5. Product safety plan
What is the difference between HACCP and HARPC?
In this article we go through the requirements for both HACCP and HARPC – the similarities, the differences and how to comply with both.
What is the difference between HACCP and HARPC?
They sound very similar, but there are distinct differences between them. Some, which at first seem contradictory. In this weeks article I’m going to go through the requirements for both, the similarities, the differences and how to comply with both.
Comparing HACCP & HARPC
The following compares the 12 logic sequence steps as defined in Codex used for HACCP, to the requirements of the preventive control rule which defines the rules for HARPC.
Codex (HACCP) | Preventive Rule (HARPC) |
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Pre-requisite Programmes (PRPs) Codex states that the HACCP plan must be based good hygienic practises, which it defines as pre-requisite programmes. |
The preventive control rule includes the two following typical pre-requisite programmes:
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Comparison
The preventive rule does not specifically require pre-requisite programmes to be in place.
However, it does expect CGMPs (current good food manufacturing practices) to be in place.
The CGMPs would also not be taken into consideration when carrying out the hazard analysis, as pre-requisites would when conducting a HACCP study.
Codex (HACCP) | Preventive Rule (HARPC) |
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Preparatory stages 1 - Assemble the team The team:
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Comparison
The FDA do not refer to ‘scope’, however when you compare the requirements there are a number of elements such as defining the hazards, which we would expect to see in a typical HACCP scope.
The FDA go one step further than HACCP by specifically stating that not only typical manufacturing hazards should be included, but also those that are inherent to the raw material and also those due to food fraud.
Codex (HACCP) | Preventive Rule (HARPC) |
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Preparatory stages 2 - Describe the product Relevant safety information about the product should include:
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No specific comparison to Codex. |
Comparison
The preventive rule does not state that a product description is required, however an understanding of the intrinsics of the product would be necessary anyway, due to:
- to meet the production and process control element of the CGMPs
- to enable inherent risks of the raw material and product to be established
Therefore, it would be advisable to have this included in the preparatory information, although it could be structured in a way in which meets the requirements of the product, rather than being set by Codex.
Codex (HACCP) | Preventive Rule (HARPC) |
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Preparatory stages 3 - Identify the intended use This should:
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No specific comparison to Codex. |
Comparison
Again, the FDA have not specified that this is required, but in order to establish all of the required hazards that need to be included in the analysis, an understanding of the intended use and intended user is essential.
Codex (HACCP) | Preventive Rule (HARPC) |
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Preparatory stages 4 -Construct flow diagram The process flow should cover all steps in the manufacturing process off the product, in line with the scope (start and end points) Preparatory stages 5 - On-site confirmation of flow diagram Walk the process flow, confirming the steps |
No specific comparison to Codex. |
Comparison
The preventive rule does not specify a process flow diagram is required.
Although it would probably advantageous to have one, to assist in identification of the relevant hazards.
However, the manufacturing process may not be only process where hazards should be identified. To ensure food fraud is covered, hazards would need to be identified prior to the raw materials delivery to site. Also, hazards may need to be included which may occur in processes prior to the production of a product, such as during development or at the artwork/labelling stage – which would be out of the scope of a typical HACCP.
Codex (HACCP) | Preventive Rule (HARPC) |
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Codex principle 1 – Hazard analysis
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Comparison
This is where it starts to get interesting. At first this may seem similar – identify the hazards and then carry out the hazard analysis using severity and likelihood to determine significance.
There is one key change though, which makes a massive difference – the hazard analysis is carried out without taking the current controls into consideration.
Typically in HACCP, the controls are taken into account when carrying out the hazard analysis, and in doing so this reduces the likelihood result.
Therefore, if controls were not taken into consideration, there would be a much greater number of hazards that come out of the analysis as significant.
So, comply with both HACCP and HARPC, this part of the typical HACCP hazard analysis method would need to be adjusted – so that all hazards were assessed without taking controls into consideration.
Just because the controls are not taken into account in the analysis, they would still need to be listed.
The type of controls that are listed, in order to comply with FSMA would need to be much more specific than you would see in a typical HACCP. Putting ‘training’ as a control for example would not be enough, as this is very vague and you could not actually prove the link between ‘training’ and the control of a hazard.
Where hazards are deemed not to be significant, they would need to be managed using the CGMPs (or as we would typically see in HACCP your pre-requisite programmes).
Codex (HACCP) | Preventive Rule (HARPC) |
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Codex principle 2 - Determine CCPs
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Comparison
Clearly this is a massive difference to HACCP, the CCPs are not a requirement of the preventive control rule.
All hazards that come out as significant in the hazard analysis need to be managed using preventive controls.
These controls can however, include CCPs if you wish.
In order to comply with both HACCP and HARPC, all the significant hazards would need to be put through the decision tree. Where CCPs are identified, these would be managed as CCPs. Where CCPs are not identified, these would be managed as preventive controls.
So now, we have three levels of control:
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- CCPs
- Preventive controls
- CGMP controls
The problem that we have here though, is that the reason that the hazard analysis for CCPs is carried out with the controls taken into consideration, is to ensure that only the really high risk hazards go through as being significant. The risk of having a lot of significant hazards, is that when these go through a typical CCP decision tree – a high proportion of them will come out as CCPs. Therefore, a new style of CCP decision tree will be required.
Codex (HACCP) | Preventive Rule (HARPC) |
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Codex principle 3 - Establish critical limits for each CCP
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No specific comparison to Codex. |
Comparison
The FDA do not use the term ‘critical limit’. They would expect limits to be set where risk assessment determines it is required, but they state that not all preventive controls would require critical limits.
It can be presumed, that were critical limits are not provided, criteria should be set to provide the boundaries of control.
Therefore, this would mean that critical limits would need validation, but where criteria are applied instead – justification would be sufficient.
Codex (HACCP) | Preventive Rule (HARPC) |
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Codex principle 4 - Establish a monitoring system for each CCP
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Comparison
Although the control that is being managed is different (CCP or preventive control), the way in which they should be managed is fully aligned.
Codex (HACCP) | Preventive Rule (HARPC) |
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Codex principle 5 - Establish corrective actions
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Comparison
Again, the type of control may be different but the requirements are the same.
Codex (HACCP) | Preventive Rule (HARPC) |
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Codex principle 6 - Establish verification procedures
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Comparison
Verifying the system and ensuring that the system stays up to date and relevant are requirements in both HACCP and HARPC.
Codex (HACCP) | Preventive Rule (HARPC) |
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Codex principle 7 -Establish documentation and record keeping
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FSMA now expects food facilities to have records to prove that protection measures have been applied and adhered to and these must be available on request of an audit. |
Comparison
Records are a requirement of both systems, the addition of preventive controls (to CCPs) means that additional records will be required, as evidence needs to be provided that the system was followed.
Your comparisons are very useful. Your statement about now having 3 levels of control reminds me a bit of the ISO 22000 format which includes OPRPs. I think once I’ve digested your next comparison with BRC I should be able to figure out how to encompass all that is required both sides of the pond! Maybe a colour coded system just like your comparison boxes might be worth a thought….
Hi Carrie, yes I’d thought the same. Colour coding sounds good, I like that idea! 🙂
Thanks, Kassy
All of this information is great help in designing the plan for HARPC. However, taking it to the next step and bringing it to life as a stand alone or Combined with HACCP Plan is going to be very challenging. So many significant differences within the interpretation of the FSMA rule compared to HACCP that makes this process just a little deceiving. Don’t get me wrong your explanation of the comparison of the two is very helpful and very much appreciated. I still think that with our simple process we can combine the two plans into one that will meet the requirements of FSMA as well as comply with the Guidelines of HACCP and BRC Food Safety Standard. Very interested in your next post as it will bring more light to the beginning process of building the steps of HARPC into our HACCP Plan. The two plans should be able to work in conjunction with each other if formatted correctly. The design may be somewhat tricky in how they reference each other in various sections. Always up for a good challenge!
Hi Kathryn,
It’s definitely a challenge! 🙂 You’re right, it’s the small details in the differences that are going to make it hard – but not impossible! There will need to be some tweaks to the well established elements of HACCP, such as the decision tree – which is causing me a few headaches, but I think I’ve got a really simple solution forming in my head!
Lots of work to do before the next post…
Thanks, Kassy