Managing a Significant Number of Outstanding Non-Conformities

S

Stuart Williams

Hi Everybody

I am at a new company and I have found that out QMS system is not in tip-top condition. We have started to do things properly, and during our audit programme we are finding a significant number of non-conformities and recording them properly.

The position I find myself in is that I have a significant number of outstanding NCs. The management team here is now pretty well engaged and the NCs are getting steadily resolved, but I do have a continuing assessment in a couple of weeks time and can only reasonably expect that there are a number of NCs outstanding, unless there is some kind of miracle in the meantime.

The standard requires that we take action to prevent non-conformities occurring in the future, and we have a process for recording and managing non-conformities, which specifies that the auditor will specify a required date for corrective action.

Is it acceptable to have outstanding NCs at an audit? What criteria would make them acceptable, perhaps if they are in progress and the required date is in the future?

Any help in this matter would be much appreciated.

Kind regards

Stuart Williams
 
P

PaulJSmith

Re: Managing Non-Conformities

Hi, Stuart!
Welcome to The Cove!

There is nothing wrong with having open NCs during an audit. In fact, as long as you are following your Noncon procedure, it is a fine opportunity to demonstrate that with a real example.

It's awesome that your management team is getting involved, too. That's essential to success.

Good luck with your audit.
 

insect warfare

QA=Question Authority
Trusted Information Resource
Re: Managing Non-Conformities

Hi Everybody

I am at a new company and I have found that out QMS system is not in tip-top condition. We have started to do things properly, and during our audit programme we are finding a significant number of non-conformities and recording them properly.

The position I find myself in is that I have a significant number of outstanding NCs. The management team here is now pretty well engaged and the NCs are getting steadily resolved, but I do have a continuing assessment in a couple of weeks time and can only reasonably expect that there are a number of NCs outstanding, unless there is some kind of miracle in the meantime.

The standard requires that we take action to prevent non-conformities occurring in the future, and we have a process for recording and managing non-conformities, which specifies that the auditor will specify a required date for corrective action.

Is it acceptable to have outstanding NCs at an audit? What criteria would make them acceptable, perhaps if they are in progress and the required date is in the future?

Any help in this matter would be much appreciated.

Kind regards

Stuart Williams

Welcome to the Cove, Stuart :bigwave:

To answer your question correctly, you need to be very clear in your definition of "outstanding". To me, "outstanding" could mean "late" and could either mean "NC's that are not closed, and the corrective actions are being implemented prior to the specified date" (which is acceptable) or "NC's that are not closed, but the corrective actions are not being implemented by the implement date" (which if those happen a lot, will indicate a systemic issue, which is not acceptable). This needs to be clearly explained to your CB.

As long as your internal audit NC resolution process recognizes this distinction and corrective actions are being implemented according to planned arrangements, you should encounter no problems with your CB regarding "NC's in process".

Brian :rolleyes:
 

somashekar

Leader
Admin
Hi Everybody

I am at a new company and I have found that out QMS system is not in tip-top condition. We have started to do things properly, and during our audit programme we are finding a significant number of non-conformities and recording them properly.

The position I find myself in is that I have a significant number of outstanding NCs. The management team here is now pretty well engaged and the NCs are getting steadily resolved, but I do have a continuing assessment in a couple of weeks time and can only reasonably expect that there are a number of NCs outstanding, unless there is some kind of miracle in the meantime.

The standard requires that we take action to prevent non-conformities occurring in the future, and we have a process for recording and managing non-conformities, which specifies that the auditor will specify a required date for corrective action.

Is it acceptable to have outstanding NCs at an audit? What criteria would make them acceptable, perhaps if they are in progress and the required date is in the future?

Any help in this matter would be much appreciated.

Kind regards

Stuart Williams
Outstanding ... Significant number ... How many ?
I see a good opportunity to quickly close many with just a correction.
All NC's do not need a corrective action.
Identify those that are systemic in nature and you can address corrective action more appropriately to address many NC's of similar nature.
When you have the audit, you are fine if some NC are still open and can be justified why they are open and what has been the progress so far. No undue delay please.
 

Wes Bucey

Prophet of Profit
My opinion:
Good things:

  1. n/c are identified
  2. progress has begun on root cause and corrective action (if required)
Bad thing:

  1. you are focusing on the negative points versus the good plan and progress to date

Things to watch:

  1. keep records of n/c, the plan for root cause, and the corrective actions planned and/or taken
  2. finally, ensure there is a process to evaluate the corrective action to ensure it does, indeed, resolve the n/c
  3. don't confuse "corrective action" with "correction or repair"
  4. deliver documents, not anecdotes, to outside auditor
 
S

Stuart Williams

Thanks everybody.

My use of Outstanding means not completed, we use SharePoint for this and have statuses of "Not Started", "In Progress and "Completed". The use of the required date in our process is not clearly defined, I think I need to do some work on that.

I think the approach I will take is to ensure that I have reviewed all of the non-conformities and make sure that the business manager has updated them with an action plan and marked the non-conformity as In-Progress. I am also going to make sure that the required date is reasonable.

I am particularly going to avoid NCs with a required date in the past and a status of "not started".

Stuart
 

Wes Bucey

Prophet of Profit
Thanks everybody.

My use of Outstanding means not completed, we use SharePoint for this and have statuses of "Not Started", "In Progress and "Completed". The use of the required date in our process is not clearly defined, I think I need to do some work on that.

I think the approach I will take is to ensure that I have reviewed all of the non-conformities and make sure that the business manager has updated them with an action plan and marked the non-conformity as In-Progress. I am also going to make sure that the required date is reasonable.

I am particularly going to avoid NCs with a required date in the past and a status of "not started".

Stuart
Perhaps you might breathe a little easier if by "required date" you defined it as "due date of first progress report." (Sometimes an N/C is simple and straightforward and can be resolved in a matter of minutes or hours. Other times, an N/C can be a real knotty situation, taking days or weeks just to get to the root cause and additional days or weeks to formulate a workable plan, then still more time to obtain financing and permissions to implement the plan, then still more time to run the plan and evaluate it for efficacy.)
 
Top Bottom