5 replies to this topic

[Quality girl]

Minor
2.5.3.1 Corrective and preventative action methods shall include the identification of the root cause(s) and the resolution.

Corrective and preventative action methods do not include the identification of the root causes for deviations from quality requirements Evidence: SQF -Safety 2.5.3 Corrective and Preventive Action Program. Policy reviewed does not include the methods for root causes Quality deviations reviewed only include corrections and investigations for CQPs. No root causes documented or available for review.

[SQFconsultant]

Did I miss read another of your postings where you said this was a customer audit and not a sqf/gfsi audit?

[Tony-C]

Hi Quality Girl,

 

You need to have a procedure and record for root cause analysis.

 

A lot of people use the 5 whys technique

 

 FS 3.7 Root Cause Analysis.jpg   120.44KB   1 downloads

 

Kind regards,

 

Tony

 

[jfrey123]

SQF gives some leeway on when a company requires themselves to conduct a full root cause analysis for a problem versus an immediate corrective the action.  Your CAPA program should define when a problem requires a full root cause analysis versus documenting a corrective action.  When a glass and bp items is found broken, you investigate whether it poses a food safety hazard and then replace the broken item.  Solved.  However, once you find the same item is being broken over and over and over again, eventually you have to have defined parameters in your SOP for when a repeated problem requires a full root cause analysis, with investigation and a corrective action to stop it from happening.

Edited by jfrey123, 11 August 2023 - 04:24 AM.

[PQAManager]

Update your CAPA Procedure with something like this:

 

Deciding if a CAPA Form is Necessary:

Does the complaint, non-conformance, or issue affect food safety? If it does, then a CAPA must be filled out. Is this the 3^rd or more time this issue has come up? If it does, then a CAPA must be filled out. We want our actions to be proactive. We will perform a corrective action immediately when at all possible.

 

Corrections Used to Find Root Cause:
What critical limits have been exceeded? Document any violations or other observations.
If product is believed to be at a food safety risk, corrections should be made.
 

Investigate and Resolve the Issue:
A root cause analysis will be completed for non-compliance to critical food safety limits.
Corrective actions will correctly deal with affected product.
Corrective actions will achieve resolutions that will prevent recurrence.

 

Attached Files

•  CAPA Form.docx   41.02KB   58 downloads

[Charles.C]

Minor
2.5.3.1 Corrective and preventative action methods shall include the identification of the root cause(s) and the resolution.

Corrective and preventative action methods do not include the identification of the root causes for deviations from quality requirements Evidence: SQF -Safety 2.5.3 Corrective and Preventive Action Program. Policy reviewed does not include the methods for root causes Quality deviations reviewed only include corrections and investigations for CQPs. No root causes documented or available for review.

Hi Qg,

 

Also see the possibly related,

 

https://www.ifsqn.co...ns/#entry198211

https://www.ifsqn.co...se/#entry198187

 

There appears to be some confusion between Safety and Quality.

 

You are more likely to get directly useful responses if you supply some context for your current OP ?