August 9, 2004
Since the last revision of food Good Manufacturing Practices (GMPs) almost 20 years ago, the food manufacturing industry has seen many changes, including newly recognized pathogens, more sophisticated technologies, and increased automation. While GMPs can control for many food safety problems, it is not clear that current GMPs adequately address these new developments. The food safety literature reviewed for this study shows that there continue to be food safety problems. The Food and Drug Administration (FDA) is currently evaluating its food GMPs regulations to ensure that they take today's technologies and food safety hazards into account.
Under contract to FDA, Eastern Research Group, Inc. (ERG) undertook this study comprising an extensive literature review and an expert elicitation of current food safety problems and the range of preventive controls needed to address them. The expert elicitation identified the most significant food safety problems, foods at high risk for these problems, and other major areas of concern. Based on the number of votes by experts who participated in the elicitation, "deficient employee training," "contamination of raw materials," "poor plant and equipment sanitation," and "poor plant design and construction" were ranked as the top four food safety problems faced by food manufacturers today. Results from the study also indicated that refrigerated and dairy foods have the highest general risk of food safety problems compared to other food categories. Baked and refrigerated foods pose the highest risk in terms of allergen hazards. The expert elicitation also showed that the needs of small and medium-sized food processors likely vary from larger processors, with smaller facilities generating higher risk scores than large facilities across all food safety problems and sectors considered.
The food safety experts who participated in the study recommended a range of preventive controls that could address most of the food safety problems faced by the food processing industry today. They did not, however, differentiate these preventive control recommendations by facility size despite the higher risk rankings of smaller facilities. The most frequently mentioned preventive controls with broad applicability across sectors and food safety problems included:
- Training -- Ongoing and targeted training on issues ranging from allergen control, cleaning and sanitation procedures, incoming ingredient receipt protocol, and monitoring for employees, management, as well as suppliers,
- Audits -- Periodic audits and inspections of facility and raw material suppliers either in-house or by third-party firms,
- Documentation -- Documentation of training activities, raw material handling policies and activities, cleaning and sanitation, receiving records, and use of sign-off logs, and
- Validation/Evaluation -- Evaluation of training effectiveness and establishment of accountability; validation of cleaning through testing (i.e., swabs, organoleptic evaluations, and bioluminescence tests)
Post-study follow-up discussions with four of the experts also generated additional recommendations. While most experts agreed that food GMPs could be improved, opinions on how this should be done varied widely. Some experts indicated that GMPs were lacking in some areas, whereas others noted that the food GMPs should remain as written and that other approaches should be taken to encourage greater compliance. Recommendations made included:
- Revision of food GMPs in key areas, such as training,
- Addition of new requirements, including components of HACCP, allergen control, and record keeping,
- Issuance of a guidance document that would clarify GMPs and its expectations, and
- Institution of positive incentive programs, such as reduced inspections for select facilities that meet certain requirements.
Finally, ERG's literature review and comparative analysis of other GMPs (i.e., for pharmaceutical/biologic products and medical devices) and quality system programs revealed that the majority of preventive control recommendations echo the principles of these other GMPs regulations and quality systems. All of the programs reviewed, including International Organization for Standardization (ISO) 9001: 2000, American Society for Quality (ASQ) Q9004-3-1993 (Quality Management and Quality System Elements -- Guidelines for Processed Materials), pharmaceutical GMPs, and medical device GMPs, have similar key provisions on training, audits, documentation, and evaluation/validation. A thorough comparison of the elements of food GMPs to these systems (see Appendix E) might aid FDA in its food GMPs modernization effort.
Section One: Current Food Good Manufacturing Practices
Appendix B: Definitions of Food Safety Problems
Appendix D: Exploratory Factor Analysis