IN THE SPOTLIGHT

The 3Cs for a Successful FDA-LTO Registration Amid COVID Pandemic

The acquisition of an FDA License to Operate have long been a challenge to MSMEs with their quest to be recognized and maintain product quality standards. The Department of Science and Technology aided this concern by establishing the Food Safety Consultancy Program that aims to provide assistance to MSMEs in preparing their food businesses become compliant to the standard requirements of the FDA. However, this quest for success of the program have become even more challenging when it was coupled with limitations brought about by the COVID pandemic.

As a Food Safety Consultant, it was a tough experience for me as the program is composed of several phases that include initial visit and assessment, conduct of training, presentation of results of the assessment and the corresponding action plans, follow-up of the extent of implementation of the action plan and development of the GMP and SSOP Guide that the firm may use on its daily operation. The initial visit and assessment alone created some difficulties because of some travel restrictions and face-to-face contact as much as possible should be minimized.  Eventually, the first two phases (assessment and training) were conducted face-to-face and it has helped identify the fundamental needs of the food establishments. Perhaps, the difference of having the assessment face-to-face is that you can readily identify the need of the firm and correct observable practices that are vital in providing safe and quality products.

One of the firms that I have engaged with was G&G Foods—a micro enterprise producing “salabat” and other varieties of herbal food products that aim to promote health and well-being of its consumers. It is located at Nueva Valencia, Guimaras—the farthest among towns of the province of Guimaras. Just recently, they have successfully acquired their License to Operate from FDA despite the process of application was coupled with limitations and difficulties that the pandemic had brought about. The success story of this company was promising and we rejoice with them as they become one of those firms whom we can call “FDA Certified”.

As the firm’s food safety consultant, I was overwhelmed with their success and as I reflected to these experiences, I have identified three “C” factors that had helped the company successfully pursue their FDA-LTO registration despite COVID pandemic. These three C’s are Commitment, Connection, and Convergence.

Though these MSMEs were assisted by professionals, their commitment to improve and desire to achieve this success was commendable. The company’s improvement plan and targets were defined and every step was anchored on a timetable. Perhaps, planning and setting company goals and being committed to reach them were just few of the fundamental elements of their success. They were quick to respond to every recommendation presented and you can feel that each of them were driven by one goal. Despite the difficulties, delays and disappointments that the company has experienced during the process of completing lacking requirements, they become consistent with their efforts and more focused on their target.

Connection as another “C” factor is primarily the key for every client-consultant relationship. The development of trust between client and consultant is very important. Transparency eliminates boundaries and thus helps the consultant become even more receptive to the needs of its client. Effective and constant communication between two parties help in determining the aspect that may need immediate response and actions. Throughout the entire consultancy engagement, though several restrictions and protocols have been implemented, our consultant-client connectivity had never been a problem because it was built on the relationship of trust.

Convergence suggests unity in achieving one goal. As consultants, we continue to converge and magnify our efforts to make our clients feel that enthusiasm and desire for success. Assistance to MSMS’s goes beyond a consultant’s personal achievement because successful consultants are products of every active, committed and goal-oriented clients. The core of success is best achieved with convergence of efforts along with paralleled perspectives of the client and the consultant.  

Organizational successes are built with exemplary efforts and positivism. Challenges and changes in governmental policies and procedures continue to be inevitable but with commitment, connectivity and convergence, there is no doubt in making an organization’s continuous improvement possible.

Written by:
Ms. Irene Betalas
Food Safety Consultant

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