11 replies to this topic

[WorkingFromWork]

Hello, I am trying to create the HARA plan for our food-contact plastic packaging. I have gone through the BRCGS training for HARA and looked at various examples online but I am confused over a few things. I was hoping I could find some help here. :)

1. What needs to be included in the process flow chart and what can be left off? For example, we make products from PET. I include the receipt of the rolls of PET, storage, etc. But should I do the same for the packing materials for our products? Do I need to include processes like preparing the boxes next to each machine before starting production? How do I know what to include exactly, as I don't want to overcomplicate it.

2. Also regarding the process flow chart: I also wanted to know if I need to include how material is consistently added to the machine throughout the day. Like the process will be something like: a. receive material, b. store material c. set up machine d. add material to machine e. thermoforming process, etc.. but then when the material roll is all used up and another roll is added, so I need to include that again partway into the process?

3. When it comes to CCP determination, I understand that we should use some methodology like the CCP decision chart with a few questions etc. However, I also saw some examples of HACCP or HARA plans that simply based CCP determination on the risk level. Is that enough? Like if I have a 3 x 3 risk matrix, and 9 is the highest result it would be a CCP? Or how exactly should CCP determination look like? I understand how to use the flow chart but I guess incorporating the risk rating into this whole process is confusing me.

 

4. When I am listing the potential hazards per process step and the control measures that we use to mitigate the risks, should the control measures be only the ones that take place at those steps? For example, we could have microbiological hazards during storage of PET rolls, but when we heat the PET the risk is basically non-existent. So should I list that as a control at the earlier process step or only later when that actually occurs? 

 

Please help me, and I really appreciate anyone who can provide guidance. Thank you.

 

[Scampi]

1. Yes as any incoming materials could pose a risk to your product and/or facility

 

2. No just that that is the point in the process where/when that occurs

 

3. No, CCP determination is NOT the same as a risk assessment   (use the CFIA decision tree, it will not cause you grief and makes it easier for any regulatory inspections)  (but typically a HARA plan only includes control points, not critical control points)

 

4. if you use the CFIA combined 8 form ( you can find it here https://inspection.c...t-program#form8) it lays out what do to 

 

Also, you can use this database to assist (it's clunky but worth the effort)  https://active.inspe...introe.aspx?i=1

[beautiophile]

- 1 & 2, they can be either flowcharts or more detailed process flow diagrams or something in between. IMEX, auditors feel satisfied by any of those forms.

- 3 & 4, no perfect risk assessment method exists in this case, you use the one (e.g. decision tree, matrix) which fits the manufacturing (a reason BRCGS Packaging states HARA, instead of HACCP like in BRCGS Food Safety) and prove it reasonable. Also, there are 2 extreme levels of risk assessment, qualitative and quantitative. HARA probably leans to the latter side.

 

Note that, the Issue 7 changes CCP to CCM, or critical control measure.

[WorkingFromWork]

Thank you for your responses, but I am still confused! If I could receive some more guidance it would be much appreciated.

 

Here are my new questions:

1. So the BRCGS training has us learn about the 12 steps for HARA. Based on that, I thought I should be doing a risk matrix based risk assessment, and then the results of that would be used for CCP determination. Now with the feedback I have received here, I do not understand what to do with the risk assessment.  Currently, my risk assessment looks something like this:

Risk Level = Likelihood x Severity
3x3 Matrix
Process Step | Hazards Identified | Control Measures | Likelihood | Severity | Risk Level | PRP| CCP Determination 1| 2| 3| 4| 5 | CCP |

What do I do with the Risk levels? Like if it scores a 1-3, that should have an associated action or something right? and if it's a 9 it is a critical risk but what do I do with that information? Previously it was "if it is a 9, then it goes through the CCP decision tree" but it seems that isn't correct. Also does that mean if something is a moderate risk like a 6 it wouldn't? This is really confusing me.

 

2. I was linked the GFSI form 8, and it looks really good but would I not need to include the Risk Level related things into that? Maybe I don't need to even do the risk matrix? I am so confused

3. Are there any examples of a completed HARA that I can look at that would maybe help me understand better? I feel like I might be missing the whole point..

[beautiophile]

1. a

 

 

Risk Level = Likelihood x Severity
3x3 Matrix
Process Step | Hazards Identified | Control Measures | Likelihood | Severity | Risk Level | PRP| CCP Determination 1| 2| 3| 4| 5 | CCP |

 

Here, I assume the step is to identify hazards. One methodology is similar to Ishikawa's fishbone.

If Ishikawa suggests 5M as man, machine, method, medium, materials, BRCGS gives classifications of microbiological, chemical, physical, etc. in Clause 2.5.1

Once, a hazard is named, its severity can reflect how unsafe it would cast on to-be-touched food, and its likelihood can be based on the amount or frequency of appearance.

 

1. b.

 

 

What do I do with the Risk levels? Like if it scores a 1-3, that should have an associated action or something right? and if it's a 9 it is a critical risk but what do I do with that information? Previously it was "if it is a 9, then it goes through the CCP decision tree" but it seems that isn't correct. Also does that mean if something is a moderate risk like a 6 it wouldn't? This is really confusing me

An example of risk levels from 3x3:

- Low risk in block 1x1, 2x1, 1x2: no need to worry.

- Mid risk in diagonal 2x2: controlled under PRP executions => periodic verifications of PRP effectiveness, such as pest control reports.

- High risk in block 3x3,3x2,2x3: extract works needed (on each production lot) like residual volatile chemicals must stay below 30mg/m2, for example which may get called CCM.

If you find the scoring looks bad, 4x4 or 5x5 propably make more sense.

 

2. Such a stage belongs to the other method, you can overlook it. You are not the one feels confused when people apply practices in food to packaging production.

[Scampi]

I think you're confusing 2 things

 

Hazard analysis  (which looks at the process, ingredients, packaging and facility) to determine WHAT hazards may exist and them add steps to mitigate them

 

Risk assessment determines how LIKELY a hazard is to become hazardous and the SEVERITY if it does

[WorkingFromWork]

I think you're confusing 2 things

 

Hazard analysis  (which looks at the process, ingredients, packaging and facility) to determine WHAT hazards may exist and them add steps to mitigate them

 

Risk assessment determines how LIKELY a hazard is to become hazardous and the SEVERITY if it does

But I need to do both of these things for the HARA right? I think currently my plan would be to identify all the hazards, check if they are mitigated by prerequisite programs, and if not, create control measures. Then, risk assess all of the hazards that are not controlled by prerequisites? And if they're critical risks they will need to be critical control measures?  That's at least what I am thinking now. Is that wrong?

[Scampi]

Have you taken a formal HACCP training course???

 

 

Your sort of one the right track  (start at step 7)

 

When ALL of the below is done, then you can look at your most critical hazards and perform a RISK ASSESMENT using the 3x3 or 4x4 format to determine the risk level

 

[WorkingFromWork]

Have you taken a formal HACCP training course???

 

 

Your sort of one the right track  (start at step 7)

 

When ALL of the below is done, then you can look at your most critical hazards and perform a RISK ASSESMENT using the 3x3 or 4x4 format to determine the risk level

 

I have completed BRCGS HARA Training. I don't understand why you suggested that I start at Step 7, since your reference image does not match that.

I am setting up the HARA Plan and we are having a team meeting tomorrow to identify all of the hazards and to assess the risk of each one. We will go process step by process step, and consider all relevant and reasonably likely hazards that might occur at each one. Then we will assess the risk of the hazard.

What I didn't understand was what am I doing with the information at the end of this process that I described above. We should not have a single "CCP" or "CCM" but I want to make sure the documentation is prepared in the event that we do have one. So I am planning to simply assess the level of risk for each hazard and then document which PRP is being used to control it.

Does this not work? What exactly is wrong with that? I am not really sure.. so unless I could be told it's wrong I plan to do so..

I'd really appreciate feedback, especially before we have the meeting tomorrow. :)

Edit: How can I know what my most critical hazards are BEFORE doing the risk assessment? Isn't that how I determine which are critical?

Edited by WorkingFromWork, 18 November 2024 - 06:47 PM.

[Scampi]

Sorry, the principals of HACCP should be steps 6-12, so start at step 6  (assuming you've done the first 5)

 

One the HA is completed, you should have direction (what to do) to mitigate any risks you identify, THEN you develop the written programs to cover those hazards

 

What you still seem to not be grasping is that a HARA/HACCP plan and a RISK MATRIX/ASSESSMENT  are not the same thing

 

the hazard analysis does only 2 things

1. Identify the hazards at each step

2. create controls to mitigate each hazard

NO MORE AND NO LESS

 

a risk assessment does the following

1. assess SEVERITY and LIKELIHOOD of a hazard

2. that's it

 

Read through this---

https://quantumfoods...-food-industry/

What Is the Difference Between “Risk” and “Hazard”?

For those in the industry, it helps to know the difference between "risk" and "hazard":

• A hazard is a biological, chemical or physical agent in food. When no controls are in place, these agents can cause illness or injury to a person who consumes it. 
• A risk is a probability that a hazard will occur in a food product. It encompasses a lot of uncertainty, mainly concerning predicting the presence or distribution of hazards in products.

[G M]

...
What I didn't understand was what am I doing with the information at the end of this process that I described above. We should not have a single "CCP" or "CCM" but I want to make sure the documentation is prepared in the event that we do have one. So I am planning to simply assess the level of risk for each hazard and then document which PRP is being used to control it.

Does this not work? What exactly is wrong with that? I am not really sure.. so unless I could be told it's wrong I plan to do so..

I'd really appreciate feedback, especially before we have the meeting tomorrow. :)

Edit: How can I know what my most critical hazards are BEFORE doing the risk assessment? Isn't that how I determine which are critical?

 

There is an unwritten rule of practicality and achievability.  You could have a process generally considered 'low risk' and go into these step-by-step processes with the best of intentions, and have very alarming results come out of your risk assessment suggesting you have 10 CCPs. 

 

The practical thing to do in a situation where you get more CCP's than seems reasonable is go back and take a hard look at your risk (and severity) ratings and tune some of them down (often by taking credit for passive GMP or sanitation controls) until your number of control points falls to a practicable number. 

 

I would also recommend using a risk matrix with more stages, 5x5 instead of 3x3 for example, this gives you more room to recognize risks without advancing so many to the highest rating in need of elaborate control measures.

Edited by G M, 18 November 2024 - 10:20 PM.

[Tflex]

First you identify the hazards. Then you look at which hazards pose a risk (likelihood x severity). When a hazard poses a significant risk you can go through a CCP tree diagram to identify it as a CCP.

Edited by Tflex, 19 November 2024 - 07:17 AM.