GMPs - Section Four: Common Food Safety Problems in the U.S. Food Processing Industry: A Delphi Study
To improve understanding of the current state of food safety hazards at food processing facilities, ERG conducted an expert elicitation. The study had two primary objectives:
- To identify the main problems that pose microbiological (i.e., pathogenic bacteria, viruses, and parasites), chemical (i.e., allergens, cleaners and solvents, and mycotoxins), and/or physical (i.e., foreign objects such as glass and metal) safety hazards to food at the processor level, and
- To determine the preventive controls and/or corrective actions that food manufacturers should implement to address each of the problems identified.
Such information helps identify those sectors where the processor-level problems are of high importance for public health. Further, the information on the effectiveness of preventive controls may help identify the most effective GMP requirements.
The study objectives posited above require gathering current data not accurately known or available. Moreover, they do not easily lend themselves to more precise analytical techniques, such as an industry survey designed to yield statistically valid estimates of population parameters. The necessary information, however, can be gathered using the subjective judgments of experts on a collective basis (Linstone and Turoff, 2002). Thus, this study uses a modified three-round Delphi technique widely applied in the forecasting and policy arenas.
A successful application of the technique requires assembling a panel, preferably consisting of 15 or more individuals who are considered "experts" in the given field of investigation. Thus, with guidance from the CFSAN Working Group, ERG assembled a 15-member panel comprising nationally recognized experts in food safety, HACCP, food plant sanitation, quality systems, process optimization, GMP compliance, and food microbiology (see Table 4-1). On average, each individual panel member possessed over 30 years of food industry experience in various sectors, such as canned foods, fresh produce, meat and poultry products, and seafood. Further, most of these individuals have served and/or are currently serving on numerous national committees related to food safety, HACCP, and GMPs.
Like most Delphi studies, our study consisted of three Delphi rounds in which the collective responses of the panel were revealed to each individual prior to the commencement of the next round. The following sections summarize the findings from each of the Delphi rounds, highlighting key findings. As a modified fourth round, ERG and FDA also conducted two post-study discussions with select experts from the panel to review the findings of the study and obtain recommendations for the effort to modernize food GMPs. Section 4.2.4 summarizes the results from these discussions.
4.2.1 Round 1 Results
In the initial Delphi round, we provided our expert panel with a list of food safety problems previously identified through our literature review and through discussions with the FDA Food GMP Modernization Working Group and select expert panel members. We then asked each panel member (1) to indicate the food sectors to which the listed problem is mainly applicable and (2) to add to the food safety problem list if necessary. Only one individual expanded our list of food safety problems, adding "lack of chemical control programs" and "lack of allergen control programs." This lends support to the comprehensiveness of our original food safety problem list. Other main findings (see Table 4-2) based on the tabulation of responses to this question (Q1) include the following:
- Refrigerated and meat and poultry products are the two main sectors to which the majority of the food safety problems are applicable.
- While some problems, such as "deficient employee training," "poor plant and equipment sanitation," "contamination of raw materials," and "poor plant design and construction," are applicable to all food sectors, other problems, such as "biofilms," "condensate on pipes and other equipment," and "stagnant water due to dead ends in plumbing," are more sector-specific. For example, biofilms are more of a concern for the refrigerated, frozen, and dairy sectors.
- The relative importance of a given food safety problem (measured by the number of votes received) varies by sector. The top-rated food safety problems by sector include (see Table 4-2, highlighted cells):
- "Incorrect labeling or packaging" and "poor plant and equipment sanitation" for baked goods;
- "Deficient employee training" and "biofilms" for dairy products;
- "Deficient employee training" and "poor plant and equipment sanitation" for frozen products;
- "Deficient employee training" and "condensate on pipes and other equipment" for refrigerated products;
- "Poor plant and equipment sanitation" for shelf-stable foods;
- "Poor plant and equipment sanitation" for meat and poultry products.
In this round, we also asked experts to select from the list provided (Q2) the ten most important food safety problems facing food manufacturers today based on the frequency and severity of the problems. Experts were directed not to include those problems that (1) are solely applicable to meat and poultry or (2) might be applicable to other food categories but whose importance is mainly driven by their frequency and severity in meat and poultry. Table 4-3 presents the ranking of food safety problems by number of votes. Interestingly, those problems identified as having broad applicability across all food sectors (i.e., "deficient employee training," "contamination of raw materials," "poor plant and equipment sanitation," and "poor plant design and construction") in the previous question ranked at the top of our top ten food safety problems list. The finding affirms, at least partially, the internal validity of our Delphi design.
4.2.2 Round 2 Results
The objective of the second Delphi round (Q3) was to determine whether each of the top ten problems identified in the previous round posed a sufficiently different food safety risk for a particular food item (e.g., pies) within a major food category (e.g., baked goods) than the risk for the major food category as a whole. Thus, we asked the expert panel members to indicate whether a separate risk score is more appropriate for a listed food item within a major food category for each of the ten food safety problems. To ensure consistency of responses and also make it possible to use related data, such as unit sales, we included a list of IRI product categories for each food sector from which experts were asked to select. An all-capture subcategory titled "All other" was also included within each food sector to ensure comprehensiveness.
Table 4-4 provides the list of food items (by food sector and food safety problem) that the panel members indicated as requiring separate risk scores. Overall, the number of food subsectors selected across the food sectors was lowest for shelf-stable foods. The refrigerated, frozen, and dairy sectors, however, had the highest number of subsectors selected for scoring in the next round. Overall, given the different areas of expertise of individual panel members, the number of food items (i.e., subsectors) within each food sector identified as meriting a separate risk score was extensive. The total number of categories for the panel members to score for "general" as well as "allergen" risks by facility size ranged from 70 to over 100 across the ten food safety problems. This substantially increased the respondent burden in the subsequent round.
4.2.3 Round 3 Results
The primary objectives of the third Delphi round were (1) to assess the risk posed by each of the top ten food safety problems by food sector and facility size and (2) to determine the types of preventive controls and/or corrective actions necessary to address each of these problems by food sector and facility size. Therefore, we asked our expert panel members to assign a "general" as well as an "allergen" risk score from 1 to 4 based on the problem's frequency and severity by food sector and facility size (Q4). We further instructed our panel that:
- The "general" risk score assigned should reflect the risk of the food safety problem with respect to all hazards (i.e., microbiological, physical, and chemical) except for allergens
- The "allergen" score should reflect the risk of the food safety problem with respect to allergens only.
To ensure consistency of responses, we requested that risk scores be assigned according to the scheme outlined in Table 4-5 below. Thus, each individual expert first had to assess whether the problem occurred at a high or low frequency in the specified food sector (i.e., how widespread the problem is) and then to evaluate whether the probability that food could be rendered unsafe due to the problem was high or low (i.e., assess the severity of potential consequences of the problem) given the typical practices of a manufacturer that experiences the problem. We also directed the panel members to skip those categories to which they thought the food safety problem did not apply or that were not relevant to "general" or "allergen" hazards.
Because of the number of food sectors that individuals had to score, data generated from this question were voluminous (over 77,000 observations). A cursory analysis of the risk score data leads to the following observations:
- Overall, the general and allergen risk scores for small and medium-sized facilities are higher than those of large ones across all problems and food sectors.
- Problems that have received the highest general risk scores (2.75 or higher) include "deficient employee training," "poor plant and equipment sanitation," "difficult-to-clean equipment," "poor employee hygiene," and "contamination of raw materials." The majority of these problems also have been identified as having broad applicability across sectors in the initial round.
- The problems that have received the highest allergen scores are "incorrect labeling or packaging," followed by "deficient employee training," and "difficult-to-clean equipment."
- The general risk scores assigned to the refrigerated food categories tend to be higher than those of other food categories across all problems. The next highest general risk scores are assigned to frozen and dairy food categories.
Given the degree of overlap among various food safety problems, we expect that some underlying factors, which are smaller than the number of variables, are mainly responsible for the covariance among our variables. Therefore, we performed an exploratory factor analysis to determine how many underlying dimensions there are for the risk score data collected. In a nutshell, factor analysis enables one to detect structure in the relationships between variables as a means of exploring the data for possible data reduction. The method also enables one to test specific hypotheses regarding the number of underlying dimensions and whether certain variables belong to a given dimension while others belong to another (Kim and Mueller, 1978). A more detailed discussion of factor analysis can be found in Appendix D.
In performing the factor analysis, ERG separated the general risk scores from the allergen risk scores. Next, for each of the ten risk problems, we calculated an average risk score for each subsector, taking the average over the experts' scores. This reduced the data to 396 observations (subsectors) for both the general and allergen risk categories, with a total of ten variables (i.e., the average risk scores for each problem). ERG performed a factor analysis on these two datasets (general and allergen risks) to determine how the information contained in the ten risk problems could be combined to provide summary information.
The factor analysis technique allows us to generate an overall risk score that combines the information in all of the ten problems. The mean values by sector for overall risk are presented in Tables 4-6 and 4-7. The mean for all sectors (and subsectors) is centered at zero. Thus, stratifying the average by sector provides an indication of the relative risk of these sectors. A value that exceeds zero indicates that overall risk in the relevant sector is greater than average risk.
The overall risk score reflects the results from using a one-factor analysis model. That is, we calculated the relationship between all of the variables and one underlying factor that we call "overall risk." Factor analysis can also separate the variables into more than one factor. ERG performed a set of preliminary analyses and determined that both general and allergen risks are best described by a four-factor model. That is, the ten variables can best be described by four underlying factors. The four factors, however, differ slightly between the general and allergen categories. We named the four factors in the general category as:
- Process-related contamination risk,
- Equipment risk,
- Quality control risk, and
- Input-related risk.
The four factors in the allergen category were named:
- In-process contamination risk,
- Quality control risk,
- Other contamination risk, and
- Equipment risk.
The names of factors are derived from those variables that contribute the most to the factor values. For example, the "process-related contamination risk" factor gets its name from the fact that the variables that contribute the most to it are "contamination during processing," "contamination of raw materials," and "poor employee hygiene." The average scores by sector are presented in Tables 4-6 and 4-7 for each of the four factors. Once again, values that exceed zero indicate above-average risk.
For comparison's sake, we have also generated the average scores (in standardized form) for each of the ten risk problems presented to the experts by sector. These are presented in Tables 4-8 and 4-9. We present these as standardized values (i.e., mean centered and zero with a standard deviation of one) to be comparable to the values presented in Tables 4-6 and 4-7. Once again, values that exceed zero indicate above-average risk.
One way to see the information in Tables 4-6 to 4-9 is as three sets of summaries of risk. The least aggregated form is that of the standardized average scores presented in Tables 4-8 and 4-9 for the ten risk problems. The four factors presented in Tables 4-6 and 4-7 aggregate the information from the ten risk problems to four summary measures. Finally, the overall risk factor summarizes the four risk factors, or the ten risk problems, into one measure for each sector. The data on the ten risk problems generate a broad picture of the problems in each sector. The one- and four-factor models, however, account for correlations among the ten risk problem scores to generate summary measures.
After the assignment of risk scores, we asked our expert panel to consider the types of preventive controls and/or corrective actions that food processors need to address each of the ten food safety problems by facility size (Q5). While large food processors might have the capital to invest in more sophisticated technologies, small processors are likely to face resource constraints, making such technologies infeasible. Therefore, we instructed our experts to take account of cost-effectiveness when making recommendations on the types of controls/actions by size of food processor and main food sector (i.e., baked goods, dairy, frozen, refrigerated, and shelf-stable).
Although the experts interviewed for the pilot indicated the need for size-specific preventive controls, a review of responses indicates that the majority did not, in fact, differentiate by facility size in their preventive control recommendations. Some even explicitly noted that facility size should not be a factor. Additionally, for some problems, experts did not feel that it was important to differentiate by food sector, hence applying the same set of preventive controls to all major food sectors for the problem in question. A minority of experts assigned different preventive controls to a minority of food subsectors.
Table 4-10 provides the complete set of preventive control recommendations for the top four food safety problems with broad applicability across all food sectors, mainly "deficient employee training," "contamination of raw materials," "poor plant and equipment sanitation," and "poor plant design and construction." Some of the recurring themes from the table are:
- Ongoing and targeted training on issues such as allergen control, cleaning and sanitation procedures, incoming ingredient receipt protocol, and monitoring,
- Training of employees, management, and suppliers,
- Evaluation of training effectiveness and establishment of accountability,
- Validation of cleaning through testing (e.g., swabs, organoleptic evaluations, and bioluminescence tests),
- Periodic audits and inspections of facility and raw material suppliers either in-house or by third-party firms, and
- Documentation of training activities, raw material handling policies and activities, cleaning and sanitation, receiving records, and use of sign-off logs.
Tables 4-11 through 4-12 present the preventive control recommendations for the remaining six food safety problems, "contamination during processing," "poor employee hygiene," "difficult-to-clean equipment," "post-process contamination at manufacturing plant," "incorrect labeling and packaging," and "no preventive maintenance." Interestingly, for majority of these problems, some experts indicated implementing GMPs and/or HACCP. The finding indicates that there are two dimensions to some of the processor-level problems, such as "contamination during processing," "poor employee hygiene," and "difficult-to-clean equipment." Food safety hazards may arise due to the lack of GMPs (i.e., plain noncompliance), through ineffective application of GMPs (i.e., deficient employee training programs), or through a combination of both.
Some experts also indicated a need for clearly defined GMP expectations for such problems as "incorrect labeling and packaging," "poor plant design and construction," and "no preventive maintenance." Ambiguities in the definitions in the food GMPs may lead to ill-defined expectations at the processor level. The same issue was also brought up during our discussions with select experts during the study pilot, as well as post-study discussions.
Across the ten food safety problems, the most frequently mentioned preventive controls include training (in-house or by outside consultants) and third-party or in-house audits of GMPs, HACCP, SSOPs, and quality programs, and implementation of HACCP and SSOPs (see Table 4-13). Other commonly noted problem-specific preventive controls were:
- Supplier audits and supplier certification programs for raw material contamination problems,
- Plant design reconfiguration and use of outside consultants for plant design, better sanitation, and improved flow and access to equipment for poor plant design and construction problems,
- SSOPs and environmental sampling and other monitoring for difficult-to-clean equipment problems,
- Use of preventive maintenance programs and documentation for deficiencies in preventive maintenance and assignment of accountability for contamination during processing problems,
- Environmental sampling, proper implementation of SSOPs, institution of HACCP, and product and process flow controls for post-process contamination problems, and
Label review and verification for incorrect labeling or packaging problems.
As noted previously, institution of certain types of records, such as training activities, raw material handling policies and activities, cleaning and sanitation, and receiving records, is one of the recurring themes in the preventive control recommendations of experts. Table 4-14 presents the frequency of the various types of records recommended as preventive controls. As the table shows, the most frequently mentioned record types include cleaning and sanitation related records (87 percent) and equipment maintenance records (73 percent), followed by supplier audit records (67 percent) and personnel records (60 percent). Other types of records indicated by some experts as preventive controls include raw material/ingredient records, labeling and packaging records, warehousing/inventory/storage records, and corrective action documentation.
4.2.4 Post-Study Discussions with Select Experts
To review the findings of the Delphi study and discuss suggestions for improvements with respect to food GMPs, ERG and FDA conducted two post-study meetings with four experts from the panel. The meetings were held on May 5th and May 26th, 2004, at FDA's Center for Food Safety and Applied Nutrition in College Park, Maryland.
Charlie Cook and Cameron Hackney were the food safety experts invited to the May 5th meeting. Cook is an independent consultant who has served in the food industry for 55 years. Throughout these years in the food industry, he has directed product and process development, quality management, regulatory compliance, food safety, and product crisis activities. Hackney is Dean of the Davis College of Agriculture, Forestry, and Consumer Sciences at West Virginia University and has extensive experience in food microbiology, dairy processing, and food toxicology.
C. Dee Clingman and Donn Ward were the food safety experts invited to the May 26th meeting. Clingman is President of CDC Global Quality and Safety and was the Vice President of Quality Assurance of Darden Restaurants for 21 years. Ward is the Associate Head of the Science Department at North Carolina State University and has served in various organizations striving for improvements in food safety, including the Seafood HACCP Alliance Curriculum Development Committee and the NSF International Food Safety Advisory Council.
While many issues relevant to food GMPs were covered during the two meetings, some main themes emerged from these discussions. Most experts agreed that the food GMP modernization effort should not be sector-specific and should be focused on addressing a few important issues. These included the following:
- Improved, documented training with a minimum set of universal requirements,
- Recordkeeping in a few important areas, especially process control,
- Allergen control, with documented allergen control programs, including training and label review,
- Use of a guidance document to achieve compliance,
- Adding components of HACCP, such as controls, verification, and corrective action, and
- Positive incentive programs to encourage compliance.
These topics, as well as other points that were raised during the meetings, are discussed in detail below.
Training. The most frequently discussed topic during both meetings was training. All experts thought that training should be improved at food facilities. Most also concurred that training tends to be worse at small facilities. Nonetheless, Clingman noted management at large facilities are under the impression that there is nothing new to learn, which is problematic as well. Opinion on the length and frequency of training varied, but experts agreed that it should be tailored to the job of the employee. Cook suggested a one-time training session of 6 to 8 hours and 20 minutes of continuous training on a weekly basis. Hackney considered 2 days of training sufficient. Other specific recommendations for training mentioned by several experts included:
- Developing a minimum set of requirements (e.g., Ward mentioned identifying the important areas for training, those that have a direct impact on food safety) without being overly prescriptive or trying to differentiate by sector,
- Requiring documentation that shows that training took place,
- Requiring trainer certification,
- Requiring written SOPs for training (for consistency and inspection purposes), and
- Requiring training in allergens (only mentioned during first meeting).
Although some of the experts recommended manager training, Cook felt that top-level management would not have the time to commit to training. Cook emphasized that training needs to be highly visual, live, and ongoing. Clingman also mentioned the effectiveness of pocket-sized 3x5 cards in training, which can serve as constant reminders of key principles. While experts noted that these are effective methods, the consensus was that training should be adapted to the needs of each company and left to the manufacturer to customize. For example, Clingman noted that small plants would require different training from large plants. Certification of training programs by FDA was also mentioned as a possible option during the first meeting.
Recordkeeping. Another theme at both meetings was the importance of recordkeeping. Experts agreed that records are important in ensuring food safety outcomes, especially with respect to ensuring that the documented activities actually took place. These records include SOPs and documentation that SOPs were followed. Ward also noted the importance of SOPs in ensuring consistency of training.
Cook mentioned the importance of risk-based records. In his experience, when plants are overwhelmed by paperwork, they are more likely to fabricate records. He added that while SOPs are needed, they should not be punitive. In other words, firms should not be fined if they do not adhere to SOPs exactly as written. He also noted that the most critical records are process control records (e.g., water temperature).
Clingman mentioned the importance of records that are produced at the time of the activity versus those created after the activity has taken place. He noted that such post-activity records are not effective for ensuring that the activity occurs as intended.
Allergen control. Allergen training was discussed in detail in the first meeting. Cook and Hackney agreed that allergens are a very important issue and that training in this area is severely lacking. Records found to be critical for allergen control include label review records, letters of guarantee for raw materials, and a documented allergen control program, with training as the main component..
Both experts felt that a label review process would increase food safety, especially with respect to allergens. A requirement for a label review could be added to the processes and controls section of the food GMPs; it would detail how to match up the formula of the product to the ingredients stated on the label. Both experts emphasized that the label review process must be managed internally. According to Cook, medium to large plants currently conduct label reviews, whereas small plants typically do not. Hackney briefly discussed rework as another issue that should be addressed in GMPs with respect to allergen control.
Development of a guidance document. There was discussion at both meetings about the development of a guidance document to supplement and help explain the concepts in the food GMPs. Cook emphasized that manufacturers need clearly defined expectations, which the current food GMPs are lacking. These, he said, could be provided in a guidance document. Some experts would prefer a guidance document to a regulation because the former could provide detail not currently available in the food GMPs without becoming too prescriptive. Hackney used the example of the Seafood Hazard Guide (http://www.cfsan.fda.gov/~comm/haccp4.html) to show that some guidance documents are like regulations in their impact on manufacturer behavior. Creating a guidance document would not address the issue of enforceability, some meeting participants noted; others argued that a good guidance document might achieve a better food safety outcome with less resistance from industry. Cook suggested trying a guidance document first and then developing metrics based on the results, as he thinks there will be major resistance from industry to changing Part 110, especially with respect to recordkeeping.
Role of HACCP. HACCP was mentioned frequently by experts as being an effective way to ensure food safety. Cook and Clingman both noted that the increase in the use of HACCP in food manufacturing has increased because large, influential customers require it. Its role in the food GMP modernization effort is, however, debatable. A few experts liked the idea of a HACCP-based approach to food GMP modernization. During the May 26th meeting, Clingman and Ward suggested taking important pieces of HACCP and incorporating them into a new regulation. Clingman recommended taking the principles of controls, verification, and corrective action and renaming them as something other than HACCP for the GMP modernization effort. Both Hackney and Cook noted that GMPs are needed as a base for HACCP, however, and that HACCP cannot substitute for GMPs.
Positive incentive programs. During the second meeting, Clingman brought up the concept of motivating food manufacturers with positive incentives to improve their practices beyond those dictated by GMPs. He recommended that FDA reward excellent performance instead of standard performance. As an example, he proposed allowing manufacturers to do self-audits after they have shown exemplary performance for a given period of time. FDA's own audits of such facilities could be reduced.
Clingman also suggested that FDA could certify an employee at a food manufacturing plant with a role in QA or food safety as an FDA inspector. This individual could then conduct official FDA inspections and provide documentation to FDA, and the plant could get reevaluated periodically for re-certification. Certified inspectors might be required to attend an annual meeting for continuing education and other updates. Eventually these individuals might be asked to conduct inspections in other food manufacturing facilities as well, once their reputation is well established. Along with these recommendations, Clingman also mentioned a similar program run by the National Marine Fisheries Services (NMFS) program for certifying seafood inspectors.
Other topics of discussion. Apart from the above, a few other topics were briefly addressed at these meetings. Pest management briefly came up at the end of the first meeting. Cook mentioned that manufacturers need to verify that their facilities are pest- and rodent-free and that this should be specified in a guidance document.
Internal audits and validation were brought up during discussions about recordkeeping in the first meeting. During the second meeting, audits were discussed in the context of providing a supervisory review. Section 126.96.36.199 provides the experts' recommendations on good examples of minimum standards.
During both meetings, the effectiveness of FDA inspections was discussed. Suggestions included training inspectors better and ensuring that the same training is provided to all. All experts noted that small manufacturers have more food safety problems than large manufacturers, with a few exceptions.
Given the difficulty of managing someone's personal hygiene, Clingman discussed solutions such as special soaps and gloves.
The issue of microbial testing was briefly raised during the second meeting. Ward commented that microbial testing would not be productive given the number of microbes and viruses that are of concern and the length of time it takes to obtain test results. He also noted that environmental sampling is conducted at large plants but generally not at small plants due to the expertise and financial investment required. Both Clingman and Ward agreed, however, that a plant that is visually clean generally does not require environmental testing. Ward commented that environmental testing usually verifies what you already suspect upon visual inspection. Clingman added that environmental testing is more relevant for certain food sectors than others.
Imports were raised as issues of concern by Clingman and Cook. No provision on how to modernize food GMPs to address this issue was discussed, however.
188.8.131.52 Additional Resources Recommended
A few experts recommend further reading for clarification and specifics on some of the topics discussed during the meetings. Most of these are described or available on the Internet, or were handed out during the meeting, as listed below:
- Basic Standards:
- Supplier Food Safety Guidelines by C. Dee Clingman (handout at 5/26 meeting)
- Training Requirements:
- Seafood HACCP
- Servsafe http://www.nraef.org/servsafe/?flag=lcd&level1_id=6&level2_id=1
- NSF International manual on food safety and quality expectations http://www.cookandthurber.com/2004_Expectations_Processing_Manual.pdf
- NFPA internal audit document http://www.nfpa-safe.org/docs/NFPA-SAFE_Policies-and-Procedures-Manual.pdf
- Silliker third-party audits http://www.silliker.com/html/auditing_gmps.php
- Pizza Hut third-party audits
- Allergen Control Programs:
- General Mills' and Kraft's SSOP documents for allergen control
184.108.40.206 Current Government Programs of Potential Interest
There are a number of existing government programs that FDA could study while preparing to modernize food GMPs. One type of program uses third party inspections, thus increasing the oversight of the governing body without incurring additional costs in most cases. An existing program of this nature is the FDA Center for Devices and Radiological Health Third Party Review Program. Under this program, FDA has accredited persons who are authorized to review 510(k)s--pre-market notifications for medical devices. Accredited persons conduct these reviews and forward them onto FDA, which makes a final determination on each application within 30 days. This program has been very successful, speeding up 510(k) reviews by 29 percent. The program has recently been extended to Class II medical devices. More information on the program can be found at Third Party Review .
CDRH has also established a third-party inspection program, which allows accredited persons to inspect eligible manufacturers of Class I or II medical devices. The manufacturers must meet certain conditions in order to be inspected by an accredited person. More information on this program can be found at Accredited Persons Inspection Program.
Positive incentive programs were mentioned by Clingman as a potential method for encouraging greater compliance. As noted earlier, NMFS runs one such program. The Occupational Safety and Health Administration (OSHA) also runs a positive incentive program, called the Voluntary Protection Program (VPP). Employers have to apply to the program and if they meet VPP requirements, they may join the program. Employers in the program are inspected regularly to ensure they continue to meet VPP requirements. The frequency of these inspections is reduced the longer the employer remains in the program, depending on which level of participation they have reached (Star, Merit, or Demonstration). Annual self-evaluations are required, the results of which are shared with OSHA. More information on the program can be found at http://www.osha.gov/dcsp/vpp/anniversary.html.
Similar programs are likely to be found at other government agencies. The ones noted above have shown great success and might be of special interest to FDA.
Kim, Jae-on, and Charles W. Mueller. 1978. Introduction to Factor Analysis: What It Is and How to Do It. Sage Publications: Beverly Hills, CA.
Linstone, Harold A., and Murray Turoff. 2002. The Delphi Method: Techniques and Applications. Addison-Wesley: Reading, MA.
|Expert Name||Areas of Expertise|
|C. Dee Clingman|
|Clifford M. Coles|
|Char les Cook|
|Cameron Ray Hackney|
|Tommy L. Shannon|
|Edmund A. Zottola|
|Food Safety Problem||Not a problem||Baked goods||Dairy||Frozen||Refrigerated||Shelf-Stable||Meat and poultry||Total # of Votes w/o Meat & Poultry|
|Poor plant design and construction||0||(0%)||10||(63%)||11||(69%)||12||(75%)||14||(88%)||8||(50%)||14||(88%)||55|
|Deficient employee training||0||(0%)||11||(69%)||13||(81%)||15||(94%)||15||(94%)||11||(69%)||14||(88%)||65|
|Poor employee hygiene||0||(0%)||10||(63%)||12||(75%)||13||(81%)||13||(81%)||7||(44%)||13||(81%)||55|
|No preventive maintenance||1||(6%)||9||(56%)||10||(63%)||10||(63%)||12||(75%)||9||(56%)||11||(69%)||50|
|Contamination of raw materials||0||(0%)||12||(75%)||11||(69%)||14||(88%)||14||(88%)||10||(63%)||14||(88%)||61|
|Contamination during processing||0||(0%)||9||(56%)||11||(69%)||13||(81%)||13||(81%)||10||(63%)||13||(81%)||56|
|Post-process contamination at manufacturing plant||0||(0%)||9||(56%)||10||(63%)||9||(56%)||13||(81%)||9||(56%)||13||(81%)||50|
|Contamination by reworked product||1||(6%)||6||(38%)||9||(56%)||7||(44%)||11||(69%)||6||(38%)||12||(75%)||39|
|Lack of equipment parts reconciliation after repairs||7||(44%)||7||(44%)||6||(38%)||7||(44%)||7||(44%)||7||(44%)||8||(50%)||34|
|Lack of crisis management protocol||3||(19%)||12||(75%)||12||(75%)||12||(75%)||12||(75%)||12||(75%)||12||(75%)||60|
|Lack of knowledge of welding standards||4||(25%)||2||(13%)||8||(50%)||4||(25%)||7||(44%)||5||(31%)||7||(44%)||26|
|Poor pest control||2||(13%)||11||(69%)||9||(56%)||10||(63%)||12||(75%)||10||(63%)||10||(63%)||52|
|Lack of equipment knowledge||2||(13%)||10||(63%)||9||(56%)||12||(75%)||11||(69%)||11||(69%)||9||(56%)||53|
|Use of unpotable water||6||(38%)||6||(38%)||7||(44%)||5||(31%)||7||(44%)||6||(38%)||7||(44%)||31|
|Stagnant water due to dead ends in plumbing||1||(6%)||5||(31%)||12||(75%)||8||(50%)||11||(69%)||10||(63%)||9||(56%)||46|
|Condensate on pipes and other equipment||0||(0%)||7||(44%)||10||(63%)||11||(69%)||15||(94%)||6||(38%)||12||(75%)||49|
|Poor plant and equipment sanitation||0||(0%)||13||(81%)||12||(75%)||15||(94%)||14||(88%)||14||(88%)||15||(94%)||68|
|Inadequate glass cleanup policy||4||(25%)||7||(44%)||8||(50%)||8||(50%)||10||(63%)||11||(69%)||8||(50%)||44|
|Lack of product recovery protocol||3||(19%)||11||(69%)||10||(63%)||11||(69%)||11||(69%)||10||(63%)||11||(69%)||53|
|Incorrect labeling or packaging||1||(6%)||13||(81%)||9||(56%)||12||(75%)||13||(81%)||11||(69%)||10||(63%)||58|
|Lack of chemical control programs||0||(0%)||1||(6%)||1||(6%)||1||(6%)||1||(6%)||1||(6%)||1||(6%)||5|
|Lack of allergen control programs||0||(0%)||1||(6%)||1||(6%)||1||(6%)||1||(6%)||1||(6%)||1||(6%)||5|
|Total number of votes||35||196||235||238||275||203||262||1,147|
|Food Safety Problem||Number of Votes|
|Deficient employee training||15||(94%)|
|Contamination of raw materials||12||(75%)|
|Poor plant and equipment sanitation||12||(75%)|
|Poor plant design and construction||12||(75%)|
|No preventive maintenance||11||(69%)|
|Post-process contamination at manufacturing plant||10||(63%)|
|Contamination during processing||9||(56%)|
|Poor employee hygiene||9||(56%)|
|Incorrect labeling or packaging||7||(44%)|
|Contamination by reworked product||5||(31%)|
|Lack of equipment knowledge||4||(25%)|
|Poor pest control||4||(25%)|
|Stagnant water due to dead ends in plumbing||4||(25%)|
|Condensate on pipes and other equipment||3||(19%)|
|Lack of crisis management protocol||3||(19%)|
|Lack of knowledge of welding standards||2||(13%)|
|Lack of product recovery protocol||2||(13%)|
|Lack of allergen control programs||1||(6%)|
|Lack of equipment parts reconciliation after repairs||1||(6%)|
|Use of unpotable water||1||(6%)|
|Food Sector||Food Subsector||Food Safety Problem|
|Deficient Employee Training||Contamination of Raw Materials||Poor Plant and Equipment Sanitation||Poor Plant Design and Construction||No Preventive Maintenance||Difficult-to-Clean Equipment||Post-Process Contamination at Manufacturing Plant||Contamination During Processing||Poor Employee Hygiene||Incorrect Labeling or Packaging|
|Baked goods||Bakery snacks||1||1||1||1||1||1||1||1|
|Fresh bread and rolls||1||1||1||1|
|Frozen||Frozen appetizers/snack rolls||1||1||1||1||1||1||1||1||1||1|
|Frozen baked goods||1||1||1||1||1||1||1||1||1|
|Frozen breakfast food||1||1||1||1||1||1||1||1||1|
|Frozen coffee creamer||1||1||1||1||1||1||1||1|
|Frozen corn on the cob||1||1|
|Frozen plain vegetables||1||1||1||1||1||1||1|
|Frozen pot pies||1||1||1||1||1||1||1||1||1||1|
|Frozen prepared vegetables||1||1||1||1||1||1||1||1||1|
|Frozen side dishes||1||1||1||1||1||1||1||1||1||1|
|Fresh cut fruits and vegetables||1||1||1||1||1||1||1||1||1||1|
|Seafood - packaged||1||1||1||1||1||1||1||1||1||1|
|Seafood - unpackaged||1||1||1||1||1||1||1||1||1||1|
|Caramel/taffy apple kits|
|Dry fruit snacks||1||1||1||1|
|Ice cream cones/mixes||1||1||1||1|
|Milk flavoring/drink mixes||1||1||1||1||1|
|Mustard and ketchup|
|Shortening and oil||1||1|
|Snack bars/granola bars||1||1||1||1|
|Tea instant tea mixes||1||1||1|
|Weight control/nutrition liquid/powder||1||1||1||1||1|
|Weigh control candy/tablets||1||1||1|
|Note: "1" indicates that the sector has been selected for individual risk scoring by one or more experts.|
|Risk Factors||Food Sectors|
|Process-related contamination [a]||-0.376||0.665||0.128||0.518||-0.249|
|Quality control [c]||-0.037||0.670||-0.087||0.182||-0.102|
|Input-related contamination [d]||0.542||0.078||0.206||0.668||-0.333|
|[a] The process-related contamination risk factor loads highly on "contamination during processing," "contamination of raw materials," and "poor employee hygiene."|
[b] The equipment risk factor loads highly on "poor plant design and construction," "difficult-to-clean equipment," and "poor plant and equipment sanitation."
[c] The quality control risk factor loads highly on "post-process contamination at plant," "no preventative maintenance," and "deficient employee training."
[d] The input-related contamination risk factor loads highly on "poor employee hygiene," "difficult-to-clean equipment," and "contamination of raw materials."
|Risk Factors||Food Sectors|
|In-process contamination [a]||0.197||-0.102||0.250||0.551||-0.261|
|Quality control [b]||0.434||0.391||0.228||0.364||-0.269|
|Other contamination [c]||-0.007||0.017||0.301||0.272||-0.184|
|[a] The in-process risk factor loads very highly on "contamination during processing," and moderately high on "incorrect labeling or packaging."|
[b] The quality control risk factor loads highly on "no preventative maintenance," "deficient employee training," and "post-process contamination at plant."
[c] The other contamination risk factor loads highly on "contamination or raw materials" and "poor employee hygiene."
[d] The equipment risk factor loads highly on "poor plant design and construction," "poor plant and equipment sanitation," and "difficult-to-clean equipment."
|Risk Problem||Food Sectors|
|Poor plant design and construction||-0.218||0.608||0.239||1.041||-0.458|
|Deficient employee training||0.000||0.671||0.177||1.088||-0.479|
|Poor employee hygiene||0.460||0.474||0.128||1.134||-0.494|
|No preventive maintenance||0.068||0.783||0.147||0.579||-0.325|
|Contamination of raw materials||-0.415||0.660||0.218||0.849||-0.380|
|Contamination during processing||-0.268||0.900||0.188||0.865||-0.414|
|Post-process contamination at plant||-0.242||0.955||-0.152||0.483||-0.192|
|Poor plant and equipment sanitation||-0.266||0.731||0.315||1.027||-0.488|
|Incorrect labeling or packaging||-0.311||0.358||-0.071||0.900||-0.279|
|Note: The numbers reported in this table reflect standardized scores. ERG standardized the values for these variables to be consistent with the values reported for the factor analysis.|
|Risk Problem||Food Sectors|
|Poor plant design and construction||0.214||0.165||0.245||1.173||-0.489|
|Deficient employee training||1.425||0.157||0.469||0.648||-0.493|
|Poor employee hygiene||0.181||0.337||0.204||0.773||-0.365|
|No preventive maintenance||0.286||0.585||0.346||0.626||-0.399|
|Contamination of raw materials||0.042||-0.147||0.378||0.451||-0.252|
|Contamination during processing||0.365||-0.016||0.380||0.794||-0.404|
|Post-process contamination at plant||-0.260||-0.376||-0.180||0.528||-0.048|
|Poor plant and equipment sanitation||0.660||0.150||0.387||0.776||-0.443|
|Incorrect labeling or packaging||0.047||-0.222||0.107||0.567||-0.194|
|Note: The numbers reported in this table reflect standardized scores. ERG standardized the values for these variables to be consistent with the values reported for the factor analysis.|
|Deficient Employee Training||Contamination of Raw Materials||Poor Plant and Equipment Sanitation||Poor Plant Design and Construction|
|3x5 pocket-sized cards to remind employees of a few vital hazards||Document all activities||Assign accountability for plant and equipment sanitation||A sanitary design control program|
|Conduct audits (in-house, by third party, of GMPs, or not specified||All transport carriers and warehouses should be inspected||Audit of outside cleaning companies||Better overall flow to prevent cross-contamination|
|Base training efforts on Vulnerability Assessment Report||Antibiotic testing||Awareness of new sanitation technologies such as ozone and chlorine dioxide||Better understanding of process flow concepts|
|Improve training on process control and pathogen monitoring||Self inspection (by department or individual)||County extension programs that offer consulting services||Building, construction, and equipment companies and engineers need to be trained in sanitary design criteria|
|Better use of chemical supplier expertise||Audit and inspection emphasis should be placed on offshore-sourced raw materials||Conduct cross-department inspections||Clearly defined expectations|
|Bilingual training (in-house or not specified)||Better controls on raw agricultural practices, e.g., foreign object control||Dedicated cleanup crew||Conduct audits (internal or third-party, GMP, of plant design, construction, and grounds, to correct deficiencies, twice a year, or not specified)|
|Conduct brief training sessions periodically||Better overall pest management||Develop SSOPs for all equipment||Consultants (use for advice or not specified)|
|Make use of county and IFT extension programs||Certificates of analysis/supplier guarantees||Documentation (of hygiene and sanitation activities, procedure, sign-offs on SSOPs, signed and verified records of activities, or not specified)||Contract out the fix, with firms that specialize in food plant design, or not specified|
|Develop in-house training programs (for new employees, using input from employees and QA team, or not specified)||Change suppliers if needed||Documented bilingual procedures||Control condensation|
|Develop monthly meetings with employees to train (short duration or not specified)||Clean/decontaminate raw materials when possible||Efficacy of sanitation process should be quantitatively measured by pre-op and op micro counts, organoleptic evaluations, by bioluminescence, swabs, or ATP)||Develop "Mr. Clean" attitude in personnel|
|Directed, work-area or product-specific training, with input from and approved by plant operations management||Color code according to risks||Use performance as criteria in employee review||Develop plant upgrades/expansion plans to reduce this problem|
|Hold discussion groups on training issues||Develop specifications for all products and make sure specs are achieved outside GMP audit at least yearly||Employee training||Develop priority list for areas needing revision and/or specific operational practices necessary due to design issues|
|Documentation of training activities||Documented handling policies||Reduce employee turnover||Develop programs for short and long-term fixes|
|Use performance as criteria in employee review||Employee training on what to look for when receiving incoming ingredients||Environmental sampling (involving QC lab, daily sanitation tests, or not specified)||Develop understanding of GMPs in all employees including the boss; clean up plant so that it complies with GMPs|
|Employee mentoring programs (e.g., match employees with same language/ethnicity)||Ensure that the storage areas are clean and maintained appropriately||Formal sanitation program with clear-cut responsibilities defined||Evaluate design issues and potential effects on food safety|
|Evaluate effectiveness of training||Establish criteria for prevention of contamination of raw materials||GMP audits (internal or external, monthly or annually, or not specified)||Greater sanitation|
|Food safety reminders on paystubs and websites||FDA Website for recalls||Hand washing facilities in processing area (sensors or not specified)||Head of maintenance has had training in sanitary design|
|Food safety training of all new employees with minimum quarterly refresher||GMP audits (internal or external; of storage areas, monthly with response from management, or not specified)||Have personnel sign off when SSOPs completed||Implement programs designed to compensate for the design flaws, e.g., more frequent cleanup, more people on the line|
|Formal training policy||GMPs||Improved worker training||Improved flow and better/easier access to equipment|
|GMPs||Greater frequency of port inspection||In-house audits of sanitation||Inspection by certified third party|
|Good orientation programs||Implement programs within the plant to prevent contamination of products with materials from the outside of packaging.||In-house training (by outside consultants or not specified)||Limit condensation|
|HACCP||Improved monitoring of incoming raw materials||Interactive training||Limit downtime|
|Handwashing||Incoming inspection and approval programs||Keypad controls||Limit splash|
|Training in temperature control, monitoring equipment, hygiene, GMP, and overall food safety risk||Sampling and testing (in-house, more frequent, periodic, or not specified)||Make sure there is sufficient time to clean||Monthly meetings to discuss problems and how to make corrections, involving all personnel including management and maintenance|
|Improved thermal process focus||Metal detectors or filters (in bulk transfer operations or not specified)||Management commitment and involvement||New equipment if needed|
|Improved training on pathogen monitoring||Mandatory handwashing or glove use||More involvement by the chemical suppliers for training and education (e.g., teaching programs)||Obtain input from buyers and their QA/sanitation/food safety people|
|Industry affiliation training programs||Multiple tanks for bulk liquids to ensure separation of lots||Ongoing cleaning (sweeping, etc.) during production operations||Owner/operator must address|
|In-house training (specific or general, by insurance carrier, consultant, or not specified)||Provide segregated storage (separate raw materials from finished products)||Outside training of personnel responsible for monitoring||Reconfigure, correct, repair, or fix problems|
|Use of broad range of training materials and learning aids, such as CD-ROM, online learning, equipment labeling, food safety icons||Review past audits of suppliers||More effective pathogen monitoring schemes and more pathogen monitoring||Relocate to a less risk area or move concerned area|
|Make training a part of supervisor's performance rating||Personal hygiene training (see training for detail)||Pay and other incentives for employees to practice good sanitation||Review by technically competent and experienced resource to identify problem areas and construction constraints|
|Management commitment/responsibility||Program for rotation and code tracking of raw materials||Improve definition of sanitation expectations and process: define "clean"||Sanitation records|
|Training on monitoring equipment||Proper cleaning and sanitizing of bulk carriers||Provide proper tools and supplies for adequate sanitation||Sign off on corrections|
|Seminars (monthly, by specialist from outside company, or not specified)||Proper in-house storage||Routine cleaning and sanitizing of refrigerators, coiling coils, and compressors||SSOPs|
|Use outside consultants who understand adult education||Purchasing of fresh produce from growers utilizing GAPs programs||Make sanitation a core corporate value||Stricter in-process controls can be used to help compensate|
|Ongoing verbal exampling and reinforcement of training concepts||Conduct random microbiological verification of lots||Signed and verified records||The sanitary design criteria must be implemented|
|Outside training courses||Raw material specifications (and product specifications appropriate to the product)||SSOPs (written, for each piece of processing equipment and processing areas, with signoff logs, or not specified)||Training|
|Posters and use of reminder icons in critical areas of plant||Maintain receiving records||Tech group training in auditing and evaluation of sanitation effectiveness||University extension services|
|Provision of learning aids, such as video and other visuals (NFPA and other professional organization video programs)||Sanitation at farms and milking operations||Employ technical staff||Use professionals on all redesigns|
|Training refresher courses||Separate or designated employees for tasks||Third-party auditing/training of tech and management group.||Weld (when possible or not specified)|
|Repetition in training of concepts taught||Separate personnel by job function (raw vs. processed)||Audits (third-party or in-house)|
|Review and update in-house training programs quarterly||Separate raw ingredients and finished product and processing||Train employees (in-house and by outside consultants, entirely in-house, interactively, verbally, or not specified)|
|Set up plant training committee, with guidance from HR or training department and plant operations as coordinators||Supplier audits||Training programs for management supervision and cleaning personnel with focus on cleaning technique, cleaning and sanitation compounds, and how to evaluate performance|
|Training on specific allergen controls and specific cleaning and sanitation procedures||Supplier training||Use contract cleaners|
|Test all employees, including management, for understanding and proficiency||Third-party audits of raw materials||Use detergent|
|Training based on show and tell examples of basic food safety practices, with use of graphics and icons||Training||Use sanitizers in condensate pans|
|Training booklets, USDA publications||Use of irradiated or pasteurized ingredients||Use video film for training|
|Training in learning to read and write English||Use of processed materials vs. raw material where appropriate||Validate the procedures being used to clean and sanitize the plant|
|Training in specific dairy issues||Use pre-process treatments to prevent contamination from raw materials||Visual daily inspections|
|Training tailored to management personnel above and beyond operational employees (managers/supervisors)--trained in GMPs, sanitation, HACCP, allergens||Use risk assessment to identify potential hazards||Weekly sanitation tests|
|Written training guidelines||Vendor qualification/supplier certification, especially for specific pathogen and chemical sensitive raw materials (based on third-party or in-house audit, conduct FOIA inquiries, call current customers)||Written cleaning and sanitation procedures that are developed by corporate staff or preferably by the companies that supply the cleaning/sanitation chemicals and systems.|
|No Preventive Maintenance||Difficult-to-Clean Equipment||Post-Process Contamination at Manufacturing Plant|
|Assign accountability (to individual or not specified)||A sanitary design control program||Adequate design of the process flow to take the product most effectively from the end of the "process" into packaging|
|Assign to a department||Additional of kill-step at end of processing||Allergen controls|
|Assign to a position description||All equipment should be certified as acceptable for use in food plants||Avoid all human contact with finished goods|
|At minimum, apply preventive maintenance program to food contact or processing equipment||Apply in-depth evaluation of cleaning practices until repairs made||Better overall understanding of post-retort handling of cans/bottles|
|Clearly defined expectations||Assign accountability to department||Conduct audits (GMP, in-house or third-party, or not specified, of controls or processes)|
|Comprehensive maintenance program is essential to food processing plants (large or small)||Assign accountability to individual||Configure product flow to prevent cross-contamination|
|Conduct audits (third-party, GMP, of facility, of maintenance plan, of processing equipment, or not specified)||Better process control schools||Control traffic patterns|
|Develop program and stick to it||Bilingual training if needed||Dedicated equipment|
|Documentation||Cleaning areas prone to niches||Denial of pest access and proper pest monitoring and control programs|
|Emergency maintenance logs||Conduct audits (in-house or third-party, GMP, of plant and grounds, SSOPs, or not specified)||Develop management controls to prevent post-processing contamination|
|Equipment manufacturer develop programs and training for maintenance personnel||Conduct regularly scheduled cleaning||Documented handling policies|
|Establish a preventive maintenance program (on critical equipment, critical infrastructure, internal, or not specified)||Consulting with manufacturer before purchase||Documented sanitation programs|
|Having production sign that they accept the repaired equipment back into service or sign off when repairs are completed||Contract out cleaning||Employee awareness through education and training|
|Identification of repairs needed||Document training||Environmental and processing area sampling|
|Identify critical equipment parameters and initiate monitoring programs||Effectiveness of cleaning is verified and pre-operational inspections are done||Finished product inspection program|
|Maintenance plan||Employee training (new hires, cleanup crew, equipment specific, in-house programs, or not specified)||GMPs|
|Maintenance request systems||Environmental sampling and testing (increase frequency, for pathogens, or not specified)||HACCP (establish, utilize to identify potential hazards, reassess)|
|Management review||Examine equipment & develop plans to upgrade hard to clean units||Immediate final packaging of finished goods|
|Monitoring and documentation of preventive maintenance process||Extra cleaning during breaks||Improve raw and cooked process flow|
|Monthly inspections||General ease of equipment cleaning needs to be improved||Improved pathogen monitoring on dry dairy products|
|Parts reconciliation program||GMPs||Incubation program (for aseptic or retorted only)|
|Planned and documented maintenance programs||HACCP||Involvement of sanitation chemical suppliers|
|Records (of emergency and routine repairs/services, maintenance activities, or not specified)||Head of maintenance has had training in sanitary design||Limit personnel access|
|Repair trending and tracking||Identify better equipment designs for future purchases||Maintain equipment|
|Signed and verified records||Identify via competent and experienced resource--develop specific cleaning procedures||Maintenance of air handling systems|
|Terminate ongoing employee offender||Implement a monitoring program to assess the actual risks||Microbiological monitoring or sampling of finished and packaged product|
|Training||Improve expectations relative to materials and design||Ozone air fogging of environment during off hours|
|Use a third party to evaluate||Improvement of CIP capabilities (better line flow design for equipment or not specified)||Package must be intact|
|Use of metrics to evaluate efficacy of preventive maintenance||Installations conducted by equipment manufacturer||Packaging inspection program|
|Utilize computer preventive maintenance program (such as MP2 system; other software is available)||Knowledge of the equipment harborage sites||Positive filtered air pressure in packaging areas|
|Label equipment with proper cleaning instructions||Product sampling|
|Management responsibility, review, and follow-up||Proper cleaning and sanitizing and documentation of valving and design|
|Meetings (monthly training meetings or short duration meetings)||Proper environmental controls|
|Microbial sampling||Proper seaming/sealing of containers and routine monitoring of same|
|Design or purchase easier-to-clean equipment||Proper storage|
|Purchase the right equipment for the task||Proper valving and design to ensure pasteurized milk is not contaminated on cold side|
|Repair, replace, or return equipment to manufacturer||Rewards for good job|
|Review and update training programs quarterly||Routine cleaning of refrigeration systems such as compressors, fans, and condensate collectors|
|Rewards for doing good job||Sanitation practices (for packaging and sealing areas, product contact surfaces and equipment, or not specified)|
|Sanitation tests (daily or weekly)||Segregate all raw and finished goods|
|Signed and verified records||SSOPs (written with signed and verified records or not specified)|
|Sign-off on cleaning||Sufficient monitoring programs for environmental conditions|
|SSOPs (for equipment, difficult cleaning, written, or not specified)||Temperature control must be appropriate for product|
|Surface sampling||Terminal kill-step in process|
|Taking equipment apart to clean||Trash handling and product handling systems and personnel for unprocessed and processed areas of the production|
|Use video tapes for training and other visuals||Warehouses and transport carriers must meet GMP expectations|
|Utilize suppliers who provide support services|
|Verification of efficacy of cleaning using swabs or ATP tests|
|Contamination During Processing||Poor Employee Hygiene||Incorrect Labeling or Packaging|
|Allergen control program (with process scheduling or not specified)||3x5 pocket-sized cards to remind employees of a few vital hazards||Two approvers for in-process label and packaging changes|
|Integrated Pest Management||Adequate restroom facilities and equipment (based on the number of employees, including handwashing and sanitizing stations, clean locker rooms and showers, centralized handwashing, warm water at handwashing stations, or not specified)||Adherence to approved formulas and suppliers|
|Assign department for self-inspection||Automated handwashing stations/keypad controls and sensor-equipped towel dispensers||All labeling material should be pre-approved by third party|
|Assign individual for self-inspection||Base training efforts on Vulnerability Assessment Report||Allergen control programs such as production scheduling, proper cleaning, and ingredient handling|
|Clearly defined expectations, i.e., food code||Clearly define expectations||Allergen identification system for all inbound ingredients|
|Color code risks||Communication||Batching programs and record keeping|
|Condensate control through proper air circulation||Conduct audits (include operating personnel, management, and maintenance, third-party GMP review, internal audits, or not specified)||Careful inventory and verification of label status|
|Conduct audits (in-house, third party, GMP, of systems and processing lines and areas, or not specified)||Define minimum standards||Check labels and product daily--all shifts|
|Configure product flow to prevent cross-contamination||Develop training materials and procedures internally, using input from employees and QA team||COA for all inbound raw materials|
|Define process capability||Develop training programs that emphasize the importance of employee hygiene||Conduct audits (third-party, of label compliance or performance, or not specified)|
|Develop appropriate control measures to prevent contamination||Directed, work-area-specific training, with input from and approved by plant operations management||Define expectations as to ingredient declaration|
|Develop preventive maintenance program||Disciplinary actions||Define when cleanup is needed to prevent carryover into non-allergen product|
|Training (improved existing training, temperature control training, personnel hygiene training, or not specified)||Discuss personal hygiene during monthly meetings||Develop control programs for scheduling formulations without allergens first in production day|
|Employment of certified food safety manager||Discussion groups||Develop label management control on issuing, storing, and disposition of obsolete labels|
|Environmental monitoring and control||Documentation of training or written training guidelines||Develop label review process with at least two persons involved|
|Environmental sampling||Emphasize personnel hygiene when hiring||Develop label/product documentation at beginning of shift and checks on each new container|
|Equipment maintenance (routine, preventative, or not specified)||Employee mentoring (by matching employees with same language/ethnicity or not specified)||Development of labeling expectations|
|Facility equipment layout||Employee supervision||Eliminate potential cross-contamination during processing|
|Glass breakage procedures||Employee training (new employees, in-house, outside, on personal sanitation and hygiene, on food safety, or not specified)||Employee training (proper labels, label/formulation control, importance of using appropriate labeling, or not specified)|
|GMPs||Enforce employee hygiene work rules||Formal process for approval of labels and printed packaging|
|HACCP (utilization, establishment, implementation, reassessment, or not specified)||Food safety reminders on paystubs and websites||HACCP (establishment of CCP, risk assessment review, and reassessment)|
|Handling practices||Formal training policy||Inspection and documentation of all labels used in production|
|Improved CIP capability||GMPs||Isolated storage for all allergen- containing ingredients|
|Improved equipment design||Good orientation programs||Label development critical, involve management, quality control, production, warehouse personnel|
|Limit personnel access||Hand wash signs posted||Label inventory control system|
|Mandatory handwashing or glove use protection and protocol||Impress on the employees the need to keep clean personally, as well as keep plant clean||Labeling allergens is most critical|
|Metal detection (with magnets and screens or not specified)||Laboratory testing||Mandatory sample label attachment to production records|
|Microbial sampling||Management commitment||Monitor as part of packaging CCP|
|Monthly meetings for management and employees||Managers set good examples||Off-shore-produced product of great concern|
|More reliance on prerequisite programs||Monitor efficacy--develop metrics||Packaging engineering|
|Plant management to do self-inspection||Monitoring of employees (including handwashing stations)||Preoperations label review and documentation before production can begin|
|Positive filtered air pressure in packaging areas||Provide ongoing verbal examples and reinforcement/repetition of training concepts||Programs to approve all labels|
|Pre-operational inspections of processing lines/equipment||Policy that all personnel will adhere to hygiene codes||QC label monitoring program during production|
|Prevent crossover of personnel from raw to finished products||Posters (bilingual or not specified)||Records|
|Preventive maintenance||Prepare demonstrations of the effects of poor hygiene||Removal of outdated/old/obsolete labels (removal program or not specified)|
|Process awareness||Provide aprons or coats (for critical employees) and uniform and shoes||Review finished packaging|
|Proper cleaning and sanitation of equipment and product contact surfaces||Regular re-training of existing employees||Review and verify labels (when new supplier, by routine inspections, upon receipt, at time of use, or not specified)|
|Proper cleaning and system design and construction||Seminars||Review process (internal, of label and on-line packing, or not specified)|
|Properly designed and documented cleaning and sanitizing programs||Set up plant training committee, with guidance from HR or training department and plant operations as coordinators||Scanning bar codes or using on-line bar code scanners|
|Record logs||Signed and verified records||SSOPs|
|Sampling||SSOPs (written or not specified)||Third-party marketplace compliance verification|
|Sanitary design program||State Public Health training handouts||Independent technical review of all labels|
|Segregation of processes, operations, products, product line, staging areas, and storage for raw and finished products||Supervision||Verify labels and maintain records|
|Separate or designated employees for tasks||Training based on show and tell examples of basic food safety practices, with use of graphics and icons|
|Sign off to make sure task is completed||Training in reading and writing English|
|SSOPs (operational, written with signed and verified records, or not specified)||Training with supervision on floor responsible for performance, not QA|
|Traffic control between processed, WIP, and raw material||Understanding needs|
|Use follow-up operational management||Use of broad range of training materials, such as video training tapes, CD-ROM, online learning, equipment labeling, booklets, food safety icons (in critical areas of plant or not specified)|
|Use covers on open food containers/equipment||Visible handwashing checks|
|Vulnerability Assessment Report by outside food safety expert|
|Food Safety Problem||Most Frequently Mentioned Controls||Count [a]|
|Deficient employee training||Audits (third-party or in-house)||6|
|Use video tapes for training and other visuals||4|
|Documentation of training activities||3|
|Contamination of raw materials||Supplier audits||8|
|Raw material and product specifications||6|
|Testing or inspecting raw materials||5|
|Segregation of storage||4|
|Poor plant and equipment sanitation||Training||9|
|Audits (third-party or in-house)||7|
|Documentation of sanitation activities and procedures||5|
|Sanitation evaluation and monitoring||4|
|Poor plant design and construction||Audits (third-party or in-house)||7|
|Fix problems and reconfigure plant design||2|
|Use outside consultants or others specialized in plant design||2|
|Contract out repair and design work||2|
|Correct, reconfigure, or repair equipment||2|
|No preventive maintenance||Preventive maintenance programs||9|
|Audits (third-party or in-house)||5|
|Records/documentation of maintenance||4|
|Sign off on repaired equipment||2|
|Environmental sampling and testing||5|
|Audits (third-party or in-house)||5|
|Repair, replace, or return equipment||3|
|Post-process contamination at manufacturing plant||Audits (third-party or in-house)||6|
|Contamination during processing||Audits (third-party or in-house)||10|
|Segregation or processes, products, and storage||6|
|Poor employee hygiene||Training||9|
|Audits (third-party or in-house)||7|
|Adequate facilities and equipment||5|
|Automated handwashing and towel dispensers||4|
|Broad range of training media and materials||4|
|Incorrect labeling or packaging||Label review/verification||8|
|Audits (third-party or in-house)||5|
|Removal of outdated labels||3|
|[a] Total number of experts that included the control in question in their list of preventive controls for the food safety problem.|
|Record Type [a]||Count||Percent|
|Cleaning and sanitation||13||87%|
|Corrective action documentation||1||7%|
|Equipment maintenance records||11||73%|
|Labeling and packaging||5||33%|
|Receipts of incoming ingredients, raw materials||3||20%|
 Although our original expert panel had 17 members, we only received responses to all three Delphi rounds from 15 individuals.
 Note that the initial question asks the respondent to evaluate the food safety problem according to one dimension, "applicability," within each food sector. The second question, however, asks the respondent to consider the food safety problem with regards to two dimensions, "frequency" and "severity."
 The need for this round was determined during the study pilot, in which some experts indicated that certain subsectors within each main food sector (baked goods, dairy, frozen, etc.) merit different risk scores.
 "IRI" refers to the InfoScan® Custom Store Tracking database provided by Information Resources, Inc. (IRI). The database consists of scanner data collected weekly from more than 32,000 supermarket, drug, and mass merchandiser outlets across the United States and is current as of January 2, 2000--the version available to FDA under its contract with IRI at the time this study was conducted. The database provides detailed information on average unit prices, sales volumes, and other measures at the product, brand, and Universal Product Code (UPC) levels.
 This, in effect, results in censored score data, which might be analyzed using applicable econometric methods, such as Tobit.
 This does not imply that each variable is assigned to specific factor. Variables can (and will) be related to more than one factor.
 The name of a factor is subjective.
 Factor analysis uses and generates standardized values.
 Although the terminology "corrective actions" was included in input received during the study pilot, none of the recommendations fell into this category.
 Given the large number of food subsectors identified for risk scoring in round 2, we only asked experts to provide preventive control recommendations for the main food sectors and note any additional controls that might be needed for a subcategory, if any.