity (ISO 9000:2000, clause 3.6.6)

Corrective action: action to eliminate the cause of a detected nonconformity or other undesirable situation (ISO 9000: 2000, clause 3.6.5)


Please note, correction can be by its own to eliminate the NC without the need for CA! So, raise a NC does not mean must lead to CA!:D

Also, let's think of the benefit to be derived before we continue on the root causes for why it is forgotten further and furher ok?;)
 
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