The FSIS Pathogen Reduction/HACCP rule published in July 1996 combines the concepts of Hazard Analysis and Critical Control Point (HACCP) systems with the FSIS requirement for written Sanitation Standard Operating Procedures (SSOPs). However, HACCP and SSOPs are only part of a total food safety system. Good Manufacturing Practices provide the foundation for SSOPs and HACCP. As you begin to comply with FSIS regulations, it is important to have a clear understanding of the relationship between the GMPs, SSOPs and HACCP plans.

GMPs or pre-requisite programs are programs that comprise the basic, universal steps and procedures that control operating conditions within establishments and ensure favorable conditions for the production of safe food. These differ from HACCP systems, which focus on the critical points in a manufacturing process that effect food safety. GMPs are the control factors that relate to the entire operation and are not process-specific. GMPs include programs such as, facilities/grounds, equipment/utensils, pest control, receiving and storage, process control, product recall and personnel training.

Prior to the development and implementation of HACCP plans, an establishment should first review existing programs and verify that all GMPs are in place and effective. Effective GMP programs ensure that HACCP plans focus specifically on the critical control points (CCPs) necessary to ensure product safety. If any portion of the GMPs is not adequately controlled, there is potential for a HACCP plan to be less than effective in ensuring product safety.

GMPs are like any policy program your company has implemented. They require a written program, an appropriate training program and schedule, a maintenance schedule, and most importantly management commitment. Management commitment is the most critical component of any program your company implements. Management?s role takes on many forms from designating funds, providing guidance, providing human resources, to following the rules themselves. Once management has committed to the implementation of a program the other components fall into place.

Written Program The written program will serve as the base for the other components. A good written program includes the who, what, where, when, why and how of the program. It clearly explains the scope of the program, responsible individuals, its importance, parameters, monitoring activities and records, corrective actions and records and verification activities. A multi-disciplinary team made up of individuals with technical and operational expertise should write the program. The written program should be written at a level that is appropriate for the educational level of your employees and in a language they understand. Furthermore, the written program should clearly set forth the record keeping system and the expectations of the record keeping system.

Records

The ability of your records to communicate your compliance with the written program may make or break you. A record keeping system creates the environment in which employees communicate with one another. Its proper design and implementation directly effects how information is shared and problems are solved. The record keeping system must be a pro-active vehicle of communication, designed primarily to be useful. Monitoring and corrective action records should be designed not only with the monitor in mind, but also the auditor. Records should include a brief description of parameters being monitored, corrective action to be taken by the monitor, product code/code date, date, time, findings, monitors initials and any other appropriate information. Records should be reviewed, prior to being filed, for accuracy and to ensure that all the parameters of the program were met and appropriate corrective actions taken. Monitors should be carefully chosen and trained appropriately. Monitors should have good written communication skills, as they will be making the records that will ensure your company?s compliance. The following section, "Good Manufacturing Practices," will go into more detail for specific areas the written program should consider.

Training Program

Next to management commitment, an effective training program and schedule are critical to the effectiveness of your GMP programs. Without the proper training of all employees, the effectiveness of and GMPs is jeopardized. The programs should stress the importance of both employee participation and employee accountability. Literacy and language are two very important issues to be considered when developing the appropriate training program for GMPs and other food safety programs. In addition, people learn visually and/or audibly. In other words, there are people who learn by reading or seeing, others learn by hearing and others who learn by some combination of the two. An effective training program will incorporate different deliveries of information. Furthermore, an effective training program is structured such that employees are told what will be taught, taught and finally a review of what was taught. Once the program has been developed, trainers must be chosen and trained. Trainers should be chosen carefully and should be chosen based on training skills and not by job description. Managers, Supervisors and QA employees do not always make the best trainers. Training schedule development should take into account turnover rate, and should have update or reminder sessions as well. All new employees, regardless of job, should go through an initial training session. On the job training (OJT) is not an effective way to train employees for GMP or food safety programs. In some situations it is conceivable to have "new employee" training on a daily basis. All training activities should be documented including who received the training, the date and the type of training delivered.

Program Maintenance

Like facilities and equipment, written programs need to be maintained to ensure their effectiveness. A maintenance schedule for written programs should be based on changes in your facility environment. Employee turnover, new process introductions, facility layout changes are just a few issues that could trigger a review of the written program. In addition, any time you re assessed food safety programs the GMPs should be re assessed as well.

Each of the following sections briefly describes specific areas where written GMP programs should be written. Each written program should include the information described in the previous section under "Written Program." This is not an all inclusive list but covers the major areas to be considered.

• Facilities/Grounds

• Facilities and their surroundings should be designed, constructed and maintained in a manner to prevent conditions that may result in the contamination of food. Included in this area are outside premises, building design and construction, sanitary facilities and water quality.

• Outside Premises

• All outside areas of the plant should be free of debris and refuse that might be a source of insect and/or rodent infestation or cause objectionable odors or other contaminants. Roadways should be properly graded and paved to prevent dust and improper drainage. Standing water, weeds or materials that may pose a hazard to food and employees should also be eliminated to ensure that satisfactory conditions are maintained.

• Buildings

• Facilities should be designed, constructed and maintained in good repair to permit easy cleaning, prevent entrance and harborage of pests and entry of environmental contaminants. Floors, walls and ceilings should be constructed of acceptable materials that are durable, smooth and cleanable. Only approved coatings and sealants should be used on these surfaces. All walls should be light colored to permit easy cleaning, and floors sufficiently sloped for liquids to drain to properly trapped outlets. Windows should be properly screened if opened and doors close fitting. Stairs, elevators and overhead structures within the plant should also be designed and constructed so that there is no possibility of contamination of food or packaging materials. The facility should have the required lighting intensities throughout so that proper operations can be carried out. Lights and their fixtures must also be designed and constructed to prevent contamination of food or packaging materials due to breakage. Ventilation, where necessary to prevent steam, condensate and heat buildup, should be provided along with positive air pressure in microbiologically sensitive areas. Drainage and sewage systems must be properly designed and equipped with appropriate traps and vents. The traffic patterns of employees, equipment, materials and product should be such that the possibility of cross contamination between raw and processed food products is eliminated.

• Sanitary Facilities

• All washrooms, lunchrooms and change rooms should be separate from the food processing areas and should be properly ventilated and maintained. Washrooms should be equipped with a sufficient number of properly installed sinks and plumbed with hot and cold potable water. Processing areas and areas where employees are in direct contact with microbiologically sensitive product should contain conveniently located hand-washing stations controlled by foot, knee or a timer. Posted in these areas should be clear signs, in appropriate languages, requiring employees to wash their hands.

• Water Quality

• Water Quality An adequate supply of potable water is of primary importance in sanitation programs and plant operations. Plant water supplies must meet the potability standards in the National Primary Drinking Water Regulations issued by the Environmental Protection Agency (EPA). Records of water potability and water treatments applied must be maintained and on file. There should be no cross-connections between potable and non-potable water supply systems. Non-potable water should not be used in food processing, packaging or storage areas. All hoses, taps, cross connections or other areas of possible contamination must be equipped with anti-backflow devices. These devices should be tested periodically to ensure that they are working properly. All water treatment chemicals must be approved for such use and properly stored. Ice must be made from potable water and protected from biological, chemical or physical contaminants. Records of the microbiological testing of the ice should be maintained. Generated steam that comes into direct contact with food or food contact surfaces should be from a potable water source. Boiler treatment compounds must be approved for such use.

All equipment/utensils installed and used in the production of food should be designed to ensure its sanitary handling. Equipment/utensils must also be maintained in a manner to prevent contamination of the food by microbiological, chemical or physical hazards.

• Equipment/Utensils Design and Installation

• All equipment/utensils should be constructed of corrosion resistant materials that can be cleaned easily. All food contact surfaces should be non-absorbent, non-toxic, smooth, free of pitting and able to withstand repeated cleaning and sanitizing. Any chemicals, coatings or lubricants used in or on the equipment/utensils must be used as labeled. All equipment/utensils should be installed to provide sufficient space within and around machinery for cleaning, sanitation, maintenance and inspections. Where applicable, equipment should be well vented to prevent fumes within food production areas.

• Equipment/Utensils Maintenance and Preventive Measures

• All food processing equipment/utensils should be maintained in acceptable working condition for its intended use. Routine maintenance should be performed to ensure that equipment/utensils are operating as intended. Maintenance personnel should be trained to recognize potential equipment failures that could lead to the contamination of food (e.g., metal shavings, leaking fluids, missing bolts, etc.). Employees should be trained to recognize potential failure of utensils that could lead to the same. Supervisors should also be aware of all maintenance activities to ensure that any equipment/utensil changes or modifications do not affect the process and the safety of the workers or product. A preventive maintenance program should be in place that lists all equipment/utensils and preventive measures and procedures. This program should identify any necessary schedule for servicing, parts replacement, and the other components of a GMP program.

• Pest Control

Establishments should have a written, effective and safe pest control program to prevent insects, rodents, birds and animals from entering the plant. The program should specify:

• the name and address of any extermination company used
• a list of all chemicals and methods used for their application
• a map of bait stations and procedures and frequency of their inspection
• a pest and survey report form
• other components of a written GMP program.

Measures should also be in place for the verification of the effectiveness of the pest control program by plant management.

Receipt and storage of ingredients, packaging materials and other incoming materials should be conducted in a manner to prevent contamination of food. Inspection of ingredients and other materials should be performed in a sanitary manner to prevent direct or indirect contact with contaminating materials. Receipt of these materials should also be in an area separate from the processing area. Restricted materials (such as nitrites or sulfites) should be stored in a locked area. Also, where applicable, storage of all incoming materials should be in temperature and humidity controlled areas. Any returned goods should be clearly identified and stored in a designated area.

Detergents, sanitizers or other chemical agents must be properly labeled, stored and used in a manner to prevent contamination of food, packaging materials and food contact surfaces. Chemicals must be stored and handled in an area that is kept well ventilated, dry and separate from any food processing areas. All chemicals must be stored, mixed, dispensed and handled only by authorized and properly trained plant employees. Secondary containers should be properly labeled.

Process control deals with the functions directly related to the manufacturing process. This guideline will only focus on the GMPs that support a food safety system not the GMPs that cover economic and quality issues. A few examples food safety oriented GMPs are employee hygiene, formulation control, labeling/code dating and reworking/reconditioning. Some examples of economic and quality GMPs are net weight programs, aesthetics (size, color, texture, and flavor), and fat content control.

Conditions under which product is manufactured are an essential part of a food safety system. Room temperature, product temperature and equipment settings are just a few areas that should be considered and monitored.

Employee hygiene is a critical GMP for support of your food safety system. Hygiene practices should cover appropriate apparel, use of disposable gloves, proper use of hair and beard nets, proper handwashing and sanitizing, use of tobacco and food, jewelry, nail polish, use of writing utensils and the list goes on. It is also important to define important employee practices such as traffic flow and appropriate behavior (i.e. no horseplay, no spitting, etc.).

Tracking what goes into your product is important for a variety of reasons, safety, quality and economic. Amounts used, vendor names/codes, item/part numbers, code dates/lot numbers of every ingredient should be monitored and recorded. It is important to record both the item/part number (what the item is) and the code date/lot number of each raw material (which one). Also, any rework or other work in process product should be clearly recorded for trace back purposes. On a regular basis formulation records should be compared to both the incoming supply inventory and finished product inventory.

Applying the appropriate label and code date is important. The label identifies the product for customers and consumers. The code date allows you to differentiate between production days and reduce exposure in the event of a crisis. Code dates should be able to provide place of production, date, time, production line and any other information that is pertinent to your facility. This can be accomplished many ways and should be appropriate for your operation. For example, if you are a small operator with one facility, one production line and one shift, the production date and time would be all that is necessary. However, if you have multiple facilities, multiple lines and shifts, it should all be indicated through your code dating system. The written program should clearly describe the code dating system used and its location on each product. Code dates and all other labeling information should be clearly legible.

Products may need to be reworked or reconditioned if they are improperly packaged or if they come into contact with the floors and other non-contact surfaces, etc. Establishments should have an outline of the steps that need to be taken when it is determined that product needs to be reworked or reconditioned. These steps should include provisions for the maintenance and handling of product prior to reworking/reconditioning, procedures for trimming or washing of product where appropriate. In addition, specifications for how product is to be reworked/reconditioned back into the system and how cycles will be broken should be included.

Recall situations are crisis situations. In order for proper crisis management to occur during a recall situation, employees must remain calm. A well-written and tested recall program that all employees understand how to use effectively will be a critical element in this process. Such a recall program should contain, at a minimum, the following elements:

• documentation identifying the product coding system and product designation
• finished product distribution records that are correlated with the product coding system for ease of tracking of shipped product
• a current list of people that will take part in any recall activities (include business and home phone numbers)
• step-by-step procedures in the event of a recall
• means of notifying customers, retailers, wholesalers, etc.
• control measures for the return of recalled product
• means of ensuring the effectiveness of the recall
• means of disposing of recalled product
• means of coordinating recall with regulatory agencies

In addition, when notifying regulatory authorities of a product recall, the company should submit the following information: reason for the recall, amount of product involved, product codes, areas of distribution, contact person within the company, copies of any news release, etc. The recall procedures should be tested with sufficient frequency to ensure that they function properly.