Recipient Organization
UNIVERSITY OF NEBRASKA
(N/A)
LINCOLN,NE 68583
Performing Department
IANR, Cooperative Extension Di
Non Technical Summary
Good Manufacturing Practices outline the minimum sanitary, environmental, and operational standards that a food processing facility must meet to manufacture, process, pack, or hold food in a safe and wholesome way, thus reducing the chances of product adulteration, and ultimately, the incidence of foodborne illness. FDA-registered facilities must comply with 21 CFR 117 Subpart B: current Good Manufacturing Practices (cGMP). To score well during an inspection, facilities must understand the fundamentals and nuances of the regulation. However, this represents a challenge for small and very small businesses that may not have the financial resources, staff, or technical assistance needed to increase compliance. cGMP violations at the national level continue to be extremely prevalent, calling for a greater effort to understand the origin and source of food safety incidents and for the development of appropriate risk-reduction strategies that can sustainably help the food industry protect public health. Therefore, the long-term goal of this project is to improve the capacity of small and very small food facilities across the United States to comply with current cGMP regulatory requirements. Specifically, we propose to (1) Conduct cGMP compliance readiness assessments in small and very small food facilities in four different U.S. geographical regions; (2) Determine cGMP preferred training and education delivery methods for food workers in small and very small food facilities across the U.S.; (3) Examine barriers to the consistent and sustainable implementation of cGMP in small and very small food processing operations across the U.S.; (4) Reconcile the content of GMP training and education materials with the most commonly reported GMP violations in food processing operations; and (5) Customize, develop, and/or expand current cGMP training materials in English and Spanish suitable for small and very small food manufacturers across different U.S. geographical regions. Our overarching hypothesis is that targeting and customizing cGMP training will increase compliance with federal regulations and protect public health while contributing to food business continuity and expansion.
Animal Health Component
(N/A)
Research Effort Categories
Basic
(N/A)
Applied
(N/A)
Developmental
(N/A)
Goals / Objectives
The long-term goal of this project is to improve the capacity of small and very small food facilities across the United States to comply with current Good Manufacturing Practices (cGMP) regulatory requirements. Our overarching hypothesis is that targeting and customizing cGMP training will increase compliance with federal regulations and protect public health while contributing to food business continuity and expansion. Specifically, we propose to:Conduct cGMP compliance readiness assessments in small and very small food facilities in four different U.S. geographical regions.Determine cGMP preferred training and education delivery methods for food workers in small and very small food facilities across the U.S.Examine barriers to the consistent and sustainable implementation of cGMP in small and very small food processing operations across the U.S.Reconcile the content of GMP training and education materials with the most commonly reported GMP violations in food processing operations.Customize, develop, and/or expand current cGMP training materials in English and Spanish suitable for small and very small food manufacturers across different U.S. geographical regions.
Project Methods
OBJECTIVE 1: "Conduct cGMP compliance readiness assessments in small and very small food facilities in four different U.S. geographical regions."Facility Selection. Five to ten food manufacturing facilities will be selected in every state (AR, NM, NE, and RI) to conduct cGMP assessments. All co-PDs will perform a search on the FDA "Inspection Classification Database" to identify FDA-registered facilities that may be eligible for selection. Additionally, co-PDs may seek input from their state food safety agencies to identify potential candidates. Overall, we will select small and very small facilities (as defined in the FSMA regulations) subjected to 21 CFR 117 Subpart B - cGMP that represent various food commodities, state geographical diversity, and workforce demographics. Once facilities are selected, a project explanation form (IRB-approved) will be mailed/emailed to the companies to explain the details of the project, including objectives, time commitment, and benefits of participating. Each co-PD will make a great effort to explain to facilities that the assessments and surveys are for research/outreach purposes and not for regulatory compliance, and that facilities identity will remain confidential.cGMP Assessments. A modified version of the Iowa State University (ISU) "Food Safety Preventive Control Plan Checklist" will be used to assess cGMP compliance readiness in two ways: facility self-reported compliance and onsite observation/document review by the project team members. Facilities will be visited three times during a one-year period and both types of assessments will be conducted every time. After each visit, a short report of observations will be shared with the companies within one week, and when needed, the team will provide onsite or remote 30- to 60-minute training sessions to mitigate the risk of blatant violations. If allowed, the team will conduct unstructured interviews with QA/QC personnel to revise documentation such HACCP/food safety plans and monitoring records.Data Analysis. Qualitative (frequencies) and semi-quantitative scores from the assessments will be compared over time for individual facilities and for observed versus self-reported levels of compliance. A final report will be shared with each participating facility..OBJECTIVE 2: "Determine cGMP preferred training and education delivery methods for food workers in small and very small food facilities across the U.S."Survey Development. In collaboration with the UNL "Methodology and Evaluation Research Core" (MERC), the team will develop a survey to assess the preferred training and education methods of various players in food manufacturing facilities. In general, the survey will inquire about preferred and desired training format (e.g., animations, factsheets, infographics, lectures, manuals, podcasts, videos, and webinars, among others), length of training, training delivery methods (e.g., in-person, remote synchronous versus asynchronous, etc.), language of instruction, and opportunities for learning (e.g., during lunch breaks or dedicated company time, among others). For managers, the survey will ask about perceived deficiencies in their subordinates training, and for line personnel, the survey will inquire about management commitment to their training. Lastly, we will ask about the impact of the COVID-19 pandemic on training effectiveness.Survey Deployment. The survey will be shared with the participating facilities in Objective. Additionally, the survey will be distributed to as many registered food facilities in each state, with an expected response rate of 10%. The team will work closely with the regional FSMA centers to further disseminate of the survey within each region.Data Analysis. Qualitative survey data will be compared for managers versus line personnel across the represented four U.S. geographical region.?OBJECTIVE 3. "Examine barriers to the consistent and sustainable implementation of cGMP in small and very small food processing operations across the U.S."Survey Development. Based on the observations from onsite assessments, a second survey will be developed in collaboration with MERC to assess QA/QC managers' perceived barriers to the implementation of cGMP regulations. The survey will ask the level of agreement (Likert scale) with various proposed barriers and applicability to their facilities.Survey Deployment. As described for Objective 2.Data Analysis. Qualitative and semi-quantitative data will indicate top barriers faced by managers to implement cGMP consistently and sustainably, as well as specific needs to overcome the identified barriers.OBJECTIVE 4: "Reconcile the content of cGMP training and education materials with the most commonly reported cGMP violations in food processing operations."FDA Citation Analysis. Information from the FDA Data Dashboard will be extracted and aggregated into several major themes of cGMP violations that will allow us to identify and generalize reasons for the citations, starting in 2016 when the PCHF rule became enforceable.Content Analysis. A content analysis of cGMP training materials available in the NECAFS Food Safety Resource Clearinghouse will be conducted to identify major deficiencies in current training that may correlate to the most frequently reported FDA citations for the cGMP violations identified above. Because there is descriptive text for every violation reported in the Data Dashboard, we will be able to determine if the reasons for the violations (e.g., adequately measuring a temperature) are addressed in the available training, thus identifying gaps between the content of the training and the reported violations.Materials in Spanish. Available cGMP materials in Spanish will be curated and subjected to content analysis as described above.OBJECTIVE 5: "Customize, develop, and/or expand current cGMP training materials in English and Spanish suitable for small and very small food manufacturers across different U.S. geographical regions."Customization. The educational materials developed under this objective will be directly informed by the results Objectives 1, 2, 3, and 4.Content. The prioritized content for any training and educational materials will be the most frequent FDA citations after reconciliation with current cGMP available training. Once the gaps are identified, the team will narrow down further topics for cGMP program development and/or expansion. PD Chaves already has a conventional 8-hour cGPM course in place that may be used across regions as remedial while targeted materials are being developed.Format. The format of the expanded materials will be informed by the results of Objectives 1, 2, and 3. It is expected that materials will be created in various formats, easily updated, and be appealing to broader audiences. Options for format may include animations, factsheets, infographics, lectures, manuals, podcasts, videos, webinars, and many others. These materials will be developed in collaboration with multimedia and videography services.Delivery. The delivery methods will be determined based on survey results, observations, and conversations with managers and line workers. The team will choose practical, 30 to 60-minute training sessions. The snippets will be very targeted, focusing on specifics within each of the content priority themes. Options for format include in-person, online synchronous or asynchronous, and printed materials.Translation. PD Chaves and co-PD Sabillón will translate the material into Spanish and ensure technical accuracy and cultural sensitivity.Peer-review. The materials developed under this objective will be submitted for peer-review via the upcoming Western Regional Center peer-review service.Impact. Pre- and post-tests will be administered for each training module along with demographic information and intent to apply the new knowledge on the job.?