United States
Department of
Agriculture
Food Safety
and Inspection
Service
September 1999
HACCP-9
Generic HACCP
Model for Meat
and Poultry
Products with
Secondary
Inhibitors,Not
Shelf Stable
Additional copies of the Guidebook for the Preparation
of HACCP Plans and the Generic HACCP Models are
available from,
U.S,Department of Agriculture
Food Safety and Inspection Service (FSIS)
Office of Policy,Program Development,
and Evaluation (OPPDE)
Inspection Systems Development Division
Room 202,Cotton Annex Building
300 12
th
Street SW
Washington,D.C,20250-3700
Phone,(202) 720-3219
Fax,(202) 690-0824
This material is also available on the FSIS Homepage,
http://www.fsis.usda.gov/index.htm
Products with Secondary Inhibitors,Not Shelf Stable Model
Table of Contents
Introduction……………………………………………………………………………..…,3
Using This Generic Model…………………………………………………………..…….,5
Process Flow Diagram and Product Description…………………………………..………,7
Hazard Analysis………………………………………………………………….…………8
Developing Your HACCP Plan………………………………………………..….……….,10
Identifying CCPs……………………………………………………………………..……,11
Appendix A
References for HACCP Teams……………………………………..…………….,17
References for Meat and Poultry Products with Secondary Inhibitors,
Not Shelf Stable …………………………………………………………..……..… 19
Appendix B
Process Flow Diagram (Figure1) Corned Beef ………………………….………… 22
Product Description Form (Figure 2) Corned Beef ……………………………… 23
Hazard Analysis Form (Figure 3)……………………………………………….…,24
HACCP Plan Form (Figure 4)…………………………………..……………….… 28
Form Letter Confirming Salmonella Compliance with Performance
Standards ……………………………………….…………………………………,32
Thermometer Calibration Log…………………………………………………….,33
Weight/Formulation Record………………………………………………………,34
Pump Percentage Log……………………………………………………………… 35
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Generic Establishment X,Room Temperature Log …………………………….… 36
Corrective Actions Log……………………………………………………………,37
Pre-Shipment Review Log………………………………………………………… 38
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GENERIC HACCP MODEL
FOR
MEAT AND POULTRY PRODUCTS
WITH SECONDARY INHIBITORS,NOT SHELF STABLE
Introduction
The Hazard Analysis Critical Control Point (HACCP) system is a scientific approach to process
control,It is designed to prevent the occurrence of problems by assuring that controls are
applied at any point in a food production system where hazardous or critical situations could
occur,Hazards include biological,chemical,or physical contamination of food products,
The Food Safety and Inspection Service (FSIS) published a final rule in July 1996 mandating
that HACCP be implemented as the system of process control in all inspected meat and poultry
plants,As part of its efforts to assist establishments in the preparation of plant-specific HACCP
plans,FSIS determined that a generic model for each process defined in the regulation would be
made available for use on a voluntary basis by inspected establishments,
The generic models have been revised since their initial publication and distribution as
DRAFTS,The most important change in the revised versions is to make certain that these
models are
fully consistent with the features of the final regulation,Also,other technical and editorial
improvements have been made,
Throughout this generic model,FSIS discusses a HACCP team with members from different
departments,In many very small establishments,there will not be separate departments with
different employees,But,there will be employees who perform these different functions – often
several of them,For purposes of explaining concepts,it is easier to speak as if these were
different people,even though in many cases,they may be the same person carrying out more
than one responsibility,
Each generic model can be used as a starting point for the development of plant-specific plan(s)
reflecting actual plant environments and the processes conducted,The generic model is not
intended to be used,as is” for plant specific HACCP plans,
The generic models are designed for use in conjunction with the list of process categories found
in the HACCP regulations in section 417.2(b)(1),
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(b) The HACCP plan,(1) Every establishment shall develop and implement a written
HACCP plan covering each product produced by that establishment whenever a hazard
analysis reveals one or more food safety hazards that are reasonably likely to occur,
based on the hazard analysis conducted in accordance with paragraph (a) of this section,
including products in the following processing categories,
(i) Slaughter--all species,
(ii) Raw product--ground,
(iii) Raw product--not ground,
(iv) Thermally processed--commercially sterile,
(v) Not heat treated--shelf stable,
(vi) Heat treated--shelf stable,
(vii) Fully cooked--not shelf stable,
(viii) Heat treated but not fully cooked--not shelf stable,
(ix) Product with secondary inhibitors--not shelf stable,
This generic model is designed for use with the process category,Product with secondary
inhibitors--not shelf stable,
The purpose of the process category listing in 417.2 is to set out the circumstances under which a
HACCP team may develop a single HACCP plan for multiple products,This may be done when
products are in the same process category,and food safety hazards,critical control points,and
other features are essentially the same,There is a generic model for each process category,plus
two for subcategories which present special issues,irradiated products and mechanically
separated products,
In order to select the model or models that will be most useful for the activities performed in any
specific plant,the following steps should be taken,
1) For slaughtering operations,select the model for the appropriate species,
2) For processed products,make a list of all products produced in the plant,
3) Examine the list and group like products,considering common processing steps and
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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 product(s) with
secondary inhibitors,not shelf stable,the ninth process category,The model can be used for all
products with secondary inhibitors,not shelf stable,either meat or poultry,The generic model is
not suitable for products that fall into any of the other process categories,
The model will be most useful to a HACCP team that includes access to one trained individual,
as specified in 417.7(b),
(b)The individual performing the functions listed in paragraph (a) of this section shall
have successfully completed a course of instruction in the application of the seven
HACCP principles to meat or poultry product processing,including a segment on the
development of a HACCP plan for a specific product and on record review,
It would be beneficial for other team members to have reviewed any of the various guidance
materials available on how to develop a HACCP plan for your company,including several useful
videos,handbooks,or computer programs,Once the HACCP team has prepared itself as
thoroughly as possible in general HACCP principles and how to use them,this model should be
helpful,
Note,This generic model includes a number of forms that can be used to record various types of
required information,The forms themselves are samples; a company HACCP team can develop
whatever forms it finds most useful,All the forms mentioned in this document are included in
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Appendix B; they appear in the order in which they are discussed in the text,
All FSIS generic models are designed to assist establishments in applying the seven HACCP
principles to their meat and poultry processing operations AND to meet the regulatory
requirements of Part 417,Therefore,the definitions used in this and all other FSIS generic
models are those found in 417.1,
§ 417.1 Definitions,
For purposes of this part,the following shall apply,
Corrective action,Procedures to be followed when a deviation occurs,
Critical control point,A point,step,or procedure in a food process at which control can
be applied and,as a result,a food safety hazard can be prevented,eliminated,or reduced
to acceptable levels,
Critical limit,The maximum or minimum value to which a physical,biological,or
chemical hazard must be controlled at a critical control point to prevent,eliminate,or
reduce to an acceptable level the occurrence of the identified food safety hazard,
Food safety hazard,Any biological,chemical,or physical property that may cause a
food to be unsafe for human consumption,
HACCP System,The HACCP plan in operation,including the HACCP plan itself,
Hazard,SEE Food Safety Hazard,
Preventive measure,Physical,chemical,or other means that can be used to control an
identified food safety hazard,
Process-monitoring instrument,An instrument or device used to indicate conditions
during processing at a critical control point,
Responsible establishment official,The individual with overall authority on-site or a
higher level official of the establishment,
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Process Flow Diagram and Product Description
To begin using this model,the company's HACCP team should first describe the product(s)
which are part of this process category and covered by this HACCP plan,The product(s) should
be described in two ways,
(1) by a simple diagram which shows the steps the company uses when it produces the product,
and
(2) in a brief written description which provides key facts about the product and its use,
In this generic model,there is an example for products with secondary inhibitors,not shelf stable
– corned (cured) beef,FSIS has developed certain forms as part of the examples in the generic
models; company HACCP teams are not required to use these forms,
Figure 1 is an example of a PROCESS FLOW DIAGRAM for the production of corned beef in
generic establishment X,Figure 2 is an example of a PRODUCT DESCRIPTION for the
corned beef produced in generic establishment X,
Once the company HACCP team in your establishment has prepared your Process Flow
Diagram,they should verify it by walking through the establishment following the flow of
product and making sure that all the steps of the process are included in the flow diagram,The
team should also review the information provided on the Product Description to make sure all
the key facts are included,such as identifying consumers,especially those with particular health
problems or known to be at risk,
Note,If your process includes steps not included in this example,those steps should be added,
Also,if your process does not include all the steps identified in this example,those steps would
be omitted when conducting the hazard analysis,That is generally,how you use these generic
model examples--just omit the features which do not apply to your operation or if your operation
includes features not included in this example,they should be added,
By completing a Process Flow Diagram and a Product Description,you have met the
requirements of 417.2(a)(2),You can use the Process Flow Diagram in particular to help you
complete the rest of the hazard analysis,Use the flow diagram to systematically review each
step in the process and ask the question,"Is there a food safety hazard which is reasonably likely
to occur which may be introduced at this step?" In answering the question,your HACCP team
needs to consider biological (including microbiological),chemical,and physical hazards,
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Hazard Analysis
Once your product(s) are accurately described through the flow diagram and product description,
the HACCP team should begin work on the HAZARD ANALYSIS,The hazard analysis is
fundamental to developing a good HACCP plan and one that meets regulatory requirements,
The regulatory requirements for a hazard analysis are found at 417.2(a),
§ 417.2 Hazard Analysis and HACCP Plan,
(a) Hazard analysis,(1) Every official establishment shall conduct,or have conducted
for it,a hazard analysis to determine the food safety hazards reasonably likely to occur
in the production process and identify the preventive measures the establishment can
apply to control those hazards,The hazard analysis shall include food safety hazards
that can occur before,during,and after entry into the establishment,A food safety
hazard that is reasonably likely to occur is one for which a prudent establishment would
establish controls because it historically has occurred,or because there is a reasonable
possibility that it will occur in the particular type of product being processed,in the
absence of those controls,
(2) A flow chart describing the steps of each process and product flow in the
establishment shall be prepared,and the intended use or consumers of the finished
product shall be identified,
Generic establishment X,which we are using for our example,is capturing these regulatory
requirements on a 6-column Hazard Analysis Form (See Figure 3),A good way to use a form
like this is to create the first column by using the Process Flow Diagram and the second by
answering the question,Once the HACCP team has considered all the steps in the flow diagram
and determined if a food safety hazard could be introduced,it needs to consider whether the
hazard is "reasonably likely to occur",using the meaning of this phrase included in 417.2(a),On
the 6-column form used by generic establishment X,the third and fourth columns address this
issue,If the establishment's HACCP team has decided that the hazard is not reasonably likely to
occur,they enter "No" in column three,explain the basis for their determination in column four,
and do not need to further consider activity at this point in the process,
If,however,the team has determined there is a "food safety hazard reasonably likely to occur"
introduced at a certain point in the process,column five is used to describe a measure which
could be applied to "prevent,eliminate,or reduce to acceptable levels" the food safety hazard
identified in column three,Column six is used when a critical control point (CCP) is identified
based upon the decision made in the hazard analysis,Each CCP has a number – the order
corresponds to steps in the process,For example,1 is the first CCP in the process flow,2 the
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next,etc,The letter indicates whether the hazard is biological – B; chemical – C; or physical –
P,
Look at the entries for,Receiving” on the first page of the six column form for products with
secondary inhibitors,not shelf stable; the HACCP team has determined that Salmonella and E,
coli O157,H7 may be food safety hazards,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
plant will require certification from suppliers that Salmonella performance standards have been
met,FSIS does not consider safe handling labels alone to be an adequate CCP for any
pathogenic microorganisms such as bacteria and viruses,
Note,Look at the entries for,Storage – (Cold – Frozen/Refrigerated) – Raw Beef” on the
second page of the six-column form,the HACCP team has determined that there is a food safety
hazard reasonably likely to occur at this step in the process,Column four contains the reason for
their thinking,pathogenic organisms can grow in this product if it is not kept sufficiently cool,
Column five contains their description of a measure that will prevent the growth of pathogenic
organisms,temperatures that are sufficiently low to preclude growth,
You will notice that on our generic hazard analysis for corned beef,there are five food safety
hazards in which the HACCP team has identified a point in the process at which a food safety
hazard is reasonably likely to occur,For each one of these they have identified a measure which
can be used to control the hazard,
When your HACCP team has completed their hazard analysis (whether they use this format or
not),it is a good idea to review the flow diagram,the product description and the hazard analysis
itself to make sure they are complete,Part 417.2(a)(3) includes a list of sources from which food
safety hazards might be expected to arise,Reviewing that list could help the HACCP team
check for completeness,
Note,If you are using this generic model to produce a different product with secondary
inhibitors,not shelf stable or if you use a different process flow,you may have different hazards
which are reasonably likely to occur,For these different hazards,there may be different
measures which could be used for control purposes,
This,and all other FSIS generic models,contains a list of references which can help your
HACCP team in making sure the hazard analysis is complete,These references are found in
Appendix A,A member of your HACCP team might want to review at least some of the
references to make sure hazards have not been omitted from the hazard analysis,
Completing the hazard analysis is a very significant and important element in developing your
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HACCP system,Your HACCP team should feel a real sense of accomplishment when they get
this far; this is like completing the foundation of a house,
Developing Your HACCP Plan
The company HACCP team can now take the materials it developed while doing the hazard
analysis and use them to build the HACCP Plan,Remember that one of the important
objectives of the FSIS generic models is to provide examples which illustrate how to meet the
regulatory requirements of Part 417,as well as to correctly apply the principles of HACCP,
Part 417.2 (c) and (d) are the regulatory requirements,
(c) The contents of the HACCP plan,The HACCP plan shall,at a minimum,
(1) List the food safety hazards identified in accordance with paragraph (a) of this
section,which must be controlled for each process,
(2) List the critical control points for each of the identified food safety hazards,
including,as appropriate,
(i) Critical control points designed to control food safety hazards that could be
introduced in the establishment,and
(ii) Critical control points designed to control food safety hazards introduced outside the
establishment,including food safety hazards that occur before,during,and after entry
into the establishment;
(3) List the critical limits that must be met at each of the critical control points,Critical
limits shall,at a minimum,be designed to ensure that applicable targets or performance
standards established by FSIS,and any other requirement set forth in this chapter
pertaining to the specific process or product,are met;
(4) List the procedures,and the frequency with which those procedures will be
performed,that will be used to monitor each of the critical control points to ensure
compliance with the critical limits;
(5) Include all corrective actions that have been developed in accordance with §417.3(a)
of this part,to be followed in response to any deviation from a critical limit at a critical
control point; and
(6) Provide for a recordkeeping system that documents the monitoring of the critical
control points,The records shall contain the actual values and observations obtained
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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 corned beef on a six column form
(See Figure 4),You do not need to use this form,although some kind of a form is probably the
easiest way to present your HACCP plan,
Identifying CCPs
The first column on this particular form is used to enter information developed and contained on
the hazard analysis form,Part 417.2(c)(1) and (2) require that the food safety hazards identified
in the hazard analysis be listed on the HACCP plan and that there be a CCP for each identified
hazard,You will notice that there were five points on the hazard analysis form for corned beef
where food safety hazards reasonably likely to occur were identified,Salmonella on raw beef at
receiving,pathogen proliferation at cold storage,excess nitrite in finished product,pathogen
survival and/or proliferation at curing,and pathogen contamination at finished product storage,
The establishment HACCP team has chosen to have five CCPs to address these five hazards,
Salmonella certification,proper cold storage of raw beef,proper control and formulation of
nitrite,proper curing application,and proper finished product cold storage,
After identifying its CCPs,the HACCP team proceeded to consider critical limits,monitoring
procedures and their frequencies,and verification procedures and their frequencies,and HACCP
records,
In deciding what would be the critical limits,the HACCP team first considered whether there
were any regulatory requirements which had to be met and would function as critical limits,
They did find FSIS regulatory requirements and guidelines,so they set the critical limit(s) using
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criteria as specified by FSIS for the control of pathogens,
Once they had decided on their critical limits,they needed to identify how the monitoring
procedures would be carried out and at what frequency,
For their cure application step,the establishment had Quality Assurance monitor the application
of and record the amount of cure and application method,
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,
The HACCP team described the verification procedures and their frequencies in the fifth column
of their HACCP plan,
The HACCP team for generic establishment X knew that their HACCP Plan needed to provide
for a recordkeeping system,They wanted their records to be easy to create and understand,
They wanted to be sure their records met regulatory requirements,so they reviewed part 417.5(a)
and (b),
§ 417.5 Records,
(a) The establishment shall maintain the following records documenting the
establishment's HACCP plan,
(1) The written hazard analysis prescribed in § 417.2(a) of this part,including all
supporting documentation;
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(2) The written HACCP plan,including decision making documents associated with the
selection and development of CCPs and critical limits,and documents supporting both
the monitoring and verification procedures selected and the frequency of those
procedures,
(3) Records documenting the monitoring of CCPs and their critical limits,including the
recording of actual times,temperatures,or other quantifiable values,as prescribed in the
establishment's HACCP plan; the calibration of process-monitoring instruments;
corrective actions,including all actions taken in response to a deviation; verification
procedures and results; product code(s),product name or identity,or slaughter
production lot,Each of these records shall include the date the record was made,
(b) Each entry on a record maintained under the HACCP plan shall be made at the time
the specific event occurs and include the date and time recorded,and shall be signed or
initialed by the establishment employee making the entry,
The HACCP team decided that their records would be kept on some simple forms,some of
which the team itself devised,
The HACCP team decided that five forms were necessary,Form letter for Salmonella,
Thermometer Calibration Log,Room Temperature Log,Pump Percentage Log,and Weight
Formulation Record,The forms were designed to provide spaces for all entries necessary for the
monitoring and verification activities at each CCP,
On its HACCP Plan,generic establishment X has listed the name of the form it will be using for
monitoring and verification records,
There is one other form included in column four,where the establishment has described its
recordkeeping system,That is the Corrective Actions Log; it is used to create the records of any
corrective actions taken because of deviations from critical limits at CCPs,Column six of the
HACCP plan references the planned corrective actions for each CCP,The HACCP team
carefully reviewed the regulatory requirements for planned corrective actions found at 417.3(a),
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§ 417.3 Corrective actions,
(a) The written HACCP plan shall identify the corrective action to be followed in
response to a deviation from a critical limit,The HACCP plan shall describe the
corrective action to be taken,and assign responsibility for taking corrective action,to
ensure,
(1) The cause of the deviation is identified and eliminated;
(2) The CCP will be under control after the corrective action is taken;
(3) Measures to prevent recurrence are established; and
(4) No product that is injurious to health or otherwise adulterated as a result of the
deviation enters commerce,
The HACCP team has developed a specific corrective action plan which will be followed
whenever there is a deviation from a critical limit at a CCP; each of the planned corrective
actions meets the four regulatory requirements of 417.3(a),
Planned Corrective Actions for CCP 3C,
1,Improperly prepared cure ingredients will be discarded,
2,QA will identify the cause of the deviation and prevent reoccurrence,
3,Monitoring will be increased to include scale calibration for each batch,
The HACCP team also develops planned corrective actions for each of the other CCPs and
attaches them to the HACCP plan,Whenever a deviation from a critical limit occurs,company
employees follow the corrective action plan and use the Corrective Action Log to create a record
of their actions,The Corrective Action Log forms are available at CCPs,so they can be used
immediately when an employee performing a monitoring check discovers and records a
deviation,All Corrective Action Logs,which have been used during the day,are turned in to the
HACCP coordinator,
There is one final verification/recordkeeping requirement which the company must perform; it is
found at 417.5(c),
(c) Prior to shipping product,the establishment shall review the records associated with
the production of that product,documented in accordance with this section,to ensure
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completeness,including the determination that all critical limits were met and,if
appropriate,corrective actions were taken,including the proper disposition of product,
Where practicable,this review shall be conducted,dated,and signed by an individual
who did not produce the record(s),preferably by someone trained in accordance with §
417.7 of this part,or the responsible establishment official,
In generic establishment X,product is shipped out,often in small lots,throughout the day,This
means that pre-shipment verification checks must be as complete as possible when finished
product is in storage,so that a shipment can be made up quickly and moved into distribution
channels,
The establishment uses a half day lotting system and a midshift cleanup,While the midshift
cleanup is being performed,QA personnel or the HACCP coordinator review results of
monitoring and verification checks applied to that lot; if there were deviations from critical
limits,they review the Corrective Action Logs to make sure all appropriate planned responses
were carried out,If everything is in order and there are complete records showing that the
establishment has controlled production of this product through its HACCP system,the HACCP
coordinator will sign the pre-shipment review form which the HACCP team devised for this
purpose,
Note,It is not a regulatory requirement that a separate form be used for pre-shipment review; in
addition,FSIS has indicated that it will be very flexible in accepting a variety of arrangements
for accomplishing pre-shipment review to reflect the variety of commercial practices which it
has encountered in the industry,It is,however,important to remember that pre-shipment review
is a regulatory requirement that must be met,as it indicates that the establishment is taking full
responsibility for the product having been produced under a well-functioning HACCP system,
The HACCP team believes it has now completed preparation of the documents which are
necessary to meet regulatory requirements for a Hazard Analysis and a HACCP Plan for their
products with secondary inhibitors,not shelf stable production process,They have secured a
copy of FSIS Directive 5000.1,Enforcement of Regulatory Requirements in Establishments
Subject to HACCP System Requirements,the HACCP Basic Compliance Checklist which will
be used by inspection program personnel,The HACCP team has modified the inspection form to
make the statements into positives,and now has a checklist for its own use to make sure they
have not omitted anything in their plan development and preparation,When they are confident
that they have done what is necessary,they will turn their Hazard Analysis and HACCP Plan
over to the establishment owner for decisions about implementation,
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APPENDIX A
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References for HACCP Teams
1. Agriculture Canada,Food Safety Enhancement Program – HACCP Implementation Manual,
Camelot Drive,Nepean,Ontario,Canada,1996,
2. American Meat Institute Foundation,HACCP,The Hazard Analysis and Critical Control
Point System in the Meat and Poultry Industry,Washington,D.C.,1994,
Useful sections in particular are,
Chapter 3 – microbiological hazards,pp,15-26
Chapter 4 – chemical hazards,pp,27-32
Chapter 5 – physical hazards,pp,33-35
Appendix A – NACMCF HACCP
Appendix C – Model HACCP plans
3. Baker,D.A,Application of Modeling in HACCP Plan Development,Int,J,Food Microbiol,
25:251-261,1995,
4. Corlett,D.A.,Jr,and Stier,R.F,Risk Assessment within the HACCP System,Food Control
2:71-72,1991,
5. Council for Agriculture Science and Technology,Risks Associated with Foodborne
Pathogens,February 1993,
6. Easter,M.C.,et al,The Role of HACCP in the Management of Food Safety and Quality,
J,Soc,Dairy Technol,47:42-43,1994,
7. Environmental Protection Agency,Tolerances for Pesticides in Foods,Title 40,Code of
Federal Regulations,Part 185,U.S,Government Printing Office,Washington,D.C.,1998,
8. Food and Drug Administration,The Food Defect Action Levels,FDA/CFSAN,
Washington,D.C.,1998,
9. Food and Drug Administration,Fish and Fishery Products Hazards and Control Guide --
Get Hooked on Seafood Safety,Office of Seafood,Washington,D.C.,1994,
10,International Commission on Microbiological Specification for Foods,HACCP in
Microbiological Safety and Quality,Blackwell Scientific Publications,Oxford,1988,
Useful sections in particular are,
Chapter 10 – raw meat and poultry,pp,176-193
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Chapter 11 – roast beef,pp,234-238
Chapter 11 – canned ham,pp,238-242
11,International Commission on Microbiological Specification for Foods,Microorganisms in
Foods 4,Application of Hazard Analysis and Critical Control Point (HACCP) Systems to
Ensure Microbiological Safety and Quality,Blackwell Scientific Publications,Boston,1989
12,National Advisory Committee on Microbiological Criteria for Foods,March 20,1992 --
Hazard Analysis and Critical Control Point System,Int,J,Food Microbiol,16,1-23,1993,
13,National Advisory Committee on Microbiological Criteria for Foods,Adopted August 14,
1997-- Hazard Analysis and Critical Control Point Principles and Application Guidelines,
J,Food Protect,61(9),1246-1259,1998,
14,National Advisory Committee on Microbiological Criteria for Foods,DRAFT document -
FSIS Microbiological Hazard Identification Guide for Meat and Poultry Components of
Products Produced by Very Small Plants,1-22,August 1999,
15,National Advisory Committee on Microbiological Criteria for Foods,June 1993 -- Report
on Generic HACCP for Raw Beef,Food Microbiol,10,449-488,1994,
16,National Research Council,An Evaluation of the Role of Microbiological Criteria for Foods
and Food Ingredients,National Academy Press,Washington,D.C.,1985,
Useful sections in particular are,
Chapter 4 – microbiological hazards,pp,72-103
Chapter 9 – raw meat,pp,193-199
Chapter 9 – processed meats,pp,199-216
17,Notermans,S.,et al,The HACCP Concept,Identification of Potentially Hazardous
Microorganisms,Food Microbiol,11:203-214,1994,
18,Pierson M.D,and Dutson,T,Editors,HACCP in Meat,Poultry,and Fish Processing,
Blackie Academic & Professional,Glasgow,1995,
Useful sections in particular are,
Chapter 4 – meat and poultry slaughter,pp,58-71
Chapter 5 – processed meats,pp,72-107
Chapter 7 – risk analysis,pp,134-154
Chapter 13 – predictive modeling,pp,330-354
19,Pierson,M.D,and Corlett,D.A.,Jr,Editors,HACCP Principles and Applications,Van
18
Products with Secondary Inhibitors,Not Shelf Stable Model
Nostrand Reinhold,New York,1992,
20,Stevenson,K.E,and Bernard,D.T,Editors,HACCP,Establishing Hazard Analysis Critical
Control Point Programs,A Workshop Manual,The Food Processors Institute,Washington,
D.C.,1995,
Useful sections in particular are,
Chapter 11 – forms for hazard analysis,CCPs,critical limits,HACCP master
sheet,example HACCP for breaded chicken
21,Stevenson,K.E,and Bernard,D.T,Editors,HACCP,A Systematic Approach to Food
Safety,3
rd
Edition,The Food Processors Institute,Washington,D.C.,1999,
22,Tompkin,R.B,The Use of HACCP in the Production of Meat and Poultry Products,
J,Food Protect,53(9),795-803,1990,
23,Tompkin,R.B,The Use of HACCP for Producing and Distributing Processed Meat and
Poultry Products,In Advances in Meat Research,Volume 10,Hazard Analysis Critical
Control Point in Meat,Poultry and Seafoods,Chapman & Hall,1995,
References for Meat and Poultry Products with Secondary
Inhibitors,Not Shelf Stable
1. American Meat Institute,Interim good manufacturing practices for fermented dry and semi-
dry sausage product,Washington,DC,1995,
2. American Meat Institute,HACCP plan for ham,The Hazard Analysis and Critical Control
Point System in the Meat and Poultry Industry,Appendix C,pp,99-101,1994,
3. Bartholomew,D.T.,et al,Inhibition of Staphylococcus by lactic acid bacteria in country-
style hams,J,Food Sci,45,420-425,1980,
4. Bunic,Sava et al,The fate of Listeria monocytogenes in fermented sausages and in vacuum-
packaged frankfurters,J,Food Protect,54,413-417,1991,
5. Christian,J.A,Curing and aging country hams,Reciprocal Meat Conf,Proc,35,47-48,
1982,
6. Collins-Thompson,D.L.,et al,The effect of nitrite on the growth of pathogens during
manufacture of dry and semi-dry sausage,Can,Inst,Food Sci,Technol,J,17,102-106,
1984,
19
Products with Secondary Inhibitors,Not Shelf Stable Model
7. Cornish,D.G.,et al,Accelerated pork processing,A quantitative study of bacterial flora of
cured and smoked hams,J,Food Sci,39,605-606,1974,
8. Draughon,D,A,et al,Microbial Profiles of Country-Cured Hams Aged in Stockinettes,
Barrier Bags and Paraffin Wax,Appl,Environ,Microbiol,1078-1080,April 1981,
9. Dykes,Gary A.,et al,Quantification of microbial populations associated with the
manufacture of vacuum-packaged,smoked Vienna sausages,Int,J,Food Microbiol,13,
239-248,1991,
10,Flores,L,M.,et al,Evaluation of a phosphate to control pathogen growth in fresh and
processed meat products,J,Food Protect,59,356-359,1996,
11,Gonzalez-Hevia,M,Angeles,et al,Diagnosis by a Combination of Typing Methods of
Salmonella typhimurium Outbreak Associated with Cured Ham,J,Food Protect,59,426-
428,1996
12,Houtsma,P,C.,et al,Model for the combined effects of temperature,pH,and sodium lactate
on growth rates of Listeria innocua in broth and bologna-type sausages,Appl,Environ,
Microbiol,62,1616-1622,1996,
13,Ockerman,H,W.,et al,Effect of Tumbling and Tumbling Temperature on Surface and
Subsurface Contamination of Lactobacillus Plantarum and Residual Nitrite in Cured Pork
Shoulder,J,Food Science,49,1634-1635,1984,
20
Products with Secondary Inhibitors,Not Shelf Stable Model
APPENDIX B
21
Products with Secondary Inhibitors,Not Shelf Stable Model
PROCESS FLOW DIAGRAM Figure 1
PROCESS CATEGORY,PRODUCTS WITH SECONDARY INHIBITORS,NOT SHELF
STABLE
PRODUCT,CORNED BEEF
RECEIVING
RAW BEEF ROUNDS
RECEIVING
PACKAGING
MATERIALS
RECEIVING
UNRESTRICTED
NONMEAT
FOOD
INGREDIENTS
STORAGE
(COLD – FROZEN/REFRIGERATED)
RAW BEEF
TEMPERING
FRO
CURE APPLICATION
STORAGE
PACKAGING
MATERIALS
STORAGE
UNRESTRICTED
NONMEAT
FOOD
INGREDIENTS
WEIGHING
UNRESTRICTED
NONMEAT
FOOD
INGREDIENTS
VACUUM
PACKAGING/LABELING
RECEIVING
RESTRICTED
NONMEAT
FOOD
INGREDIENTS
STORAGE
RESTRICTED
NONMEAT
FOOD
INGREDIENTS
FINISHED PRODUCT STORAGE
(COLD)
SHIPPING
ZEN BEEF
22
WEIGHING
RESTRICTED
NONMEAT
FOOD
INGREDIENTS
Products with Secondary Inhibitors,Not Shelf Stable Model
PRODUCT DESCRIPTION Figure 2
PROCESS CATEGORY,PRODUCTS WITH SECONDARY INHIBITORS,
SHELF STABLE
PRODUCT,CORNED (CURED) BEEF
1,COMMON NAME? CORNED BEEF
2,HOW IS IT TO BE USED? COOKED BY PURCHASER
3,TYPE OF PACKAGE? VACUUM PACKED
4,LENGTH OF SHELF LIFE,UNDER REFRIGERATION SHELF
AT WHAT TEMPERATURE? LIFE OF VACUUM PACKAGED
PRODUCT IS 8 DAYS
FROZEN 14 DAYS
5,WHERE WILL IT BE SOLD? WHOLESALE TO DISTRIBUTORS
CONSUMERS? ONLY
INTENDED USE?
6,LABELING INSTRUCTIONS? KEEP REFRIGERATED OR FROZEN
7,IS SPECIAL DISTRIBUTION KEEP REFRIGERATED OR FROZEN
CONTROL NEEDED?
23
Products with Secondary Inhibitors,Not Shelf Stable Model
HAZARD ANALYSIS – PRODUCTS WITH SECONDARY INHIBITORS,NOT SHELF STABLE –
Corned Beef
Process Step Food Safety
Hazard
Reasonably
Likely to
Occur?
Basis If Yes in Column 3,
What Measures Could
be Applied to Prevent,
Eliminate,or Reduce
the Hazard to an
Acceptable Level?
Critical Control
Point
Receiving – Raw Beef
Rounds
Biological,Pathogens
Salmonella
E,coli O157:H7
Yes Salmonella and E,coli
O157:H7 may be present on
incoming raw product,
Curing process will inhibit
growth of pathogens (E.coli)
at a further step in the
process,
Proper storage and
handling at subsequent
steps can reduce the growth
of E,coli if present,
Certification from suppliers
that product has been
sampled for Salmonella and
meets FSIS performance
standards,
1B
Chemical – None
Physical – Foreign
materials such as
broken needles
No Plant records show that
there has been no incidence
of foreign materials in
products received into the
plant,
Figure 3
24
Products with Secondary Inhibitors,Not Shelf Stable Model
HAZARD ANALYSIS – PRODUCTS WITH SECONDARY INHIBITORS,NOT SHELF STABLE –
Corned Beef
Process Step Food Safety
Hazard
Reasonably
Likely to
Occur?
Basis If Yes in Column 3,
What Measures Could
be Applied to Prevent,
Eliminate,or Reduce
the Hazard to an
Acceptable Level?
Critical Control
Point
Receiving – Restricted
and Unrestricted
Nonmeat Food
Ingredients; Packaging
Materials
Biological – None
Chemical – Not
acceptable for
intended use
No Letters of guaranty are
received from all suppliers
of packaging materials,
Physical – Foreign
materials (insects,
glass,metal,etc.)
No Plant records demonstrate
that foreign material
contamination has not
occurred during the past
several years,
Storage – Restricted and
Unrestricted Nonmeat
Food Ingredients;
Packaging Materials
Biological – None
Chemical – None
Physical – None
Storage (Cold –
Frozen/Refrigerated) –
Raw Beef
Biological
E,coli O157:H7
Yes Pathogens are reasonably
likely to grow in this
product if temperature is
not maintained at or below
a level sufficient to preclude
their growth,
Maintain product
temperature at or below a
level sufficient to preclude
pathogen growth,
2B
Chemical – None
Physical – None
Figure 3
25
Products with Secondary Inhibitors,Not Shelf Stable Model
HAZARD ANALYSIS – PRODUCTS WITH SECONDARY INHIBITORS,NOT SHELF STABLE –
Corned Beef
Process Step Food Safety
Hazard
Reasonably
Likely to
Occur?
Basis If Yes in Column 3,
What Measures Could
be Applied to Prevent,
Eliminate,or Reduce
the Hazard to an
Acceptable Level?
Critical Control
Point
Tempering Frozen
Beef
Biological – None
Chemical – None
Physical – None
Weighing Restricted
and Unrestricted
Nonmeat Food
Ingredients
Biological – None
Chemical – Cure
Ingredients (nitrite)
Yes Excess nitrite in a finished
product may create a health
hazard,
Proper control and formu-
lation of nitrite to prevent
creating a health hazard,
3C
Physical – None
Cure Application Biological
Clostridium botulinum
Clostridium perfringens
Yes Application of cure at the
proper level will inhibit the
growth of pathogenic
organisms,
Proper injection of cure
solution to provide
microbial inhibition,
4B
Chemical – None
Physical – None
Packaging/Labeling Biological
Clostridium botulinum
Clostridium perfringens
No Proper nitrite pump and
vacuum package will allow
competing organisms to
grow to the exclusion of
clostridia,
See CCP 3C and CCP 4B
Chemical – None
Physical – None
Figure 3
26
Products with Secondary Inhibitors,Not Shelf Stable Model
HAZARD ANALYSIS – PRODUCTS WITH SECONDARY INHIBITORS,NOT SHELF STABLE –
Corned Beef
Process Step Food Safety
Hazard
Reasonably
Likely to
Occur?
Basis If Yes in Column 3,
What Measures Could
be Applied to Prevent,
Eliminate,or Reduce
the Hazard to an
Acceptable Level?
Critical Control
Point
Finished Product
Storage (Cold)
Biological
Salmonella
Yes Pathogens are reasonably
likely to grow on this
product if temperature is
not maintained at or below
a level sufficient to preclude
their growth,
Maintain product
temperature at or below a
level sufficient to preclude
pathogen growth,
5B
Chemical – None
Physical – None
Shipping Biological - None
Chemical – None
Physical – None
Figure 3
27
Products with Secondary Inhibitors,Not Shelf Stable Model
HACCP PLAN
PROCESS CATEGORY,PRODUCTS WITH SECONDARY INHIBITORS,NOT SHELF STABLE
PRODUCT EXAMPLE,CORNED BEEF
CCP# and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP Records Verification Procedures and
Frequency
Corrective Actions
1B
Receiving –
Raw Beef
Rounds
Supplier
certification
that product
has been
sampled for
Salmonella
must
accompany
shipment,
Receiving
personnel will
check each
shipment for
Salmonella
certification,
Receiving Log
Corrective Action
Log
Every two months QA will request
FSIS Salmonella data results from
the company for at least 2 suppliers,
Will not receive product unaccompanied
by Salmonella certification,
2B
Storage
(Cold–
Frozen/
Refrigerated
– Raw Beef
Raw product
storage areas
will not
exceed 40° F
in refrigerated
rooms or
exceed 28° F
in freezer
rooms,
Maintenance
personnel will
check raw product
storage area
temperature every
two hours,
Room Temperature
Log
Thermometer
Calibration Log
Corrective Action
Log
Maintenance supervisor will verify
accuracy of the Room Temperature
Log once per shift,
QA will check all thermometers
used for monitoring and verification
for accuracy daily and calibrate to
within 2° F accuracy as necessary,
QA will reject or hold product dependent
on time and temperature deviation and use
pathogen modeling to determine product
disposition,
QA will identify the cause of the deviation
and prevent reoccurrence,
Monitoring frequency will be increased
until it is assured that the process step is
under control,
Signature,__________________________________ Date,__________________________ Figure 4
28
Products with Secondary Inhibitors,Not Shelf Stable Model
HACCP PLAN
PROCESS CATEGORY,PRODUCTS WITH SECONDARY INHIBITORS,NOT SHELF STABLE
PRODUCT EXAMPLE,CORNED BEEF
CCP# and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP Records Verification Procedures and
Frequency
Corrective Actions
3C
Weighing
Restricted and
Unrestricted
Nonmeat
Food
Ingredients
2 lb,sodium
nitrite to 100
gallon pickle
at 10%
pump,
QA technician will
monitor weighing
and formulation of
sodium nitrite for
each batch,
Weight/
Formulation Record
Corrective Action
Log
QA supervisor will observe QA
technician perform monitoring
activity once per shift,
QA supervisor will check
Weight/Formulation Record twice
per shift,
Scale will be calibrated once per
week,
Improperly prepared cure ingredients will
be discarded,
QA will identify the cause of the deviation
and prevent reoccurrence,
Monitoring will be increased to include
scale calibration for each batch,
Signature,__________________________________ Date,__________________________ Figure 4
29
Products with Secondary Inhibitors,Not Shelf Stable Model
HACCP PLAN
PROCESS CATEGORY,PRODUCTS WITH SECONDARY INHIBITORS,NOT SHELF STABLE
PRODUCT EXAMPLE,CORNED BEEF
CCP# and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP Records Verification Procedures and
Frequency
Corrective Actions
4B
Cure
Application
120 ppm
sodium
nitrite at
10% pump,
Pump percentage
will be monitored
before and after
pump to assure
10% gain,
Ten pieces will be
weighed before and
after pump % gain
calculated every 2
hours,
Pump Percentage
Log
Corrective Action
Log
QA will observe pump technician
perform pump check once per lot,
QA will review pump log once per
shift,
Product not meeting critical limit will be
held and either repumped to 10% or
drained to 10%,
Needle settings will be checked and
adjusted as required,
Pump technician will monitor every hour
until assured that the CCP is under control,
Signature,__________________________________ Date,__________________________ Figure 4
30
Products with Secondary Inhibitors,Not Shelf Stable Model
HACCP PLAN
PROCESS CATEGORY,PRODUCTS WITH SECONDARY INHIBITORS,NOT SHELF STABLE
PRODUCT EXAMPLE,CORNED BEEF
CCP# and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP Records Verification Procedures and
Frequency
Corrective Actions
5B
Finished
Product
Storage
Product
storage area
will not
exceed 40°F
Maintenance
personnel will
monitor storage
room temperature
once per shift,
Corrective Action
Log
Room Temperature
Log
Thermometer
Calibration Log
QA will observe maintenance
personnel perform storage
temperature monitoring and review
room temperature log once per
week,
Cooler thermometers will be
calibrated once per week by
maintenance supervisor,
If room temperature exceeds 40° F product
will be held and internal temperature taken,
Internal product temperature and amount of
time product and room temperature
deviated will determine product
disposition,
Product temperature will be monitored
when room temperature is monitored until
CCP is under control,
Cause of deviation will be identified,
Maintenance will repair thermometer units
or cooling coils as required based on cause
of deviation,
Signature,__________________________________ Date,__________________________ Figure 4
31
Products with Secondary Inhibitors,Not Shelf Stable Model
FORM LETTER Confirming Salmonella Compliance with Performance Standards
Date
To,Plant XYZ
This is to confirm results of any Salmonella performance standard sample sets completed during the past six months from your
establishment listed below,
Thank you,
Product Date Results
Received
Test Results Two Consecutive Failed Tests
32
Products with Secondary Inhibitors,Not Shelf Stable Model
THERMOMETER CALIBRATION LOG
Calibrate to 32
0
F while thermometer is in slush ice water
Date Time Department or
Area
Thermometer ID# Personal
Thermometer
Reading
Adjustment
Required (Yes
or No)
Initials Comments
If a thermometer is broken or taken out of service,document this in the comment column,
Reviewed by,_______________________ Date,_______________________
33
Products with Secondary Inhibitors,Not Shelf Stable Model
WEIGHT / FORMULATION RECORD
Date Time Lot # Weight
Sodium Nitrite
No,of Gallon
Pickle
PPM Initials Comments
Reviewed by,_______________________ Date,___________________
34
Products with Secondary Inhibitors,Not Shelf Stable Model
PUMP PERCENTAGE LOG
Date Time Lot # Weight Before
Pump
Weight After
Pump
% Gain Initials Comments
Reviewed by,_______________________ Date,_______________________
35
Products with Secondary Inhibitors,Not Shelf Stable Model
GENERIC ESTABLISHMENT X,
ROOM:__________ DATE:_________
TIME TEMP Deviation from
CL?
yes)
If Yes,
Action?
Monitored by,Verified by,
ROOM TEMPERATURE LOG
(Check if
36
Products with Secondary Inhibitors,Not Shelf Stable Model
CORRECTIVE ACTIONS LOG
Product,___________________________________________ Lot # ______________________
CCP Deviation/
Problem
Corrective Action
Procedures/Explain
Disposition of
Product
Responsible
Person
Date/Time
SIGNATURE,__________________________ DATE,______________________
37
Products with Secondary Inhibitors,Not Shelf Stable Model
PRE-SHIPMENT
Date:______________
PRODUCT LOT
ID
TIME
RECORDS
REVIEWED
BY
WHOM
LOT RELEASED FOR
SHIPMENT?
SIGNATURE
COMMENTS *
LOG REVIEW
*Monitoring frequency as per plan; Critical limits met; Certification (if applicable) as per plan; Deviations if occurred were reviewed
for appropriate corrective actions; Records complete and accurate,
38
Department of
Agriculture
Food Safety
and Inspection
Service
September 1999
HACCP-9
Generic HACCP
Model for Meat
and Poultry
Products with
Secondary
Inhibitors,Not
Shelf Stable
Additional copies of the Guidebook for the Preparation
of HACCP Plans and the Generic HACCP Models are
available from,
U.S,Department of Agriculture
Food Safety and Inspection Service (FSIS)
Office of Policy,Program Development,
and Evaluation (OPPDE)
Inspection Systems Development Division
Room 202,Cotton Annex Building
300 12
th
Street SW
Washington,D.C,20250-3700
Phone,(202) 720-3219
Fax,(202) 690-0824
This material is also available on the FSIS Homepage,
http://www.fsis.usda.gov/index.htm
Products with Secondary Inhibitors,Not Shelf Stable Model
Table of Contents
Introduction……………………………………………………………………………..…,3
Using This Generic Model…………………………………………………………..…….,5
Process Flow Diagram and Product Description…………………………………..………,7
Hazard Analysis………………………………………………………………….…………8
Developing Your HACCP Plan………………………………………………..….……….,10
Identifying CCPs……………………………………………………………………..……,11
Appendix A
References for HACCP Teams……………………………………..…………….,17
References for Meat and Poultry Products with Secondary Inhibitors,
Not Shelf Stable …………………………………………………………..……..… 19
Appendix B
Process Flow Diagram (Figure1) Corned Beef ………………………….………… 22
Product Description Form (Figure 2) Corned Beef ……………………………… 23
Hazard Analysis Form (Figure 3)……………………………………………….…,24
HACCP Plan Form (Figure 4)…………………………………..……………….… 28
Form Letter Confirming Salmonella Compliance with Performance
Standards ……………………………………….…………………………………,32
Thermometer Calibration Log…………………………………………………….,33
Weight/Formulation Record………………………………………………………,34
Pump Percentage Log……………………………………………………………… 35
1
Products with Secondary Inhibitors,Not Shelf Stable Model
Generic Establishment X,Room Temperature Log …………………………….… 36
Corrective Actions Log……………………………………………………………,37
Pre-Shipment Review Log………………………………………………………… 38
2
Products with Secondary Inhibitors,Not Shelf Stable Model
GENERIC HACCP MODEL
FOR
MEAT AND POULTRY PRODUCTS
WITH SECONDARY INHIBITORS,NOT SHELF STABLE
Introduction
The Hazard Analysis Critical Control Point (HACCP) system is a scientific approach to process
control,It is designed to prevent the occurrence of problems by assuring that controls are
applied at any point in a food production system where hazardous or critical situations could
occur,Hazards include biological,chemical,or physical contamination of food products,
The Food Safety and Inspection Service (FSIS) published a final rule in July 1996 mandating
that HACCP be implemented as the system of process control in all inspected meat and poultry
plants,As part of its efforts to assist establishments in the preparation of plant-specific HACCP
plans,FSIS determined that a generic model for each process defined in the regulation would be
made available for use on a voluntary basis by inspected establishments,
The generic models have been revised since their initial publication and distribution as
DRAFTS,The most important change in the revised versions is to make certain that these
models are
fully consistent with the features of the final regulation,Also,other technical and editorial
improvements have been made,
Throughout this generic model,FSIS discusses a HACCP team with members from different
departments,In many very small establishments,there will not be separate departments with
different employees,But,there will be employees who perform these different functions – often
several of them,For purposes of explaining concepts,it is easier to speak as if these were
different people,even though in many cases,they may be the same person carrying out more
than one responsibility,
Each generic model can be used as a starting point for the development of plant-specific plan(s)
reflecting actual plant environments and the processes conducted,The generic model is not
intended to be used,as is” for plant specific HACCP plans,
The generic models are designed for use in conjunction with the list of process categories found
in the HACCP regulations in section 417.2(b)(1),
3
Products with Secondary Inhibitors,Not Shelf Stable Model
(b) The HACCP plan,(1) Every establishment shall develop and implement a written
HACCP plan covering each product produced by that establishment whenever a hazard
analysis reveals one or more food safety hazards that are reasonably likely to occur,
based on the hazard analysis conducted in accordance with paragraph (a) of this section,
including products in the following processing categories,
(i) Slaughter--all species,
(ii) Raw product--ground,
(iii) Raw product--not ground,
(iv) Thermally processed--commercially sterile,
(v) Not heat treated--shelf stable,
(vi) Heat treated--shelf stable,
(vii) Fully cooked--not shelf stable,
(viii) Heat treated but not fully cooked--not shelf stable,
(ix) Product with secondary inhibitors--not shelf stable,
This generic model is designed for use with the process category,Product with secondary
inhibitors--not shelf stable,
The purpose of the process category listing in 417.2 is to set out the circumstances under which a
HACCP team may develop a single HACCP plan for multiple products,This may be done when
products are in the same process category,and food safety hazards,critical control points,and
other features are essentially the same,There is a generic model for each process category,plus
two for subcategories which present special issues,irradiated products and mechanically
separated products,
In order to select the model or models that will be most useful for the activities performed in any
specific plant,the following steps should be taken,
1) For slaughtering operations,select the model for the appropriate species,
2) For processed products,make a list of all products produced in the plant,
3) Examine the list and group like products,considering common processing steps and
4
Products with Secondary Inhibitors,Not Shelf Stable Model
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 product(s) with
secondary inhibitors,not shelf stable,the ninth process category,The model can be used for all
products with secondary inhibitors,not shelf stable,either meat or poultry,The generic model is
not suitable for products that fall into any of the other process categories,
The model will be most useful to a HACCP team that includes access to one trained individual,
as specified in 417.7(b),
(b)The individual performing the functions listed in paragraph (a) of this section shall
have successfully completed a course of instruction in the application of the seven
HACCP principles to meat or poultry product processing,including a segment on the
development of a HACCP plan for a specific product and on record review,
It would be beneficial for other team members to have reviewed any of the various guidance
materials available on how to develop a HACCP plan for your company,including several useful
videos,handbooks,or computer programs,Once the HACCP team has prepared itself as
thoroughly as possible in general HACCP principles and how to use them,this model should be
helpful,
Note,This generic model includes a number of forms that can be used to record various types of
required information,The forms themselves are samples; a company HACCP team can develop
whatever forms it finds most useful,All the forms mentioned in this document are included in
5
Products with Secondary Inhibitors,Not Shelf Stable Model
Appendix B; they appear in the order in which they are discussed in the text,
All FSIS generic models are designed to assist establishments in applying the seven HACCP
principles to their meat and poultry processing operations AND to meet the regulatory
requirements of Part 417,Therefore,the definitions used in this and all other FSIS generic
models are those found in 417.1,
§ 417.1 Definitions,
For purposes of this part,the following shall apply,
Corrective action,Procedures to be followed when a deviation occurs,
Critical control point,A point,step,or procedure in a food process at which control can
be applied and,as a result,a food safety hazard can be prevented,eliminated,or reduced
to acceptable levels,
Critical limit,The maximum or minimum value to which a physical,biological,or
chemical hazard must be controlled at a critical control point to prevent,eliminate,or
reduce to an acceptable level the occurrence of the identified food safety hazard,
Food safety hazard,Any biological,chemical,or physical property that may cause a
food to be unsafe for human consumption,
HACCP System,The HACCP plan in operation,including the HACCP plan itself,
Hazard,SEE Food Safety Hazard,
Preventive measure,Physical,chemical,or other means that can be used to control an
identified food safety hazard,
Process-monitoring instrument,An instrument or device used to indicate conditions
during processing at a critical control point,
Responsible establishment official,The individual with overall authority on-site or a
higher level official of the establishment,
6
Products with Secondary Inhibitors,Not Shelf Stable Model
Process Flow Diagram and Product Description
To begin using this model,the company's HACCP team should first describe the product(s)
which are part of this process category and covered by this HACCP plan,The product(s) should
be described in two ways,
(1) by a simple diagram which shows the steps the company uses when it produces the product,
and
(2) in a brief written description which provides key facts about the product and its use,
In this generic model,there is an example for products with secondary inhibitors,not shelf stable
– corned (cured) beef,FSIS has developed certain forms as part of the examples in the generic
models; company HACCP teams are not required to use these forms,
Figure 1 is an example of a PROCESS FLOW DIAGRAM for the production of corned beef in
generic establishment X,Figure 2 is an example of a PRODUCT DESCRIPTION for the
corned beef produced in generic establishment X,
Once the company HACCP team in your establishment has prepared your Process Flow
Diagram,they should verify it by walking through the establishment following the flow of
product and making sure that all the steps of the process are included in the flow diagram,The
team should also review the information provided on the Product Description to make sure all
the key facts are included,such as identifying consumers,especially those with particular health
problems or known to be at risk,
Note,If your process includes steps not included in this example,those steps should be added,
Also,if your process does not include all the steps identified in this example,those steps would
be omitted when conducting the hazard analysis,That is generally,how you use these generic
model examples--just omit the features which do not apply to your operation or if your operation
includes features not included in this example,they should be added,
By completing a Process Flow Diagram and a Product Description,you have met the
requirements of 417.2(a)(2),You can use the Process Flow Diagram in particular to help you
complete the rest of the hazard analysis,Use the flow diagram to systematically review each
step in the process and ask the question,"Is there a food safety hazard which is reasonably likely
to occur which may be introduced at this step?" In answering the question,your HACCP team
needs to consider biological (including microbiological),chemical,and physical hazards,
7
Products with Secondary Inhibitors,Not Shelf Stable Model
Hazard Analysis
Once your product(s) are accurately described through the flow diagram and product description,
the HACCP team should begin work on the HAZARD ANALYSIS,The hazard analysis is
fundamental to developing a good HACCP plan and one that meets regulatory requirements,
The regulatory requirements for a hazard analysis are found at 417.2(a),
§ 417.2 Hazard Analysis and HACCP Plan,
(a) Hazard analysis,(1) Every official establishment shall conduct,or have conducted
for it,a hazard analysis to determine the food safety hazards reasonably likely to occur
in the production process and identify the preventive measures the establishment can
apply to control those hazards,The hazard analysis shall include food safety hazards
that can occur before,during,and after entry into the establishment,A food safety
hazard that is reasonably likely to occur is one for which a prudent establishment would
establish controls because it historically has occurred,or because there is a reasonable
possibility that it will occur in the particular type of product being processed,in the
absence of those controls,
(2) A flow chart describing the steps of each process and product flow in the
establishment shall be prepared,and the intended use or consumers of the finished
product shall be identified,
Generic establishment X,which we are using for our example,is capturing these regulatory
requirements on a 6-column Hazard Analysis Form (See Figure 3),A good way to use a form
like this is to create the first column by using the Process Flow Diagram and the second by
answering the question,Once the HACCP team has considered all the steps in the flow diagram
and determined if a food safety hazard could be introduced,it needs to consider whether the
hazard is "reasonably likely to occur",using the meaning of this phrase included in 417.2(a),On
the 6-column form used by generic establishment X,the third and fourth columns address this
issue,If the establishment's HACCP team has decided that the hazard is not reasonably likely to
occur,they enter "No" in column three,explain the basis for their determination in column four,
and do not need to further consider activity at this point in the process,
If,however,the team has determined there is a "food safety hazard reasonably likely to occur"
introduced at a certain point in the process,column five is used to describe a measure which
could be applied to "prevent,eliminate,or reduce to acceptable levels" the food safety hazard
identified in column three,Column six is used when a critical control point (CCP) is identified
based upon the decision made in the hazard analysis,Each CCP has a number – the order
corresponds to steps in the process,For example,1 is the first CCP in the process flow,2 the
8
Products with Secondary Inhibitors,Not Shelf Stable Model
next,etc,The letter indicates whether the hazard is biological – B; chemical – C; or physical –
P,
Look at the entries for,Receiving” on the first page of the six column form for products with
secondary inhibitors,not shelf stable; the HACCP team has determined that Salmonella and E,
coli O157,H7 may be food safety hazards,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
plant will require certification from suppliers that Salmonella performance standards have been
met,FSIS does not consider safe handling labels alone to be an adequate CCP for any
pathogenic microorganisms such as bacteria and viruses,
Note,Look at the entries for,Storage – (Cold – Frozen/Refrigerated) – Raw Beef” on the
second page of the six-column form,the HACCP team has determined that there is a food safety
hazard reasonably likely to occur at this step in the process,Column four contains the reason for
their thinking,pathogenic organisms can grow in this product if it is not kept sufficiently cool,
Column five contains their description of a measure that will prevent the growth of pathogenic
organisms,temperatures that are sufficiently low to preclude growth,
You will notice that on our generic hazard analysis for corned beef,there are five food safety
hazards in which the HACCP team has identified a point in the process at which a food safety
hazard is reasonably likely to occur,For each one of these they have identified a measure which
can be used to control the hazard,
When your HACCP team has completed their hazard analysis (whether they use this format or
not),it is a good idea to review the flow diagram,the product description and the hazard analysis
itself to make sure they are complete,Part 417.2(a)(3) includes a list of sources from which food
safety hazards might be expected to arise,Reviewing that list could help the HACCP team
check for completeness,
Note,If you are using this generic model to produce a different product with secondary
inhibitors,not shelf stable or if you use a different process flow,you may have different hazards
which are reasonably likely to occur,For these different hazards,there may be different
measures which could be used for control purposes,
This,and all other FSIS generic models,contains a list of references which can help your
HACCP team in making sure the hazard analysis is complete,These references are found in
Appendix A,A member of your HACCP team might want to review at least some of the
references to make sure hazards have not been omitted from the hazard analysis,
Completing the hazard analysis is a very significant and important element in developing your
9
Products with Secondary Inhibitors,Not Shelf Stable Model
HACCP system,Your HACCP team should feel a real sense of accomplishment when they get
this far; this is like completing the foundation of a house,
Developing Your HACCP Plan
The company HACCP team can now take the materials it developed while doing the hazard
analysis and use them to build the HACCP Plan,Remember that one of the important
objectives of the FSIS generic models is to provide examples which illustrate how to meet the
regulatory requirements of Part 417,as well as to correctly apply the principles of HACCP,
Part 417.2 (c) and (d) are the regulatory requirements,
(c) The contents of the HACCP plan,The HACCP plan shall,at a minimum,
(1) List the food safety hazards identified in accordance with paragraph (a) of this
section,which must be controlled for each process,
(2) List the critical control points for each of the identified food safety hazards,
including,as appropriate,
(i) Critical control points designed to control food safety hazards that could be
introduced in the establishment,and
(ii) Critical control points designed to control food safety hazards introduced outside the
establishment,including food safety hazards that occur before,during,and after entry
into the establishment;
(3) List the critical limits that must be met at each of the critical control points,Critical
limits shall,at a minimum,be designed to ensure that applicable targets or performance
standards established by FSIS,and any other requirement set forth in this chapter
pertaining to the specific process or product,are met;
(4) List the procedures,and the frequency with which those procedures will be
performed,that will be used to monitor each of the critical control points to ensure
compliance with the critical limits;
(5) Include all corrective actions that have been developed in accordance with §417.3(a)
of this part,to be followed in response to any deviation from a critical limit at a critical
control point; and
(6) Provide for a recordkeeping system that documents the monitoring of the critical
control points,The records shall contain the actual values and observations obtained
10
Products with Secondary Inhibitors,Not Shelf Stable Model
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 corned beef on a six column form
(See Figure 4),You do not need to use this form,although some kind of a form is probably the
easiest way to present your HACCP plan,
Identifying CCPs
The first column on this particular form is used to enter information developed and contained on
the hazard analysis form,Part 417.2(c)(1) and (2) require that the food safety hazards identified
in the hazard analysis be listed on the HACCP plan and that there be a CCP for each identified
hazard,You will notice that there were five points on the hazard analysis form for corned beef
where food safety hazards reasonably likely to occur were identified,Salmonella on raw beef at
receiving,pathogen proliferation at cold storage,excess nitrite in finished product,pathogen
survival and/or proliferation at curing,and pathogen contamination at finished product storage,
The establishment HACCP team has chosen to have five CCPs to address these five hazards,
Salmonella certification,proper cold storage of raw beef,proper control and formulation of
nitrite,proper curing application,and proper finished product cold storage,
After identifying its CCPs,the HACCP team proceeded to consider critical limits,monitoring
procedures and their frequencies,and verification procedures and their frequencies,and HACCP
records,
In deciding what would be the critical limits,the HACCP team first considered whether there
were any regulatory requirements which had to be met and would function as critical limits,
They did find FSIS regulatory requirements and guidelines,so they set the critical limit(s) using
11
Products with Secondary Inhibitors,Not Shelf Stable Model
criteria as specified by FSIS for the control of pathogens,
Once they had decided on their critical limits,they needed to identify how the monitoring
procedures would be carried out and at what frequency,
For their cure application step,the establishment had Quality Assurance monitor the application
of and record the amount of cure and application method,
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,
The HACCP team described the verification procedures and their frequencies in the fifth column
of their HACCP plan,
The HACCP team for generic establishment X knew that their HACCP Plan needed to provide
for a recordkeeping system,They wanted their records to be easy to create and understand,
They wanted to be sure their records met regulatory requirements,so they reviewed part 417.5(a)
and (b),
§ 417.5 Records,
(a) The establishment shall maintain the following records documenting the
establishment's HACCP plan,
(1) The written hazard analysis prescribed in § 417.2(a) of this part,including all
supporting documentation;
12
Products with Secondary Inhibitors,Not Shelf Stable Model
(2) The written HACCP plan,including decision making documents associated with the
selection and development of CCPs and critical limits,and documents supporting both
the monitoring and verification procedures selected and the frequency of those
procedures,
(3) Records documenting the monitoring of CCPs and their critical limits,including the
recording of actual times,temperatures,or other quantifiable values,as prescribed in the
establishment's HACCP plan; the calibration of process-monitoring instruments;
corrective actions,including all actions taken in response to a deviation; verification
procedures and results; product code(s),product name or identity,or slaughter
production lot,Each of these records shall include the date the record was made,
(b) Each entry on a record maintained under the HACCP plan shall be made at the time
the specific event occurs and include the date and time recorded,and shall be signed or
initialed by the establishment employee making the entry,
The HACCP team decided that their records would be kept on some simple forms,some of
which the team itself devised,
The HACCP team decided that five forms were necessary,Form letter for Salmonella,
Thermometer Calibration Log,Room Temperature Log,Pump Percentage Log,and Weight
Formulation Record,The forms were designed to provide spaces for all entries necessary for the
monitoring and verification activities at each CCP,
On its HACCP Plan,generic establishment X has listed the name of the form it will be using for
monitoring and verification records,
There is one other form included in column four,where the establishment has described its
recordkeeping system,That is the Corrective Actions Log; it is used to create the records of any
corrective actions taken because of deviations from critical limits at CCPs,Column six of the
HACCP plan references the planned corrective actions for each CCP,The HACCP team
carefully reviewed the regulatory requirements for planned corrective actions found at 417.3(a),
13
Products with Secondary Inhibitors,Not Shelf Stable Model
§ 417.3 Corrective actions,
(a) The written HACCP plan shall identify the corrective action to be followed in
response to a deviation from a critical limit,The HACCP plan shall describe the
corrective action to be taken,and assign responsibility for taking corrective action,to
ensure,
(1) The cause of the deviation is identified and eliminated;
(2) The CCP will be under control after the corrective action is taken;
(3) Measures to prevent recurrence are established; and
(4) No product that is injurious to health or otherwise adulterated as a result of the
deviation enters commerce,
The HACCP team has developed a specific corrective action plan which will be followed
whenever there is a deviation from a critical limit at a CCP; each of the planned corrective
actions meets the four regulatory requirements of 417.3(a),
Planned Corrective Actions for CCP 3C,
1,Improperly prepared cure ingredients will be discarded,
2,QA will identify the cause of the deviation and prevent reoccurrence,
3,Monitoring will be increased to include scale calibration for each batch,
The HACCP team also develops planned corrective actions for each of the other CCPs and
attaches them to the HACCP plan,Whenever a deviation from a critical limit occurs,company
employees follow the corrective action plan and use the Corrective Action Log to create a record
of their actions,The Corrective Action Log forms are available at CCPs,so they can be used
immediately when an employee performing a monitoring check discovers and records a
deviation,All Corrective Action Logs,which have been used during the day,are turned in to the
HACCP coordinator,
There is one final verification/recordkeeping requirement which the company must perform; it is
found at 417.5(c),
(c) Prior to shipping product,the establishment shall review the records associated with
the production of that product,documented in accordance with this section,to ensure
14
Products with Secondary Inhibitors,Not Shelf Stable Model
completeness,including the determination that all critical limits were met and,if
appropriate,corrective actions were taken,including the proper disposition of product,
Where practicable,this review shall be conducted,dated,and signed by an individual
who did not produce the record(s),preferably by someone trained in accordance with §
417.7 of this part,or the responsible establishment official,
In generic establishment X,product is shipped out,often in small lots,throughout the day,This
means that pre-shipment verification checks must be as complete as possible when finished
product is in storage,so that a shipment can be made up quickly and moved into distribution
channels,
The establishment uses a half day lotting system and a midshift cleanup,While the midshift
cleanup is being performed,QA personnel or the HACCP coordinator review results of
monitoring and verification checks applied to that lot; if there were deviations from critical
limits,they review the Corrective Action Logs to make sure all appropriate planned responses
were carried out,If everything is in order and there are complete records showing that the
establishment has controlled production of this product through its HACCP system,the HACCP
coordinator will sign the pre-shipment review form which the HACCP team devised for this
purpose,
Note,It is not a regulatory requirement that a separate form be used for pre-shipment review; in
addition,FSIS has indicated that it will be very flexible in accepting a variety of arrangements
for accomplishing pre-shipment review to reflect the variety of commercial practices which it
has encountered in the industry,It is,however,important to remember that pre-shipment review
is a regulatory requirement that must be met,as it indicates that the establishment is taking full
responsibility for the product having been produced under a well-functioning HACCP system,
The HACCP team believes it has now completed preparation of the documents which are
necessary to meet regulatory requirements for a Hazard Analysis and a HACCP Plan for their
products with secondary inhibitors,not shelf stable production process,They have secured a
copy of FSIS Directive 5000.1,Enforcement of Regulatory Requirements in Establishments
Subject to HACCP System Requirements,the HACCP Basic Compliance Checklist which will
be used by inspection program personnel,The HACCP team has modified the inspection form to
make the statements into positives,and now has a checklist for its own use to make sure they
have not omitted anything in their plan development and preparation,When they are confident
that they have done what is necessary,they will turn their Hazard Analysis and HACCP Plan
over to the establishment owner for decisions about implementation,
15
Products with Secondary Inhibitors,Not Shelf Stable Model
APPENDIX A
16
Products with Secondary Inhibitors,Not Shelf Stable Model
References for HACCP Teams
1. Agriculture Canada,Food Safety Enhancement Program – HACCP Implementation Manual,
Camelot Drive,Nepean,Ontario,Canada,1996,
2. American Meat Institute Foundation,HACCP,The Hazard Analysis and Critical Control
Point System in the Meat and Poultry Industry,Washington,D.C.,1994,
Useful sections in particular are,
Chapter 3 – microbiological hazards,pp,15-26
Chapter 4 – chemical hazards,pp,27-32
Chapter 5 – physical hazards,pp,33-35
Appendix A – NACMCF HACCP
Appendix C – Model HACCP plans
3. Baker,D.A,Application of Modeling in HACCP Plan Development,Int,J,Food Microbiol,
25:251-261,1995,
4. Corlett,D.A.,Jr,and Stier,R.F,Risk Assessment within the HACCP System,Food Control
2:71-72,1991,
5. Council for Agriculture Science and Technology,Risks Associated with Foodborne
Pathogens,February 1993,
6. Easter,M.C.,et al,The Role of HACCP in the Management of Food Safety and Quality,
J,Soc,Dairy Technol,47:42-43,1994,
7. Environmental Protection Agency,Tolerances for Pesticides in Foods,Title 40,Code of
Federal Regulations,Part 185,U.S,Government Printing Office,Washington,D.C.,1998,
8. Food and Drug Administration,The Food Defect Action Levels,FDA/CFSAN,
Washington,D.C.,1998,
9. Food and Drug Administration,Fish and Fishery Products Hazards and Control Guide --
Get Hooked on Seafood Safety,Office of Seafood,Washington,D.C.,1994,
10,International Commission on Microbiological Specification for Foods,HACCP in
Microbiological Safety and Quality,Blackwell Scientific Publications,Oxford,1988,
Useful sections in particular are,
Chapter 10 – raw meat and poultry,pp,176-193
17
Products with Secondary Inhibitors,Not Shelf Stable Model
Chapter 11 – roast beef,pp,234-238
Chapter 11 – canned ham,pp,238-242
11,International Commission on Microbiological Specification for Foods,Microorganisms in
Foods 4,Application of Hazard Analysis and Critical Control Point (HACCP) Systems to
Ensure Microbiological Safety and Quality,Blackwell Scientific Publications,Boston,1989
12,National Advisory Committee on Microbiological Criteria for Foods,March 20,1992 --
Hazard Analysis and Critical Control Point System,Int,J,Food Microbiol,16,1-23,1993,
13,National Advisory Committee on Microbiological Criteria for Foods,Adopted August 14,
1997-- Hazard Analysis and Critical Control Point Principles and Application Guidelines,
J,Food Protect,61(9),1246-1259,1998,
14,National Advisory Committee on Microbiological Criteria for Foods,DRAFT document -
FSIS Microbiological Hazard Identification Guide for Meat and Poultry Components of
Products Produced by Very Small Plants,1-22,August 1999,
15,National Advisory Committee on Microbiological Criteria for Foods,June 1993 -- Report
on Generic HACCP for Raw Beef,Food Microbiol,10,449-488,1994,
16,National Research Council,An Evaluation of the Role of Microbiological Criteria for Foods
and Food Ingredients,National Academy Press,Washington,D.C.,1985,
Useful sections in particular are,
Chapter 4 – microbiological hazards,pp,72-103
Chapter 9 – raw meat,pp,193-199
Chapter 9 – processed meats,pp,199-216
17,Notermans,S.,et al,The HACCP Concept,Identification of Potentially Hazardous
Microorganisms,Food Microbiol,11:203-214,1994,
18,Pierson M.D,and Dutson,T,Editors,HACCP in Meat,Poultry,and Fish Processing,
Blackie Academic & Professional,Glasgow,1995,
Useful sections in particular are,
Chapter 4 – meat and poultry slaughter,pp,58-71
Chapter 5 – processed meats,pp,72-107
Chapter 7 – risk analysis,pp,134-154
Chapter 13 – predictive modeling,pp,330-354
19,Pierson,M.D,and Corlett,D.A.,Jr,Editors,HACCP Principles and Applications,Van
18
Products with Secondary Inhibitors,Not Shelf Stable Model
Nostrand Reinhold,New York,1992,
20,Stevenson,K.E,and Bernard,D.T,Editors,HACCP,Establishing Hazard Analysis Critical
Control Point Programs,A Workshop Manual,The Food Processors Institute,Washington,
D.C.,1995,
Useful sections in particular are,
Chapter 11 – forms for hazard analysis,CCPs,critical limits,HACCP master
sheet,example HACCP for breaded chicken
21,Stevenson,K.E,and Bernard,D.T,Editors,HACCP,A Systematic Approach to Food
Safety,3
rd
Edition,The Food Processors Institute,Washington,D.C.,1999,
22,Tompkin,R.B,The Use of HACCP in the Production of Meat and Poultry Products,
J,Food Protect,53(9),795-803,1990,
23,Tompkin,R.B,The Use of HACCP for Producing and Distributing Processed Meat and
Poultry Products,In Advances in Meat Research,Volume 10,Hazard Analysis Critical
Control Point in Meat,Poultry and Seafoods,Chapman & Hall,1995,
References for Meat and Poultry Products with Secondary
Inhibitors,Not Shelf Stable
1. American Meat Institute,Interim good manufacturing practices for fermented dry and semi-
dry sausage product,Washington,DC,1995,
2. American Meat Institute,HACCP plan for ham,The Hazard Analysis and Critical Control
Point System in the Meat and Poultry Industry,Appendix C,pp,99-101,1994,
3. Bartholomew,D.T.,et al,Inhibition of Staphylococcus by lactic acid bacteria in country-
style hams,J,Food Sci,45,420-425,1980,
4. Bunic,Sava et al,The fate of Listeria monocytogenes in fermented sausages and in vacuum-
packaged frankfurters,J,Food Protect,54,413-417,1991,
5. Christian,J.A,Curing and aging country hams,Reciprocal Meat Conf,Proc,35,47-48,
1982,
6. Collins-Thompson,D.L.,et al,The effect of nitrite on the growth of pathogens during
manufacture of dry and semi-dry sausage,Can,Inst,Food Sci,Technol,J,17,102-106,
1984,
19
Products with Secondary Inhibitors,Not Shelf Stable Model
7. Cornish,D.G.,et al,Accelerated pork processing,A quantitative study of bacterial flora of
cured and smoked hams,J,Food Sci,39,605-606,1974,
8. Draughon,D,A,et al,Microbial Profiles of Country-Cured Hams Aged in Stockinettes,
Barrier Bags and Paraffin Wax,Appl,Environ,Microbiol,1078-1080,April 1981,
9. Dykes,Gary A.,et al,Quantification of microbial populations associated with the
manufacture of vacuum-packaged,smoked Vienna sausages,Int,J,Food Microbiol,13,
239-248,1991,
10,Flores,L,M.,et al,Evaluation of a phosphate to control pathogen growth in fresh and
processed meat products,J,Food Protect,59,356-359,1996,
11,Gonzalez-Hevia,M,Angeles,et al,Diagnosis by a Combination of Typing Methods of
Salmonella typhimurium Outbreak Associated with Cured Ham,J,Food Protect,59,426-
428,1996
12,Houtsma,P,C.,et al,Model for the combined effects of temperature,pH,and sodium lactate
on growth rates of Listeria innocua in broth and bologna-type sausages,Appl,Environ,
Microbiol,62,1616-1622,1996,
13,Ockerman,H,W.,et al,Effect of Tumbling and Tumbling Temperature on Surface and
Subsurface Contamination of Lactobacillus Plantarum and Residual Nitrite in Cured Pork
Shoulder,J,Food Science,49,1634-1635,1984,
20
Products with Secondary Inhibitors,Not Shelf Stable Model
APPENDIX B
21
Products with Secondary Inhibitors,Not Shelf Stable Model
PROCESS FLOW DIAGRAM Figure 1
PROCESS CATEGORY,PRODUCTS WITH SECONDARY INHIBITORS,NOT SHELF
STABLE
PRODUCT,CORNED BEEF
RECEIVING
RAW BEEF ROUNDS
RECEIVING
PACKAGING
MATERIALS
RECEIVING
UNRESTRICTED
NONMEAT
FOOD
INGREDIENTS
STORAGE
(COLD – FROZEN/REFRIGERATED)
RAW BEEF
TEMPERING
FRO
CURE APPLICATION
STORAGE
PACKAGING
MATERIALS
STORAGE
UNRESTRICTED
NONMEAT
FOOD
INGREDIENTS
WEIGHING
UNRESTRICTED
NONMEAT
FOOD
INGREDIENTS
VACUUM
PACKAGING/LABELING
RECEIVING
RESTRICTED
NONMEAT
FOOD
INGREDIENTS
STORAGE
RESTRICTED
NONMEAT
FOOD
INGREDIENTS
FINISHED PRODUCT STORAGE
(COLD)
SHIPPING
ZEN BEEF
22
WEIGHING
RESTRICTED
NONMEAT
FOOD
INGREDIENTS
Products with Secondary Inhibitors,Not Shelf Stable Model
PRODUCT DESCRIPTION Figure 2
PROCESS CATEGORY,PRODUCTS WITH SECONDARY INHIBITORS,
SHELF STABLE
PRODUCT,CORNED (CURED) BEEF
1,COMMON NAME? CORNED BEEF
2,HOW IS IT TO BE USED? COOKED BY PURCHASER
3,TYPE OF PACKAGE? VACUUM PACKED
4,LENGTH OF SHELF LIFE,UNDER REFRIGERATION SHELF
AT WHAT TEMPERATURE? LIFE OF VACUUM PACKAGED
PRODUCT IS 8 DAYS
FROZEN 14 DAYS
5,WHERE WILL IT BE SOLD? WHOLESALE TO DISTRIBUTORS
CONSUMERS? ONLY
INTENDED USE?
6,LABELING INSTRUCTIONS? KEEP REFRIGERATED OR FROZEN
7,IS SPECIAL DISTRIBUTION KEEP REFRIGERATED OR FROZEN
CONTROL NEEDED?
23
Products with Secondary Inhibitors,Not Shelf Stable Model
HAZARD ANALYSIS – PRODUCTS WITH SECONDARY INHIBITORS,NOT SHELF STABLE –
Corned Beef
Process Step Food Safety
Hazard
Reasonably
Likely to
Occur?
Basis If Yes in Column 3,
What Measures Could
be Applied to Prevent,
Eliminate,or Reduce
the Hazard to an
Acceptable Level?
Critical Control
Point
Receiving – Raw Beef
Rounds
Biological,Pathogens
Salmonella
E,coli O157:H7
Yes Salmonella and E,coli
O157:H7 may be present on
incoming raw product,
Curing process will inhibit
growth of pathogens (E.coli)
at a further step in the
process,
Proper storage and
handling at subsequent
steps can reduce the growth
of E,coli if present,
Certification from suppliers
that product has been
sampled for Salmonella and
meets FSIS performance
standards,
1B
Chemical – None
Physical – Foreign
materials such as
broken needles
No Plant records show that
there has been no incidence
of foreign materials in
products received into the
plant,
Figure 3
24
Products with Secondary Inhibitors,Not Shelf Stable Model
HAZARD ANALYSIS – PRODUCTS WITH SECONDARY INHIBITORS,NOT SHELF STABLE –
Corned Beef
Process Step Food Safety
Hazard
Reasonably
Likely to
Occur?
Basis If Yes in Column 3,
What Measures Could
be Applied to Prevent,
Eliminate,or Reduce
the Hazard to an
Acceptable Level?
Critical Control
Point
Receiving – Restricted
and Unrestricted
Nonmeat Food
Ingredients; Packaging
Materials
Biological – None
Chemical – Not
acceptable for
intended use
No Letters of guaranty are
received from all suppliers
of packaging materials,
Physical – Foreign
materials (insects,
glass,metal,etc.)
No Plant records demonstrate
that foreign material
contamination has not
occurred during the past
several years,
Storage – Restricted and
Unrestricted Nonmeat
Food Ingredients;
Packaging Materials
Biological – None
Chemical – None
Physical – None
Storage (Cold –
Frozen/Refrigerated) –
Raw Beef
Biological
E,coli O157:H7
Yes Pathogens are reasonably
likely to grow in this
product if temperature is
not maintained at or below
a level sufficient to preclude
their growth,
Maintain product
temperature at or below a
level sufficient to preclude
pathogen growth,
2B
Chemical – None
Physical – None
Figure 3
25
Products with Secondary Inhibitors,Not Shelf Stable Model
HAZARD ANALYSIS – PRODUCTS WITH SECONDARY INHIBITORS,NOT SHELF STABLE –
Corned Beef
Process Step Food Safety
Hazard
Reasonably
Likely to
Occur?
Basis If Yes in Column 3,
What Measures Could
be Applied to Prevent,
Eliminate,or Reduce
the Hazard to an
Acceptable Level?
Critical Control
Point
Tempering Frozen
Beef
Biological – None
Chemical – None
Physical – None
Weighing Restricted
and Unrestricted
Nonmeat Food
Ingredients
Biological – None
Chemical – Cure
Ingredients (nitrite)
Yes Excess nitrite in a finished
product may create a health
hazard,
Proper control and formu-
lation of nitrite to prevent
creating a health hazard,
3C
Physical – None
Cure Application Biological
Clostridium botulinum
Clostridium perfringens
Yes Application of cure at the
proper level will inhibit the
growth of pathogenic
organisms,
Proper injection of cure
solution to provide
microbial inhibition,
4B
Chemical – None
Physical – None
Packaging/Labeling Biological
Clostridium botulinum
Clostridium perfringens
No Proper nitrite pump and
vacuum package will allow
competing organisms to
grow to the exclusion of
clostridia,
See CCP 3C and CCP 4B
Chemical – None
Physical – None
Figure 3
26
Products with Secondary Inhibitors,Not Shelf Stable Model
HAZARD ANALYSIS – PRODUCTS WITH SECONDARY INHIBITORS,NOT SHELF STABLE –
Corned Beef
Process Step Food Safety
Hazard
Reasonably
Likely to
Occur?
Basis If Yes in Column 3,
What Measures Could
be Applied to Prevent,
Eliminate,or Reduce
the Hazard to an
Acceptable Level?
Critical Control
Point
Finished Product
Storage (Cold)
Biological
Salmonella
Yes Pathogens are reasonably
likely to grow on this
product if temperature is
not maintained at or below
a level sufficient to preclude
their growth,
Maintain product
temperature at or below a
level sufficient to preclude
pathogen growth,
5B
Chemical – None
Physical – None
Shipping Biological - None
Chemical – None
Physical – None
Figure 3
27
Products with Secondary Inhibitors,Not Shelf Stable Model
HACCP PLAN
PROCESS CATEGORY,PRODUCTS WITH SECONDARY INHIBITORS,NOT SHELF STABLE
PRODUCT EXAMPLE,CORNED BEEF
CCP# and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP Records Verification Procedures and
Frequency
Corrective Actions
1B
Receiving –
Raw Beef
Rounds
Supplier
certification
that product
has been
sampled for
Salmonella
must
accompany
shipment,
Receiving
personnel will
check each
shipment for
Salmonella
certification,
Receiving Log
Corrective Action
Log
Every two months QA will request
FSIS Salmonella data results from
the company for at least 2 suppliers,
Will not receive product unaccompanied
by Salmonella certification,
2B
Storage
(Cold–
Frozen/
Refrigerated
– Raw Beef
Raw product
storage areas
will not
exceed 40° F
in refrigerated
rooms or
exceed 28° F
in freezer
rooms,
Maintenance
personnel will
check raw product
storage area
temperature every
two hours,
Room Temperature
Log
Thermometer
Calibration Log
Corrective Action
Log
Maintenance supervisor will verify
accuracy of the Room Temperature
Log once per shift,
QA will check all thermometers
used for monitoring and verification
for accuracy daily and calibrate to
within 2° F accuracy as necessary,
QA will reject or hold product dependent
on time and temperature deviation and use
pathogen modeling to determine product
disposition,
QA will identify the cause of the deviation
and prevent reoccurrence,
Monitoring frequency will be increased
until it is assured that the process step is
under control,
Signature,__________________________________ Date,__________________________ Figure 4
28
Products with Secondary Inhibitors,Not Shelf Stable Model
HACCP PLAN
PROCESS CATEGORY,PRODUCTS WITH SECONDARY INHIBITORS,NOT SHELF STABLE
PRODUCT EXAMPLE,CORNED BEEF
CCP# and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP Records Verification Procedures and
Frequency
Corrective Actions
3C
Weighing
Restricted and
Unrestricted
Nonmeat
Food
Ingredients
2 lb,sodium
nitrite to 100
gallon pickle
at 10%
pump,
QA technician will
monitor weighing
and formulation of
sodium nitrite for
each batch,
Weight/
Formulation Record
Corrective Action
Log
QA supervisor will observe QA
technician perform monitoring
activity once per shift,
QA supervisor will check
Weight/Formulation Record twice
per shift,
Scale will be calibrated once per
week,
Improperly prepared cure ingredients will
be discarded,
QA will identify the cause of the deviation
and prevent reoccurrence,
Monitoring will be increased to include
scale calibration for each batch,
Signature,__________________________________ Date,__________________________ Figure 4
29
Products with Secondary Inhibitors,Not Shelf Stable Model
HACCP PLAN
PROCESS CATEGORY,PRODUCTS WITH SECONDARY INHIBITORS,NOT SHELF STABLE
PRODUCT EXAMPLE,CORNED BEEF
CCP# and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP Records Verification Procedures and
Frequency
Corrective Actions
4B
Cure
Application
120 ppm
sodium
nitrite at
10% pump,
Pump percentage
will be monitored
before and after
pump to assure
10% gain,
Ten pieces will be
weighed before and
after pump % gain
calculated every 2
hours,
Pump Percentage
Log
Corrective Action
Log
QA will observe pump technician
perform pump check once per lot,
QA will review pump log once per
shift,
Product not meeting critical limit will be
held and either repumped to 10% or
drained to 10%,
Needle settings will be checked and
adjusted as required,
Pump technician will monitor every hour
until assured that the CCP is under control,
Signature,__________________________________ Date,__________________________ Figure 4
30
Products with Secondary Inhibitors,Not Shelf Stable Model
HACCP PLAN
PROCESS CATEGORY,PRODUCTS WITH SECONDARY INHIBITORS,NOT SHELF STABLE
PRODUCT EXAMPLE,CORNED BEEF
CCP# and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP Records Verification Procedures and
Frequency
Corrective Actions
5B
Finished
Product
Storage
Product
storage area
will not
exceed 40°F
Maintenance
personnel will
monitor storage
room temperature
once per shift,
Corrective Action
Log
Room Temperature
Log
Thermometer
Calibration Log
QA will observe maintenance
personnel perform storage
temperature monitoring and review
room temperature log once per
week,
Cooler thermometers will be
calibrated once per week by
maintenance supervisor,
If room temperature exceeds 40° F product
will be held and internal temperature taken,
Internal product temperature and amount of
time product and room temperature
deviated will determine product
disposition,
Product temperature will be monitored
when room temperature is monitored until
CCP is under control,
Cause of deviation will be identified,
Maintenance will repair thermometer units
or cooling coils as required based on cause
of deviation,
Signature,__________________________________ Date,__________________________ Figure 4
31
Products with Secondary Inhibitors,Not Shelf Stable Model
FORM LETTER Confirming Salmonella Compliance with Performance Standards
Date
To,Plant XYZ
This is to confirm results of any Salmonella performance standard sample sets completed during the past six months from your
establishment listed below,
Thank you,
Product Date Results
Received
Test Results Two Consecutive Failed Tests
32
Products with Secondary Inhibitors,Not Shelf Stable Model
THERMOMETER CALIBRATION LOG
Calibrate to 32
0
F while thermometer is in slush ice water
Date Time Department or
Area
Thermometer ID# Personal
Thermometer
Reading
Adjustment
Required (Yes
or No)
Initials Comments
If a thermometer is broken or taken out of service,document this in the comment column,
Reviewed by,_______________________ Date,_______________________
33
Products with Secondary Inhibitors,Not Shelf Stable Model
WEIGHT / FORMULATION RECORD
Date Time Lot # Weight
Sodium Nitrite
No,of Gallon
Pickle
PPM Initials Comments
Reviewed by,_______________________ Date,___________________
34
Products with Secondary Inhibitors,Not Shelf Stable Model
PUMP PERCENTAGE LOG
Date Time Lot # Weight Before
Pump
Weight After
Pump
% Gain Initials Comments
Reviewed by,_______________________ Date,_______________________
35
Products with Secondary Inhibitors,Not Shelf Stable Model
GENERIC ESTABLISHMENT X,
ROOM:__________ DATE:_________
TIME TEMP Deviation from
CL?
yes)
If Yes,
Action?
Monitored by,Verified by,
ROOM TEMPERATURE LOG
(Check if
36
Products with Secondary Inhibitors,Not Shelf Stable Model
CORRECTIVE ACTIONS LOG
Product,___________________________________________ Lot # ______________________
CCP Deviation/
Problem
Corrective Action
Procedures/Explain
Disposition of
Product
Responsible
Person
Date/Time
SIGNATURE,__________________________ DATE,______________________
37
Products with Secondary Inhibitors,Not Shelf Stable Model
PRE-SHIPMENT
Date:______________
PRODUCT LOT
ID
TIME
RECORDS
REVIEWED
BY
WHOM
LOT RELEASED FOR
SHIPMENT?
SIGNATURE
COMMENTS *
LOG REVIEW
*Monitoring frequency as per plan; Critical limits met; Certification (if applicable) as per plan; Deviations if occurred were reviewed
for appropriate corrective actions; Records complete and accurate,
38
