United States 

Department of

Agriculture 

Food Safety 

and Inspection 

Service 

September 1999 

HACCP-7 

Generic HACCP 

Model for 

Thermally

Processed, 

Commercially

Sterile 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 
Thermally Processed, Commercially Sterile 

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............................................................ 19

References for Thermally Processed, Commercially Sterile

Meat and Poultry Products................................................................... 21

Part I – Epidemiology of Foodborne Illness....................................... 21

Part II – Product Spoilage .......................................................... 22

Part III – Physical and Chemical Contamination ..................................23

Appendix B 

Process Flow Diagram (Figure 1) Beef Stew............................................ 26

Product Description Form (Figure 2)...................................................... 27

Hazard Analysis Form (Figure 3).......................................................... 28

HACCP Plan Form (Figure 4).............................................................. 33

Thermometer Calibration Log.............................................................. 40

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Generic Establishment X: Metal Detection Log........................................ 41

Generic Establishment X: Process Operating Log....................................... 42

Generic Establishment X: Process Deviation Log........................................ 43

Corrective Actions Log...................................................................... 44

Pre-Shipment Review Log.................................................................. 45

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GENERIC HACCP MODEL 

FOR 

THERMALLY PROCESSED, COMMERCIALLY STERILE 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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(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 fourth process category: Thermally processed --

commercially sterile. 

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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Thermally Processed, Commercially Sterile 

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 thermally processed, 

commercially sterile product(s), the fourth process category. The model can be used for all 

thermally processed, commercially sterile products: either meat or poultry; with or without cure; 

whether low-acid or acidified low-acid product. The model can be used for those products 

generally referred to as canned. 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. 

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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 

higher level official of the establishment. 

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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 thermally processed, commercially sterile - beef

stew. 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 thermally

processed, commercially sterile beef stew in generic establishment X. Figure 2 is an example of

a PRODUCT DESCRIPTION for the thermally processed, commercially sterile beef stew

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.

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 

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). 

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Thermally Processed, Commercially Sterile 

§ 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-Non-meat Food Ingredients” on the first page of the six 

column form; the HACCP team has determined that even though bacterial spore loads may be 

present at high levels in incoming product, they put a “No” in the third column. Column four 

explains the basis for the team’s determination. The bacterial spore load which is introduced 

into the product either at the producer or supplier operations, can be controlled at the canning 

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Thermally Processed, Commercially Sterile 

establishment. Therefore, the team decided that the hazard can be controlled by the thermal 

process or by using irradiated spices. 

You will notice that on our generic hazard analysis for thermally processed, commercially sterile 

beef stew, there are seven 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 thermally processed, 

commercially sterile 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 thermally 

processed, commercially sterile 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 

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: 

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Thermally Processed, Commercially Sterile 

(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. 

(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; 

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Thermally Processed, Commercially Sterile 

(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 thermally processed, commercially 

sterile beef stew 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 seven process steps on the hazard analysis form where 

food safety hazards reasonably likely to occur were identified: microbial growth on incoming 

meat; presence of foreign material on non-meat food ingredients; presence of foreign materials 

in cans and packaging materials; presence of foreign materials after can washing; improper 

product formulation; improper filling of can; and, improper application of the thermal process 

and cooling. 

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

temperature monitoring of incoming meat; visual inspection of incoming meat; letter of guaranty 

for non-meat food ingredients; visual inspection of non-meat food ingredients; visual inspection 

of cans and packaging on receipt; visual inspection of cans after exiting washer; and the 

processing authority specifications for product formulation, filling of cans, and the process 

schedule. 

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. If 

the plant decided to use the current regulations for thermally processed, commercially sterile 

product to address bacterial hazards, only physical and chemical hazards would have to be 

addressed in the HACCP Plan. However, the team decided to address bacterial hazards in their 

plan and set limits that met or exceeded regulatory requirements. 

Although meat would remain frozen below 32°F, the team decided that 10°F or below would be 

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Thermally Processed, Commercially Sterile 

more conservative and protective of the frozen product. There would be less chance of the 

product reaching thaw temperature before use and, thus, reducing the chance for temperature 

abuse. 

In addition to the critical limit regarding metal in the packaging and non-metal containers, the 

team decided that any other visible hazardous non-food material, such as glass, was unacceptable 

not only at receipt of packaging materials and containers but also during the washing of the cans. 

For non-meat ingredients, the bacterial spore load in spices is the bacteriological concern. 

However, the bacteriological load is incorporated before the non-meat ingredients reach the 

thermal processing establishment. The team therefore decided that purchase specifications and/or 

letters of guarantee would be the best method for controlling the bacterial hazards. 

With respect to metal contamination, the team knew that their detector was capable of 

identifying particles as small as 1/32 of an inch, as long as it was working well. Therefore, they 

decided that their critical limit would be the capability of a properly functioning metal detector. 

The processing authority determines the formulation, container filling, and thermal process and 

cooling specifications that will produce a safe and stable product. Therefore, the critical limits 

for these steps in processing are those specified by the processing authority for the specific 

product. 

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 – Frozen Cooked Diced Beef and Non-meat Food Ingredient controls on 

incoming product, they decided the operational personnel who normally checked arriving 

products would check product temperature for each load. This individual would also visually 

inspect each load of frozen cooked diced beef, non-meat ingredients, and packaging in addition 

to checking letters of guarantee and ensuring that all goods are from approved suppliers. The 

team determined that this might be an excessive frequency for suppliers with good performance, 

and decided that when they validated their HACCP plan (by actually trying it out and recording 

results), they would consider whether another frequency should be used. 

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: 

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(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 determined that since receiving personnel were performing the temperature 

checks on incoming meat, their supervisor would be a good person to involve in verification. He 

will review the temperature logs and receiving logs, and may either observe the employee taking 

the temperature or take a temperature of his own, once per shift. 

There is a regulatory requirement (Part 417.4(a)(2)(i)) for including as a verification, the 

calibration of process-monitoring instruments; the thermometers being used to take the 

temperature checks are obviously process monitoring instruments, so someone outside the 

maintenance unit, in this case the Quality Assurance unit, will check those thermometers for 

accuracy on a daily basis, and calibrate them to within 1 degree as necessary. 

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 

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 

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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 team created a separate form to be used by the QA personnel 

who were checking the thermometers and calibrating them as necessary. Each employee who 

was performing a temperature check had a thermometer assigned to him, which was identifiable 

by its serial number. QA personnel picked up thermometers from employees throughout the day 

when employees were not using them, and checked them against a known standard; recalibration 

was performed immediately if it was necessary. There were only four different employees and 

different thermometers being used in the HACCP monitoring and verification activities, and they 

were to be checked once a day, so the HACCP team decided that this form could be used by QA 

for more than one day. QA personnel were located in a different part of the plant; employees 

delivered their thermometers to QA once a day immediately after they had performed a 

temperature check. QA checked the thermometer and returned it to the employee with a copy of 

the record showing results; in addition, QA e-mailed the results to the HACCP coordinator at the 

end of each day, and each time there was a variation of more than 2° F noted when the 

thermometer was checked. 

The HACCP team also created a form to be used by employees with assigned tasks concerning 

the functioning of the metal detector. The Metal Detector Performance Log includes both 

monitoring and verification checks results; the form has entries from both the packaging 

supervisor and from QA personnel. The form is kept near the metal detector and is turned in to 

the HACCP coordinator at the end of each day. 

The Process Operating Log was designed to include all the information required by the 

regulations Part 318.306. The team also designed a form to be used in the event of a deviation in 

processing. The Process Deviation Log includes date of the deviation, product information, and 

disposition of the product after evaluation by the processing authority. 

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

for monitoring and verification records. 

Another form is 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 

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). For example, this is the 

establishment's planned corrective action whenever there is a deviation from the thermal 

processing and cooling critical limit, i.e., an improper application of the process schedule as 

specified by the processing authority. 

Planned Corrective Actions for CCP 9: 

1. The plant designee will apply a filed alternate process schedule appropriate for the situation 

or 

2. The plant designee will place product on hold pending evaluation of the process deviation by 

the processing authority. 

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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 

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. 

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Thermally Processed, Commercially Sterile 

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 

thermally processed, commercially sterile beef stew 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. 

17
Thermally Processed, Commercially Sterile 

APPENDIX A

18
Thermally Processed, Commercially Sterile 

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: 

19
Thermally Processed, Commercially Sterile 

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. 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 

20
Thermally Processed, Commercially Sterile 

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. 

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 Thermally Processed, 

Commercially Sterile Meat and Poultry Products 

Part I – Epidemiology of Foodborne Illness 

1. Barker, W. H., Jr., J. B. Weissman, V. R. Dowell Jr., L. Gutmann, and D. A. Kautter. Type B 

botulism outbreak caused by a commercial food product. West Virginia and Pennsylvania, 

1973. JAMA 237(5):456-459, 1977. 

2. Billon, J., A. Perpezat, and M. Charrier. [Studies on 114 cases of food poisoning.] Medecine 

et Nutrition 13(4):277-280, 1977. 

3. Blake, P. A., M. A. Horwitz, L. Hopkins, G. L. Lombard, J. E. McCroan, J. C. Prucha, J.C. 

and M. H. Merson. Type A botulism from commercially canned beef stew. South. Med. J. 

70(1):5-7, 1977. 

21
Thermally Processed, Commercially Sterile 

4. Gilbert, R. J., J. L. Kolvin, and D. Roberts. Canned foods – the problems of food poisoning 

and spoilage. Health and Hygiene 4(2/3/4):41-47, 1982. 

5. Guilfoyle, D. E. and J. F. Yager. Survey of infant foods for Clostridium botulinum spores. J. 

Association Official Analytical Chemists 66(5):1302-1304, 1983. 

6. Odlaug, T. E. and I. J. Pflug. Clostridium botulinum and acid foods. J. Food Protect. 

41(7):566-573, 1978. 

7. Osherhoff, B. J., G. G. Slocum, and W. M. Decker. Status of botulism in the United States. 

Public Health Reports 79(10):871-878, 1964. 

8. Sours, H. E. and D. G. Smith. Outbreaks of foodborne disease in the United States, 1972-

1978. J. Infect. Dis. 142(1):122-125, 1980. 

9. Stersky, A., E. Todd, and H. F. Pivnick. Food poisoning associated with post-process 

leakage (PPL) in canned foods. J. Food Protect. 43(6):465-476, 483, 1980. 

10. Terranova, W., J. G. Breman, R. P. Locey, S. B. Speck. Botulism type B: epidemiologic 

aspects of an extensive outbreak. Am. J. Epidemiol. 108(2):150-156, 1978. 

11. Thompson, R. C. A tin of salmon had but a tiny hole. FDA Consumer 16(5).7-9, 1982. 

Part II – Product Spoilage 

1. Ashton, D. H. Thermophilic organisms involved in food spoilage: thermophilic anaerobes 

not producing hydrogen sulfide. J. Food Protect. 44(2):146-148, 1981. 

2. Davidson, P. M., I. J. Pflug, and G. M. M. Smith. Microbiological analysis of food product 

in swelled can of low-acid foods collected from supermarkets. J. Food Protect. 44(9):686-

691, 1981. 

3. Howitz, M. A., J. S. Marr, M. H. Merson, V. R. Dowell, and J. M. Ellis. A continuing 

common-source outbreak of botulism in a family. Lancet 2(7940):861-863, 1975. 

22
Thermally Processed, Commercially Sterile 

4. Lake, D. E., R. R. Graves, R. S. Lesniewski, and J. E. Anderson. Post-processing spoilage of 

low-acid canned foods by mesophilic sporeformers. J. Food Protect. 48(3):221-226, 1985. 

5. Lynt, R. K., D. A. Kautter, and R. B. Read, Jr. Botulism in commercially canned foods. J. 

Milk Food Technol. 38(9):546-550, 1975. 

6. Matsuda, N., M. Komaki, R. Ichikawa, and S. Gotoh. [Cause of microbial spoilage of canned 

foods analysed during 1968-1980.] J. Japanese Society Food Science Technology 32(6):444-

449, 1985. 

7. McDaniel, M. R., R. Diamant, E. R. Loewen, and D. H. Berg. Dangerous canning practices 

in Manitoba. Canadian J. Public Health 72(1):58-62, 1981. 

8. Pflug, I. J., P. M. Davidson, and R. G. Holcomb. Incidence of canned food spoilage at the 

retail level. J. Food Protect. 44(9):682-685, 1981. 

9. Rhodehamel, E. J., N. R. Reddy, and M. D. Pierson. Botulism: the causative agent and its 

control in foods. Food Control 3(3):125-143, 1992. 

10. Tsai, S. J., Y. C. Chang, J. D. Wang, and J. H. Chou. Outbreak of type A botulism caused by 

a commercial food product in Taiwan: clinical and epidemiological investigations. Chung 

Hua I Hsueh Tsa Chih. 46(1):43-48, 1990. 

11. United States of America, National Food Processors Association/Can Manufacturing 

Institute, Container Integrity Task Force. Botulism risk from post-processing contamination 

of commercially canned foods in metal containers. NFPA/CMI container integrity task 

force, microbiological assessment group report. J. Food Protect. 47(10):801-816, 1984. 

Part III – Physical and Chemical Contamination 

1. Andres, C. Food processors benefit from 2-piece vs. 3-piece can technology race. Food 

Processing 42(6):124-126, 1981. 

2. Barbieri, G. [Tinplate cans for foods, soldered with Pb/Sn alloys.] Rivista della Societa 

Italiana de Scienza dell’Alimentazione 12(2):125-126, 1983. 

3. Biffoli, R. et al. [Contamination of canned foods with metals.] Rivista della Societa Italiana 

de Scienza dell’Alimentazione 9(4):241-246, 1980. 

4. Brand, N. G. [Broken glass in bottles.] Brygmesteren 35(2):55-56, 1978. 

23
Thermally Processed, Commercially Sterile 

5. Gibson, R. [Food contamination is not an isolated occurrence.] 

Voedingsmiddelentechnologie 26(24):23, 1993. 

6. Jorhem, L. and S. Slorach. [Less lead and tin in canned foods.] Var Foeda 43(6):312-316, 

337, 1991. 

7. Lopez-Martinez, C., et al. [Levels of Pb contamination in canned foods: meat, sea-foods, 

vegetables and prepared dishes.] Anales de Bromatologia 39(2):239-246, 1987. 

8. Ludwigsen, R. J. Container contribution to lead in canned foods. Rivista della Societa 

Italiana de Scienza dell’Alimentazione 11(6):369-382, 1982. 

9. Prosic, Z., et al. [Organochlorine pesticides in canned meat.] Hrana I Ishrana 28(4):199-202, 

1987. 

10. Renesse, R. L., van and J. W. Klumper. [Glass in foods: prevention is not always possible.] 

Voedingsmiddelentechnologie 26(24):31-34, 1993. 

11. Sanchez-Saez, J. J., et al. [Pb and Cu contents of canned cooked meals.] Boletin del Centro 

Nacional de Alimentacion y Nutricion No. 5, 14-17, 1981. 

12. Thomas, G. [Measures for prevention of contamination of canned foods.] Revue Francaise 

de Dietetique 18(71):27-31, 1974. 

13. Yokomizo, Y. [Contamination of processed foods with pesticide residues.] Boletin del 

Centro Nacional de Alimentacion y Nutricion 16(1):41-51, 1979. 

24
Thermally Processed, Commercially Sterile 

APPENDIX B

25
Thermally Processed, Commercially Sterile 

PROCESS FLOW DIAGRAM Figure 1 

PROCESS CATEGORY: THERMALLY PROCESSED, COMMERCIALLY STERILE 

PRODUCT: BEEF STEW 

RECEIVING 

CANS/PACKAGING 

MATERIALS 

STORAGE 

CANS/ 

MATERIALS 

RECEIVING 

NON-MEAT 

FOOD 

INGREDIENTS 

STORAGE 

NON-MEAT FOOD 

INGREDIENTS 

ASSEMBLE / PRE-WEIGH 

CUT-UP / PRE-MIX 

NON-MEAT FOOD 

INGREDIENTS 

RECEIVING 

FROZEN COOKED 

DICED BEEF 

STORAGE 

FROZEN COOKED 

DICED BEEF 

ASSEMBLE/ WEIGH 

PRE-GRIND / RE-WORK 

FINAL GRIND 

COOKED DICED BEEF 

FORMULATION 

FILLING 

SEALING 

SHIPPING 

CLEANING 

CANS 

THERMAL 

PROCESSING & 

COOLING 

LABELING 

AND 

CASING 

STORAGE 

PACKAGING 

26
Thermally Processed, Commercially Sterile 

PRODUCT DESCRIPTION Figure 2

PROCESS CATEGORY: THERMALLY PROCESSED, COMMERCIALLY STERILE 

PRODUCT: BEEF STEW 

1. COMMON NAME? BEEF STEW 

2. HOW IS IT TO BE USED? PRODUCT IS READY-TO-EAT; TYPICALLY 

HEATED BEFORE CONSUMPTION. INTENDED 

FOR PERSONS WITHOUT SPECIAL DIETARY 

REQUIREMENTS OR PROBLEMS 

3. TYPE OF PACKAGE? METAL, DOUBLE-SEAMED(“SANITARY”) CAN 

4. LENGTH OF SHELF LIFE, 2-3 YEARS UNDER COOL (e.g., 75°F OR 

AT WHAT TEMPERATURE? LOWER), DRY CONDITIONS; MUST BE 

PROTECTED FROM FREEZING 

5. WHERE WILL IT BE SOLD? RETAIL 

CONSUMERS? GENERAL PUBLIC 

INTENDED USE? HEAT AND CONSUME 

6. LABELING INSTRUCTIONS? NO SPECIAL INSTRUCTIONS 

7. IS SPECIAL DISTRIBUTION NONE REQUIRED 

CONTROL NEEDED? 

27
Thermally Processed, Commercially Sterile 

HAZARD ANALYSIS – THERMALLY PROCESSED, COMMERCIALLY STERILE 

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 – Frozen 

Cooked Diced Beef 

Biological: Listeria monocytogenes 

Yes Growth of pathogens due 

to improper temperature and handling. 

Measure and record temperature of incoming lots. Check container integrity. 

Chemical – Antibiotic and pesticide residues. 

No Supplied by inspected 

establishments. 

Physical – Foreign materials 

No Pieces of broken glass, 

metal, or plastic has been found in product in the past. 

Visual examination 

Receiving – Non-meat Food Ingredients 

Biological – Bacterial spores Clostridium botulinum 

No The bacterial spore load 

is controlled at the establishment by the thermal process sufficient to destroy > 1012 spores of 

Clostridium botulinum. 

Proper application of the thermal process 

Chemical –Pesticides No Plant records show that 

there has not been a problem in the past. 

Physical – wood, metal in dried beans, potatoes, etc. 

Yes Pieces of broken glass, 

metal, or plastic have been found in ingredients in the past. 

Visual examination and metal detectors used at receiving. 

28
Thermally Processed, Commercially Sterile 

HAZARD ANALYSIS – THERMALLY PROCESSED, COMMERCIALLY STERILE 

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 – Cans/ Packaging Materials 

Biological – None Chemical – None Physical –Foreign Material 

Yes Wood, metal, or glass 

may get on the cans during storage and shipping if protective packaging or containers are damaged. 

Control can be applied most effectively at process steps where cans are inverted and cleaned. 

Storage -Frozen Cooked Diced Beef 

Biological - Pathogens No Pathogens are not 

reasonably likely to grow in this product if temperature is maintained at or below a level sufficient to preclude their growth. 

Chemical – None Physical – None 

Storage – Non-meat Food Ingredients 

Biological – None Chemical – None Physical - None 

29
Thermally Processed, Commercially Sterile 

HAZARD ANALYSIS – THERMALLY PROCESSED, COMMERCIALLY STERILE 

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 – Cans/ 

Packaging Materials 

Biological - None Chemical – Chemicals No Packing materials 

stored in a location that does not allow chemical contamination. 

Physical – Foreign Material 

No Packing materials 

stored in a location that does not allow foreign material contamination. 

Assemble /Weigh 

Pre-grind / Re-work 

Final Grind – Cooked 

Diced Beef 

Biological – None Chemical – None Physical - None 

Assemble / Pre-weigh 

Cut-up / Pre-mix 

Non-meat Food 

Ingredients 

Biological – None Chemical- None Physical – None 

30
Thermally Processed, Commercially Sterile 

HAZARD ANALYSIS – THERMALLY PROCESSED, COMMERCIALLY STERILE 

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? 

Cleaning Cans Biological --None 

Chemical – None Physical – Foreign Material 

Yes Foreign material in 

container. 

Control of cleaning operation. Use of removable can twists. 

Formulation Biological – Improper 

formulation may allow survival of Clostridium 

botulinum spores. 

Yes Improper application 

of thermal process may allow the survival of Clostridium botulinum spores. 

Operational formulation controls as defined by a Process Authority. 

Chemical – None Physical - None 

Filling Biological – Improper 

Fill 

Yes If the containers are 

not filled per the processing authority’s recommendations, the thermal process may be inadequate. 

Operational filling controls. 

Chemical- None Physical – None 

31
Thermally Processed, Commercially Sterile 

HAZARD ANALYSIS – THERMALLY PROCESSED, COMMERCIALLY STERILE 

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? 

Sealing Biological – None 

Chemical- None Physical – None 

Thermal Processing 

and Cooling 

Biological – Survival of Clostridium botulinum spores due to inadequate process. 

Yes Improper application of 

thermal process may 

allow the survival of Clostridium botulinum spores. 

Operational thermal processing controls. 

Chemical- None Physical – None 

Labeling and Casing Biological – None 

Chemical- None Physical – None 

Storage Biological – None 

Chemical- None Physical – None 

Shipping Biological – None 

Chemical- None Physical – None 

32
Thermally Processed, Commercially Sterile 

HACCP PLAN 

PROCESS CATEGORY: THERMALLY PROCESSED, COMMERCIALLY STERILE PRODUCT EXAMPLE: BEEF STEW 

CCP # and 

Location 

Critical 

Limits 

Monitoring 

Procedures and 

Frequency 

HACCP 

Records 

Verification Procedures and 

Frequency 

Corr

1B Receiving – Frozen Cooked Diced Beef 

Temperature within plant specifications. Meat must be received at 10°F or below to maintain in frozen state. 

Receiver will check the temperature of each load of meat received. Results will be recorded, initialed, signed & dated in the Product Temperature Receiving Log. 

Product Temperature Receiving Log Thermometer Calibration Log Corrective Action Log 

Receiving supervisor will observe receiving employee taking product temperature or will take product temperature once per shift Receiving supervisor will review Product Temperature Receiving Log, Corrective Action Log, Calibration Log & Verification records 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. 

Receiver will h10°F and notifrejected meat wsupplier. Supplier historCondemned m

the plant. 

Signature : _______________________________ Date:___________________________ 

33
Thermally Processed, Commercially Sterile 

HACCP PLAN 

PROCESS CATEGORY: THERMALLY PROCESSED, COMMERCIALLY STERILE PRODUCT EXAMPLE: BEEF STEW 

CCP # and 

Location 

Critical 

Limits 

Monitoring 

Procedures and 

Frequency 

HACCP 

Records 

Verification Procedures and 

Frequency 

Corr

2P Receiving – Frozen Cooked Diced Beef 

No visible hazardous foreign material (e.g., glass); no visible metal contamination. 

Receiver will visually examine a random sample from each lot received for foreign material. 

Receiving Log Corrective Action Log 

QA supervisor will review Receiving Log twice per shift. QA supervisor will observe visual inspection of incoming product by receiver once per shift. 

Receiver will ereceived is from company approSupplier historthere is a trend meet the criticano longer be uIf hazardous fo

detected in or oidentify and cofor dispositioncontrolled prodQA will take areoccurrence. 

Signature : ________________________________ Date:___________________________ 

34
Thermally Processed, Commercially Sterile 

HACCP PLAN 

PROCESS CATEGORY: THERMALLY PROCESSED, COMMERCIALLY STERILE PRODUCT EXAMPLE: BEEF STEW 

CCP # and 

Location 

Critical 

Limits 

Monitoring 

Procedures and 

Frequency 

HACCP 

Records 

Verification Procedures and 

Frequency 

Corr

3P Receiving -Non-meat Food Ingredients 

No visible hazardous foreign material (e.g., glass); no metal contamination ∃1/32 inch. 

Receiver will examine each lot for foreign material using metal detector and visual examination. QA will examine a random sample from each lot for foreign material using metal detector and visual examination. 

Receiving Log Metal Detector Log Corrective Action Log 

Maintenance supervisor will verify metal detectors are functioning. QA will verify that the metal detectors are functioning as intended by running a seeded sample through the metal detectors twice per shift (once in the AM and once in the PM). 

Receiving supesegregate affecMaintenance pand eliminate tmetal detectorsPreventive mai

be implementeQA will run a the metal detec

Signature : ________________________________ Date:___________________________ 

35
Thermally Processed, Commercially Sterile 

HACCP PLAN 

PROCESS CATEGORY: THERMALLY PROCESSED, COMMERCIALLY STERILE PRODUCT EXAMPLE: BEEF STEW 

CCP # and 

Location 

Critical 

Limits 

Monitoring 

Procedures and 

Frequency 

HACCP 

Records 

Verification Procedures and 

Frequency 

Corr

4P Cleaning Cans 

No visible hazardous foreign material (e.g., glass, metal). 

Can washer operator will visually examine cans as they exit washer to ensure unit is operating properly and cans are adequately cleaned. QA will randomly visually check cans as they exit washer at a frequency determined using a statistical randomization chart. Daily check to determine that can twists are installed & working properly. 

Can Washer Log Corrective Action Log 

QA supervisor will review Can Washer Log and Corrective Action Log twice per shift. QA supervisor will observe can washer operator. Maintenance will verify can twists are properly installed and operating on a weekly basis. 

If can washer ooperator will suncleaned cansdesignee. Wherestored, cans rexamined by Qwasher. QA will take areoccurrence. Maintenance wrepairs to cleanmaintenance sc

Signature : ________________________________ Date:___________________________ 

36
Thermally Processed, Commercially Sterile 

HACCP PLAN 

PROCESS CATEGORY: THERMALLY PROCESSED, COMMERCIALLY STERILE PRODUCT EXAMPLE: BEEF STEW 

CCP # and 

Location 

Critical 

Limits 

Monitoring 

Procedures and 

Frequency 

HACCP 

Records 

Verification Procedures and 

Frequency 

Corr

5B Formulation 

Criteria as specified by the Processing Authority (e.g. maximum sauce viscosity value). 

Head formulation cook will check ingredient characteristics, quantities, sauce viscosity and conformance with specified formulation procedure for each batch prepared. Plant designee will check the time elapsed from assembly to 

commercial 

sterilization for each batch to determine that it meets limits specified by the processing authority. * 

Formulation Log Process Deviation Log Corrective Action Log 

QA will review the formulation log twice a week to verify that every batch is properly formulated. QA will audit to verify sampling techniques and accuracy of records; determine if the critical limit corresponds to the plant records; check to see if critical limits are adequate for hazard; assure corrective actions are adequate, document findings. 

Head formulatbatch for transnot been formuexceeded the tipossible, rejectreformulated. Owill be condemQA will take areoccurrence. 

* Time elapsed will not always be specified as critical factor by a Processing Authority.Signature : ________________________________ Date:___________________________ 

37
Thermally Processed, Commercially Sterile 

HACCP PLAN 

PROCESS CATEGORY: THERMALLY PROCESSED, COMMERCIALLY STERILE PRODUCT EXAMPLE: BEEF STEW 

CCP # and 

Location 

Critical 

Limits 

Monitoring 

Procedures and 

Frequency 

HACCP 

Records 

Verification Procedures and 

Frequency 

Corr

6B Filling 

Criteria as specified by the Processing Authority (e.g. maximum fill weight). 

Fill operator will ensure that filled containers are run through an automatic 

over/under check weigher set to reject above the weight limit once per hour. Also, the “toppers” on the seamer will be set to produce headspace in excess of prescribed minimum. 

Weight / Headspace Log Process Deviation Log Corrective Action Log 

QA will review the records and twice weekly verify the accuracy and measure sample weights and headspaces daily to ensure that weight and headspace standards are met. QA will audit to verify sampling techniques and accuracy of the records; determine if the critical limit 

corresponds to the plant records; check to see if critical limits are adequate for hazard; assure corrective actions are adequate, document findings. Weekly 

calibration of filler. 

Production forthat all rejected and contents reQA will take areoccurrence. 

Signature : ________________________________ Date:___________________________ 

38
Thermally Processed, Commercially Sterile 

HACCP PLAN 

PROCESS CATEGORY: THERMALLY PROCESSED, COMMERCIALLY STERILE PRODUCT EXAMPLE: BEEF STEW 

CCP # and 

Location 

Critical 

Limits 

Monitoring 

Procedures and 

Frequency 

HACCP 

Records 

Verification Procedures and 

Frequency 

Corr

7B Thermal Processing and Cooling 

Criteria as specified by the Processing Authority (e.g. minimum product initial temperature, minimum retort temperature, minimum process time, etc.). 

Retort operator will monitor and record thermal processing conditions at intervals determined to be sufficient by the processing authority to ensure that the process schedule is properly applied, including process application, venting procedures. 

Process Operating Log Recorder Charts Process Deviation Log Corrective Action Log 

QA will review the logs and charts within one working day after the thermal process. QA will audit to verify sampling techniques and accuracy of records; determine if the critical limit corresponds to the plant records; check to see if critical limits are adequate for hazard; assure corrective actions are adequate, document findings. Quarterly calibration of retort. 

If a process dedesignee will aprocess schedusituation or hoprocessing authQA will take areoccurrence. Product will be using the altern

Signature : ________________________________ Date:___________________________ 

39
Thermally Processed, Commercially Sterile 

THERMOMETER CALIBRATION LOG 

Calibrate to 320 F while thermometer is in slush ice water. 

Date Time Department or 

Area 

Thermometer ID# Personal 

Thermometer Reading 

Adjustment Required (Yes or No) 

Initials Comments 

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

40
Thermally Processed, Commercially Sterile 

GENERIC ESTABLISHMENT X: METAL DETECTION LOG 

Date Product Lot # Results Seeded 

Sample 

Time Monitored By Ve

41
Thermally Processed, Commercially Sterile 

GENERIC ESTABLISHMENT X: PROCESS OPERATING LO

Product ______________________ Retort OperaCode ________________________ Date _______Can Size _____________________No. Cans/Retort _______________Min. Product Int. Temp. _________Process Time/Temperature ______/________Batch No. Retort No. Int 

Temp 

Time Steam On 

Time Vent Closed 

Retort Temp at End of Vent 

Actual Process Time Start Stop Total 

TemperatuMIG Ch

42
Thermally Processed, Commercially Sterile 

GENERIC ESTABLISHMENT X: PROCESS DEVIATION LOG 

Date of Deviation 

Retort No. Product Product Code Product Disposition 

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Thermally Processed, Commercially Sterile 

CORRECTIVE ACTIONS LOG 

Product: ___________________________________________ Lot # ________

CCP Deviation/ 

Problem 

Corrective Action 

Procedures/Explain 

Disposition of 

Product 

Respo

Per

SIGNATURE: __________________________ DATE: ___________________

44
Thermally Processed, Commercially Sterile 

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 met; Certification (if applicable) as per plan; Deviations if occfor appropriate corrective actions; Records complete and accurate. 

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