Karine was the best part of this [SQF] course. It is clear that she is an authority in many processes based on the examples provided. I like that Karine went into detail and spoke of her own experiences. I really enjoyed how she kept everyone engaged.
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 Preventive Control Plan for Human Food. We use the FSPCA plan templates and guidance to develop your Preventive Control Plan (Human Food).
- We also offer FSPCA training and remote training options
- We can review your food safety plan to ensure that it meets FDA and PCHF regulations.
Next Step
Start by booking an expert chat to assess where you are in the process and clarify next steps.
Have Questions or Want guidance on developing your plan?
Email us to request the common list of food safety hazards that must be included in a PCHF plan (FSPCA guidance document).
What Clients Are Saying
We had the privilege of working with Karine at Sirocco Food + Wine Consulting for a gap assessment of our facility to SQF standards. Karine demonstrated exceptional expertise, provided a very thorough and insightful analysis, and really went above and beyond to take the time to clearly explain each requirement and provide suggestions. She developed a comprehensive, actionable report despite a tight timeline, and would highly recommend her services to any organization.
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.
QA Specialist/SQF Practitioner
Blue Ocean Teaz & Herbalz Inc.
We successfully passed our initial HACCP certification audit, without a single finding! While this seemed quite surprising, I then realized that this was due to the thorough gap assessment provided by Sean Xia at Sirocco Consulting, along with additional documentation support.
Sean inspected our facility and dug through all of our systems and records in such detail as to be able to expose all of our issues. We were then provided with our initial HACCP plan and a set of GMP documentation that we were able to edit and integrate with our existing documentation. But these documents were not just provided to us, they were each individually reviewed in a handover that provided further insights. And Sean also made himself available for future questions – such amazing support!
As we proceeded to work through implementation of the new GMP’s and to address all items in the gap assessment, I felt quite confident – albeit a bit trepidatious – about the pending audit. However, on the audit date, things went so much more smoothly than I ever could have imagined.
Thank you, Sirocco!
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!
Oceanside Brands
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.
Graduate Student
Utah State University
I have been very pleased and satisfied with the SQF Bundle edition 9 developed by Karine Lawrence from Sirocco Food + Wine Consulting.
All procedures (templates) are professionally and beautifully written, saved us a tremendous amount of time, and enabled us to achieve our goal of gaining an excellent score in the audit.
Karine is very knowledgeable, and it has been a pleasure working with her. I highly recommend the SQF Bundle and her consulting services.
Quality Systems Manager
California Packaging Centers
“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.”
Food Safety and Compliance Specialist (Leafy Green Industry)
We have been using the expertise of Karine in the implementation of the SQF program and have always been completely satisfied with her help and guidance. She did an excellent job by directing us to the right resources and to obtain an excellent score in the SQF audit. We have also used the SQF templates available with Sirocco Food Safety Consulting to write our SOPs to comply with the SQF codes. The Spanish templates were very useful in creating SOPs in Spanish to cater most of our employees. I’m happy to recommend the services of Sirocco Food Safety Consulting for your SQF certification needs.
DIRECTOR OF QUALITY
AEGLE NUTRITION LLC
“As a Faculty Instructor in the area of Food Technology, a key course taught in the BCIT programme, is sensory evaluation. Most of it is a hands-on approach with physically applying and calculating the correct statistics associated with the testing. When Karine reached out to me with the opportunity to try out a sensory software programme from Tastelweb©, it enabled the students to look at tests such as QDA and Pivot Profiling Tests in more detail. Its ease of use, ability to conduct on a smartphone and automatic calculation of statistical analysis was a winner with the students! This programme also created very good impactful visuals for easy interpretation even for the non-scientist. Karine was also available to provide backup support for set up and interpretation of the results. This programme provides the flexibility of usage without a contract, especially to a smaller business where cost is a big factor. In addition, exposure to software programmes like Tastelweb© helps build a good portfolio for students graduating in a competitive industry.”
FACULTY INSTRUCTOR, FOOD TECHNOLOGY
BC INSTITUTE OF TECHNOLOGY