The U.S. Food and Drug Administration (FDA) is considering whether to propose regulations under existing legislative authorities that would require food manufacturers to provide food safety controls based upon the seven (7) principles of Hazard Analysis Critical Control Point (HACCP) published by the National Advisory Committee on Microbiological Criteria for Foods (NACMCF). FDA has concluded that its determination on whether to adopt such regulations will be facilitated by the operation of a HACCP Pilot Program. FDA is conducting a pilot program with a number of volunteers from the food manufacturing industry who are using HACCP to control food safety hazards.
This interim report provides observations and comments on the HACCP Pilot Program. Information for the report is obtained from three primary sources. First, FDA's reports from the detailed on-site evaluations of the HACCP pilot firms were reviewed. Second, FDA interviewed representatives of each pilot firm to obtain their observations as to how the pilot program is progressing at their company, and their comments regarding developing and implementing a HACCP plan. Third, the FDA personnel involved in reviewing the HACCP plans and operations at each pilot firm were interviewed for their perspectives and insights. The interim report includes information on aspects of the program that have worked well to date, areas that present challenges, and issues that need to be addressed to decide how to proceed with a HACCP program. No conclusions are presented.
Purpose of HACCP Pilot Program
The pilot program is intended to provide information that food science professionals can use in determining whether HACCP should be expanded beyond seafood as a food safety regulatory program. The information is being gathered from firms that produce several different types of food products and from firms which control against a variety of potential food safety hazards. The pilot program is also intended to provide FDA with experience in working with the audit type inspection necessary for verifying a HACCP program.
Scope of the HACCP Pilot Program
The companies that have volunteered to participate in the pilot, and the products and hazards involved, represent a wide range of foods and manufacturing processes. The pilot program is limited to food manufacturers other than seafood. FDA and the National Marine Fisheries Service had previously joined together to conduct a seafood HACCP Pilot Program with volunteer domestic seafood processors and retailers. This experience was quite valuable in helping to determine FDA's course of action relative to seafood HACCP. Retail food operations are also not included in the pilot program at this time. However, HACCP principles have been incorporated into the Food Code, and FDA is actively cooperating with state food agencies to expand the adoption of the Food Code and HACCP at retail establishments.
The food products manufactured by some pilot firms undergo further manufacturing before reaching consumers, while others are produced for final consumer marketing. The number of significant food safety hazards that the pilot firms designated in their HACCP plans as requiring HACCP controls ranges from one (1) to eight (8). However, the significance of the hazards identified by the firms and the best means of their control continue to be reevaluated during the course of the pilot program. As a result, the number of significant hazards controlled under HACCP plans continues to change at some of the firms involved.
The Role of FDA in the HACCP Pilot Program
HACCP enhances food safety by providing the same type of systematic approach to control the manufacturing process as is used in scheduled processing of low-acid canned foods. FDA will maintain the capability of determining whether the food manufacturer has acceptable process controls in place and is producing a safe product on a continuing basis. All the provisions, powers, and requirements under existing regulations will continue to apply. FDA's role under HACCP is to verify that HACCP programs are effective and are being followed. Verification involves on-site evaluations of the firm's HACCP system as documented by the firm's HACCP records. The focus of the evaluation is to determine whether all significant hazards are being properly controlled through preventive measures.
The Role of Industry Participants in the HACCP Pilot Program
The HACCP Pilot is a voluntary, nonregulatory program. Industry participants have agreed to (1) provide management support for HACCP; (2) develop, implement, and maintain HACCP plans; (3) maintain records of HACCP controls; and (4) train staff at all levels in their areas of HACCP responsibility. Data voluntarily submitted to FDA under the pilot program are considered confidential.
The Role of State and Industry Trade Associations in the HACCP Pilot Program
State authorities who share regulatory oversight responsibilities for the food manufacturing industry are participating with FDA in two of the pilot programs. FDA has identified several goals in working with state authorities, including helping to identify and assess the potential impact of HACCP on state inspection, compliance, analytical, and policy development workloads. Another goal is to help identify staffing, equipment, and operational changes that would be needed to accommodate smooth implementation of federal-state partnerships. FDA also recognizes that food manufacturing trade associations, third-party food safety certification organizations, and food safety consultants play an important role in HACCP. FDA has sought input and cooperation from several groups in addressing issues of how HACCP can be effectively applied to the food manufacturing industry. One pilot firm is using the technical expertise of an industry trade association in conjunction with a state university research center. These organizations have been partners in the pilot program at the firm where they worked closely on the hazard analysis and HACCP plan development. They continue to be involved during the implementation and ongoing administration of the HACCP program.
The procedures FDA is following to implement the pilot program are based on the "Invitation to Participate in a Voluntary HACCP Pilot Program for the Food Industry", published in the Federal Register on August 4, 1994. Firms are invited to provide letters of interest to FDA. FDA then meets with representatives of each of the interested firms selected as being suited for the program and representatives of industry trade associations, if invited by the firms. An agreement is signed by the firms and FDA. Firms submit proposed HACCP programs for a specific product and production facility. Preliminary site visits to the facilities are arranged in preparation for FDA's review of the proposed HACCP program.
HACCP Pilot Agreement
FDA and the interested firms sign cooperative agreements. The agreements indicate each firm will (a) prepare a written HACCP plan based on the seven principles of HACCP, which includes a written hazard analysis with supporting scientific data, designated critical control points (CCPs) and critical limits for each, monitoring protocols, records to be kept, corrective actions to be taken, and the firm's verification procedures and records; (b) make its facilities available for HACCP verification evaluations; (c) make HACCP records available; and (d) provide FDA with cost-benefit, training, and environmental information relative to the implementation of the HACCP program. The agreement is provided in Attachment A.
HACCP Plan Review
FDA reviews the HACCP program of each firm to determine whether the HACCP plan follows the NACMCF guidelines and whether other components of the firm's HACCP program, including training and prerequisite programs, are provided. FDA provides written comments and discusses any issues necessary for the firm's HACCP program to meet the objectives of the HACCP Pilot Program. FDA provides limited assistance to the pilot firm in preparing the HACCP plan where necessary. An example of a checklist with the type of information reviewed by FDA is provided in Attachment B.
HACCP Site Evaluation Team
FDA assigns a HACCP site evaluation team to each pilot plant for the duration of the pilot. The team normally consists of (1) an FDA Headquarters official and/or an Office of Regulatory Affairs (ORA) expert; and (2) one or two ORA Field representatives from the district in which the pilot firm is located. Some site teams also include a state program official in states which have a HACCP Partnership Agreement with FDA with concurrence of the pilot firm. An FDA economist may accompany the teams on some occasions to collect cost and benefit information relating to HACCP.
Initial Site Visit
The HACCP site evaluation team conducts an initial site visit with the HACCP team of each firm and, if requested by the firm, with industry trade association representatives. The purpose of the initial site visits are to ensure that (1) the HACCP program provides effective food safety controls, (2) HACCP training has been provided, and (3) prerequisite programs are fully functional. A checklist of the type of information reviewed by FDA is provided in Attachment C. This checklist is based upon the NACMCF guidelines for HACCP programs and is structured after the seven principles of HACCP. FDA collects information as to how the firm is addressing each item, and compares this against the NACMCF guidelines.
Based on FDA's review, the firm determines whether any modifications are needed in its prerequisite programs, training, and HACCP plan to be consistent with the NACMCF guidelines. Any modifications that are to be made are documented with the FDA site team.
Start-up Date
FDA and the firm agree upon a date for the pilot program to start at the firm after the initial visit has been completed and any modifications to the firm's HACCP program have been implemented.
Quarterly Site Evaluations
A start-up site evaluation, which begins the pilot evaluation schedule, is conducted approximately six (6) weeks after the firm's start-up date for the program. The same checklist of information provided in Attachment C and used by FDA during the initial site visit is used for each quarterly evaluation. FDA reviews the product operations and collects information as to how the firm continues to address each item. This information is assessed against the NACMCF guidelines, and any needed improvements are discussed with the firm.
Two additional site visits are conducted approximately quarterly after the start-up evaluation. These quarterly site evaluations are intended to verify that the firm's prerequisite programs and HACCP plan are being effectively implemented, and that the HACCP plan provides necessary food safety controls. The site evaluation is coordinated with the firm's HACCP program representative. FDA's evaluation is based on an audit type inspection comparable with those conducted by internal company audit teams or third party auditors doing NACMCF-based verification audits.
FDA receives copies of the firm's HACCP plan including the hazard analysis prior to the start of the site evaluations. The plan includes examples of records used for monitoring. During the site evaluations FDA reviews the firm's HACCP records, including prerequisite program documents and records, daily monitoring records, corrective action logs, etc. Copies of additional records are requested when they illustrate or document certain information that is important to the purpose of the pilot program. Further, FDA may request copies of any verification audits conducted by the firm.
It is FDA's intent to reach agreement with each firm regarding the evaluation findings. Once there is agreement on FDA's evaluation findings, FDA and the firm also will agree on any modifications needed in the firm's HACCP plan to address the evaluation findings and on a time frame to implement these modifications.
A third quarterly, and final site evaluation, is conducted approximately ten (10) months after the pilot begins at each firm. At the final evaluation, FDA and the firm discuss the changes that have occurred in the firm's food safety controls as a result of the HACCP Pilot Program, and the achievements and problems associated with implementing the HACCP program. This is discussed further in the final section of the report on "Next Steps".
FDA will prepare a summary of the results of the pilot program within approximately six (6) months after the conclusion of the pilot program. Data from individual firms will be combined in the summary report so as not to divulge privileged or confidential information on individual firms.
The firms participating in the HACCP Pilot Program and the products included in the pilot are listed in Table 1. Seven active firms are listed. Four additional firms have volunteered to participate, and FDA has signed agreements with them. However, these firms are still in the initial stages of the HACCP Pilot Program, and they are not included in this interim report.(1) The types of hazards represented in the HACCP plans provided by the participating pilot firms are listed in Table 2. The status of the pilot at each firm is shown in Figure 1.
| FIRM | PRODUCT | LOCATION* |
|---|---|---|
| Alto Dairy | Hard Cheese | Wisconsin |
| Campbell Soup Company | Salad Dressing | (New Jersey) |
| Campbell-Taggart, Inc. ** | Pan Breads | (Missouri) |
| ConAgra | Flour | (Nebraska) |
| Hans Kissle Foods | Quiche | Massachusetts |
| Pillsbury | Frozen Dough | (Minnesota) |
| Ralston Foods | Breakfast Cereal | (Missouri) |
* ( ) Denotes location of corporate headquarters and not pilot firm. ** Campbell-Taggart changed its name to The Earthgrains Company in February 1996. | ||
| PHYSICAL | CHEMICAL | MICROBIOLOGICAL |
|---|---|---|
| Glass | Allergens | Cross Contamination |
| Metal | Animal Drug Residues | - Post-Cooked |
| Other Foreign Materials | Cleaning Compound Residues | Pathogens |
| Illegal Residues/Pesticides | - Raw Ingredients | |
| - Packing Materials | - Raw Storage | |
| - Raw Ingredients | ||
| - Shipping Containers | ||
| Natural Toxins |
1 These firms and their
products are
(1) Anchor Food Products, Appleton, WI, stuffed peppers;
(2) Bruce Foods, New Iberia, LA, hot sauce;
(3) Ocean Spray Cranberries, Lakeville-Middleboro, MA, fruit juice; and
(4) R.L. Schreiber, Pompano Beach, FL, soup stock.
Representatives of each pilot firm were asked a number of questions about their experiences in developing and implementing a HACCP program. In part, these questions were taken from the Advance Notice of Proposed Rulemaking (ANPR), published in the Federal Register on August 4, 1994, which raised several issues and questions regarding how to best implement a HACCP program for the food manufacturing industry. Many of these issues are being examined in the context of the pilot program. Information on other aspects of the pilot program is presented as well. The observations and comments are arranged in sections that follow the sequential order of the seven principles of the HACCP program.
Role of Preexisting Quality Assurance Programs
An important issue in developing a HACCP program is determining how HACCP should be integrated with existing quality assurance (QA) programs. All of the pilot firms had a number of preexisting programs which provided (1) basic sanitary control over buildings and facilities, personnel, equipment and utensils, and production processing operations, and (2) compliance with regulations for labeling. Under HACCP, these preexisting sanitation programs are called "prerequisite programs".
A few pilot firms that had prior experience with HACCP understood the role that the HACCP plan and the prerequisite programs played in their overall QA programs. These pilot firms adopted HACCP by incorporating it into their existing QA systems. One large company, for example, reported that HACCP became the "principal pillar" of its new comprehensive QA program. The importance of the role HACCP played was emphasized by this pilot participant, who reported that:
HACCP is an important management tool and has been integrated into all phases of the operation. If every QA system outside of HACCP failed, we would still have a safe product. If HACCP failed, we would not. The other QA systems cannot support safety.
Companies with strong prerequisite programs and QA programs reported that adopting HACCP was not "any great departure from what we had before". One firm reported that:
HACCP required modifying our previous program but not going to something completely new. Systems and controls are similar. However, HACCP is different from other QA systems primarily with respect to presenting hazards in a format that is common and understood. HACCP is also different in the level of knowledge needed on the floor. HACCP's advantage is that it provides a formalized, structured, documented program that helps explain to people why they are implementing controls.
Another large company reported that its prerequisite programs were effective. "We had a good control program before HACCP, and we look at HACCP as a refinement rather than a drastic change." This company stated that:
HACCP is really just a spin-off of a previously used control concept. With respect to controlling physical hazards, there is little difference from previously used controls except that HACCP requires more stringent monitoring, documentation, and record review, as well as follow-up documentation.
This same company reported that:
Follow-up to the food incident reports normally leads to improvements in our prerequisite programs. It helps us catch things before they get to the CCP. We have come to realize that prerequisite programs are even more important than we originally thought. They prevent things from getting out of control and becoming food safety hazards. We need to understand the relationship between cause and effect on HACCP. It helps us become more preventive on all aspects of safety and quality.
Firms that did not have prior experience with HACCP, however, often had initial problems developing a HACCP plan that focused on food safety and distinguished the hazards controlled under the HACCP plan from the hazards controlled under the prerequisite programs. One small firm observed that before starting the pilot program:
We did not have trained professionals in the QA section at the firm who thoroughly understood the concepts of food safety control. We also lacked written procedures for our QA program and written monitoring records. Little formal QA training had been provided for line employees.
The FDA site evaluation team found during the initial site visit that this firm needed a written standard operating procedure (SOP) for general sanitation including the type of sanitation records which were to be maintained by the firm. The SOP also needed to include an equipment maintenance schedule. This firm was committed to providing a comprehensive HACCP program and hired a QA manager who is incorporating HACCP throughout its operations. The new QA manager had 15 years prior experience working with HACCP and advises that HACCP will take time to implement and will be a major cultural change.
HACCP Team Formation and Leadership
A second key issue is determining the role management needs to play in developing a HACCP program and understanding how to form an effective HACCP team. The HACCP team is responsible for developing and implementing the HACCP plan.
Most of the pilot firms had similar experiences in forming their HACCP teams. Three larger firms initially included corporate representatives on the team. These corporate officials played a major role in conducting the hazard analysis and developing the HACCP plan. The team members had training and experience in food sanitation and safety, and they had ready access to experts throughout the company. At another firm there is active involvement by a vice president, and the firm established a full-time dedicated position of HACCP Administrator at the plant in the pilot. A fifth large firm with extensive HACCP experience provided corporate oversight but placed responsibility for the HACCP plan development and implementation on the operating facility. The corporation provided input at the initial stages by preparing a basic hazard analysis which the operating unit then used to develop its HACCP plan.
Once the HACCP plan was developed, each company with corporate involvement turned the plan implementation over to local firm management and HACCP team members. One firm reduced the size of its original HACCP team once it determined its CCPs by eliminating from the team any representatives from production units that did not have a CCP. This was done after the program was fully implemented and operational. Another firm, however, advised that it will increase representation on its team, once HACCP is operational, to include line people. It felt this is needed to give the team an additional perspective. One company developed a two-level in-plant team system. A "Steering Committee" oversees HACCP development, while an "Implementation Committee" deals with HACCP at the operational level. It felt this approach was necessary to integrate HACCP into all phases of its operations.
One smaller company did not have corporate support to draw upon and sought assistance from a trade association and a research center associated with a local state university. These third parties participated on the team at no cost during the development phase and provided valuable technical expertise not available at the firm. The company stated that:
Third party help was very valuable to our small company with limited resources...small companies need help. Also, companies go off on their own tangents. Outside groups provide some standardization and common focus. Otherwise, approaches adopted by firms will be too scattered.
Two firms noted that it was important in implementing the HACCP plan to have the same people involved on the team who helped develop the plan. They explained that if the same people remained on the HACCP team, there is a shorter learning curve and a shorter time frame needed to implement HACCP.
FDA's site team representatives reported that teams that worked well usually had strong leadership in the plant and support from corporate headquarters. One of these teams also had a full-time HACCP administrator who kept HACCP documents up-to-date. This firm established a core team which was expanded as necessary to deal with specific issues.
HACCP Training
A third important issue is the role training plays in effectively developing and implementing a HACCP plan. Several types of training are available including training in HACCP principles and in developing and implementing a HACCP plan. There is training targeted for managers, the HACCP team members, operation supervisors, and/or line employees.
All the pilot firms had someone on the HACCP teams who received some type of HACCP training. However, in some cases the training consisted only of information from college courses, on-the-job training, and/or HACCP books or manuals. Teams from two firms received additional training after the start of the pilot program.
Some HACCP teams did receive extensive HACCP training. They benefited from internal corporate training programs or received training from trade or professional associations. These teams reported that the training manuals provided in these courses were an important source of guidance in preparing their HACCP plans.
One firm has a sophisticated corporate train-the-trainer type program that provides different levels of HACCP training to employees depending upon their responsibilities. All employees receive at least a basic introduction to HACCP training. In another firm each Plant Manager and QA Manager participates in a two-day HACCP training program and, in turn, trains members of the plant's HACCP team. This company prepared training video tapes on HACCP which are shown to employees throughout the plant. Both of these companies also stressed that training helps ensure that a common format is used for HACCP throughout the corporation in terms of definitions, standards, establishing CCPs, and developing HACCP plans. The training also makes it easier for employees to transfer their knowledge of HACCP should they move to another plant in the corporation.
Another firm participated on an industry trade association task force and helped develop generic HACCP plans for its products and a HACCP manual. This HACCP manual was used by the pilot firm to provide training to its HACCP team.
Training for line employees in HACCP concepts and responsibilities varied among pilot firms. One firm provides a two-hour introduction to HACCP for all hourly employees. HACCP is also reinforced through weekly 15 to 30-minute meetings throughout the year. Another firm has begun training its operational employees one department at a time since beginning the pilot program. This firm has adopted a company policy that all employees are to be trained in HACCP.
Less extensive training has been provided in several other pilot firms. One firm reported that:
The training of line employees is ongoing, general training, but it is not HACCP specific unless they monitor a CCP. Persons responsible for monitoring have written instructions regarding the HACCP requirements on their monitoring sheets. Nevertheless, we need to do more in-house training and involve line employees in the HACCP program to further empower them.
One firm with a low-risk product advised that it had not provided employees with formal training on HACCP, but it does provide formal training on sanitation to line employees.
Another firm is providing an overview of HACCP to its employees including explaining the new record-keeping that is required. The employees with responsibilities for CCPs receive more detailed training. Each month this firm holds departmental meetings for all employees in each department as well as the regional and plant sanitarians. HACCP and Good Manufacturing Practice (GMP) issues are covered at these meeting. Employees on the line reported to FDA representatives that they like the new system and feel HACCP has had a positive impact on improving communications and morale. Another firm uses the team concept and requires that all production team members have at least weekly meetings to discuss problems, successes, and improvements needed. If the HACCP team believes changes are necessary to the plan, they will consult with the affected production personnel.
One firm advised that it has a problem training line employees because many speak a foreign language for which HACCP training materials are not available. The firm reported that:
In determining how best to control hazards, we have to consider language and how to train people. The biggest problem is the language barrier. Someone has to translate the training and instructional materials so we can train employees in their language. Training of production staff is the biggest time factor for us in developing our HACCP program.
The FDA site team members advised that training appeared to be one of the key components that determines how rapidly a firm is able to develop and implement a HACCP plan. One site team member, speaking about one of the larger corporations, reported that:
Training of employees is instrumental to their success and attitude. Training seems to empower employees. They are also cross-trained. Employees know the importance of their job and what to do if there is a problem. The employees understand they are upholding the image of the product's brand name, and they are proud of the quality of their product.
This firm videotapes training sessions and keeps the tapes on file for future reference. The firm also maintains a training file for each employee. The employees have their own copy of the HACCP plan for use within the plant.
Another team member reported that:
The type and quality of training provided by corporate officials can be very important because the plant employees' understanding of HACCP principles and requirements will mirror the training provided by corporate staff. They do not have an independent understanding of HACCP. The training can particularly influence the manner in which they conduct their hazard analysis.
One pilot firm that produces a low-risk product, however, did not think that training needed to be formal or extensive. At this firm, two representatives from the corporation lead the HACCP team. One took a HACCP seminar, and the other learned about HACCP from written materials. The latter explained that HACCP is "not rocket science" and felt that for products with only physical hazards, HACCP can be self-taught.
Developing Product Specifications and Process Flow Diagrams
The product specifications and process flow diagram provide a basis for the hazard analysis. At a number of the pilot firms, the product specifications were developed at the corporate level. These firms have written procedures in place to approve any product specification changes and to communicate the changes from corporate headquarters to the production level at the local firm. Another firm used verbal orders and written notes from the production manager to staff employees to modify product descriptions. Under the pilot program this firm now plans to develop a standard form to authorize product changes and to ensure that recipes and ingredient statements are properly correlated.
Three firms made some modifications to their process flow diagram based upon discussions with FDA site team members. At one firm, updating and verifying its process flow diagram resulted in only minor adjustments. The firm reported that:
We dressed up the flow diagram since the words we were using were not specific enough. We knew what we meant, but the diagram did need to be clarified. This was to our benefit since it made the diagram more easily understood by our employees.
However, more effort was needed by the HACCP teams at the other two firms. At one firm the original flow diagram actually tracked the flow of materials through the plant rather than describing the process for producing the product. The HACCP team had to revise and verify the flow diagram several times before they were satisfied. The second firm initially used a complex engineering diagram that was very hard to understand. The HACCP team eventually brought in departmental supervisors to help them reformat, revise, and verify that the process flow diagram was correct.
Hazard Analysis
An important step in developing a HACCP program is conducting the hazard analysis. A comprehensive, science-based hazard analysis provides the foundation of a well-designed HACCP plan and an effective food safety control program. During the hazard analysis, it is intended that the pilot firms (1) identify all the potential hazards that impact on its product; (2) assess the relative risks of these hazards and determine which are significant hazards; and (3) specify the preventive measures that best can be used to control the hazards. The hazard analysis is the one component of a HACCP program that a firm is least likely to have conducted under a preexisting program, and the component that requires the most scientific and technical knowledge to prepare.
Pilot firms that had not had prior experience with HACCP found this step in developing a HACCP plan to be one of the most challenging. Many of the firms reported that they found interacting with FDA on the hazard analysis to be very beneficial. Even larger firms that had done their hazard analysis before the pilot began, found they gained additional insights concerning their list of hazards when their HACCP plan was reviewed by FDA. The pilot program has provided some important insights in several areas as follows.
Some HACCP plans originally submitted to FDA did not include a written hazard analysis. Often firms based their assessment of hazards on past experiences, industry data, and consumer complaints, and they did not believe they had significant hazards that needed analysis.
Other HACCP plans, which did contain a hazard analysis, usually included a list of hazards associated with the product and process, but little or no documentation of the rationale used to determine which hazards were selected. Some hazard analyses did not include an assessment of the risk of the hazard which is needed to determine the potential significance of the hazard. The following comment by a member of one of FDA's site evaluation teams during an initial visit to a pilot firm was typical:
The list of all hazards, their potential significance, and how they are controlled, eliminated, or reduced to acceptable levels throughout the process have not been documented for review. This is also true for the criteria for evaluating hazards and determining their likelihood of occurrence.
This resulted in discussions between FDA and several firms about specific hazards that needed to be covered by the plan. This discussion and closer examination of the significance of hazards seemed to benefit the firms in several ways. In general, firms appeared to have an increased understanding of the significance of each hazard associated with their product, the documentation needed to support their determination of ways to control these hazards, and what employees need to understand about why controls are necessary. For example, one FDA site evaluation team member reported that:
The firm reevaluated its hazard analysis and determined they needed to prepare a written analysis and risk assessment. A full list of hazards now is provided. Based on data and prerequisite programs, the firm determined that most of the hazards are controlled through processing. The exception is metal which was determined to be a significant hazard. Preventive measures, which at first were not documented, are now included in the written hazard analysis.
Three firms that had developed their HACCP plans prior to the pilot program reported that they benefited from a reevaluation of their hazard analysis after discussions with FDA. One firm reported that it reevaluated the hazard analysis and found that it was more qualitative than science-based. "After we entered the pilot, we did a more scientific analysis." This led to discussion about the potential significance of each hazard. As a result, the firm concluded that there are some important qualitative considerations that need to be integrated with the scientific issues. This is discussed in more detail in the section in this report on selecting CCPs.
Another firm reported that:
We learned from the pilot that we did not have a clear document describing the hazards. In the past, we relied on product specifications. Now, we are developing a hazard analysis document that clearly distinguishes and communicates to our plant employees the hazards that are being controlled.
Firms that used the NACMCF guidelines, and firms that were supported by corporate or third party experts, tended to prepare more comprehensive hazard analyses. One large corporation had its hazard analysis done at the corporate level and then reviewed at the local level and tailored to make sure it "reflects reality". This firm reported:
Our hazard analysis is based upon the steps in the flow chart. It is handled as a group discussion process involving various experts. What 'might be' is examined on the basis of experience and practice. Input from the people is important. The NACMCF and the International Life Sciences Institute (ILSI) decision trees provide good guidelines. We then assess risk by applying probability or likelihood of harm based on experience.One firm that used assistance from an industry task force reported:The hazard analysis is important to educate everyone on hazards and control measures. Educating people about risks helps them to rely on more than experience. People need to understand why something is a risk and why specific controls are selected.
The hazard analysis was a difficult area. There was extensive discussion and different views from the task force members. The hard part was trying to determine what was a true hazard versus a theoretical hazard. Likelihood of occurrence was an issue. We tried to use the NACMCF guidelines as a guide to resolve disagreements.Some firms commented that while the NACMCF guidelines are useful, practical experience also needs equal consideration. Another firm noted that the most difficult challenge was the time required to adequately prepare the hazard analysis, especially since no one in this firm is in a full-time HACCP position.
Some important insights were gained into the rational thought process needed in conducting a hazard analysis. The NACMCF guidelines provide that once a potential hazard is identified, questions need to be asked as to the likelihood of occurrence in the final product, and the potential severity of the hazard. This analysis is necessary to determine which hazards are significant and require control. If sufficient data exist to conclude that a hazard is unlikely to occur or the injury is insignificant, the rationale for exclusion needs to be identified in the hazard analysis. The following are examples of the analyses some of the pilot firms used in assessing the significance of potential hazards.
Raw milk has a high likelihood of contamination with pathogens and must have an adequate pasteurization step in place as a CCP. After pasteurization, the possibility exists for cross-contamination of microbiological sensitive ingredients. Three firms listed the pathogens Salmonella spp., Escherichia coli O157:H7, and Listeria monocytogenes as potential hazards that may be present in incoming ingredients such as pasteurized milk, cheese, whey powder, and other dairy products. These firms assessed the level of significance of contamination from incoming ingredients and the adequacy of preventive measures that are in place to eliminate or limit survival and growth of the organisms. The firms felt that these pathogens need not be considered a significant hazard because, as a result of existing preventive measures, no incoming product has been detected, and there have not been problems reported in the literature.
The firms determined that in the case where dairy products are incoming ingredients, and they receive pasteurization and acidification treatments, there are no documented incidents of E. coli or L. monocytogenes contamination of the ingredients. Therefore, these potential hazards were not significant and need not be controlled at a CCP. Nevertheless, because E. coli O157:H7 organisms have a high tolerance to low pH environments and the infectious dose is unknown, this organism could remain as a potential hazard for future reevaluations of the hazard analysis. In addition, possible recontamination of incoming dairy products, which would put the product at risk for Salmonella spp. and L. monocytogenes, needs to be continually evaluated to determine whether CCP controls should be applied.
The hazard analysis conducted by two other firms determined that raw products made from grains cannot be inherently considered pathogen free. They concluded that using a baking step in producing the product would render the product pathogen free. However, they recognized that the hazard analyses needed to be very product- and process-specific.
Another hazard that has been addressed by several pilot firms has been the presence of allergens such as dairy, egg, and nut products. These firms determined that if products intentionally include a potential allergen, then a CCP for labeling is warranted; and two firms do have such labeling CCPs. However, when the name of the product itself, e.g., cheese, indicates an allergen is present, the firms do not believe additional controls are needed.
These firms also analyzed whether there is a potential in their operations for inadvertent cross-contamination of an allergen-free product with other products which may contain an allergen. The firms determined that adequate preventive measures are in place to prevent this from occurring. For example, one firm schedules their production so product containing allergens are run at the end of the production cycles, and clean-up is performed before the lines are reused.
Two firms listed cleaning and sanitizing compounds as potential chemical hazards that needed to be assessed as to their severity and likelihood of occurrence. As with microbial hazards, these firms felt that the analysis of chemical hazards must be product- and-process specific. Both firms conducted an analysis regarding the potential chemical hazards from their CIP (cleaning in place) systems. One firm determined that the preventive measure for this hazard could be controlled as a control point (CP) under the sanitation prerequisite program. While the other firm agreed that the CIP preventive measure was per se a CP, the firm's prior experience led it to conclude that there was a sufficient consequence and likelihood of occurrence to warrant controlling the final rinse of caustic cleaning compound before start-up as a CCP under the HACCP plan.
The potential for chemical hazards, such as pesticides and other industrial chemicals, was considered by several firms. These firms determined that the potential for pesticide contamination falls into two main categories for control. The firms were controlling the field application of pesticides through purchase agreements, certificates of analysis from suppliers, and analytical testing. Pesticides applied to control storage insects may be applied prior to receipt or during storage at the pilot firm. In these cases, documentation is required by the pilot for proper use by licensed applicators of pesticides.
Verifying the adequacy of these controls, and whether they are best placed in prerequisite programs or more properly addressed in the HACCP plan, is a subject for further study by the firms and with additional firms in the pilot program. For example, one firm advised that:
We are collecting data on pesticide residue testing at various locations in order to make a more quantitative risk assessment of the potential hazards associated with pesticide residues. In addition, we are instituting a comprehensive prerequisite program for pesticide residue testing of raw materials before they are actually in route to the manufacturing facility. This will provide additional data to perform a risk assessment of pesticide residues. This may determine that control at the receiving point, in terms of a CCP, is not needed.The second type of controls was applied to chemical contaminants such as diesel fuel and agricultural chemicals that might be introduced during storage and shipping. The firms controlled these hazards at the point of entry by inspecting raw materials and shipping containers. These preventive measures were considered CCPs covered under the firm's HACCP plans. However, one firm is considering reclassifying these hazards as low-risk based on past history, and moving control to a CP under a prerequisite program. Other industrial chemicals used at the pilot firms have not been considered significant hazards because food-grade chemicals are used during manufacture.
One firm identified drug residues in its raw ingredients as a specific chemical hazard associated with its product. This potential hazard is normally monitored at the point of receipt. The controls conform with the procedures provided in the state regulations governing drug residues. This preventive measure is considered a CCP covered by the firm's HACCP plan.
Another chemical hazard considered by some pilot firms is natural toxins. These hazards are an example of conditional hazards that must be assessed on a situational basis. The firms determined that the production of significant levels of natural toxin in grain such as vomitoxin (DON) is dependent on climatic conditions in the growing area. Monitoring of the growing areas is handled as a CP under the firms' prerequisite programs. Control is accomplished by monitoring for a specific indicator of DON. If the monitoring information reveals that toxin levels in the incoming grain are a significant concern, the firm will reassess the likelihood of occurrence of this hazard and initiate CCP level control when conditions warrant. However, since the start of the pilot program, technological advances have increased the speed and accuracy of test methods, providing faster, more reliable test results. As a result, one firm advises that it is reassessing whether this control is best placed under a prerequisite program or HACCP.
Physical hazards have received a great deal of attention in the hazard analyses conducted by the pilot firms. Six of the seven pilot firms control physical hazards as a CCP. Hazards listed by the firms include foreign objects such as glass, metal, and wood splinters. Of these hazards, metal fragments that may pass through processing or be introduced during processing have been most often identified as significant hazards. One firm has a product packed in glass, and it considers container breakage at the point of filling to be a significant hazard. The firm has implemented a glass breakage control plan. These firms also used consumer and commercial customer complaints during the hazard analysis process to help assess the likelihood of occurrence of their physical hazards.
Most firms felt that it was unlikely that their lists of physical and chemical hazards would change often except, perhaps, for allergens. Some firms felt, however, that new microbiological hazards might be identified because of more sensitive analytical methods or emerging pathogens being found in foods. One of the larger firms explained that all hazards need to be periodically assessed.
The hazard analysis is a continual education process. We must always be aware of problems of other firms. Changes in hazards often occur because of the worldwide scope of the food supply. New hazards may arise. It is important to our company that we have mechanisms to look at emerging technologies and any issues that may impact on our company's products.
This firm developed a corporate hazard analysis form which it uses to perform hazard analyses. During the pilot, this firm reassessed its hazards and their significance and, as a result, added three CCPs.
Selecting CCPs
All significant hazards identified during the hazard analysis need to be controlled by preventive measures. Determining how the preventive measures, in turn, are to be controlled is a primary factor in developing the HACCP plan. Preventive measures can be either CCPs under the HACCP plan or CPs under a preexisting GMP-based program. The safety of the product can be compromised if preventive measures are not properly monitored and controlled. Identifying which preventive measures need to be controlled as a CCP was the most challenging aspect of the pilot for most firms, and the issue that received the most attention in discussions between the pilot firms and FDA.
In general, the number of CCPs substantially decreased as the pilot proceeded through its various stages. This is shown graphically in Figure 2. One pilot firm started with as many as 80 CCPs in the HACCP plan originally submitted to FDA. Two other firms had over 20 CCPs. The firms reduced these numbers to eight (8) or less after being requested to provide their rationale for selecting CCPs, including how they used the NACMCF or other decision trees. One firm actually has 16 CCPs listed in their HACCP plan, but these CCPs include duplicate control point on different production lines.
Examples of different reasons why the number of CCPs changed may be helpful to understand the rationale the pilot firms used to select their CCPs. First, in some instances firms had multiple production lines, and each line has the same type of preventive measure designated as a CCP (e.g., a metal detector). For these firms, the number of CCPs was reduced, in part, because their revised HACCP plans listed the preventive measures only once although several duplicative units may be on the production floor. Such grouping of preventive measures served to reduce repetitiveness within the HACCP plans.
In several instances, control points were determined by the firm to be quality-related or insignificant in terms of safety. These firms designated the preventive measures as CPs in preexisting sanitation, vendor compliance, and total quality management (TQM) programs rather than designating them as CCPs in the HACCP plan. The HACCP plans then were built upon these CPs in the prerequisite programs. In these instances, the number of CCPs was reduced.
If the firm determined the CP was significant in terms of safety, it may have been redesignated as a CCP where no subsequent step or action aided in controlling the hazard. In these instances, the number of CCPs was increased. For example, one firm originally designated a thermal processing step as a CP because the firm felt that this preventive measure was more related to controlling quality. However, the firm took a closer look at its vendor controls. It used the NACMCF decision tree and concluded that potential pathogens in raw ingredients could not be controlled adequately in its vendor compliance program. The firm determined that the thermal processing was the only step sufficient to destroy any pathogens, and that this step needed to be controlled as a CCP.
Another result of further analysis was that some firms realized they did not have enough information and that additional quantitative data would be helpful to determine the significance of some hazards. These firms either analyzed existing records and/or began collecting data to document the likelihood of occurrence of a hazard. As one firm reported:
Potential hazards were designated as CPs and assigned to prerequisite programs for control or were designated as CCPs for control under the HACCP plan. This determination was based on experience and the capabilities of the equipment and process. We did not initially consider the significance or the likelihood of occurrence of an identified hazard because of a lack of data and, again, the capabilities of the equipment. Now we have data and are beginning to reexamine which hazards need to be controlled under our HACCP plan or under a prerequisite program.The firm that considered whether thermal processing needed to be a CP or a CCP for destroying potential microbial hazards also felt that additional information was needed and decided to conduct time and temperature studies on the traditional thermal process. These studies demonstrated that in order to have a thermally treated product with acceptable quality parameters, bacterial destruction was ensured manyfold. The pilot firm concluded that since adequate thermal processing must be attained by the process for the product to be saleable, no underprocessed product could be marketed. It felt that maintaining CCP monitoring records for time and temperature of the baking process was superfluous since all product was visually inspected as a quality control. This approach does not adhere to the NACMCF monitoring and record-keeping principles, but the firm felt it was a rational approach that needed to be tried.
A further result was that two firms concluded they needed to consider factors other than strictly food safety in determining which hazards are to be controlled as a CCP. Each company has a strong commitment to the quality of its nationally known brand name, and HACCP has been integrated with its QA programs. One firm advised that all hazards controlled under its HACCP plan are safety related. However, it is controlling some upstream and redundant preventive measures as CCPs "because it is easier to manage them in HACCP when the product has very few true CCPs". This firm noted that if HACCP were mandatory, it probably would reduce the number of CCPs because of the record-keeping requirements.
The second firm reported that:
We started with 80 CCPs, and in working with the NACMCF decision tree, we reduced the number to one CCP. The other hazards were designated as CPs under our prerequisite programs. However, then we became concerned that we were not taking full advantage of HACCP. CPs under the prerequisites may become routine and may not get the same attention as CCP monitoring under HACCP. We have a successful QA system that is integrated with our performance management system. We decided to reexamine one or two gray areas that may or may not have required CCPs in each processing area in order to keep our performance management and QA systems working. As a result we assigned more CCPs because we felt we needed to consider other factors in addition to food safety. Consumer perception of our product is critical to us. If the consumer perceives something is undesirable, but it is a gray area under HACCP, we may still have to consider and control against it as if it were a CCP. Wisdom and experience should also be considered, not just the NACMCF guidelines. We know from experience that we need to focus on control, and HACCP should support our efforts.Other pilot firms, however, reported that they are following the NACMCF guidelines closely and are limiting their CCPs to food safety-related hazards.
FDA reviewed these varying approaches to designating CCPs with interest. On one hand, FDA stated in the Federal Register announcing the pilot program that HACCP plans needed to be based upon the HACCP principles outlined by the 1992 NACMCF guidelines. These guidelines are explicit that CCPs are to be safety-based. On the other hand, the NACMCF guidelines do not discuss control of hazards by prerequisite programs, so the guidelines are limited at this time. In addition, the FDA's HACCP seafood regulation allows seafood firms flexibility in assigning hazards to be controlled, either under their prerequisite programs or under their HACCP plan. FDA, in general, advocated limiting the CCPs to preventive measures that provided final control of safety hazards only. Nevertheless, both of these companies had prior experience with HACCP and were confident in their approach. The philosophy of these organizations is that if control of a hazard is critical to their system of controls of the product, it should be able to be controlled as a CCP.
Using A Standardized HACCP Plan Format
The ANPR raised the issue of whether a standardized format or structure for HACCP plans is helpful in developing a HACCP plan. A standardized format can be used to ensure that the HACCP plan covers each of the seven principles of HACCP, and that the information is presented in an easily understood manner. On the other hand, firms may want to have flexibility in structuring their plans in a manner that suits their individual needs.
All of the pilot firms reported that they used standardized formats to develop and document their HACCP plans. These formats are similar to the format provided in the NACMCF guidelines.
Two firms that developed their HACCP plans for the first time for the pilot program reported that:
- We needed the generic plans and structure that NACMCF provides. This is positive, particularly for firms without experience in developing HACCP plans.
- I used my own, nonstandard HACCP plan format at my last company. But, now that I am using the NACMCF-based standardized format at this pilot firm, I think it is better. I realize the advantages of a standardized approach.
Two firms that had experience with HACCP prior to the pilot reported that:
- Our customers have been demanding a HACCP plan. One of our facilities that had a HACCP program failed a customer's audit. We rewrote the plan in the NACMCF-based format, and the firm passed the audit. This standard HACCP plan format gives customers assurance of our controls and that we know what we are doing. We think this standard format is extremely useful because it provides a plan that is organized and easy to read.
- Our company transfers people regularly and a standardized HACCP format is beneficial. We also have several facilities that have similar customers. A standardized, NACMCF-based HACCP plan format makes it easier for the customers to understand our controls. Customers continually ask to see our HACCP plans.
Assistance in Developing HACCP Plans
Another important issue is determining the type of assistance needed by firms as they develop HACCP plans. The pilot program was structured so that pilot firms could receive assistance from other sources and include third parties in the pilot program if desired. In addition, FDA reviewed each firm's HACCP plan prior to the start of the pilot program, and FDA provided consultation to the firms during the pilot. FDA, however, did not provide any formal training to the pilot firms.
Third parties were helpful in facilitating initial discussions between FDA and some potential pilot participants. However, once the pilot firms signed agreements with FDA, consultants and third parties were used by only one firm in developing its HACCP plan. Other firms felt that working within the firm or corporate structure was preferable. One large firm commented that with its numerous facilities across the country, it cannot use consultants and still have a consistent program within the entire corporation. Instead, the corporate staff serves as internal consultants by providing training and scientific expertise, developing product specifications, preparing hazard analyses, identifying CCPs, and conducting verification audits.
The firm that used outside assistance had been actively involved with its trade association in developing a model HACCP plan. This firm invited the trade association to participate in the pilot. Assistance from the trade association was valuable because of the firm's small size and lack of technical expertise on food safety. The firm commented that it "could not have participated in the pilot or succeeded" without the outside assistance. Firm representatives believe that small companies need outside help to approach HACCP in a timely, effective way and to be consistent.
Companies that had prior experience with HACCP needed little assistance from FDA. Nevertheless, these firms felt that the HACCP plan review by FDA was helpful. One firm reported that:
FDA has been helpful because of its focus on food safety, and its efforts to keep hazards associated only with quality out of the HACCP plan. This helped our company move in this direction. In addition, working with FDA in the pilot encouraged us to develop a more reasonable and rational record-keeping system, and it helped us realize we need better follow-through on record audits.
Another large firm that produces a low-risk product had a different opinion. It reported that:
FDA's plan review did not result in many changes. The pilot program has not changed our operations since HACCP is similar to the other control concept we were using. However, FDA's review did point out that the thoroughness of our documentation needed improvement.
Some of the firms that did not have HACCP plans prior to the pilot reported that FDA's assistance was helpful. One firm advised that FDA was helpful in working with the firm to review its flow diagram and identify CCPs. Another firm reported that:
FDA's review of our first plan was helpful, and we used it as a guide for our revised plan. Knowing how much detail was needed was hard for us. FDA's comments helped focus our attention on what was required. Otherwise, we would not have been as specific as needed.
FDA's site team members reported that the assistance they provided appeared to have a positive impact on the firms HACCP plans and subsequent implementation. FDA's review of firms' HACCP plans and subsequent discussions with the firms often resulted in firms decreasing the number of hazards controlled as a CCP. FDA's assistance also appeared to be positive for those firms that had little HACCP training or understanding of HACCP concepts. One site team member reported that:
The assistance was more like training. FDA's input helped them understand that additional training was needed. Some firms also initially wanted to continue to use the control program they had before HACCP and just relabel it HACCP. They did not understand the cultural shift required for HACCP.
However, this type of assistance also resulted in the HACCP plan development phase of the pilot program taking longer and being more involved than originally projected.
Preapproval Process
One possible form of assistance is establishing a process that would allow firms to submit their draft HACCP plan to some HACCP authority for review prior to any audits by FDA. In preparing this report, FDA asked the firms whether they believed such a process would be helpful.
Different views were expressed concerning the desirability of a preapproval process. One company stated that preapproval may be helpful if HACCP is mandatory, and if some specific guidelines were issued to identify risks. Another firm felt that professional associations could serve as a review authority for HACCP plans, but that members of the association would need extensive knowledge of HACCP to perform this role. This firm also felt that each firm is in a better position to approve its own plan since only the firm understands the intricacies of its business. They stated that "the HACCP plan is approved each day product is shipped".
Another firm that had prior HACCP experience reported that:
From the perspective of an individual plant, there needs to be higher level review to verify the HACCP plan prior to implementation. This needs to be provided by someone with proper expertise and practical knowledge of the operation. We provide this review from the corporate level. Any preimplementation review should be from a recognized third party. Trade associations could fill this role, but standardization would be needed. A floor review, not just a desk review, is required. Otherwise, the reviewer could miss important hazards. Preimplementation review would work better for smaller firms that do not have strong corporate support and expertise.A guide which specifies the normal hazards and controls associated with each type of process is not a good idea. Companies that do not understand HACCP will take the model off the shelf and stick it on the floor. This would not be effective in providing food safety controls. A guide which identifies hazards, only, could be helpful, but not a guide for process controls.
One firm that obtained help from a trade association in developing its HACCP plan reported that there was some value in preimplementation review by a third party for standardization. However, it cautioned that the review process should not become as formal as some other FDA processes because each firm is different, and flexibility is needed. "The review should be aimed only at keeping everyone in the same ball park."
A different view was expressed by another firm which stated that:
Preimplementation review would be helpful for small companies. It forces companies to prepare their plans and to keep focused on the project. Small companies have a problem keeping on task because of so many demands on the time of the few people available. Deadlines are needed. Review by government is the first choice because consultants are too expensive.Time Needed to Develop a Workable HACCP Plan
An important issue regarding the development of a HACCP program is the amount of time that firms need to receive HACCP training and develop a workable HACCP plan. The amount of time required by the pilot firms was influenced by several factors, some of which were unrelated to the pilot. For example, two pilot firms were expanding or reorganizing their production operations at the same time they began developing their HACCP plans. New process lines were tested, new people were hired, and some key people originally involved with the HACCP program were transferred. Delays resulted at these firms in starting the pilot.
Other factors that were related to the pilot program caused the amount of time involved to develop a HACCP program to vary from firm-to-firm. One firm reported that it had been working with its trade association prior to the pilot program to develop a model HACCP plan. This work made it easier for it to develop a plant-specific HACCP plan, and it only took about one month. However, the firm commented that if the generic model had not been available and if it had not participated in developing the model, at least six months would have been needed.
Another firm reported that only a month was needed to develop a workable HACCP plan once its team was trained in HACCP. A third company dedicated one person full-time to write the HACCP plan and several other employees part-time to support the effort. It took the firm less than two months to develop the HACCP plan with this level of commitment. The firm stated that:
The time required depends upon the size of the firm. A large firm like ours takes longer because of many products and process lines, and the need to get corporate approval of local firms' plans. Once the plan is developed, additional time is needed for review, verification, and training of line employees. We estimate it would take a firm about nine months to develop and implement a plan if it had a similar QA program prior to HACCP.
Role of Microbial Sampling
One important issue associated with the implementation of the HACCP plan is the manner in which controls for microbiological hazards are monitored. Under GMP-based control programs, end product microbial testing is often used to assess whether the product is produced under safe conditions. However, some firms that have had experience with HACCP feel that once HACCP type in-line controls are instituted, the role of microbiological sampling can change from a monitoring tool to one of verification. The pilot program seems to confirm this.
Five pilot firms established CCPs to control microbiological hazards. Only one of these firms used microbial sampling to monitor the CCP. In this instance, monitoring was done on an incoming ingredient that was microbiologically sensitive for a particular pathogen. This monitoring was done on a monthly basis. Microbial testing results were also provided by the supplier on a lot-by-lot basis.
Other firms controlled microbial hazards in a variety of ways. They included (1) supplier testing of raw ingredients, (2) time and temperature controls, (3) cooking, and (4) pH controls. In each instance critical limits were established that did not require microbial testing for monitoring. One of these firms reported that:
Microbial testing is a poor monitoring tool because results are too late. Also, there are too many pathogens, and you cannot test for everything. We will use microbial sampling if there is a known risk in an incoming ingredient.
Although microbial testing was not used by these firms to monitor critical limits, it was used to verify other systems of control that supported the firm's HACCP plans. For example, one firm reported that:
We use microbial testing sparingly as a verification tool. The company uses certificates of analysis to assure the safety and quality of incoming ingredients. We audit these suppliers by occasionally sampling incoming ingredients to verify the certificates.Another firm used historical microbiological test results as a data base for its hazard analysis. The microbial sampling data can help evaluate the likelihood of occurrence of potential hazards. Microbiological sampling also was used by several firms to check sanitation as part of the firms' verification of their prerequisite programs.
Frequency of Monitoring CCPs
Another potential issue regarding the implementation of a HACCP plan is determining the frequency with which CCPs need to be monitored. Monitoring not only requires resources, but its frequency determines the number of records that need to be maintained. The frequency of monitoring also affects the level of confidence a firm has in the safety of its product, with continuous monitoring providing the highest level of confidence.
Ideally, monitoring should be at the 100% level, and many CCPs in the pilot program were monitored at this level. For example, continuous temperature recorders are used to monitor the temperature of sensitive ingredients during storage, pasteurization equipment is subject to continuous monitoring, and continuous visual monitoring is provided to check against product container breakage. When continuous monitoring was not feasible, most CCPs were monitored on a lot-by-lot basis. Examples of this type of monitoring by the pilot firms include monitoring shipments of bulk incoming ingredients, sets of product labels, cooking/cooling temperatures, and cooling times.
Nevertheless, it is not practical or necessary for some critical limits to be monitored on a continuous or lot-by-lot basis. For example, sifter screens used in flour operations and tailings may be checked after each shift, daily if used, or even weekly for bulk product. Firms also check metal detectors at varying frequencies ranging from hourly to daily.
Firms reported to FDA that they use different criteria for determining frequency, although most firms base it primarily on prior experience. One firm stated that the frequency of some of its monitoring was determined by working with the people involved on the line and not solely through formal analysis. Its monitoring frequency was based on experience and practicality. The frequency of its other monitoring was based upon state regulations. Another firm reported something similar.
We based frequency of monitoring on prior experience. However, when we began documenting what we do and began auditing the records, we realized we needed to increase frequency in some instances. For example, the level of monitoring on weekends did not follow the same level as monitoring during the week. We feel this increase was needed to fill in some gaps in our monitoring. However, since we will be cutting back on the number of CCPs because some are quality related, we will also be cutting back on the level of monitoring at these production points. We now have better data to justify our monitoring frequency.
A large firm reported that:
The frequency of monitoring determines how much product a firm needs to put on hold when there is a deviation. Infrequent monitoring results in larger lots that must be held or destroyed. Experience is the key factor. The company needs to determine how much product is at risk. We will redesign a production system in order to monitor more frequently. We like to provide continuous monitoring of the critical limits at each CCP since this reduces the amount of product put at risk.
For other firms, considering the amount of product being put at risk was a new concept. One firm reported that:
Frequency of monitoring has been a slower learning area for our plant people. The plant developed the plan, but then it had the tendency not to monitor as much as what was needed. Corporate oversight was important in this area to help develop a rational basis for the frequency.
Another firm considered its product liability in determining the frequency of monitoring. It reported that:
We have been monitoring and documenting all along. We may, in fact, need to have a more relaxed frequency of monitoring than what is currently in our standard operating procedures. Making a monitoring point a CCP should not mean we have to change monitoring and record-keeping just because it is a CCP. The key is to insure that reasonable effort is being made to provide protection and to control hazards.
Two FDA site team members advised that if monitoring frequency is based on prior experience, FDA generally did not challenge the firm in this area. However, in some instances, FDA recommended that firms develop data showing how much variation existed or how often problems were expected at a particular monitoring point as a basis to determine the appropriate monitoring frequency.
Follow-up Corrective Actions
Another implementation issue is the type of follow-up corrective action necessary when there is a deviation from a critical limit at a CCP, and whether a recall plan should be part of these follow-up actions.
There have been only a few deviations from critical limits during the pilot program. In each case the firm took appropriate corrective action to address the problem. One firm noted that its ability to detect a particular hazard in its product has improved as a result of the HACCP program. Should deviations occur under its HACCP program, the cause is identified, the problem is corrected, and findings are recorded using a specialized deviation documentation system. Another firm commented that it had had one problem concerning a deviation at a CCP prior to the start of the pilot program. This problem was not noted immediately but was detected during an audit. As a result, this firm destroyed some product, conducted additional training with its operators, and changed its procedures to better prevent the problem in the future. At this firm a corrective action form is completed if there are any deviations.
A third firm stated that because of the HACCP program, its documentation of corrective actions is more specific and detailed than under previous procedures. Items are placed "on hold" until problems are corrected, and a deviation reporting form is completed.
A fourth firm reported that it had two deviations since the pilot program began, and food safety incident reports were completed for each one. This firm believes that because of its HACCP program and increased employee awareness, situations are detected earlier in the process before critical limits are exceeded at a CCP. It said that each time there is a deviation it has a better understanding of what to expect. In part this is because the firm carefully reviews each deviation from critical limits and assesses the significance of the safety hazard associated with the deviation in developing its corrective action options. This helps plant managers provide guidance on corrective actions that best provide for safe food. The firm reported that: "We are becoming more preventative as a result of HACCP, and there is a higher level of quality and food safety awareness".
At another firm, which has CCPs to control microbiological, chemical, and physical hazards, deviations have occurred in the controls of its chemical and physical hazards. The affected product has been isolated until the problems have been corrected. At FDA's suggestion, this firm developed and will begin using a deviation log, which has become a HACCP record that is assessed as part of the firm's HACCP verification procedures. The firm feels that HACCP has helped it respond more quickly to problems because of an increased awareness among employees as to procedures to follow.
Several of the firms had recall programs prior to the pilot program. One firm stated that the "recall program removes added stress in times of panic". During the pilot program, one firm actually conducted a product recall due to a nonfood safety-related issue, and the recall was highly effective. Another firm said it has a recall program in place, but it has not tested or used the program. Three other firms have conducted mock recalls to test the effectiveness of their recall programs. One of these firms conducts monthly mock recalls on finished product. Another firm conducts quarterly recalls on both raw ingredients and finished product. The goal is for the firm to be able to determine the location of 99% of its product within 24 hours. Mock recalls are rerun if a lower level of success if achieved. At the pilot firm mock recalls are routinely completed within two hours rather than the 24 hours allowed.
HACCP Record Systems
Implementing a HACCP program depends on adequate records to document the controls at each CCP, and the corrective actions taken in response to any deviations. HACCP records also include the HACCP plan and any verification audits that are conducted. An important issue is the parameters of an adequate record-keeping system. Record systems used by the pilot firms included hand written logs, filing systems for continuous recording charts and inspection sheets, and computer files of data of monitoring results and follow-up corrective actions.
Although all firms keep records, not all firms had critically examined their record-keeping systems to determine whether they adequately documented the controls that were in place. In three instances, pilot firms either formalized or otherwise altered their record systems to be more precise in the information that is being collected. One firm expressed the opinion that the pilot program has helped it distinguish between records needed to document food safety and those needed to document quality and production parameters. Another firm reported that its new record sign-off system helps improve plant wide communications because of increased dialogue between managers, supervisors, and line employees about record results.
One firm, with a HACCP plan that controls physical hazards, expressed concern about the increased documentation that seems to be necessary with HACCP. This firm did not have a formal record-keeping program at the beginning of the pilot program that specified the records to be kept; information required on the records; who is responsible for signing, reviewing, and filing the records; and the record retention time. The firm commented that: "In reality all the record-keeping may not be feasible and worth the costs".
Another important consideration is the length of time that records are retained. Most firms have policies to retain their records for the shelf life of the product or a minimum of one to two years. One firm is keeping its records for one year after the shelf life of the product, and another firm is keeping records for at least three years. The shortest period of retention is six months for a product with a shelf life of about 30 days.
HACCP Plan Verification
Another issue of importance is the procedures needed to verify HACCP plans. There are two types of verification. The first is verifying that the HACCP plan is being properly followed. HACCP records are reviewed, and any deviations are evaluated to determine whether appropriate follow-up corrective actions were taken. The second type of verification, called validation, is assessing whether the HACCP plan is effective in protecting against food safety hazards. This type of verification requires a review of the flow chart, the hazard analysis, the CCPs, and the critical limits.
Most audit activities have focused on verifying records to confirm that the plans are being properly implemented because the pilot program has not progressed to the point where most firms have conducted the validation type of audits to assess the effectiveness of their HACCP plan. However, the firms are conducting verification audits on a daily basis as HACCP records are reviewed. FDA is also conducting verification audits when quarterly site evaluations are conducted.
FDA has found during the quarterly site evaluations that the firms are having little trouble implementing their HACCP programs consistent with NACMCF guidelines as long as they have a well-structured HACCP program at the start of the pilot. Most of FDA's recommendations regarding improvements needed in the HACCP plans were made during the plan review, initial site visit, and start-up site evaluation stages of the pilot. Once the pilot progressed to the quarterly site evaluation stage, only minor adjustments to the plans were usually needed. The exception was when firms changed their production operations, such as by adding new pieces of equipment to the production line, and the HACCP plan needed to be updated. This progression is shown in Table 3, which provides examples of the type of improvements recommended by FDA at the different stages of the pilot program.
Implementation of the HACCP programs has progressed well because, in part, the pilot firms have or are developing effective verification programs. Information provided by the pilot firms is helpful in understanding the type of verification programs being used.
Consumer and Commercial Customer Complaints
The procedures used to review consumer and commercial customer complaints in a HACCP program are another important issue. The pilot firms all feel they need to be aware of consumers' experience with their products, and all firms review consumer and commercial customer complaints. However, the pilot firms report that complaints are largely related to quality or economic factors unrelated to the HACCP controls. Nevertheless, all pilot firms have review procedures, which allow them to react promptly to any illness or injury complaints.
The procedures varied among firms. One small firm reviewed complaints but did not have a formal, written review procedure at the beginning of the pilot program. This firm is developing a written SOP. All other pilot firms have written procedures. Another smaller firm has an uncomplicated system that simply involves reviewing complaints and taking action as necessary. In contrast, other larger firms have more elaborate systems that involve referrals to local firms from corporate headquarters, prompt investigation and reporting back by the local firm, contact with the consumer who complained, and computer-generated reports and analyses of trends and processing areas that needed investigation.
Consumer complaints helped some pilot firms develop and implement their HACCP programs. Firms that supply intermediate ingredients to secondary commercial customers use customer complaints to determine the likelihood of occurrence of hazards which are controlled in the HACCP plan. In one case, a firm installed metal detectors based upon commercial customer demands. This preventive measure is now designated as a CCP.
Three other firms also advised that they used consumer complaints as an aid in conducting their hazard analysis and/or in verifying their controls. One firm reported that:
Our company has to listen to our customers. We may miss something that impacts negatively on the consumer. However, there are many other issues that come through the consumer complaint system, and it is easy to misinterpret a complaint. Consumer complaints are used for hazard analysis and verification, but they need to be assessed by the company because we know how to interpret the complaints and their relevancy. Complaints only have value internally and should not be shared with outsiders.
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One firm advised that consumer complaints are received at corporate headquarters and processed on the computer. The complaints are sent to the plant for investigation. The plant tracks the complaints by category and breaks them down by line, system, date, code, etc., to analyze for trends and possible production areas needing attention. The firm also has incorporated consumer complaints into its performance management system. It reported that:
Consumers are of paramount importance to us and our brand and store brand labels. We risk losing a considerable amount of business if there are problems that are not solved quickly. Our corporate office sends a monthly report to each plant on complaints. An analysis is provided as part of our goals and objectives and the gain sharing plan. This report and analysis are important components. This is an example of how we use HACCP to help drive the performance program and promote our emphasis on consumer satisfaction.
Not all pilot firms felt that consumer complaints played an important role in their HACCP plan. One firm reported that:
Consumer complaints play a minimal role in our HACCP program. Our product is for food service accounts, and any consumer complaints do not come directly to us. Customer complaints are more relevant. With other products we produce for retail sales, we track any complaints and conduct follow-ups. There was one instance where there was some metal in the product, and we traced the complaint back to a production line problem, which was corrected.Most of the complaints are not health related. Information from consumer complaints is too limited, and it is hard to determine whether a particular product caused a particular problem. Consumer complaints can help determine whether changes are needed in prerequisite programs which are supposed to control quality parameters.
This does not mean, however, that follow-up procedures for pilot firms with institutional accounts are inadequate. At this firm, if there is more than one complaint from an institutional customer on a specific date-coded product, the investigation is escalated, and the product may be removed from the institutions. Procedures are in place to investigate any complaints which are received within 24 hours, and there is close communication between corporate headquarters, the plant, and institutional customers involved.
Measuring the Effectiveness of HACCP
Assessing whether there are benefits to the industry and FDA in adopting a HACCP program is another important issue. The firms were asked how effectiveness was assessed, about the benefits experienced, and about useful information learned from the pilot that can be shared with other firms.
One firm said that "HACCP is an integral part of our corporate culture". This firm measures effectiveness on the basis of the number of recalls and food safety incidents. Both are rare, which shows that HACCP is successful. Another firm said that with HACCP, it can make more intelligent risk assessments, and HACCP has helped improve safety in terms of control of its physical hazards.
Several firms commented that there are benefits from HACCP in terms of relationships with customers. One firm said that one of its major customers conducts an annual audit of the firm's production operations, and that its new HACCP program will help the firm pass this annual audit. Another firm reported that: "Some customers want to conduct an in-depth review of our HACCP program, while other customers just want to know that HACCP exists at the company".
One firm reported that HACCP has helped it formalize its operating procedures and has encouraged the firm to include an explanation of "why" certain controls are required. This has led to an improved understanding by line personnel of hazards and control requirements. The firm also reformatted its HACCP plans to make them consistent among different operations and plants and easier to understand. This firm believes that because of HACCP its employees are working with improved levels of confidence and competence.
Another firm has been following the principles of TQM at the corporate level for three years. HACCP has helped the firm implement TQM concepts at the plant level. The pilot facility is the only one in the corporation that had a formal HACCP program based upon the NACMCF guidelines at the beginning of the pilot program. A corporate representative commented that:
HACCP has had an impact in the plant and has fostered a greater awareness of why things are being done. It has resulted in more direct line personnel involvement, more ownership in jobs and in the product, and greater empowerment of employees. It also has helped us reassure our customers of our controls because more detailed information is available.
Several firms commented that they will share aspects of their HACCP program with professional and trade associations. Two firms are preparing "lessons learned" reports from their experiences with the pilot program, which will be used in expanding HACCP to other operations of the company.
The HACCP pilot is evolving into a two-phase program because of the different start dates of the participants. The quarterly evaluations have begun at five of the seven pilot firms. Final site evaluations will be completed at two firms by the end of June 1996. The final evaluations at the other three firms should be completed by November 1996. Two of the other seven firms are not yet at this point, and it is projected that the pilot will extend into the summer of 1997 before the final site evaluations are completed. In addition, FDA has signed agreements with four new firms and is talking with additional firms who are manufacturing other products and who are interested in participating in the pilot program. These new firms will also cause the pilot to be extended into 1997. FDA plans to continue conducting this program in the future to gain additional useful insights on the scope, development, implementation, focus, and cost/benefits of HACCP programs in various segments of the food industry.
FDA's agreement with each pilot firm to participate in the pilot program extends over a 10-12 month period. At the end of the pilot program, FDA conducts a final site evaluation, and the firm's experiences with HACCP are discussed. The criteria used in the final site evaluations are the same as used in the quarterly evaluations and are provided in Attachment C. These evaluations identify how well the firms are following the NACMCF guidelines for HACCP, and how well they are taking appropriate corrective actions whenever there are deviations from critical limits at the CCPs. The type of questions FDA discusses with the firms to document their experiences with HACCP are summarized in Attachment D. These questions concern the achievements and problems encountered by the pilot firms in developing their HACCP plans and implementing each of the seven principles of a HACCP program. At the completion of the pilot program, these individual site evaluations and final program analyses from each pilot firm will be consolidated into a final summary report of the HACCP pilot program.
At the final site evaluation, FDA will also work with each pilot firm to develop a continuing relationship based upon HACCP. HACCP is the Agency's preferred approach to food safety to carry into the 21st century. FDA is offering the pilot firms the option of having FDA continue HACCP audits at their HACCP firms as an alternative to the traditional inspectional approach involving direct observation and end product testing. Under this approach, FDA will conduct follow-up HACCP audits similar to those conducted during the pilot at the firms on an 8-12 month schedule or more frequently if needed by FDA or the firms. The purpose of the audits will be to ensure the continued effectiveness of the HACCP programs. A continuing relationship with the pilot firms will be beneficial to FDA because it will allow the Agency to gain additional experience and useful information regarding the long-term implementation of a HACCP program at a variety of food manufacturing companies.
FOOD AND DRUG ADMINISTRATION
AND
{INSERT COMPANY NAME & ADDRESS}
Under existing legislative authorities, the U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration (FDA) is considering whether to propose to put in place regulations that would require that food manufacturers operate based upon the seven (7) Hazard Analysis Critical Control Point (HACCP) principles outlined by the National Advisory Committee on Microbiological Criteria for Foods. FDA has concluded that its determination on whether to adopt such regulations will be facilitated by the operation of a pilot program.
{Insert Company Name} (the participant), recognizes the potential benefit to itself, the FDA, the food industry, and the public of such a pilot program. This program offers the industry participant an opportunity to volunteer to work with FDA to determine how best to apply HACCP principles in food manufacturing facilities, engage in a scientific dialogue with FDA, and contribute to the possible development of new food safety regulatory policy based upon HACCP principles.
The FDA Pilot program is intended to provide information that FDA can use in deciding whether to propose a HACCP-based regulatory system. The information includes insights into the problems, costs, and benefits of developing and implementing HACCP for firms that produce a variety of food products. The pilot program is also intended to provide FDA with experience in working with HACCP and information as to whether HACCP is practical for the food industry as a whole. It is projected that the pilot program will operate approximately ten (10) months after the start date at each pilot firm.
Correspondence regarding this agreement should be directed to the following:
| FDA | PARTICIPANT |
|---|---|
|
John Kvenberg, PhD Strategic Manager for HACCP Policy HFS-10, Rm 3014 Food and Drug Administration 200 C St. S.W. Washington, D.C. 20204 |
{Contact Person} {Company Name} {Company Address} {Contact Phone Number} |
| FDA | PARTICIPANT |
|---|---|
|
_________________________ Date:____________________ |
_________________________ Date:____________________ |
HACCP Team - Team information including:
Product Description - Plan specifications including:
Consumer Use - Intended consumers and specified use.
Process Flow Diagram - Sequence of steps of the whole
production process describing how the product is made, including:
Scope of HACCP Plan - The plan specifications regarding:
Hazard Analysis - The analysis of the biological,
chemical, or physical properties which may cause a food to be unsafe; and
the methods used to control the identified hazards, including:
Significance of Hazard - The significance and likelihood of
occurrence of each hazard.
Preventive Measures - Preventive measures that eliminate
or reduce the likely occurrence of a hazard to an acceptable
level, including:
Critical Control Points (CCPs) - The points, steps, or
procedures where a hazard is prevented, eliminated, or reduced to
acceptable levels, including:
Critical Limits for CCPs - The criteria that are met for
each preventive measure to be effective, including:
Monitoring Procedures - Measurements or observations at a
CCP that ensure the process is operating within limits, including:
Corrective Actions - Actions taken when the monitoring
results show deviations from the critical limit(s), including:
Record-Keeping - Records of the total HACCP system that verify
the plan is operating properly, including:
Verification Procedures - Procedures that examine
whether the HACCP plan works and is complied with on a daily basis,
including:
| HAZARD ANALYSIS | CRITICAL CONTROL POINT PLAN DEVELOPMENT | ||||||
|---|---|---|---|---|---|---|---|
| Process Step/ CP/CCP No. | Chem, Phys, Micro Hazard | Preventive Measure | Critical Limits | Monitoring | Corrective Action | HACCP Records | Verification Procedure |
| Procedure/ Frequency | |||||||
General Sanitation SOP - The general sanitation standard
operating procedure (SOP) including cleaning and sanitation, pest
control, equipment and facility maintenance, and employee health
Receiving and Shipping Controls - Controls for ingredient
and product receiving and storage, and final product shipping and
distribution
Raw Ingredient Controls - Controls regarding raw
ingredient safety including purchasing specifications and letters
of guarantee
General Sanitation Records - Prerequisite program
records being maintained
Water Supply Controls - Procedures for ensuring
a safe water supply under all operating conditions
Recall Plan - The firm's recall plan
HACCP Training Program - HACCP training
plan/program including who is
being trained, what type of training is being provided, and by whom
HACCP Team Members - The experience, HACCP training,
and location of the HACCP team members
Management Support - The type of upper management
support
Updating Product Descriptions - Procedures for
updating product descriptions, as necessary
Process flow diagram - A process flow diagram
consistent with the actual process operations
Scope of HACCP Plan - Specifications as to which
products and/or processes are covered in the plan
HACCP Team Structure - The type of HACCP team
approach used, and the use of an outside consultant
Product Description - Information on product descriptive
parameters, packaging, storage
conditions, and ingredients for the products covered in the plan
Intended Consumer Use - The intended consumers
of the product and the product's intended use
Updating Flow Diagram - Procedures for updating
flow diagram, as necessary
Hazard Analysis Criteria - Criteria used in
identifying hazards and their likelihood of occurrence
List of Hazards - Food safety hazards identified and the
significance of each
Preventive Measures - Preventive measures
identified for each hazard
General Sanitation Hazards - Hazards covered by
the sanitation SOPs and other prerequisite programs
CCP Criteria - The decision-making criteria
used to identify CCPs
List of CCPs - The significant hazards controlled as CCPs
Critical Limits - The critical limits established for
each CCP
Scientific Basis for Limits - The scientific/ technical
basis for each
critical limit and criteria used to establish the critical limit
Process Target Limits - The process target limits,
if used, to prevent deviations at CCPs
Monitoring Procedures - The monitoring procedures
used to ensure the CCPs are under control
Monitoring Frequency - The frequency with which the
monitoring procedures are performed
Monitoring Records Sheets - The monitoring record
sheets, if used, and the information contained on the sheets
Monitoring Responsibilities - The level of understanding of the
individual responsible for monitoring of the process target limits
and/or critical limits associated with the CCP
Actions To Be Taken - The level of understanding of the
individual responsible for monitoring actions to be taken if monitoring
indicates a deviation from a process target limit and/or critical limit
at the CCP
Deviations - The written corrective actions for each CCP
which address likely problems and prevent unsafe food from reaching the
consumer
Noncompliant Product - The corrective action procedures to
determine the disposition of noncompliant product, to fix the reason
or cause of the deviation, and to generate appropriate records to
document the corrective action
Corrective Actions - The corrective actions taken
when deviations occur
Auditing Corrective Actions - The procedures to
reassess the HACCP plan after corrective actions are necessary
Responsible Person - The assigning of responsibility
for taking corrective actions
Record-Keeping System - The record-keeping system
that documents the effectiveness of the HACCP system
CCP Monitoring Records - The monitoring records for
each CCP, including:
Corrective Actions Records - The corrective action records
documenting actions taken to hold, trace, and recall product
Changes to HACCP Plan - The firm's records detailing
changes made to the HACCP plan
Calibration Records - The calibration records
Verification Records - Records that document the verification
procedures, including verification analyses, investigations, and
noncompliance notes/reports generated
Computer Records - Computer records that are
part of the HACCP plan
Verification Program - The firm's verification procedures and
frequency of verification to ensure that the HACCP system is effective
Verification of CCPs - The operational procedures and
monitoring records
that are reviewed to verify preventive measures are implemented, each
CCP is under control, and employees understand responsibilities
Corrective Actions - The procedures used to review records and
the frequency of verifying that deviations are acted upon and proper
dispositions/corrective actions are made
Consumer Complaints - The written verification
procedures (SOPs) used to review consumer complaints and determine
whether actions need to be taken
Calibration - The verification procedures for
calibrating process monitoring instruments
Computers - The verification procedures for
validating computer hardware and software