United States 

Department of

Agriculture 

Food Safety 

and Inspection 

Service 

September 1999 

HACCP-11 

Generic HACCP 

Model for Heat 

Treated But Not 

Fully Cooked,

Not Shelf 

Stable 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. 
Heat Treated But Not Fully Cooked, Not Shelf Stable 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....................................................................................... 11

Appendix A 

References for HACCP Teams.............................................................. 17

References for Heat Treated But Not Fully Cooked, Not Shelf Stable

Meat and Poultry Products....................................................................19

Appendix B 

Process Flow Diagram (Figure1) Smoked Sausage, Partially Cooked

Chicken Patties ............................................................................... 22

Product Description (Figure 2)............................................................. 23

Hazard Analysis Form (Figure 3)........................................................... 24

HACCP Plan Form (Figure 4)............................................................... 29

Form Letter Confirming Salmonella Compliance with

Performance Standards .......................................................................35

Thermometer Calibration Log...............................................................36

Generic Establishment X: Room Temperature Log ......................................37

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Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

Generic Establishment X: Metal Detection Log..........................................38 

Corrective Actions Log......................................................................39 

Pre-Shipment Review Log..................................................................40 

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Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

GENERIC HACCP MODEL 

FOR 

HEAT TREATED BUT NOT FULLY COOKED, NOT SHELF STABLE 

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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Heat Treated But Not Fully Cooked, Not Shelf Stable 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 category: Heat treated but not fully 

cooked--not shelf stable. 

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 which 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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Heat Treated But Not Fully Cooked, Not Shelf Stable 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 heat treated but not 

fully cooked, not shelf stable product(s), the eighth process category. The model can be used for 

all heat treated but not fully cooked, not shelf stable products: either meat or poultry. The 

generic model is not suitable for products that fall into any of the other process categories. 

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. 

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 

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 

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Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

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 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 

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) 

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Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

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 heat treated but not fully cooked, not shelf stable –

smoked sausage and partially cooked chicken patties. 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 smoked

sausage and partially cooked chicken patties in generic establishment X. Figure 2 is an example

of a PRODUCT DESCRIPTION for the smoked sausage and partially cooked chicken patties

produced in 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: If your process includes steps not included in this example, those steps should be added.

Also, if your process does not include all the steps identified in this example, those steps would

be omitted when conducting the hazard analysis. 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

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 

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Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

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" 

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. Column six is used when a critical control point (CCP) is identified 

based upon the decision made in the hazard analysis. Each CCP has a number – the order 

corresponds to steps in the process. For example, 1 is the first CCP in the process flow, 2 the 

next, etc. The letter indicates whether the hazard is biological – B; chemical – C; or physical – 

P. 

Look at the entries for “Receiving – Raw Meat/Poultry” on the first page of the six column form 

8
Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

for heat treated but not fully cooked, not shelf stable; 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 labels alone to be an adequate CCP for any 

pathogenic microorganisms such as bacteria and viruses. 

Note: Look at the entries for “Storage – (Cold – Frozen/Refrigerated) – Raw Meat/Poultry” on 

the second page of the six-column form: the HACCP team has determined that there is a food 

safety hazard reasonably likely to occur at this step in the process. Column four contains the 

reason for their thinking: pathogenic organisms can grow in this product if it is not kept 

sufficiently cool. Column five contains their description of a measure that will prevent the 

growth of pathogenic organisms: temperatures that are sufficiently low to preclude growth. 

You will notice that on our generic hazard analysis for smoked sausage and partially cooked 

chicken patties, there are six food 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 heat treated but not fully cooked, 

not shelf stable 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 which 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. These references 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 

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

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Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

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 which 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 

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

during monitoring. 

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Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

(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 smoked sausage and partially cooked 

chicken patties 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 were six points on the hazard analysis form for smoked 

sausage and partially cooked chicken patties where food safety hazards reasonably likely to 

occur were identified: Salmonella on raw meat/poultry at receiving, pathogen proliferation at 

cold storage, metal contamination during mechanical processing, trichina in finished product 

being packaged and labeled, pathogen proliferation at chilling, and pathogen proliferation at 

finished product storage (cold). The establishment HACCP team has chosen to have six CCPs to 

address these six hazards: Salmonella certification, proper cold storage of raw meat/poultry, 

metal detectors prior to packaging and labeling, clear product labeling to show product is raw 

and must be fully cooked to prevent any trichina survival, proper chilling of finished product, 

and proper maintenance of finished product temperatures during storage. 

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. 

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Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

They found no regulatory requirements for receiving raw meat/poultry, but realized that 

Salmonella coming into the plant could result in cross-contamination with other product. The 

HACCP team knew that Salmonella may be present on incoming raw product, so they set the 

critical limit at requiring the supplier of the carcass parts to send a Salmonella certificate with 

each shipment stating that the product has been sampled for Salmonella. 

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

procedures would be carried out and at what frequency. 

For their receiving – raw meat/poultry step, the establishment had the receiving personnel check 

each shipment for Salmonella certification. 

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

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 they could verify the suppliers’ Salmonella certifications by 

requesting Salmonella data results from FSIS for at least two suppliers every two months. 

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. 

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(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 

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 since receiving personnel had a form that they had been using for 

receiving product, that they would modify that form. The form was modified to provide spaces 

for all entries necessary for the monitoring and verification activities at the receiving – raw 

meat/poultry 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 of the 

HACCP plan 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. 

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(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 

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 Action for CCP 1: 

Receiving personnel will not receive product unaccompanied by Salmonella certification. 

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 

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 

14
Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

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 

heat treated but not fully cooked, not shelf stable 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. 

15
Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

APPENDIX A

16
Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

References for HACCP 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 

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 Stier, R.F. 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. 

10. International Commission on Microbiological Specification 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 

17
Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

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. March 20, 1992 --

Hazard Analysis and Critical Control Point System. Int. J. Food Microbiol. 16: 1-23, 1993. 

13. National Advisory Committee on Microbiological Criteria for Foods. Adopted August 14, 

1997-- Hazard Analysis and Critical Control Point Principles and Application Guidelines. 

J. Food Protect. 61(9): 1246-1259, 1998. 

14. National Advisory Committee on Microbiological Criteria for Foods. DRAFT document -

FSIS Microbiological Hazard Identification Guide for Meat and Poultry Components of 

Products Produced by Very Small Plants. 1-22, August 1999. 

15. National Advisory Committee on Microbiological Criteria for Foods. June 1993 -- Report 

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

16. 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 

17. Notermans, S., et al. The HACCP Concept: Identification of Potentially Hazardous 

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

18. Pierson 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 

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

Nostrand Reinhold, New York, 1992. 

18
Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

20. 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 sections in particular are: 

Chapter 11 – forms for hazard analysis, CCPs, critical limits, HACCP master 

sheet, example HACCP for breaded chicken 

21. Stevenson, K.E. and Bernard, D.T. Editors. HACCP: A Systematic Approach to Food 

Safety. 3rd Edition. The Food Processors Institute, Washington, D.C., 1999. 

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

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

23. 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 in Meat, Poultry and Seafoods. Chapman & Hall, 1995. 

References for Heat Treated But Not Fully Cooked, Not Shelf Stable 

Meat and Poultry Products 

1. American Meat Science Association. Flowchart for uncooked, cured summer sausage. 

AMSA, Chicago, IL, 1995. 

2. Bushway, A.A., et al. Residual nitrite concentration and total plate counts in white and dark 

chicken patties. J. Food Protect. 47: 119-121, 1984. 

3. Marcy, J.A., et al. Effect of acid and neutral pyrophosphates on the natural bacterial flora 

of a cooked meat system. J. Food Sci. 52: 1183-1185, 1987. 

4. Stevenson, K.E. and Bernard, D.T. Editors. Process flow diagram for battered and breaded 

chicken pieces. In HACCP Establishing Hazard Analysis Critical Control Point Programs., 

A Workshop Manual. Chapter 11: 14-15, The Food Processors Institute, Washington, DC, 

1995. 

5. Yen, L.C., et al. Effect of meat curing ingredients on thermal destruction of Listeria 

monocytogenes in ground pork. J. Food Protect. 54: 408-412. 

19
Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

6. Yi, Y.H., et al. Yields, color, moisture and microbial contents of chicken patties as affected

by frying and internal temperatures. J. Food Sci. 52: 1183-1185, 1987.

20
Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

APPENDIX B

21
Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

PROCESS FLOW DIAGRAM Figure 1 

PROCESS CATEGORY: HEAT TREATED BUT NOT FULLY COOKED, 

NOT SHELF STABLE 

PRODUCT: SMOKED SAUSAGE, PARTIALLY COOKED CHICKEN PATTIES 

RECEIVING 

RAW MEAT/POULTRY 

RECEIVING 

PACKAGING 

MATERIALS 

RECEIVING 

NONMEAT/ 

NONPOULTRY 

FOOD 

INGREDIENTS STORAGE 

(COLD – FROZEN/REFRIGERATED) 

RAW MEAT/POULTRY 

TEMPERING 

FROZEN MEAT/POULTRY 

WEIGHING 

RAW MEAT/POULTRY 

COMBINE INGREDIENTS 

MECHANICAL PROCESSES 

(Note: List all used) * 

SMOKING/PARTIAL COOKING 

PACKAGING/LABELING 

CHILLING 

FINISHED PRODUCT STORAGE (COLD) 

SHIPPING 

REWORK 

STORAGE 

PACKAGING 

MATERIALS 

STORAGE 

NONMEAT/ 

NONPOULTRY 

FOOD 

INGREDIENTS 

WEIGHING 

NONMEAT/ 

NONPOULTRY 

FOOD 

INGREDIENTS 

* 

Examples 

Deboning 

Skinning 

Brine injection 

Comminution 

Marination 

Tumbling 

Portioning 

Massaging 

Emulsifying 

Forming 

Coating 

Flaking 

Mixing 

Blending 

Stuffing 

22
Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

PRODUCT DESCRIPTION Figure 2

PROCESS CATEGORY: HEAT TREATED BUT NOT FULLY COOKED, 

NOT SHELF STABLE 

PRODUCT: SMOKED SAUSAGE, PARTIALLY COOKED CHICKEN 

PATTIES 

1. COMMON NAME? SMOKED SAUSAGE, PARTIALLY 

COOKED CHICKEN PATTIES 

2. HOW IS IT TO BE USED? ENTREES, NUGGETS, SNACK 

FOODS, SALADS 

3. TYPE OF PACKAGE? BULK-PACKED (E.G., PLASTIC 

BAG, VACUUM PACKED) 

4. LENGTH OF SHELF LIFE, 3-6 MONTHS AT 0° F OR 

AT WHAT TEMPERATURE? BELOW;7 DAYS AT 40° F 

5. WHERE WILL IT BE SOLD? WHOLESALE TO DISTRIBUTORS 

CONSUMERS? ONLY 

INTENDED USE? 

6. LABELING INSTRUCTIONS? KEEP FROZEN; KEEP 

REFRIGERATED 

7. IS SPECIAL DISTRIBUTION KEEP FROZEN; KEEP 

CONTROL NEEDED? REFRIGERATED 

23
Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

HAZARD ANALYSIS – HEAT TREATED BUT NOT FULLY COOKED, NOT SHEL

Smoked Sausage, Partially Cooked Chick

en Patties 

Process Step Food Safety 

Haz

ard 

Reasonably 

Lik

ely to 

Occur? 

Basis If Yes in Column 3, 

What Measures Could 

be Applied to Prevent

Eliminate, or Reduce 

the Haz

ard to an 

Acceptable Level? 

Receiving – Raw 

Meat/Poultry 

Biological: Pathogens Salmonella Trichina 

Yes Salmonella may be present 

on incoming raw product. 

Certification from supplierthat product has been sampled for Salmonella meets performance standards 

Chemical – None 

Physical – Foreign materials such as broken needles, bone/ bone fragments 

Yes 

Bone/bone fragments 

(size/shape) that would represent a hazard to consumers have been found in incoming product. 

Supplier specification that all 

product must have been run 

through a bone detector/bone 

collector in process or if wholmuscle product received use 

of a bone detector/bone collector in process. 

Receiving – 

Nonmeat/Nonpoultry 

Food Ingredients; 

Packaging Materials 

Biological – None Chemical – Not acceptable for intended use 

No Letters of guaranty are 

received from all suppliers of packaging materials. 

Physical – Foreign materials (wood, metal, glass, etc.) 

No Plant records demonstrate 

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

24
Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

HAZARD ANALYSIS – HEAT TREATED BUT NOT FULLY COOKED, NOT SHELF S

Sausage, Partially Cooked Chick

en Patties 

Process Step Food Safety 

Haz

ard 

Reasonably 

Lik

ely to 

Occur? 

Basis If Yes in Column 3, 

What Measures Could 

be Applied to Prevent

Eliminate, or Reduce 

the Haz

ard to an 

Acceptable Level? 

Storage – 

Nonmeat/Nonpoultry 

Food Ingredients; 

Packaging Materials 

Biological – None Chemical – None Physical – None 

Storage (Cold – 

Frozen/Refrigerated) – 

Raw Meat/Poultry 

Biological Salmonella Listeria monocytogenes 

Yes Pathogens are reasonably 

likely to grow in this product if temperature is not maintained at or below a level sufficient to preclude their growth and coolers are not maintained to hold temperatures. 

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

Chemical – None 

Physical – None 

Tempering Frozen 

Meat/Poultry 

Biological – None Chemical – None 

Physical – None 

Weighing 

Nonmeat/Nonpoultry 

Food Ingredients 

Biological – None Chemical – None 

Physical – None 

25
Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

HAZARD ANALYSIS – HEAT TREATED BUT NOT FULLY COOKED, NOT SHELF S

Sausage, Partially Cooked Chick

en Patties 

Process Step Food Safety 

Haz

ard 

Reasonably 

Lik

ely to 

Occur? 

Basis If Yes in Column 3, 

What Measures Could 

be Applied to Prevent

Eliminate, or Reduce 

the Haz

ard to an 

Acceptable Level? 

Weighing Raw 

Meat/Poultry 

Biological – None Chemical – None 

Physical – None 

Combine Ingredients Biological – None 

Chemical – None 

Physical – None 

Mechanical Process 

* See list on flow chart on page 21 

Biological – None Chemical – None 

Physical – Metal Contamination 

Yes Plant records show that during 

mechanical processing metal contamination is likely to occur. 

Metal detectors are installed prior to packaging. 

Smoking/Partial 

Cooking 

Biological – None Chemical – None Physical – None 

Rework Biological – Pathogens No Rework at the end of the 

day is condemned. 

Chemical – None 

Physical – None 

26
Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

HAZARD ANALYSIS – HEAT TREATED BUT NOT FULLY COOKED, NOT SHELF S

Sausage, Partially Cooked Chick

en Patties 

Process Step Food Safety 

Haz

ard 

Reasonably 

Lik

ely to 

Occur? 

Basis If Yes in Column 3, 

What Measures Could 

be Applied to Prevent

Eliminate, or Reduce 

the Haz

ard to an 

Acceptable Level? 

Packaging/Labeling Biological – Pathogens 

-parasitic (Trichina) 

Yes Trichina has historically 

occurred in raw pork products. 

Labels that clearly indicate this is a raw product, along with cooking instructions and a safe food handling statement. 

Chemical – None Physical – None 

Chilling Biological - Pathogens Yes 

Pathogens are reasonably 

likely to grow if improper chilling procedures are used. 

Proper chilling procedures are used. 

Chemical – None Physical – None 

27
Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

HAZARD ANALYSIS – HEAT TREATED BUT NOT FULLY COOKED, NOT SHELF S

Sausage, Partially Cooked Chick

en Patties 

Process Step Food Safety 

Haz

ard 

Reasonably 

Lik

ely to 

Occur? 

Basis If Yes in Column 3, 

What Measures Could 

be Applied to Prevent

Eliminate, or Reduce 

the Haz

ard 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 sufficient to preclude their growth. 

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

Chemical – None 

Physical – None 

Shipping Biological – None 

Chemical – None 

Physical – None 

28
Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

HACCP PLAN 

PROCESS CATEGORY: HEAT TREATED BUT NOT FULLY COOKED, NOT SHELF STABLE PRODUCT EXAMPLE: SMOKED SAUSAGE, PARTIALLY COOKED CHICKEN PATTIES 

CCP# and 

Location 

Critical 

Limits 

Monitoring 

Procedures and 

Frequency 

HACCP Records 

Verification Procedures and 

Frequency 

Corr

1B Receiving – Raw Meat/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 Action Log 

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

Will not receive by Salmonella ceProduct found noperformance stanaccepted. If suppconsecutive sets supplier will not that the results of 

baseline standard

2B Storage (Cold– Frozen/ Refrigerated – Raw Meat/Poultry 

Raw product storage areas shall not exceed 40° F. 

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

Room Temperature Log T

hermometer 

Calibration Log Corrective Action Log 

Maintenance supervisor will verify accuracy of the Room Temperature Log once per shift and observe temperature checks. QA will check all thermometers used for monitoring and verification for accuracy daily and calibrate to within 2°F accuracy as necessary. 

Product internal tdetermined. QA dependent on timVolume or mannadjusted if determdeviation. CooliAuthority will be disposition determQA will identify and prevent reocrepaired & maintnecessary. 

Signature: __________________________________ Date: __________________________ 

29
Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

HACCP PLAN 

PROCESS CATEGORY: HEAT TREATED BUT NOT FULLY COOKED, NOT SHELF STABLE PRODUCT EXAMPLE: SMOKED SAUSAGE, PARTIALLY COOKED CHICKEN PATTIES 

CCP# and 

Location 

Critical 

Limits 

Monitoring 

Procedures and 

Frequency 

HACCP Records 

Verification Procedures and 

Frequency 

Corr

3P Mechanical Processes 

No metal particles to exceed 1/32 inches. 

Maintenance personnel will check the metal 

detector with a seeded sample once per shift & determine that kick out device is functioning as intended. 

Metal Detection Log Corrective Action Log 

Maintenance supervisor will verify metal detector is functioning and perform routine maintenance as required by manufacturer. QA will verify that the metal detector is functioning as intended by observing maintenance test with 

seeded sample once every other day. 

Mechanical sepacontrol and segreMaintenance pereliminate the prodetector. Preventive maintimplemented and QA will run seeddetector after repAll potentially cobe visually exam

Product will be xshipment. 

Signature: __________________________________ Date: __________________________ 

30
Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

HACCP PLAN 

PROCESS CATEGORY: HEAT TREATED BUT NOT FULLY COOKED, NOT SHELF STABLE PRODUCT EXAMPLE: SMOKED SAUSAGE, PARTIALLY COOKED CHICKEN PATTIES 

CCP# and 

Location 

Critical 

Limits 

Monitoring 

Procedures and 

Frequency 

HACCP Records 

Verification Procedures and 

Frequency 

Corr

4B Packaging/ Labeling (Trichina) 

Product must clearly be labeled as raw or partially cooked and requiring cooking. Cooking instructions must be on the package. Safe food handling statement must be part of the label. 

Packaging line supervisor will select 2 packages of each type of product produced at the start & finish of each lot and ensure labeling requirements are 

met. 

Labeling Log Corrective Action Log 

QA will observe packaging line supervisor perform monitoring activity once per shift. QA will select 3 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 segregatproduct. QA will ensure thapplied to all affeshipment. Labeling equipmrequired. Label mcertification that printed properly. examined to assu

Signature: __________________________________ Date: __________________________ 

31
Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

HACCP PLAN 

PROCESS CATEGORY: HEAT TREATED BUT NOT FULLY COOKED, NOT SHELF STABLE PRODUCT EXAMPLE: SMOKED SAUSAGE, PARTIALLY COOKED CHICKEN PATTIES 

CCP# and 

Location 

Critical 

Limits 

Monitoring 

Procedures and 

Frequency 

HACCP Records 

Verification Procedures and 

Frequency 

Corr

5B Chilling 

Internal product temperature < 70°F within 3 hours and will reach < 41°F within an additional 6 hours after reaching < 70 °F (Total chilling time of 9 hours). 

QA technician will observe chilling handling procedures to ensure critical limits are met. Product coolers will be monitored and recorded continuously on temperature recording charts. QA technician will randomly select 5 samples of each type of product at 3 and 9 hours from start of chilling and determine internal temperature. 

Product Chilling Log Product Coolers Temperature Recording Charts T

hermometer 

Calibration Log Corrective Action Log 

Once per shift the QA supervisor will review the Product Chilling Log and observe temperature monitoring activity. Maintenance supervisor will verify accuracy of the product cooler temperature recording charts once per shift. QA will check all thermometers used for monitoring and verification for accuracy daily and calibrate to within 2°F accuracy as necessary. 

QA will reject or on time and temp

product time/temdetermined & usdisposition. Prodfully cooked. QA will identify and prevent reocCooler will be remaintenance sche

Signature: __________________________________ Date: __________________________ 

32
Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

HACCP PLAN 

PROCESS CATEGORY: HEAT TREATED BUT NOT FULLY COOKED, NOT SHELF STABLE PRODUCT EXAMPLE: SMOKED SAUSAGE, PARTIALLY COOKED CHICKEN PATTIES 

CCP# and 

Location 

Critical 

Limits 

Monitoring 

Procedures and 

Frequency 

HACCP Records 

Verification Procedures and 

Frequency 

Corr

6B Finished Product Storage (Cold) (Continued on next page) 

Finished product storage areas will not exceed 40° F. 

Maintenance personnel will check finished product storage areas temperatures every two hours. 

Room Temperature Log T

hermometer 

Calibration Log Corrective Action Log 

Maintenance supervisor will verify the accuracy of the room temperature log once per shift. QA will check all thermometers used for monitoring and verification activities for accuracy daily and calibrate to within 2° F accuracy as necessary. QA will observe maintenance personnel check finished product storage area once per shift. 

If a deviation frothe following cortaken: 1. The cause of 

exceeding 40eliminated. 

2. The CCP wi

after the corrensure that i

3. 

W

hen the ca

identified, mprevent it frocause is equimaintenance and revised, 

Signature: __________________________________ Date: __________________________ 

33
Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

HACCP PLAN 

PROCESS CATEGORY: HEAT TREATED BUT NOT FULLY COOKED, NOT SHELF STABLE PRODUCT EXAMPLE: SMOKED SAUSAGE, PARTIALLY COOKED CHICKEN PATTIES 

CCP# and 

Location 

Critical 

Limits 

Monitoring 

Procedures and 

Frequency 

HACCP Records 

Verification Procedures and 

Frequency 

Corr

6B Finished Product Storage (Cold) 

If a deviation frothe following cortaken: 4. If room temp

critical limitwill evaluate to ensure the to preclude prelease for shnot sufficiengrowth, prodestablishmenpathogens or 

Signature: __________________________________ Date: __________________________ 

34
Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

FORM LETTER Confirming Salmonella Compliance with Performance S

Date 

To: 

Plant XYZ 

This is to confirm results of any Salmonella perform

ance standard sample sets completed during the past six mon

establishment listed below. 

Thank you. 

Product 

Date Results 

Received 

Test Results Two Consecutive Failed Tests 

35
Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

THERMOMETER CALIBRATION LOG 

Calibrate to 320 F while therm

o

m

eter is in slush ice water 

Date Time Departm

ent 

or Area 

T

h

ermometer I

D# 

P

erso

n

al 

T

h

ermometer 

Reading 

Adjustm

ent 

Required (Yes or No) 

Initials Com

m

ents 

• If a thermometer is broken or taken out of service, document this in the comment column. Reviewed by: ______________________________ Date: _______________________ 

36
Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

GENERIC ESTABLISHMENT X: 

ROOM:__________ DATE:_________ 

TIME TEMP 

Deviation from 

CL? yes) 

If Yes, 

Action? 

Monitored by

ROOM TEMPERATURE LOG 

(Check if 

37
Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

GENERIC ESTABLISHMENT X: METAL DETECTION LOG 

Date Product 

Lot # Results Seeded 

Sample 

Time Monitored By Ve

38
Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

CORRECTIVE ACTIONS LOG 

Product: ___________________________________________ Lot # ________

CCP Deviation/ 

Problem 

Corrective Action 

Procedures/Explain 

Disposition of 

Product 

Respo

Per

SIGNATURE: __________________________ DATE: ___________________

39
Heat Treated But Not Fully Cooked, Not Shelf Stable Model 

PRE-SHIPMENT 

Date:______________ 

PRODUCT LOT 

ID 

TIME RECORDS REVIEWED 

BY WHOM 

LOT RELEASED FOR SHIPMENT? SIGNATURE 

COM

REVIEW LOG 

*Monitoring frequency as per plan; Critical limits m

et; Certification (if applicable) as per plan; Deviations if occ

for appropriate corrective actions; Records complete and accurate. 

40