Validation Audit

OK – I generally talk about the various issues and techniques around the Food Safety and Food Quality programs.  What I have not written about is best practices.  I recently saw a particular best practice and wished to share.  If you (as a reader) have a best practice – please tell me about it.  The one that I saw related to Validation audits.

We know that we need to do validcation audits as part of HACCP and GFSI systems.  But how do we structure / organize the audit?  Here are my thoughts and the best practice that I recently saw.

 STEP 1: Training

A .Train personnel on how to conduct themselves as auditors and how to conduct an audit.
B. Know that Validation audits should be done by personnel who are not responsible for the area being audited.
C. Create a matrix of who audits and which element of the the GFSI system.

 STEP 2: The Schedule

Create a folder in Outlook or a calendar specific for when each audit is to occur / who will do the audit / and when all CARs (Corrective Action Required) and other various due dates are required for completion. 
 

STEP 3: The Folder                                                          

Create a folder for each process being audited. From what I have seen, this folder has several areas and everything for the audit is in one folder.

Section A – Front of folder.  All SOPs and Policies, pertaining to the element, are attached.  Auditor is to review the SOPs / Policies before conducting the audit.  To understand the element training may need to be conducted so the auditor understands the element that they will be verifying.

Section B – The Audit Form. 

 

 

 Section C – Back of folder information.  Attach blank copies of all records / logs that pertain to the validation audit.  This is for reference only.

 STEP 4: After Audit.

Return the audit to the responsible manager and audit committee for review, creation of CARs, action plans and due dates.  There should also be regularly scheduled meetings to review audits and keep all members up-to-date.