How do you define repeated non conformity (aka Recurrence)?

[qusys]

What is the real definition of "repeat" non conformity if it is exists?

For example, in an internal audit or Registrar audit if there is a not an effective implementation of a corrective action for a minor non conformity , do auditors consider this as a "repeat" or raise the level to "major non conformity"?
Could a repeat non conformity only be successive to a previuous non corfomity, whose implmentation was not effective?
Thks a lot for your ideas and help.

 

[DrM2u]

For example, in an internal audit or Registrar audit if there is a not an effective implementation of a corrective action for a minor non conformity , do auditors consider this as a "repeat" or raise the level to "major non conformity"?

An external auditor could look at such an instance from two perspectives:
- one would be wether the corrective action was ineffective in this case, in which case has the option to kep the nonconformance as minor or elevate it to a major, depending on its severity and significance
- another would be to look at the corrective & preventive actions system to evaluate if this is a systemic failure or an isolated incident, which could result in keeping the existing nonconformance and issuance of other nonconformance(s).

What is the real definition of "repeat" non conformity if it is exists?
(...)
Could a repeat non conformity only be successive to a previuous non corfomity, whose implmentation was not effective?
Thks a lot for your ideas and help.

The usual approach is that 'repeat' means that the same symptom(s) is observed even after the implementation of corrective actions. My personal definition is that 'repeat' means that the same root cause is identified regardless of the symptoms observed, which usually points toward a systemic failure.

For example, one observed failure would be that the control plan does not identify all key product characteristics. Another observed failure for another product would be that gages are not available to inspect certain product features. And a third failure would be that the company did not obtain customer's approval for the process before starting production on a third product. These might not seem related if taken individually even over a short period of time, however a thorough root cause analysis could identify an ineffective product quality system as a common system for all incidents and a potential root cause of poor planning from management's side. As Deming used to say, quality starts in the boardroom.

 

[Big Jim]

You need to define the term "major nonconformance".

The general interpretation is a requirement that has been missed or that the way it is being met is ineffective.

The repeat of a nonconformance might not make it ineffective. It depends on the circumstances. So a repeat may or may not mean that it becomes a major nonconformance. It is not automatic.

 

[DrM2u]

You need to define the term "major nonconformance".

The general interpretation is a requirement that has been missed or that the way it is being met is ineffective.

The repeat of a nonconformance might not make it ineffective. It depends on the circumstances. So a repeat may or may not mean that it becomes a major nonconformance. It is not automatic.

I think that the term is defined in the CB's guideline or something like that. It used to be defined as a systemic failure or failure (to at least attempt) to implement a requirement of the standard. I am not sure how it changed in the past 1.5 years.

 

[Stijloor]

Guys,

If we're talking internal audits, don't get bend out of shape with minor and major nonconformities. There is no requirement to differentiate; don't waste your time on it; just implement effective corrective action so that it can not recur.

Stijloor.

 

[Big Jim]

For internal audits, the organization is free to define "Major" or "Minor" however they please. It is becoming very common for them to just call them "nonconformances" without a classification.

CB auditors do indeed need to follow the guidance of their CB.

As to if a Minor Nonconformance automatically becomes a Major Nonconformance if it repeats the answer is "it depends".

 

[Proyecto]

Closing of Non comformities is not an easy job, however in my experience, a lot of corrective actions take place or are started (in an almost unresponsible attitude) without being sure which are the real root cause(s).

Normally, when a good analisys/identification/proofing of root cause is made, followed of course of a good choosing/ analisys/ identification and testing of the proper corrective action(s ), the probability to repeat is, in my opinion too low.

Proyecto

 

[Big Jim]

Closing of Non comformities is not an easy job, however in my experience, a lot of corrective actions take place or are started (in an almost unresponsible attitude) without being sure which are the real root cause(s).

Normally, when a good analisys/identification/proofing of root cause is made, followed of course of a good choosing/ analisys/ identification and testing of the proper corrective action(s ), the probability to repeat is, in my opinion too low.

Proyecto

Agreed. But no matter how diligent you may be, there will be some nonconformance that repeat. The fewer the better. There is only so much you can do when responding to them. At some point you need to do the best you can and move on.

If they do repeat, you ALWAYS have greater insight on how to resolve it. For one thing you know for sure that what you did before was not adequate. Also the conditions found or observed will be enough different to provide additional insight. The likelihood of it repeating again is even less.

 

[JaneB]

What is the real definition of "repeat" non conformity if it is exists?

For example, in an internal audit or Registrar audit if there is a not an effective implementation of a corrective action for a minor non conformity , do auditors consider this as a "repeat" or raise the level to "major non conformity"?
Could a repeat non conformity only be successive to a previuous non corfomity, whose implmentation was not effective?

There isn't any single definitive answer possible here.

It would be helpful if you'd separate out: internal audits from external audits (external = their rules, and they will define the terms used, internal = yours) and what you mean by a 'minor' or 'major' nonconformity. Also - is this an academic query, or has something prompted it? If the latter, can you give some more detail? Otherwise, you may well find that there is extensive but very 'theoretical' discussion which doesn't actually help you with your more specific issue.

I don't think either term (minor/major) is particularly useful internally - Jan (Stihljoor ) points out, the more important thing is to focus on the effective action, not a hunt for definitions.

 

[qusys]

Thks for response to all and also to you, Jane.
It is not an accademic question and it is referred to the internal audit, in order to review the internal procedure of internal audit.
Question inside the team was born how the different organization at world wide level had defined "repeated" non conformity, also to consolidate data of the internal audit in xls file to understand how much repeats happened in a year with regards to the previous one.
If the organization are not aligned, data might be different.
Thks for response

There isn't any single definitive answer possible here.

It would be helpful if you'd separate out: internal audits from external audits (external = their rules, and they will define the terms used, internal = yours) and what you mean by a 'minor' or 'major' nonconformity. Also - is this an academic query, or has something prompted it? If the latter, can you give some more detail? Otherwise, you may well find that there is extensive but very 'theoretical' discussion which doesn't actually help you with your more specific issue.

I don't think either term (minor/major) is particularly useful internally - Jan (Stihljoor ) points out, the more important thing is to focus on the effective action, not a hunt for definitions.