Corrective Action Effectiveness also for correction?

[QAMTY]

Hi guys
Im applying CA's in my ISO 9001 system. I do the CA, and when is finished, I evaluate it, for effectiveness, but I wonder if I have to do it also in corrections? (containment action).
Thanks

 

[JoShmo]

Hi guys
Im applying CA's in my ISO 9001 system. I do the CA, and when is finished, I evaluate it, for effectiveness, but I wonder if I have to do it also in corrections? (containment action).
Thanks

How will you know if the correction has happened if you don't?

 

[RoxaneB]

How will you know if the correction has happened if you don't?

In my experience, corrections are typically documented after the fact (i.e., paperwork is completed after corrections have been made) along with a quick statement indicating that the situation has been fixed.

If I experience a paper cut, I clean the wound, apply a bandage, make sure there is no bleeding and go back to doing my job.

If I slice my finger down to the bone with a knife, well, the investigation and actions taken will be a bit more detailed and in-depth.

That said...if I start to experience paper cuts on a regular basis, there is obviously a problem with my paper-handling process and corrections are insufficient. A more in-depth investigation will now be required.

An organization does not wish to become bogged down in corrective actions for minor issues. That being said, regular analysis of all nonconformances (corrections and corrective actions) is needed to determine if triggers need to be refined (i.e., what situations and results will result in correction versus a corrective action).

 

[QAMTY]

Tanks Roxane ,very helpful your comment.
Joshmo, I only ensure correction was done, having the evidences,nothing more.

 

[JoShmo]

Tanks Roxane ,very helpful your comment.
Joshmo, I only ensure correction was done, having the evidences,nothing more.

How do your know is the correction actually corrected the situation?

 

[QAMTY]

Because I Close the report once I ensured the problem was corrected.

 

[JoShmo]

Because I Close the report once I ensured the problem was corrected.

How do you do that? What steps do you take? Some concrete examples would help.

 

[TWA - not the airline]

Hi guys
Im applying CA's in my ISO 9001 system. I do the CA, and when is finished, I evaluate it, for effectiveness, but I wonder if I have to do it also in corrections? (containment action).
Thanks

From the wording "containment actions" I gather that you are mainly thinking of non-conforming product. Here, effectiveness control on corrections typically is simple and straightforward, so in most cases you would not have to do anything special: Reworked product is tested again per SOP, scrap is documented in the batch records and/or the ERP system, product that will be "used as is" will be released following the respective regulations of your QMS, any recall will be tracked regarding the number of returned product etc.

 

[Mike_H]

Are you asking if you need to verify effectiveness of containment actions? I guess you could paint a picture where faulty products might continue to leak after corrective action , if containment isn't performed effectively ie) faulty products exist until the C/A is fully implemented and you might not be able to capture every item in time. You would need to weigh up the risk of this happening and the effect it would have to your business. The more risk, the more resource you would want to throw at it (in theory). Hope this helps.

 

[Candi1024]

We would prove the correction took place with evidence, separate from the corrective action.