ISO 9001:2015 Clause 10.2.2 - Evidence of all nonconformities and actions

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Hi All,

We have a process hole in that we aren't documenting corrections(nonconformities deemed as minor not worthy of a root cause analysis). As a result we're working on creating a process where any one in the org can submit an issue which will go the quality and management team for disposition in a monthly meeting where we review all open quality issues. If the issue is a nonconformance(process or requirement violated) then we disposition as a CAR or correction and capture required info. If there was no nonconformance we disposition as N/A or OFI(we will track actions taken which I think is non-standard for OFIs).

We brought in another manager for feedback on the idea and the concerns were:

• Are we really going to have to fill this out for every super minor nonconformance(e.g. if someone uses black ink instead of blue ink we have to fill this form out and have the management team review it)?
• Others have tried similar approaches and it turned into a complain about your manager/coworker. How can we prevent this from happening again?

In regards to the first concern. I'm wondering if we are creating an inefficient process(it'll be a webpage to make it fast and easy to fill out) where we document every minor thing that goes wrong. Any suggestions or feedback? Please keep in mind we're a small business where we all wear multiple hats?

In regards to the second concern, historically most of the non-value add concerns came from the production floor. To prevent this from reoccurring (e.g."I don't like the person I sit next to at work, you should move me"), we are thinking to create an OFI group, where a rotating group of production workers and a process engineer meet one hour a week to discuss possible improvements. The idea is the group will serve as a filter to prevent non-value added issues being reported and also to have the side effect of improved morale(people feeling like they have a voice).

Thanks,
Eddie

 

[AndyN]

Are we really going to have to fill this out for every super minor nonconformance(e.g. if someone uses black ink instead of blue ink we have to fill this form out and have the management team review it)?

Yeah, I'd be concerned too...

 

[Eredhel]

Do you think the standard requires that you do this for every nonconformity? Or is this an internal decision?

 

[Mark Meer]

...Are we really going to have to fill this out for every super minor nonconformance (e.g. if someone uses black ink instead of blue ink we have to fill this form out and have the management team review it)?...

Remember: a non-conformance is a requirement not being met.

Insofar as there is such thing as a "super minor nonconformance", and these are happening frequently, then I might suggest that you may have requirements that are not all that important (e.g. how important is the color of ink?). Perhaps such things could be relegated to "best practices guidelines", as opposed to stated QS requirements, and can be handled outside your NC process.

 

[Sidney Vianna]

In regards to the first concern. I'm wondering if we are creating an inefficient process(it'll be a webpage to make it fast and easy to fill out) where we document every minor thing that goes wrong. Any suggestions or feedback? Please keep in mind we're a small business where we all wear multiple hats?

The quickest way to deflate and self sabotage a maturing quality system is to create bureaucracy which is perceived by everyone (management, supervisors and doers) as non value added. I would strongly suggest you don't do this. On the other hand, you don't want to have a situation where, on a daily basis, the same minor problems recur, because, small problems that are frequent also detract significantly from your efficiency and bottom line. That's where supervisors need to keep their eyes and ears open to see if these small repeated problems escalate to a frequency where true corrective action will end saving the company money and aggravation. The discussion if something is recurring too often could be done in the weekly meeting you suggested

In regards to the second concern, historically most of the non-value add concerns came from the production floor. To prevent this from reoccurring (e.g."I don't like the person I sit next to at work, you should move me"), we are thinking to create an OFI group, where a rotating group of production workers and a process engineer meet one hour a week to discuss possible improvements. The idea is the group will serve as a filter to prevent non-value added issues being reported and also to have the side effect of improved morale(people feeling like they have a voice).

I think this suggestion is a winner, for the reasons you already mentioned. It engages, involves and empowers the workforce. I wholeheartedly support such idea and initiative and my only comment is: as you start conducting these meetings, chances are, there will be a lot to be discussed, so, the early 1-hour/week meeting might seem short. As things improve, there should be fewer topics to discuss and the hour a week should be sufficient.

Good luck.

 

[AMIT BALLAL]

NC is raised if a requirement is not fulfilled. If it is a requirement and hasn't complied, root cause analysis and corrective actions have to be taken. If you find the NCs were small deviations, why raise NC in the first place?

 

[Mark Meer]

...If it is a requirement and hasn't complied, root cause analysis and corrective actions have to be taken. ...

I don't think this is correct. The idea is that non-conformities are evaluated to determine the need for further investigation & corrective action. Not all non-conformities warrant investigation & corrective action.

...If you find the NCs were small deviations, why raise NC in the first place?

To document them, so you can identify trends and have data to drive improvement. If NCs are not documented, they cannot be evaluated, nor do you get a sense of occurrence rates or trends. An individual NC might be evaluated as minor and an isolated incident, not warranting any action. But if there's subsequently more of the same being documented, then the issue might be escalated to something requiring an investigation and corrective action.

 

[AMIT BALLAL]

Thanks for your reply Mark Meer. Agree that need for corrective action can be evaluated. I didn't come across a Nonconformity which won't require corrective action. Can you give an example of a NC which didn't require a corrective action?

 

[Kronos147]

Hi All,

We have a process hole in that we aren't documenting corrections(nonconformities deemed as minor not worthy of a root cause analysis). As a result we're working on creating a process where any one in the org can submit an issue which will go the quality and management team for disposition in a monthly meeting where we review all open quality issues....

We brought in another manager for feedback on the idea and the concerns were:

• Are we really going to have to fill this out for every super minor nonconformance(e.g. if someone uses black ink instead of blue ink we have to fill this form out and have the management team review it)?
• Others have tried similar approaches and it turned into a complain about your manager/coworker. How can we prevent this from happening again?

Insofar as there is such thing as a "super minor nonconformance", and these are happening frequently, then I might suggest that you may have requirements that are not all that important (e.g. how important is the color of ink?).

I believe a log is a good thing to have. Without a log, organizations are not truly aware of how often the event actually occurs. The log would be useful to address the 'not documenting NC' issue and additionally useful for Management Review Meetings. Two birds (10.2 & 9.3.2), one stone (log).

And Mark Meer has a great point. The log will let you review if you actually keep harping over the ink color, or other meaningless nonsense.

I believe that because of Evidence-based Decision Making organizations should accumulate data in order to transform it into (useful guiding) information.

I believe that because of Risk Based Thinking and the availability of resources, that opting to categorize events on the log as "log only" and no need to do a complete corrective action is reasonable.

To satisfy your co-worker, explain that this is one of the methods the organization uses to determine where to commit resources to a continual improvement projects in a responsible manner, and to create the document information required to demonstrate conformance to the standard.

 

[Ninja]

We brought in another manager for feedback on the idea and the concerns were:

• Are we really going to have to fill this out for every super minor nonconformance(e.g. if someone uses black ink instead of blue ink we have to fill this form out and have the management team review it)?
• Others have tried similar approaches and it turned into a complain about your manager/coworker. How can we prevent this from happening again?

Perhaps a different point of view (not all that "different").

Are we really going to have to fill this out? Yes, something required was not done.
The Correction/Corrective action is to edit that silly document and remove the requirement for blue ink.
It is either important to use blue ink, or it isn't.
If it isn't important, stop requiring it.
If it is important, then using black ink is not a super-minor thing, it's something important that has gone wrong.

Every system I've seen has someone's silliness in it...sometimes a great deal of silliness.
Each time it turns to a complaint about a person, turn it instead to an opportunity to rid yourself and your system of the silliness.
Over time, people will look for that silliness on the initial document and remove it before it even comes into force.
Also over time, you may learn what authors to pay special attention to...some people can't help but write ridiculous things into documents.

If your system has so much silliness in it that it is burdensome...start by removing the obvious junk through PA or just rewrite the silly things (have your operators give you a list...you may be surprised at how long the list is), then get the rest through the CA system.
Your business has required certain things of itself. If it has required nonsense of itself, start removing those nonsensical requirements...then you wont have to fill this form out so much, and you'll have a better system.