Becoming a PCQI expert: The truth about how FSMA will be enforced

In my former life as a Quality Assurance manager, I watched the Food Safety Modernization Act (FSMA) gradually take shape. First came the law, then the hearings and finally the rules. While most businesses might be skeptical towards government interference in their work, this law has been generally well received because it does what government should do: create and enforce regulations.

That’s not to say that all is rosy in the garden of FSMA. One of the Acts biggest perceived flaws is that it is such a big bite that the US Food and Drug Administration (FDA) will never be able to enforce it. That may be true. However, after going through the Preventive Controls Qualified Individual (PCQI) training, I discovered that FDA has a secret weapon: you.

Perform a quick scan of the internet for PCQI, and you’ll find dozens of options for the new training programs. All mention the new requirement, but none go into much, if any details about why FDA requires it. It certainly stems from the mantra of accountability built into the legislation. But I think there is something more.

Remember that FSMA was, in part, the result of a series of highly public food safety incidents. Something wasn’t working, and someone needed to be held accountable.

How does the PCQI relate to FSMA?

For accountability, the regulations could have stopped at upper management signatures. I think the reason FSMA created the role of PCQI, is to establish a common understanding of the requirements, and to make it clear that this work must be a shared responsibility.

The PCQI makes it clear that there must be a shared responsibility

With the PCQI requirement, they’ve quietly deputized food safety managers, both requiring and empowering them to manage their supply chains.

Now, in addition to an annual inspection from FDA or a local surrogate, every food producer will have to fulfill food safety requirements, with teeth, from every one of their customers, every year. Producers can proceed with the knowledge that, since PCQI is now a requirement, all their suppliers will also understand the rules. The simple steps of requiring preventive controls and requiring facilities to have a PCQI, make supplier control a real, and powerful food safety step.

The need for training

Much has been written about the new FSMA requirements, including by Safefood 360° CEO George Howlett here. The PCQI training goes through this in a very thorough manner, providing common ground for food safety managers.

The training clearly illustrates the level of hazard analysis that is now required, including identifying those hazards that require preventive controls. The definition of preventive controls itself calls out the necessity of common understanding:

“Those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent hazards identified under hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packaging, or hold at the time of analysis.”

21 CFR 117.3 Definitions

It is clear that in order to successfully employ the teachings of FSMA the PCQI needs to be an informed and aware enforcer.

Weak links and supplier audits

There have always been smart people involved in food safety, from veterinary doctors to PhDs in microbiology, to experts in statistical process control. But like any system, food safety fails at its weakest link.

Like any system, food safety fails at its weakest link

The weak links in food safety tend to be found where food safety schemes are poorly designed, or where good schemes are poorly implemented. Because of FSMA and the newly deputized PCQIs, it will be much harder to maintain either of those types of defective systems.

Management and customers will find out, and demand changes. Real changes will occur when customers vote with their wallets and drop suppliers.

The tragedy of the food safety outbreak caused by peanut butter contaminated with Salmonella, might have been averted had the producer’s preventive controls been more robust. However, it could also have been averted, or minimized, if more customers had done what one large customer did: conduct a supplier audit and say, “No, thank you.”

The future of FSMA implementation

With FSMA, it is much more likely that supplier audits and approvals will have real teeth since a Supply Chain Preventive Control has the same status as a Critical Control Point (CCP).

In fact, many Allergen Preventive Controls will also relate to the supply chain, and quality managers will closely scrutinize the Sanitation Preventive Controls used by their suppliers. Supplier approvals will need to be real and robust for these preventive controls to pass muster.

Clearly the days of hand-waving supplier approvals after receiving a binder full of unread documents are over. Supplier approvals will need to include documents that are read and reviewed with expiration dates that are monitored.

Site visits will need to include tough questions, such as asking your suppliers what they do to ensure their preventive controls are working. QA managers can expect to be asked the same questions of their own products.

The very essence of Supply Chain Preventive Controls is that you are relying on someone else to support your food safety plan. Likewise, someone else is relying on you.

Supply Chain Preventive Controls mean you rely on someone else to support your food safety plan, likewise, someone else relies on you as well

This web of preventive controls, reviews and approvals ties each of you to your suppliers and customers. Those ties already exist, but in the world of preventive controls and PCQI, they have become even more important.

Of course, we won’t know exactly how this works until the first few audits are completed using the new regulations. Until then, food safety plans will be reviewed, hazards assessed, and preventive controls put in place. As a newly minted PCQI, you will be the de facto enforcement of FSMA.

Next time you hear someone say FSMA will never be enforced, you can point out that you’re already on the job, and politely refer them to the next PCQI training session. The bigger the posse the better.


6 replies
  1. Katrina Cooks Fitten
    Katrina Cooks Fitten says:

    Excellent article those who are manage Supplier Quality and encouraging for newly trained PCQI’s.

  2. Tom Webber
    Tom Webber says:

    Well written Chris. Expectations of Supplier Preventative Control systems will change our industry for the better. It will be interesting to see our Distributors and Brokers will adapt.

    • Chris Fuller
      Chris Fuller says:

      Distributors and Brokers have gotten very good at the logistics of recalls. The industry will benefit greatly, as Tom notes, if they can reallocate some of that energy into robust supplier approvals that prevent the recalls from occurring in the first place.

  3. Suwimol Surareungchai
    Suwimol Surareungchai says:

    It is very good article, but i still doubt on fsma that the factory in thailand also need to take course pcqi training as well as the mfg and importer in us, isn’t it?
    Please kind share this idea for non native english speaker like me, due to i aware on my misunderstanding.

    • Chris Fuller
      Chris Fuller says:

      The requirement for having a PCQI is only for facilities registered with FDA. However, if you supply to a US company, you would benefit from understanding what they need from you. I checked online and found someone in Thailand that might me able to help. There is an office of Perry Johnson Registrars in Bangkok. Try contacting them at [email protected].

      • Suwimol Surareungchai
        Suwimol Surareungchai says:

        Thank you so much for your kind help.


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