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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 contacted Sirocco Food + Wine Consulting” to prepare various evaluation protocols for the sensory profiling of our fair trade cocoa beans and chocolate. Finished products were also assessed using the Tastel web sensory software. Karine developed an aroma wheel for our products which we now use to support Marketing and Sales. Our next step is to train an internal sensory panel so that we are able to track the sensory quality of our cocoa beans and chocolate.”

I have had the pleasure of working with Karine for over a year now. She helped our company pass our first SQF audit Ed. 8.1 with a score of 94. For our recertification audit, which was on SQF Ed. 9.0, Karine visited our site and performed a gap assessment. She was able to identify a lot of areas for improvement and with her help our company passed the audit and achieved a score of 96. Karine is really knowledgeable on SQF. She is easy to work with and extremely helpful.

“We have been working with Karine Lawrence for about 8 months as we work to achieve our HACCP certification. She has been such a great support for us; providing training for our HACCP team and being present to answer our questions. She has so much knowledge on food safety requirements and has been able to provide us with resources to ensure that we have strong programs in place. Early in the process she conducted a gap assessment of our programs and the facility, which helped us identify the areas that we had to improve on. We feel confident that we will successfully reach our food safety goals. Thank you for all your guidance throughout this process.”

“This is to tell everyone that we have been dealing with Karine Lawrence for 2 years in doing our HACCP Plan & PCP importer plan for our wholesale company and it has been a pleasure dealing with her. She is hardworking, organized, passionate, intelligent and truly knowledgeable and knows how to accommodate our personal needs. Without her knowledge, guidance and expertise, we could not have finished our PCP plan/HACCP plan in time. Because of her, we are now fully compliant and very safe in running our wholesale food business. We are blessed to know Karine and without her, we would not be where we are today in our business.”

“Karine was a wonderful instructor. She was thorough and ensured we understood content before moving on rather than trying to rush through things to follow the course schedule. She was engaging and asked a lot of questions, appreciating all of our different backgrounds and ideas.”

“ The instructor (Karine Lawrence) was extremely knowledgeable and the class was enjoyable” “This course (SQF 9 System Implementation taught by Karine Lawrence) definitely increased my knowledge and understanding of SQF.”
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!
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