Aegle Nutrition LLC is a U.S.-based manufacturer of nutritional supplements and nutraceuticals founded in 2013 with top industry professionals who recognized a need to provide a different standard of customer service and expertise. AEGLE Nutrition’s facility is based in Carrollton, Texas, and is a state-of-the-art certified GMP and FDA-registered facility built to exceed quality and safety standards.
Director of Operations Shantha Sithambaram, Ph.D., and Quality Assurance Manager Sandra Martinez contacted Sirocco Consulting last summer (2022) to seek information about certifying to Safe Quality Food (SQF). Their scope included Food Sector Category #31 (Dietary Supplement Manufacturing) and #16 (Ice, Drink, and Beverage Processing).
Shantha and Sandra attended accredited HACCP training to obtain their certificate so that they could act as Lead and Backup SQF Practitioners for Aegle Nutrition LLC. They proceeded with the SQF implementation with the guidance of Karine Lawrence, Master’s of Food Science, Lead FSPCA Instructor, and Certified SQF Trainer and Consultant. The project lasted 6 months and started with the purchase of SQF Templates in English and Spanish. The team was already inspected by the US FDA and compliant with GMP so possessed most of the site documents for SQF 9. They were still in need of help with the development of 2 HACCP plans and 2 Preventive Control Plans for Human Food to meet SQF requirements.
Aegle Nutrition LLC sought consulting guidance and training as well as assistance with internal audit services. The SQF consulting activities included advising and training a team of 10+ employees from Operations to implement food safety standard operating procedures. Shantha and Sandra acted as team coordinators and assigned responsibilities based on the Sirocco SQF Implementation Chart. They acted as document controllers and merged their existing written GMP program into the SQF 9.0 System with the help of the Sirocco document package. Sandra trained the employees using the Sirocco SQF Bundle in Spanish while Shantha acquired credentials in Crisis Management to be able to lead the business continuity activities. Meanwhile, Karine Lawrence completed the internal audits using the SQFI audit checklists for Dietary Supplements (Module 17) and Food Manufacturing (Module 11). The GFSI Amendments were also audited as part of the annual internal reviews. Toward the end of the SQF implementation timeline, Sirocco Consulting facilitated the Management Review as well as the setting of the Food Safety Culture Plan objectives for the site. Sirocco Consulting conducted mock interviews and document reviews to help the team become audit ready.
The SQF certification audit was completed in 2 days on-site. The facility achieved a GOOD score of 91% and submitted their Corrective Action Reports (CARs) to the Certification Body (CB). They received their certificate when the CARs were accepted by the auditor and by the CB’s technical review committee. Aegle Nutrition LLC plans to collaborate with Sirocco Consulting in the future to conduct onsite PCQI/FSPCA training. They will also continue to hold SQF Monthly Updates and Management Reviews with Karine Lawrence of Sirocco Food + Wine Consulting to ensure that the system is maintained and ready for recertification in 12 months.
Interview with Dr. Sithambaram – Aegle Nutrition LLC
What was your overall experience of implementing SQF (it took your team 6 months to become audit ready)?
Certifying to SQF was a new challenge for me and my team.
- Aegle Nutrition LLC was compliant with GMP for dietary supplements but was not ready for SQF, an international food safety standard. We were bridging the gap between GMP for Dietary supplements (CFR Part 111) and SQF (FSMA for beverages and Codex HACCP).
- My background is in chemistry, and I was familiar with dietary supplement manufacturing. Beverage manufacturing was a new scope for me.
- The management team at Aegle Nutrition LLC (10+ employees) did not have previous knowledge of preparing for third-party certification audits.
Did you feel the team was well prepared? Did the SQF audit surprise you?
We were not surprised during the SQF audit because Karine Lawrence (Certified SQF Consultant and Trainer) had prepared us well. We knew what to expect during the audit. We made a decision early on to invest in food safety consulting and scheduled weekly team meetings with Karine to get the documentation ready and to be audit ready. The weekly meetings were very beneficial to Sandra Martinez, our SQF team backup SQF practitioner.
How did Sirocco Consulting and Karine Lawrence’s training and consulting services help your team prepare for the certification audit? Was the process less daunting and stressful with Karine’s guidance?
Karine helped bring the food safety culture into the facility. Sandra, I, and the rest of the team learned a lot about food safety management during the weekly meetings and training sessions. At times, there was resistance to change but everybody embraced the project in the end.
How will SQF help your business?
With SQF, Aegle Nutrition LLC is planning to expand and acquire new contracts.
Would you recommend Sirocco Consulting to other prospects who want to be SQF certified? How can Sirocco Consulting support you moving forward?
Karine is a technical advisor on the team now and we will be meeting monthly to prepare for our re-certification audit. We will also schedule PCQI/Food Safety training at the site this year.
Quick Facts – Implementation of SQF 9
Consulting Services provided by Sirocco Consulting:
- Codex HACCP Plan (X2)
- FDA Preventive Control Plans for Human Food (X2)
- SQF Internal Audits (document and record review, interviews)
- SQF Bundle Edition 9
- 17 hours of Consulting (Zoom/Teams) (SQF Success Pack)
Training Courses purchased by Aegle Nutrition LLC and required for SQF Certification
- Crisis Management
- 2-day HACCP (Lead and backup Practitioners)
References:
SQFI – Safe Quality Food Institute
Sirocco Consulting is a full-service consulting firm knowledgeable about food safety compliance/certification process. We are experienced in all levels of Food Safety Compliance and Certification (Canada, US), and are qualified to provide Food Safety Consulting for GMP, HACCP, SQF, FSMA, and Canadian SFCR. Contact us to request more information.