3 replies to this topic

[lorlandini]

Hi

 

We are transitioning from GMP audits to SQF Fundamentals Intermediate and I need help with section 2.5.3.1 and 2.5.3.2.

 

I understand the difference between a correction, corrective action and preventative action.  I have a CAPA form that I use for misses on CCP's and product complaints.

 

I am having a hard time wrapping my head around how to write the policy.   Can any help?

 

Thank you.

 

Leo

[Spidey]

We are certified under SQF Fundamentals Intermediate, below is what I have in our policy.  I make reference to our internal policy and record keeping practices.  I have my internal SOPs and SSOPs that detail everything in my facility, and I have SQF documents that state my compliance with the code by summarizing and referencing the applicable SOPs and SSOPs.

 

 

PROCEDURE:

 

Corrective action is taken to resolve non-compliance (2.5.3.1) and records of corrective action are maintained (2.5.3.2).

 

Corrective Actions may result from a number of situations.  In all instances requiring Corrective Actions, the deficiency will be documented, corrective actions implemented, root cause analysis performed, and appropriate preventative actions taken per the “Corrective Action SOP”.  The Preventative Actions will be reviewed for effectiveness 30 days after implementation.  All of this is documented on a “Corrective Action Form”.

[kingstudruler1]

For each deviation that causes or might cause a food safety risk you need to have a procedure for CAPA

 

1.  Who initiates the CAPA

2.  Who determines the root cause and the methods used to determine root cause  (fish bone, 5 why, etc.)

3.  Who determines corrective and preventative actions.

4.  Who carries out the corrective and preventative actions or who assigns the tasks.  

5.  When are corrective and preventive actions due to be completed.  

6.   Who and how are corrective and preventative actions verified as complete and effective

7.  where is this information recorded.   

 

 

make sure you have a capa procedure(s) that cover "........customer complaints, non-conformances raised at internal or external audits and inspections, non-conforming product and equipment, withdrawals and recalls, as appropriate."   Some of these may already be covered in other clauses such as 2.1.3, 2.5.4, etc. i typically address the corrective and preventative action in these programs and then have a generic procedure and log for things like equipment failures, gmp/facility issues that are found outside of inspections - kind of a catch all for everything else.  

[Charles.C]

Note that the OP sought a Policy, not a Procedure ?

 

@ lorlandini - I do not see any mention of "Policy" requirement in the referenced Clauses ?

 

Just as a  miniscule, generic, Policy suggestion -

 

All identified non-conformities generated by the site must be subject to corrective action(s) as documented in a Procedure(s)..

Edited by Charles.C, 02 May 2022 - 10:53 PM.
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