Insights into Preventive Controls for Human Food

I have just spent the last week in the USA learning about the new FSMA rules. Yes…that is right…I flew 14 hours across the Pacific ocean to further my education. I also completed my Lead Instructor training which enables me to deliver the FSPCA Preventive Controls for Human Food training. As always, it was a great learning experience to observe a different perspective. However, what I did have reconfirmed and that is food safety is international. It really has no geographical boundaries.

I have always known this, but somehow, it was even more focused in the past week. I am very lucky to live in Australia. We have one of the safest and highly regulated food safety systems in the world. It is definitely an expectation of not only me, but of the wider community, that the food we purchase and consume will be safe and not make use sick.

The majority of changes introduced via the new FSMA legislation are outcomes that in Australia, and many parts of the world, have been law for over 10 years. To me, the rationale for certain requirements was easy to understand. But for others in the group, it seemed to be a whole new world of compliance. So based on this notion, I wanted to share three of my key learning’s from the first two and a half days of the course.

1. Assessing the probability (likelihood) of a hazard

It was great to see this one in the legislation as it is the way that I have been teaching hazard analysis for the past 10 years. When you assess the probability of a hazard, it needs to be assessed based on no control measure in-place or implemented. This is an area of non-conformance that I have commonly found over my years of auditing HACCP plans. To read the exact wording in the regulation refer to section 117.130 Hazard Analysis under Subpart C.

2. Hazard Categories

If you are familiar with traditional Codex HACCP you should be aware that potential microbiological, chemical and physical hazards need to be identified and assessed as part of your hazard analysis. The regulation now requires the following hazards to be identified:

  • Biological, including microbiological hazards such as parasites, environmental pathogens, and other pathogens
  • Chemical hazards, including radiological hazards, substances such as pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives, and food allergens: and
  • Physical hazards (such as stones, glass, and metal fragments
  • Naturally occurring hazards
  • Unintentionally introduced hazards
  • Intentionally introduced for purposes of economic gain

This is a significant change in what was previously required especially around radiological and economically motivated hazards.


Although the course did not cover the FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals, we did however touch on the concept of SAHCDHA. This is not something that I had heard of before, so it was great to get some further understanding of this concept.

SAHCODHA stands for Serious Adverse Health Consequences or Death to Humans or Animals. This is used as part of the hazard analysis process specifically in relationship to your foreign supplier verification program. In a nutshell, if you identify a hazard as being a SAHCODHA hazard that’s reasonably likely to occur, then you will be required to implement the highest level of verification activities—on-site audits of the supplier’s facility.

However, the importer can choose another means of verification provided that the importer documents that the alternate choice is appropriate and provides adequate assurances that the foreign supplier is producing the food in accordance with applicable U.S. safety standards.

Where to from here for Preventive Controls for Human Food?

So….where to from here? For the first time, FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply. Under the regulation, certain tasks must be performed (or overseen) by a “preventive controls qualified individual” (PCQI).

Now that I have completed Lead Instructor Training for FSPCA Preventive Controls for Human Food, I can now train you and your staff in FSPCA Preventive Controls for Human Food. Successfully completing this course, which is based on the standardized curriculum recognized by the FDA, is one way to meet the requirements for a PCQI.

To register your interest, click here to contact me. There will be courses scheduled in 2017 in the USA. If you would like me to facilitate an in-house course, please let me know.

If you are located in Australia or New Zealand, you can register for an upcoming course by clicking here.

21 thoughts on “Insights into Preventive Controls for Human Food”

  1. Hi Amanda
    Thank you to share such a helpful information, could you have any data about the ketchup, mayonnaise, salad dressings, specialty sauces, that how we apply HACCP in this field and how we provide a quality food to the market

    1. HI Shahiran, you first step would be to follow the HACCP methodology of the 5 preliminary steps and 7 principles. Unfortunately I cannot provide specific hazards associated with each but to give you a start please refer to Hazard Identification 101

  2. Paulo Renato Machado

    Hi Amanda
    I’ll wait for more articles yours. You have opened me new knowledge. I need to go deeper. I hope your help.

  3. Amazing article , could you provide a little info about SAHCODHA .. As I never heard about it before?

    Is online course available!


  4. Very helpful information; thank you Amanda for the good work keeping us updating, all your topics have a positive impact when implementition are a priority for “Manufacturer Safty Procedures”.

  5. Benyapa Chartthanapaisarn

    Hi Amanda,
    I finished PCQI training course in Thailand in August but I did not famlliar with SAHCODAH at all.Thanks for your sharing,could you please share this topic for more information ?
    Kind Regards,

  6. Hi Amanda,
    Often I go through your articles but whenever I read them one thing that comes to my mind is that how simply you explain such complicated things.
    I appreciate and admire your writing skills.

    I have just gone through PCQI course and yes this concept was also new and interesting for me- SAHCODHA.

  7. Hi Amanda

    Could you please send me any slides you might have on this course you done in the USA .thanks


  8. Hi Amanda,

    I was really excited on what you have shared with us, that is the learning you have gain while attending the training.
    I always follow you on your”HM HACCP MENTOR”, I never missed a single article you wrote in your space.

    At any rate, I would like to know if the “Preventive Controls for Human or Animal” is what some similar or almost equivalent to an operational prerequisite program implemented to prevent the likelihood of introducing the above mentioned hazards into the materials, product or system. I would appreciate if you could comment on this, thanks and more power to you

    1. Thanks for your kind words Patricio! To answer your question, there are many similarities between the two however more aligned with CCPs. You may currently have food allergen controls, sanitation controls and supply chain controls captured under your pre-requisite / support programs however there may not be sufficient documentation to comply with FDA requirements.

  9. Syed Farhat Raza Raza

    The introduction is quite good.
    The training is available in USA and Australia. What about UK and other countries?

    1. Thanks for your comment Syed. I will hopefully have virtual training available next year and face-to-face available in the UK.

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