PCQI Training (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.
  • We can review your food safety plan to ensure that it meets US FDA regulatory requirements.

What Clients Are Saying

I would like to thank both of you for organizing & presenting this informative valuable training for Food Industry Professionals within the QA Sector. With the SFCR enactment recently, I have gained valuable insight on the expectations of CFIA along with the opportunities & grants  that are available from the “Post - Farm Food Safety Program through your presentation.
Also, Ketki’s presentation on compliance with the FSMA-“Foreign Supplier Verification” gave me valuable information on the expectations of the “Importer” from the “supplier” with regards to pertinent documents associated to food products being exported to the US.
Thanks once again  for all you support.
We contacted Sirocco Consulting after scoring lower than desired on a SQF 8.0 audit. Karine visited our plant and did a gap assessment. We found her efficient and helpful and used her guidance to get our CARs addressed. Subsequently, we hired Karine to return and train our key personnel on the FSPCA course. Again, we appreciate her knowledge and ability to teach in efficiently. I would recommend Sirocco to anyone needing help building their food safety program. Read More
We just had a gap assessment conducted in preparation for our SQF audit. We developed our written program with the help of Sirocco Food and Wine Consulting. These templates are terrific and easy to implement. The SQF consultant who performed the document review was very impressed with the quality of the procedures and record templates. Knowing that our written documents meet the standard, we feel that we are in a good position to pass our SQF audit and obtain our certification.
As a worldwide importer, in-house re-packager, and direct supplier of over 200 diverse food and dietary supplement ingredients, we faced significant compliance challenges surrounding FSMA, FSVP, and dietary supplement GMP, on top of customer requirements for GFSI compliance.  We interviewed multiple food safety consultants prior to choosing Karine Lawrence at Sirocco, and we couldn’t be happier with our choice— Karine’s FSPCA PCQI Lead Instructor, certified SQF trainer/consultant, auditing and R&D background among other experience was the perfect match for our needs.  She took a practical, entity-based approach in helping us design and implement a comprehensive SQF Edition 8 QMS tailored to effectively and efficiently manage our risks and compliance requirements, while keeping the customer service and operational aspects of our business a priority.  We were impressed with both the form and function of her modern SOP and document sets, as well as all the detail HACCP, risk assessment and other diligence she performed, including working within our cloud-based document management/FSVP software system.  Now we’re receiving “Excellent” audit scores and are delivering better value to our customers than ever.  Sirocco was a great choice!
We worked with Sirocco Food & Wine Consulting to get our FSVP. Karine was great to work with. She was very helpful and always got back to us promptly with any questions we had. I would recommend Sirroco to anyone working on getting their FSVP.
What I appreciated about the course taught by Karine and Sirocco, was that it was organized and well presented. Each day had hands on situations presented that could be worked out by the teams as well as volumes of information at hand. This allowed good participation and dialogue about situations and these discussions could lead to real time questions that we could ask as well and work through as needed. It was a good few days of intense learning and exchange.
I got a better understanding of the Food Safety Plan required for FSMA from this [FDA’s Preventive Controls Human Food] training. Karine has skillfully conducted the training as she provided fact-based examples and links to additional resources to help first-timers build an FSP.  Karine was a wonderful trainer with her knowledge of the subject matter and extensive experience in food safety.
I attended the FSPCA Preventive Controls (Human Food)/PCQI course offered in Vancouver, British Columbia. Course materials were good, the mentoring approach was good, and working with other people in group setting made the course content much clearer. Karine Lawrence, the PCQI instructor did a good job of communicating and... Read More
I recently attended the training session for PCQI (Preventive Controls Qualified Individual) required by the FDA for food exporters and U.S. food processing facilities. Karine Lawrence presented a clear view of the requirements and provided good practical example on how to implement them. She worked her way though the extensive manual in a... Read More
Karine Lawrence of Sirocco Consulting was the best choice we could have made when preparing for our first GFSI audit at Libre Naturals.  Karine’s vast knowledge of food manufacturing best practices and auditing code combined with her calm and patient approach brought much needed structure to what can be a very stressful experience... Read More
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