Remote Assessment: A Virtual Mechanism to Verify Field Compliances of Approved Efficacy Trial Protocols

Remote Assessment: A Virtual Mechanism to Verify Field Compliances of Approved Efficacy Trial Protocols

May 6, 2021.  The BAFS Organic Agriculture Division - Registration & Evaluation Section (OAD-RES), is the team responsible for the registration of integrated organic farms, organic input producers and products.

Field assessment is among the activities being conducted to check compliance during actual execution of efficacy trials if they are in accordance with the approved protocols. This will ensure that organic bio-control agents (OBCA) products that are being sold in the market are effective according to its claims. However, with the travel restrictions brought about by the COVID-19 pandemic, on-site field assessments is not an option.

Utilizing available technologies during this restricted time, the OAD-RES explored remote compliance assessment to continuously assess efficacy trials without personally being there. To proceed with the remote compliance assessment, a Feasibility Risk Analysis (FRA) is first established. The FRA is a planning tool to assess the auditor and auditee’s competencies including the available resources [e.g. information and communication technology (ICT), personnel]. From here, the information gathered will be used in the development of the remote assessment plan.

Then the OAD-RES team communicates the remote assessment plan with the researchers and the company’s regulatory staff for the components and aspects of trials that will be checked during the activity.

The first remote compliance activity was conducted in September 2020 and by the end of that year OAD-RES was able to conduct six (6) remote compliance assessments. Since its initial implementation, there were no recorded non-compliances from the assessed efficacy trials. The team was able to make observations and discussions on how the trials were being conducted. However, conducting such activity via virtual platform was without challenges; the concerns of strong internet availability on the trial sites hinders the researchers from providing live recordings of their activities. It likewise affects further the presentation efforts as well as video recordings that are supposed to be presented during the scheduled remote compliance activity. Some researchers prefer to go live (online) while in the field to show the trial components whenever the internet connectivity becomes stable.

For 2021, the OAD-RES continued the implementation of the remote compliance assessment. In fact, for the months of April and May, two remote field assessments were conducted by the team of Ms. Jenina B. Cusay, Anna Dominique V. Cadsawan and Mr. Charlie T. Palilio. 

On April 28, 2021 a remote assessment was conducted for Oracle Chem Corporation, for their product Plant Shield 4.6 SL located in Science City of Munoz, Nueva Ecija. It was participated by their company representative, Mr. Roy Candelaria and BAFS Certified Researcher, Dr. Constancia Dacumos.

The most recent remote assessment was conducted on May 4, 2021 on the efficacy trial of Mpede, a product of Agspec Philippines Corporation located in Carmen, Davao del Norte. It was participated by company representatives: Mr. Felicitos Palis, Ms. Hannah De Guzman and BAFS Certified Researcher Ms. Elsie Gahuman.

The team assessed their compliance on the approved objectives, cultural management practices, methodology and specifically checked on the critical aspects of the trial that include the following: 1) stage of the crop; 2) actual formulation and application of the treatments; 3) activities on how to avoid spray drifts; 4) gathering of data; and 5) presentation of initial data gathered.  Based on the findings of the remote assessment, it was verified that the two efficacy trials were compliant with the approved efficacy protocols. ###



April 28, 2021: Oracle Chem Corporation (Clockwise:  Roy Candelaria of Oracle Chem Corp, BAFS Certified Researcher Dr. Constancia Dacumos and
OAD-RES compliance assessment team, Jenina Cusay, Anna Dominique Cadsawan and Charlie Palilio)


May 4, 2021: Agspec Philippines Corporation (Clockwise: OAD-RES compliance assessment team members Anna Dominique Cadsawan,
Jenina Cusay, Hannah de Guzman of Agspec, Charlie T. Palilio of BAFS, and Felicitos Palis of Agspec
)