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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

We would like to express how grateful we are to have found Sirocco Consulting. We were a week away from our first ever SQF desk audit when we decided to purchase the SQF Templates Bundle from Sirocco. We had about 60% of our procedures in place but were able to rely on Sirocco’s template to cover the rest. The SOPs and Forms provided by Sirocco were detailed and covered all requirements of the SQF code.  We did not have any non-conformities on procedures that we implemented using the templates provided by Sirocco. After the desk audit we continued to work with Karine. A month and a half later we passed our first SQF site audit with only 6 minor non-conformities. This would not have been possible without Sirocco Consulting. Thank you from the team at Blue Ocean.
I would like to take this opportunity to express how very satisfied I was to receive and work with the Sirocco SQF bundle.  What a time saver! The templates are very easy to use and adjust to make your own. They saved me countless hours of work, guiding me through the necessary steps and gave my program a cohesive professional look. One can become overwhelmed with the volumes of paperwork that is needed for SQF and HACCP.  The Sirocco SQF bundle definitely lightened that load and combined with Karine's expertise, I couldn't be happier. Highly recommended.
I am very happy with the service Sirocco provided us. Karine and Sean are amazing food scientists/experts!  They are super knowledgeable and respond in such a timely manner when I need the support urgently with my seafood business. I cannot thank them enough for their help. Highly recommended!

Karine, […] I just wanted to thank you for the work you did on our PCP [plan]. We were audited by CFIA in November and did very well.

We were in a situation that required that we get an SQF Certification in a very short period of time. Sirocco Consulting provided us with the templates we needed and talked us through the process. No doubt without them we could not have achieved receiving our certification in the allotted time. Karine was our consultant and she made the process understandable and much less daunting than it would have been otherwise. I highly recommend Sirocco Consulting to any company that needs a third-party audit. It was one of the best investments we made in our trek to become third-party certified. We are counting on significant return on investment having achieved this milestone in our growth. Thanks Sirocco!
When we decided to implement the SQF program in our facility we knew we would have to develop a lot of new procedures and forms. We reached out to Karine Lawrence of Sirocco Consulting and with her guidance and templates, we were able to smoothly implement the code. The template package was very complete and easy to follow; each document made reference to the element of the code being covered making it easy to track our progress and if we had any questions Karine was quick to answer and provide examples. We had our desk audit recently and the auditor was happy to see how complete our documentation was, the template package and Karine’s support were key in this accomplishment.
“Thank you” very much for being with us for conducting the “Basic Sensory Science” Training here at Silver Spring Foods on the 27th September 2019. It was a great pleasure meeting with you and working with you during the course of the workshop and It was indeed a great training session. [...]It was great that our teams had the opportunity to screen the basic characteristic of the food products and along with our own range of product samples. We were very delighted the way that you presented the training and conducted the sample screenings during the session. Once again Thanking You for the job well done and for providing Certificates of Accomplishments to our Teams!
I would like to express my gratitude to my instructor Karine Lawrence, for dedicating her valuable time and energy into the FSPCA (Preventive Controls for Human Food) workshop which I attended in Toronto. The workshop was extremely informative. The teaching method, contents, and the combination of presentations and assignments were in a perfect accordance with the objectives of the workshop, as it addressed all my questions and the ambiguities that I had in my mind before the meeting. I believe that the enthusiasm and positive responses of all participants to the workshop were a reflection of usefulness and credibility of Karine’s performance during the event as well as the importance of the presented topics throughout the workshop.
I am writing this testimonial to express my gratitude to Karine Lawrence from Sirocco Food + Wine Consulting. We started our SQF implementation using the Sirocco SQF templates last August (2019) and just passed SQF 8.1 stage 1 and 2 audits on October and December. The templates are professionally written and the implementation was very easy. I highly recommend the Sirocco Consulting Templates. Thank you very much Karine.
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.
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