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FSMAWelcome to my brand new FSMA fortnightly posts!

I’m really glad you’re here at the beginning of a journey that is going to take us to a clear, practical understanding of the FDA’s NEW Food Safety Modernization Act (FSMA) launched in the USA.  This year I’ve set myself the task of finding out everything there is to know about it so I’d like to share my learnings with you as I go.

If you’ve arrived at this page through a search on Google, I’d better tell you a bit about myself and why you should come on this learning journey with me…

I’ve worked in the food industry since leaving university , working my way through new product development roles and into technical and compliance. During this time I found out that I actually love risk assessment (I really do, I’m not lying!) and especially food safety hazard analysis (known commonly as HACCP in the UK). Since then I’ve specialised in HACCP and have developed new risk assessment methods for threats and errors, which resulted in me publishing books on the subject with my co-author Adele Adams.

So, with HACCP and hazard analysis risk assessment being my passion, when I heard that the FDA had a new requirement as part of the FSMA of ‘hazard analysis and risk based preventive controls’ I was keen to find out more. The more I’ve read about the new Act, the more interested in this new approach I’ve become.

In the UK all food processors no matter what they make or how big or small they are have to have a HACCP plan. Their HACCP also has to be developed for the individual site, with no government guidance at all. Although we follow Codex principles, the way they are applied to the USA is very different. The retailers in the UK also have very strict standards so this has driven food processors to have very detailed procedures and recording systems. I’d like to share my knowledge and experience of this with processors in the USA, as I think it’ll help you comply with FSMA.

A quick search on Google made me realise that there’s not much help out there for the processors in America with regard to how they should actually apply the new Act. There’s lots of websites that have regurgitated the information provided by the FDA, but none (I literally couldn’t find one!) that explains in practical terms what you actually do. That’s when I realised that I could use my interest in the FSMA to help people and share my learnings in the only way I know how using a pragmatic, methodical and practical approach that in my experience always works best!

So, this blog post is my introduction to ‘Your FSMA Companion’, which I will publish every fortnight as I go through the detail of the act and how I think it should be practically applied. I really want this to be an interactive forum, every post will have a reply section (like this one) and I really want to hear your opinions, feedback and what you’re working on to comply with FSMA. Where ever possible I’ll also set you a task to do, which will hopefully take you one step closer to FSMA compliance!

Here’s what I want you to do today – I’d really like to know what you want to know about FSMA. Where would you like me to start? There’s a lot to get through, so I want to be as effective as possible and tackle the things you really need now, first…

  • What confuses you the most?

  • What are you struggling with?

  • What questions do you have?

  • Where are you on your journey of complying with FSMA?

Please let me know in the reply box below and I will send you a reply or direct you to the areas I’ve covered in ‘Your FSMA Companion’ articles.

Thanks for reading and I look forward to us learning together, Kassy.

p.s please accept my apologies for my UK ‘speak’. I’d really like to learn the American lingo – would you do me a favor (we spell it ‘favour’ in the UK so you can see I’m trying) and point out where I go wrong? 😀

Here’s a list of all the FSMA Companion posts below, click to view a topic you’re interested in…

Your FSMA Companion 2: The Preventive Rule and HARPC
Your FSMA Companion 3: What is the difference between HACCP and HARPC?
Your FSMA Companion 4: How BRC sites can comply with HARPC
Your FSMA Companion 5: How to manage preventive controls
Your FSMA Companion 6: Your HARPC plan – hazards explained
Your FSMA Companion 7: Special Issue: Combine your HACCP & HARPC Plan Step-by-Step
Your FSMA Companion 8: FDA Intentional Adulteration Rule: what is required?
Your FSMA Companion 9: FDA Intentional Adulteration Rule: How to carry out your FDA Vulnerability Assessment
Your FSMA Companion 10: FDA Intentional Adulteration Rule: How to carry out your FDA Food Defense Plan
Your FSMA Companion 11: FDA FSVP: Understanding the foreign supplier verification program for Importers
Your FSMA Companion 12: 8 Things you need to know about the FSMA Intentional Adulteration Rule
Your FSMA Companion 13: How not to tie your food defense plan up in knots
Your FSMA Companion 14: The solution to combining HACCP & HARPC
Your FSMA Companion 15: Key learnings from my PCQI Training
Your FSMA Companion 16: Supply-chain preventive controls
Your FSMA Companion 17: Food Allergen preventive controls
Your FSMA Companion 18: Sanitation preventive controls
Your FSMA Companion 19: Process preventive controls
Your FSMA Companion 20: Recall Plan preventive controls
Your FSMA Companion 21: Preventive controls food safety plan
Your FSMA Companion 22: Preventive Controls – The BRC FSMA Voluntary Module
Your FSMA Companion 23: The Sanitary Transportation Rule

20 Comments

  • First of all I have been in Food Safety for about 25 years. I have only have hands on experience along with industry training for Rice & Almond processing. The company I currently work for became BRC Certified 2-years ago. I originally left a company of 15-years that had been BRC Certified for 4-years prior to my leaving. I find that the BRC Certification program is one of the best at keeping companies honest.
    * What confuses me most – What is the difference between FSMA and BRC
    * What are you struggling with? The general rule and the level of compliance a company has with FSM if they are BRC Certified.
    * What questions do you have? What do we need to do to take our BRC Certification to the next level to comply with FSMA
    * Where are you on your journey of complying with FSMA? Not sure until I find out just where the BRC Certification fits with FSMA. I am going to take a two and a half day certification course to become a PCOI “Preventive Controls Qualified Individual” so that my company has one on site. My training will be at the DFA Safe Food Conference in Monterey California on April 18, 19 & 20.
    Thank you for your assistance in helping me to understand the difference between FSMA and BRC compliant.

    • Kassy Marsh says:

      Hi Kathryn,
      I love your idea of comparing BRC and FSMA for those sites that are BRC accredited – I will definitely keep that in mind while I’m writing for you. It would be great for me to go on a PCOI training course too, to be able to hear if for myself and to be able to ask questions (I think I’d drive the trainer crazy!)- have you heard of any on-line options?
      Thanks, Kassy

  • Simon Webster says:

    How the hazard analysis determines what controls need to be in place or recorded.
    What risk based controls look like and how does this strengthen food safety culture.
    How to document all the data being monitored – there seems to be a big push for some sort of automation in the US.
    Don’t need to comply with FSMA as in UK and don’t supply to US but would like to see if there is anything of value to add to or change our HACCP – what starts in the US usually gets pushed worldwide if shown to be effective in reducing food borne harm.

    • Kassy Marsh says:

      Hi Simon,
      I think your point about documenting monitoring data is key – I also get the impression that there is a push for automation. As you know in the UK we have to record practically everything, because basically if you don’t have documented evidence of it, you can’t prove you’ve done it. Although we do have some level of automation in the UK, generally manual recording is most common. There are ways and means of having hard copy data and managing it. I’ll make sure I share how we do this in the UK.
      This new approach of HARPC is definitely an interesting one and there’s always things to be learnt from understanding a different perspective of thinking, which like you say we may be able to take and use to improve our HACCP too.
      Thanks, Kassy

  • Rina says:

    Hello,
    I am hoping to find more information on the HARPC. We currently have a Risk Assessment for the product we have incorporated in the HACCP, I am looking to find out if we can expand to HARPC, or if we even need to since the Risk assessment is pretty detailed for the facility.

    Thanks,
    So happy to have received the email to join.
    Looking forward to all knowledge.
    Best
    Rina

    • Kassy Marsh says:

      Hi Rina,
      I’m looking forward to learning about HARPC the most too (I get excited by this kind of thing!!!).
      You’re very welcome, I love to learn and I love to share my learnings even more – what’s the point of learning if you keep it to yourself?!
      Thanks, Kassy

  • Bronwyn Gordon says:

    This is more of an interest / learning curve for me. Australia has had HACCP for many years and is very aligned to UK requirements. We do export to the US, so it is more around learning what their requirements may be going forward.

    • Kassy Marsh says:

      Hi Bronwyn,
      Ok great to have you on board! 🙂 I think the intention for the FDA is for exporters into the US to comply with FSMA too, so understanding what that means worldwide may become necessary.
      Thanks, Kassy

  • Karen Dawes says:

    How can companies modify current HACCP programs into FSMA compliant programs? There is not much guidance on validation of some pre-requisite programs. How can we simply documents so they are easy to use and meaningful?

    • Kassy Marsh says:

      Hi Karen,
      I’m make sure when I’m writing that I explain the changes that will be required to ‘step up’ a HACCP into a HARPC plan. Validation is a good point – I noticed in the Act that they have made a point to say that things like cleaning and allergen management do not need validating, which to me doesn’t make any sense. I would have picked those two subjects out as some of the most important elements to validate. I’m sure when I delve further, it will all become clear though 🙂
      Thanks, Kassy

  • Like some other folks I work for a company that exports ingredients to America so am interested where the differences are between being BRC accredited and FSMA compliant.

  • Nicole says:

    What is the difference between HACCP and HARCCP? I see a lot of people have already touched on this.
    What changes have been made to GMPs?
    I’m also curious about the correlation between FSMA and BRC, what we need to add to maintain our certification and become FSMA compliant.

    Thank you!

    • Kassy Marsh says:

      Hi Nicole, great – sounds like we all want to work through the same things. I think we need to work through the CGMPs at the same time too, as they will affect the HARPC. Thanks, Kassy

  • James D. Madsen says:

    Currently, my company has been BRC certified (5) years with an “A” rating and last year with the new “AA” rating (located in U.S.). We are delving into the the HARPC requirements as we speak. As we develop the differences (both in terminology and practices/documents) I will try to put them on this site. Glad to be here. Great forum. Jim

    • Kassy Marsh says:

      Hi Jim, Thank you for your comment, I just love it! Really pleased to have you on board and it would be fantastic hear about your learnings – it would be great for the rest of our community shared their learnings too. Thanks,
      Kassy

  • Andrea says:

    We are BRC certified (AA rating on issue 7). We are located in Canada and ship finished product to warehouses in the USA for further distribution. I am trying to find out (without success) what our responsibilities are for FSMA in this instance. We are not selling to an end user right away, so do not fall under FSVP. I want to know what we have to do as the importer, not being located in the USA.

    • Kassy Marsh says:

      Hi Andrea,

      Thanks for your comment, great to have you in our little FSMA community!

      You’ve said you don’t sell your product into the end user right away, so I’m presuming you supply raw materials. I believe that because you supply (your raw material) into a manufacturer (for further processing), you will need to be approved as a supplier by your customer – under the PC rule (Supply-chain control). Therefore, your customer would need to document their approval process, which would include verification of your manufacturing site in order to approve you as a supplier. The verification process may include on-site audits, testing or a review of your food safety documentation. Which verification method your customer uses to approve you will need to be based on risk, with high risk raw materials ideally being approved through on-site audits.

      If however, some of your product is sold ultimately to the end user, without any further processing or packing, I believe the FSVP would apply.

      Does that help? 🙂

      Thanks
      Kassy

      • Andrea says:

        Hi Kassy,

        Just want to clarify from my first post. We are not supplying a raw material. It is a finished product (jarred, ambient product) that we ship to a third-party distribution warehouse from Canada into the USA. As we receive orders (retail food chains mostly) we arrange shipping from the warehouse to the customer. But when we first ship into the USA we do not have a customer specified. We are still the owners of the product, and therefore are the importers. I am guessing, from what I’ve seen so far, that we are responsible for FSMA compliance, even though we are in Canada. The warehouse is not responsible, as they are contracted by us to store and ship the product. What, then, is our responsibility for FSMA? Thanks.

        Andrea

        • Kassy Marsh says:

          Hi Andrea,
          Ok, I see. It is the importers responsibility to ensure that the manufacturing sites who supplies their product, meet the requirements of FSMA. As both importer and supplier you have two different responsibilities, but overall the result is the same – your site must comply.
          The warehouse is also responsible in their own right to meet the FSMA requirements that apply to them.
          Thanks
          Kassy