5 replies to this topic

[WorkingFromWork]

Hi, I am reviewing my HARA and looking at BRCGS requirements for issue 7. When we prepared the HARA for issue 6, we included every step of the process from product specification approval until customer returns as part of the process flow chart. Then we also included each of those steps in the hazard analysis itself.

 

Reading the requirements now for issue 7, it says in 2.5.1 "The HARA team shall identify and record all the potential hazards that are reasonably expected to occur at each manufacturing process step.."

 

Are things like specification approval and customer returns considered manufacturing process steps? Should hazards for those processes also be part of the HARA? The wording used in the requirements leads me to think no as they are not part of the manufacturing itself. The same could be said for storage and distribution.

 

Is there anyone that could clear this up for me? I would really appreciate it. 

[kconf]

You are right. They are not part of manufacturing process itself, but you are required to be in compliance. Think of more like pre requisites before you even get to manufacturing anything. I hope this clears up. 

[Tony-C]

Hi WorkingFromWork,

 

BRCGS requirements for Issue 7 clearly indicate that ‘receipt and approval of artwork and specification’ and ‘customer returns or materials to be returned to the supplier’ are steps in the operation to be considered when constructing a flow diagram. It is then normal to use this flow diagram in complying with clause 2.5.1 which is effectively the first part of CODEX Step 6 Principle 1.

 

Therefore I would include them when identifying all potential hazards and considering control measures. There may be issues such as the material isn’t the correct specification for the intended use of the packaging or customer returns being contaminated. I wouldn't really want bits and pieces of hazard analysis elsewhere.

 

Kind regards,

 

Tony

 

[GMO]

HARA isn't something I have a lot of experience in but as I've reviewed it before there is a lot of overlap with HACCP.  To my mind, the specification and returns processes are not process steps.  The process step would be receipt of packaging which then part of the control to ensure that's the right packaging will be your specification.  Part of the corrective action if an error is still found will be the customer returns. 

 

If you mean returns to you, then both still apply.  The process step will be despatch.  The control measures for accuracy to the standard will be around the specification.  You will have monitoring against the specification (or record from it) to prove compliance at earlier stages in the process and at that despatch step.  Returns will be part of the corrective action should this go wrong.

In both cases, returns should be part of the verification that your plan is working i.e. if you're having to get to that stage either with your suppliers or with the customers and you, it should ring alarm bells.

 

So personally I wouldn't include them as flow steps but they are activities which support the flow.  The flow is the "experience" of the packaging.  I suppose you could include returns on the flow but I'd only do so if there was a legitimate non error related reason why this happens OR if you then end up reusing that packaging if it does occur.  In a food plant you wouldn't have on a process flow diagram that the product could be rejected back to manufacturer even though theoretically that can happen because it will only do so if the HACCP plan has failed and, as part of the corrective action, the material will be destroyed.

[WorkingFromWork]

Hi WorkingFromWork,

 

BRCGS requirements for Issue 7 clearly indicate that ‘receipt and approval of artwork and specification’ and ‘customer returns or materials to be returned to the supplier’ are steps in the operation to be considered when constructing a flow diagram. It is then normal to use this flow diagram in complying with clause 2.5.1 which is effectively the first part of CODEX Step 6 Principle 1.

 

Therefore I would include them when identifying all potential hazards and considering control measures. There may be issues such as the material isn’t the correct specification for the intended use of the packaging or customer returns being contaminated. I wouldn't really want bits and pieces of hazard analysis elsewhere.

 

Kind regards,

 

Tony

Hi Tony, I think what was confusing me was that in 2.4.1 for the process flow diagram it lists 'receipt and approval of artwork and specification', 'receipt and preparation of raw materials...', 'each step of the manufacturing process...' as separate things but then 2.5.1 only mentions 'each manufacturing process step'. If they should have been included as part of the requirement for 2.5.1, it should have mentioned all the pieces as described in 2.4.1 instead of only listing one of them.

 

In your example of "the material isn't the correct specification for the intended use of the packaging", I would have said that this would be a hazard introduced whenever the material itself is input into the manufacturing process. I think customer returns is a bit different, and it might make more sense to include that one in particular.

 

HARA isn't something I have a lot of experience in but as I've reviewed it before there is a lot of overlap with HACCP.  To my mind, the specification and returns processes are not process steps.  The process step would be receipt of packaging which then part of the control to ensure that's the right packaging will be your specification.  Part of the corrective action if an error is still found will be the customer returns. 

 

If you mean returns to you, then both still apply.  The process step will be despatch.  The control measures for accuracy to the standard will be around the specification.  You will have monitoring against the specification (or record from it) to prove compliance at earlier stages in the process and at that despatch step.  Returns will be part of the corrective action should this go wrong.

In both cases, returns should be part of the verification that your plan is working i.e. if you're having to get to that stage either with your suppliers or with the customers and you, it should ring alarm bells.

 

So personally I wouldn't include them as flow steps but they are activities which support the flow.  The flow is the "experience" of the packaging.  I suppose you could include returns on the flow but I'd only do so if there was a legitimate non error related reason why this happens OR if you then end up reusing that packaging if it does occur.  In a food plant you wouldn't have on a process flow diagram that the product could be rejected back to manufacturer even though theoretically that can happen because it will only do so if the HACCP plan has failed and, as part of the corrective action, the material will be destroyed.

On our last audit we actually had a minor NC for not including customer returns (returns from our customer back to us) on the flow diagram. They are not process steps but the BRCGS requirement for the flow diagram does include those other parts of the process to be included in the flow diagram. I am more so trying to get clarity on if those required elements in the flow diagram that are clearly not "manufacturing process steps" still need to be included in the hazard analysis beyond being included in the flow diagram. 

[GMO]

Fair enough.  I concede my knowledge is lacking here.  I would absolutely include it though as I said if it's routine (which it might be in packaging and not in food for example).  

 

As I said, they're also control measures or corrective actions etc but I'm not a HARA expert so I will leave it to those who are.