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  #1  
Old 26th July 2000, 10:55 AM
AJPaton
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Question Controls for Corrective Actions

ISO 4.14.2 d) application of controls to ensure that corrective action is taken and that it is effective.

Does this indicate that there should be a:
1) plan for corrective action
2) schedule for corrective action
3) any other time limit for completion of corrective actions?

How do you control that corrective action is taken if you have no proposed close out date?

Thanks,

AJP
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  #2  
Old 26th July 2000, 11:13 AM
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AJ - Don't know for sure why - but have always "read- TIMLEY" - into this one - sure setting dates is fine and within x days normally works out ..but some reasonably take longer than others .

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Jim
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  #3  
Old 26th July 2000, 12:11 PM
AJPaton
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Read This!

We've got a time limit for coming up with a corrective action plan, but now we're discussing what should be in the plan. Specifically, a completion date for the corrective action.

The assignee is best able to assess how long the action items will take. However, should s/he include that information in the plan?

My argument is that in order to implement controls some due date for action items must be set up.

Can you have controls on the corrective actions without some schedule involved, minimum - projected/required completion date?

I'd say no, but I may be missing something.

Thanks,

AJP

[This message has been edited by AJPaton (edited 26 July 2000).]
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  #4  
Old 27th July 2000, 01:50 AM
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AJ you have a good basis for argument - I see a number of variables & possible good/bad outcomes to each side of the situation.

Quote:
Originally posted by AJPaton:

The assignee is best able to assess how long the action items will take. However, should s/he include that information in the plan?
I for one would tend to agree - the assignee should take origional responsibility and include completion due timing as long as it is "REASONABLE" and "TIMLEY" to the task at hand. A free pass to set a date possibly years down the road is however not a good thing.

The responsibility for accepting the date supplied should/could be agreed and communicated to the assignees superior.

Sad part is that when you start "Setting Dates/timelines" that may/could be missed - what action steps would be included in the plan/procedures to cover a "missing the date issue" ?

It COULD turn into a "if I wait long enough the situation will go away item" and if nothing has been covered on the "what will happen if I just ignore it anyway" syndrome. - That would tend to give ammunition to anyone that really believes this ISO document stuff is "just bull" anyway.

IMHO PROJECTED could work - as long as there is a mechinisim in planning/procedure for moving the projected date due to unseen circumstances that come to light after the origional planning stage.... That way the assignees supierior would retain some semblance of "control" over what is or is not happening/when with the issue.

The final outcome of what works...where depends heavily on the individual workplace environment, commitment and attitudes.

Regards
Jim

[This message has been edited by Marc Smith (edited 28 July 2000).]
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  #5  
Old 14th August 2000, 06:52 PM
Bryan
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We see setting a reply due date for CAR's issued works ok, but setting a date for actual closure of CAR is more difficult. We had an understanding that a CAR could not be closed until the CA has been validated. Now recently, during an audit, we were told by our auditor that we did not have to wait to varify, in fact we could close the CAR if we accepted the reply, trusted the CA to take place from the CAR. If the CA did not work, we could just issue a new CAR.
I guess my guestion would be, is this a true statement made by the autitor that CAR'S can be closed before we validate the CA ??
Thanks for any input.

Bryan
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  #6  
Old 15th August 2000, 11:12 AM
AJPaton
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Bryan,

Our current take on this is that the Corrective Action can be closed when the action items are completed.

However, we then have an "Effectiveness Review" date that is set to check on the efficacy of the corrective action. That's how we set a control on the effectiveness, which I mentioned in my opening for this topic.

Hope this helps.

AJP
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Old 15th August 2000, 07:29 PM
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Yin Yang

I think the 'typical' approach is to consider the CA open until effectiveness is confirmed. However, in some instances this may take months or more. Typically a few weeks or so is sufficient time before confirming effectiveness in a high volume production operation.
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Old 21st August 2000, 12:17 PM
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For long term complex CA I close them when action is complete and schedule a follow up audit when there is too long a period between...... For simple stuff I followup first, then close.....there is an option box on the CAR for choosing....

Your auditor should not be giving you advice that detailed/specific...it is only his opinion...You can be flexible, as these wounds for CA/PA are self inflicted typically

[This message has been edited by barb butrym (edited 21 August 2000).]
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