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[WorkingFromWork]

Hello,

 

I am trying to make sure my HARA is ready for audit, and I am a bit confused over this part for BRCGS Packaging Materials Issue 7.

 

2.5.4 - Where the control of a specific product safety hazard is achieved through a PRP, it must be stated and the adequacy of the program to control the specific hazard shall be validated. (paraphrasing just a bit..)

 

So does this mean that every PRP that controls an identified hazard needs to be validated?

 

If so, how do I document that? Let's say I have a simple list of hazards like this:

 

A. Pest infestation contaminates stored products in the warehouse.

B. Dirty packing tables contaminates products when they are being packed.

C. Maintenance worker leaves tools laying around manufacturing area and they fall into a case of products.

 

A is controlled by the pest control. How do I document validation that the pest control by the third party contractor works? I have their reports but that's the verification right?

B is easier to understand. We can do swab testing to validate the cleaning is effective for removing the contamination hazard.

C I have no sweet clue. Obviously if the tools are removed they can't fall into a box, but how do I document that as they expect? I don't get it.

 

 

So to conclude,

Question 1. Every PRP that controls an identified hazard needs to be validated?

Question 2. How do you document the validation? Especially where it seems extremely obvious/common sense.

 

Please help. Maybe I'm way off..

[Tony-C]

Hi WorkingFromWork

 

I think the wording in this clause isn’t great and better clarification would have been if it stated ‘Where the control of a specific significant product safety hazard is achieved through a PRP’

 

BRCGS Guidance regarding validation of such hazards includes:

 

'It is not a requirement that a documented validation of every prerequisite is undertaken, as prerequisite programmes typically cover a wide range of general environmental controls…...

However, where a prerequisite programme is used to manage a specific hazard (e.g. cleaning regimes used to prevent allergen cross- contamination), there needs to be a documented validation that the prerequisite controls the identified hazard.

Some companies prefer to differentiate these prerequisites that manage specific hazards from other prerequisites, by referring to them as operational prerequisites (oPRPs).'

 

You can document the validation by challenge studies on site in the case of cleaning, external validation can also be used when appropriate such as legislation and scientific literature.

 

Kind regards,

 

Tony