CAPA Follow-up - Format for Addressing the Assessment

[Dottie123]

I have implemented a quarterly CAPA follow-up for three or more occurrences of the same problem/nonconformance. Can someone help me with the format for addressing the assessment for follow-up and the conclusion (leave the CAPA closed or re-open based on assessment), etc.

 

[silentrunning]

Re: CAPA Follow-up

Dottie, are you saying you are still having non-conformances after initiating corrective actions? Please clarify.

 

[Dottie123]

Re: CAPA Follow-up

Yes, sometimes. Is it true that the follow-up assessment on the nonconformance report is to determine if the CAPA truly fixed the problem or to see if you are having continued problems. If there are continued problems it is evident that some more investigations and/or fixes need to be implemented. I am trying to determine the format to address the follow-up. For example, I have three occurrences in one quarter related to earloops popping. The fix is to adjust the homing, ensure the anvil is level, check weld pressure. These things become undone because it is inherent in machine operation, that as the machine continues to run, the pounding, pressure, vibration or the machine may cause initial settings to become undone and need to be reset. So, for my follow-up assessment, would I - just say - that it is inherent in the machine operation and consider the NCR follow-up closed. I am just trying to document that I have reviewed these repeat problems and say there is nothing else that can be done - i.e. we are going to continue to have this problem.

 

[Jen Kirley]

Re: CAPA Follow-up

Hi Dottie,

The format I am familiar with is to send the same (repeat) nonconformance to the next-up in the management chain. The process is called "elevation" which is intended to help address issues like inadequate resources, or possibly the need to pursue the fix as a team effort versus a local one.

 

[isoalchemist]

Re: CAPA Follow-up

As Jennifer stated elevation is a good one if it can be solved at that level like her examples stated.

Documenting why it can't be fixed and that the risk of not fixing it is low (safety, $$$, allowing bad product out the door etc.) is also valid

Not knowing the process would it be possible to put a preventative maintenance schedule it to make the adjustments at some frequency. I had a more frequent problem that by having some rollers speeds checked/adjusted once a day I dropped the scrap rate by 25%. "Fixing" the machine was cost prohibitive a two minute adjustment......

You know the root cause, now it becomes a business decision as much as a quality decision.