What is the value of writing Good Manufacturing Practices (GMPs)?
GMPs are a written description of what you are doing in your operation to control conditions and ensure the production of safe meat products. GMPs include facilities/product flow, equipment/utensils, pest control, receiving and storage of meat and non-meat items, processing, product recall and personnel training.
GMPs are important in an operation, as a guide for all existing employees and for training of new employees. GMPs are a part of the foundation onto which HACCP is built. GMPs serve as a cushion of safety against the many potential hazards that are not likely to occur, so are therefore, not addressed as Critical Control Points in a HACCP plan.
GMPs do not require a record, as do SSOPs and CCPs. For that reason, the mere existence of GMPs is not sufficient to justify that a hazard is not likely to occur. On the other hand, existence of records, taken voluntarily, at control points in GMPs could provide sufficient justification that a hazard was not likely to occur, assuming records do indeed support that a hazard is not likely to occur.
While GMPs are important to an operation, they are of greatest value to your HACCP plan, if they are written early (now, for very small plants) and records are generated to help you determine the likelihood of occurrence of hazards. Examples of GMP records that you might keep include:
- for product receiving: surface and internal meat temperatures at receiving, condition of boxes/packages received, package leaker rates, delivery truck temperatures, incidence of product rejection/returns, age of product post-kill, etc.)
- for raw product storage: cooler air temperatures, FIFO rotation
- for tempering of frozen product: air or water temperatures and time
- for processing: room temperatures, nitrite quanitities in products,
To simplify your hazard analysis later, start now writing your GMPs. Take each of the areas mentioned in the first paragraph and write down what you are doing in each. If it helps, write about: who, what, when, where, how, and why, for each area. After your GMPs are written, start keeping records voluntarily where appropriate. You will see later that voluntarily keeping records, based on your GMPs will be very beneficial to you, when you start doing your hazard analysis and CCP identification.
What do I tell my customer who calls about Listeria and the safety of my meat products?
Until recently, Listeriosis, due to Listeria monocytogenes, has been primarily a concern for the cheese and dairy industries. Most recently, listeriosis has has become a major issue for the meat industry. For the meat industry, it is primarily a concern with fully cooked products, which could potentially become contaminated after cooking, but before packaging, and products which consumers would typically not reheat prior to eating, such as sliced luncheon meats, ham, and possibly, wieners. Normally, cooking meat products prior to eating, should eliminate the problem. However, microwave reheating might be the least desirable reheating method to prevent Listeriosis, as heating in a microwave oven is often not very uniform, leaving some parts of a product cold, while other parts are over heated.
Listeriosis is also more of a problem for young children, pregnant women, older adults, and anyone with a reduced immunity, such as cancer patients. The rest of your customers who are of good health would likely not experience much of a problem with Listeriosis.
Listeria monocytogenes is destroyed with heating to temperatures of 160 ºF, so cooking products to internal temperatures less than 160 ºF may present a problem. Starting with highly contaminated raw materials requires higher cooking temperatures to destroy pathogens to acceptable levels. In other words, if you are working with raw meat ingredients which have low levels of contamination, then final internal temperatures of less than 160 ºF would likely be sufficient, but if you have highly contaminated raw meat ingredients, even 160 ºF might not be sufficient to produce a safe product.
Listeria problems could also arise during the handling of the cooked product, either during chilling or packaging. Workers handling cooked product without gloved hands, or with contaminated gloves, or handling cooked product on contaminated table tops, slicers, or in contaminated tubs, could be adding Listeria to the surfaces of the cooked products. Even with vacuum packaging and proper refrigerated storage, Listeria monocytogenes can survive and grow, which makes it a particularly troublesome type of bacteria.
Listeria monocytogenes is not a rare type of bacteria. It is very commonly found in soil, water, animal and human feces, and can travel through the air. It is not unusual to find Listeria in household refrigerators. Therefore, in spite of the pride that you may take in cleaning and sanitizing your plant and equipment, Listeria could be in your plant somewhere.
In the Bil-Mar situation, it is speculated that Listeria might have been carried through the plant from building construction dust, or may have been growing on refrigeration units, in processing or packaging areas. Your GMP, HACCP and SSOP programs could all provide additional means of preventing Listeria from being a problem for your products. Related to your GMPs, does your receiving program prevent product from entering your plant, which has been temperature abused, or otherwise improperly handled? Does your rotation system prevent raw meat from being held too long before being processed?
In your HACCP plan, are you properly controlling the Listeria hazard in your cooking process (in other words, are you cooking your products to 160 ºF or above?)?
Your SSOP program may be the most helpful in preventing Listeria problems. For example, how often do you clean your refrigeration units? Is there a potential for air-borne contamination of your cooked products while they are being sliced and/or packaged? Do you fold or make boxes in the same room as the cooked products are being sliced or packaged? Do you require workers to handle cooked product with clean and sanitized disposable gloves? Does any uncooked product pass through areas of your plant where cooked product is stored or processed? Are procedures in place to ensure that cross contamination does not occur from raw to cooked products, by workers hands, coats, aprons, etc.?
Listeria monocytogenes has not historically been a major problem for the meat industry. Recent meat industry problems with Listeriosis is a big concern for everyone - consumers and meat processors alike. While you may think that Listeria problems haven't happened or won't happen to you, you can't be so sure with Listeria. Let's operate in the future assuming that Listeria is somewhere in all of our plants, and that we must do everything we can to keep it out of our fully cooked products.
How can I, or why should I form a HACCP team, when my company is so small?
HACCP teams for very small meat plants will obviously be small, considering the size of the very small plants. Someone needs to be chosen, who works well with company employees, company owners, and inspectors, as this person will be dealing with all three groups of people, during the HACCP writing and implementation process. However, one person should not be expected to be the entire team for a company. While owners may prefer to not be involved in the actual writing of the plans, they should be part of the team and be updated regularly on progress, problems, etc. Establishment owners need to supportive of this process, or those assigned to complete this process are doomed for a difficult task in completing the HACCP program. Responsible production workers, with experience in your operation, should be considered as good candidates for this team, and including them in this process will likely be good for their morale. Some companies have included wives, children or other family members who are either good at writing, typing or using a computer. The old addage "two heads are better than one, applies in the HACCP writing process.
What training is needed to develop and implement a HACCP program in my plant?
USDA-FSIS regulations require that only people who have successfully completed a course of instruction in the application of the seven HACCP principles to meat or poultry processing, shall develop or modify HACCP plans for meat and poultry establishments. Those involved in developing HACCP plans may either be employees of the company or may be hired to do this for a company. Even if consultants are hired to develop a company's HACCP program, it would still be advisable to have at least one company employee who has completed HACCP training, particularly when implementation of the plan is to occur.
Where do I start to develop my HACCP plans for my operation?
The first step that each establishment should take in preparing for HACCP is to establish a HACCP team, and determine who is to be the team leader, for this process. In the case of very small plants, it may not be possible to establish a team, and one individual may need to develop the HACCP program.
Once the HACCP team or individual has been identified, a list needs to be compiled of all products produced or operations conducted at each establishment. Information about each product or operation (product labels, formulations, process specifications, etc.) should be compiled at this time.
How many plans do I need to write?
Each establishment should consider all of the processes that they produce and where each fits into one of the following categories:
- Examples: slaughter, slaughter & minimal processing (cutting) may be combined
Raw product - ground:
- Examples: ground beef, breakfast sausage
Raw product - not ground
- Examples: primal cuts, roasts, steaks, marinated cuts
Thermally processed - commercially sterile
- Example: sterile canned products
Not heat treated - shelf stable
- Examples: dry salami, dry cured pork, pepperoni, pickled pigs feet
Heat treated - shelf stable
- Examples: snack sticks, popped pork skins, lard
Fully cooked - not shelf stable
- Examples: hot dogs, hams
Heat treated, but not fully cooked - not shelf stable
Examples: bacon, smoked sausages
Products with secondary inhibitors, not shelf stable:
- Examples: uncooked corned beef, uncooked cured pork
A separate HACCP plan would be needed for each of the above categories. It is expected that products which are made, using essentially the same processes, and therefore have essentially the same hazards, critical control points, critical limits, etc., would fit under the same HACCP plan.
Registration form (let me know if you have questions about these comments):
Add check list of available dates/locations
Add: First priority will be given for very small companies, from which no one has been previously trained.
Targeted for those who have completed training previously, but are needing a session to get them back up to speed/get them started again??? in the HACCP development process.
What do the signs, that OAMP mailed to me, mean to me in my (very small) slaughter plant?
While in a perfect world, the signs address an important issue of receiving safe products (meat and livestock), the reality of the issue is that the Ohio livestock industry does not currently have the technology to be able to say accurately that their animals do not have E.coli 0157:H7 in their intestines. What is even more of a concern is that many livestock producers, who think that they are doing everything correctly (selling clean animals, complying with drug withdrawal times, etc.), might be willing to sign off on the safety of their animals, not knowing the legal ramifications of their signature. While we would all like to point fingers at the other person to direct blame, we are all in this food safety business together. Imagine the impact of your business, if a lawsuit puts your local livestock producers out of business. The livestock industry is aware of its contribution to food safety, and is working on a solution to this problem. Besides, the OAMP signs would really only be applicable if you have a CCP for receiving of livestock at slaughter, or receiving of meat cuts.
Can my inspector dictate my monitoring procedures?
Your inspector cannot dictate your monitoring procedures, your CCPs or anything else about your plan. We are getting more and more questions about this issue. If you are feeling that this is happening to you, please contact either your district supervisor, your circuit supervisor, or if they are part of your concern, feel free to call Lynn Knipe at (614)292-4877 (He will pass this concern on to those in charge of your inspection, without divulging your company name).
If zero tolerance is used as the CCP, doesn't each carcass have to be monitored and verified prior to the carcass wash?
You would not have to check every carcass if you would choose not to. The frequency of your monitoring procedure is determined by you and should be dependent on what is feasible for your operation to handle. However, if you decide to monitor every fourth carcass and then halfway through your slaughter process you, or your inspector, find fecal contamination on a "fourth carcass", or any other carcass, would need to check all of the other carcasses that were processed since the last good check. If your inspector found fecal contamination, you would likely be expected to check all other carcasses processed that day.
May pre-shipment review, monitoring and verification be conducted by the same person in the same CCP at one particular step in a process?
The original HACCP regulation was not likely written with very small plants in mind, when it required that different people should do each of the three important tasks: monitoring, verification and pre-shipment review. FSIS now understands the problem this poses for very small plants and no longer requires that three individuals are required. I would recommend for very small plants that at least two people be involved; one person to monitor, a second person to verify and the first person could then do pre-shipment review. It is very easy for all of us to overlook our own mistakes, so it is wise to have someone else check our work. There is one married couple who checks each other's work (one monitors, the other checks the checker), but while it might be good for their HACCP plan, it might not be good for their marriage.
When cooking products such as spareribs that are too thin to hold a probe and cannot be thoroughly checked for an internal temperature, what is the best way to monitor these products? This may also include jerky products.
Monitoring oven temperatures, time that product is held at each temperature and cooking yield could substitute for temperature probing very thin meat products. With this approach, your critical limits should be based upon documented performance (times, temperatures and yields) in each oven and with each product (product diameter as well as moisture and fat content would affect your critical limits). For example, in the case of beef jerky, you would need to show that losing X % of weight, during cooking and drying would result in at least a 0.7:1 moisture:protein ratio.
Since trichina is a microbe, does it constitute a microbial hazard and should it be incorporated into every plan as a CCP due to cross contamination possibilities or even as heat treatment to kill it?
Any product that contains pork has the potential biological hazard of trichinae. This hazard is addressed by cooking, safe handling instruction labels for non-fully cooked products, and product separation in time and space.
Obviously any step in a process in the "absence of controls" can constitute a hazard occurring. It has been suggested that we prioritize our CCP's using those with the most critical limits first. What CCP's will stand alone in a HACCP plan and which will not? For example: safe handling statement and/or product temperatures may be used as CCP's but they cannot be the only CCP in a plan.
The buzz words "biological hazards" and "processing" may help to prioritize your CCP's. FSIS seems to be more concerned with biological hazards, then chemical or physical hazards. Also, FSIS is more concerned with hazards during processing, where you are cutting, grinding, mixing, etc., exposed product. As an example, for a raw ground (or non-ground) process, the buzz words (above) would translate to checking meat temperatures during cutting, grinding or packaging (wherever temperatures are most likely to be highest in your operation). Assuming your specific problem offers no other hazards that are obvious to your inspector, raw product temperature should stand alone. On the other hand, FSIS has had a problem with companies having a CCP only at receiving or only applying the safe handling label at packaging. I support FSIS' concern that those two options are not sufficient to prevent, reduce or eliminate a hazard, in the absence of the controls.