Planned vs. Unplanned Deviation & Nonconformance

[Clarence.L]

Anybody can helps to have a explanation of the term "Unplanned Deviation"?

And what is the difference between "Nonconformance" & "Unplanned Deviation"?

Many thanks.

 

[Marc]

A nonconformance is something (product or service) which is not to print or in some way does not fulfill the agreed to requirements.

I've really never heard of anything referrred to as an 'unplanned' deviation. If something screws up and its not detected until after the process is finished (or a part of a 'batch' or whatever) one determines whether its usable or not and may ask for waiver (concession) if it is. If I was in a court room I might want to call it 'an unplanned deviation' to keep the verbiage sounding neutral to a jury.

Another thing I guess you could call an 'unplanned' deviation might be if something happened and an engineer dictated an 'on the fly' immediate change. Example: Part is running and you run out of nuts to press in. You find another part in-house uses a nut with all the same characteristics EXCEPT it has a deeper ring groove. You start using the nut with the deeper groove (and later find out why you're using two different nuts causing you to stock 2 different part numbers - and yes, this is a real example...). As this happens you write up the deviation and walk it around for signatures (during which you are 'running at risk' - producing parts not to print without authorization). Technically these are nonconforming - wrong nut.

Can you give more details of the event specifics?

 

[Wes Bucey]

"unplanned" is a euphemism

A nonconformance is something (product or service) which is not to print or in some way does not fulfill the agreed to requirements.

I've really never heard of anything referrred to as an 'unplanned' deviation. If something screws up and its not detected until after the process is finished (or a part of a 'batch' or whatever) one determines whether its usable or not and may ask for waiver (concession) if it is. If I was in a court room I might want to call it 'an unplanned deviation' to keep the verbiage sounding neutral to a jury.

In my experience, use of the word "unplanned" is a euphemism for human error in most cases. Other times, "unplanned" is a euphemism for a pure special cause event (lightning bolt or power surge affects performance of machine.)

The bulk of the time, "unplanned" deviation results in a nonconforming product or service. Very rarely (almost never) it results in a happy (lucky?) improvement.

The premier example of this happy improvement is the oft-cited creation of Ivory brand bar soap (99-44/100% pure. It floats!) being the result of an unplanned deviation wherein an operator left a mixer running longer than the planned time and it entrained sufficient air bubbles into the soap mixture to make the resulting bar of less specific gravity than water, hence It floats!
((broken link removed))

I hope this little discourse helps put the term unplanned deviation in perspective.

 

[Clarence.L]

Nonconformance

That is a finding in a formal audit~

When they were reviewing our nonconformance handling, they found that when there is any nonconformance found, we shall notify our customer in a timely manner, that's what we are doing now. But then, they questioned about the "unplanned deviation", shall we also notify our customer when there is an unplanned deviation found.

They suggested that we shall also consider "unplanned deviation" in the NC handling, but my opinion is Unplanned Deviation = Nonconformance, so I wanna address it out, and see whether any idea.

Many thanks.

 

[Marc]

I would simply ask your registrar for their definition of an 'unplanned' deviation and go from there. That will eliminate any ambiguity.

 

[Vincnet]

Clarence,

my understanding of unplanned deviation is in regard to good practices. Let's say if you have a study Plan to follow to assess a drug toxicity, you can have two types of deviations to the study plan:
1) type 1 deviations occured if for technical reasons you have to modify your protocol, but you know that before starting the experiment in this case it is a planned deviation in the sense that you know it before hand and can ask the promotors of the study if they accept it or not.
2) type 2 deviations occure when during the course of the study something goes wrong and you can't do a thing about it, it's an unplanned deviation.

So unplanned deviations can be seen as non conformities related to something planned such as a production process validation for example.

This is the way I interpret it. Might be wrong.

Vincnet

 

[glenneperez]

Unplanned Deviation

Hi Clarence,

Unplanned Deviation is a deviation which is not yet registered in your "Deviation List" or not part of your Risk Analysis or FMEA.

You need to update your deviation list when Unplanned Deviation arised.

GEP

 

[uhohraggy]

Clarence -

Been trying to figure this out for awhile now. The FDA has cited deviations being used as mechanisms to circumvent NCR's. We eliminated unplanned deviations, but even planned deviations are sketchy as just because you planned to create nonconforming product doesn't make it less nonconforming. We still do deviations, but only for development and clinical builds, where we are intentionally altering things.

I'm still stuck on minor things. For example... a PM was due on equipment Jan 1, but it was missed, or even intentionally skipped and not done til say Jan 15th. Now I've got an NC because the process wasn't followed. I get that we want to track that and see if there is a trend, but mixing it in with true product NC's seems wrong.

Did you ever come up with a good resolution?

 

[Ronen E]

Clarence -

Been trying to figure this out for awhile now. The FDA has cited deviations being used as mechanisms to circumvent NCR's. We eliminated unplanned deviations, but even planned deviations are sketchy as just because you planned to create nonconforming product doesn't make it less nonconforming. We still do deviations, but only for development and clinical builds, where we are intentionally altering things.

I'm still stuck on minor things. For example... a PM was due on equipment Jan 1, but it was missed, or even intentionally skipped and not done til say Jan 15th. Now I've got an NC because the process wasn't followed. I get that we want to track that and see if there is a trend, but mixing it in with true product NC's seems wrong.

Did you ever come up with a good resolution?

Please note that Clarence has last logged in here on December 1st 2009.

 

[Ajit Basrur]

Thanks for your response.

Please note that the OP had raised this questions about 10 years back and his Last Login was on 30th November 2009, so there will not be response !