3 replies to this topic

[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

[GMO]

Tony got there before me but cleaning is often the PRP which is validated in many programmes. This would include for both allergen and microbiological controls. 

 

I remember back in the day when FSMA first came in and more evidence was asked for in terms of wider controls for food safety, I went down the route of trying to validate every PRP. Surprisingly interesting but a lot of time wasted I have to admit.

 

The key is significant. 

 

In a warehouse context, from the controls you've listed, in their absence, I'd call out pest management as one which is most likely to be significant. We have all seen it done badly.

 

So if validation is all about "can it work" for food safety, then what proves to you that the integrated pest management programme you've put in place is likely to be effective? Things I'd expect to see are that you've risk assessed the number of visits you have, you've chosen suitable pest species to target and can reference why they've been chosen. You've used a reputable pest contractor who has received suitable training and ongoing CPD. All of that is, in my mind, validation.

 

You probably also though have lots of verification activities you're already doing. So for example, I bet there's a review somewhere that you're on track with actions, there might be the requirement that one of your team accompanies the contractor for some of their visit and signs off their report. I bet there's an internal audit and also you will be trending pest species findings and looking for adverse trends with action limits etc and alerts into you meeting structure if this happened.

 

So all in all you are probably both validating and verifying all of this already. I'm not sure the other two hazards I'd call significant but we could have a think about them if you have identified them as such in your plan?

Edited by GMO, Today, 01:48 PM.

[WorkingFromWork]

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’

This is probably where my misunderstanding comes from. We do not have many significant hazards. Thank you for clarifying this.

 

So all in all you are probably both validating and verifying all of this already. I'm not sure the other two hazards I'd call significant but we could have a think about them if you have identified them as such in your plan?

The other examples, as with many of my hazards, are actually not significant. So now I think I can manage. Thanks for your explanation. 

 

I really appreciate the help here. :)