Haccp 10 PDF

Generic
United States
Department of HACCP
Agriculture
Food Safety Model for

and Inspection
Service
Heat Treated,
Revised February 2005
HACCP-10 Shelf Stable

Meat and
Poultry
Products
Additional copies of the Guidebook for the Preparation of HACCP
Plans and the Generic HACCP Models are available from:
U.S. Department of Agriculture

Food Safety and Inspection Service (FSIS)
Office of Public Affairs Education and Outreach
Strategic Initiatives Partnerships and Outreach Staff
Aerospace Building
3rd Floor Room 405
901 D Street SW
Washington, D.C. 20250-3700
Phone: (202) 690-6520
Fax: (202) 690-6519
This material is also available on the FSIS Homepage:

http://www.fsis.usda.gov
United States Food Safety Washington, D.C.
Department of and Inspection 20250
Agriculture Service
TO THE USERS OF THESE VOLUMES
When the Pathogen Reduction; Hazard Analysis and Critical Control Point Systems
(PR/HACCP); Final Rule was published on July 25, 1996, the Guidebook for the Preparation of
HACCP Plans was included as an appendix. The Generic Models for different meat and poultry
processes, developed for FSIS under contract, were available shortly thereafter in April 1997.
There were significant differences between the final regulatory language of Title 9 Code of
Federal Regulations (9 CFR) Part 417 and the DRAFT Generic Models because they were
developed independently. FSIS developed the final regulatory language of 9 CFR 417. The
contractor based the Generic Models on HACCP documents from the National Advisory
Committee on Microbiological Criteria for Foods (NACMCF). FSIS accepted the Generic
Models with full knowledge that significant revisions would be necessary.
The Generic HACCP Models are the Agency‘s major technical assistance documents on
developing HACCP plans, but they did not clearly inform the regulated industry of Agency
expectations regarding regulatory compliance. Because the intended audience for these technical
assistance materials was primarily the small and very small establishments that have the least
HACCP-experience, the Agency began the systematic revision of the documents.
The Generic Models contain a description of the steps in preparing a HACCP plan and the
thinking process used by a HACCP team in developing their plan. Two appendices are included.
Appendix A contains one reference list on HACCP systems and regulatory requirements and a
second reference list on microbiological principles and processing procedures for specific meat
and poultry product(s) described in the generic model. Appendix B contains the process flow
diagram, product description, hazard analysis, HACCP plan, and monitoring logs of the model.
The generic models are designed to provide establishments with guidance in meeting the
regulatory requirements in 9 CFR 417. The generic models are not intended to be used "as is."
Because HACCP plans are specific to an individual establishment‘s processing procedures and
products, each establishment must determine their own critical control points (CCPs) and critical
limits based on their hazard analysis of their processing procedures. The Generic Models provide
the basics; they are not designed to be the ultimate teaching and training materials. The Generic
Models do not interpret existing regulations; rather, they are designed to send the user back to
the regulations so he/she can become familiar with the requirements as well as the flexibility
they permit. The generic models are not intended to present new or alternative methods of
producing and processing meat and poultry products.
FSIS Form 2630-9 (6/86) EQUAL OPPORTUNITY IN EMPLOYMENT AND SERVICES

As an establishment‘s team members begin their work, and as they proceed, some questions arise
as to whether what they have developed is appropriate. This is the point when FSIS expects the
team to pick up the appropriate generic model and get a sense of whether they are on the right
track. They should be able to determine whether the forms that they have developed, while
different from the various ones in the generic models and not the same as what other companies
use, are acceptable because they include the required information. They will also be able to
identify the food safety hazards that are reasonably likely to occur in their establishment, as
explicitly in 9 CFR 417.2, and how to think through the problems that these hazards represent for
their own products. They can see how critical limits might arise from existing regulatory
requirements, such as the ones for rapid chilling of poultry products. Resources are identified for
sources of scientific expertise. The HACCP team can choose to make a conservative decision to
provide a good margin of safety. They can find out the essential differences between monitoring
and verification and have a basis for making their choices about verification activities and their
frequencies. FSIS believes that these are useful, beneficial and worthwhile functions for which
its generic models can be used.
FSIS is updating the generic models to include new technical information and to revise those
parts that are out of date. Although water activity replaces moisture protein ratio (MPR) as a
measure of dryness for food safety assurance in this model, an MPR of 0.75:1 or less remains
part of the standard of identity for jerky. As noted above, this model, and the other FSIS generic
HACCP models, is intended as guidance material to which industry can refer.
We hope that these documents are helpful.
FSIS Form 2630-9 (6/86) EQUAL OPPORTUNITY IN EMPLOYMENT AND SERVICES

Heat Treated, Shelf Stable Model
Table of Contents
Introduction……………………………………………………………………………..…. 3
Using This Generic Model…………………………………………………………..…….. 5
Process Flow Diagram and Product Description…………………………………..………. 7
Hazard Analysis………………………………………………………………….………… 8
Developing Your HACCP Plan………………………………………………..….……….. 10
Identifying CCPs……………………………………………………………………..……. 11
Appendix A
References for General HACCP and Regulatory Issues …………..…………….. 17
References for Heat Treated, Shelf Stable Meat and Poultry Products……..………19
Appendix B
Process Flow Diagram (Figure1) ………………………………………………….. 22
Product Description Form (Figure 2)…………………………………………….… 23
Hazard Analysis Form (Figure 3)……………………………………………….…. 25
HACCP Plan Form (Figure 4)…………………………………..……………….… 30
Fermentation Log …………...………………………………………………………35
Corrective Actions Log….………………………………………………...………...36
Smokehouse/Product Temperature Log……....…………………….……….….….. 37

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Thermometer Calibration Log………..…………………………………………….38
Generic Establishment X: Oven Temperature/Humidity Log...………….……….. 39
Water Activity Log……………………………………..…………………………. 40
Generic Establishment X: Metal Detector Performance Log…………………..…. 41
Pre-Shipment Review Log………………………………………………………….42
GENERIC HACCP MODEL
FOR
HEAT TREATED, SHELF STABLE MEAT AND POULTRY PRODUCTS
Introduction
The Hazard Analysis Critical Control Point (HACCP) system is a scientific approach to process
control. It is designed to prevent the occurrence of problems by assuring that controls are
applied at any point in a food production system where hazardous or critical situations could
occur. Hazards include biological, chemical, or physical contamination of food products. There
are two basic kinds of bacteriological hazards: (1) infectious bacteria (e.g. Escherichia coli
O157:H7, Listeria monocytogenes, Salmonella, and Clostridium perfringens) that must be
inactivated by an effective lethal treatment and prevented from contaminating the treated
product, and (2) toxigenic bacteria (e.g. Clostridium botulinum and enterotoxigenic
staphylococci) that must be inhibited from growing and producing their toxin during processing
and in the finished product. For heat treated, shelf stable products, the control of infectious
bacteria is ordinarily a validated heat treatment but in some cases a combination of curing, heat,
and drying has been validated. The toxigenic bacteria and mold can pose a hazard if the drying
process is too slow or insufficient. The hazard from these microorganisms is controlled by
controlling the time and temperature of drying or curing, water activity, and packaging of the
final product.
The Food Safety and Inspection Service (FSIS) published a final rule in July 1996 mandating
that HACCP be implemented as the system of process control in all inspected meat and poultry
plants. As part of its efforts to assist establishments in the preparation of plant-specific HACCP
plans, FSIS determined that a generic model for each process defined in the regulation would be
made available for use on a voluntary basis by inspected establishments.
The generic models have been revised since their initial publication and distribution as DRAFTS.
The most important change in the revised versions is to make certain that these models are fully
consistent with the features of the final regulation. Also, other technical and editorial
improvements have been made.
Throughout this generic model, FSIS discusses a HACCP team with members from different
departments. In many very small establishments, there will not be separate departments with
different employees. But, there will be employees who perform these different functions œ often
several of them. For purposes of explaining concepts, it is easier to speak as if these were
different people, even though in many cases, they may be the same person carrying out more
than one responsibility.
Each generic model can be used as a starting point for the development of plant-specific plan(s)
reflecting actual plant environments and the processes conducted. The generic model is not
intended to be used —as is“ for plant specific HACCP plans.
The generic models are designed for use in conjunction with the list of process categories found
in the HACCP regulations in section 417.2(b)(1).
(b) The HACCP plan. (1) Every establishment shall develop and implement a written
HACCP plan covering each product produced by that establishment whenever a hazard
analysis reveals one or more food safety hazards that are reasonably likely to occur,
based on the hazard analysis conducted in accordance with paragraph (a) of this section,
including products in the following processing categories:
(i) Slaughter--all species.
(ii) Raw product--ground.
(iii) Raw product--not ground.
(iv) Thermally processed--commercially sterile.
(v) Not heat treated--shelf stable.
(vi) Heat treated--shelf stable.
(vii) Fully cooked--not shelf stable.
(viii) Heat treated but not fully cooked--not shelf stable.
(ix) Product with secondary inhibitors--not shelf stable.
This generic model is designed for use with the process category: Heat treated--shelf stable.
The purpose of the process category listing in 417.2 is to set out the circumstances under which a
HACCP team may develop a single HACCP plan for multiple products. This may be done when
products are in the same process category, and food safety hazards, critical control points, and
other features are essentially the same. There is a generic model for each process category, plus
two for subcategories which present special issues: irradiated products and mechanically
separated products.
In order to select the model or models that will be most useful for the activities performed in any
specific plant, the following steps should be taken:
1) For slaughtering operations, select the model for the appropriate species.
2) For processed products, make a list of all products produced in the plant.
3) Examine the list and group like products, considering common processing steps and
equipment used.
4) Compare the grouped products with the list of processes in the regulations; this step should
reveal how many and which of the generic models might be useful.
Deciding on a generic model and which products can be covered by a single plan is an important
achievement. If the team does it well, it can save a lot of unnecessary effort and paperwork.
Selecting an inappropriate generic model reduces its potential benefits. However, often the
HACCP team will discover they have made this error when they develop their process flow
diagram or during their hazard analysis. These are early stages in the process when it is
relatively easy to make changes.
In any case, establishments must meet all regulatory requirements for their products.
Using This Generic Model
This generic model is designed to be used by establishments that produce heat treated, shelf
stable product(s), the sixth process category listed above. The model can be used for all heat
treated, shelf stable products: either meat or poultry. The generic model is not suitable for
products that fall into any of the other process categories.
The model will be most useful to a HACCP team that includes access to one trained individual,
as specified in 417.7(b).
(b)The individual performing the functions listed in paragraph (a) of this section shall
have successfully completed a course of instruction in the application of the seven
HACCP principles to meat or poultry product processing, including a segment on the
development of a HACCP plan for a specific product and on record review.
It would be beneficial for other team members to have reviewed any of the various guidance
materials available on how to develop a HACCP plan for your company, including several useful
videos, handbooks, or computer programs. References 12 and 13 in the —References for General
HACCP and Regulatory Issues“ in Appendix A of this model provide a detailed description of
the seven principles. Once the HACCP team has prepared itself as thoroughly as possible in
general HACCP principles and how to use them, this model should be helpful.
Note: This generic model includes a number of forms that can be used to record various types of
required information. The forms themselves are examples; a company HACCP team can
develop whatever forms it finds most useful. All the forms mentioned in this document are
included in Appendix B; they appear in the order in which they appear in the HACCP plan. All
of the forms in the previous generic model have been modified or replaced. The Form Letter
Confirming Salmonella Compliance with Performance Standards was removed since the
performance standard for Salmonella in raw product is not a critical control point (CCP) for heat
treated, shelf stable meat and poultry products. The Oven Temperature/Humidity Log is a
modification of the Room Temperature Log. The Water Activity (aw) Log replaces the Shrink
Log as water activity is a better measure of proper drying for shelf stability or safety. Each form
now contains a section for record review.
All FSIS generic models are designed to assist establishments in applying the seven HACCP
principles to their meat and poultry processing operations AND to meet the regulatory
requirements of Part 417. Therefore, the definitions used in this and all other FSIS generic
models are those found in 417.1:
§ 417.1 Definitions.
For purposes of this part, the following shall apply:
Corrective action. Procedures to be followed when a deviation occurs.
Critical control point. A point, step, or procedure in a food process at which control can
be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced
to acceptable levels.
Critical limit. The maximum or minimum value to which a physical, biological, or

chemical hazard must be controlled at a critical control point to prevent, eliminate, or
reduce to an acceptable level the occurrence of the identified food safety hazard.
Food safety hazard. Any biological, chemical, or physical property that may cause a
food to be unsafe for human consumption.
HACCP System. The HACCP plan in operation, including the HACCP plan itself.
Hazard. See Food Safety Hazard.
Preventive measure. Physical, chemical, or other means that can be used to control an
identified food safety hazard.
Process-monitoring instrument. An instrument or device used to indicate conditions

during processing at a critical control point.
Responsible establishment official. The individual with overall authority on-site or a

higher level official of the establishment.
Process Flow Diagram and Product Description
To begin using this model, the company's HACCP team should first describe the product(s)
which are part of this process category and covered by this HACCP plan. The product(s) should
be described in two ways:
(1) by a simple diagram which shows each of the steps the company uses when it produces the
product, and
(2) in a brief written product description which provides key facts about the product and its use.
In this generic model, there are two examples for heat treated, shelf stable products œ snack
sticks and jerky. Other examples of these types of products include summer sausage sticks and
pickled sausages. FSIS has developed certain forms as part of the examples in the generic
models; company HACCP teams are not required to use these forms.
Figure 1 is an example of a PROCESS FLOW DIAGRAM for the production snack sticks and
jerky in generic establishment X. Figure 2 is an example of a PRODUCT DESCRIPTION for
the snack sticks and jerky produced in generic establishment X.
Once the company HACCP team in your establishment has prepared your Process Flow
Diagram, they should verify it by walking through the establishment following the flow of
product and making sure that all the steps of the process are included in the flow diagram. The
team should also review the information provided on the Product Description to make sure all
the key facts are included, such as identifying consumers, especially those with particular health
problems or known to be at risk.
Note: If the establishment‘s process includes steps not included in this example, those steps
should be added. Also, if that process does not include all the steps identified in this example,
those steps would be omitted when conducting the hazard analysis. That is generally how the
HACCP team should use these generic model examples--just omit the features which do not
apply to their operation or add those features of their operation not included in this example.
By completing a Process Flow Diagram and a Product Description, the HACCP team meets the
requirements of 417.2(a)(2). The team can use the Process Flow Diagram to help you complete
the rest of the hazard analysis. They use the flow diagram to systematically review each step in
the process and ask the question, "Is there a food safety hazard which is reasonably likely to
occur which may be introduced, increased, or controlled at this step?" In answering the question,
the HACCP team needs to consider biological (including microbiological), chemical, and
physical hazards.
Hazard Analysis
Once the establishment‘s product(s) are accurately described through the flow diagram and
product description, the HACCP team should begin work on the HAZARD ANALYSIS. The
hazard analysis is fundamental to developing a good HACCP plan that meets regulatory
requirements. The regulatory requirements for a hazard analysis are found at 417.2(a).
§ 417.2 Hazard Analysis and HACCP Plan.
(a) Hazard analysis. (1) Every official establishment shall conduct, or have conducted
for it, a hazard analysis to determine the food safety hazards reasonably likely to occur in
the production process and identify the preventive measures the establishment can apply
to control those hazards. The hazard analysis shall include food safety hazards that can
occur before, during, and after entry into the establishment. A food safety hazard that is
reasonably likely to occur is one for which a prudent establishment would establish
controls because it historically has occurred, or because there is a reasonable possibility
that it will occur in the particular type of product being processed, in the absence of
those controls.
(2) A flow chart describing the steps of each process and product flow in the
establishment shall be prepared, and the intended use or consumers of the finished
product shall be identified.
Generic establishment X, which we are using for our example, is capturing these regulatory
requirements on a 6-column Hazard Analysis Form (See Figure 3). The first column contains
each step listed in the process flow chart. The second column lists the hazards that can be
introduced, increased, or controlled at each step in the first column. A good way to use a form
like this is to create the first column by using the Process Flow Diagram and the second by
answering the question. Once the HACCP team has considered all the steps in the flow diagram
and determined if a food safety hazard could be introduced, increased, or controlled, it needs to
consider whether the hazard is "reasonably likely to occur", using the meaning of this phrase
included in 417.2(a). On the 6-column form used by generic establishment X, the third and
fourth columns address this issue. If the establishment's HACCP team has decided that the
hazard is not reasonably likely to occur, they enter "No" in column three, explain the basis for
their determination in column four, and do not need to further consider activity at this point in
the process.
If, however, the team has determined there is a "food safety hazard reasonably likely to occur"
introduced at a certain point in the process, column five is used to describe a measure which
could be applied to "prevent, eliminate, or reduce to acceptable levels" the food safety hazard
identified in column three. Column six is used when a critical control point (CCP) is identified
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based upon the decision made in the hazard analysis. Each CCP has a number œ the order
corresponds to steps in the process. For example, 1 is the first identified CCP in the process
flow, 2 the next, etc. The letter indicates whether the hazard is biological œ B; chemical œ C; or
physical œ P.
Look at the entries for —Drying“ on the six-column Hazard Analysis form for heat treated, shelf
stable: the HACCP team has determined that Staphylococcus aureus may be present, so it has put
a —Yes“ in the third column. Column four explains the basis for the team‘s determination. In the
fifth column, the HACCP team has described the preventive measures it will use to make sure
that each hazard has been prevented, eliminated, or reduced to an acceptable level. For this
hazard, the HACCP team decided that the water activity (aw) will be checked to ensure that
growth and toxigenesis will not occur. FSIS does not consider safe handling labels alone to be an
adequate CCP for any pathogenic microorganisms such as bacteria and viruses.
IMPORTANT: Manufacturers should not use the moisture protein ratio (MPR) as a measure
of proper drying for shelf-stability or safety. This is because MPR is a product standard
and because the water activity can vary greatly at any given MPR (as a result of the
different kinds and quantity of solutes such as sugar and salt). It is product water activity
that is best correlated to inhibition of each pathogen's growth.
Note: Look at the entries for —Storage œ (Cold œ Frozen/Refrigerated) œ Raw Meat/Poultry“ on
the six-column Hazard Analysis form: the HACCP team has determined that a food safety hazard
is not reasonably likely to occur at this step in the process. Column four contains the reason for
their thinking: pathogenic organisms are not likely to grow if the product is maintained at the
proper temperature. Column five contains their description of a measure that will prevent the
growth of these organisms: prerequisite program is in place to prevent pathogen growth from
being likely to occur.
In this generic hazard analysis for snack sticks and jerky, there are five food safety hazards likely
to occur (metal contamination is listed as a hazard in two process steps) . The HACCP team has
identified a point in the process to control each hazard.
When the HACCP team has completed their hazard analysis (whether they use this format or
not), it is a good idea to review the flow diagram, the product description and the hazard analysis
itself to make sure they are complete. Part 417.2(a)(3) includes a list of sources from which food
safety hazards might be expected to arise. Reviewing that list could help the HACCP team
check for completeness.
Note: If the team is using this generic model to produce a different heat treated, shelf stable
product or if the establishment uses a different process flow, different hazards which are
reasonably likely to occur may be identified. For these different hazards, there may be different
measures that could be used for control purposes.
This generic model, and all other FSIS generic models, contains a list of references which can
help the HACCP team in making sure the hazard analysis is complete. These references are
found in Appendix A. A member of the HACCP team might want to review at least some of the
references to make sure hazards have not been omitted from the hazard analysis.
Completing the hazard analysis is a very significant and important element in developing the
HACCP system. The HACCP team should feel a real sense of accomplishment when they get
this far; this is like completing the foundation of a house.
Developing Your HACCP Plan
The company HACCP team can now take the materials developed while doing the hazard
analysis and use them to build the HACCP plan. Remember that one of the important
objectives of the FSIS generic models is to provide examples which illustrate how to meet the
regulatory requirements of Part 417, as well as to correctly apply the principles of HACCP.
Part 417.2 (c) and (d) are the regulatory requirements:
(c) The contents of the HACCP plan. The HACCP plan shall, at a minimum:
(1) List the food safety hazards identified in accordance with paragraph (a) of this
section, which must be controlled for each process.
(2) List the critical control points for each of the identified food safety hazards, including,
as appropriate:
(i) Critical control points designed to control food safety hazards that could be
introduced in the establishment, and
(ii) Critical control points designed to control food safety hazards introduced outside the
establishment, including food safety hazards that occur before, during, and after entry
into the establishment;
(3) List the critical limits that must be met at each of the critical control points. Critical
limits shall, at a minimum, be designed to ensure that applicable targets or performance
standards established by FSIS, and any other requirement set forth in this chapter
pertaining to the specific process or product, are met;
(4) List the procedures, and the frequency with which those procedures will be
performed, that will be used to monitor each of the critical control points to ensure
compliance with the critical limits;
(5) Include all corrective actions that have been developed in accordance with §417.3(a)
of this part, to be followed in response to any deviation from a critical limit at a critical
control point; and
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(6) Provide for a recordkeeping system that documents the monitoring of the critical
control points. The records shall contain the actual values and observations obtained
during monitoring.
(7) List the verification procedures, and the frequency with which those procedures will
be performed, that the establishment will use in accordance with § 417.4 of this part.
(d) Signing and dating the HACCP plan. (1) The HACCP plan shall be signed and
dated by the responsible establishment individual. This signature shall signify that the
establishment accepts and will implement the HACCP plan.
(2) The HACCP plan shall be dated and signed:
(i) Upon initial acceptance;
(ii) Upon any modification; and
(iii) At least annually, upon reassessment, as required under § 417.4(a)(3) of this part.
Generic establishment X has prepared its HACCP plan for snack sticks and jerky on a six
column form (See Figure 4). You do not need to use this form, although some kind of a form is
probably the easiest way to present your HACCP plan.
Identifying CCPs
The first column on the HACCP plan is used to enter information previously developed and
contained on the Hazard Analysis Form. Part 417.2(c)(1) and (2) require that the food safety
hazards identified in the hazard analysis be listed on the HACCP plan and that there be a CCP
for each identified hazard. You will notice that there were five points on the Hazard Analysis
form for snack sticks and jerky where food safety hazards reasonably likely to occur were
identified: 1) pathogens on incoming raw product, 2) metal contamination during mechanical
processing, 3) S. aureus proliferation at fermentation (snack sticks); 4) pathogen (including L.
monocytogenes) survival and subsequent growth if inadequate heat and humidity is not used, and
5) S. aureus proliferation at drying. The establishment HACCP team has chosen to have four
CCPs to address these five hazards: 1) time for product to reach a pH of ≤5.3 at the end of the
fermentation step in order to meet the relative good manufacturing practice (GMP) degree-hour*
limits for control of S. aureus, 2) proper time/temperature/humidity is reached during heat
treatment, 3) proper drying to preclude growth of S. aureus and L. monocytogenes, and 4) a
metal detector prior to packaging and labeling.
* Degree-hours is the time, in hours, for the product to reach a pH ≤ 5.3 multiplied by the
number of degrees the fermentation chamber is over 60°F (minimum growth temperature for
S. aureus). The degree-hours is calculated for each temperature used during fermentation, but
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a constant chamber temperature may be used (as in the examples provided in 1B of the
HACCP plan and on the Fermentation Log). The number of degree-hours is limited by the
highest temperature in the fermentation process prior to reaching a pH of 5.3 or less. For
example, if the highest chamber temperature is less than 90°F, the process is limited to fewer
than 1200 degree-hours; fewer than 1000 degree-hours if the chamber temperature is between
90 and 100°F; or fewer than 900 degree-hours if the chamber temperature is greater than
100°F. (A more detailed explanation of degree-hours can be found in the American Meat
Institute Foundation document —Good Manufacturing Practices for Fermented Dry and Semi-
Dry Sausage Products at www.amif.org/FactsandFigures/SAUSAGE.pdf).
• Process passing the guideline (Limit: 1200 degree-hours)
Degrees: 80 œ 60 = 20
Hours: 55
Degree-hours: 20 x 55 = 1100 degree-hours
• Process failing the guideline (Limit: 1200 degree-hours)
Degrees: 80 œ 60 = 20
Hours: 65
Degree-hours: 20 x 65 = 1300 degree-hours
Look at the entries for —Heat Treatment (jerky)“ six column HACCP plan form for heat treated,
shelf stable; the HACCP team determined that humidity must be applied during heating in order
to eliminate the pathogens of concern (e.g., Salmonella, E. coli O157:H7, L. monocytogenes and
Staphylococcus aureus). Bacterial resistance to heat has been shown to increase with a decrease
in the moisture level. If humidity is not applied during heating, the bacteria may survive the heat
process and remain viable.
After identifying its CCPs, the HACCP team proceeded to consider critical limits, monitoring
procedures and their frequencies, and verification procedures and their frequencies, and HACCP
records.
In deciding what would be the critical limits, the HACCP team first considered whether there
were any regulatory requirements which had to be met and would function as critical limits.
They did find FSIS regulatory requirements for shelf stability (water activity of 0.85 or below).
They also found guidelines for MPR as a product identity standard for jerky and lethality
compliance guidelines in Appendix A of the final rule, —Performance Standards for the
Production of Certain Meat and Poultry Products.“ MPR is not a safety consideration and is not
included in a hazard analysis or HACCP plan.
Once they had decided on their critical limits, they needed to identify how the monitoring
procedures would be carried out and at what frequency.
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For their drying step, the establishment had a production employee perform water activity (aw)
checks on each lot and the drying time/temperature will be monitored using room recorder
charts.
These decisions by the HACCP team regarding critical limits, plus monitoring procedures and
their frequencies, are written up in columns two and three of the HACCP plan.
The team then went on to consider appropriate verification procedures; the team knew that there
were different types of verification and that Part 417.4(a)(2) included specific regulatory
requirements for each. The regulatory requirements for ongoing verification are:
(2) Ongoing verification activities. Ongoing verification activities include, but are not
limited to:
(i) The calibration of process-monitoring instruments;
(ii) Direct observations of monitoring activities and corrective actions; and
(iii) The review of records generated and maintained in accordance with §417.5(a)(3) of
this part.
The HACCP team decided they could verify through the following procedures and frequency:
1. QA supervisor or designee will review the Fermentation Log, Corrective Actions Log,
Smokehouse/Product Temperature Log, Thermometer Calibration Log, Oven
Temperature/Humidity Log, Water Activity Log and Metal Detector Performance Log
once per shift.
2. Maintenance supervisor or designee will check the calibration and functioning of the
metal detector before the start of operations and after lunch; verify that the wet bulb wick
well contains appropriate amount of water prior to startup and during operation if
necessary.
3. QA technician or designee will check all thermometers used for monitoring and
verification activities daily and calibrate to within 1 °F accuracy as necessary.
4. QA technician or designee will check all pH meters used for monitoring and verification
activities for accuracy daily and calibrate to within 0.1 pH unit as necessary.
5. QA technician or designee will check all water activity meters used for monitoring and
verification activities for accuracy daily to within 0.003 units as necessary.
6. The QA supervisor or designee will observe the QA technician or designee perform each
monitoring activity once per shift.
The HACCP team described the verification procedures and their frequencies in the fifth column
of their HACCP plan.
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The HACCP team for generic establishment X knew that their HACCP plan needed to provide
for a recordkeeping system. They wanted their records to be easy to create and understand.
They wanted to be sure their records met regulatory requirements, so they reviewed part 417.5(a)
and (b):
§ 417.5 Records.
(a) The establishment shall maintain the following records documenting the
establishment's HACCP plan:
(1) The written hazard analysis prescribed in § 417.2(a) of this part, including all
supporting documentation;
(2) The written HACCP plan, including decision making documents associated with the
selection and development of CCPs and critical limits, and documents supporting both
the monitoring and verification procedures selected and the frequency of those
procedures.
(3) Records documenting the monitoring of CCPs and their critical limits, including the
recording of actual times, temperatures, or other quantifiable values, as prescribed in the
establishment's HACCP plan; the calibration of process-monitoring instruments;
corrective actions, including all actions taken in response to a deviation; verification
procedures and results; product code(s), product name or identity, or slaughter
production lot. Each of these records shall include the date the record was made.
(b) Each entry on a record maintained under the HACCP plan shall be made at the time
the specific event occurs and include the date and time recorded, and shall be signed or
initialed by the establishment employee making the entry.
The HACCP team decided that their records would be kept on some simple forms, some of
which the team itself devised. The forms for monitoring and verification records are listed under
the HACCP Records column of the HACCP plan. They are: Fermentation Log, Corrective
Actions Log, Smokehouse/Product Temperature Log, Thermometer Calibration Log, Oven
Temperature/Humidity Log, Water Activity Log, and Metal Detector Performance Log.
Column four (HACCP Records) in the HACCP plan references the Corrective Actions Log. This
is used to create the records of any corrective actions taken because of deviations from critical
limits at CCPs. Column six in the HACCP plan describes the planned corrective actions for each
CCP. The HACCP team carefully reviewed the regulatory requirements for planned corrective
actions found at 417.3(a):
14
§ 417.3 Corrective actions.
(a) The written HACCP plan shall identify the corrective action to be followed in
response to a deviation from a critical limit. The HACCP plan shall describe the
corrective action to be taken, and assign responsibility for taking corrective action, to
ensure:
(1) The cause of the deviation is identified and eliminated;
(2) The CCP will be under control after the corrective action is taken;
(3) Measures to prevent recurrence are established; and
(4) No product that is injurious to health or otherwise adulterated as a result of the

deviation enters commerce.
The HACCP team has developed a corrective action plan that meets the four regulatory
requirements of 417.3(a). Whenever a deviation from a critical limit occurs, company employees
follow the corrective action plan and use the Corrective Actions Log to create a record of their
actions. The Corrective Actions Log forms are available at CCP locations, so they can be used
immediately when an employee performing a monitoring check discovers and records a
deviation. All Corrective Actions Logs, which have been used during the day, are turned in to
the HACCP coordinator.
There is one final verification/recordkeeping requirement which the company must perform; it is
found at 417.5(c):
(c) Prior to shipping product, the establishment shall review the records associated with
the production of that product, documented in accordance with this section, to ensure
completeness, including the determination that all critical limits were met and, if
appropriate, corrective actions were taken, including the proper disposition of product.
Where practicable, this review shall be conducted, dated, and signed by an individual
who did not produce the record(s), preferably by someone trained in accordance with
§ 417.7 of this part, or the responsible establishment official.
In generic establishment X product is shipped out, often in small lots, throughout the day. This
means that pre-shipment verification checks must be as complete as possible when finished
product is in storage, so that a shipment can be made up quickly and moved into distribution
channels.
The establishment uses a half day lotting system and a midshift cleanup. While the midshift
cleanup is being performed, QA personnel or the HACCP coordinator review results of
monitoring and verification checks applied to that lot; if there were deviations from critical
limits, they review the Corrective Actions Logs to make sure all appropriate planned responses
15
were carried out. If everything is in order and there are complete records showing that the
establishment has controlled production of this product through its HACCP system, the HACCP
coordinator will sign the pre-shipment review form which the HACCP team devised for this
purpose.
Note: It is not a regulatory requirement that a separate form be used for pre-shipment review; in
addition, FSIS has indicated that it will be very flexible in accepting a variety of arrangements
for accomplishing pre-shipment review to reflect the variety of commercial practices in the
industry. It is, however, important to remember that pre-shipment review is a regulatory
requirement that must be met, as it indicates that the establishment is taking full responsibility
for the product having been produced under a well-functioning HACCP system.
The HACCP team believes it has now completed preparation of the documents which are
necessary to meet regulatory requirements for a hazard analysis and a HACCP plan for their heat
treated, shelf stable production process. They obtained a copy of FSIS Directive 5000.1, Rev. 1,
Verifying an Establishment‘s Food Safety System. The Basic Compliance Checklist will be used
by inspection program personnel. The HACCP team has modified the inspection form to make
the statements into positives, and now has a checklist for its own use to make sure they have not
omitted anything in their plan development and preparation. When they are confident that they
have done what is necessary, they will turn their hazard analysis and HACCP plan over to the
establishment owner for decisions about implementation.
16
APPENDIX A
17
References for General HACCP and Regulatory Issues

1. Agriculture Canada. 1996. Food Safety Enhancement Program œ HACCP Implementation Manual.
Camelot Drive, Nepean, Ontario, Canada..
2. American Meat Institute Foundation. 1994. HACCP: The Hazard Analysis and Critical Control Point
System in the Meat and Poultry Industry. Washington, D.C.
Useful sections in particular are:
Chapter 3 œ microbiological hazards, pp. 15-26
Chapter 4 œ chemical hazards, pp. 27-32
Chapter 5 œ physical hazards, pp. 33-35
Appendix A œ NACMCF HACCP
Appendix C œ Model HACCP plans
3. Baker, D.A. 1995. Application of modeling in HACCP plan development. Int. J. Food Microbiol. 25:251-
261.
4. Corlett, D.A., Jr. and Stier, R.F. 1991. Risk assessment within the HACCP system. Food Control 2:71-72.
5. Council for Agriculture Science and Technology. 1993. Risks Associated with Foodborne Pathogens.
February.
6. Easter, M.C., et al. 1994. The role of HACCP in the management of food safety and quality. J. Soc. Dairy
Technol. 47:42-43.
7. Environmental Protection Agency. 1998. Tolerances for Pesticides in Foods. Title 40, Code of Federal
Regulations, Part 185. U.S. Government Printing Office, Washington, D.C.
8. Food and Drug Administration. 1998. The Food Defect Action Levels. FDA/CFSAN. Washington, D.C.
9. Food and Drug Administration. Fish and Fishery Products Hazards and Control Guide --Get Hooked on
Seafood Safety. Office of Seafood. Washington, D.C., 1994.
10. International Commission on Microbiological Specification for Foods. 1988. HACCP in Microbiological
Safety and Quality. Blackwell Scientific Publications, Oxford.
Chapter 10 œ raw meat and poultry, pp. 176-193
Chapter 11 œ roast beef, pp. 234-238
Chapter 11 œ canned ham, pp. 238-242
11. International Commission on Microbiological Specification for Foods. 1989. Microorganisms in Foods 4.
Application of Hazard Analysis and Critical Control Point (HACCP) Systems to Ensure Microbiological
Safety and Quality. Blackwell Scientific Publications, Boston.
12. National Advisory Committee on Microbiological Criteria for Foods. –1993. Hazard analysis and critical
control point system. Int. J. Food Microbiol. 16: 1-23.
13. National Advisory Committee on Microbiological Criteria for Foods. 1998. Hazard analysis and critical
control point principles and application guidelines. J. Food Protect. 61(9): 1246-1259.
18
14. National Advisory Committee on Microbiological Criteria for Foods. August 1999. DRAFT document -
FSIS Microbiological Hazard Identification Guide for Meat and Poultry Components of Products Produced
by Very Small Plants. 1-22.
15. National Advisory Committee on Microbiological Criteria for Foods. 1994. Report on generic HACCP for
raw beef. Food Microbiol. 10: 449-488.
16. National Research Council. 1985. An Evaluation of the Role of Microbiological Criteria for Foods and
Food Ingredients. National Academy Press, Washington, D.C.,
Chapter 4 œ microbiological hazards, pp. 72-103
Chapter 9 œ raw meat, pp. 193-199
Chapter 9 œ processed meats, pp. 199-216
17. Notermans, S., M. H. Zwietering and G. C. Mead. 1994. The HACCP concept: Identification of
potentially hazardous microorganisms. Food Microbiol. 11:203-214.
18. Pierson M.D. and Dutson, T. Editors. 1995. HACCP in Meat, Poultry, and Fish Processing. Blackie
Academic & Professional. Glasgow.
Chapter 4 œ meat and poultry slaughter, pp. 58-71
Chapter 5 œ processed meats, pp. 72-107
Chapter 7 œ risk analysis, pp. 134-154
Chapter 13 œ predictive modeling, pp. 330-354
19. Pierson, M.D. and Corlett, D.A., Jr. Editors. 1992. HACCP Principles and Applications. Van Nostrand
Reinhold, New York.
20. Stevenson, K.E. and Bernard, D.T. Editors. 1995. HACCP: Establishing Hazard Analysis Critical Control
Point Programs. A Workshop Manual. The Food Processors Institute, Washington, D.C...

Chapter 11 œ forms for hazard analysis, CCPs, critical limits, HACCP master sheet, example
HACCP for breaded chicken
21. Stevenson, K.E. and Bernard, D.T. Editors. 1999. HACCP: A Systematic Approach to Food Safety. 3rd
Edition. The Food Processors Institute, Washington, D.C.
22. Tompkin, R.B. 1990. The use of HACCP in the production of meat and poultry products. J. Food Protect.
53(9): 795-803.
23. Tompkin, R.B. 1995. The Use of HACCP for Producing and Distributing Processed Meat and Poultry
Products. In Advances in Meat Research. Volume 10. Hazard Analysis Critical Control Point in Meat,
Poultry and Seafoods. Chapman & Hall.
19
References for Heat Treated, Shelf Stable Meat and Poultry Products
1. Albright, S.N., P. A. Kendall, J. A. Avens and J.N. Sofos. 2002. Effect of marinade and drying temperature
on inactivation of Escherichia coli O157:H7 on inoculated home dried beef jerky. J. Food Safety. 22:155-
167.
2. Albright, S.N., P. A. Kendall, J. A. Avens and J.N. Sofos. 2003. Pretreatment effect on inactivation of
Escherichia coli O157:H7 inoculated beef jerky. Food Science and Technology/LWT. 36:381-389.
3. American Meat Institute Foundation. 1997. Good Manufacturing Practices for Fermented Dry and Semi-
Dry Sausage Products.
4. American Meat Science Association. 1995. Flowchart for beef jerky. AMSA, Chicago, IL.
5. Bunic, S., L. Paunovic and D. Radisic. 1991. The fate of Listeria monocytogenes in fermented sausages and
in vacuum-packaged frankfurters. J. Food Prot. 54: 413-417.
6. Calicioglu, M., J.N. Sofos, J. Samelis, P. A. Kendall and C. G. Smith. 2002. Destruction of acid- and non-
adapted Listeria monocytogenes during drying and storage of beef jerky. Food Microbiol. 19:545-559.
7. Calicioglu, M., J.N. Sofos, J. Samelis, P.A, Kendall and G.C. Smith. 2002. Inactivation of acid-adapted and
nonadapted Escherichia coli O157:H7 during drying and storage of beef jerky treated with different
marinades. J. Food Prot. 65:1394-1405.
8. Calicioglu, M., J.N. Sofos and P.A. Kendall. 2003. Influence of marinades on survival during storage of
acid-adapted and nonadapted Listeria monocytogenes inoculated post-drying on beef jerky. Intl. J. Food
Microbiol. 86:283-292
9. Calicioglu, M., J.N. Sofos, J. Samelis, P.A. Kendall and G.C. Smith. 2003. Effect of acid-adaptation on
inactivation of Salmonella during drying and storage of beef jerky treated with marinades. Intl. J. Food
Microbiol. 89:51-65.
10. Calicioglu, M., J.N. Sofos, P.A. Kendall and G.C. Smith. 2003. Effects of aid-adaptation and modified
marinades on survival of post-drying Salmonella contamination on beef jerky during storage. J. Food Prot.
66:396-401.
11. Calicioglu, M., J.N. Sofos, J. Samelis, P.A. Kendall and G.C. Smith. 2003. Fate of Acid-Adapted and
Nonadapted Escherichia coli O157:H7 Inoculated Post-drying on Beef Jerky Treated with Marinades
Before Drying. Food Microbiol. 20:169-177.
12. Centers for Disease Control and Prevention. 1995. Outbreak of salmonellosis associated with beef jerky œ
New Mexico, 1995. Morbidity and Mortality Weekly Report. 44: 785-787.
13. United States Department of Agriculture. Food Safety and Inspection Service. 1999. Performance standards
for the production of certain meat and poultry products. Federal Register 64(3):732-49.
14. Dykes, G., T. E. Cloete and A. von Holy. 1991. Quantification of microbial populations associated with the
manufacture of vacuum-packaged, smoked Vienna sausages. Int. J. Food Microbiol. 13:239-248.
20
15. Genigeorgis, C. and S. Lindroth. 1984. The safety of basturma, an Armenian-type dried beef product with
regard to Salmonella. Proceedings of the 30th European Meeting of Meat Research Workers. 30:217-224.
16. Goepfert, J. M., I. K. Iskander and C.H. Amundson. 1970. Relation of the heat resistance of salmonellae to
the water activity of the environment. Appl. Microbiol. 19(3):429-33.
17. Harrison, J. A. and M. A. Harrison. 1996. Fate of Escherichia coli O157:H7, Listeria monocytogenes, and
Salmonella typhimurium during preparation and storage of beef jerky. J. Food Prot. 59(12):1336-8.
18. Harrison, J. A., M. A. Harrison, R. A. Rose-Morrow and R. L. Shewfelt. 2001. Home-style beef jerky:
effect of four preparation methods on consumer acceptability and pathogen inactivation. J. Food Prot.
64(8):1194-98.
19. Holley, R. 1984. Beef jerky: viability of food-poisoning microorganisms on jerky during its manufacture
and storage. J. Food Prot. 48(2):100-106.
20. Levine, P., B. Rose, S. Green, G. Ransom and W. Hill. 2001. Pathogen testing of ready-to-eat meat and
poultry products collected at federally inspected establishments in the United States, 1990 to 1999. J. Food
Prot. 64(8):1188-1193.
21. Smith, S.E., J. L. Mauer, A. Orta-Ramirez, E. T. Ryser and D. M. Smith. 2001. Thermal inactivation of
Salmonella spp., Salmonella typhimurium DT104, and Escherichia coli O157:H7 in ground beef. J. Food
Prot. 66(8):1164-68.
21
APPENDIX B
22
PROCESS FLOW DIAGRAM
PROCESS CATEGORY: HEAT TREATED, SHELF STABLE

PRODUCT: SNACK STICKS, JERKY
RECEIVING RECEIVING
PACKAGING RAW MEAT/POULTRY
MATERIALS RECEIVING AND
STORAGE OF
RESTRICTED AND
STORAGE UNRESTRICTED
(COLD œ FROZEN/REFRIGERATED) NONMEAT/NONPOULTRY
RAW MEAT/POULTRY FOOD INGREDIENTS
TEMPERING
FROZEN MEAT/POULTRY WEIGHING OF
RESTRICTED AND
UNRESTRICTED
NONMEAT/NONPOULTRY
WEIGHING RAW MEAT/POULTRY FOOD INGREDIENTS
COMBINE INGREDIENTS
(LIST ALL AS SEPARATE
STEPS*) MARINATING**
RACKING/HANGING
FERMENTING
HEAT TREATMENT
DRYING
STORAGE
PACKAGING
MATERIALS Metal Detector
PACKAGING/LABELING
FINISHED PRODUCT STORAGE
SHIPPING
* These steps include: grinding, chopping, mixing, stuffing, forming, and slicing. Include all applicable in flow chart
and hazard analysis.
** No interventions (acid dip, heating in marinade) used in this process.
No product is reworked back into the process. Figure 1
23
PRODUCT DESCRIPTION
PRODUCT: SNACK STICKS, JERKY

1. COMMON NAME? SNACK STICKS (SOME
FERMENTED
TYPES:
COMMON NAME?
BEEF JERKY (NON-FERMENTED)
2. HOW IS IT TO BE USED?
CONSUME AS PURCHASED
(READY TO EAT)
3. TYPE OF PACKAGE?
BULK-PACKED (E.G., PLASTIC
BAG, VACUUM PACKED)
4. LENGTH OF SHELF LIFE,

VARIES WITH PACKAGING AND
AT WHAT TEMPERATURE?
STORAGE TEMPERATURE: MAY
LAST 6 MONTHS NON-
REFRIGERATED & INDEFINITELY
UNDER REFRIGERATION
5. WHERE WILL IT BE SOLD?

WHOLESALE TO DISTRIBUTORS
CONSUMERS?
ONLY
INTENDED USE?
6. LABELING INSTRUCTIONS?
—REFRIGERATE AFTER OPENING“
7. IS SPECIAL DISTRIBUTION
NONE
CONTROL NEEDED?
Figure 2
24
HAZARD ANALYSIS œ HEAT TREATED, SHELF STABLE œ Snack Sticks, Jerky
Process Step Food Safety Reasonably Basis If Yes in Column 3, What Critical Control
Hazard Likely to Measures Could be Applied Point
Occur? to Prevent, Eliminate, or
Reduce the Hazard to an
Acceptable Level?
Receiving œ Raw Biological: Pathogens Yes Pathogens may be present Pathogens will be
Meat/Poultry Salmonella on incoming raw product. controlled at a subsequent
Listeria monocytogenes step through heat
E. coli O157:H7 treatment and drying
Trichinella spiralis* (jerky & snack sticks)
and/or fermentation (snack
sticks).
Chemical œ None
Physical œ Foreign No Plant records show that
materials such as there has been no incidence
metal fragments of foreign materials in
products received into the
plant.
Receiving œ Restricted Biological œ None
and Unrestricted Chemical œ Packaging No Letters of guaranty are
Nonmeat/Nonpoultry material acceptable for received from all suppliers
Food Ingredients; intended use. of packaging materials.
Packaging Materials Physical – None
* Snack sticks may contain pork. T. spiralis may also be present in some game animals.
Figure 3
25
Acceptable Level?
Storage œ Restricted Biological œ None
and Unrestricted Chemical œ None
Nonmeat/Nonpoultry Physical œ None
Food Ingredients;
Packaging Materials
Storage (Cold œ Biological œ Pathogen No Salmonella, E. coli O157:H7
Frozen/Refrigerated) œ Growth and Listeria monocytogenes
Raw Meat/Poultry Salmonella are not likely to grow if the
Listeria monocytogenes product is maintained at
E. coli O157:H7 proper temperature.
Trichinella spiralis*
Prerequisite program in
place to prevent pathogen
growth from being likely to
occur.
Chemical œ None
Physical œ None
Tempering Frozen Biological œ None
Meat/Poultry Chemical œ None
Physical œ None
Weighing Restricted Biological œ None
and Unrestricted Chemical œ Excessive No Prerequisite program in
Nonmeat/Nonpoultry Level of Nitrite place to prevent addition of
Food Ingredients greater than allowed
amount of nitrite.
Physical œ None
*Snack sticks may contain pork. T. spiralis may also be present in some game animals.
Figure 3
26
Acceptable Level?
Weighing Raw Biological œ None
Meat/Poultry Chemical œ None
Physical œ None
Combining Biological œ None
Ingredients/ Chemical œ None
Processing (Includes Physical œ Metal Yes Plant records show that Metal detection is located at
one or more of the Contamination during mechanical a subsequent step in the
following: grinding, processing metal process.
chopping, mixing, contamination has
stuffing, forming, and occurred.
slicing)
Marinating Biological œNone
Chemical œ None
Physical œ None
Racking/Hanging Biological œ None
Chemical œ None
Physical œ None
Fermenting (Used for Biological œ Pathogens Yes Potential growth of S. Fermentation to the degree- 1B
pH reduction on snack Staphylococcus aureus aureus and toxigenesis if hours required will achieve
sticks produced with a Salmonella fermentation process is the pH needed to inhibit S.
fermentation step) E. coli O157:H7 inadequate. aureus. Fermentation also
reduces levels of Salmonella
and E. coli O157:H7.
Chemical œ None
Physical œ None
Figure 3
27
Acceptable Level?
Heat Treatment Biological œ Pathogens Yes Potential survival and Heat treatment using 2B
Listeria monocytogenes growth of pathogens and appropriate
Salmonella toxigenesis from S. aureus time/temperature/humidity
Staphylococcus aureus with inadequate process to produce
E. coli O157:H7 time/temperature/humidity. lethality/pasteurization.
T. spiralis
Chemical œ None
Physical œ None
Drying Biological œ Pathogens Yes L. monocytogenes can grow Low water activity (aw) 3B
Staphylococcus aureus if aw above 0.92 and S. precludes bacterial
Listeria monocytogenes aureus growth & pathogen growth. The aw
toxigenesis can occur if S. required to prevent growth
aureus survived heat of S. aureus (0.86) is lower
treatment. than that for other
pathogens.
Chemical œ None
Physical œ None
Figure 3
28
Acceptable Level?
Metal Detector Biological œ None
Chemical œ None
Physical œ Metal Yes Metal detector. 4P
Contamination
Packaging/Labeling Biological œ Pathogens No L. monocytogenes growth

Growth of Listeria precluded by previous
monocytogenes drying step - water activity
of product much less than
0.92 min required for Lm
growth. The drying process
meets the criteria described
in 9 CFR 430.4 for
Alternative 2.
Chemical œ None
Physical œ None
Finished Product Biological œ None
Storage Chemical œ None
Physical œ None
Shipping Biological œ None
Chemical œ None
Physical œ None
Figure 3
29
HACCP PLAN
PRODUCT EXAMPLE: SNACK STICKS, JERKY
CCP# and Critical Limits Monitoring Procedures HACCP Records Verification Procedures and Corrective Actions
Location and Frequency Frequency
1B pH ≤ 5.3 - achieved QA technician or Fermentation Log QA Supervisor or designee If a deviation from a critical
Fermenting by using one of the designee will take 5 will review the Fermentation limit occurs, the QA supervisor
(Snack Sticks following combination individual product Corrective Action Log and Corrective Action or designee is responsible for
produced with of chamber samples for pH Log Log once per shift. corrective action protocols:
a temperature œ measurement from each
fermentation maximum hours of lot at the completion of Thermometer QA technician or designee 1. The cause of the deviation
step) fermentation the fermentation cycle. Calibration Log will check all thermometers will be identified and
Before removal from for accuracy daily against eliminated.
Constant fermentation, determine thermometer of known 2. The CCP will be under
Chamber compliance with the time accuracy and calibrate to ±1° control after the corrective
Temp (°F) Max Hrs* critical limit related to the F accuracy as necessary. action is taken.
specified fermentation 3. Measures to prevent
75 80 chamber temperature in QA or designee will check all recurrence are established.
80 60 order to meet the pH meters used for monitoring 4. No product that is injurious
85 48 documented degree-hour and verification for accuracy to health or otherwise
90 33 limit. daily against a known standard adulterated as a result of the
95 28 The pH is measured by and calibrate for accuracy to ± deviation will be permitted
100 25 placing a pH electrode in 0.1. to enter commerce.
105 20 a 1:1 (w/w) meat/distilled
110 18 water slurry of each QA supervisor or designee
sample. Methodology will observe QA technician or
reference on file. designee perform monitoring
QA technician or activity once per shift.
designee will record
chamber temperature and
time to pH ≤5.3.
*Maximum time critical limits at specified fermentation chamber temperature for product to reach pH ≤ 5.3 at the end of the fermentation step in order to meet
the relative degree hour limits for control of S. aureus toxin production. (Validated support on file.)
Signature: __________________________________Date: __________________________ Figure 4
30
HACCP PLAN

CCP# and Critical Monitoring HACCP Records Verification Procedures and Corrective Actions
Location Limits Procedures and Frequency
Frequency
2B Snack sticks QA technician or Smokehouse/ Once per shift the QA supervisor or If a deviation from a critical limit occurs,
Heat to be cooked designee will take Product designee will review the the QA supervisor or designee is
Treatment to an the internal Temperature Log Smokehouse/Product Temperature responsible for corrective action protocols:
(snack sticks internal temperature using Log, Corrective Action Log, and
with temperature an internal probe Thermometer Thermometer Calibration Log. 1. The cause of the deviation will be
fermentation of ≥160°F. and check 10 sticks Calibration Log . identified and eliminated.
step) in coldest part of Once per shift QA supervisor or 2. The CCP will be under control after
smokehouse for Corrective Action designee will observe the QA the corrective action is taken.
each lot at Log technician or designee perform the 3. Measures to prevent recurrence are
completion of cook monitoring activity. established.
cycle and before 4. No product that is injurious to health
removal from or otherwise adulterated as a result of
smokehouse. the deviation will be permitted to enter
commerce.
Signature: ____________________________ Date: __________________________ Figure 4
31
HACCP PLAN
Frequency
2B Jerky to be Oven temperature Oven Temperature / Maintenance supervisor or designee If a deviation from a critical limit occurs,
cooked at an
Heat oven temperature
monitored with dry Humidity Log will verify that the wet bulb water the QA supervisor or designee is
Treatment of ≥180°F for ≥2 bulb thermometer. wick well contains the appropriate responsible for corrective action protocols:
(jerky) hours with ≥90% Thermometer amount of water prior to startup and
humidity Humidity* will be Calibration Log during operation if necessary. 1. The cause of the deviation will be
throughout the
cook.
monitored by identified and eliminated.
comparison of wet Corrective Action Once per shift the QA supervisor or 2. The CCP will be under control after
and dry bulb Log designee will review the Oven the corrective action is taken.
thermometers Temperature/Humidity Log and 3. Measures to prevent recurrence are
every 30 minutes. Documentation on Corrective Action Log. established.
Wet bulb file for lethality. 4. No product that is injurious to health
temperature must Once per shift QA supervisor or or otherwise adulterated as a result of
be within 4.5°F of designee will observe the QA the deviation will be permitted to enter
the dry bulb technician or designee perform the commerce.
temperature. monitoring activity.
*Humidity control is critical during the heat treatment. Without adequate humidity, the required level of pathogen reduction will not be achieved.
Signature: ____________________________ Date: __________________________ Figure 4
32
HACCP PLAN
Frequency
3B aw* of ≤ 0.80 aw checks will be Water Activity (aw) QA technician or designee will If a deviation from a critical limit occurs,
Drying done by separately Log check all water activity meters used the QA supervisor or designee is
placing portions of for monitoring and verification for responsible for corrective action protocols:
5 product samples Corrective Action accuracy daily against a known
from each lot in a Log standard and calibrate to ± 0.003 of 1. The cause of the deviation will be
aw meter. the standard. identified and eliminated.
2. The CCP will be under control after
QA supervisor or designee will the corrective action is taken.
review the aw Log and Corrective 3. Measures to prevent recurrence are
Action Log once per shift. established.
4. No product that is injurious to health
Once per shift QA supervisor will or otherwise adulterated as a result of
observe the QA technician or the deviation will be permitted to enter
designee perform the monitoring commerce.
activity.
* Manufacturers should not use MPR as a measure of proper drying for shelf-stability or safety. MPR is a product standard and the
water activity can vary greatly at any given MPR (as a result of the different solutes such as sugar and salt). It is product water activity
that can be easily correlated to inhibition of each pathogen's growth.
Signature: __________________________________ Date: __________________________ Figure 4
33
HACCP PLAN
Frequency
4P Metal QA technician or Metal Detector QA supervisor or designee will If a deviation from a critical limit occurs,
Metal detector designee will check Performance Log review the Metal Detector the QA supervisor or designee is
Detector functioning. that the metal Performance Log and Corrective responsible for corrective action protocols:
detectors are Corrective Action Action Log once per shift.
functioning as Log 1. The cause of the deviation will be
intended by Before start of operations and after identified and eliminated.
running a seeded lunch, maintenance supervisor or 2. The CCP will be under control after
sample through the designee will check calibration of the corrective action is taken.
metal detector(s) metal detector by running a seeded 3. Measures to prevent recurrence are
every 2 hours and sample (≤7 mm seed) through the established.
record results in the detector and adjusting when 4. No product that is injurious to health
metal detector log. necessary. or otherwise adulterated as a result of
the deviation will be permitted to enter
Twice a week QA supervisor or commerce.
designee will observe the QA
technician or designee perform the
monitoring activity.
Signature: __________________________________ Date: __________________________ Figure 4
34
FERMENTATION LOG
Critical Limit: pH ≤ 5.3 at the appropriate degree-hour limit for the fermentation chamber temperature.
Date Product Chamber Time Time pH* Time to pH ≤5.3 Monitor Verification**
ID Temperature In Out Initials
[ °F] [ max hrs.] Initial/Time Comments/Results
Constant Chamber Temperature (°F): 75 80 85 90 95 100 105 110

Max. Hours to pH ≤ 5.3 80 60 48 33 28 25 20 18
Instructions: Enter the appropriate chamber temperature in the brackets under Chamber Temperature and associated maximum time to pH ≤ 5.3
in the brackets under Time to pH ≤5.3. If the chamber temperature lies between two values, select the next highest value. These will serve as the
control values. Record requested information. Do not remove the product from the fermentation chamber until the product pH is equal to
or less than 5.3. Time and temperature may be recorded directly on the log or taken from a chart recorder. The constant
*pH meter is checked against known standard at the beginning of each sample lot.
**Direct observation verification œ results per HACCP plan
**Records review œ results per HACCP plan
35
CORRECTIVE ACTIONS LOG

Product: ___________________________________________ Lot # ______________________
Date/Time: _________________________________________ Responsible Person/Date: ________________
Deviation
Cause of Deviation
Cause of Deviation
Eliminated By
CCP Under Control
After Corrective Actions
Taken
Preventive Measures
Product Disposition
Verification by and Date: ______________________________
Verification Comments: ______________________________
36
SMOKEHOUSE/PRODUCT TEMPERATURE LOG*

Date: _____ Critical Limit: Smokehouse Temperature will be ≥ 180°F for ≥ 2 hours.
Smokehouse/Product Temperature
Product ID TIME TEMP TEMP TEMP TEMP TEMP Monitor Verified by

Initials
Smokehouse/Product Temperature Log may be used if smokehouse chart is not available.
*Direct observation verification œ results per HACCP plan
** Records review œ results per HACCP plan
Verification comments: ____________________________________________
37
THERMOMETER CALIBRATION LOG

Criteria Within ±1°F of Control Thermometer
Date Time Department Thermometer Control Personal Adjustment Adjustment(s) Made Initials
or ID# Thermometer Thermometer Required (State Thermometer
Area Reading Reading (Yes or No) Reading)
If a thermometer is broken or taken out of service, document this in the —Adjustment(s) Made“ column.
38
GENERIC ESTABLISHMENT X: OVEN TEMPERATURE/HUMIDITY LOG

PRODUCT: ___________________________ ROOM:__________ DATE:_________
Critical limit: 90% humidity throughout the cook.

Product TIME TIME TEMP Calculated Deviation If Yes, Action Taken? Monitor Verification
ID IN OUT Relative from CL? Initials Date/
Humidity (Check if
Time/
yes)
Initial Comment
DRY WET
BULB BULB
Instructions: If a recording chart is not used, the wet and dry bulb temperatures should be recorded every 30 minutes. Attach the
recording chart.
39
WATER ACTIVITY (aw) LOG
Date: _____ Critical Limit: Water activity will be ≤0.80 at the end of drying
Product aw* aw aw Time Comments Monitor Verification **

ID NaCl Distilled Product Initials
(.753) H2O Initial/Date Comments
(1.000)
*Water activity of control solutions (saturated solution of NaCl) and product conducted at 77°F.
**Direct observation verification œ results per HACCP plan
40
GENERIC ESTABLISHMENT X: METAL DETECTOR PERFORMANCE LOG
Date Time Product ID Metal Detector Size of Adjustment(s) Monitor Verified

Functioning Seeded Made Initials by
(Yes or No) Sample
+Seed sample verification results recorded in —Size of Seeded Sample“ column.
**Records review - results per HACCP plan
Verification comments: _____________________________________________
41
PRE-SHIPMENT REVIEW LOG
PRODUCT ID LOT RELEASED FOR DATE COMMENTS

SHIPMENT?
SIGNATURE
42

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Generic

Food Safety Model for

HACCP-10 Shelf Stable

U.S. Department of Agriculture

This material is also available on the FSIS Homepage:

TO THE USERS OF THESE VOLUMES

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

We hope that these documents are helpful.

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

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

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

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

References for General HACCP and Regulatory Issues …………..…………….. 17

Process Flow Diagram (Figure1) ………………………………………………….. 22

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

Hazard Analysis Form (Figure 3)……………………………………………….…. 25

HACCP Plan Form (Figure 4)…………………………………..……………….… 30

Fermentation Log …………...………………………………………………………35

Corrective Actions Log….………………………………………………...………...36

Smokehouse/Product Temperature Log……....…………………….……….….….. 37

Heat Treated, Shelf Stable Model

Thermometer Calibration Log………..…………………………………………….38

Generic Establishment X: Oven Temperature/Humidity Log...………….……….. 39

Water Activity Log……………………………………..…………………………. 40

Generic Establishment X: Metal Detector Performance Log…………………..…. 41

Pre-Shipment Review Log………………………………………………………….42

Heat Treated, Shelf Stable Model

GENERIC HACCP MODEL

HEAT TREATED, SHELF STABLE MEAT AND POULTRY PRODUCTS

Heat Treated, Shelf Stable Model

(i) Slaughter--all species.

(ii) Raw product--ground.

(iii) Raw product--not ground.

(iv) Thermally processed--commercially sterile.

(v) Not heat treated--shelf stable.

(vi) Heat treated--shelf stable.

(vii) Fully cooked--not shelf stable.

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

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

Heat Treated, Shelf Stable Model

Using This Generic Model

Heat Treated, Shelf Stable Model

For purposes of this part, the following shall apply:

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

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

Hazard. See Food Safety Hazard.

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

Heat Treated, Shelf Stable Model

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

Process Flow Diagram and Product Description

Heat Treated, Shelf Stable Model

§ 417.2 Hazard Analysis and HACCP Plan.

Heat Treated, Shelf Stable Model

Heat Treated, Shelf Stable Model

Developing Your HACCP Plan

Heat Treated, Shelf Stable Model

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

(i) Upon initial acceptance;

(ii) Upon any modification; and

Signature: ________Date: Figure 4

Signature: __ Date: Figure 4

Signature: __ Date: Figure 4

Signature: ________ Date: Figure 4

Date/Time: _________________________ Responsible Person/Date: