2013-08-25 00:09:57Ame.

Food Safety Management Systems II assignment.

Food Safety Management Systems II

A shrimp manufacturer has been notified by their accredited contract laboratory that the level of Enterobacteriaceae present in their final products has increased. Trend analysis of the finished product data shows an increase from less than 102 cfu/g to 104 cfu/g over a period of four weeks.



The reason why food safety management system has been designed, is not only for monitoring the food industry to reach operating standards (so that all food production industry to follow certain production pathway). We all understand that the most important thing in the food safety surveillance is aimed for the ultimate goal “safe food, better business”. If something goes wrong in the food product line, the HACCP plan or HACCP-based guidelines can be helpful.


For there are various kinds of food products, different hazard plans for different food process. Even though the formulas of the hazard plans are similar to each other; it still emphasizes that one hazard plan corresponds to one product line. For example, the processes of some kinds of fishery products are similar, there still several processing steps (such as sterilizing temperature, packaging and storage temperature), and their shelf-life standards may not be exactly the same; due to these small differences can derive more variations. So that’s why it is better suggested to have one specific HACCP-based plan to one unique product line, it will help decrease the number of control points and make the process smooth and safe.


Since there was little information provided from the shrimp plant, enclosed with the blue plan and the data: “the raw material is frozen raw prawns, sourced from an approved supplier. The raw material specification demands levels of 100 Enterobacteriaceae or below”. With regard to the information, the hypothesis of contamination by the raw material is omitted. According to the information provided by the factory and the laboratory, the prerequisite programs and ssop are not suitable to apply into this situation.


Investigating the source and reason for increase in the levels of Enterobacteriaceae:

Base upon the information provided from the accredited laboratory of the shrimp plant, also, with reference to HACCP: Hazard Analysis and Critical Control Point Training Curriculum Trainer’s Guide & CA/RCP 1-1969, Rev.4-2003. There are 8 aspects for the Seafood and fishery product CCP (which HACCP as a basis for); it’s useful to start investigation in these 8 items. When these 8 items are not handled properly, then food problems occur. Here are the 8 items which need to be considered in the food plant:

1. Water safety (water source and protection from contamination by cross connections).

2. Condition and cleanliness of food contact surfaces are acceptable.

3. Prevention of cross contamination (includes training, employee practices and facility).

4. Maintenance of hand washing, sanitation and toilet facilities.

5. Protection of food, food packaging and food contact surfaces from adulteration.

6. Labeling, storage and use of toxic compounds.

7. Employee health.

8. Pest control.


Though the points above are useful, they can help finding the problem in the product line that ruins the final product. But, after studied the blue plan of the plant, there are more doubts have been found.


Identifying the possible source for the contamination:

In order to find out the main cause of the increasing bacteria (Enterobacteriaceae) level, review the work flow of the shrimp processing should be needed. From the FDA website, relevant information (including guidelines, work forms and hazard plans etc.) of fishery processing is listed for people in the industry to reference. In this step, it is recommended to have the plant checked by the third party specifications (Inspectors from government officials, or certified system investigators). Since the check was done by other professionals, they can discover the problems easier and they can find out some parts that the plant staffs have neglected.


The first thing we need to know is the common progress of ready-to-eat shrimp production. The trainer’s guide from the Seafood HACCP Alliance for Education and Training has given an example for the common progress of the cooked shrimp product:


Due to the work flow of the shrimp processing, briefly describe the next six steps (thawing, size grader, peeling, razor slide, tumbler/de-veiner, and conveyor/cull table cover) which a rapid automated process designed to convert shell-on shrimp to a peeled and de-veined product form.


Fresh raw shrimp are commonly treated with sulfites to prevent the oxidation of shell pigments from forming a quality defect known as “black spot.” Mention that the ABC Shrimp Co. has quality and inventory control procedures for incoming product plus specific specifications regarding sulfites for frozen shrimp.


From the summary of the shrimp product making process, we may know that probably there is not only one reason for the increasing level of the Enterobacteriaceae, the consequence may be derived from consolidated conditions. It may caused by not totally eliminated the bacterial pathogens and then it takes chance to growth; or decontaminated by other bacteria due to process, and both of these happened during the process. Conditions that can cause the bacterial level increase, such as cooking temperature, cooking time, water, equipment and the plant environment; if more than one part of the process goes wrong, the probably of forming hazards in the end product will be higher.


1.      Cooking / pasteurization temperature

As the first reason, the cooking temperature or the cooking time has not reach the safety level. Though they are less to happen, it still needs to take into account. Mostly the ready-to-eat shrimps are processed by cooking (heat processing) before it was packaged or put into container. And then the products have to be pasteurized. Through the heating process and pasteurization can reduce a large number of the bacterial pathogens, there still remains some resistant pathogenic bacteria than cannot be eliminated through high temperature heating. As it was shown in the factory plan, two cooking boilers were found. Besides these, no other heating equipment or sterilization device (such as UV light room for sterilization or other cold sterilization equipment) were found in the factory plan.


So what is the adequate cooking temperature and time for the shrimp that can kill most of the bacteria but will not affect the taste and the texture of the shrimp? A study about the quality management programme based on HACCP in cooked shrimp processing plant in Vietnam(2001), researcher has listed out different temperature of cooking the shrimp will take different amount of time for killing the bacteria.


2.      Water that use in the making process

Water safety is also an important part to the process. Whatever the water is added as ingredient or using as an agent during the process (for rinsing or cooling use), water still has a direct contact to the food product. So if the quality of the water is not suitable for food processing, or contaminated with some toxins or bacteria, will be cross-contaminate to the food.


Suppose that may be the water for washing and cooling process that contains the Enterobacteriaceae. Since the Enterobacteriaceae is killed due to the high temperature cooking, while using the cooling/ washing water that is not fit for the HACCP guideline level. If the water contacts the food directly which contains the Enterobacteriaceae may contaminate the food. The salmonella is not affected by freezing among those Enterobacteriaceae (but the activity of E.coli will be reduced). And one thing is that, there is no UV light room shown on the blueprint, it may be reckoned that they did not use the UV light sterilization in the production process. Thus, the probability that the shrimp is contaminated by the salmonella is higher.


Water can be treated as a “food ingredient/ agent” in the food processing. In the A Technical Guide to Food Hygiene provided by Macao Health Bureau, the guideline suggested that if the water or ice being used in the food processing or having direct contact with the food surface in food industries or other food processing place, both the quality of water and ice should conform to relative regulations stated in the Regulations on Water Supply and Drainage of Macao. That means the quality of water is safe for people to drink.


The microbiological and quality criteria for water that used in seafood processing:

In accordance with FDA's Good Manufacturing Practices (GMP) regulations, 21CFR Part 110, all food process water must be safe and suitable for its intended use. (Part 110.37(a) Facilities, Water Supply: "The water supply shall be sufficient for the operations intended and shall be derived from an adequate source." Part 110.80, (a)(1) Processes and Controls, Raw materials and other ingredients: "...Water used for washing, rinsing, or conveying food shall be safe and of adequate sanitary quality....")

In certain situations, "safe and suitable" water may be water that is not of potable water quality but is known to be sanitary and to pose no risk of chemical or biological contamination to the food product. Any processor using such water, however, must be able to demonstrate that the water is safe and suitable for the use.


3.      Condition, cleanliness and function of the equipment and machines :

For the equipment and the machines, since they will contact the food directly. Those will be discussed in three parts. In the washing/ cooling and grading/ peeling processes; those utensils and equipment should be always keep clean and sterilized after use; if they have been contaminated by the Enterobacteriaceae, it will cause the cross-contamination. And in the packing part, the most likely to spread bacteria is a packaging machine.


The problem may be occurred in the freezer, when dealing with the large batches of food in process, the equipment is needed to fulfill the condition of cleanliness. If the freezer is not always cleaned and checked whether there is ice cube or other foreign objects hide in the freezer, and that can become a good hiding place for the bacteria; also the foreign bodies may affect the airflow distribution inside the freezer and then the cooling effect was affected. Besides, if the flat packs of shrimp are not cut in the same size or cut in different thickness, (as it was shown in the fig) the packs will have a poor contact with the freezer plate (either too thick to touch the freezing plate or too thin to make a gap with the freezer plate); and the food packs are not freezing evenly and thoroughly. All the reasons will lead to not freezing probably of the product and contamination of bacteria.


4.      Distance between freezers and plant room

The forth reason may cause the increasing of the bacteria is the freezers are too close to the plant room, as the plant room produces lot of heat, the one of the entrance is facing  the space between the two freezers. Heat spreads through convection and radiation may also affect the freezing process of the food product and giving the chance for the bacteria to growth.


5.      Package material and method of the product

The product may be using the modified atmosphere (MAP) and vacuum packing (for the picture of the end product was shown in the question). The picture was obviously shown that the product was not totally vacuumed. Also, it the blue plan we cannot be clearly told that what kind of packing machine was used in the factory. So we can consider and guess form the package that the food product may be using the MAP packing.

The package of the product includes the PE (polyethylene) trays and the PE films. No information of leakage was found in the question. And that can be considered as PRPs of the process. Thus, the main reason of the increasing level of Enterobacteriaceae may not relevant to this.


6.      Maintenance of hand washing, sanitation and toilet facilities, Prevention of cross contamination (includes training, employee practices and facility)

Even these are the minor ones that are always neglected. Personal hygiene, the sanitation of toilets is important control point in the hazard control plans. Keep the notices of “flushing after use”; “wash your hands” can alert staffs to do so. Conduct workshops regularly so as to educate the staffs that the importance of hygiene; standardize operation practice are the main points of safe processing.


7.      Employee health.

The staff health is similar to the personal hygiene. If a staff carries infectious bacteria (the staff becomes a vehicle of transmission), not only contaminated food in the processes, that will let bacteria transmitted to the consumers through the medium of food product, and resulting in foodborne illness or food poisoning.


8.      Pest control:

Pest is also a common vehicle of bacteria and virus. Always keep the food plant free of pest is very important. 


Combining all of the conditions above and evaluating of them, the most possible to cause the increase level of Enterobacteriaceae among those are the water and the freezer. Because the increase of bacteria level was latest occurred issue, not happened in the former products; so we can infer that there may be something goes wrong in the water source; and secondly, since the freezers are early placed near the plant room, the cooling effect has been affected by the heat released from the plant room early in the beginning.


In order to anticipate implementing and managing, controls will be taken as follow:

Using the logic of the CCP decision tree, the condition of water, i.e. the bacteria levels of the water can be refined to an acceptable level; and the freezing temperature of the freezer. The probability of the hazards can be decreased by regulating these two conditions; so definitely they were the critical control points (CCPs). These conditions can be improved by human, coordinate with periodic testing data; the situation of the product line can be well monitored.


Cold storage of the product

Though we suspect that the freezing process was altered by the heat from the plan room, we should remind that the recommended temperature for cold storage of fish and fish products in the UK is -30°C and this temperature has also been adopted throughout Europe. The recommended temperature of FAO is more flexible, due to the size, time and the species of the fishery product.


And The International Institute of Refrigeration recommends a storage temperature of -18°C for lean fish such as cod and haddock and -24°C for fatty species such as herring and mackerel. The code also recommends that for lean fish intended to be kept in cold storage for over a year, the storage temperature should be -30°C. For their storage life can be longer with the storage temperature lower than -30°C.


From the following table from FAO, it shows that the cooked/peeled shrimp can be store from - 18°C to - 30°C, depends on how long will the manufactures sell out their products or distribute to wholesalers.  


To solve the problem of poor ventilation and heats comes out from the engine room, it is suggested to cover some Insulating materials outside the plant room, and convert exit to a bit far away from the freezers, so that the heat from the plant room are not easily to affect the freezing process through convection and radiation. Install several exhaust fans and louvers in the engine room, which will also improve releasing the heat to another side so not to affect the temperature of the cold storage.


Table 16 Practical storage lives (PLS) of fish products


Storage life in months


- 18°C

- 24°C

- 30°C

Fatty fish (glazed)



> 12

Lean fish (fillet)







> 24

Shrimp (cooked/peeled)





Review the efficacy of control systems

Though the water is not the main ingredient of the food product, the water is a media which has direct contact with the food; it should be focus on the water safety as it was basically consider in the HACCP plan, if it was sure that something went wrong in the water, use the ISO2000 to standardize.


DATA and records, which can reflect the result of the efficacy of the control

Monitoring the records is important, it can be easily to know the products were last produced has exceeded the critical limit or not. Always the records show out the clues of the deviations. Make both the critical limit deviation and corrective action to be documented. These steps are useful for adopting solutions and referencing when similar situation occurs. The establishment of critical limits is one of the most important steps of the HACCP principles.


Enforcement of the critical control points of the product

The flaws of the product occurred due to the human negligence. But the error was discovered by the monitoring system (the accredited contract laboratory of the food factory). So in this situation, strengthen the testing of the critical limits is the modifying action to the CCP (bacteria level in the water). Thus, as mentioned above, the ISO2000 water standard can fully cover the control point of water safety. If the budget of regulating the quality of the process is not much, then try to change to use the drinkable water throughout the process.


Establish a recordkeeping system.

According to the Fish and Fishery Products Hazards and Controls Guidance, fishery industries are recommended to keep records as it was necessary. It is important to document the monitoring of the critical factors of the brining or pickling process, as established by a study (e.g., a processing record showing the results of the brine or acid strength and temperature, brine or acid to fish ratio, size and species of fish, time of brining or pickling); or record of determinations of the finished product water phase salt, pH, or water activity.


Besides, it’s important to remember that all corrective action records shall include the following:

-              Product identification (e.g., product description, amount of product on hold).

-              Description of the critical limit deviation.

-              Corrective action taken and final disposition of the affected product. This is a critical learning objective. Take the time to make sure students understand proper disposition of suspect product. This is a teachable moment and good time to encourage class participation.

-              Date and time of the correction.

-              Signature or initials of the individual responsible for taking the corrective action.


The advantage if using Corrective action procedures is that it can ensure that unsafe product does not reach the end user and the problem that caused the critical limit deviation is corrected.


Enforcement of the prerequisite programs such as the SSOP (Sanitation Standard Operating Procedures) After all, the prerequisite programs can be introduced into the process again for a new evaluation and development of critical control points.



When monitoring shows that a critical limit deviation has occurred, corrective actions should be taken for both short term and long term fixes for process deviations. Reference to the effect of the operating procedures of the HACCP relatively perfect, even if the production line is a problem in a timely manner according to the guidelines to identify the problems, safe practice guidelines to solve the situation, In addition, the industry training is also an important part of the surveillance programme. From the study of S Suwanrangsi (2000), concluded the implementation of a HACCP-based system and compliance with HACCP-based regulations can help improve the product safety level, decrease in total quality costs and increase in product quality. It still a long road to regulate all the food enterprises with HACCP-based system and HACCP audit, as the writer said those are essential management functions in modern context of the fishery and other kinds of food industries.



COLD STORES. (1994) Freezing and refrigerated storage in fisheries  FAO Corporate Document Repository.

Available at: http://www.fao.org/docrep/003/V3630E/v3630e08.htm


FDA - Seafood HACCP -Including Fish and Fishery Products Hazards and Controls Guidance and FDA's Evaluation of the Seafood HACCP Program 2004/2005

Available at: http://www.fda.gov/food/foodsafety/hazardanalysiscriticalcontrolpointshaccp/default.htm



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Available at: http://www.fao.org/docrep/003/T1768E/T1768E03.htm


Sirilak Suwanrangsi (2000). HACCP implementation in the Thai fisheries industry. Fish Inspection and Quality Control Division, Department of Fisheries, Bangkok, Thailand.

Available at:  http://www.thaiscience.info/Article%20for%20ThaiScience/Article/1/Ts-1%20haccp%20implementation%20in%20the%20thai%20fisheries%20industry.pdf