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Hazard Analysis and Risk-Based 

Preventive Controls for Human Food: 

Draft Guidance for Industry1

This draft guidance, when finalized, will represent the current thinking of the Food and Drug 

Administration (FDA or we) on this topic. It does not establish any rights for any person and is 

not binding on FDA or the public. You can use an alternative approach if it satisfies the 

requirements of the applicable statutes and regulations. To discuss an alternative approach, 

contact FDA’s Technical Assistance Network by submitting your question

at https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm.

Chapter 6: Use of Heat Treatments as a Process Control

Table of Contents

6.1 Purpose of this Chapter

6.2 Considerations to Keep in Mind If You Use a Heat Treatment as a 

Process Control

6.3 Examples Used in this Chapter

6.4 Understand the Potential Hazard

6.5 Terms Used in This Chapter

6.6 Design and Validation of the Heat Treatment

6.7 Develop a Strategy for Preventive Control Management Components

6.8 Establish and Implement Monitoring Procedures

6.8.1 What to Monitor

6.8.2 How to Monitor

6.8.2.1 How to monitor batch heating equipment

6.8.2.2 How to monitor continuous heating equipment

 1 This guidance has been prepared by the Office of Food Safety in the Center for Food Safety and 

Applied Nutrition at the U.S. Food and Drug Administration. Underlined text in yellow highlights 

represents a correction from the draft Chapter 6 that we issued for public comment in August 2017.
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6.8.3 How Often to Monitor (Frequency of Monitoring)

6.8.3.1 How often to monitor batch heating equipment

6.8.3.2 How often to monitor continuous heating equipment

6.8.4 Who performs the monitoring

6.9 Establish and Implement Corrective Action Procedures

6.10 Determine Verification Procedures

6.11 Establish and Maintain Records

6.11.1 Records of Monitoring Activities

6.11.1.1 Records of monitoring activities for batch heating equipment

6.11.1.2 Records of monitoring activities for continuous heating equipment

6.11.2 Records of Corrective Actions

6.11.3 Record of On-going Verification Activities

6.12 Example of Cookie Processor A’s Heat Treatment

6.12.1 Cookie Processor A’s Product, Hazard Analysis, and Batch Heat Treatment

6.12.2 Cookie Processor A’s Process Design and Validation

6.12.3 Cookie Processor A’s Monitoring

6.12.3.1 What Cookie Processor A monitors

6.12.3.2 How Cookie Processor A monitors

6.12.3.3 How often Cookie Processor A monitors

6.12.3.4 Who monitors critical factors for Cookie Processor A’s heat treatment

6.12.4 Cookie Processor A’s Corrective Action Procedures

6.12.5 Cookie Processor A’s Verification Procedures

6.12.6 Cookie Processor A’s Monitoring Records

6.12.7 Cookie Processor A’s Records of Corrective Actions

6.12.8 Cookie Processor A’s Verification Records

6.12.9 Summary Process Control Table for Cookie Processor A

6.13 Example of Cookie Processor B’s Heat Treatment

6.13.1 Cookie Processor B’s Product, Hazard Analysis, and Continuous Heat 

Treatment

6.13.2 Cookie Processor B’s Process Design and Validation

6.13.3 Cookie Processor B’s Monitoring
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6.13.3.1 What Cookie Processor B monitors

6.13.3.2 How Cookie Processor B monitors

6.13.3.3 How often Cookie Processor B monitors

6.13.3.4 Who monitors critical factors for Cookie Processor B’s heat treatment

6.13.4 Cookie Processor B’s Corrective Action Procedures

6.13.5 Cookie Processor B’s Verification Procedures

6.13.6 Cookie Processor B’s Monitoring Records

6.13.7 Cookie Processor B’s Records of Corrective Actions

6.13.8 Cookie Processor B’s Verification Records

6.13.9 Summary Process Control Table for Cookie Processor B

6.14 Example of Soup Processor A’s Heat Treatment

6.14.1 Soup Processor A’s Product, Hazard Analysis, and Batch Heat Treatment

6.14.2 Soup Processor A’s Process Design and Validation

6.14.3 Soup Processor A’s Monitoring

6.14.3.1 What Soup Processor A monitors

6.14.3.2 How Soup Processor A monitors

6.14.3.3 How often Soup Processor A monitors

6.14.3.4 Who monitors critical factors for Soup Processor A’s heat treatment

6.14.4 Soup Processor A’s Corrective Action Procedures

6.14.5 Soup Processor A’s Verification Procedures

6.14.6 Soup Processor A’s Monitoring Records

6.14.7 Soup Processor A’s Records of Corrective Actions

6.14.8 Soup Processor A’s Verification Records

6.14.9 Summary Process Control Table for Soup Processor A

6.15 Example of Soup Processor B’s Heat Treatment

6.15.1 Soup Processor B’s Product, Hazard Analysis, and Continuous Heat Treatment

6.15.2 Soup Processor B’s Process Design and Validation

6.15.3 Soup Processor B’s Monitoring

6.15.3.1 What Soup Processor B monitors

6.15.3.2 How Soup Processor B monitors

6.15.3.3 How often Soup Processor B monitors
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6.15.3.4 Who monitors critical factors for Soup Processor B’s heat treatment

6.15.4 Soup Processor B’s Corrective Action Procedures

6.15.5 Soup Processor B’s Verification Procedures

6.15.6 Soup Processor B’s Monitoring Records

6.15.7 Soup Processor B’s Records of Corrective Actions

6.15.8 Soup Processor B’s Verification Records

6.15.9 Summary Process Control Table of Soup Processor B

6.16 Example of Salsa Processor A’s Heat Treatment

6.16.1 Salsa Processor A’s Product, Hazard Analysis, and Heat Treatment

6.16.2 Salsa Processor A’s Process Design and Validation

6.16.3 Salsa Processor A’s Monitoring

6.16.3.1 What Salsa Processor A monitors

6.16.3.2 How Salsa Processor A monitors

6.16.3.3 How often Salsa Processor A monitors

6.16.3.4 Who monitors critical factors for Salsa Processor A’s heat treatment

6.16.4 Salsa Processor A’s Corrective Action Procedures

6.16.5 Salsa Processor A’s Verification Procedures

6.16.6 Salsa Processor A’s Monitoring Records

6.16.7 Salsa Processor A’s Records of Corrective Actions

6.16.8 Salsa Processor A’s Verification Records

6.16.9 Summary Process Control Table for Salsa Processor A

6.17 References

Appendix 6. Summary Process Control Tables for the Examples in 

Chapter 6

Appendix 6-A: Summary Process Control Table for Baking; Cookie Processor A

Appendix 6-B: Summary Process Control Table for Baking; Cookie Processor B

Appendix 6-C: Summary Process Control Table for Cooking; Soup Processor A

Appendix 6-D: Summary Process Control Table for Cooking; Soup Processor B

Appendix 6-E: Summary Process Control Table for Heat Treatment; Salsa 

Processor A
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6.1 Purpose of this Chapter

The purpose of this chapter is to explain how to establish and implement a heat treatment (e.g., 

baking or cooking) as a process control for bacterial pathogens. See Chapter 4 – Preventive 

Controls for additional detail on heat and other lethal treatments. 

This chapter does not address controlling bacterial pathogens by those heat treatments, such 

as retort processes, that are subject to 21 CFR part 113 (Thermally Processed Low-Acid Foods 

Packaged in Hermetically Sealed Containers; commonly called “Low-Acid Canned Foods”

(LACF)) because the microbial hazards in LACF are not subject to the requirements for hazard 

analysis and risk-based preventive controls. 

6.2 Considerations to Keep in Mind If You Use a Heat Treatment as a 

Process Control

Heating is only one of the process controls that you may choose to use to produce a safe 

product. Based on your hazard analysis, there may be other process controls to consider. In 

addition, the heat treatments discussed in this chapter are designed to kill/destroy vegetative 

cells of bacterial pathogens (e.g., Salmonella), but are not adequate to inactivate spores of 

sporeforming bacteria (e.g., all strains of C. botulinum). Therefore, if you use one of the heat 

treatments described in this chapter, you may need to establish and implement additional 

preventive controls to control spores. See Chapter 4 for further information regarding additional 

process controls for pathogenic sporeformers. See Table 6-1 for additional strategies for 

controlling bacterial pathogens.

Table 6-1 Strategies Other than Heat Treatment for Controlling Bacterial Pathogens

Preventive Control Chapter 

Time/Temperature Control 7

Formulation Control (e.g., water activity, pH, 

and chemical preservatives)

8

Dehydration/Drying 9

Sanitation Controls 10

6.3 Examples Used in this Chapter

Sections 6.12 through 6.16 of this chapter provide examples to illustrate how to properly apply 

heat treatments as a process control and to establish and implement preventive control 

management components (i.e., monitoring, corrective actions and corrections, and verification)

for those heat treatments. These examples are:
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• Cookie Processor A: Cookies baked using a batch process (in batches on trays in 

convection ovens), wrapped by twos in plastic (Section 6.12) 

• Cookie Processor B: Cookies baked using a continuous process (in a continuous band 

oven), packaged in boxes of 24 cookies (Section 6.13)

• Soup Processor A: Ready-to-Eat (RTE) soups containing vegetable particles, cooked using 

a batch process (in a kettle), packaged in 8 ounce plastic bowls, and frozen (Section 6.14)

• Soup Processor B: RTE soups (clear broths and creamed vegetable soups, without 

vegetable particles) cooked using a continuous process (in a continuous flow heat 

exchanger), packaged in 5 gallon bags, and refrigerated (Section 6.15)

• Salsa Processor A: Chopped mixed vegetable salsa (an acidified food) that is directly 

acidified, cooked in a kettle, and hot-filled into glass jars (Section 6.16)2

Each of these examples describes certain activities that must be either performed, or overseen 

by, a preventive controls qualified individual (PCQI). When a PCQI oversees (rather than 

performs) these activities, the activity could be performed by a designee of the PCQI. For 

simplicity, we describe the activity as performed by a PCQI, without specifying each time that 

the activity could be performed by a designee of a PCQI.

6.4 Understand the Potential Hazard

Heat is known to be effective against bacterial pathogens and is a common process control for 

these hazards. However, if heat treatments are not properly designed and implemented, the 

pathogens of concern may survive the process and cause illness. See Chapter 3 for more 

information on bacterial pathogens.

6.5 Terms Used in This Chapter 

Part 117 specifies that process controls include procedures, practices, and processes to ensure 

the control of parameters during operations such as heat processing, acidifying, irradiating, and 

refrigerating foods. Process controls must include, as appropriate to the nature of the applicable 

control and its role in the facility’s food safety system: (1) Parameters associated with the 

control of the hazard; and (2) the maximum or minimum value, or combination of values, to 

which any biological, chemical, or physical parameter must be controlled to significantly 

minimize or prevent a hazard requiring a process control. (See 21 CFR 117.135(c)(1).)

The examples in this chapter describe:

• Process parameters such as baking/cooking time, baking/cooking temperature, dough 

weight, particle size, belt speed, and pump speed;

• Maximum values for some of these process parameters (e.g., 28 g portion of dough); and

 2 In forthcoming chapters, we will provide an example of formulation control for this acidified food

(Chapter 8 – Use of Formulation as a Process Control) and an example of control of glass hazards 

(Chapter 13 – Preventive Controls for Physical Hazards).
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• Minimum values for some of these process parameters (e.g., 350°F (177°C) minimum 

baking temperature, 13 minutes minimum baking time).

Process controls typically are established at “critical control points” (CCPs). “CCP” is a term 

commonly used in HACCP systems. In HACCP systems, the maximum or minimum values for a 

process parameter established at a CCP are called “critical limits.” Our HACCP regulation for 

juice (21 CFR part 120) defines “critical limit” as the maximum or minimum value to which a 

physical, biological, or chemical parameter must be controlled at a critical control point to 

prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food hazard.

Part 117 does not preclude the use of terms (such as “critical limits” and “critical factors”) that 

are associated with HACCP systems. Because the maximum or minimum values for the 

process parameters described in the examples in this chapter are established at CCPs, we see 

no meaningful difference between the terms “maximum value” and “minimum value” used in part 

117 for a process control and the term “critical limit” used in HACCP systems for controls 

established at CCPs. Therefore, in this chapter we use the term “critical limit” when referring to 

a maximum or minimum value established for a process control parameter. Because part 117 

specifies that preventive controls include controls, other than those at CCPs, that are also 

appropriate for food safety (21 CFR 117.135(a)(2)(ii)), in this chapter we use the more general 

term “process parameter” (rather than “critical factor”) when referring to parameters other than 

those specified in the examples with critical limits. 

Part 117 does not define the term “operating limit.” In this guidance, we use the term “operating 

limit” to mean criteria that may be more stringent than critical limits and are established for 

reasons other than food safety. For example, if you bake cookies and establish 13 minutes as 

the critical limit for the minimum baking time to control bacterial pathogens, you could establish 

15 minutes as an operating limit for the baking time and assess the cookies for quality if the 

baking time is less than 15 minutes, but still exceeds the critical limit of 13 minutes (e.g., if the 

baking time was 14 minutes). 

Part 117 does not define the term “adjustment.” In this guidance, we use the term “adjustment” 

when referring to an intervention that you take if you determine that there is a deviation from an 

operating limit, without a deviation from a critical limit. For example, if you bake cookies,

establish 28 g as the maximum value (critical limit) for the weight of cookie dough deposited by 

an automatic dough depositor, and establish 27 g as the operating limit for the weight of cookie 

dough, you could make an adjustment to the dough depositor if you observe that the amount of 

dough deposited exceeds the operating limit of 27 g, but does not exceed the critical limit of 28 

g. 

6.6 Design and Validation of the Heat Treatment

The heat treatments discussed in this chapter are designed to significantly minimize (eliminate 

or reduce to an acceptable level) vegetative cells of bacterial pathogens that may have been 

introduced into the food by raw materials or during processing steps that occur before the heat 

step. With few exceptions, the PCHF requirements specify that you must validate that the 

preventive controls are adequate to control the hazard as appropriate to the nature of the 

preventive control and its role in your food safety system. The validation of the preventive 

controls must be performed (or overseen) by a PCQI. (See 21 CFR 117.160.)
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To control bacterial pathogens using a heat treatment adequate to ensure that the pathogens do 

not survive the process, you should:

• Scientifically establish a heat treatment that will significantly minimize the target bacterial 

pathogens (eliminate them or reduce their numbers to acceptable levels); 

• Design and operate the heat treatment equipment so that every unit of product receives at 

least the established minimum heat treatment; and

• Monitor the established process parameters to verify achievement of the scientifically 

established heat treatment (e.g., time and temperature).

You could establish process parameters and the critical limits for the process parameters based 

on scientific information, usually obtained by a scientific study (often from studies in the 

literature). You also could obtain this information from a process authority that has knowledge 

about process parameters and minimum/maximum values (e.g., critical limits) for the product 

being produced. A process authority could also conduct the studies that would establish a valid 

heat treatment. 

For heat treatments, examples of process parameters include:

• Amount of time for the heat treatment (e.g., the amount of time exposed to heat as 

determined by the speed of the belt through a continuous oven, or observed number of 

minutes at a boil for some cooking processes)3

; 

• Temperature of the heating medium (e.g., temperature of oven or steam or water used for 

cooking); 

• Internal Temperature (IT) of the product; 

• Final temperature of the product; 

• Particle size (e.g., when heat must penetrate particles such as chopped vegetables so that 

the interior of the particles receives a complete heat treatment); 

• Depth of product on a conveyor belt; 

• Container size (e.g., can dimensions when products are heated in containers); and 

• Product formulation. 

When a study is conducted to establish a valid heat treatment, that study could identify other 

process parameters that affect the rate of heating of the product. 

 3 When an End-Point Internal Product Temperature (EPIPT) has been determined by a study, there is no 

time associated with the heat treatment.
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6.7 Develop a Strategy for Preventive Control Management 

Components 

With few exceptions, part 117 specifies that preventive controls are subject to the following 

preventive control management components as appropriate to ensure the effectiveness of the 

preventive controls, taking into account the nature of the preventive control and its role in the 

facility’s food safety system: (1) Monitoring; (2) corrective actions and corrections; and (3) 

verification. (See 21 CFR 117.140.) In the remainder of this chapter, we discuss each of these 

preventive control management components when the process control is a heat treatment. See 

Sections 6.12 through 6.16 for examples that provide more detail about how to apply each of 

these preventive control management components to specific types of heat treatments. 

6.8 Establish and Implement Monitoring Procedures

Part 117 requires that, as appropriate to the nature of the preventive control and its role in your 

food safety system, you establish and implement written procedures, including the frequency 

with which they are to be performed, for monitoring the preventive control. You must monitor the 

preventive controls with adequate frequency to provide assurance that they are consistently 

performed. (See 21 CFR 117.145.)

6.8.1 What to Monitor

Heat treatments designed to significantly minimize pathogens play a key role in your food safety 

system. When a heat treatment is your preventive control and you have established critical 

factors for the heat treatment (e.g., as identified by a scientific study or provided by an expert in 

thermal processing, such as a process authority), you would monitor those critical factors. 

Exceptions to such monitoring include heat treatments that are designed such that a process 

parameter is automatically controlled, e.g., when a bar is placed at a specified height above a 

conveyor belt to ensure that the bed depth of product being heat treated cannot exceed the 

depth determined to be the critical limit for the depth of product. 

6.8.2 How to Monitor

6.8.2.1 How to monitor batch heating equipment

For most temperature determinations in batch heating equipment, you should use a continuous 

temperature-recording device (e.g., a recording thermometer). You should install the device 

where it measures the coldest temperature of the cooking equipment (the cold spot determined 

by a study). In some instances (e.g., to determine the IT prior to heating or to determine the 

EPIPT), you could use a temperature-indicating device (e.g., a thermometer). Where cooking is 

performed at the boiling point, you could visually observe minutes at a boil.

For the heating time of a batch process, you should record the times of the start and the end of 

the cooking or baking cycle and calculate the heating time from this information. To help you do 

so, you could set timers to give an audible or visible indication that the cooking or baking time 

has been completed.
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For most heat treatments, you should monitor both temperature and time. However, when an 

EPIPT has been scientifically established, you could monitor only the finished product 

temperature, because there is no time associated with the heat treatment.

For other process parameters, use appropriate equipment to monitor the parameter, e.g., scales 

when you establish a critical limit for a weight; rulers or calipers when you establish a critical

limit for size.

6.8.2.2 How to monitor continuous heating equipment 

For monitoring temperature in continuous heating equipment, you should use a continuous 

temperature-recording device (e.g., a recording thermometer). You should install the device 

where it measures the coldest temperature of the cooking equipment (the cold spot determined 

by a study). For larger heating chambers such as continuous baking or roasting ovens, you 

should install temperature recording devices in multiple locations, e.g., the top, middle, and 

bottom baking areas of the oven. For continuous monitoring of the temperature of continuous 

flow heated liquids, you could use a resistance temperature detector (RTD) placed in line.

For monitoring time (e.g., cooking or baking times) in continuous heating equipment, you could

use a stopwatch or tachometer to monitor the speed of the belt drive wheel, or use a stopwatch 

to monitor the time it takes for a test unit or a belt mark to pass through the equipment. In other 

systems, you could determine time by the flow rate of a fluid product pumped through a 

continuous heating system. (In simple terms, the heating time is determined by the speed with 

which a food flows through the heating system. Determining the appropriate flow rate can be 

complicated – we recommend you use an expert in thermal processing to establish processes 

for such continuous heating systems.) To achieve a process-specific flow rate, you could 

calibrate the pump to a set RPM, mark a set point on the pump, and visually observe the pump 

setting (i.e., speed measured in RPM). Some systems provide a mechanism whereby you could

lock the pump to prevent a change in the pump speed that would affect the product flow rate. 

For other process parameters, you should use appropriate equipment to monitor the factor, e.g., 

scales when you establish a critical limit for a weight; rulers or calipers when you establish a 

critical limit for size.

6.8.3 How Often to Monitor (Frequency of Monitoring)

6.8.3.1 How often to monitor batch heating equipment

If you use a continuous temperature-recording device (e.g., a recording thermometer) for 

monitoring, you should do a visual check of the recorded data at least once per batch. If you 

establish an EPIPT, you should monitor the EPIPT for each batch.

For the heating time of a batch process, you should monitor the recorded start and end times for 

each batch unless you are using an EPIPT. (When using an EPIPT, the frequency of checking 

temperature is often designed to minimize exposure to heat once the EPIPT is reached, and it is 

product quality, rather than product safety, that generally would be negatively impacted.)

You should monitor other process parameters with sufficient frequency to achieve control. 
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6.8.3.2 How often to monitor continuous heating equipment 

If you use a continuous temperature-recording device (e.g., a recording thermometer) for 

monitoring, you should do a visual check of the recorded data at least once per day. 

For the heating time of a continuous process, you should monitor the automated timers at least 

once per day or pump speed setting at least twice per shift, and whenever you make any 

changes in the automated timer or pump speed setting.

You should monitor other process parameters with sufficient frequency to achieve control.

6.8.4 Who performs the monitoring

When a person (rather than a machine) is assigned to perform monitoring, that person must 

have the education, training, or experience (or a combination of these) necessary to perform the 

individual’s assigned duties. (See 21 CFR 117.4(b)(1).)

Examples of who performs the monitoring, or devices that perform monitoring, include:

• A continuous monitoring thermometer measures the product IT or the oven temperature;

• The person who puts ingredients together before they are taken to the line determines the 

weight of ingredients critical to the formulation of the product or determines that particle size 

is within specifications;

• The line operator (e.g., kettle cook, bakers), Quality Control (QC) personnel, or any other 

person who has an understanding of the nature of the preventive controls;

o Visually checks data generated by a continuous monitoring device to ensure that the 

critical limits have consistently been met4

;

o Monitors the temperature for manual (non-automated or non-continuous) devices; 

and

o Performs other monitoring activities that occur on the processing line.

6.9 Establish and Implement Corrective Action Procedures

Part 117 requires that, as appropriate to the nature of the hazard and the nature of the 

preventive control, you must establish and implement written corrective action procedures that 

must be taken if preventive controls are not properly implemented, including procedures to 

address, as appropriate: (1) The presence of a pathogen or appropriate indicator organism in a 

ready-to-eat product detected as a result of product testing; and (2) The presence of an 

environmental pathogen or appropriate indicator organism detected through environmental 

monitoring. The corrective action procedures must describe the steps to be taken to ensure that: 

(1) Appropriate action is taken to identify and correct a problem that has occurred with 

implementation of a preventive control; (2) Appropriate action is taken, when necessary, to 

reduce the likelihood that the problem will recur; (3) All affected food is evaluated for safety; and 

 4 This is sometimes considered a verification activity.
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(4) All affected food is prevented from entering into commerce, if you cannot ensure that the 

affected food is not adulterated or misbranded. (See 21 CFR 117.150(a).)

When your preventive control is a heat treatment, your corrective action procedures would

describe the steps you will take when the heat treatment does not achieve the process-specified 

temperature or time (as well as any other critical limits established for the heat treatment). 

Examples of steps identified in corrective action procedures applicable to a heat treatment 

include:

• Continue heating a product that has not reached the specified temperature after the 

specified number of minutes;

• Extend the length of the heat cycle to compensate for a temperature drop (e.g., by 

continuing to heat the product for a longer time; by slowing the belt speed or flow rate to 

increase time of exposure to heat), using an alternate process developed by a process 

authority; 

• Process at a higher temperature or longer time to compensate for a low IT, using an 

alternate process developed by a process authority;

• Reprocess the product (deliver the full process as if no heating had already occurred);

• Chill and hold the product for an evaluation of the adequacy of the heat treatment that has 

been delivered, and stipulate the disposition of the product if the product has not received 

an adequate process (e.g., destroy the product, divert it to a non-food use, or reheat it); 

• Divert the product to a use in which the critical limits for the parameter are not applicable 

(e.g., an RTE product may become a not-RTE product or may become an ingredient for 

further processing by you or another manufacturer/processor);

• Divert the product to animal food (usually for animals other than pets);

5 and

• Destroy the product.

Although part 117 establishes requirements applicable to your corrective action procedures, it 

neither establishes requirements for other procedures, such as for adjustments, you might 

establish in your plant nor precludes you from establishing such procedures. Likewise, part 117 

neither establishes requirements applicable to any assessment that you do for food quality if a 

process parameter deviates from an operating limit but does not deviate from a critical limit 

(e.g., if you have a procedure to assess food quality if the baking temperature for cookies is 

more than 5-10 degrees above the temperature set as a critical limit). 

 5 FDA is developing guidance on the use of human food by-products in animal food, including diversion of 

human food products to animal food use. In 2016, FDA issued for public comment a draft guidance for 

industry entitled “Human Food By-Products For Use As Animal Food” (FDA, 2016 and 81 FR 58521, 

August 25, 2016). In determining whether it is appropriate to divert a food product to animal food use, we 

recommend that you consult the final guidance on this subject when it becomes available.
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6.10 Determine Verification Procedures

Part 117 requires that verification activities include, as appropriate to the nature of the 

preventive control and its role in your food safety system: (1) Validation; (2) Verification that 

monitoring is being conducted; (3) Verification that appropriate decisions about corrective 

actions are being made; (4) Verification of implementation and effectiveness; and (5) reanalysis.

(See 21 CFR 117.155.) For a discussion of validating a heat treatment, see section 6.6 of this 

chapter.

Part 117 also requires that you verify that the preventive controls are consistently implemented 

and are effectively and significantly minimizing or preventing the hazards. To do so you must 

conduct activities that include the following, as appropriate to the facility, the food, and the 

nature of the preventive control and its role in the facility’s food safety system: 

• Calibration of process monitoring instruments and verification instruments (or checking them 

for accuracy) (21 CFR 117.165(a)(1)); 

• Product testing, for a pathogen (or appropriate indicator organism) or other hazard (21 CFR 

117.165(a)(2)); 

• Environmental monitoring, for an environmental pathogen or for an appropriate indicator 

organism, if contamination of a ready-to-eat food with an environmental pathogen is a 

hazard requiring a preventive control, by collecting and testing environmental samples (21 

CFR 117.165(a)(3)); and

• Review of certain records by (or under the oversight of) a PCQI, to ensure that the records 

are complete, the activities reflected in the records occurred in accordance with the food 

safety plan, the preventive controls are effective, and appropriate decisions were made 

about corrective actions (21 CFR 117.165(a)(4)).

Part 117 also requires, as appropriate to the facility, the food, the nature of the preventive 

control, and the role of the preventive control in the facility’s food safety system, that you 

establish and implement written procedures for: (1) The method and frequency of calibrating 

process monitoring instruments and verification instruments (or checking them for accuracy); (2) 

Product testing; and (3) Environmental monitoring. (See 21 CFR 117.165(b).)

Examples of verification activities applicable to heat treatments include:

• Calibrating devices used for monitoring (and for verification), such as thermometers, RTDs,

timers, and scales, before use (or verifying their accuracy); 

• Reviewing monitoring records (e.g., process logs) to confirm that the heat treatment was 

performed at the proper temperature and for the appropriate amount of time (sometimes 

also called “batch records review”);

• Performing measurements at the monitoring points independent of the routine monitoring 

activity or observing line operators performing measurements;

• Verifying that appropriate decisions about corrective actions are being made when there are 

process deviations from critical limits; and
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• Conducting, when appropriate, product testing to confirm that the heat treatment has 

adequately controlled bacterial pathogens that are relevant to the product.

This chapter does not discuss verification activities that are not directly related to heat 

treatments. For example, this chapter does not discuss environmental monitoring for an 

environmental pathogen as verification of sanitation controls. Likewise, this chapter does not 

discuss corrective action procedures that could be associated with such verification activities, 

such as product testing if the results of environmental monitoring for an environmental pathogen 

are positive.

6.11 Establish and Maintain Records

Part 117 requires that you document the preventive control management components as 

follows: (1) The monitoring of preventive controls in records that are subject to verification and 

records review; (2) all corrective actions (and, when appropriate, corrections) in records that are 

subject to verification and records review; and (3) all verification activities. (See 21 CFR 

117.145(b)-(c), 117.150(d), and 117.155(b).)

Examples of what to document in records applicable to a heat treatment include:

• Monitoring activities of the process parameters that were established by a scientific study or 

provided by a process authority;

• Corrective actions that you take when a heat treatment does not achieve the processspecified temperature or time or when other critical limits are not met;

• Verification activities for implementation of the heat treatment such as:

o Calibration records for monitoring/measuring devices, and a review of the calibration 

records;

o Review of process records (e.g., logs of IT, process temperatures, process times, 

temperature charts);

o Review of any corrective actions taken as a result of a deviation from any of the 

critical limits for the heat treatment; and

o Any other verification activities conducted, including any product testing used to 

verify the adequacy of the heat treatment.

6.11.1 Records of Monitoring Activities

6.11.1.1 Records of monitoring activities for batch heating equipment

Examples of what to document in records of monitoring activities for batch heating equipment 

include:

• Records of temperature and time, if you monitor both temperature and time;
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• Records of the finished product temperature, if you establish an EPIPT (where there is no 

time associated with the heat treatment); 

• Records applicable to a continuous temperature recording device (e.g., a recording 

thermometer), if you use one, such as:

o Recorder charts;

o When applicable, records documenting the visual checks of recorded data (e.g., a 

hand written note on the recorder charts); and

o When applicable, records noting the start time and end time of the cooking or baking 

periods;

• Records of monitoring of critical limits for other process parameters for your heat treatment 

(e.g., weight or size).

You should keep these records in a “process log” for each production line, with information to 

identify the plant or facility, dates (and when appropriate, the time) of monitoring, the signature 

or initials of the person performing the monitoring (e.g., operator initials) and evidence of review 

(i.e., the initials of the PCQI or designee). 

6.11.1.2 Records of monitoring activities for continuous heating 

equipment 

Examples of what to document in records of monitoring activities for batch heating equipment 

include:

• Records of any continuous temperature-recording device (e.g., a recording thermometer) 

(When applicable, this would include records of each temperature-recording device installed 

for each heating area in an oven with multiple temperature recording devices); 

• Records of the time interval (in minutes) determined by a stopwatch and automated timer if 

you use a stopwatch to monitor the time interval of an automated timer;

• Records of the pump speed (RPM) in the line process log every time you do a visual check

(if you determine time by the flow rate of a fluid product through a continuous heating 

system and you visually monitor the pump setting); and

• Records of monitoring of critical limits for other process parameters for your heat treatment 

(e.g., weights, size, thickness, etc.). 

You should keep these records in a “process log” for each production line (or other forms of 

documentation), with information to identify the plant or facility, dates (and when appropriate, 

the time) of monitoring, the signature or initials of the person performing the monitoring (e.g., 

operator initials) and evidence of review (i.e., the initials of the PCQI or designee).

6.11.2 Records of Corrective Actions

Examples of what to document in records of corrective actions that you take when a heat 

treatment is not properly implemented include records of corrective actions if your heat 
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treatment does not achieve the process-specified temperature or time established for your food 

product, or any other critical limit you established for a process parameter for your heat 

treatment. 

6.11.3 Record of On-going Verification Activities

Examples of what to document in records of verification activities applicable to your heat 

treatment include:

• Records (e.g., a log) documenting:

o The calibration of measuring devices (such as thermometers, RTDs, timers, and 

scales);

o Who conducted the calibration; 

o The method of calibration (which could be a Standard Operating Procedure); 

o The date of calibration; 

o Whether the device was in or out of specification; and 

o Adjustments needed and performed;

• A record of the process logs review, by whom, and date of review;

• A report of reviewing corrective actions taken when there are process deviations, including 

initials of the reviewer and the date of review; and

• A report of product testing (when determined appropriate) to verify that the heat treatment 

has adequately controlled bacterial pathogens that are relevant to the product.

6.12 Example of Cookie Processor A’s Heat Treatment 

6.12.1 Cookie Processor A’s Product, Hazard Analysis, and Batch Heat 

Treatment

Cookie Processor A bakes cookies in batches on trays in convection ovens and packages them

by wrapping the cookies by twos in plastic. Cookie dough is made and deposited on trays in the 

dough preparation room and racks of trays are moved to the baking room. Trays are removed 

from the convection oven after baking, placed on clean racks, and moved to the packaging 

room. 

Cookie Processor A’s PCQI identified Salmonella as the hazard associated with the ingredients 

(e.g., flour, eggs, peanut butter) used in making the cookies and determined that baking the 

cookies was the preventive control that would address this hazard. However, to ensure the

adequacy of the baking process used as the preventive control in Cookie Processor A’s food 

safety plan, Cookie Processor A’s PCQI needed to determine the appropriate processing 

parameters, including any critical limits, that would provide adequate lethality for Salmonella

during a batch baking process in a convection oven. To do so, Cookie Processor A’s PCQI 
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consulted with a local university’s extension specialist in process design and validation of heat 

treatments. Cookie Processor A’s PCQI asked the extension specialist to:

• Identify processing parameters that need critical limits for food safety; and

• Determine critical limits for those processing parameters. 

6.12.2 Cookie Processor A’s Process Design and Validation

The extension specialist provided Cookie Processor A’s PCQI with a published study by Lathrop 

et al., (2014) on survival of Salmonella during baking of peanut butter cookies. The published 

study showed that peanut butter cookie dough made with peanut butter inoculated with high 

levels of Salmonella (28 g portions of dough, water activity (aw) of 0.82) and baked at 350°F 

(177°C) for 15 minutes had no detectable Salmonella. Cookies baked for 13 minutes showed at 

least a 5.2 log reduction in Salmonella. In that published study, the cookie temperature at the 

end of 15 minutes was 229°F (109°C). 

The extension specialist identified the following processing parameters that need critical limits 

for food safety in Cookie Processor A’s heat treatment:

• Convection oven temperature (°F) to achieve specified minimum product temperature; 

• Baking time in oven (minutes); and

• Dough delivery process resulting in the specified cookie portion weight (g).

To determine critical limits for those processing parameters when baking cookies in batches in 

Cookie Processor A’s convection oven, and demonstrate that these critical limits can be 

achieved in Cookie Processor A’s convection oven, the extension specialist conducted in-house 

heat distribution tests on Cookie Processor A’s ovens and heat penetration tests on the cookies 

using a fully loaded oven (each oven rack contained a full tray of cookies, deposited in 28 g 

portions using a dough depositor). These in-house heat distribution and heat penetration tests

showed that all parts of each of Cookie Processor A’s oven were at or above 350°F (177°C) 

when the ovens were set at that temperature and that the coldest cookie temperature was 

above 230°F (110°C) after 13 minutes. In addition, aw determinations by an outside laboratory 

on the cookie dough were equal to or greater than 0.82 using Cookie Processor A’s recipes. 

Based on the in-house tests, and the published study by Lathrop et al. (Lathrop, 2014), the 

extension specialist determined that the baking process of 350°F or greater for a minimum of 13 

minutes (operating limit of 15 minutes) would provide adequate lethality for Salmonella for the 

recipe tested, so long as cookie dough portions did not exceed 28 g. The extension specialist 

informed Cookie Processor A that any subsequent change to the cookie recipe should be 

evaluated to determine whether it would impact these determinations.

Based on the information obtained from the extension specialist, Cookie Processor A’s PCQI

established three critical limits for the production of the cookies to ensure adequate lethality: 

• The critical limit (minimum value) for the baking temperature is 350°F (177°C); 

• The critical limit (minimum value) for the baking time is 13 minutes; and
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• The critical limit (maximum value) for the cookie dough portion size is 28 g.

Based on the information obtained from the extension specialist, Cookie Processor A’s PCQI

also established three operating limits for the production of the cookies: 

• The operating limit for the baking temperature is 352°F (178°C); 

• The operating limit for the baking time is 15 minutes; and 

• The operating limit for cookie dough portion size is 27 g.

Cookie Processor A calibrated a dough depositor to deliver 27 g portions of dough onto cookie 

sheets and produces cookies according to the established operating limits by baking 27 g 

portions of cookie dough in 352°F (178°C) ovens for 15 minutes.

6.12.3 Cookie Processor A’s Monitoring

6.12.3.1 What Cookie Processor A monitors 

Cookie Processor A monitors oven temperature, baking time, the dough depositor setting, and 

the weight of dough deposited. 

6.12.3.2 How Cookie Processor A monitors 

Cookie Processor A: 

• Uses a recording thermometer with recording chart to continuously monitor oven 

temperature; 

• Manually checks the temperature recorder chart and marks it with the batch number;

records time when the cookies enter the oven and the oven temperature, calculates and 

records the time cookies should be removed, records the time the cookies are removed from 

the oven on baking record sheets, and calculates and records the elapsed baking time;

• Checks the set point of the dough depositor that controls the weight of dough portions 

deposited; and 

• Periodically checks the weight of a few individual raw cookie dough portions using a 

calibrated scale located near the depositor.

6.12.3.3 How often Cookie Processor A monitors 

Cookie Processor A:

• Checks the oven temperature (continuously recorded) before putting each batch of cookies 

into the oven to ensure it is reading at the minimum specified set point (i.e., at least 350°F 

(177°C);

• Records the start and end baking times of each batch of cookies;

• Checks the set point of the dough depositor every 2 hours; and
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• Checks the weight of a few deposited cookie portions twice per shift.

6.12.3.4 Who monitors critical factors for Cookie Processor A’s heat 

treatment

At Cookie Processor A:

• The baker checks the oven temperature before putting each batch of cookies into the oven 

and notes and records the start and end times of the baking cycle for each batch of cookies. 

• A QC technician checks the set point of the dough depositor and the weight of the raw 

cookie dough portions. 

6.12.4 Cookie Processor A’s Corrective Action Procedures

Cookie Processor A’s corrective action procedures specify that:

• If cookies were baked in an oven that was not at least 350°F (177°C), the cookies will be 

diverted to animal food (non-pet food) and employees will be retrained on the importance of 

ensuring that the oven temperature has reached the set point;

• If the bake time calculated from the start and end times is less than the critical limit of 13 

minutes, the cookies will be diverted to animal food (non-pet food) and the PCQI will 

determine why the bake time was not met to prevent this from happening in the future;

• If the dough depositor is depositing a dough weight that exceeds the critical limit of 28 g: 

o The cookies will be diverted to animal food (non-pet food);

o The PCQI will take steps to determine (if possible) what caused the depositor to 

deliver an incorrect weight so that actions can be taken to prevent such occurrences; 

and

o The dough depositor will be adjusted to deliver the correct weight.

Cookie Processor A also has adjustment procedures that provide for:

• An assessment of product quality if the bake time is less than the operating limit of 15 

minutes but more than the critical limit of 13 minutes, with an investigation of why the bake 

time was less than the operating limit to prevent this from happening in the future; and

• An adjustment of the dough depositor if the cookie dough weight exceeds the operating limit 

of 27 g but does not exceed the critical limit of 28 g.

6.12.5 Cookie Processor A’s Verification Procedures

At Cookie Processor A:

• The following are calibrated at least annually:

o The recording thermometer that monitors oven temperature; 
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o The dough depositor; and 

o The scales used to check the weights of cookie portions. 

• Within a week of their creation, the PCQI:

o Reviews calibration logs (records of calibrating monitoring equipment) to make sure 

that the devices are properly calibrated using the appropriate methods and at the 

appropriate frequencies as specified in the calibration procedures;

o Checks the baking record sheets and the temperature recording chart for monitoring 

records for temperature and time (i.e., time when the cookies enter the oven, 

calculated time for removal, and time the cookies were removed from the oven) to 

verify that the oven temperature was at least at the critical limit of 350°F (177°C) and 

that the cookies were baked for 15 minutes;

o Checks the dough weight logs for the cookie dough portion weighing records to verify 

that none of the dough portions exceeded 28 g in weight; and

o Initials and dates each of the records reviewed in the place marked “Verified by.”

• The PCQI reviews the corrective action records within a week of a deviation, and initials and 

dates each of the records reviewed in the place marked “Verified by.”

6.12.6 Cookie Processor A’s Monitoring Records

Cookie Processor A keeps:

• The recording charts of the recording thermometer as a record of monitoring the oven 

temperature; 

• The baking record sheets as a record of monitoring the baking times; and 

• A dough weight log as a record of the dough depositor setting and the dough portioning 

weight. 

6.12.7 Cookie Processor A’s Records of Corrective Actions

Cookie Processor A keeps records:

• Documenting that cookies placed in an oven that was not at least 350°F (177°C) or cookies 

baked for less than 13 minutes were diverted to animal food (non-pet food);

• Of any investigations of the cause of any deviations;

• Of all changes made to correct a problem and to prevent reoccurrence of deviations; and

• Documenting any retraining.
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Cookie Processor A also keeps records of adjustments, because such records could be useful 

in identifying ongoing production problems that could demonstrate a need to review and change 

applicable production procedures. 

6.12.8 Cookie Processor A’s Verification Records 

Cookie Processor A maintains records, initialed and dated by the PCQI, of the PCQI’s review of:

• The calibration logs; 

• The monitoring records (such as the oven temperature recording chart, records containing 

the bake time for cookies, and dough weight log); and

• The corrective action log.

6.12.9 Summary Process Control Table for Cookie Processor A

Appendix 6-A summarizes the above information for Cookie Processor A on the FSPCA’s 

Process Control Form (Form 2-C (Modified) from Appendix 2).

6.13 Example of Cookie Processor B’s Heat Treatment 

6.13.1 Cookie Processor B’s Product, Hazard Analysis, and Continuous 

Heat Treatment

Cookie Processor B bakes cookies in a continuous band oven and packages them in boxes of 

24 cookies. Cookie dough is made in the dough preparation room and placed in totes that are 

taken to the dough hopper of an extruder at the front of the continuous band oven in the baking 

room. The dough extruder automatically deposits the dough across the oven band (solid 

conveyor), where the cookie dough is conveyed through the heating tunnel (oven). After baking, 

the band drops the cookies onto a conveyor that cools them and moves them to the packaging 

room.

Cookie Processor B’s PCQI identified Salmonella as the hazard associated with the ingredients 

(e.g., flour, eggs, peanut butter) used in making cookies and determined that baking the cookies 

was the preventive control that would address this hazard. However, to ensure the adequacy of 

the baking process used as the preventive control in Cookie Processor B’s food safety plan,

Cookie Processor B’s PCQI needed to determine the appropriate processing parameters, 

including any critical limits, that would provide adequate lethality for Salmonella for a continuous 

baking process using a band oven. To do so, Cookie Processor B’s PCQI consulted with a 

process design specialist at a food research consulting firm regarding the process design and 

validation of the heat treatment. Cookie Processor B’s PCQI asked the process design 

specialist to:

• Identify processing parameters that need critical limits for food safety; and

• Determine critical limits for those processing parameters. 
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6.13.2 Cookie Processor B’s Process Design and Validation 

The process design specialist provided Cookie Processor B’s PCQI with a published study by 

Lathrop, et al., (2014) on survival of Salmonella during baking of peanut butter cookies. The 

published study showed that peanut butter cookie dough made with peanut butter inoculated 

with high levels of Salmonella (28 g portions of dough, aw of 0.82) and baked at 350o

F (177°C) 

for 15 minutes had no detectable Salmonella. Cookies baked for 13 minutes showed at least a

5.2 log reduction in Salmonella. In that published study, the cookie temperature at the end of 15 

minutes was 229°F (109°C). 

The process design specialist identified the following processing parameters that need critical 

limits for food safety in Cookie Processor B’s heat treatment:

• Band oven temperature (o

F) to achieve specified minimum product temperature; 

• Baking time in oven (minutes) controlled by the speed of the conveyor belt through the 

continuous band oven; and

• Dough extrusion process resulting in the specified cookie portion weight (g).

To determine the critical limits for these processing parameters for baking cookies in Cookie 

Processor B’s continuous band oven, and demonstrate that these critical limits can be achieved 

in Cookie Processor B’s continuous band oven, the process design specialist conducted inhouse oven temperature mapping (heat distribution) studies on the continuous band oven and 

heat penetration studies on the cookies. The results of these studies, and the recommendations

of the process design specialist after conducting these studies, were as follows:

• Results of the in-house oven temperature mapping (heat distribution) study confirmed that 

the continuous band oven achieved and maintained the desired minimum temperature of 

350o

F (177°C) at the coldest spot in the oven at a set point temperature of 350oF (177°C) (or 

higher).

• The in-house heat penetration studies for the baking process used thermocouples with the 

sensors placed in the geometric center of the cookie dough portions (in 16 cookie dough 

portions deposited in 28 g portions at different points across the width of the oven band, in 

each of 3 trials conducted over 3 days). The speed of the conveyor belt in the band oven 

was set to result in a residence time of cookies in the oven of 13.0 minutes (as a worst case, 

or conservative, speed setting). Results from the heat penetration study demonstrated that 

all 28 g cookie dough portions achieved a minimum internal temperature of 231o

F at the end 

of a 13.0-minute baking time.6

• Because the operating limit for Cookie Processor B’s baking process is 15 minutes, the 

process design specialist also established the tachometer RPM reading that would result in

a residence time of cookies in the continuous band oven of 15-minutes.

 6 Note that these data demonstrate that if a deviation results in a baking time less than 15 minutes but 13 

or more minutes, the cookies receive more than a 5-log reduction for Salmonella (they reach a 

temperature of 231o

F) and are safe for consumption.
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• To ensure that the nominal weight of each raw cookie dough portion does not exceed the 

established process critical parameter weight of 28 g, the process design specialist specified 

that the cookie dough extruder should be calibrated to deliver 27 g raw cookie dough 

portions as an operating limit, and that the delivery should be verified by performing weight 

measurements at startup of the dough extruder each day.

Based on the information derived from this in-house validation study, in combination with the 

study published by Lathrop et al. (Lathrop, 2014), the process design specialist determined that 

Cookie Processor B’s band oven would provide adequate lethality for Salmonella for the specific 

recipe tested, so long as the weight of the raw cookie dough portion did not exceed 28 g and the 

cookies were baked for at least 13 minutes at a 350°F (177°C) oven setting.

Based on the information obtained from the process design specialist, Cookie Processor B’s 

PCQI, established three critical limits for the production of the cookies to ensure adequate 

lethality: 

• The critical limit (minimum value) for the baking temperature is 350°F (177°C);

• The critical limit (minimum value) for the baking time is 13 minutes; and

• The critical limit (maximum value) for the cookie dough portion size is 28 g.

Based on the information obtained from the process design specialist, Cookie Processor B’s 

PCQI also established three operating limits for the production of the cookies: 

• The operating limit for the baking temperature is 352°F (178°C);

• The operating limit for the baking time is 15 minutes; and

• The operating limit for cookie dough portion size is 27 g.

Cookie Processor B calibrated a dough depositor to deliver 27 g portions of dough onto cookie 

sheets and produces cookies according to the established operating limits by baking 27 g 

portions of cookie dough in a 352°F (178°C) band oven for 15 minutes.

6.13.3 Cookie Processor B’s Monitoring

6.13.3.1 What Cookie Processor B monitors

Cookie Processor B monitors oven temperature (at the identified cold spot), belt speed as 

indicated by tachometer RPM (for control of baking time), the dough depositor setting, and the 

weight of dough deposited.

6.13.3.2 How Cookie Processor B monitors

Cookie Processor B: 

• Uses a recording thermometer with recording chart to continuously monitor oven 

temperature at the cold spot; conducts a visual check of the chart and records the check in 

the operator’s baking log; 
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• Uses an automated tachometer with recorder chart to monitor the speed of the conveyor 

belt through the band oven (which is tied to the baking time) and conducts a visual check of 

the tachometer RPM; 

• Checks the set point of the dough depositor that controls the weight of the raw cookie dough 

portions deposited; and

• Periodically checks the weight of a few individual cookie dough portions using a calibrated 

scale located near the depositor.

6.13.3.3 How often Cookie Processor B monitors

Cookie Processor B:

• Checks the oven continuous temperature-recording device every hour to ensure it is reading 

at a minimum the specified set point (i.e., at least 350o

F) (177°C);

• Monitors the automated tachometer recording (RPM) at start up and twice per shift;

• Checks the set point of the dough depositor at start up and every 2 hours; and

• Checks the weight of deposited cookie portions at least twice per shift.

6.13.3.4 Who monitors critical factors for Cookie Processor B’s heat 

treatment

At Cookie Processor B:

• The baker checks the oven temperatures and monitors the automated tachometer 

recording; and

• A dough preparer checks the set point of the dough depositor and the weight of the raw 

cookie dough portions.

6.13.4 Cookie Processor B’s Corrective Action Procedures

Cookie Processor B’s corrective action procedures specify that:

• If cookies were baked in an oven that was not at least 350°F (177°C):

o The cookies will be diverted to further processing (e.g., baking for cookie crumbles 

ingredient production) or to animal food (non-pet food);

o Maintenance will determine the cause of the low temperature and fix the oven so the 

temperature is reset to the operating limit of 352°F (178°C) before more cookies are 

baked; and 

o Employees will be retrained, if necessary, on the importance of ensuring that the 

oven temperature has reached the set point before allowing the line to run. 

• If the tachometer RPM recording indicates that the baking time is less than 13 minutes: 
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o The cookies will be put on QC hold. The PCQI will determine whether the product will 

be diverted to further processing (e.g., baking) to make cookie crumbles as a baking 

ingredient or to animal food (non-pet food); and 

o The PCQI will conduct an investigation to determine why the bake time was not met 

and will inform plant management of actions they need to take to prevent this from 

happening in the future. 

If the dough depositor is depositing a dough weight that exceeds the maximum 28 g: 

o The PCQI will determine whether the product will be further processed into 

alternative products or be diverted to animal food (non-pet food), and (if possible) 

determine what caused the depositor to deliver an incorrect weight so that actions 

can be taken to prevent such occurrences; and

o The dough depositor will be adjusted by maintenance or by the equipment 

manufacturer to deliver the correct weight.

Cookie Processor B also has adjustment procedures that provide for:

• An assessment of product quality if the bake time is less than the operating limit of 15 

minutes but more than the critical limit of 13 minutes, with an investigation of why the bake 

time was less than the operating limit to prevent this from happening in the future; and

• An adjustment of the dough depositor if the cookie dough weight exceeds the operating limit 

of 27 g but does not exceed the critical limit of 28 g.

6.13.5 Cookie Processor B’s Verification Procedures

At Cookie Processor B: 

• The following are calibrated at least annually: 

o Recording thermometer and chart that monitors oven temperature; 

o The automated tachometer and recorder chart that monitors belt speed (baking 

time); 

o The dough depositor; and 

o The scales used to check the weights of cookie portions. 

• A QC technician checks the recorder charts twice per shift to confirm that the oven is 

maintained at the specified baking temperature of at least 350°F (177°C) and the 

tachometer RPM resulted in baking times of 15 minutes; the QC technician writes the date 

and time on the recorder charts, and initials the recorder charts. 

• A QC technician checks the raw cookie dough portion weighing records (dough weight logs)

twice per shift to verify that none of the dough portions exceeded 28 g in weight; the QC 

technician writes the date and time on the dough weight log and initials the dough weight 

log. 
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• The PCQI collects the oven recording thermometer charts, operator’s baking log, 

tachometer charts, and dough weight sheets daily for subsequent review within 7 days of 

their creation.

• Within 7 days of their creation the PCQI reviews the following records, dates and initials the 

records or a verification cover sheet to document that review, and then files the records:

o The calibration logs to make sure that the devices are properly calibrated using the 

appropriate methods and at the appropriate frequencies as specified in the 

calibration procedures; and

o The oven recording thermometer charts, operator’s baking log, tachometer charts,

and dough weight sheets for accuracy and to ensure the parameter values were met.

• The PCQI reviews corrective action records at the end of each week, initials and dates them 

to document that review, and files them chronologically (based on the date of the deviation)

in a folder with other corrective actions.

6.13.6 Cookie Processor B’s Monitoring Records

Cookie Processor B keeps:

• The recording charts of the recording thermometer and the operator’s baking log as a record 

of monitoring temperature in the oven;

• The recording charts of the recording tachometer with the visual observation noted on the 

chart as a record of monitoring the RPMs that achieve the baking time; and 

• A dough weight record sheet as a record of monitoring the check of the dough depositor 

setting and the check of the weight of the raw dough portions deposited. 

6.13.7 Cookie Processor B’s Records of Corrective Actions

Cookie Processor B keeps records:

• Of any lot of cookies diverted to further processing (e.g., baking for cookie crumbles) or to

animal food (non-pet food);

• Of any investigation of the cause of any deviations;

• Of all changes made to correct a problem and to prevent reoccurrence of deviations; and

• Documenting any retraining.

Cookie Processor B also keeps records of adjustments, because such records could be useful 

in identifying ongoing production problems that could demonstrate a need to review and change 

applicable production procedures.

6.13.8 Cookie Processor B’s Verification Records

Cookie Processor B maintains records initialed and dated by the PCQI, of the review of: 
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• Calibration logs;

• Oven recording thermometer charts;

• Operator’s baking log with the hourly checks of the temperature chart and the twice-per-shift 

tachometer RPM reading;

• Tachometer charts;

• Dough weight logs; and

• Corrective action logs. 

6.13.9 Summary Process Control Table for Cookie Processor B

Appendix 6-B summarizes the above information for Cookie Processor B on the FSPCA’s 

Process Control Form (Form 2-C (Modified) from Appendix 2).

6.14 Example of Soup Processor A’s Heat Treatment 

6.14.1 Soup Processor A’s Product, Hazard Analysis, and Batch Heat 

Treatment

Soup Processor A makes cooked, frozen RTE vegetable soups containing vegetable particles 

as ingredients. Soup Processor A cooks the soups to a minimum of 180°F (82°C) using a batch 

process in a 150 gallon steam-jacketed kettle, packages the soups in 8 ounce plastic bowls, and 

freezes the bowls of soup.

Soup Processor A’s PCQI identified L. monocytogenes as the hazard associated with the RTE 

vegetable soups and determined that cooking the soup using a batch process in a steamjacketed kettle maintained at a minimum of 180°F (82°C) was the preventive control to address 

this hazard. Soup Processor A’s PCQI identified cooking time and vegetable particle size as 

processing parameters that needed critical limits to provide adequate lethality for L. 

monocytogenes during the batch kettle-cooking process. Soup Processor A’s PCQI used Table 

3-D in Appendix 3 of this guidance to determine process times for a range of cooking 

temperatures with L. monocytogenes as the target pathogen and arranged for food scientists at 

Soup Processor A to conduct in-house studies that could be used to determine the critical limits 

for vegetable particle size.

6.14.2 Soup Processor A’s Process Design and Validation 

Using Table 3-D in Appendix 3 of this guidance, Soup Processor A’s PCQI determined that 0.05 

minutes (3 seconds) at 180°F achieves an acceptable 6-log (i.e., 6 logarithm) reduction, 

typically called a 6D (6 decimal reduction) process. (See Chapter 4 for further details.) Because 

of the additional lethality during the heating time needed for the soup to reach 180°F (82°C), 

and because more than 3 seconds would elapse before cooling from 180°F could begin, Soup 

Processor A’s PCQI decided to use an EPIPT and cook the soups until the temperature reaches 

180°F rather than to continuously monitor temperature during cooking.
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Food scientists at Soup Processor A conducted in-house studies to determine the critical limit 

for vegetable particle size. Based on those studies, Soup Processor A’s PCQI determined that 

as long as vegetable particles in the soup did not exceed 1⁄2 inch (13 mm) square, the particles 

would also be at 180°F when the liquid portion of the soup reached that temperature, provided 

that the particles were stored refrigerated (i.e., at least 33°F) (0.6 °C) and not frozen. (Soup 

Processor A’s SOPs specify that vegetable particles are stored refrigerated at a temperature of 

33 - 40°F (0.6 - 4 °C).) 

Soup Processor A established two critical limits for the production of the soup to ensure 

adequate lethality: 

• Minimum EPIPT of 180°F (82°C); and

• Maximum size of vegetable particles (1⁄2 inch (13 mm)).

Soup Processor A determined that a critical limit for the temperature of the particles in the soup 

is not necessary as long as the production line follows the SOP to store the particles 

refrigerated.

6.14.3 Soup Processor A’s Monitoring

6.14.3.1 What Soup Processor A monitors

Soup Processor A monitors the temperature of soup in the kettle and the size of any particles.

6.14.3.2 How Soup Processor A monitors

Soup Processor A:

• Uses a thermometer to periodically determine the temperature of soup in the top inch (2.5 

cm) of the kettle (where it is coldest) until the EPIPT is reached and records the measured 

temperature in a cook log; and

• Collects a statistically-based sample of vegetable particles (e.g., diced carrots, potatoes, 

onions), uses digital calipers to ensure they do not exceed 1⁄2 inch (13 mm) in any direction, 

and records the measured size of the vegetable particles in a log.

6.14.3.3 How often Soup Processor A monitors

Soup Processor A:

• Begins measuring the temperature of the soup after approximately 30 minutes of heating; 

• Measures the temperature approximately every 10 minutes after the temperature of the 

soup reaches approximately 170°F (77°C), until the temperature reaches 180°F (82°C); and

• Checks the particle size of every third lot of vegetable particles used as an ingredient in 

production upon receipt of the ingredient. 
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6.14.3.4 Who monitors critical factors for Soup Processor A’s heat 

treatment

At Soup Processor A: 

• The kettle cook operator measures the temperature of the soup during processing; and

• A formulation control operator checks the vegetable particle size.

6.14.4 Soup Processor A’s Corrective Action Procedures

Soup Processor A’s corrective action procedures specify that:

• If it is determined that the EPIPT did not reach 180°F (82°C) while the soup is being 

packaged but has not been frozen, packaging will be stopped and the remaining soup, 

including soup returned to the kettle from packages that have been filled but not frozen, will 

be reprocessed until the EPIPT reaches 180°F. Any packages that have already been 

frozen will be destroyed;

• If it is determined that the EPIPT did not reach 180°F (82°C) after the soup is packaged and 

frozen, the PCQI will assess the safety of the product to determine appropriate disposition. If 

the PCQI determines that the process delivered was inadequate to ensure product safety, 

the soup will be diverted to animal food (non-pet food) or destroyed;

• When soup is packaged before the EPIPT reaches 180°F (82°C) due to operator error, the 

kettle cook operator will be retrained, as appropriate, in proper procedures for, and the 

importance of, ensuring the product is not packaged before the EPIPT reaches 180°F; and

• If it is determined that the mean plus 2.5 standard deviation of the vegetable particle sizes 

exceeds 1⁄2 inch (13 mm) the lot of vegetables is rejected. The unopened packages will be 

returned to the supplier, and the PCQI will discuss the issue with the supplier so the supplier 

can investigate the root cause for incorrect particle size. The formulation control operator will 

check the vegetable particle size of every lot for the next 15 lots to verify particle sizes meet 

specification. If all 15 lots meet specification, the formulation control operator will return to 

monitoring every third lot.

6.14.5 Soup Processor A’s Verification Procedures

At Soup Processor A:

• The thermometers used to measure soup temperature are:

o Checked for accuracy at least daily by the QC technician; and

o Calibrated by the QC technician against a NIST-calibrated reference thermometer at 

least annually or whenever an accuracy check shows that recalibration is needed. 

The PCQI reviews, dates, and initials the calibration log within a week of the 

calibration.
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• The accuracy of digital calipers is checked by the QC technician before use by verifying that 

when fully closed the caliper reads zero (if not, the caliper is sent for repair or replaced);

• When calibration and accuracy checks of the thermometers and calipers are performed, the 

date and time are recorded in a log;

• On a weekly basis, the PCQI:

o Reviews monitoring records (cook logs) to confirm that all soups were cooked to a 

minimum temperature of 180°F (82°C) as indicated by the records of the EPIPT 

readings; 

o Reviews the accuracy checks of the thermometers and the digital calipers;

o Reviews the particle measurement logs to verify that vegetable particles used in the 

soup did not exceed 1⁄2 inch (13 mm) in size; and

• Before a lot of soup is released, the PCQI reviews corrective action records as part of a preshipment review to ensure all lot records are in order. (Because Soup Processor A uses an 

EPIPT and employees have been with Soup Processor A for many years, Soup Processor A

experiences few deviations, so the PCQI has determined and documented that this 

timeframe, rather than 7 working days, is reasonable.)

6.14.6 Soup Processor A’s Monitoring Records

Soup Processor A keeps:

• A production line cook log as a record of monitoring the temperatures; and

• A log of the size of vegetable particles checked upon receipt for the lots of raw materials 

used in production. 

6.14.7 Soup Processor A’s Records of Corrective Actions

Soup Processor A keeps records:

• Of the reprocessing of product (e.g., recooked to 180o

F) (82°C) if a soup was filled before 

the process-specified EPIPT was achieved and had not been frozen;

• Of any product safety assessment by the PCQI (e.g., soup that had been filled before 

reaching the EPIPT but that had been frozen) and the disposition of such product;

• Of any investigations of the cause of any deviations (including investigation into the 

supplier’s procedures for control of particle size); 

• Of all changes made to correct a problem and to prevent reoccurrence of deviations; and

• Documenting any retraining.
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6.14.8 Soup Processor A’s Verification Records

Soup Processor A maintains records with the date and initials of the PCQI for the review of:

• The log of the accuracy checks and calibration of the thermometer; 

• The cook log for monitoring the soup temperatures; 

• The log of the accuracy checks of the digital calipers; and

• The log of vegetable particle size; 

• Corrective action records.

6.14.9 Summary Process Control Table for Soup Processor A

Appendix 6-C summarizes the above information for Soup Processor A on the FSPCA’s 

Process Control Form (Form 2-C (Modified) from Appendix 2).

6.15 Example of Soup Processor B’s Heat Treatment 

6.15.1 Soup Processor B’s Product, Hazard Analysis, and Continuous Heat 

Treatment

Soup Processor B makes RTE clear broths and RTE creamed vegetable soups (with no 

particles) that are cooked using a continuous process (in a continuous flow heat exchanger), 

hot-filled into 5 gallon bags, and refrigerated. The ingredients include dehydrated vegetable 

powders, pasteurized liquid fresh cream, spice blends, starch, and other thickeners.

Soup Processor B’s PCQI, a food scientist/food engineer who functions as the facility’s food 

processing expert7

, identified Salmonella, L. monocytogenes, C. botulinum type A, C. botulinum

proteolytic type B, and C. botulinum non-proteolytic type B as hazards associated with the 

soups. Soup Processor B’s PCQI determined that cooking the soups using a continuous 

process (in a continuous flow heat exchanger) was a preventive control to address most of

these hazards. (Refrigeration will be needed to control C. botulinum type A and C. botulinum

proteolytic type B in the heat-treated soups.) In identifying the processing parameters and 

determining the critical limits for these processing parameters, Soup Processor B’s PCQI/food 

processing expert needed to evaluate which of the potential hazards would be the target 

organism.

 7 The individual who identifies critical limits, and establishes a heat treatment in a continuous flow system, 

for a product such as Soup Processor B’s soup, should have specialized experience adequate to 

evaluate processing parameters, establish appropriate minimum/maximum values (e.g., the residence 

time in the hold tube based on flow characteristics of the product and the length and diameter of the hold 

tube) and ensure the safety of an RTE product packaged in reduced oxygen packaging. When the 

regulatory framework does not require that the individual be a “process authority,” individuals with a 

variety of backgrounds (in this case, a food engineering background) could have such specialized 

experience.
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Because hot-filling into 5-gallon bags would result in reduced oxygen packaging, and because 

the soups will be distributed refrigerated, Soup Processor B’s PCQI/food processing expert

determined that C. botulinum non-proteolytic type B is an appropriate target organism for the 

soup heat treatment.8

6.15.2 Soup Processor B’s Process Design and Validation 

Using Table 3-E of Appendix 3 of this guidance, Soup Processor B’s PCQI/food processing

expert determined that a heat treatment that targeted C. botulinum non-proteolytic type B as the 

most heat resistant pathogen would also address Salmonella and L. monocytogenes and that 

hot-filling at 185°F (85°C) would minimize risk of recontamination after the heat treatment.

Based on an assessment and review of the scientific literature, Soup Processor B’s PCQI/ food 

processing expert decided to use a process of 205°F (96°C) for 2.5 minutes (equivalent to a 

minimum temperature of 194°F (90°C) for a minimum of 10 minutes) based on Table 3-E of in 

Appendix 3 of this guidance. This time and temperature combination will deliver a 6D process 

for the most heat resistant spores for strains of C. botulinum non-proteolytic type B.

Briefly, the procedure for the continuous heat and hot-fill process for clear broths and creamed 

vegetable soups is as follows:

• Add the dry ingredients to the blend tank with the volume of water specified in the 

formulation and mix at a high speed (> 2000 rpm) for 30 minutes to ensure all dry materials 

are wetted and in solution (no clumps), and then blend in fresh cream that has been 

refrigerated to 40o

F - 45oF (4°C- 7°C);

• Pump the untreated soup from the blend tank to the pre-process agitated surge tank (which 

is water jacketed to control the contents at the set process Initial Temperature (IT) (between 

40o

F and 45oF) (4°C- 7°C)) through in-line sieves to ensure no mix particles larger than 0.1 

inch (2.5 mm) pass to the pre-process agitated surge tank;

• Pump the untreated soup via a metering pump (at a flow rate specified in gal/min) from the 

pre-process agitated surge tank to the indirect continuous heat exchanger (scraped surface) 

and then to the hold tube (which is sized to ensure the soup mix is held at the process 

temperature for a minimum of 2.5 minutes);

• The heat-treated soup flows from the hold tube into an agitated hot-holding surge tank that 

keeps the soup at > 185o

F (85°C); the heat-treated soup is then pumped to the filling hopper 

for the hot-fill process;

• Hot fill the heat-treated soup into 5-gallon pre-labeled bags and seal the bags; and

• Cool the sealed, hot-filled soup bags, pack them in a carton, and store the carton under 

refrigeration prior to distribution.

 8 Annex 6 of the Food Code (FDA, 2013) is a source of additional information about selection of the target 

organism.
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Soup Processor B’s PCQI/ food processing expert determined that five process parameters are 

critical to the safety of the food product and established critical limits for each of these process 

parameters:

• IT of product held in the pre-process agitated surge tank (between 40o

F and 45°F) (4°C7°C);

• Metering pump speed (RPM) to deliver process-specified flow rate (gal/min);

• Hold tube size (must deliver a minimum 2.5 minute product hold time prior to hot-filling);

• Temperature of the heat-treated soup at discharge end of hold tube (minimum value of 

205o

F) (96°C); and

• Temperature of the heat-treated soup in the agitated hot-holding surge tank (minimum value 

of 185o

F) (85°C).

6.15.3 Soup Processor B’s Monitoring

6.15.3.1 What Soup Processor B monitors

Soup Processor B:

• Monitors the IT in the surge tank;

• Checks the pump speed RPM setting;

• Checks that the correct hold tube is in place prior to production;

• Checks the temperature of the heat-treated soup exiting the hold tube using an RTD probe 

connected to a recording device; and

• Monitors the temperature of the heat-treated soup held in the agitated hot-holding surge 

tank prior to final packaging (i.e., hot fill).

6.15.3.2 How Soup Processor B monitors

Soup Processor B:

• Uses a Resistance Temperature Detector (RTD) probe attached to a recording chart to 

monitor the IT of the untreated soup in the pre-processing surge tank; 

• Visually observes that the RPM dial setting on the pump (i.e., pump speed in RPM) is 

appropriate to achieve the process-specified flow rate of the soup;

• Visually observes that the correct hold tube is in place (hold tubes are numbered and each 

numbered hold tube is assigned to specific soup recipes);

• Uses an RTD probe attached to a recording chart to monitor the temperature of the heattreated soup exiting the hold tube; and
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• Uses another RTD probe attached to a recording chart to monitor the temperature of the 

heat-treated soup in the hot-holding surge tank. 

6.15.3.3 How often Soup Processor B monitors

Soup Processor B:

• Checks the continuously recorded IT (RTD chart recorder) of the untreated soup in the preprocess surge tank twice per shift;

• Checks and records the pump speed setting (flow rate) at the beginning of production and 

twice per shift; 

• Notes the hold tube used on the pump speed log at the beginning of production and 

whenever the variety of soup being produced changes; 

• Checks the continuously recorded temperature (RTD chart recorder) of the heat-treated 

soup at the exit of the hold tube twice per shift; and

• Checks the continuously recorded temperature (RTD chart recorder) of the heat-treated 

soup in the filling surge tank twice per shift. 

6.15.3.4 Who monitors critical factors for Soup Processor B’s heat 

treatment

At Soup Processor B, the line operator monitors the recorded temperature data (IT of the 

untreated soup, temperature of the heat-treated soup exiting the hold tube, and temperature of 

the heat-treated soup in the agitated hot-holding surge tank), the pump speed setting, and the 

hold tube identification. 

6.15.4 Soup Processor B’s Corrective Action Procedures

Soup Processor B’s corrective action procedures specify:

• A list of:

o Those soups that can be fully reprocessed in instances where soup was underprocessed; and 

o Those soups that cannot be fully reprocessed and therefore will be diverted to animal 

food (non-pet food) or destroyed if the PCQI determines that the process delivered 

was inadequate to ensure product safety. 

• If the IT of the untreated soup was too low during the production of that soup:

o The product will be held until the PCQI determines whether the process was 

adequate or if the soup can be reprocessed; and

o The production manager will investigate why the IT was too low and take appropriate 

actions to prevent the situation from reoccurring.
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• If the metering pump speed during production of the soup was too fast:

o Any ongoing production will be stopped and affected product will be held until the 

PCQI evaluates the safety of the product; 

o The PCQI will assess the safety of the product and determine whether it will be 

released, re-processed, diverted to animal food (non-pet food), or destroyed; and

o The production manager will investigate why the pump speed was too fast and take 

appropriate actions to prevent the situation from reoccurring.

• If the incorrect hold tube was used: 

o The PCQI will assess the safety of the product to determine appropriate disposition;

o The production manager will investigate why the incorrect hold tube was used; and

o Employees will be retrained if necessary in light of the reason the incorrect hold tube 

was used. 

• If the RTD at the end of the hold tube recorded a low temperature and the soup was not 

diverted to the batch tank for automatic reprocessing:

o The PCQI will assess the safety of the product to determine appropriate disposition; 

and

o The production manager will investigate the low temperature and the diversion failure 

and take appropriate action to fix the problem. 

• If the temperature of the heat-treated soup in the agitated hot-holding surge tank is below 

the process set point: 

o The product will be held until the PCQI determines whether the temperature was 

adequate for safety or if the soup should be reprocessed, diverted to animal food

(non-pet food), or destroyed. 

o The production manager will investigate why the temperature was too low and take 

appropriate actions to prevent the situation from reoccurring.

6.15.5 Soup Processor B’s Verification Procedures

At Soup Processor B: 

• An outside calibration service annually performs on-site calibration of the RTDs and 

recording devices used to measure IT of the untreated soup, the temperature of the heattreated soup at the exit of the hold tube, and the hot-fill temperature. A sticker with the 

calibration date is affixed to each recording device and the date and results are recorded in 

a calibration log. Soup Processor B’s PCQI also reviews, initials, and dates the monitoring 

device calibration logs within a week of their creation;
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• The Quality Assurance Manager or designee verifies twice a year that the pump speed 

provides the correct flow rate for the hold tubes used for the different soups, and the PCQI 

reviews this within one week;

• On a daily basis, the PCQI :

o Reviews recorder charts and pump speed log with the hold tube identification to 

confirm that the soup was cooked at the specified temperature of 205°F (96°C) for a 

minimum of 2.5 minutes; and

o Checks the other process logs to confirm that the soup in the pre-process agitated 

surge tank was maintained at an IT between 40°F and 45°F (4°C- 7°C), that the 

temperature of the heat-treated soup at hold tube exit was at least 205 °F (96°C),

and that the temperature of the heat-treated soup held in the agitated hot-holding 

surge tank prior to hot-filling was maintained at the specified process temperature of 

> 185o

F (852°C), and also checks that process log temperatures agree with the 

recorder charts;

• The PCQI reviews corrective action records within one week of when the deviation occurred;

and

• Soup Processor B does not conduct product testing for pathogens or environmental 

monitoring because the product, which is subjected to a heat treatment validated to be 

highly lethal to vegetative pathogens and filled hot, is not exposed to the environment after 

the heat treatment.

6.15.6 Soup Processor B’s Monitoring Records

Soup Processor B keeps:

• The recording charts from the RTDs used to monitor the IT of the untreated soup exiting the 

pre-process agitated surge tank, the temperature of heat-treated soup exiting the hold tube,

and the temperature at the agitated hot-holding surge tank; 

• The process logs for the temperature checks (IT of the untreated soup, temperature of the 

heat-treated soup exiting the hold tube, and temperature at the agitated hot-holding surge 

tank); and

• A process log for each line to record pump speeds and hold tube number for the product 

being processed.

6.15.7 Soup Processor B’s Records of Corrective Actions

Soup Processor B keeps records:

• Of any product safety assessment by the PCQI of the safety of product to determine 

appropriate disposition if:

o The IT of the untreated soup was too low; 

o The metering pump speed was too fast; 
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o An incorrect hold tube was used;

o The RTD at the end of the hold tube recorded a low temperature and the heattreated soup was not diverted to the batch tank for automatic reprocessing; or

o The temperature for the heat-treated soup held in the agitated hot-holding surge tank 

prior to hot-filling was too low.

• Of the reprocessing of a soup that can be reprocessed if the RTD at the end of the hold tube 

recorded a low temperature and the soup was not diverted to the batch tank for automatic 

reprocessing;

• Of any soup that cannot be reprocessed and thus is sent to animal food (non-pet food) or 

destroyed;

• Of any investigations of the cause of any deviations;

• Of all changes made to correct a problem and to prevent reoccurrence of deviations; and

• Documenting any retraining.

6.15.8 Soup Processor B’s Verification Records

Soup Processor B maintains the following records with the date and initials of the PCQI for the 

review of:

• The monitoring records - i.e.: 

o The temperature recording chart for all RTD probes (IT of the untreated soup exiting 

the pre-process agitated surge tank, the temperature of heat-treated soup exiting the 

hold tube, and the temperature at the agitated hot-holding surge tank);

o The process logs for the temperature checks (IT of the untreated soup exiting the 

blend tank, the temperature of heat-treated soup exiting the hold tube, and 

temperature at the agitated hot-holding surge tank); and 

o The process logs for each line with pump speeds and hold tube number for the 

product being processed;

• The calibration logs, including notes of the actions taken when any adjustments were 

needed;

• The semi-annual verification tests that the pump speed provides the correct flow rate for the 

hold tubes used for the different soups, including notes of when any adjustments to the 

pump speed were needed; and

• The corrective action records. 
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6.15.9 Summary Process Control Table of Soup Processor B

Appendix 6-D summarizes the above information for Soup Processor B on the FSPCA’s 

Process Control Form (Form 2-C (Modified) from Appendix 2).

6.16 Example of Salsa Processor A’s Heat Treatment 

6.16.1 Salsa Processor A’s Product, Hazard Analysis, and Heat Treatment

Salsa Processor A manufactures a shelf-stable chopped mixed vegetable salsa product that is 

an acidified food subject to the requirements of 21 CFR part 114 (part 114). Our regulations for 

acidified foods in part 114 require that an acidified food be manufactured, processed, and 

packaged so that the finished equilibrium pH value of 4.6 or lower is achieved within the time 

designated in the scheduled process and maintained in all finished products. (See 21 CFR 

114.80(a)(1).) Acidified foods are shelf-stable foods and must be thermally processed to an 

extent that is sufficient to destroy the vegetative cells of microorganisms of public health 

significance and those of non-health significance capable of reproducing in the food under the 

conditions in which the food is stored, distributed, retailed and held by the user. (See 21 CFR 

114.80(a)(1).) The “scheduled process” (i.e., the process selected by a processor as adequate 

for use under the conditions of manufacture for a food in achieving and maintaining a food that 

will not permit the growth of microorganisms having public health significance) includes control 

of pH and other critical factors equivalent to the process established by a competent processing 

authority (21 CFR 114.3). Salsa Processor A’s PCQI is also a thermal process authority for the 

purpose of establishing a scheduled process in accordance with part 114.9

Salsa Processor A’s product consists of chopped vegetables (i.e., tomatoes, long green chilies, 

onions, jalapeño peppers, and garlic), salt, spices, and vinegar. Each batch is directly acidified, 

cooked in a kettle, and then hot-filled into glass jars. The hermetically sealed jars are shelf 

stable under ambient storage temperatures.

Salsa Processor A’s PCQI/process authority identified Salmonella, E. coli O157:H7, Listeria 

monocytogenes and Clostridium botulinum as hazards associated with the salsa because these 

pathogenic bacteria can be present on some of the ingredients and can be a hazard if the salsa 

is not properly acidified to a pH that is low enough to prevent the germination of spores of C. 

botulinum and if the heat treatment is not adequate to kill vegetative cells of the pathogenic 

bacteria. 

Salsa Processor A’s PCQI/process authority consulted the scientific literature and found that 

some sporeforming microorganisms that are generally associated with spoilage (such as 

Bacillus subtilis (B. subtilis), and B. licheniformis) could potentially affect the safety of an 

acidified food if spores that are not destroyed during the product heat treatment germinate, 

grow, and cause the pH to increase above 4.6 such that spores of C. botulinum could 

 9 Our regulations require that a commercial processor engaged in the processing of acidified foods 

provide us with information, submitted on Form FDA 2541e, on the scheduled processes for each 

acidified food in each container size. (See 21 CFR 108.25(c)(2).) For additional information about 

submitting a “process filing” for an acidified food using Form FDA 2541e, see our guidance for industry 

entitled “Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, 

FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper 

Format” (FDA, 2015).
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germinate, grow and produce toxin (Rodriguez et al, 1992). However, the scientific literature 

indicated that these sporeformers do not grow at pH 4.2 or less and require oxygen for growth 

at pH 4.4 (Rodriguez et al, 1992). Salsa Processor A’s salsa is acidified to pH 4.1; thus Salsa 

Processor A’s PCQI/process authority determined that the heat treatment should target 

vegetative pathogens such as Salmonella, E. coli O157:H7, and Listeria monocytogenes. Salsa 

Processor A’s PCQI/process authority also determined that there were non-pathogenic 

sporeformers that would survive a heat treatment designed for vegetative pathogens that could 

spoil the product under ambient conditions. 

6.16.2 Salsa Processor A’s Process Design and Validation 

Based on an assessment and review of scientific literature, Salsa Processor A’s PCQI/ process 

authority selected a process (158°F (70°C) for 1.5 minutes) that will deliver a 5D process for 

Salmonella, E. coli O157:H7, and Listeria monocytogenes at a product pH of no higher than 4.1

(Breidt et al., 2010). Salsa Processor A’s PCQI/process authority also determined that the pH of 

4.1 would control sporeforming pathogens such as C. botulinum, as well as sporeformers that 

could potentially grow and raise the pH of the salsa. (See Chapter 8 – “Use of Formulation as a 

Process Control” for information on the use of acidification to control C. botulinum.) Salsa 

Processor A’s PCQI/process authority also determined that a process that delivers 200°F (93°C) 

for 2 minutes is adequate to destroy any other sporeformers that could survive the process and 

potentially spoil the product, and thus achieve a shelf-stable product.

In-house studies determined that as long as the chopped vegetable particles in the salsa did not 

exceed 1.0 cm (0.4 inch) square, the particles would also be at 158°F (70°C) when the liquid 

portion of the salsa reached that temperature, provided that the particles were stored 

refrigerated (i.e., at least 33°F (0.6°C)) and not frozen. (Salsa Processor A’s SOPs specify that 

vegetables to be chopped are stored refrigerated (at a temperature of 33 - 40°F (0.6 - 4 °C)) 

until used.) Salsa Processor A determined that the size of the particles in the vegetable salsa is 

a parameter requiring a critical limit (i.e., a maximum value of 1.0 cm square). However, Salsa 

Processor A’s PCQI/process authority determined that a critical limit for the temperature of the 

particles in the vegetable salsa is not necessary as long as the production line follows the SOP 

to store the particles refrigerated.

Briefly, the procedure for the production of the mixed vegetable salsa is as follows:

• All vegetables, which have been held refrigerated, are washed and or peeled, cored or 

seeded, and chopped;

• Vinegar (5 percent acetic acid), salt, and spices are prepped and weighed per recipe;

• Salsa is made by combining all ingredients in an agitated 150 gallon steam-jacketed cook 

kettle that heats the salsa to 200°F (93°C); the salsa is then held for at least 2 minutes;

• Heat-treated salsa is pumped from the cook kettle to a temperature-controlled filling surge 

tank and equilibrated to 200°F (93°C);

• The heat-treated salsa is then hot-filled into clean pint glass jars via a volumetric filler. Jars 

are capped under flowing steam, then inverted and conveyed for one minute (to kill 

microorganisms on the container) prior to being re-inverted, and conveyed through a cold 

water shower for cooling; and
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• Cooled and sealed jars are then dried prior to being labelled, packed 12 to a carton, and 

stored on pallets.

Salsa Processor A’s PCQI/ process authority determined that the following process parameters 

related to the heat treatment are critical to the safety of the chopped vegetable salsa10 and 

established critical limits for each of these process parameters:

• Maximum particle size of chopped vegetables (1.0 cm) (0.4 inch);

• Minimum process temperature for the salsa (158°F) (70°C)11;

• Minimum process time for the salsa (1.5 minutes);

• Minimum temperature of the heat-treated salsa in the filling surge tank (158°F) (70°C); and

• Minimum inverted jar hold time (1 minute).

Because Salsa Processor A needs to make a shelf-stable food, Salsa Processor A treats the 

operating limits established for shelf-stability as if they were the critical limits established for 

food safety. 

6.16.3 Salsa Processor A’s Monitoring

6.16.3.1 What Salsa Processor A monitors

Salsa Processor A:

• Monitors the particle size of the chopped vegetables;

• Monitors the temperature of the in-process salsa in the cook kettle;

• Monitors the time that the in-process salsa is at the process temperature (operating limit) of 

200°F (93°C) or higher in the cook kettle (which ensures that the critical limit of 158°F (70°C) 

will be met); 

• Monitors the temperature of the heat-treated salsa held in the filling surge tank prior to final 

packaging (i.e., hot fill); and

• Checks conveyor belt speed as indicated by automated tachometer RPM (for control of 

inversion time) for inverted jars.

6.16.3.2 How Salsa Processor A monitors

Salsa Processor A:

 10 See Chapter 8 – Use of Formulation as a Process Control – for additional information about pH as a 

critical factor in the production of an acidified food, including the preventive control management 

components.

11 This is the process for safety. However, the acidified foods regulation requires the destruction of 

spoilage organisms such that the food is shelf-stable. Thus the operating limits are actually 200°F (93°C) 

for 2 minutes.
Contains Non-binding Recommendations

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Chapter 6 (Heat Treatments) - Page 41

• Collects a statistically-based sample of vegetable particles (e.g., chopped tomatoes, green 

chilies, onions, jalapeño peppers), uses digital calipers to ensure they do not exceed 1 cm 

(0.4 inch) in any direction, and records the results in the process log;

• Uses an RTD probe attached to a recording chart to monitor the temperature of the inprocess salsa at the cold point in the cook kettle (in top inch (2.5 cm) of kettle), visually

checks the chart and records the observed temperature in the process log;

• Visually checks the temperature recorder chart and marks it with the batch number, records 

the time when the in-process salsa reaches the process temperature in the process log, 

calculates the processing time, records the processing time on the recorder chart and in the 

process log, notes when product should be transferred from cook kettle in the process log,

and records the time when product is transferred from the cook kettle to the filling surge tank

in the process log; 

• Uses another RTD probe attached to a recording chart to monitor the temperature of the 

heat-treated salsa in the filling surge tank, visually checks the chart, and records the 

temperature in the process log; and

• Uses an automated tachometer with recorder chart to monitor the conveyor speed (which is 

tied to the jar inversion time), visually checks the tachometer RPM, and records the RPM in 

the process log.

6.16.3.3 How often Salsa Processor A monitors

Salsa Processor A:

• Checks the particle size of one in-process lot of each chopped vegetable once per 

production shift;

• Checks the continuously recorded temperature (RTD chart recorder) of the in-process salsa 

in the cook kettle once for each batch;

• Checks the processing time once for each batch;

• Checks the continuously recorded temperature (RTD chart recorder) of the in-process salsa 

in the filling surge tank twice per shift; and

• Monitors the automated tachometer RPM (inversion conveyor belt speed) at the beginning 

of production and twice per shift.

6.16.3.4 Who monitors critical factors for Salsa Processor A’s heat 

treatment

At Salsa Processor A:

• A formulation control operator checks the particle size of the chopped vegetables; and
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Chapter 6 (Heat Treatments) - Page 42

• The line operator monitors the recorded temperature and time data (in-process salsa in 

cook kettle and filling surge tank, and the automated tachometer RPM (conveyor belt 

speed) for jar inversion. 

6.16.4 Salsa Processor A’s Corrective Action Procedures

Salsa Processor A’s corrective action procedures specify:

• If it is determined that the mean plus 2.5 standard deviation of the vegetable particle sizes 

exceeds 1 cm (0.4 inch), the in-process lot of chopped vegetables is rejected and will be 

reworked for a different recipe. The PQCI will check with the vegetable processing operator 

to investigate the root cause of the incorrect particle size and, when applicable, notify 

maintenance to reset the vegetable chopper operation to specification. The formulation 

control operator will check the vegetable particle size of every in-process lot for the next 15 

in-process lots to verify particle sizes meet specification. If all 15 lots meet specification, the 

formulation control operator will return to monitoring one in-process lot of each chopped 

vegetable once per production shift;

• If the RTD at the cook kettle records a low temperature or a shortened process time: 

o The product will be held until the PCQI determines whether the process was 

adequate for safety or if the product should be reprocessed or destroyed; 

o The production manager will investigate why the under-processing occurred and take 

appropriate actions to prevent the situation from reoccurring; and

o Employees will be retrained if necessary in light of the reason for the underprocessing;

• If the temperature at the filling surge tank is below the process set point:

o The product will be held until the PCQI determines whether the fill temperature was 

adequate for safety or if the product should be reprocessed or destroyed; 

o The production manager will investigate why the fill temperature was too low and 

take appropriate actions to prevent the situation from reoccurring; and

o Employees will be retrained if necessary; and

• If it is determined that the jar inversion time is below the process set point:

o The product will be held until the PCQI determines whether the process was

adequate or if the product can be reprocessed; 

o The production manager will investigate why the belt speed deviated from the 

process set point and take appropriate actions to prevent the situation from 

reoccurring; and

o Employees will be retrained if necessary in light of the reason for the belt speed 

deviation.
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Chapter 6 (Heat Treatments) - Page 43

6.16.5 Salsa Processor A’s Verification Procedures

At Salsa Processor A: 

• An outside calibration service annually performs on-site calibration of the RTDs, tachometer, 

and recording charts used to measure the temperature at the cook kettle and the hot-fill 

surge tank, and the belt speed of the jar inversion conveyor. A sticker with the calibration 

date is affixed to each recording device and the date and results are recorded in a 

calibration log. The PCQI reviews, initials, and dates the monitoring device calibration logs 

within a week of their creation;

• The Quality Assurance Manager or designee verifies the jar inversion belt speed and time

twice each year, and the PCQI reviews this within one week;

• On a daily basis, the PCQI :

o Checks process logs to confirm that the particle size of the chopped vegetables was 

at the specified value of < 1 cm (0.4 inch);

o Reviews process logs and recorder charts to confirm that the in-process salsa was 

cooked to 200°F (93°C) for a minimum of 2.0 minutes, and checks that process log 

temperatures agree with the recorder;

o Reviews process logs and recorder charts to confirm that the jars were filled at the 

specified temperature of >200°F (93°C), and checks that process log temperatures 

agree with the recorder charts; and

o Reviews the recorded RPM for the conveyor belt to confirm that the jars were 

inverted for the minimum specified time of 1 minute;

• The PCQI reviews corrective action records within one week of when the deviation occurred

and

• Salsa Processor A does not conduct product testing for pathogens or environmental 

monitoring because the product, which is acidified and subjected to a heat treatment 

validated to be highly lethal to vegetative pathogens and filled hot, is not exposed to the 

environment after the heat treatment.

6.16.6 Salsa Processor A’s Monitoring Records

Salsa Processor A keeps:

• The process logs for checks of the particle size of the chopped vegetables;

• The recording charts from the RTDs used to monitor the temperature and time of the inprocess salsa in the cook kettle and in the filling surge tank;

• The recording chart from the automated tachometer used to monitor the jar inversion 

conveyor belt speed; 
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Chapter 6 (Heat Treatments) - Page 44

• The process logs for temperature checks (cook kettle and filling surge tank) and process 

times in the cook kettle; and 

• The process logs for the belt speed for the jar inversion conveyor belt. 

6.16.7 Salsa Processor A’s Records of Corrective Actions

Salsa Processor A keeps records:

• Of any product safety assessment by the PCQI of the safety of product to determine 

appropriate disposition if:

o The RTD at the cook kettle recorded a low temperature;

o The cooking process time was less than the minimum specified time;

o The product temperature in the filling surge tank was too low; or

o The jar inversion time was too short;

• Of the reprocessing of a product that can be reprocessed if:

o Particle size of the chopped vegetables exceeded process set point;

o The process temperature of the in-process salsa in the cook kettle was too low; 

o The process time was less than the minimum specified time;

o The temperature of the heat-treated salsa in the filling surge tank was too low; or 

o The jar inversion time was too short;

• Of any product that cannot be reprocessed and thus is destroyed;

• Of any investigations of the cause of any deviations;

• Of all changes made to correct problems and to prevent reoccurrence of deviations; and

• Documenting any retraining.

6.16.8 Salsa Processor A’s Verification Records

Salsa Processor A maintains the following verification records:

• The date and initials of the PCQI on the monitoring record (e.g., on the charts or in the logs) 

for the review of: 

o Each temperature recording chart for all RTD probes (cook kettle and filling surge 

tank);

o The process logs for the temperature checks (cook kettle and filling surge tank); 
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Chapter 6 (Heat Treatments) - Page 45

o The recording charts for the automated tachometer on the jar inversion conveyor 

belt; 

o The process logs for checks of the particle size of the chopped vegetables and belt 

speed of the jar inversion conveyor belt; and

• The date and initials in the calibration log of the PCQI’s review of the results of the outside 

calibration service’s calibration of the RTDs and automated tachometer, as well as any 

notes by the PCQI of the actions taken when any adjustments were needed;

• The date and initials of the PCQI’s review of the results of the semi-annual verification tests 

that the jar inversion conveyor belt speed is correct, as well as any notes by the PCQI when 

any adjustments to the conveyor belt were needed; and

• The date and initials of the PCQI’s review of corrective action records.

6.16.9 Summary Process Control Table for Salsa Processor A

Appendix 6-E summarizes the above information for Salsa Processor A on the FSPCA’s 

Process Control Form (Form 2-C (Modified) from Appendix 2).

6.17 References

FDA. 2013. FDA Food Code 2013: Annex 6 Food processing 

criteria. http://www.FDA.gov/downloads/Food/GuidanceRegulation/RetailFoodProtection/FoodC

ode/UCM374510.pdf.

FDA. 2015. Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment 

Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process 

Filing Forms) to FDA in Electronic or Paper 

Format http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformatio

n/ucm309376.htm.

FDA. 2016. Guidance for Industry #239: Human Food By-Products For Use As Animal Food. 

Draft 

Guidance. https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/Guidancefo

rIndustry/default.htm.

Lathrop, A.A., T. Taylor, and J. Schenpf. 2014. Survival of Salmonella during Baking of Peanut 

Butter Cookies. Journal of Food Protection 77: 635–639.

Rodriguez J, Cousin M, and Nelson P. 1992. Evaluation of anaerobic growth of Bacillus 

licheniformis and Bacillus subtilis in tomato juice. Journal of Food Protection 55: 672-677.
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 6 (Heat Treatments) - Page 46

Appendix 6. Summary Process Control Tables for the Examples in Chapter 6

Appendix 6-A: Summary Process Control Table for Baking; Cookie Processor A

FORM 2-C (Modified)12 PROCESS CONTROLS

PAGE _________

PRODUCTS: Cookies baked in batches on trays in ovens and packaged by wrapping the cookies by twos in plastic 

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)___________________________________________________

PROCESS CONTROL STEP: __Baking__________________________________________

HAZARD(S): ___Salmonella___________________________________________________

Critical 

Limits

What to 

Monitor How to Monitor Frequency of Monitoring

Who

Monitors Corrective Action Verification Records13

Minimum 

oven 

temperature 

of 350°F 

(177°C) 

(operating 

limit is 352°F 

(178°C))

Temperature 

of oven

• Recording 

thermometer in 

oven 

• Manual check 

of recording chart 

and mark the 

recording with the 

batch number

• Record 

temperature on 

baking record 

sheet

Continuous 

recording 

during each 

batch; manual 

check before 

putting cookies 

in oven 

Baker If oven was not at least 350°F

(177°C):

• Cookies will be diverted to 

cattle feed; and 

• Employees will be retrained 

on the importance of ensuring 

that the oven temperature has 

reached the set point.

• Annual calibration of 

thermometer

• Records review by PCQI 

within one week of record 

creation (baking sheets, 

temperature recording chart, 

calibration logs)

• Review of corrective action 

records within one week of a 

deviation

• Baking record 

sheets

• Temperature 

recording charts

• Calibration records

• Corrective action 

records

 12 Modified from Form 2-C in Appendix 2 to address a single process control step. Form 2-C in Appendix 2 can be used to list multiple process control steps. 13 Records include the date and initials of the PCQI (or designee) as verification.
Contains Non-binding Recommendations

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Chapter 6 (Heat Treatments) - Page 47

Critical 

Limits

What to 

Monitor How to Monitor Frequency of Monitoring

Who

Monitors Corrective Action Verification Records13

Minimum 

process time 

of 13 minutes 

(operating 

limit is 15 

minutes)

Time in oven On baking record 

sheets:

• Record time 

that cookies are 

placed in the 

oven

• Calculate and 

record the time 

when the cookies 

should be 

removed from 

oven

• Record time 

that cookies are 

removed from the 

oven

• Calculate the 

elapsed baking 

time 

Each batch Baker If the bake time is less than 13 

minutes: 

• Cookies will be diverted to 

cattle feed; and

• PCQI determines why the 

bake time was not met to 

prevent this from happening in 

the future.

• Records review by PCQI 

within one week of record 

creation (Baking record 

sheets)

• Review of corrective action 

records within one week of a 

deviation

• Baking record 

sheets

• Corrective action 

records

Dough 

weight ≤28 g 

(operating 

limit is ≤27 g)

• Dough 

depositor 

setting

• Dough 

weight

• Check set 

point of depositor

• Weigh dough 

portions

• Check set 

point every 2 

hours

• Weigh 

dough 

portions twice 

per shift

QC 

technician

If dough weight exceeds 28 g:

• Product will be diverted to 

cattle feed;

• PCQI will determine (if 

possible) what caused the 

depositor to deliver an incorrect 

weight; and. 

• Dough depositor adjusted to 

deliver correct weight.

• Annual calibration of dough 

depositor and scales

• Records review by PCQI 

within one week of record 

creation (calibration logs, 

dough weight logs)

• Review of corrective action 

records within one week of a 

deviation

• Dough weight log 

• Calibration records 

• Corrective action 

records
Contains Non-binding Recommendations

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Chapter 6 (Heat Treatments) - Page 48

Appendix 6-B: Summary Process Control Table for Baking; Cookie Processor B

FORM 2-C (Modified)14 PROCESS CONTROLS

PAGE _________

PRODUCTS: Cookies baked in a continuous band oven and packaged in boxes of 24 cookies 

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)____________________________________________________

PROCESS CONTROL STEP: __Baking___________________________________________

HAZARD(S): ___Salmonella____________________________________________________

Critical 

Limits

What to 

Monitor How to Monitor Frequency of Monitoring

Who

Monitors Corrective Action Verification Records15

Minimum 

oven 

temperature 

of 350°F 

(177°C) 

(operating 

limit is 352°F 

(178°C))

Temperature 

of oven at the 

identified cold 

spot

Recording 

thermometer in 

oven, visual check 

of recording chart, 

with a note of the 

check in the 

operator’s baking 

log

Continuous 

recording during 

each batch with 

visual check 

every hour

Baker If oven was not at least 350°F

(177°C):

• Cookies will be diverted to 

further processing (baking for 

cookie crumbles) or cattle feed; 

• Maintenance will determine 

the cause of the low temperature 

and fix the oven so the 

temperature is at least 350 °F 

(177°C) before more cookies are 

baked; and

• Employees will be retrained if 

necessary.

• Annual calibration of 

oven thermometer and 

temperature recording 

chart

• QC technician check of 

thermometer recording 

chart

• Records review by 

PCQI within 7 days of 

record creation (operator’s 

baking log, temperature 

recording chart, calibration 

log)

• Review of corrective 

action records at the end 

of each week

• Operator’s baking 

log

• Temperature 

recording chart

• Calibration records 

for thermometer and 

temperature recording 

chart 

• Corrective action 

records

 14 Modified from Form 2-C in Appendix 2 to address a single process control step. Form 2-C in Appendix 2 can be used to list multiple process control steps. 15 Records include the date and initials of the PCQI (or designee) as verification.
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 6 (Heat Treatments) - Page 49

Critical 

Limits

What to 

Monitor How to Monitor Frequency of Monitoring

Who

Monitors Corrective Action Verification Records15

Maximum 

belt speed 

(tachometer 

RPM) to 

achieve a 

minimum 

process time 

of 13 minutes 

(operating 

limit is 

maximum 

tachometer 

RPM to 

achieve a 

process time 

of 15 

minutes)

Belt speed 

(tachometer 

RPM)

Automated 

tachometer with 

recorder chart and 

visual observation 

of tachometer 

RPM

Continuous 

recording during 

each batch with 

visual check at 

start-up and twice 

per shift

Baker If the tachometer reading 

indicates that the baking time is 

less than 13 minutes:

• The cookies are placed on 

hold;

• The PCQI assesses whether 

the cookies will be diverted to 

bake as cookie crumbles or 

diverted to cattle feed; and 

• The PCQI determines why the 

bake time was not met and 

informs management of actions 

they need to take to prevent this 

from happening.

• Annual calibration of 

tachometer and its 

recorder chart

• QC technician check of 

tachometer recording chart

• Records review by 

PCQI within 7 days of 

record creation 

(tachometer chart, 

calibration logs)

• Review of corrective 

action records at the end 

of each week 

• Recording chart for 

automated tachometer

• Calibration records 

for tachometer and its 

recording chart

• Corrective action 

records

Dough 

weight ≤28 g 

(operating 

limit is ≤27 g)

• Dough 

depositor 

setting

• Dough 

weight

• Check set 

point of depositor

• Weigh dough 

portions

• Check set 

point at start-up 

and every 2 

hours

• Weigh dough 

portions twice 

per shift

Dough 

preparer

If dough weight exceeds 28 g:

• PCQI will determine whether 

the product will be further 

processed or diverted to cattle 

feed; and 

• PCQI will determine (if 

possible) what caused the 

depositor to deliver an incorrect 

weight. 

• Dough depositor adjusted to 

deliver correct weight.

• Annual calibration of 

dough depositor and 

scales

• QC technician check of 

dough weight log twice per 

shift

• Records review by 

PCQI within 7 days of 

record creation (calibration 

logs, dough weight logs)

• Review of corrective 

action at the end of each 

week

• Dough weight 

record sheets

• Calibration records 

for dough depositor 

and scales

• Corrective action 

records
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Chapter 6 (Heat Treatments) - Page 50

Appendix 6-C: Summary Process Control Table for Cooking; Soup Processor A

FORM 2-C (Modified)16 PROCESS CONTROLS

PAGE _________

PRODUCTS: Soup cooked in a kettle, packaged in 8 ounce plastic bowls, and frozen _____

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)____________________________________________________

PROCESS CONTROL STEP: ___Cooking________________________________________

HAZARD(S): __Listeria monocytogenes__________________________________________

 16 Modified from Form 2-C in Appendix 2 to address a single process control step. Form 2-C in Appendix 2 can be used to list multiple process control steps.
Contains Non-binding Recommendations

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Chapter 6 (Heat Treatments) - Page 51

Critical 

Limits

What to 

Monitor How to Monitor Frequency of Monitoring

Who

Monitors Corrective Action Verification Records17

Minimum soup 

temperature of 

180°F (82°C) 

(EPIPT)

Temperature of 

soup in kettle 

Thermometer 

inserted into 

soup in top inch 

(2,5 cm) of 

kettle; 

measured 

temperature is 

recorded in the 

cook log

Begin after 30 

min; then 

every 10 min 

after reaching 

170°F (77°C) 

until the EPIPT 

is reached 

(180°F (82°C))

Kettle cook 

operator

• If EPIPT did not reach 180°F 

(82°C) and soup is being 

packaged but has not been 

frozen: stop packaging and 

reprocess soup until the EPIPT 

reaches 180°F. Packages that 

have been frozen will be 

destroyed. 

• If EPIPT did not reach 180°F 

(82°C) and soup has been 

packaged and frozen, the PCQI 

will assess the safety of the 

product to determine appropriate 

disposition. If process delivered 

was inadequate to ensure product 

safety, soup will be diverted to 

animal food or destroyed.

• If soup is packaged before the 

EPIPT reaches 180°F (82°C) due 

to operator error, the kettle cook 

operator will be retrained.

• PCQI reviews cook 

log weekly.

• QC technician 

calibrates thermometers 

against NIST reference 

thermometer at least

annually; PCQI reviews 

the calibration log within 

a week of the calibration.

• QC technician checks 

accuracy of 

thermometers daily; 

PCQI reviews these 

accuracy checks on a 

weekly basis.

• PCQI reviews

corrective action records

before shipment of each 

lot of soup.

• Cook log of 

monitoring 

temperature 

• Thermometer 

calibration and 

accuracy checks log 

• Corrective action 

records 

Maximum 

particle size 

no greater 

than 1⁄2 inch

(13 mm) in 

any direction

Size of diced 

carrots, 

potatoes, onions

Collect a 

statisticallybased sample of 

vegetable 

particles and 

then use digital 

calipers to 

ensure they do 

not exceed 1⁄2 

inch (13 mm) in 

any direction; 

record the 

measurement in 

a log

Every third lot 

on receipt

Formulation 

control 

operator

If vegetable particle sizes exceed 

1⁄2 inch (13 mm): 

• The lot of vegetables is 

rejected and unopened packages 

are returned to the supplier; 

• PCQI discusses with the 

supplier so the supplier can 

investigate the root cause for 

incorrect particle size; and

• Formulation control operator 

checks vegetable particle size of 

every lot for the next 15 lots. If all 

15 lots meet specification, the 

formulation control operator will 

return to monitoring every third lot.

• QC technician checks 

accuracy of digital 

calipers before use.

• PCQI reviews particle 

measurement log and 

accuracy checks of the 

digital calipers weekly.

• PCQI reviews 

corrective action records

before shipment of each 

lot of soup

• Vegetable particle 

size log 

• Digital caliper 

accuracy check logs 

• Corrective action 

records 

 17 Records include the date and initials of the PCQI (or designee) as verification.
Contains Non-binding Recommendations

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Chapter 6 (Heat Treatments) - Page 52

Appendix 6-D: Summary Process Control Table for Cooking; Soup Processor B

FORM 2-C (Modified)18 PROCESS CONTROLS

PAGE _________

PRODUCTS: Soup cooked in a continuous flow heat exchanger, packaged in 5 gallon bag, and refrigerated 

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)____________________________________________________

PROCESS CONTROL STEP: Cooking 

HAZARD(S): Vegetative pathogens such as Salmonella and Listeria monocytogenes; and

Clostridium botulinum (especially non-proteolytic type B)

 18 Modified from Form 2-C in Appendix 2 to address a single process control step. Form 2-C in Appendix 2 can be used to list multiple process control steps.
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 6 (Heat Treatments) - Page 53

Critical 

Limits

What to 

Monitor How to Monitor Frequency of Monitoring

Who

Monitors Corrective Action Verification Records19

Minimum 

soup IT of 

40°F (4°C)

IT in preprocess 

agitated 

surge tank

RTD probe with 

recording chart 

monitors IT

Continuous 

recording of IT 

checked twice 

per shift

Line operator If the IT of a batch of soup was too 

low during the processing of that 

soup:

• Product will be held until the 

PCQI determines whether the 

process was adequate or if the soup 

can be reprocessed; and

• Production manager will 

investigate why the IT was too low 

and take appropriate actions to 

prevent the situation from 

reoccurring.

• Outside service 

calibrates RTDs and 

recorder charts 

annually. 

• PCQI reviews 

calibration logs within 1 

week of creation.

• PCQI reviews 

recorder charts and the 

process logs containing 

IT daily.

• PCQI reviews 

corrective action 

records within one week 

of when deviation 

occurs.

• Process logs for 

temperature checks of 

IT

• Recording charts of

IT

• Calibration records 

for RTDs and recorder 

charts

• Corrective action 

records

Metering 

pump 

speed to 

deliver 

processspecified 

flow rate 

(gal/min)

Pump RPM 

setting

Visual observation 

of RPM dial setting

At beginning of 

production and 

twice per shift

Line operator If the metering pump speed during 

production of the soup was too fast:

• Any ongoing production will be 

stopped and affected product will be 

held until the PCQI evaluates the 

safety of the product; and

• The PCQI will assess the safety 

of the product and determine 

whether it will be released, reprocessed, diverted to animal food, 

or destroyed.

• Production manager will 

investigate why the pump speed was 

too fast and take appropriate actions 

to prevent the situation from 

reoccurring

• QA manager verifies 

pump speed provides 

correct flow rate for the 

hold tubes twice a year

and PCQI reviews this 

within 1 week.

• PCQI reviews pump 

speed log daily.

• PCQI reviews 

corrective action 

records within one week 

of when deviation 

occurs.

• Process logs for 

pump speeds

• Calibration records 

for flow rates

• Corrective action 

records

 19 Records include the date and initials of the PCQI (or designee) as verification.
Contains Non-binding Recommendations

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Chapter 6 (Heat Treatments) - Page 54

Critical 

Limits

What to 

Monitor How to Monitor Frequency of Monitoring

Who

Monitors Corrective Action Verification Records19

Correct hold 

tube to 

deliver 2.5 

minute hold 

time at 

specified

pump 

speed

Correct hold 

tube in place

Visual observation 

that hold tube 

number is correct

for the specific 

soup recipe

At beginning of 

production and 

when soup 

variety changes

Line operator If the incorrect hold tube was used:

• PCQI will assess the safety and 

determine disposition of the product; 

• Production manager will 

investigate why the incorrect hold 

tube was used; and

• Employees will be retrained if 

necessary

• PCQI reviews pump 

speed log with hold tube 

identification daily.

• PCQI reviews 

corrective action 

records within one week 

of when deviation 

occurs.

• Process logs 

containing hold tube 

number for the product 

being processed (i.e., 

the pump speed log) 

• Corrective action 

records

Minimum 

product 

temperature 

at end of 

hold tube of 

205°F

(96°C)

Temperature 

at end of hold 

tube

RTD probe with 

recording chart 

monitors 

temperature at 

hold tube exit

Continuous 

recording of 

product at hold 

tube exit 

checked twice 

per shift

Line operator If soup is not automatically diverted 

for reprocessing when the 

temperature at the end of the hold 

tube is low:

• PCQI will assess the safety of the 

product and determine appropriate 

disposition; and

• Production manager will 

investigate the low temperature and 

the diversion failure and take 

appropriate action to fix the problem.

• Outside service 

calibrates RTDs and 

recorder charts 

annually. 

• PCQI reviews 

calibration logs within 1 

week of creation.

• PCQI reviews 

recorder charts and the 

process logs containing 

temperature at hold 

tube exit daily.

• PCQI reviews 

corrective action 

records within one week 

of when deviation 

occurs.

• Process logs for 

temperature checks of 

hold tube exit 

temperature

• Recording charts of 

product exiting hold 

tube

• Calibration records 

for RTDs and recorder 

charts

• Corrective action 

records
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 6 (Heat Treatments) - Page 55

Critical 

Limits

What to 

Monitor How to Monitor Frequency of Monitoring

Who

Monitors Corrective Action Verification Records19

Minimum 

product 

temperature 

in agitated 

hot holding 

surge tank 

of 185°F 

(85°C)

Temperature 

in agitated 

hot holding 

surge tank

RTD probe with 

recording chart 

monitors 

temperature of 

product in agitated 

hot-holding surge 

tank

Continuous 

recording of fill 

temperature 

checked twice 

per shift

Line operator If the temperature in the agitated hotholding surge tank was below the 

process set point:

• Product will be held until the 

PCQI determines whether the 

temperature was adequate for safety 

or if the soup should be reprocessed 

or destroyed; and

• Production manager will 

investigate why the temperature in 

the agitated hot-holding surge tank

was too low and take appropriate 

actions to prevent the situation from 

reoccurring.

• Outside service 

calibrates RTDs and 

recorder charts 

annually. 

• PCQI reviews 

calibration logs within 1 

week of creation.

• PCQI reviews 

recorder charts and the 

process logs containing 

temperature in the 

agitated hot-holding 

surge tank daily.

• PCQI reviews 

corrective action 

records within one week 

of when deviation 

occurs.

• Process logs for 

temperature checks of 

filling temperature

• Recording charts of 

filling temperature

• Calibration records 

for RTDs and recorder 

charts

• Corrective action 

records
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 6 (Heat Treatments) - Page 56

Appendix 6-E: Summary Process Control Table for Heat Treatment; Salsa Processor A

FORM 2-C (Modified)20 PROCESS CONTROLS

PAGE _________

PRODUCTS: Chopped mixed vegetable salsa that is an acidified food _________________

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)____________________________________________________

PROCESS CONTROL STEP: Heat 

treatment____________________________________ HAZARD(S): Salmonella, E. coli O157:H7, Listeria monocytogenes and Clostridium botulinum _____________

 20 Modified from Form 2-C in Appendix 2 to address a single process control step. Form 2-C in Appendix 2 can be used to list multiple process control steps.
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 6 (Heat Treatments) - Page 57

Critical 

Limits

What to 

Monitor How to Monitor Frequency of Monitoring

Who

Monitors Corrective Action Verification Records21

Maximum 

particle size of 

chopped 

vegetables 

(1.0 cm) (0.4 

inch)

Particle size of 

the chopped 

vegetables

• Collect 

statisticallybased sample 

of vegetable 

particles;

• Use digital 

calipers to

measure 

particle size; 

and

• Record 

results in the 

process log

Check one inprocess lot of 

each chopped 

vegetable once 

per production 

shift

Formulation 

control 

operator

If the mean plus 2.5 standard deviation of 

the vegetable particle sizes exceeds 1 cm 

(0.4 inch):

• The in-process lot of chopped 

vegetables is rejected and will be 

reworked for a different recipe.

• The PQCI will check with the vegetable 

processing operator to investigate the root 

cause of the incorrect particle size and, 

when applicable, notify maintenance to 

reset the vegetable chopper operation to 

specification. 

• The formulation control operator will 

check the vegetable particle size of every 

in-process lot for the next 15 in-process 

lots to verify particle sizes meet 

specification. If all 15 lots meet 

specification, the formulation control 

operator will return to monitoring every 

one lot per vegetable per production shift.

On a daily basis, 

the PCQI checks 

process logs to 

confirm that the 

particle size of the 

chopped vegetables 

was at the specified 

value 

• The process logs 

for checks of the 

particle size of the 

chopped vegetables

• Corrective action 

records

 21 Records include the date and initials of the PCQI (or designee) as verification.
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 6 (Heat Treatments) - Page 58

Critical 

Limits

What to 

Monitor How to Monitor Frequency of Monitoring

Who

Monitors Corrective Action Verification Records21

Minimum 

process 

temperature 

for the salsa 

(200°F) (93°C)

Temperature 

of the inprocess salsa 

in the cook 

kettle

• RTD probe 

with recording 

chart monitors 

temperature of 

the in-process 

salsa (in top 

inch (2.5 cm) of 

kettle);

• Visual 

check of the 

chart;

• Record 

temperature in 

process log

Once for each 

batch

Line operator If the RTD at the cook kettle records a low 

temperature: 

• The product will be held until the PCQI 

determines whether the process was 

adequate for safety or if the product 

should be reprocessed or destroyed. 

• The production manager will 

investigate why the under-processing 

occurred and take appropriate actions to 

prevent the situation from reoccurring.

• Employees will be retrained if 

necessary in light of the reason for the 

under-processing.

• Annual 

calibration of the 

RTDs and 

recording chart 

used to measure 

temperature at the 

cook kettle, with 

the date and 

results recorded in 

a calibration log. 

The PCQI reviews, 

initials, and dates 

the calibration logs 

within a week of 

their creation.

• On a daily 

basis, the PCQI 

reviews recorder 

charts and process 

logs to confirm that 

the in-process 

salsa was cooked 

at the specified 

temperature, and 

checks that 

process log 

temperatures 

agree with the 

recorder charts. 

• The recording 

charts from the RTDs 

used to monitor the 

temperature of the inprocess salsa in the 

cook kettle 

• The process logs 

for temperature checks 

of the cook kettle 

• Corrective action 

records

• Of calibration of the 

RTDs and recording 

charts, with any notes 

by the PCQI about 

adjustments
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 6 (Heat Treatments) - Page 59

Critical 

Limits

What to 

Monitor How to Monitor Frequency of Monitoring

Who

Monitors Corrective Action Verification Records21

Minimum 

process time 

at 200°F

(93°C) for the 

salsa (2

minutes)

Time that the 

in-process 

salsa is at the 

process 

temperature

• Visual 

checks of 

recorder chart;

• Mark chart

with batch 

number;

• Record time

when inprocess salsa 

reaches 

process 

temperature in 

process log;

• Calculate 

processing 

time;

• Record 

processing

time on the 

recorder chart 

and in the 

process log;

• Note when 

product should 

be transferred 

to filling surge 

tank in the 

process log;

• Record the 

time when 

product is 

transferred 

from to the 

filling surge 

tank in the 

process log

Once for each 

batch

Line operator If the RTD at the cook kettle records a 

shortened process time: 

• The product will be held until the PCQI 

determines whether the process was 

adequate for safety or if the product 

should be reprocessed or destroyed. 

• The production manager will 

investigate why the under-processing 

occurred and take appropriate actions to 

prevent the situation from reoccurring.

• Employees will be retrained if 

necessary in light of the reason for the 

under-processing.

On a daily basis, 

the PCQI reviews 

recorder charts and 

process logs to 

confirm that the inprocess salsa was 

cooked for the 

specified time 

• Of the temperature 

recording chart marked 

with various times, and 

the process log, 

• Corrective action 

records
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 6 (Heat Treatments) - Page 60

Critical 

Limits

What to 

Monitor How to Monitor Frequency of Monitoring

Who

Monitors Corrective Action Verification Records21

Minimum 

temperature of 

the heattreated salsa 

in the filling 

surge tank 

(200°F) (93°C)

Temperature 

of the heattreated salsa 

held in the 

filling surge 

tank

• RTD probe 

with recording 

chart monitors

temperature of 

heat-treated 

salsa in filling 

surge tank;

• Visual 

check of chart; 

• Record 

temperature in 

process log

Twice per shift Line operator If the temperature at the filling surge tank 

is below the process set point:

• The product will be held until the PCQI 

determines whether the fill temperature 

was adequate for safety or if the product 

should be reprocessed or destroyed. 

• The production manager will 

investigate why the fill temperature was 

too low and take appropriate actions to 

prevent the situation from reoccurring.

• Employees will be retrained if 

necessary

• Annual 

calibration of the 

RTDs and 

recording chart 

used to measure 

the temperature at 

the filling surge 

tank, with the date 

and results 

recorded in a 

calibration log. The 

PCQI reviews, 

initials, and dates 

the calibration logs 

within a week of 

their creation

• On a daily 

basis, the PCQI 

reviews process 

logs and recorder 

charts to confirm 

that the jars were 

filled at the 

specified 

temperature, and 

checks that 

process log 

temperatures 

agree with the 

recorder charts.

• The recording 

charts from the RTDs 

used to monitor the 

temperature of the 

filling surge tank

• The process logs 

for temperature checks 

of the filling surge tank

• Corrective action 

records

• Of calibration of the 

RTDs and recording 

charts, with any notes 

by the PCQI about 

adjustments
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 6 (Heat Treatments) - Page 61

Critical 

Limits

What to 

Monitor How to Monitor Frequency of Monitoring

Who

Monitors Corrective Action Verification Records21

Minimum 

inverted jar 

hold time (1 

minute)

Conveyor belt 

speed as 

indicated by 

automated 

tachometer 

RPM

• Automated 

tachometer 

with recorder 

chart monitors

conveyor 

speed;

• Visual

check of chart

• Record 

RPM in 

process log

At the 

beginning of 

production and 

twice per shift

Line operator If it is determined that the jar inversion time 

is below the process set point:

• The product will be held until the PCQI 

determines whether the process was 

adequate or if the product can be 

reprocessed.

• The production manager will 

investigate why the belt speed deviated 

from the process set point and take 

appropriate actions to prevent the 

situation from reoccurring. 

• Employees will be retrained if 

necessary in light of the reason for the 

belt speed deviation

• Annual 

calibration of the 

tachometer and 

recording chart 

used to measure 

belt speed of the 

jar inversion 

conveyor, with the 

date and results 

recorded in a 

calibration log. The 

PCQI reviews, 

initials, and dates 

the calibration logs 

within a week of 

their creation.

• The QA

Manager verifies 

the jar inversion 

belt speed and 

time twice each 

year, and the PCQI 

reviews this within 

one week.

• On a daily 

basis, the PCQI 

reviews the 

recorded RPM for 

the conveyor belt

• The recording chart 

from the automated 

tachometer used to 

monitor the jar 

inversion conveyor belt 

speed

• The process logs 

for checks of the belt 

speed for the jar 

inversion conveyor belt

• Corrective action 

records

• Of calibration of the 

tachometer and 

recording charts, and 

verification tests that 

the jar inversion time is 

correct, with any notes 

by the PCQI about 

adjustments