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PCQI Consultation Services (Preventive Controls Qualified Individual) to meet FSMA Regulations

What is FSMA?

The FDA Food Safety Modernization Act (FSMA) has been dubbed the most sweeping reform of the US food law in more than 70 years. It was signed into law by President Obama on January 4, 2011. With public health its core mandate, the law intends to make the US domestic food supply and food imported into the United States safe through the implementation of preventive controls.

On September 17, 2015, the US FDA published final regulations on Current Good Manufacturing Practice (cGMP) and Hazard Analysis and Risk-based Preventive Controls for Human Food. The US food safety regulations are more encompassing than the internationally recognized HACCP standard in that it looks at radiological hazards and food safety hazards associated with fraud and bio-security. The new US FDA regulations also go beyond HACCP by categorizing preventive controls based on the 4 following types: process controls, food allergen controls, sanitation controls and supply-chain controls.

Do I Need PCQI Training?

The new US FDA regulations require that specific activities be conducted by a “Preventive Controls Qualified Individual” or PCQI, a person who has experience in implementing risk-based preventive controls plans. The PCQI has the mandate to develop or oversee the preparation of the food safety plan, validates the preventive controls, reviews records and is responsible for re-assessing the food safety plan a minimum of every 3 years unless changes are required. The PCQI may be but is not required to be an employee of the facility.

One way to become a PCQI is to attend an FSPCA course taught by an FSPCA lead instructor. The course developed by the Food Safety Preventive Controls Alliance (FSPCA) is recognized by the US FDA as meeting the requirements of the new food safety regulations.

How can Sirocco Food and Wine Consulting help?

  • As an FSPCA lead Instructor, Karine Lawrence, Principal/owner of Sirocco Food and Wine Consulting, is qualified to act as a PCQI and can develop and validate your food safety plan.
  • We offer onsite FSPCA training and remote training options
  • We can review your food safety plan to ensure that it meets US FDA regulatory requirements.

Next Step

Start by booking an expert chat to assess where you are in the process and clarify next steps.

SCHEDULE A FREE CONSULTATION

Have Questions?

Email [email protected], and let us know how we can help you.

Email Karine

What Clients Are Saying

"Karine taught the PCQI course clearly, and at a good pace that didn't feel too fast. She asked insightful questions that sparked discussions and helped broaden the expertise of those involved in the class, I would recommend it to others."

Karine is such a wonderful teacher. As a student for the PCQI hybrid course I learned a lot from the virtual course but was left with a lot of questions. I was looking forward to the instructor-led course to get some more practice and answers to my questions. Karine was clear and thorough in her explanations. Her consulting business experience gave her a plethora of examples to draw from. I was impressed by her ability to address my questions and give me resources to continue my study. She is very well versed in the regulations required and is up to date on any changes or new publications that may influence your business. She was very accommodating to my needs. I highly recommend taking a class from Karine. She is an expert in her field. I left the class feeling confident in my ability to act as a PCQI and make a positive impact on my company.

My company needed to create a more robust Preventative Control Plan than what we had, and I am so thankful to have found Sirocco Food + Wine Consulting. Their templates were just what I needed, and Karine and Sean were readily available to answer my questions and provide guidance when necessary. Karine and her team are highly competent, knowledgeable, friendly, and prompt to respond with help. I can't recommend them enough!

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