United States 

Department of

Agriculture 

Food Safety 

and Inspection 

Service 

May 1999 

HACCP-8 

Generic HACCP 

Model for 

Irradiated, Raw 

Meat and 

Poultry

Products 
Additional copies of the Guidebook for the Preparation

of HACCP Plans and the Generic HACCP Models are

available from:

U.S. Department of Agriculture

Food Safety and Inspection Service (FSIS)

Office of Policy, Program Development, 

and Evaluation (OPPDE) 

Inspection Systems Development Division 

Room 202, Cotton Annex Building 

300 12th Street SW 

Washington, D.C. 20250-3700 

Phone: (202) 720-3219 

Fax: (202) 690-0824 

This material is also available on the FSIS Homepage: 

http://www.fsis.usda.gov/index.htm 
United States Food Safety Washington, D.C. 

Department of and Inspection 20250 

Agriculture Service 

September 8, 1999 

TO THE USERS OF THESE VOLUMES 

As some of you may know, the Food Safety and Inspection Service (FSIS) received a substantial 

package of comments on its Guidebook for Hazard Analysis and Critical Control Point 

(HACCP) Plan Development and the 13 Generic HACCP models, from a coalition of industry 

and trade associations. This package represents a large and thoughtful effort on the part of these 

organizations. FSIS intends to give it the careful attention and response that it deserves. 

The comments included many technical suggestions for improvements in the FSIS documents. It 

also included reiteration of longstanding differing policy viewpoints that have been frequently 

discussed by the Agency and the regulated industry. For the first time, the comments revealed 

substantially differing expectations on the part of these organizations and FSIS with respect to 

the purpose of the FSIS documents and their intended use. We want to address some aspects of 

this latter point. 

When the Pathogen Reduction/Hazard Analysis and Critical Control Point systems (PR/HACCP) 

final regulation was published on July 25, 1996, the DRAFT Guidebook was included as an 

appendix. The Generic Models, developed for FSIS under contract, were available shortly 

thereafter in April 1997. It was probably inevitable that there were significant differences 

between the final regulatory language of CFR Part 417 and the DRAFT Generic Models as they 

were developed independently. It would have been inappropriate for FSIS to discuss its final 

regulatory language with any outside group. The contractor was appropriately proceeding from 

what it knew best, the National Advisory Committee on Microbiological Criteria for Foods 

(NACMCF) documents on the subject of HACCP. Therefore, FSIS accepted that work product 

with full knowledge that significant revisions would be necessary. 

As time passed, FSIS managers became increasingly uncomfortable with the situation in which 

its major technical assistance documents did not appropriately and completely inform the 

regulated industry of Agency expectations regarding regulatory compliance. Because the 

intended audience for these technical assistance materials was primarily the very small 

establishments, which the Agency believed to have the least HACCP-experience, the Agency 

began the systematic revision of the documents to overcome this problem. We targeted the 

summer of 1999 as the completion date for this effort. 

FSIS now believes that others had very different ideas about the purpose and use of the 

documents than it did. As is consistently reiterated in the documents themselves, they are not 

designed to be used "as is." That is, they cannot be copied and used by an establishment to meet 

all the regulatory requirements of 9 CFR Part 417. Nor were they designed to be the ultimate 

teaching and training materials, as some would suggest. The development of ideal generic 

models is left to others who may have an interest in doing so. The generic models are not 

FSIS Form 2630-9 (6/86) EQUAL OPPORTUNITY IN EMPLOYMENT AND SERVICES 
2 

designed to extend or further interpret existing regulations; rather, they are designed to send the 

user back to the regulations so he/she can become familiar with the requirements as well as the 

flexibility they permit. The generic models are not designed to present new or alternative 

methods of producing and processing meat and poultry products. That is also left to others with 

an interest in doing so. 

FSIS envisioned that the generic models might be used in the following way: Suppose a HACCP 

team leader of a three-person HACCP team in a very small establishment attended a training 

course, but the others on his/her team were not able to do so. Suppose the HACCP training 

course met all the requirements of 417.7 but did not provide participants with much in the way of 

"take away materials" like workbooks, practical questions and answers, access to follow-up 

resources, etc., which the Research Triangle Institute (RTI) needs assessment indicated were so 

important to these establishments. The trained HACCP team leader returns to the establishment 

and begins the process of attempting to develop HACCP plans for the company's products and 

processes. He/she is quite confident that he/she has grasped the material presented in the training 

course and begins to work with this team immediately, while the concepts are fresh in his/her 

mind. 

First, he/she has the rest of the team review the Canadian video and the Guidebook from FSIS so 

that all members of his team have a basic level of information. 

The team members begin their work, and as they proceed, some questions arise as to whether 

what they have developed is appropriate. This is the point when FSIS expects the team to pick up 

the appropriate generic model and get a sense of whether they are on the right track. They should 

be able to determine whether the forms that they have developed, while different from the 

various ones in the generic models and not the same as what other companies use, are acceptable 

because they include the required information. They will also be able to discover what are some 

typical food safety hazards that are reasonably likely to occur, as explicitly defined in 417.2, and 

how to think through the problems that these hazards represent for their own products. They can 

see how critical limits might arise from existing regulatory requirements like the ones for rapid 

chilling of poultry products. They can also see that in the absence of settled regulatory 

requirements, there may be several sources of scientific expertise, and they can choose to make a 

conservative decision to provide a good margin of safety. They can find out the essential 

differences between monitoring and verification and have a basis for making their choices about 

verification activities and their frequencies. FSIS believes that these are useful, beneficial and 

worthwhile functions for which its generic models can be used. 

FSIS is publishing these updated revisions of the generic models, beginning with the Guidebook 

and the Generic Model for Raw, Ground Product, because a large backlog of requests exists for 

these two documents. FSIS intends to publish revisions of all the generic models no later than 

September 30, 1999. Moreover, as a result of public consultation, it may publish an additional 

revision of some of these models, but given the backlog and the impending HACCP 

implementation date, we considered it important to get a version of these documents out now. 

We hope that these documents are helpful. 
Irradiated, Raw Model 

Table of Contents 

Introduction............................................................................................ 3

Using This Generic Model........................................................................... 5

Process Flow Diagram and Product Description.................................................. 7

Hazard Analysis....................................................................................... 8

Developing Your HACCP Plan...................................................................... 10

Identifying CCPs...................................................................................... 12

Appendix A 

References for all HACCP Model Teams................................................ 19

References for Irradiated, Raw Meat and Poultry Products............................ 21

Appendix B 

Process Flow Diagram (Figure 1).......................................................... 25

Product Description Form (Figure 2)...................................................... 26

Hazard Analysis Form (Figure 3).......................................................... 27

HACCP Plan Form (Figure 4).............................................................. 32

Form letter requesting Salmonella data (1)............................................... 37

Form letter requesting Salmonella data (2)................................................ 38

Generic Establishment X: Product Temperature Log ................................... 39

Generic Establishment X: Room Temperature Log...................................... 40

Thermometer Calibration Log............................................................... 41

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Irradiated, Raw Model 

Generic Establishment X: Irradiation/Dose Mapping Log ............................. 42

Corrective Actions Log...................................................................... 43

Pre-Shipment Review Log.................................................................. 44

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GENERIC HACCP MODEL 

FOR 

IRRADIATED, RAW MEAT AND POULTRY PRODUCTS 

Introduction 

The Hazard Analysis Critical Control Point (HACCP) system is a scientific approach to process 

control. It is designed to prevent the occurrence of problems by assuring that controls are 

applied at any point in a food production system where hazardous or critical situations could 

occur. Hazards include biological, chemical, or physical contamination of food products. 

The Food Safety and Inspection Service (FSIS) published a final rule in July 1996 mandating 

that HACCP be implemented as the system of process control in all inspected meat and poultry 

plants. As part of its efforts to assist establishments in the preparation of plant-specific HACCP 

plans, FSIS determined that a generic model for each process defined in the regulation would be 

made available for use on a voluntary basis by inspected establishments. 

The generic models have been revised since their initial publication and distribution as 

DRAFTS. The most important change in the revised versions is to make certain that these 

models are fully consistent with the features of the final regulation. Also, other technical and 

editorial improvements have been made. 

Throughout this generic model, FSIS discusses a HACCP team, with members from different 

departments. In many very small establishments, there will not be separate departments with 

different employees. But there will be employees who perform these different functions – often 

several of them. For purposes of explaining concepts, it is easier to speak as if these were 

different people, even though in many cases, they may be the same person carrying out more 

than one responsibility. 

Each generic model can be used as a starting point for the development of plant-specific plan(s) 

reflecting actual plant environments and the processes conducted. The generic model is not 

intended to be used “as is” for plant specific HACCP plans. 

The generic models are designed for use in conjunction with the list of process categories found 

in the HACCP regulations in section 417.2(b)(1). 

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Irradiated, Raw Model 

(b) The HACCP plan. (1) Every establishment shall develop and implement a written 

HACCP plan covering each product produced by that establishment whenever a hazard 

analysis reveals one or more food safety hazards that are reasonably likely to occur, 

based on the hazard analysis conducted in accordance with paragraph (a) of this 

section, including products in the following processing categories: 

(i) Slaughter--all species. 

(ii) Raw product--ground. 

(iii) Raw product--not ground. 

(iv) Thermally processed--commercially sterile. 

(v) Not heat treated--shelf stable. 

(vi) Heat treated--shelf stable. 

(vii) Fully cooked--not shelf stable. 

(viii) Heat treated but not fully cooked--not shelf stable. 

(ix) Product with secondary inhibitors--not shelf stable. 

This generic model is designed for use with the process subcategory: Irradiated, raw product. 

The purpose of the process category listing in 417.2 is to set out the circumstances under which a 

HACCP team may develop a single HACCP plan for multiple products. This may be done when 

products are in the same process category, and food safety hazards, critical control points, and 

other features are essentially the same. There is a generic model for each process category, plus 

two for subcategories that present special issues: irradiated products and mechanically separated 

products. 

In order to select the model or models that will be most useful for the activities performed in any 

specific plant, the following steps should be taken: 

1) For slaughtering operations, select the model for the appropriate species. 

2) For processed products, make a list of all products produced in the plant. 

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Irradiated, Raw Model 

3) Examine the list and group like products, considering common processing steps and 

equipment used. 

4) Compare the grouped products with the list of processes in the regulations; this step should 

reveal how many and which of the generic models might be useful. 

Deciding on a generic model and which products can be covered by a single plan is an important 

achievement. If the team does it well, it can save a lot of unnecessary effort and paperwork. 

Selecting an inappropriate generic model reduces its potential benefits. However, often the 

HACCP team will discover they have made this error when they develop their process flow 

diagram or during their hazard analysis. These are early stages in the process when it is 

relatively easy to make changes. 

In any case, establishments must meet all regulatory requirements for their products. 

Using This Generic Model 

This generic model is designed to be used by establishments that produce irradiated, raw 

product(s). The model can be used for all irradiated, raw meat and poultry products. 

The model will be most useful to a HACCP team that includes access to one trained individual, 

as specified in 417.7(b). 

(b) The individual performing the functions listed in paragraph (a) of this section shall 

have successfully completed a course of instruction in the application of the seven 

HACCP principles to meat or poultry product processing, including a segment on the 

development of a HACCP plan for a specific product and on record review. 

Since this generic model entails the use of ionizing radiation, at least one team member must be 

trained in quality control, food technology, irradiation processing, and radiation health and 

safety. This team member must have a working knowledge of FSIS regulations on irradiation 

(e.g. 9 CFR 381.135, 381.147, and 381.149 for poultry), and other requirements set forth by the 

FDA, National Regulatory Commission, and the Office of Safety and Health Administration. 

It would be beneficial for other team members to have reviewed any of the various guidance 

materials available on how to develop a HACCP plan for your company, including several useful 

videos, handbooks, or computer programs. Once the HACCP team has prepared itself as 

thoroughly as possible in general HACCP principles and how to use them, this model should be 

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Irradiated, Raw Model 

helpful. 

Note: This generic model includes a number of forms that can be used to record various types of 

required information. The forms themselves are samples; a company HACCP team can develop 

whatever forms it finds most useful. All the forms mentioned in this document are included in 

Appendix B; they appear in the order in which they are discussed in the text. 

All FSIS generic models are designed to assist establishments in applying the seven HACCP 

principles to their meat and poultry processing operations AND to meet the regulatory 

requirements of Part 417. Therefore, the definitions used in this and all other FSIS generic 

models are those found in 417.1: 

§ 417.1 Definitions. 

For purposes of this part, the following definitions shall apply: 

Corrective action. Procedures to be followed when a deviation occurs. 

Critical control point. A point, step, or procedure in a food process at which control can 

be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced 

to acceptable levels. 

Critical limit. The maximum or minimum value to which a physical, biological, or 

chemical hazard must be controlled at a critical control point to prevent, eliminate, or 

reduce to an acceptable level the occurrence of the identified food safety hazard. 

Food safety hazard. Any biological, chemical, or physical property that may cause a 

food to be unsafe for human consumption. 

HACCP System. The HACCP plan in operation, including the HACCP plan itself. 

Hazard. SEE Food Safety Hazard. 

Preventive measure. Physical, chemical, or other means that can be used to control an 

identified food safety hazard. 

Process-monitoring instrument. An instrument or device used to indicate conditions 

during processing at a critical control point. 

Responsible establishment official. The individual with overall authority on-site or a 

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higher level official of the establishment. 

Process Flow Diagram and Product Description 

To begin using this model, the company's HACCP team should first describe the product(s),

which are part of this process category and covered by this HACCP plan. The product(s) should

be described in two ways: 

(1) by a simple diagram which shows the steps the company uses when it produces the product,

and

(2) in a brief written description which provides key facts about the product and its use.

In this generic model, there is an example for irradiated, raw product - fresh poultry. FSIS has

developed certain forms as part of the examples in the generic models; company HACCP teams

are not required to use these forms.

Figure 1 is an example of a PROCESS FLOW DIAGRAM for the production of irradiated

fresh poultry in generic establishment X. Figure 2 is an example of a PRODUCT

DESCRIPTION for the production of irradiated fresh poultry produced by generic

establishment X.

Once the company HACCP team in your establishment has prepared your Process Flow

Diagram, they should verify it by walking through the establishment following the flow of

product and making sure that all the steps of the process are included in the flow diagram. The

team should also review the information provided on the Product Description to make sure all

the key facts are included, such as identifying consumers, especially those with particular health

problems or known to be at risk.

Note: In this generic model, it is assumed that packaged poultry will be transported to another

facility for the irradiation process. If in your process, irradiation is to be done in the same

establishment that the poultry is received and packaged, then the transporting step may be

omitted. That is generally, how you use these generic model examples--just omit the features

which do not apply to your operation, or if your operation includes features not included in this

example, they should be added.

By completing a Process Flow Diagram and a Product Description, you have met the

requirements of 417.2(a)(2). You can use the Process Flow Diagram in particular to help you

complete the rest of the hazard analysis. Use the flow diagram to systematically review each

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Irradiated, Raw Model 

step in the process and ask the question, "Is there a food safety hazard which is reasonably likely 

to occur which may be introduced at this step?" In answering the question, your HACCP team 

needs to consider biological (including microbiological), chemical, and physical hazards. 

Hazard Analysis 

Once your product(s) are accurately described through the flow diagram and product description, 

the HACCP team should begin work on the HAZARD ANALYSIS. The hazard analysis is 

fundamental to developing a good HACCP plan and one that meets regulatory requirements. 

The regulatory requirements for a hazard analysis are found at 417.2(a). 

§ 417.2 Hazard Analysis and HACCP Plan. 

(a) Hazard analysis. (1) Every official establishment shall conduct, or have conducted 

for it, a hazard analysis to determine the food safety hazards reasonably likely to occur 

in the production process and identify the preventive measures the establishment can 

apply to control those hazards. The hazard analysis shall include food safety hazards 

that can occur before, during, and after entry into the establishment. A food safety 

hazard that is reasonably likely to occur is one for which a prudent establishment would 

establish controls because it historically has occurred, or because there is a reasonable 

possibility that it will occur in the particular type of product being processed, in the 

absence of those controls. 

(2) A flow chart describing the steps of each process and product flow in the 

establishment shall be prepared, and the intended use or consumers of the finished 

product shall be identified. 

Generic establishment X, which we are using for our example, is capturing these regulatory 

requirements on a 6-column Hazard Analysis Form (See Figure 3). A good way to use a form 

like this is to create the first column by using the Process Flow Diagram and the second by 

answering the question. Once the HACCP team has considered all the steps in the flow diagram 

and determined if a food safety hazard could be introduced, it needs to consider whether the 

hazard is "reasonably likely to occur", using the meaning of this phrase included in 417.2(a). On 

the 6-column form used by generic establishment X, the third and fourth columns address this 

issue. If the establishment's HACCP team has decided that the hazard is not reasonably likely to 

occur, they enter "No" in column three, explain the basis for their determination in column four, 

and do not need to further consider activity at this point in the process. 

If, however, the team has determined there is a "food safety hazard reasonably likely to occur" 

8
Irradiated, Raw Model 

introduced at a certain point in the process, column five is used to describe a measure which 

could be applied to "prevent, eliminate, or reduce to acceptable levels" the food safety hazard 

identified in column three. 

Look at the entries for “Receiving-Raw Poultry” on the first page of the six column form; the 

HACCP team has determined that Salmonella may be present at high levels in incoming raw 

product, so it has put a “Yes” in the third column. Column four explains the basis for the team’s 

determination. In the fifth column, the HACCP team has described the preventive measures it 

will use to make sure that each hazard has been prevented, eliminated, or reduced to an 

acceptable level. For the Salmonella hazard, the HACCP team decided to tell its suppliers that 

product could not be accepted unless it was accompanied by the most recent Salmonella 

performance standard sampling results which demonstrated that the supplier had not failed two 

consecutive Salmonella performance standard sets. FSIS does not consider safe handling 

instructions on labels alone to be an adequate CCP for any pathogenic microorganisms such as 

bacteria and viruses. 

You will notice that in our generic hazard analysis for irradiated fresh poultry, there are five 

safety hazards in which the HACCP team has identified a point in the process at which a food 

safety hazard is reasonably likely to occur. For each one of these they have identified a measure 

which can be used to control the hazard. 

When your HACCP team has completed their hazard analysis (whether they use this format or 

not), it is a good idea to review the flow diagram, the product description and the hazard analysis 

itself to make sure they are complete. Part 417.2(a)(3) includes a list of sources from which food 

safety hazards might be expected to arise. Reviewing that list could help the HACCP team 

check for completeness. 

Note: If you are using this generic model to produce a different raw irradiated product or if you 

use a different process flow, you may have different hazards which are reasonably likely to 

occur. For these different hazards, there may be different measures that could be used for 

control purposes. 

This, and all other FSIS generic models, contains a list of references which can help your 

HACCP team in making sure the hazard analysis is complete. The references for raw, irradiated 

product are found in Appendix A. A member of your HACCP team might want to review at 

least some of the references to make sure hazards have not been omitted from the hazard 

analysis. 

Completing the hazard analysis is a very significant and important element in developing your 

HACCP system. Your HACCP team should feel a real sense of accomplishment when they get 

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Irradiated, Raw Model 

this far; this is like completing the foundation of a house. 

Developing Your HACCP Plan 

The company HACCP team can now take the materials it developed while doing the hazard 

analysis and use them to build the HACCP Plan. Remember that one of the important 

objectives of the FSIS generic models is to provide examples that illustrate how to meet the 

regulatory requirements of Part 417, as well as to correctly apply the principles of HACCP. 

Part 417.2 (c) and (d) are the regulatory requirements: 

(c) The contents of the HACCP plan. The HACCP plan shall, at a minimum: 

(1) List the food safety hazards identified in accordance with paragraph (a) of this 

section, which must be controlled for each process. 

(2) List the critical control points for each of the identified food safety hazards, 

including, as appropriate: 

(i) Critical control points designed to control food safety hazards that could be 

introduced in the establishment, and 

(ii) Critical control points designed to control food safety hazards introduced outside the 

establishment, including food safety hazards that occur before, during, and after entry 

into the establishment; 

(3) List the critical limits that must be met at each of the critical control points. Critical 

limits shall, at a minimum, be designed to ensure that applicable targets or performance 

standards established by FSIS, and any other requirement set forth in this chapter 

pertaining to the specific process or product, are met; 

(4) List the procedures, and the frequency with which those procedures will be 

performed, that will be used to monitor each of the critical control points to ensure 

compliance with the critical limits; 

(5) Include all corrective actions that have been developed in accordance with §417.3(a) 

of this part, to be followed in response to any deviation from a critical limit at a critical 

control point; and 

(6) Provide for a recordkeeping system that documents the monitoring of the critical 

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control points. The records shall contain the actual values and observations obtained 

during monitoring. 

(7) List the verification procedures, and the frequency with which those procedures will 

be performed, that the establishment will use in accordance with § 417.4 of this part. 

(d) Signing and dating the HACCP plan. (1) The HACCP plan shall be signed and 

dated by the responsible establishment individual. This signature shall signify that the 

establishment accepts and will implement the HACCP plan. 

(2) The HACCP plan shall be dated and signed: 

(i) Upon initial acceptance; 

(ii) Upon any modification; and 

(iii) At least annually, upon reassessment, as required under § 417.4(a)(3) of this part. 

Generic establishment X has prepared its HACCP plan for irradiated fresh poultry on a six 

column form (See Figure 4). You do not need to use this form, although some kind of a form is 

probably the easiest way to present your HACCP plan. 

Identifying CCPs 

The first column on this particular form is used to enter information developed and contained on 

the hazard analysis form. Part 417.2(c)(1) and (2) require that the food safety hazards identified 

in the hazard analysis be listed on the HACCP plan and that there be a CCP for each identified 

hazard. You will notice that there are five points on the hazard analysis form where food safety 

hazards reasonably likely to occur were identified: Salmonella on raw poultry at receiving, 

pathogen proliferation at packaging and labeling, pathogen proliferation at storage 

(cold)/transporting, pathogen survival and/or proliferation after irradiation, and pathogen 

proliferation at finished product storage(cold). 

The establishment HACCP team has chosen to have five CCPs to address these five hazards: 

Salmonella certification, use of approved packaging material for irradiation and clear product 

label features to indicate the product is irradiated, raw, and must be fully cooked, proper 

temperature maintenance during transport and storage, compliance with FSIS/FDA requirements 

for the process of irradiation, and proper temperature maintenance at finished product storage 

(cold). 

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After identifying its CCPs, the HACCP team proceeded to consider critical limits, monitoring

procedures and their frequencies, and verification procedures and their frequencies, and HACCP

records.

In deciding what would be the critical limits, the HACCP team first considered whether there

were any regulatory requirements which had to be met and would function as critical limits. 

The team was aware of regulatory requirements for the packaging material and labeling of

irradiated products as stated in 9 CFR 381.135 and 21 CFR 179.45. For their critical limit, the

HACCP team decided that air permeable packaging material, and a label with features to indicate

a raw, irradiated product has the irradiation logo, the radura, along with the statement “Treated

with radiation” or “Treated by Irradiation”, handling statement, clear cooking instructions, and 

safe handling instructions.

.

The team set the critical limits for the minimum and maximum absorbed dose for irradiation of

poultry as found in 9 CFR 381.147. For developing a HACCP plan for irradiation of pork, the

required absorbed dose will be different.

Once they had decided on their critical limits, they needed to identify how the monitoring

procedures would be carried out and at what frequency. 

The HACCP team decided that receiving personnel check the packaging and labeling materials

for irradiated products at Receiving-packaging materials. At this location, receiving personnel

also routinely check all letters of guarantee and incoming packaging materials to make sure they

met specifications. Since labels are manufactured in large lots by a single company, the

receiving clerks would randomly sample each arriving lot. Some packaging materials do not

have their labels and safe handling instructions printed on them and therefore these need to be

applied to the packaging material later in the process. Monitoring at the packaging and labeling

step ensures that the necessary pressure sensitive sticker labels are applied to the package.

For the CCP on the irradiation process, the HACCP team decided that the production supervisor

would be in the best position to assure that the irradiation unit was functioning properly by

checking the data log printout from the irradiation control board or “process monitoring

instrument” as the product goes through the irradiation process. The irradiation control board

shows all function movement which take place within the irradiation chamber during the

irradiation process. It will indicate whether the unit is functioning properly, and will alert the

operator for any abnormal movements.

These decisions by the HACCP team regarding critical limits, plus monitoring procedures and

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their frequencies are written up in columns two and three of the HACCP Plan. 

The team then went on to consider appropriate verification procedures; the team knew that there 

were different types of verification and that Part 417.4(a)(2) included specific regulatory 

requirements for each. The regulatory requirements for ongoing verification are: 

(2) Ongoing verification activities. Ongoing verification activities include, but are not 

limited to: 

(i) The calibration of process-monitoring instruments; 

(ii) Direct observations of monitoring activities and corrective actions; and 

(iii) The review of records generated and maintained in accordance with § 417.5(a)(3) 

of this part. 

The HACCP team decided that they could verify the raw poultry irradiation step through the 

following procedures and frequency: 

1. QA will verify the irradiation data log printout. 

2. QA will verify the letter of guarantee for calibration of the dosimeter every 12 months. 

3. QA will verify that absorbed doses received by product are within the minimum and 

maximum limits from results of dose mapping. 

The HACCP team described the verification procedures and their frequencies in the fifth column 

of their HACCP plan. 

The HACCP team for generic establishment X knew that their HACCP Plan needed to provide 

for a recordkeeping system. They wanted their records to be easy to create and understand. 

They wanted to be sure their records met regulatory requirements, so they reviewed part 417.5(a) 

and (b): 

§ 417.5 Records. 

(a) The establishment shall maintain the following records documenting the 

establishment's HACCP plan: 

(1) The written hazard analysis prescribed in § 417.2(a) of this part, including all 

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supporting documentation; 

(2) The written HACCP plan, including decision making documents associated with the 

selection and development of CCPs and critical limits, and documents supporting both 

the monitoring and verification procedures selected and the frequency of those 

procedures. 

(3) Records documenting the monitoring of CCPs and their critical limits, including the 

recording of actual times, temperatures, or other quantifiable values, as prescribed in the 

establishment's HACCP plan; the calibration of process-monitoring instruments; 

corrective actions, including all actions taken in response to a deviation; verification 

procedures and results; product code(s), product name or identity, or slaughter 

production lot. Each of these records shall include the date the record was made. 

(b) Each entry on a record maintained under the HACCP plan shall be made at the time 

the specific event occurs and include the date and time recorded, and shall be signed or 

initialed by the establishment employee making the entry. 

The HACCP team decided that their records would be kept on some simple forms, some of 

which the team itself devised. The HACCP team decided that three records were necessary: 

Irradiation Data Log, Irradiation/Dose Mapping Log, and Letter of guarantee for dosimeter 

calibration. 

The forms(logs) were designed to provide spaces for all entries necessary for the monitoring and 

verification activities at the raw poultry irradiation step. 

On its HACCP Plan, generic establishment X has listed the names of the forms it will be using 

for monitoring and verification records. 

There is one other form included in column four, where the establishment has described its 

recordkeeping system. That is the Corrective Actions Log; it is used to create the records of any 

corrective actions taken because of deviations from critical limits at CCPs. Column six 

references the planned corrective actions for each CCP. The HACCP team carefully reviewed 

the regulatory requirements for planned corrective actions, found at 417.3(a): 

§ 417.3 Corrective actions. 

(a) The written HACCP plan shall identify the corrective action to be followed in 

response to a deviation from a critical limit. The HACCP plan shall describe the 

corrective action to be taken, and assign responsibility for taking corrective action, to 

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ensure: 

(1) The cause of the deviation is identified and eliminated; 

(2) The CCP will be under control after the corrective action is taken; 

(3) Measures to prevent recurrence are established; and 

(4) No product that is injurious to health or otherwise adulterated as a result of the 

deviation enters commerce. 

The HACCP team has developed a specific corrective action plan which will be followed 

whenever there is a deviation from a critical limit at a CCP; each of the planned corrective 

actions meets the four regulatory requirements of 417.3(a). 

Planned Corrective Actions for CCP 4: 

1. QA supervisor takes control of and segregates all products processed when the irradiation unit 

was not functioning properly. 

2. QA condemns affected products and dispose according to standard operating procedures. 

3. Certified irradiation maintenance personnel identify problem with the irradiation unit and 

repair it so that the integrity of the unit is restored and the same problem does not recur. 

4. QA implements preventive maintenance checks. 

The HACCP team also develops planned corrective actions for each of the other CCPs and 

attaches them to the HACCP plan. Whenever a deviation from a critical limit occurs, company 

employees follow the corrective action plan and use the Corrective Action Log to create a record 

of their actions. The Corrective Action Log forms are available at CCPs, so they can be used 

immediately when an employee performing a monitoring check discovers and records a 

deviation. All Corrective Action Logs, which have been used during the day, are turned in to the 

HACCP coordinator. 

There is one final verification/recordkeeping requirement which the company must perform; it is 

found at 417.5(c): 

(c) Prior to shipping product, the establishment shall review the records associated with 

the production of that product, documented in accordance with this section, to ensure 

15
Irradiated, Raw Model 

completeness, including the determination that all critical limits were met and, if 

appropriate, corrective actions were taken, including the proper disposition of product. 

Where practicable, this review shall be conducted, dated, and signed by an individual 

who did not produce the record(s), preferably by someone trained in accordance with § 

417.7 of this part, or the responsible establishment official. 

In generic establishment X, product is shipped out, often in small lots, throughout the day. This 

means that pre-shipment verification checks must be as complete as possible when finished 

product is in storage, so that a shipment can be made up quickly and moved into distribution 

channels. 

The establishment uses a half day lotting system and a midshift cleanup. While the midshift 

cleanup is being performed, QA personnel or the HACCP coordinator review results of 

monitoring and verification checks applied to that lot; if there were deviations from critical 

limits, they review the Corrective Action Logs to make sure all appropriate planned responses 

were carried out. If everything is in order and there are complete records showing that the 

establishment has controlled production of this product through its HACCP system, the HACCP 

coordinator will sign the pre-shipment review form which the HACCP team devised for this 

purpose. 

Note: It is not a regulatory requirement that a separate form be used for pre-shipment review; in 

addition, FSIS has indicated that it will be very flexible in accepting a variety of arrangements 

for accomplishing pre-shipment review to reflect the variety of commercial practices which it 

has encountered in the industry. It is, however, important to remember that pre-shipment review 

is a regulatory requirement that must be met, as it indicates that the establishment is taking full 

responsibility for the product having been produced under a well-functioning HACCP system. 

The HACCP team believes it has now completed preparation of the documents which are 

necessary to meet regulatory requirements for a Hazard Analysis and a HACCP Plan for their 

irradiated, raw production process. They have secured a copy of FSIS Directive 5000.1, 

Enforcement of Regulatory Requirements in Establishments Subject to HACCP System 

Requirements, the HACCP Basic Compliance Checklist which will be used by inspection 

program personnel. The HACCP team has modified the inspection form to make the statements 

into positives, and now has a checklist for its own use to make sure they have not omitted 

anything in their plan development and preparation. When they are confident that they have done 

what is necessary, they will turn their Hazard Analysis and HACCP Plan over to the 

establishment owner for decisions about implementation. 

16
Irradiated, Raw Model 

APPENDIX A

17
Irradiated, Raw Model 

References for all HACCP Model Teams 

1. Agriculture Canada. Food Safety Enhancement Program – HACCP Implementation 

Manual. Camelot Drive, Nepean, Ontario, Canada, 1996. 

2. American Meat Institute Foundation. HACCP: The Hazard Analysis and Critical Control 

Point System in the Meat and Poultry Industry. Washington, D.C., 1994. 

Useful sections in particular are: 

Chapter 3 – microbiological hazards, pp. 15-26 

Chapter 4 – chemical hazards, pp. 27-32 

Chapter 5 – physical hazards, pp. 33-35 

Appendix A – NACMCF HACCP 

Appendix C – Model HACCP plans (beef slaughter, roaster beef, ham, chicken 

slaughter, etc.) 

3. Baker, D.A. Application of Modeling in HACCP Plan Development. Int. J. Food Microbiol. 

25:251-261, 1995. 

4. Corlett, D.A., Jr. and R.F. Steir. Risk Assessment Within the HACCP System. Food Control 

2:71-72, 1991. 

5. Council for Agriculture Science and Technology. Risks Associated with Foodborne 

Pathogens. February 1993. 

6. Easter, M.C., et al. The role of HACCP in the management of food safety and quality. J. Soc. 

Dairy Technol. 47:42-43, 1994. 

7. Environmental Protection Agency. Tolerances for Pesticides in Foods. Title 40, Code of 

Federal Regulations, Part 185. U.S. Government Printing Office, Washington, D.C., 1998. 

8. Food and Drug Administration. The Food Defect Action Levels. FDA/CFSAN. Washington, 

D.C., 1998. 

9. Food and Drug Administration Fish and Fishery Products Hazards and Control Guide – Get 

Hooked on Seafood Safety. Office of Seafood. Washington, D.C., 1994. 

18
Irradiated, Raw Model 

10. International Commission on Microbiological Specifications for Foods. HACCP in 

Microbiological Safety and Quality. Blackwell Scientific Publications, Oxford, 1988. 

Useful sections in particular are: 

Chapter 10 – raw meat and poultry, pp. 176-193 

Chapter 11 – roast beef, pp. 234-238 

Chapter 11 – canned ham, pp. 238-242 

11. International Commission on Microbiological Specification for Foods. Microorganisms in 

Foods 4. Application of Hazard Analysis and Critical Control Point (HACCP) Systems to 

Ensure Microbiological Safety and Quality. Blackwell Scientific Publications, Boston, 1989. 

12. National Advisory Committee on Microbiological Criteria for Foods (NACMCF). March 

20, 1992 – Hazard Analysis and Critical Control Point System. Int. J. Food Micr. 16: 1-23, 

1993. 

13. National Advisory Committee on Microbiological Criteria for Foods (NACMCF). June 

1993-Report on Generic HACCP for Raw Beef. Food Microbiol. 10: 449-488, 1994. 

14. National Research Council. An Evaluation of the Role of Microbiological Criteria for Foods 

and Food Ingredients. National Academy Press, Washington, D.C, 1985. 

Useful sections in particular are: 

Chapter 4 – microbiological hazards, pp. 72-103 

Chapter 9 – raw meat, pp. 193-199 

Chapter 9 – processed meats, pp. 199-216 

15. Notermans, S., et al. The HACCP concept: Identification of potentially hazardous 

microorganisms. Food Microbiol. 11:203-214, 1994. 

16. Pearson, M.D. and Dutson, T. Editors. HACCP in Meat. Poultry. and Fish Processing. 

Blackie Academic & Professional. Glasgow, 1995. 

Useful sections in particular are: 

Chapter 4 – meat and poultry slaughter, pp. 58-71 

Chapter 5 – processed meats. pp. 72-107 

Chapter 7 – risk analysis, pp. 134-154 

Chapter 13 – predictive modeling, pp. 330-354 

17. Pierson, M.D. and Corlett, D.A., Jr. Editors. HACCP/Principles and Applications. Van 

19
Irradiated, Raw Model 

Nostrand Reinhold, 1992. 

18. Stevenson, K. E. and Bernard, D. T. Editors. HACCP Establishing Hazard Analysis Critical 

Control Point Programs., A Workshop Manual. The Food Processors Institute, Washington, 

D.C, 1995. 

Useful section in particular is: 

Chapter 11 – forms for hazard analysis, CCP, limits, HACCP master sheet, 

example HACCP for breaded chicken 

19. Tompkin, R.B. The Use of HACCP in the Production of Meat and Poultry Products. J. of 

Food Protect. 53(9): 795-803, 1990. 

20. Tompkin, R.B. The Use of HACCP for Producing and Distributing Processed Meat and 

Poultry Products. In Advances in Meat Research. Volume 10. Hazard Analysis Critical 

Control Point (HACCP) in Meat, Poultry and Seafoods. Chapman & Hall, 1995. 

References for Irradiated, Raw Meat and Poultry Products 

1. American Meat Institute. Palatability, Color, and Shelf life of Low-Dose Irradiated Beef. 

AMI, Washington, DC, 1995. 

2. American Society for Tests and Measures. Standard Guide for Selection and Application 

of Dosimetry Systems for Radiation Processing of Food. In Annual Book of ASTM 

Standards. ASTM. Washington, DC, 12.02: 785-788, 1989. 

3. Clavero, M. Rocelle S. Inactivation of Escherichia coli 0157:H7, Salmonellae, and 

Campylobacter jejuni in Raw Ground Beef by Gamma Irradiation. App. Environ. 

Microbiol. June 1994: 2069-2075, 1994. 

4. Codex. Codex General Standard for Irradiated Foods (Annex 2)(and other sections 

regarding irradiation). In Codex Alimentarius, Vol. XV, 1984. 

5. FDA. Irradiation in the Production, Processing and Handling of Food (Part 179). In 

Code of Federal Regulations. National Archives and Records Administration. 

Washington, DC 21:179.2: 411-415, 1977. 

6. FDA. Irradiation in the Production, Processing and Handling of Food. In Federal 

20
Irradiated, Raw Model 

Register/Rules and Regulations. Food and Drug Administration. Washington, DC, 

55:18538-18533, 1990. 

7. FSIS, USDA. Irradiation of Pork for Control of Trichinella spiralis (Part 318). In 

Federal Register/Rules Regulations. U.S. Department of Agriculture, Washington, DC, 

51:1769-1771, 318.7 p. 257, 1999. 

8. Hashim, I. B., et al. Consumer Attitudes Toward Irradiated Poultry. Food Technol. 

March 1996: 77-80, 1996. 

9. Monk, J. David., et al. Irradiation Inactivation of Listeria monocytogenes and 

Staphylococcus aureus in Low-and High-fat, Frozen and Refrigerated Ground Beef. J. 

Food Protect. 57:969-974, 1994. 

10. Murano, Elsa A. Irradiation of Fresh Meats. Food Technol. December 1995: 52-54, 

1995. 

11. Murano, E. A., Editor. Irradiation Processing (Chapter 1). In Food Irradiation A 

Sourcebook. Iowa State University Press. Ames, IA, 1995. 

12. Patterson, Margaret. Sensitivity of Bacteria to Irradiation of Poultry Meat Under Various 

Atmospheres. Letters in Appl. Microbiol. 7: 55-58, 1988. 

13. Radomyski, Tomasz., et al. Elimination of Pathogens of Significance in Food by Lowdose Irradiation: A Review. J. Food Protect. 57: 73-86, 1994. 

14. Renwick, Stephen P., et al. The RF Linear Accelerator in In-Lear E-Beam Processing of 

Beef and Poultry. Dairy Food Environ. Sanit. 16: 214-221, 1996. 

15. Robeck, Mark R. Product Liability Issues Related to Food Irradiation. Food Technol. 

February 1996: 78-82, 1996. 

16. Rodriguez, H. Ricardo, et al. Low-dose Gamma Irradiation and Refrigeration to Extend 

Shelf Life of Aerobically Packed Fresh Beef Round. J. Food Protect. 56: 505-509, 1993. 

17. Tarte, R. R., et al. Survival and Injury of Listeria monocytogenes. Listeria innocua and 

Listeria ivanovii in Ground Pork Following Electron Beam Irradiation. J. Food Protect. 

59: 596-600, 1996. 

18. Thayer, D. W. Use of Irradiation to Kill Pathogens on Meat and Poultry. J. Food 

21
Irradiated, Raw Model 

Science. 15: 181-192, 1995.

19. Thayer, D. W., et al. Extending Shelf Life of Poultry and Red Meat by Irradiation

Processing. J. Food Protect. 56: 831-833, 1993.

20. Thayer, D. W., et al. Elimination of Escherichia coli 0157:H7 in Meats by Gamma 

Irradiation. Appl. Environ. Microbiol. April 1993: 1030-1034, 1993. 

21. USDA. Irradiation of Poultry Products (Part 381). In Federal Register/Rules and 

Regulation. U.S. Department of Agriculture. Washington, DC 57:43588-43600, 1992. 

22
Irradiated, Raw Model 

APPENDIX B

23
Irradiated, Raw Model 

PROCESS FLOW DIAGRAM Figure 1 

PROCESS CATEGORY: IRRADIATED, RAW PRODUCT 

PRODUCT: FRESH POULTRY 

RECEIVING 

PACKAGING 

MATERIALS 

STORING 

PACKAGING 

MATERIALS 

RECEIVING 

RAW 

POULTRY 

STORAGE 

(COLD)RAW 

POULTRY 

PACKAGING/ 

LABELING 

**Processes separated by dotted line may 

actually occur in separate storage facilities. This 

model considers receiving of fresh raw product 

to distribution; however, product may enter at 

this process step for contract irradiators. 

SHIPPING 

RAW POULTRY 

IRRADIATION 

STORAGE 

(COLD)/ 

TRANSPORTING 

FINISHED 

PRODUCT 

STORAGE 

(COLD) 

24
Irradiated, Raw Model 

PRODUCT DESCRIPTION Figure 2

PROCESS CATEGORY: IRRADIATED, RAW PRODUCT 

PRODUCT: FRESH POULTRY 

1. COMMON NAME? FRESH POULTRY 

2. HOW IS IT TO BE USED? COOKED AND CONSUMED 

3. TYPE OF PACKAGE? BULK-PACK/RESEALABLE 

POUCH OR RETAIL PACKAGE(with 

air permeable and approved packaging 

material for irradiation) 

4. LENGTH OF SHELF LIFE, APPROX. 1-3 WEEKS AT 27-40° F 

AT WHAT TEMPERATURE? 

5. WHERE WILL IT BE SOLD? RETAIL AND HRI, WHOLESALE 

CONSUMERS? GENERAL PUBLIC 

INTENDED USE? 

6. LABELING INSTRUCTIONS? RADURA SIGN, “TREATED WITH 

RADIATION” OR “TREATED BY 

IRRADIATION”; KEEP 

REFRIGERATED ; COOKING 

INSTRUCTIONS; SAFE HANDLING 

INSTRUCTIONS. 

7. IS SPECIAL DISTRIBUTION KEEP REFRIGERATED 

CONTROL NEEDED? 

25

Irradiated, Raw Model 

HAZARD ANALYSIS – IRRADIATED, RAW PRODUCT 

Process Step Food Safety 

Hazard 

Reasonably 

Likely to 

Occur? 

Basis If Yes in Column 3, 

What Measures Could 

be Applied to Prevent, 

Eliminate, or Reduce 

the Hazard to an 

Acceptable Level? 

Receiving – Raw Poultry 

Biological: Pathogens -microbial (Salmonella) 

Yes Salmonella may be 

present on incoming raw product. 

Certification from suppliers that product has been sampled for Salmonella and 

passed standards. 

Chemical – None Physical – Foreign materials 

No Plant records show that 

there has been no incidence of foreign materials in products received into the plant. 

27
Irradiated, Raw Model 

HAZARD ANALYSIS – IRRADIATED, RAW PRODUCT 

Process Step Food Safety 

Hazard 

Reasonably 

Likely to 

Occur? 

Basis If Yes in Column 3, 

What Measures Could 

be Applied to Prevent, 

Eliminate, or Reduce 

the Hazard to an 

Acceptable Level? 

Receiving – Packaging Materials 

Biological – None Chemical – Not acceptable for intended use 

No Letters of guarantee for 

air permeable direct 

food contact packaging material and labels with required features approved for irradiation. 

Physical – Foreign materials (insects, dirt, etc.) 

No Plant records 

demonstrate that foreign material contamination has not occurred during the past several years. 

28
Irradiated, Raw Model 

HAZARD ANALYSIS – IRRADIATED, RAW PRODUCT 

Process Step Food Safety 

Hazard 

Reasonably 

Likely to 

Occur? 

Basis If Yes in Column 3, 

What Measures Could 

be Applied to Prevent, 

Eliminate, or Reduce 

the Hazard to an 

Acceptable Level? 

Storage (Cold)- Raw Poultry 

Biological - Pathogens No Temperature of 

product and storage area will be maintained below a level to prevent pathogen growth. 

Chemical – None Physical – None 

Storage –Packaging Materials 

Biological – None Chemical – None Physical - None 

Packaging/Labeling Biological - Pathogens Yes Improper packaging 

materials and labeling may allow pathogen growth including anaerobes. 

Plant will use approved packaging materials for irradiation. Labels with radura, and required features will clearly indicate an irradiated, raw product. 

Chemical - None Physical - None 

29
Irradiated, Raw Model 

HAZARD ANALYSIS – IRRADIATED, RAW PRODUCT 

Process Step Food Safety 

Hazard 

Reasonably 

Likely to 

Occur? 

Basis If Yes in Column 3, 

What Measures Could 

be Applied to Prevent, 

Eliminate, or Reduce 

the Hazard to an 

Acceptable Level? 

Storage (Cold)/ 

Transporting 

Biological - Pathogens Yes Pathogens are 

reasonably likely to grow in this product if temperature is not maintained at or below a level sufficient to prevent growth. 

Maintain product temperature at or below a level sufficient to prevent pathogen growth. 

Chemical – None Physical – None 

Raw Poultry 

Irradiation 

Biological – Pathogens Yes Improper use of 

irradiation may not reduce/kill pathogens as intended. 

Correct dose range as per FSIS regulation (according to approved treatment protocol in 9 CFR 381.147, 381.149) will be used. 

Chemical- None Physical – None 

30
Irradiated, Raw Model 

HAZARD ANALYSIS – IRRADIATED, RAW PRODUCT 

Process Step Food Safety 

Hazard 

Reasonably 

Likely to 

Occur? 

Basis If Yes in Column 3, 

What Measures Could 

be Applied to Prevent, 

Eliminate, or Reduce 

the Hazard to an 

Acceptable Level? 

Finished Product 

Storage (Cold) 

Biological – Pathogens Yes Pathogens are 

reasonably likely to grow in this product if temperature is not maintained at or below a level to maintain process integrity. 

Maintain product temperature at or below a level sufficient to prevent pathogen growth. 

Chemical – None Physical – None 

Shipping Biological – None 

Chemical – None Physical - None 

31
Irradiated, Raw Model 

HACCP PLAN 

PROCESS CATEGORY: IRRADIATED, RAW PRODUCT PRODUCT EXAMPLE: FRESH POULTRY 

CCP # and 

Location 

Critical 

Limits 

Monitoring 

Procedures and 

Frequency 

HACCP 

Records 

Verification Procedures and 

Frequency 

Corr

1B Receiving – Raw Poultry 

Supplier certification that product has been sampled for Salmonella must accompany shipment. 

Receiving personnel will check each shipment for Salmonella certification. 

Receiving Log Corrective Actions Log 

Every two months QA will request Salmonella testing results from FSIS for at least 2 suppliers. 

Will not receivunaccompaniecertification. 

Signature : _______________________________ Date:___________________________ 

32
Irradiated, Raw Model 

HACCP PLAN 

PROCESS CATEGORY: IRRADIATED, RAW PRODUCT PRODUCT EXAMPLE: FRESH POULTRY 

CCP # and 

Location 

Critical 

Limits 

Monitoring 

Procedures and 

Frequency 

HACCP 

Records 

Verification Procedures and 

Frequency 

Corr

2B Packaging/ Labeling 

Approved packaging material listed in 21 CFR 179.45 and 9 CFR 381.149. Label with radura, “Treated with 

radiation”, or 

“Treated by irradiation” Handling Statement, Cooking Instructions, Safe Handling Instructions. 

Packaging line supervisor will randomly sample 

packages of product once per shift and ensure packaging material and labeling requirements are met. 

Packaging/ Labeling Log Corrective Actions Log 

QA will observe packaging line supervisor perform monitoring activity once per shift. QA will sample labels intended for use from label storage area twice weekly to ensure label accuracy. QA will check labels once a day on packaged product to ensure label accuracy on packaged product. 

QA will segregpackaged and/Follow SOPs fQA will identideviation and p

Signature : _______________________________ Date:___________________________ 

33
Irradiated, Raw Model 

HACCP PLAN 

PROCESS CATEGORY: IRRADIATED, RAW PRODUCT PRODUCT EXAMPLE: FRESH POULTRY 

CCP # and 

Location 

Critical 

Limits 

Monitoring 

Procedures and 

Frequency 

HACCP 

Records 

Verification Procedures and 

Frequency 

Corr

3B Storage (Cold)/Trans porting 

Temperature of product, storage and transport at 27-38° F. 

QA personnel will check raw product temperature every two hours. Maintenance personnel will check storage area temperature every two hours. 

Product Temperature Log Room Temperature Log Thermometer Calibration Log Corrective Actions Log 

QA supervisor will check Product Temperature Log and Room Temperature Log twice per shift. Maintenance supervisor will verify accuracy of the Room Temperature Log once per shift. QA will check all thermometers used for monitoring and verification for accuracy daily and calibrate to within 1° F accuracy as necessary. 

QA will reject temperature is time and tempestandard operaproduct disposQA and mainteidentify the cauprevent reoccu

Signature : ________________________________ Date:___________________________ 

34
Irradiated, Raw Model 

HACCP PLAN 

PROCESS CATEGORY: IRRADIATED, RAW PRODUCT PRODUCT EXAMPLE: FRESH POULTRY 

CCP # and 

Location 

Critical 

Limits 

Monitoring 

Procedures and 

Frequency 

HACCP 

Records 

Verification Procedures and 

Frequency 

Corr

4B Raw Poultry Irradiation 

Minimum absorbed dose: 1.5 kilogray (150 kilorads) Maximum absorbed dose: 3.0 kilogray (300 kilorads) as found in 9 CFR 381.147 and 381.149 

Production supervisor will monitor the data log printout from the irradiation control board for each irradiated batch. Production supervisor will take dosimeter readings for each irradiated batch 

Irradiation Data Log printout Irradiation/Dose Mapping Log Letter of guarantee for dosimeter calibration Corrective Actions Log 

QA will verify irradiation data log printout. QA will verify letter of guarantee for calibration of the dosimeter every 12 months. QA will verify that absorbed doses received by product are within the minimum and maximum limits from 

results of dose mapping. 

QA supervisor affected produQA will condeFollow standarfor disposition Certified irradipersonnel will problem with tensure no reocQA will implemmaintenance p

Signature : ________________________________ Date:___________________________ 

35
Irradiated, Raw Model 

HACCP PLAN 

PROCESS CATEGORY: IRRADIATED, RAW PRODUCT PRODUCT EXAMPLE: FRESH POULTRY 

CCP # 

and 

Location 

Critical 

Limits 

Monitoring 

Procedures and 

Frequency 

HACCP 

Records 

Verification Procedures and 

Frequency 

Corr

5B Finished Product Storage (Cold) 

Finished product and storage area shall be maintained at 27-38° F. 

QA personnel will check raw product temperature every two hours. Maintenance personnel will check storage area temperature every two hours. 

Product Temperature Log Room Temperature Log Thermometer Calibration Log Corrective Actions Log 

QA supervisor will check Product Temperature Log and Room Temperature Log twice per shift. Maintenance supervisor will verify accuracy of the Room Temperature Log once per shift. QA will check all thermometers used for monitoring and verification for accuracy daily and calibrate to within 1° F accuracy as necessary. 

QA will reject temperature is time and tempestandard operaproduct disposQA and mainteidentify the cauprevent reoccu

Signature : ________________________________ Date:___________________________ 

36
Irradiated, Raw Model 

FORM LETTER requesting Salmonella Data 

Date 

To: FSIS 

FOIA Coordinator USDA 

This is to request results of any Salmonella performance standard sample sets completed during the past two mon

establishments listed below. 

Thank you. 

File Copy Date Results 

Received 

Two Consecutive Failed Sets? 

If Yes, Remarks 

Est. YYY Est. ZZZ Est. AAA 

37
Irradiated, Raw Model 

FORM LETTER requesting Salmonella Data To: FSIS 

FOIA Coordinator USDA 

This is to request results of any Salmonella performance standard sample sets completed during the past two mon

establishments listed below.Thank you.Est. YYYEst. ZZZEst. AAA

38 
Irradiated, Raw Model 

GENERIC ESTABLISHMENT X: 

PRODUCT:______________________________ 

TIME TEMP Deviation from 

CL? if yes) 

If Yes, Corrective Action? 

Monitored by

6:36 AM 34°F PS 8:30 AM 33°F PS 10:32 AM 34°F PS 12:30 PM 36°F  Notify maint. supv., CB & QA PS 

PRODUCT TEMPERATURE LOG 

DATE:_________ 

(Check

TIME/TEMPERATURE CRITICAL LIMIT: 

39
Irradiated, Raw Model 

GENERIC ESTABLISHMENT X: 

STORAGE ROOM:_________________________ 

TIME TEMP Deviation from 

CL? if yes) 

If Yes, Corrective Action? 

Monitored by

6:36 AM 34°F PS 8:30 AM 33°F PS 10:32 AM 34°F PS 12:30 PM 36°F  Notify maint. supv., CB & QA PS 

ROOM TEMPERATURE LOG 

DATE:_________ 

(Check

TIME/TEMPERATURE CRITICAL LIMIT: 

40
Irradiated, Raw Model 

THERMOMETER CALIBRATION LOG 

Criteria Within 1∀ °F of Control Thermometer Date Time Department or 

Area 

Thermometer ID# Control 

Thermometer Reading 

Personal Thermometer Reading 

Adjustment Required (Yes or No) 

Init

6/15 1:00 PM Chiller 2A 32°F 32°F No HK 

* If a thermometer is broken or taken out of service, document this in the comment column.Verified by: _______________________Date/Time: 

_______________________

41
Irradiated, Raw Model 

GENERIC ESTABLISHMENT X: IRRADIATION/ DOSE MAPPING LOG DATE: _________________ Lot or Irradiation ID 

Dosimeter Positions 

Absorption Dose (KGY) Verified B

42
Irradiated, Raw Model 

CORRECTIVE ACTIONS LOG 

Product: ___________________________________________ 

CCP Deviation/ 

Problem 

Disposition of 

Product 

Corrective Action 

Procedures/Explain 

Measures to 

Prevent 

Recurrence 

R

SIGNATURE: __________________________ DATE: ______________

43
Irradiated, Raw Model 

Pre-Shipment Review Log Date:______________

LOT ID TIME RECORDS 

REVIEWED 

BY WHOM 

LOT RELEASED FOR SHIPMENT? SIGNATURE 

11:10 a.m. 11:10 p.m. 

44