Process preventive controls explained!…
In this post we’re going to cover the FDA’s requirements for process preventive controls and how they may differ from those required in the BRC Food Safety standard. This is one of a series of posts on preventive controls – if you would like to read the rest, you can find them here:
Process preventive controls
The rule states:
“§117.135 Preventive Controls
(c) Preventive controls include, as appropriate to the facility and the food:
(1) Process controls. Process controls include procedures, practices, and processes to ensure the control of parameters during operations such as heat processing, acidifying, irradiating, and refrigerating foods. Process controls must include, as appropriate to the nature of the applicable control and its role in the facility’s food safety system:
(i) Parameters associated with the control of the hazard; and
(ii) The maximum or minimum value, or combination of values, to which any biological, chemical, or physical parameter must be controlled to significantly minimize or prevent a hazard requiring a process control.”
Reference: FDA FSMA Title 21 of the Code of Federal Regulation Part 117—Current Good Manufacturing Practice, Hazard Analysis, and Risk‐based Preventive Controls for Human Food
In my opinion, process preventive controls are the most difficult to understand, mainly because the FSPCA training states that process preventive controls are what we would class as typical CCPs in HACCP. They do not however, make it clear what the difference is between a process preventive control and other preventive controls such as sanitisation or food allergen preventive controls.
During the training a number of theories for this was offered:
- A process preventive control is linked to a particular point in the process or a particular piece of equipment.
- A process preventive control is any control that does not fit within the other groups of preventive controls, i.e. one that is not a supply-chain preventive control, sanitation preventive control or a food allergen preventive control.
It is really important to understand which of your preventive controls need to be labelled as process preventive controls, as the FDA would expect you to apply critical limits to these types of controls where possible and that you validate them.
It is even more important to understand which of your preventive controls need to be labelled as process preventive controls or CCPs – when you are trying to meet HACCP requirements as well.
I have covered this topic in detail in my book ‘Combine your HACCP & HARPC plan, step-by-step” – because I think for any facility manufacturing product in the EU and exporting to the US, or any facility manufacturing in the US and exporting to the EU, will need to adhere to not only the FDA’s preventive control rule but also EU law which requires HACCP principles.
In the book I have the explained the differences between preventive controls and CCPs and have established definitions for each, so that a simple assessment can be carried out on each preventive control – to understand if it is a CCP.
The definitions I have used are:
PC: A control which prevents or significantly minimizes the hazard
CCP: A control which eliminates or reduces the hazard to an acceptable level
A PC is one which either prevents the hazard from occurring in the first place, or if the hazard has occurred, it identifies it and minimizes the impact of the hazard, by ensuring that it is not released as good product.
A CCP is a hazard which is inherently expected in the product, it therefore knows to tackle it, by eliminating it or reducing it to a level at which it is safe (such as cooking).
Once you have determined which of your preventive controls are process preventive controls (or CCPs) you need to make sure that you validate your critical limits for the control.
Comparison to BRC
As long as your hazard analysis and risk assessment identifies clearly which of the preventive controls are process preventive controls, i.e. CCP’s, and then you manage these as you would CCP’s – as stated in section 2, HACCP of the BRC Food Safety Standard you should be compliant to both systems.