2 replies to this topic

[ral491994]

Hi All, 

 

I could you use some help to clarify internal auditing vs validation.

 

What i am thinking both are: 

 

Internal auditing  and validation are both reviewing your program is working effective? Validation can be completed during you internal audit. 

 

Example. Food Safety Plan. - You HACCP team validates that the plan is effective. Your internal audit team reviews effectiveness of the plan? 

 

Thanks! 

 

 

[ebb30]

Validation is making sure you have data backing up that something works the way you say it works. For example, a kill step is validated if you have data showing that in your process with your parameters at your facility does, in fact, kill pathogens by more than 5 logs, or whatever your limits are. 

 

Internal auditing is more of a verification that everything is being done the way it is supposed to be, that metal detectors are being checked as described in your program, that the maintenance department or production departments are documenting what they are supposed to and when. 

 

For a HACCP plan, I would say you are verifying the plan when you and your team go through it for an internal audit. You make sure everything is in order, and records are kept. Validation would be for specific steps throughout the HACCP plan, such as CCPs, to prove they work. The HACCP team can review effectiveness of the plan, for example, if you find metal in your product and your HACCP plan does not address metal anywhere, then you need to reassess the risks, but I don't know that I would think of it in terms of validating the plan. An internal audit is usually a checklist to verify that everything is in order for when you get a third party audit or customer audit, etc.  

[majoy]

Agree with the above comment on internal audit - it is verification step

 

Validation is having an expected outcome and then comparing your results based on that expected outcome - see pathogen kill step above.

 

Other examples of validation:

Allergen - 0 complaints/ recalls related to allergen for xx period

Foreign material - acceptable # FO complaint per xx units of products produced

Deviations - acceptable # of deviations closed