A product recall is an effective method of removing or correcting violative products that may represent a health hazard to the consumer or user. It is an action taken by a manufacturer, distributor, or importer to carry out their responsibility to protect the public health and well-being.
The 3 classes of recall are:
1. Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
2. Class II is a situation in which the use of, or exposure to, a violative product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote.
3. Class III is a situation in which the use of, or exposure to, a violative product is not likely to cause any adverse health consequences.
Recall Procedure:
1) Recall Notification with Information
a. The name of the recalled product and, where applicable, the identifying model designation, serial number, code, lot number and any other means of identification.
b. The total quantity of the recalled product originally in his possession.
c. The total quantity of the recalled product that had been distributed up to the time of the recall.
d. Area of the distribution of the recalled product by province and, if exported, by country.
e. The quantity of the recalled product still in his possession.
f. The reason for initiating the recall.
2) Health Hazard Evaluation and Recall Classification.
Before initiating a recall, the firm will normally gather, correlate and evaluate all known information on the nature and extent of the reputed health risk.
The following factors will be taken into factor before a recall is being carried out:
a. Whether any disease or injuries have already occurred from the use of the product.
b. Assessment of hazard to various segments of the population, e.g., children, surgical patients, etc., who are expected to be exposed to the product being considered, with particular attention paid to the hazard to those individuals who may be at greatest risk.
c. Assessment of the degree of seriousness of the health hazard to which the population at risk would be exposed.
d. Assessment of the likelihood of occurrence of the hazard.
e. Assessment of the consequences (immediate or long-range) of occurrence of the hazard.
3) Recall Strategy
A recall strategy that takes into account the following factors will be developed by the recalling firm to suit the individual circumstances of the particular recall:
a. Results of health hazard evaluation.
b. Ease in identifying the product.
c. Degree to which the product's deficiency is obvious to the consumer or user.
d.Degree to which the product remains unused in the marketplace.
e. Continued availability of essential products.
4) Elements of Recall Strategy
a. Depth of recall - Depending on the product's degree of hazard and extent of distribution, the recall strategy will specify the level in the distribution chain to which the recall is to extend, as follows:
- Consumer or user level, which may vary with product, including any intermediate wholesale or retail level; or
- Retail level, including any intermediate wholesale level; or
- Wholesale level.
b. Recall Communications
b.1 Generic
A recalling firm is responsible for promptly notifying each of its affected accounts about the recall. The format, content, and extent of a recall communication should be commensurate with the hazard of the product being recalled and the strategy developed for that recall. In general terms, the purpose of a recall communication is to convey:
i) That the product in question is subject to a recall;
ii) That further distribution or use of any remaining product should cease immediately;
iii) Where applicable and required as part of the recall strategy, that the direct account should in turn notify its accounts that received the product about the recall;
iv)Instructions regarding what to do with the product.
b.2 Implementation and Labelling
As determined by the recall strategy, a recall communication can be accomplished by telephone, telex, telegrams, or special delivery letters conspicuously marked, preferably in bold red type, on the letter and envelope: "DRUG (or FOOD, BIOLOGIC, etc.) RECALL". The letter and the envelope should also be marked: "URGENT" for Class I and Class II recalls. Telephone calls or other personal contacts should ordinarily be confirmed by one of the other above methods and/or documented in an appropriate manner.
b.3 Content
A recall communication should be written in accordance with the following guidelines:
i) Be brief and to the point;
ii) Identify clearly the product, size, lot number(s), code(s), or serial number(s) and any other pertinent descriptive information to enable accurate and immediate identification of the product;
iii) Explain concisely the reason for the recall and the hazard involved;
iv) Provide specific instructions on what should be done with respect to the recalled products; and
v) Provide a ready means for the recipient of the communication to report to the recalling firm whether it has any of the product, e.g., by allowing the recipient to place a collect call to the recalling firm.
The recall communication should not contain irrelevant qualifications, promotional materials, or any other statement that may detract from the message. Where necessary, follow-up communications should be sent to those who fail to respond to the initial recall communication.
b.4 Responsibility of Receipient of the Recall being communicated.
Consignees that receive a recall communication should immediately carry out the instructions set forth by the recalling firm and, where necessary, extend the recall to its consignees in accordance with paragraphs (b.3) and (b.4) of this section.
c. Public Warning - The purpose of a public warning is to alert the public that a product being recalled presents a serious hazard to health. It is reserved for urgent situations (Class I and occasionally Class II Recalls) where other means for preventing use of the recalled product appear inadequate. The Assistant Deputy Minister decides whether a public recall announcement is mandatory and whether the Health Protection Branch will issue the warning.
The recall strategy will specify the type of public warning, for example:
i) General public warning through the general news media, either national or local as appropriate, or
ii) Public warning through specialized news media, e.g., professional, trade or ethnic press, or to specific segments of the population such as physicians, hospitals, etc.
d. Effectiveness checks - The purpose of effectiveness checks is to verify that all consignees at the recall depth specified by the strategy have received notification about the recall and have taken appropriate action. The method for contacting consignees may be accomplished by personal visits, telephone calls, letters, or a combination thereof. The recalling firm is responsible for conducting effectiveness checks. The firm's recall strategy will specify the method(s) to be used for and the level of effectiveness checks that will be conducted by the recalling firm as follows.
Level A - 100 percent of the total number of consignees to be contacted;
Level B - Some percentage of the total number of consignees to be contacted, which percentage is to be determined on a case-by-case basis, but is greater than 10 percent and less than 100 percent of the total number of consignees
Level C - 10 percent or less of the total number of consignees to be contacted, which percentage is to be determined on a case-by-case basis; or
Level D - No effectiveness checks.
Food Recall research materials from:
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/recall_proc-marche_retrait-eng.php
http://books.google.com.sg/books?id=pk6Cjm5cYyMC&pg=PA117&lpg=PA117&dq=Product+Food+Recall+Procedure&source=web&ots=LweULE5lhx&sig=ffrbhobnD7ZYDqPgFc5is-0g9Pc&hl=en&sa=X&oi=book_result&resnum=4&ct=result
http://www.nzfsa.govt.nz/animalproducts/seafood/guidelines/listeria/lsteri19.htm
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Hazard Analysis Critical Control Point (HACCP) is a tool used and implemented in various kind of industries that offers risk and management system. HACCP can be establish with the use of the 7 principles of HACCP.
7 Principles of HACCP
The seven principles of HACCP have been universally accepted by government agencies, trade associations and the food industry around the world:
1. Analyze hazards. Potential hazards associated with a food and measures to control those hazards are identified. The hazard could be biological, such as a microbe; chemical, such as a toxin; or physical, such as ground glass or metal fragments.
2. Identify critical control points. These are points in a food's production--from its raw state through processing and shipping to consumption by the consumer--at which the potential hazard can be controlled or eliminated. Examples are cooking, cooling, packaging, and metal detection.
3. Establish preventive measures with critical limits for each control point. For a cooked food, for example, this might include setting the minimum cooking temperature and time required to ensure the elimination of any harmful microbes.
4. Establish procedures to monitor the critical control points. Such procedures might include determining how and by whom cooking time and temperature should be monitored.
5. Establish corrective actions to be taken when monitoring shows that a critical limit has not been met--for example, reprocessing or disposing of food if the minimum cooking temperature is not met.
6. Establish procedures to verify that the system is working properly--for example, testing time-and-temperature recording devices to verify that a cooking unit is working properly.
7. Establish effective recordkeeping to document the HACCP system. This would include records of hazards and their control methods, the monitoring of safety requirements and action taken to correct potential problems. Each of these principles must be backed by sound scientific knowledge: for example, published microbiological studies on time and temperature factors for controlling foodborne pathogens.
7 Principles of HACCP are from http://www.afdo.org/afdo/HACCP/Seven-HACCP-Principles.cfm
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Throughout package 1, the use of the principles 1 to 6 should be reflected in out HACCP template and documents.
Application of Principles 1 to 6 into the package.
1. Analyze hazards. Potential hazards associated with a food and measures to control those hazards are identified.
An example extracted from our HACCP.
In the Hazard Analysis table above, the listing of hazard at every process steps (#) are being mentioned, together with the type of hazard, whether chemical, biological or pysical. A hazard number is also given for identification purposes (H#)
With this, Principle 1 has been fulfilled.
2. Identify critical control points. These are points in a food's production--from its raw state through processing and shipping to consumption by the consumer--at which the potential hazard can be controlled or eliminated.
In the CCP Decision Tree above, by answering Questions 1 to 5, we are able to tell whether or not the process is a CCP. For example in our product process flow, Process 3 which is Sifting of Raw Ingredients is a CCP because there will NOT be a subsequent step or action eliminate or reduce the hazard to an acceptable level.
Hence, Principle 2 have been fulfilled.
3. Establish preventive measures with critical limits for each control point.
On the critical limits spreadsheet, we state the critical limits for each identified CCP together with a monitoring procedure to prevent any risk from occuring.
Now, principle 3 have been achived.
4. Establish procedures to monitor the critical control points.
The corrective action table established will prevent deviation and the resposibility of process owners are stated for each CCP named.
Thus, Principle 4 is met.
5. Establish corrective actions to be taken when monitoring shows that a critical limit has not been met.
Principle 5 is met. Referring to the picture on Principle 4, a corrective action has been establish. This procedure will be use if deviation occurs from the process step.
6. Establish procedures to verify that the system is working properly--for example, testing time-and-temperature recording devices to verify that a cooking unit is working properly.
Since this is just a project and we are not actually going to verify whether process system is working or not, so another alternative is to come up with a control procedure whereby what test/quality checks to be done with stated frequency.
With these evidences, Principles 1 to 6 has been met.
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