United States
Department of
Agriculture
Food Safety
and Inspection
Service
September 1999
HACCP-4
Generic HACCP
Model for Raw,
Not Ground
Meat and
Poultry
Products
Additional copies of the Guidebook for the Preparation
of HACCP Plans and the Generic HACCP Models are
available from,
U.S,Department of Agriculture
Food Safety and Inspection Service (FSIS)
Office of Policy,Program Development,
and Evaluation (OPPDE)
Inspection Systems Development Division
Room 202,Cotton Annex Building
300 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
Raw,Not Ground Model
Table of Contents
Introduction……………………………………………………………………………..…,3
Using This Generic Model…………………………………………………………..…….,5
Process Flow Diagram and Product Description…………………………………..………,6
Hazard Analysis………………………………………………………………….…………7
Developing Your HACCP Plan………………………………………………..….……….,9
Identifying CCPs……………………………………………………………………..……,11
Appendix A
References for HACCP Teams ……………………………………..…………..,17
References for Raw,Not Ground Meat and Poultry Products…….…………..…… 19
Appendix B
Process Flow Diagram (Figure1)………………………….……………………….,22
Product Description Form (Figure 2)……………………………………………… 23
Hazard Analysis Form (Figure 3)……………………………………………….…,24
HACCP Plan Form (Figure 4)…………………………………..……………….… 27
Form Letter Confirming Salmonella Compliance with Performance Standards,… 31
Thermometer Calibration Log…………………………………………………….,32
Generic Establishment X,Room Temperature Log ………………………………,33
Generic Establishment X,Metal Detection Log…………………….....................,34
Corrective Actions Log……………………………………………………………,35
Pre-Shipment Review Log………………………………………………………… 36
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Raw,Not Ground Model
GENERIC HACCP MODEL
FOR
RAW,NOT GROUND MEAT AND POULTRY PRODUCTS
Introduction
The Hazard Analysis Critical Control Point (HACCP) system is a scientific approach to process
control,It is designed to prevent the occurrence of problems by assuring that controls are
applied at any point in a food production system where hazardous or critical situations could
occur,Hazards include biological,chemical,or physical contamination of food products,
The Food Safety and Inspection Service (FSIS) published a final rule in July 1996 mandating
that HACCP be implemented as the system of process control in all inspected meat and poultry
plants,As part of its efforts to assist establishments in the preparation of plant-specific HACCP
plans,FSIS determined that a generic model for each process defined in the regulation would be
made available for use on a voluntary basis by inspected establishments,
The generic models have been revised since their initial publication and distribution as
DRAFTS,The most important change in the revised versions is to make certain that these
models are
fully consistent with the features of the final regulation,Also,other technical and editorial
improvements have been made,
Throughout this generic model,FSIS discusses a HACCP team with members from different
departments,In many very small establishments,there will not be separate departments with
different employees,But,there will be employees who perform these different functions – often
several of them,For purposes of explaining concepts,it is easier to speak as if these were
different people,even though in many cases,they may be the same person carrying out more
than one responsibility,
Each generic model can be used as a starting point for the development of plant-specific plan(s)
reflecting actual plant environments and the processes conducted,The generic model is not
intended to be used,as is” for plant specific HACCP plans,
The generic models are designed for use in conjunction with the list of process categories found
in the HACCP regulations in section 417.2(b)(1),
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(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,Raw product—not ground,
The purpose of the process category listing in 417.2 is to set out the circumstances under which a
HACCP team may develop a single HACCP plan for multiple products,This may be done when
products are in the same process category,and food safety hazards,critical control points,and
other features are essentially the same,There is a generic model for each process category,plus
two for subcategories which present special issues,irradiated products and mechanically
separated products,
In order to select the model or models that will be most useful for the activities performed in any
specific plant,the following steps should be taken,
1) For slaughtering operations,select the model for the appropriate species,
2) For processed products,make a list of all products produced in the plant,
3) Examine the list and group like products,considering common processing steps and
equipment used,
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Raw,Not Ground Model
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 raw,not ground
product(s),the third process category,The model can be used for all raw,not ground products,
either meat or poultry,The generic model is not suitable for products that fall into any of the
other process categories,
The model will be most useful to a HACCP team that includes access to one trained individual,
as specified in 417.7(b),
(b)The individual performing the functions listed in paragraph (a) of this section shall
have successfully completed a course of instruction in the application of the seven
HACCP principles to meat or poultry product processing,including a segment on the
development of a HACCP plan for a specific product and on record review,
It would be beneficial for other team members to have reviewed any of the various guidance
materials available on how to develop a HACCP plan for your company,including several useful
videos,handbooks,or computer programs,Once the HACCP team has prepared itself as
thoroughly as possible in general HACCP principles and how to use them,this model should be
helpful,
Note,This generic model includes a number of forms that can be used to record various types of
required information,The forms themselves are samples; a company HACCP team can develop
whatever forms it finds most useful,All the forms mentioned in this document are included in
Appendix B; they appear in the order in which they are discussed in the text,
All FSIS generic models are designed to assist establishments in applying the seven HACCP
principles to their meat and poultry processing operations AND to meet the regulatory
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requirements of Part 417,Therefore,the definitions used in this and all other FSIS generic
models are those found in 417.1,
§ 417.1 Definitions,
For purposes of this part,the following shall apply,
Corrective action,Procedures to be followed when a deviation occurs,
Critical control point,A point,step,or procedure in a food process at which control can
be applied and,as a result,a food safety hazard can be prevented,eliminated,or reduced
to acceptable levels,
Critical limit,The maximum or minimum value to which a physical,biological,or
chemical hazard must be controlled at a critical control point to prevent,eliminate,or
reduce to an acceptable level the occurrence of the identified food safety hazard,
Food safety hazard,Any biological,chemical,or physical property that may cause a
food to be unsafe for human consumption,
HACCP System,The HACCP plan in operation,including the HACCP plan itself,
Hazard,SEE Food Safety Hazard,
Preventive measure,Physical,chemical,or other means that can be used to control an
identified food safety hazard,
Process-monitoring instrument,An instrument or device used to indicate conditions
during processing at a critical control point,
Responsible establishment official,The individual with overall authority on-site or a
higher level official of the establishment,
Process Flow Diagram and Product Description
To begin using this model,the company's HACCP team should first describe the product(s)
which are part of this process category and covered by this HACCP plan,The product(s) should
be described in two ways,
(1) by a simple diagram which shows 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,
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Raw,Not Ground Model
In this generic model,there is an example for raw,not ground – beef trimmings and tenderized
(mechanically) beef cuts,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 beef
trimmings and/or tenderized (mechanically) beef cuts in generic establishment X,Figure 2 is an
example of a PRODUCT DESCRIPTION for the beef trimmings and/or tenderized
(mechanically) beef cuts produced in generic establishment X,
Once the company HACCP team in your establishment has prepared your Process Flow
Diagram,they should verify it by walking through the establishment following the flow of
product and making sure that all the steps of the process are included in the flow diagram,The
team should also review the information provided on the Product Description to make sure all
the key facts are included,such as identifying consumers,especially those with particular health
problems or known to be at risk,
Note,If your process includes steps not included in this example,those steps should be added,
Also,if your process does not include all the steps identified in this example,those steps would
be omitted when conducting the hazard analysis,That is generally,how you use these generic
model examples--just omit the features which do not apply to your operation or if your operation
includes features not included in this example,they should be added,
By completing a Process Flow Diagram and a Product Description,you have met the
requirements of 417.2(a)(2),You can use the Process Flow Diagram in particular to help you
complete the rest of the hazard analysis,Use the flow diagram to systematically review each
step in the process and ask the question,"Is there a food safety hazard which is reasonably likely
to occur which may be introduced at this step?" In answering the question,your HACCP team
needs to consider biological (including microbiological),chemical,and physical hazards,
Hazard Analysis
Once your product(s) are accurately described through the flow diagram and product description,
the HACCP team should begin work on the HAZARD ANALYSIS,The hazard analysis is
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
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Raw,Not Ground Model
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,
Look at the entries for,Receiving – Carcasses” on the first page of the six column form for raw
products,not ground; the HACCP team has determined that Salmonella may be present at high
levels in incoming raw product,so it has put a,Yes” in the third column,Column four explains
the basis for the team’s determination,In the fifth column,the HACCP team has described the
preventive measures it will use to make sure that each hazard has been prevented,eliminated,or
reduced to an acceptable level,For the Salmonella hazard,the HACCP team decided to tell its
suppliers that product could not be accepted unless it was accompanied by the most recent
Salmonella performance standard sampling results which demonstrated that the supplier had not
failed two consecutive Salmonella performance standard sets,FSIS does not consider safe
handling labels alone to be an adequate CCP for any pathogenic microorganisms such as bacteria
and viruses,
Note,Look at the entries for,Storage – Carcasses” 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
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Raw,Not Ground Model
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 beef trimmings and tenderized
(mechanically) beef cuts,there are four 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 raw,not ground product or if you
use a different process flow,you may have different hazards which are reasonably likely to
occur,For these different hazards,there may be different measures which could be used for
control purposes,
This,and all other FSIS generic models,contains a list of references which can help your
HACCP team in making sure the hazard analysis is complete,These references are found in
Appendix A,A member of your HACCP team might want to review at least some of the
references to make sure hazards have not been omitted from the hazard analysis,
Completing the hazard analysis is a very significant and important element in developing your
HACCP system,Your HACCP team should feel a real sense of accomplishment when they get
this far; this is like completing the foundation of a house,
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,
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Raw,Not Ground Model
(2) List the critical control points for each of the identified food safety hazards,
including,as appropriate,
(i) Critical control points designed to control food safety hazards that could be
introduced in the establishment,and
(ii) Critical control points designed to control food safety hazards introduced outside the
establishment,including food safety hazards that occur before,during,and after entry
into the establishment;
(3) List the critical limits that must be met at each of the critical control points,Critical
limits shall,at a minimum,be designed to ensure that applicable targets or performance
standards established by FSIS,and any other requirement set forth in this chapter
pertaining to the specific process or product,are met;
(4) List the procedures,and the frequency with which those procedures will be
performed,that will be used to monitor each of the critical control points to ensure
compliance with the critical limits;
(5) Include all corrective actions that have been developed in accordance with §417.3(a)
of this part,to be followed in response to any deviation from a critical limit at a critical
control point; and
(6) Provide for a recordkeeping system that documents the monitoring of the critical
control points,The records shall contain the actual values and observations obtained
during monitoring,
(7) List the verification procedures,and the frequency with which those procedures will
be performed,that the establishment will use in accordance with § 417.4 of this part,
(d) Signing and dating the HACCP plan,(1) The HACCP plan shall be signed and
dated by the responsible establishment individual,This signature shall signify that the
establishment accepts and will implement the HACCP plan,
(2) The HACCP plan shall be dated and signed,
(i) Upon initial acceptance;
(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 beef trimmings and tenderized
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Raw,Not Ground Model
(mechanically) beef cuts 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 three points on the hazard analysis form for beef
trimmings and tenderized (mechanically) beef cuts where food safety hazards reasonably likely
to occur were identified,Salmonella on carcasses at receiving,pathogen proliferation at cold
storage,and pathogen proliferation at finished product storage (cold),The establishment
HACCP team has chosen to have four CCPs to address these three hazards,Salmonella
certification,proper cold storage of carcasses,and proper maintenance of finished product
temperatures during storage,
After identifying its CCPs,the HACCP team proceeded to consider critical limits,monitoring
procedures and their frequencies,and verification procedures and their frequencies,and HACCP
records,
In deciding what would be the critical limits,the HACCP team first considered whether there
were any regulatory requirements which had to be met and would function as critical limits,
They found no regulatory requirements for receiving carcasses,but realized that Salmonella
coming into the plant could result in cross-contamination with other product,The HACCP team
knew that Salmonella may be present on incoming raw product,so they set the critical limit at
requiring the supplier of the carcass parts to send a Salmonella certificate with each shipment
stating that the product has been sampled for Salmonella,
Once they had decided on their critical limits,they needed to identify how the monitoring
procedures would be carried out and at what frequency,
For their receiving – carcasses step,the establishment had the receiving personnel check each
shipment for Salmonella certification,
These decisions by the HACCP team regarding critical limits,plus monitoring procedures and
their frequencies are written up in columns two and three of the HACCP Plan,
The team then went on to consider appropriate verification procedures; the team knew that there
were different types of verification and that Part 417.4(a)(2) included specific regulatory
requirements for each,The regulatory requirements for ongoing verification are,
(2) Ongoing verification activities,Ongoing verification activities include,but are not
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limited to,
(i) The calibration of process-monitoring instruments;
(ii) Direct observations of monitoring activities and corrective actions; and
(iii) The review of records generated and maintained in accordance with §417.5(a)(3) of
this part,
The HACCP team decided they could verify the suppliers’ Salmonella certifications by
requesting Salmonella data results from FSIS for at least two suppliers every two months,
The HACCP team described the verification procedures and their frequencies in the fifth column
of their HACCP plan,
The HACCP team for generic establishment X knew that their HACCP Plan needed to provide
for a recordkeeping system,They wanted their records to be easy to create and understand,
They wanted to be sure their records met regulatory requirements,so they reviewed part 417.5(a)
and (b),
§ 417.5 Records,
(a) The establishment shall maintain the following records documenting the
establishment's HACCP plan,
(1) The written hazard analysis prescribed in § 417.2(a) of this part,including all
supporting documentation;
(2) The written HACCP plan,including decision making documents associated with the
selection and development of CCPs and critical limits,and documents supporting both
the monitoring and verification procedures selected and the frequency of those
procedures,
(3) Records documenting the monitoring of CCPs and their critical limits,including the
recording of actual times,temperatures,or other quantifiable values,as prescribed in the
establishment's HACCP plan; the calibration of process-monitoring instruments;
corrective actions,including all actions taken in response to a deviation; verification
procedures and results; product code(s),product name or identity,or slaughter
production lot,Each of these records shall include the date the record was made,
(b) Each entry on a record maintained under the HACCP plan shall be made at the time
the specific event occurs and include the date and time recorded,and shall be signed or
initialed by the establishment employee making the entry,
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The HACCP team decided that their records would be kept on some simple forms,some of
which the team itself devised,
The HACCP team decided that since receiving personnel had a form that they had been using for
receiving product,that they would modify that form,The form was modified to provide spaces
for all entries necessary for the monitoring and verification activities at the receiving – carcasses
step,
On its HACCP Plan,generic establishment X has listed the names of the forms it will be using
for monitoring and verification records,
There is one other form included in column four,where the establishment has described its
recordkeeping system,That is the Corrective Actions Log; it is used to create the records of any
corrective actions taken because of deviations from critical limits at CCPs,Column six of the
HACCP plan references the planned corrective actions for each CCP,The HACCP team
carefully reviewed the regulatory requirements for planned corrective actions found at 417.3(a),
§ 417.3 Corrective actions,
(a) The written HACCP plan shall identify the corrective action to be followed in
response to a deviation from a critical limit,The HACCP plan shall describe the
corrective action to be taken,and assign responsibility for taking corrective action,to
ensure,
(1) The cause of the deviation is identified and eliminated;
(2) The CCP will be under control after the corrective action is taken;
(3) Measures to prevent recurrence are established; and
(4) No product that is injurious to health or otherwise adulterated as a result of the
deviation enters commerce,
The HACCP team has developed a specific corrective action plan which will be followed
whenever there is a deviation from a critical limit at a CCP; each of the planned corrective
actions meets the four regulatory requirements of 417.3(a),
Planned Corrective Action for CCP 1,
Receiving personnel will not receive product unaccompanied by Salmonella certification,
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Raw,Not Ground Model
The HACCP team also develops planned corrective actions for each of the other CCPs and
attaches them to the HACCP plan,Whenever a deviation from a critical limit occurs,company
employees follow the corrective action plan and use the Corrective Action Log to create a record
of their actions,The Corrective Action Log forms are available at CCPs,so they can be used
immediately when an employee performing a monitoring check discovers and records a
deviation,All Corrective Action Logs,which have been used during the day,are turned in to the
HACCP coordinator,
There is one final verification/recordkeeping requirement which the company must perform; it is
found at 417.5(c),
(c) Prior to shipping product,the establishment shall review the records associated with
the production of that product,documented in accordance with this section,to ensure
completeness,including the determination that all critical limits were met and,if
appropriate,corrective actions were taken,including the proper disposition of product,
Where practicable,this review shall be conducted,dated,and signed by an individual
who did not produce the record(s),preferably by someone trained in accordance with §
417.7 of this part,or the responsible establishment official,
In generic establishment X,product is shipped out,often in small lots,throughout the day,This
means that pre-shipment verification checks must be as complete as possible when finished
product is in storage,so that a shipment can be made up quickly and moved into distribution
channels,
The establishment uses a half day lotting system and a midshift cleanup,While the midshift
cleanup is being performed,QA personnel or the HACCP coordinator review results of
monitoring and verification checks applied to that lot; if there were deviations from critical
limits,they review the Corrective Action Logs to make sure all appropriate planned responses
were carried out,If everything is in order and there are complete records showing that the
establishment has controlled production of this product through its HACCP system,the HACCP
coordinator will sign the pre-shipment review form which the HACCP team devised for this
purpose,
Note,It is not a regulatory requirement that a separate form be used for pre-shipment review; in
addition,FSIS has indicated that it will be very flexible in accepting a variety of arrangements
for accomplishing pre-shipment review to reflect the variety of commercial practices which it
has encountered in the industry,It is,however,important to remember that pre-shipment review
is a regulatory requirement that must be met,as it indicates that the establishment is taking full
responsibility for the product having been produced under a well-functioning HACCP system,
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
raw,not ground production process,They have secured a copy of FSIS Directive 5000.1,
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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
Chapter 11 – roast beef,pp,234-238
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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
17
Raw,Not Ground Model
19,Pierson,M.D,and Corlett,D.A.,Jr,Editors,HACCP Principles and Applications,Van
Nostrand Reinhold,New York,1992,
20,Stevenson,K.E,and Bernard,D.T,Editors,HACCP,Establishing Hazard Analysis Critical
Control Point Programs.,A Workshop Manual,The Food Processors Institute,Washington,
D.C.,1995,
Useful sections in particular are,
Chapter 11 – forms for hazard analysis,CCPs,critical limits,HACCP master
sheet,example HACCP for breaded chicken
21,Stevenson,K.E,and Bernard,D.T,Editors,HACCP,A Systematic Approach to Food
Safety,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 Raw,Not Ground Meat and Poultry Products
1,American Meat Science Association,Flowchart for fresh meat,AMSA,Chicago,IL,1995,
2. Blair,I.S.,et al,Microbiological examination of pre-storage and post-storage intervention
beef,Meat Sci,38,155-161,1994,
3. Coates,K.J.,et al,The contribution of carcass contamination and the boning process to
microbial spoilage of aerobically stored pork,Food Microbiol,12,49-54,1995,
4. Gill,C.O.,et al,Changes in the microflora on commercial beef trimmings during their
collection,distribution and preparation for retail sale as ground beef,Int,J,Food
Microbiol,18,321-332,1993,
5. Gill,C.O.,et al,Hygienic effects of trimmings and washing operations in beef –carcass-
dressing process,J,Food Protect,59,666-669,1996,
6. Kotula K.L.,et al,Microbiological and sensory attributes of retail cuts of beef treated with
acetic acid and lactic acid solutions,J,Food Protect,57,665-670,1994,
18
Raw,Not Ground Model
7. Miller,M.F.,et al,Microbiology of hot-fat-trimmed beef,Staphylococcus by lactic acid
bacteria in country-style hams,J,Anim,Sci,1368-1371,1995,
19
Raw,Not Ground Model
APPENDIX B
20
Raw,Not Ground Model
PROCESS FLOW DIAGRAM Figure 1
PROCESS CATEGORY,RAW PRODUCT,NOT GROUND
PRODUCT,BEEF TRIMMINGS,TENDERIZED (MECHANICALLY) BEEF CUTS
RECEIVING
PACKAGING
MATERIALS
RECEIVING
CARCASSES
STORAGE
PACKAGING
MATERIALS
STORAGE
(COLD)
CARCASSES
FABRICATION OF
BEEF
TRIMMINGS
AND/OR
BEEF CUTS
PACKAGING/
LABELING
FINISHED PRODUCT STORAGE
(COLD)
BEEF TRIMMINGS
BEEF CUTS
TENDERIZING
(MECHANICAL)
SHIPPING
21
Raw,Not Ground Model
PRODUCT DESCRIPTION Figure 2
PROCESS CATEGORY,RAW PRODUCT,NOT GROUND
PRODUCT,BEEF TRIMMINGS,TENDERIZED (MECHANICALLY) BEEF
CUTS
1,COMMON NAME? BEEF TRIMMINGS,TENDERIZED
(MECHANICALLY) BEEF CUTS
2,HOW IS IT TO BE USED? BEEF TRIMMINGS – FOR FURTHER
PROCESSING INTO GROUND OR
PROCESSED PRODUCTS,
TENDERIZED BEEF CUTS – FOR
FURTHER PROCESSING INTO
BREADED PRODUCTS OR SOLD AS
RAW TENDERIZED BEEF CUTS
3,TYPE OF PACKAGE? BULK-PACKED (E.G.,PLASTIC
BAG,VACUUM PACKED)
4,LENGTH OF SHELF LIFE,3-6 MONTHS AT 0° F OR
AT WHAT TEMPERATURE? BELOW;7 DAYS AT 40° F
5,WHERE WILL IT BE SOLD? WHOLESALE TO DISTRIBUTORS
CONSUMERS? ONLY
INTENDED USE?
6,LABELING INSTRUCTIONS? KEEP FROZEN; KEEP
REFRIGERATED
7,IS SPECIAL DISTRIBUTION KEEP FROZEN; KEEP
CONTROL NEEDED? REFRIGERATED
22
Raw,Not Ground Model
HAZARD ANALYSIS – RAW PRODUCT,NOT GROUND - Beef Trimmings/Beef Cuts
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 – Carcasses Biological,Pathogens
– microbial
Salmonella,
Escherichia coli
0157:H7
Yes Salmonella and Escherichia
coli 0157:H7 may be
present on incoming raw
product,
Certification from suppliers
that product has been
sampled for Salmonella and
meets standard set by FSIS,
and that it has been
subjected to E,coli
sampling without
presumptive positive
results,
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,
Receiving – 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
No Plant records demonstrate
that foreign material
contamination has not
occurred during the past
several years,
Figure 3
23
Raw,Not Ground Model
HAZARD ANALYSIS – RAW PRODUCT,NOT GROUND
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
Storage –Packaging
Materials
Biological – None
Chemical – None
Physical – None
Storage (Cold) –
Carcasses
Biological – Pathogens
Salmonella
Escherichia 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
Fabrication of Beef
Trimmings and/or
Beef Cuts; Tenderizing
(Mechanical) Beef
Cuts
Biological – None
Chemical – None
Physical – Metal
contamination from
injection needles and
machine wear,
Yes Plant records show that
during the fabrication and
tenderizing process metal
contamination is likely to
occur,
Metal detector prior to
packaging and/or visual
examination and
maintenance of tenderizers
Figure 3
24
Raw,Not Ground Model
HAZARD ANALYSIS – RAW PRODUCT,NOT GROUND
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
Packaging/Labeling Biological – None
Chemical – None
Physical – Metal
contamination
Yes Metal contamination that
may have come into the
establishment with raw
product or occurred during
the fabrication process,
Functional metal detector is
on-line in the
packaging/labeling area to
remove product with metal
contamination,
3P
Finished Product
Storage (Cold)
Biological – Pathogens
Salmonella E,coli
0157: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,
4B
Chemical – None
Physical – None
Shipping Biological – None
Chemical – None
Physical – None
Figure 3
25
Raw,Not Ground Model
HACCP PLAN
PROCESS CATEGORY,RAW PRODUCT,NOT GROUND
PRODUCT EXAMPLE,BEEF TRIMMINGS,TENDERIZED (MECHANICALLY) BEEF CUTS
CCP# and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP Records Verification Procedures and
Frequency
Corrective Actions
1B
Receiving –
Carcasses
Supplier
certification
that product
meets FSIS
performance
standard 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
the most recent FSIS Salmonella
data results from at least 2 suppliers,
Product not meeting specifications will not
be accepted for entry and supplier history
examined, If supplier has exceeded
specifications,the source will no longer be
used until performance standards are met,
2B
Storage
(Cold) –
Carcasses
Raw product
storage area
shall not
exceed 40° F,
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 1° F accuracy as necessary,
QA will reject or hold product,&
dependent on time/temperature deviation
will make a disposition,Maintenance will
review cooler service records and
placement of carcasses,
Product > 50°F for 2 hours will be diverted
to a cooking process,Determination on
product < 50°F for < 2 hours will be made
using Process Authority or pathogen
growth modeling,
QA will identify the cause of the deviation
and prevent reoccurrence,
Cooler unit will be repaired if necessary,
26
Raw,Not Ground Model
Signature,__________________________________ Date,__________________________ Figure 4
27
Raw,Not Ground Model
HACCP PLAN
PROCESS CATEGORY,RAW PRODUCT,NOT GROUND
PRODUCT EXAMPLE,BEEF TRIMMINGS,TENDERIZED (MECHANICALLY) BEEF CUTS
CCP# and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP Records Verification Procedures and
Frequency
Corrective Actions
3P
Packaging/
Labeling
No metal
particles to
exceed 1/32
inch,
All
contaminated
product is
removed from
system by
functioning
kick out
mechanism,
Packaging line
supervisor will
check the metal
detector using a
seeded sample
every 2 hours to
determine limits
are not exceeded,
Metal Detection
Control Log
Corrective Action
Log
QA,outside the packaging unit,will
verify that the metal detector is
functioning as intended by running
the seeded sample through the metal
detector twice per shift (once AM,
once PM),QA will observe
monitoring to assure that product
from kick out is placed on hold,
Packaging supervisor will control and
segregate affected product,
Maintenance personnel will identify and
eliminate any problems with the metal
detector or kick out mechanism,Preventive
maintenance program will be implemented,
QA will run seeded sample through
detector after repair,
All potentially contaminated product will
be run through functional metal detector
prior to shipment,
All product rejected by detector will be
reworked after visual examination,
Signature,__________________________________ Date,__________________________ Figure 4
28
Raw,Not Ground Model
HACCP PLAN
PROCESS CATEGORY,RAW PRODUCT,NOT GROUND
PRODUCT EXAMPLE,BEEF TRIMMINGS,TENDERIZED (MECHANICALLY) BEEF CUTS
CCP#
and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP Records Verification Procedures and
Frequency
Corrective Actions
4B
Finished
Product
Storage
(Cold)
(Continued
on next
page)
Finished
product
storage areas
will not
exceed 40° F,
Maintenance
personnel will
check finished
product storage
areas temperatures
every 2 hours,
Room Temperature
Log
Thermometer
Calibration Log
Corrective Action
Log
Maintenance supervisor will verify
the accuracy of the room
temperature log once per shift,
QA will check all thermometers
used for monitoring and verification
activities for accuracy daily and
calibrate to within 1° F accuracy as
necessary,
QA will observe maintenance
personnel check finished product
storage area once per shift,
If a deviation from a critical limit occurs,
the following corrective actions will be
taken,
1,The cause of the temperature
exceeding 40° F will be identified and
eliminated,
2,The CCP will be monitored hourly
after the corrective action is taken to
ensure that it is under control,
3,When the cause of the deviation is
identified,measures will be taken to
prevent it from recurring e.g.,if the
cause is equipment failure,preventive
maintenance program will be reviewed
and revised,if necessary,
Signature,__________________________________ Date,__________________________ Figure 4
29
Raw,Not Ground Model
HACCP PLAN
PROCESS CATEGORY,RAW PRODUCTS,NOT GROUND
PRODUCT EXAMPLE,BEEF TRIMMINGS,TENDERIZED (MECHANICALLY) BEEF CUTS
CCP# and
Location
Critical
Limits
Monitoring
Procedures
and Frequency
HACCP
Records
Verification Procedures and
Frequency
Corrective Actions
4B
Finished
Product
Storage
(Cold)
If a deviation from a critical limit occurs,
the following corrective actions will be
taken,
4,If room temperature exceeds the
critical limit,the processing authority
will evaluate the product temperature
to ensure the temperature is sufficient
to preclude pathogen growth before
release for shipment,If temperature is
not sufficient to preclude pathogen
growth,product will be cooked in the
establishment to ensure destruction of
pathogens or condemned,
Signature,__________________________________ Date,__________________________ Figure 4
30
Raw,Not Ground 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
31
Raw,Not Ground Model
THERMOMETER CALIBRATION LOG
Calibrate to 32
0
F while thermometer is in slush ice water
Date Time Department
or
Area
Thermometer
ID#
Personal
Thermomete
r 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,_______________________
32
Raw,Not Ground Model
GENERIC ESTABLISHMENT X,ROOM TEMPERATURE LOG
ROOM,______________
TIME TEMP Deviation from CL?
(Check if yes)
If Yes,
Action?
Monitored by,Verified by,
DATE,_________________
TIME/TEMPERATURE CRITICAL LIMIT ---- 40o F
33
Raw,Not Ground Model
GENERIC ESTABLISHMENT X,METAL DETECTION LOG
Date Product Lot # Results Seeded
Sample
Time Monitored By Verified By
34
Raw,Not Ground Model
CORRECTIVE ACTIONS LOG
Product,___________________________________________ Lot # ______________________________
CCP/ Deviation/
Problem
Corrective Action
Procedures/Explain
Disposition of
Product
Responsible
Person
Time
SIGNATURE,__________________________ DATE,______________________
35
Raw,Not Ground Model
PRE-SHIPMENT REVIEW LOG
Date:______________
LOT ID TIME RECORDS
REVIEWED
BY
WHOM
LOT RELEASED FOR
SHIPMENT?
SIGNATURE
COMMENTS *
*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
36
Department of
Agriculture
Food Safety
and Inspection
Service
September 1999
HACCP-4
Generic HACCP
Model for Raw,
Not Ground
Meat and
Poultry
Products
Additional copies of the Guidebook for the Preparation
of HACCP Plans and the Generic HACCP Models are
available from,
U.S,Department of Agriculture
Food Safety and Inspection Service (FSIS)
Office of Policy,Program Development,
and Evaluation (OPPDE)
Inspection Systems Development Division
Room 202,Cotton Annex Building
300 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
Raw,Not Ground Model
Table of Contents
Introduction……………………………………………………………………………..…,3
Using This Generic Model…………………………………………………………..…….,5
Process Flow Diagram and Product Description…………………………………..………,6
Hazard Analysis………………………………………………………………….…………7
Developing Your HACCP Plan………………………………………………..….……….,9
Identifying CCPs……………………………………………………………………..……,11
Appendix A
References for HACCP Teams ……………………………………..…………..,17
References for Raw,Not Ground Meat and Poultry Products…….…………..…… 19
Appendix B
Process Flow Diagram (Figure1)………………………….……………………….,22
Product Description Form (Figure 2)……………………………………………… 23
Hazard Analysis Form (Figure 3)……………………………………………….…,24
HACCP Plan Form (Figure 4)…………………………………..……………….… 27
Form Letter Confirming Salmonella Compliance with Performance Standards,… 31
Thermometer Calibration Log…………………………………………………….,32
Generic Establishment X,Room Temperature Log ………………………………,33
Generic Establishment X,Metal Detection Log…………………….....................,34
Corrective Actions Log……………………………………………………………,35
Pre-Shipment Review Log………………………………………………………… 36
1
Raw,Not Ground Model
GENERIC HACCP MODEL
FOR
RAW,NOT GROUND MEAT AND POULTRY PRODUCTS
Introduction
The Hazard Analysis Critical Control Point (HACCP) system is a scientific approach to process
control,It is designed to prevent the occurrence of problems by assuring that controls are
applied at any point in a food production system where hazardous or critical situations could
occur,Hazards include biological,chemical,or physical contamination of food products,
The Food Safety and Inspection Service (FSIS) published a final rule in July 1996 mandating
that HACCP be implemented as the system of process control in all inspected meat and poultry
plants,As part of its efforts to assist establishments in the preparation of plant-specific HACCP
plans,FSIS determined that a generic model for each process defined in the regulation would be
made available for use on a voluntary basis by inspected establishments,
The generic models have been revised since their initial publication and distribution as
DRAFTS,The most important change in the revised versions is to make certain that these
models are
fully consistent with the features of the final regulation,Also,other technical and editorial
improvements have been made,
Throughout this generic model,FSIS discusses a HACCP team with members from different
departments,In many very small establishments,there will not be separate departments with
different employees,But,there will be employees who perform these different functions – often
several of them,For purposes of explaining concepts,it is easier to speak as if these were
different people,even though in many cases,they may be the same person carrying out more
than one responsibility,
Each generic model can be used as a starting point for the development of plant-specific plan(s)
reflecting actual plant environments and the processes conducted,The generic model is not
intended to be used,as is” for plant specific HACCP plans,
The generic models are designed for use in conjunction with the list of process categories found
in the HACCP regulations in section 417.2(b)(1),
2
Raw,Not Ground 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,Raw product—not ground,
The purpose of the process category listing in 417.2 is to set out the circumstances under which a
HACCP team may develop a single HACCP plan for multiple products,This may be done when
products are in the same process category,and food safety hazards,critical control points,and
other features are essentially the same,There is a generic model for each process category,plus
two for subcategories which present special issues,irradiated products and mechanically
separated products,
In order to select the model or models that will be most useful for the activities performed in any
specific plant,the following steps should be taken,
1) For slaughtering operations,select the model for the appropriate species,
2) For processed products,make a list of all products produced in the plant,
3) Examine the list and group like products,considering common processing steps and
equipment used,
3
Raw,Not Ground Model
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 raw,not ground
product(s),the third process category,The model can be used for all raw,not ground products,
either meat or poultry,The generic model is not suitable for products that fall into any of the
other process categories,
The model will be most useful to a HACCP team that includes access to one trained individual,
as specified in 417.7(b),
(b)The individual performing the functions listed in paragraph (a) of this section shall
have successfully completed a course of instruction in the application of the seven
HACCP principles to meat or poultry product processing,including a segment on the
development of a HACCP plan for a specific product and on record review,
It would be beneficial for other team members to have reviewed any of the various guidance
materials available on how to develop a HACCP plan for your company,including several useful
videos,handbooks,or computer programs,Once the HACCP team has prepared itself as
thoroughly as possible in general HACCP principles and how to use them,this model should be
helpful,
Note,This generic model includes a number of forms that can be used to record various types of
required information,The forms themselves are samples; a company HACCP team can develop
whatever forms it finds most useful,All the forms mentioned in this document are included in
Appendix B; they appear in the order in which they are discussed in the text,
All FSIS generic models are designed to assist establishments in applying the seven HACCP
principles to their meat and poultry processing operations AND to meet the regulatory
4
Raw,Not Ground Model
requirements of Part 417,Therefore,the definitions used in this and all other FSIS generic
models are those found in 417.1,
§ 417.1 Definitions,
For purposes of this part,the following shall apply,
Corrective action,Procedures to be followed when a deviation occurs,
Critical control point,A point,step,or procedure in a food process at which control can
be applied and,as a result,a food safety hazard can be prevented,eliminated,or reduced
to acceptable levels,
Critical limit,The maximum or minimum value to which a physical,biological,or
chemical hazard must be controlled at a critical control point to prevent,eliminate,or
reduce to an acceptable level the occurrence of the identified food safety hazard,
Food safety hazard,Any biological,chemical,or physical property that may cause a
food to be unsafe for human consumption,
HACCP System,The HACCP plan in operation,including the HACCP plan itself,
Hazard,SEE Food Safety Hazard,
Preventive measure,Physical,chemical,or other means that can be used to control an
identified food safety hazard,
Process-monitoring instrument,An instrument or device used to indicate conditions
during processing at a critical control point,
Responsible establishment official,The individual with overall authority on-site or a
higher level official of the establishment,
Process Flow Diagram and Product Description
To begin using this model,the company's HACCP team should first describe the product(s)
which are part of this process category and covered by this HACCP plan,The product(s) should
be described in two ways,
(1) by a simple diagram which shows 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,
5
Raw,Not Ground Model
In this generic model,there is an example for raw,not ground – beef trimmings and tenderized
(mechanically) beef cuts,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 beef
trimmings and/or tenderized (mechanically) beef cuts in generic establishment X,Figure 2 is an
example of a PRODUCT DESCRIPTION for the beef trimmings and/or tenderized
(mechanically) beef cuts produced in generic establishment X,
Once the company HACCP team in your establishment has prepared your Process Flow
Diagram,they should verify it by walking through the establishment following the flow of
product and making sure that all the steps of the process are included in the flow diagram,The
team should also review the information provided on the Product Description to make sure all
the key facts are included,such as identifying consumers,especially those with particular health
problems or known to be at risk,
Note,If your process includes steps not included in this example,those steps should be added,
Also,if your process does not include all the steps identified in this example,those steps would
be omitted when conducting the hazard analysis,That is generally,how you use these generic
model examples--just omit the features which do not apply to your operation or if your operation
includes features not included in this example,they should be added,
By completing a Process Flow Diagram and a Product Description,you have met the
requirements of 417.2(a)(2),You can use the Process Flow Diagram in particular to help you
complete the rest of the hazard analysis,Use the flow diagram to systematically review each
step in the process and ask the question,"Is there a food safety hazard which is reasonably likely
to occur which may be introduced at this step?" In answering the question,your HACCP team
needs to consider biological (including microbiological),chemical,and physical hazards,
Hazard Analysis
Once your product(s) are accurately described through the flow diagram and product description,
the HACCP team should begin work on the HAZARD ANALYSIS,The hazard analysis is
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
6
Raw,Not Ground Model
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,
Look at the entries for,Receiving – Carcasses” on the first page of the six column form for raw
products,not ground; the HACCP team has determined that Salmonella may be present at high
levels in incoming raw product,so it has put a,Yes” in the third column,Column four explains
the basis for the team’s determination,In the fifth column,the HACCP team has described the
preventive measures it will use to make sure that each hazard has been prevented,eliminated,or
reduced to an acceptable level,For the Salmonella hazard,the HACCP team decided to tell its
suppliers that product could not be accepted unless it was accompanied by the most recent
Salmonella performance standard sampling results which demonstrated that the supplier had not
failed two consecutive Salmonella performance standard sets,FSIS does not consider safe
handling labels alone to be an adequate CCP for any pathogenic microorganisms such as bacteria
and viruses,
Note,Look at the entries for,Storage – Carcasses” 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
7
Raw,Not Ground Model
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 beef trimmings and tenderized
(mechanically) beef cuts,there are four 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 raw,not ground product or if you
use a different process flow,you may have different hazards which are reasonably likely to
occur,For these different hazards,there may be different measures which could be used for
control purposes,
This,and all other FSIS generic models,contains a list of references which can help your
HACCP team in making sure the hazard analysis is complete,These references are found in
Appendix A,A member of your HACCP team might want to review at least some of the
references to make sure hazards have not been omitted from the hazard analysis,
Completing the hazard analysis is a very significant and important element in developing your
HACCP system,Your HACCP team should feel a real sense of accomplishment when they get
this far; this is like completing the foundation of a house,
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,
8
Raw,Not Ground Model
(2) List the critical control points for each of the identified food safety hazards,
including,as appropriate,
(i) Critical control points designed to control food safety hazards that could be
introduced in the establishment,and
(ii) Critical control points designed to control food safety hazards introduced outside the
establishment,including food safety hazards that occur before,during,and after entry
into the establishment;
(3) List the critical limits that must be met at each of the critical control points,Critical
limits shall,at a minimum,be designed to ensure that applicable targets or performance
standards established by FSIS,and any other requirement set forth in this chapter
pertaining to the specific process or product,are met;
(4) List the procedures,and the frequency with which those procedures will be
performed,that will be used to monitor each of the critical control points to ensure
compliance with the critical limits;
(5) Include all corrective actions that have been developed in accordance with §417.3(a)
of this part,to be followed in response to any deviation from a critical limit at a critical
control point; and
(6) Provide for a recordkeeping system that documents the monitoring of the critical
control points,The records shall contain the actual values and observations obtained
during monitoring,
(7) List the verification procedures,and the frequency with which those procedures will
be performed,that the establishment will use in accordance with § 417.4 of this part,
(d) Signing and dating the HACCP plan,(1) The HACCP plan shall be signed and
dated by the responsible establishment individual,This signature shall signify that the
establishment accepts and will implement the HACCP plan,
(2) The HACCP plan shall be dated and signed,
(i) Upon initial acceptance;
(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 beef trimmings and tenderized
9
Raw,Not Ground Model
(mechanically) beef cuts 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 three points on the hazard analysis form for beef
trimmings and tenderized (mechanically) beef cuts where food safety hazards reasonably likely
to occur were identified,Salmonella on carcasses at receiving,pathogen proliferation at cold
storage,and pathogen proliferation at finished product storage (cold),The establishment
HACCP team has chosen to have four CCPs to address these three hazards,Salmonella
certification,proper cold storage of carcasses,and proper maintenance of finished product
temperatures during storage,
After identifying its CCPs,the HACCP team proceeded to consider critical limits,monitoring
procedures and their frequencies,and verification procedures and their frequencies,and HACCP
records,
In deciding what would be the critical limits,the HACCP team first considered whether there
were any regulatory requirements which had to be met and would function as critical limits,
They found no regulatory requirements for receiving carcasses,but realized that Salmonella
coming into the plant could result in cross-contamination with other product,The HACCP team
knew that Salmonella may be present on incoming raw product,so they set the critical limit at
requiring the supplier of the carcass parts to send a Salmonella certificate with each shipment
stating that the product has been sampled for Salmonella,
Once they had decided on their critical limits,they needed to identify how the monitoring
procedures would be carried out and at what frequency,
For their receiving – carcasses step,the establishment had the receiving personnel check each
shipment for Salmonella certification,
These decisions by the HACCP team regarding critical limits,plus monitoring procedures and
their frequencies are written up in columns two and three of the HACCP Plan,
The team then went on to consider appropriate verification procedures; the team knew that there
were different types of verification and that Part 417.4(a)(2) included specific regulatory
requirements for each,The regulatory requirements for ongoing verification are,
(2) Ongoing verification activities,Ongoing verification activities include,but are not
10
Raw,Not Ground Model
limited to,
(i) The calibration of process-monitoring instruments;
(ii) Direct observations of monitoring activities and corrective actions; and
(iii) The review of records generated and maintained in accordance with §417.5(a)(3) of
this part,
The HACCP team decided they could verify the suppliers’ Salmonella certifications by
requesting Salmonella data results from FSIS for at least two suppliers every two months,
The HACCP team described the verification procedures and their frequencies in the fifth column
of their HACCP plan,
The HACCP team for generic establishment X knew that their HACCP Plan needed to provide
for a recordkeeping system,They wanted their records to be easy to create and understand,
They wanted to be sure their records met regulatory requirements,so they reviewed part 417.5(a)
and (b),
§ 417.5 Records,
(a) The establishment shall maintain the following records documenting the
establishment's HACCP plan,
(1) The written hazard analysis prescribed in § 417.2(a) of this part,including all
supporting documentation;
(2) The written HACCP plan,including decision making documents associated with the
selection and development of CCPs and critical limits,and documents supporting both
the monitoring and verification procedures selected and the frequency of those
procedures,
(3) Records documenting the monitoring of CCPs and their critical limits,including the
recording of actual times,temperatures,or other quantifiable values,as prescribed in the
establishment's HACCP plan; the calibration of process-monitoring instruments;
corrective actions,including all actions taken in response to a deviation; verification
procedures and results; product code(s),product name or identity,or slaughter
production lot,Each of these records shall include the date the record was made,
(b) Each entry on a record maintained under the HACCP plan shall be made at the time
the specific event occurs and include the date and time recorded,and shall be signed or
initialed by the establishment employee making the entry,
11
Raw,Not Ground Model
The HACCP team decided that their records would be kept on some simple forms,some of
which the team itself devised,
The HACCP team decided that since receiving personnel had a form that they had been using for
receiving product,that they would modify that form,The form was modified to provide spaces
for all entries necessary for the monitoring and verification activities at the receiving – carcasses
step,
On its HACCP Plan,generic establishment X has listed the names of the forms it will be using
for monitoring and verification records,
There is one other form included in column four,where the establishment has described its
recordkeeping system,That is the Corrective Actions Log; it is used to create the records of any
corrective actions taken because of deviations from critical limits at CCPs,Column six of the
HACCP plan references the planned corrective actions for each CCP,The HACCP team
carefully reviewed the regulatory requirements for planned corrective actions found at 417.3(a),
§ 417.3 Corrective actions,
(a) The written HACCP plan shall identify the corrective action to be followed in
response to a deviation from a critical limit,The HACCP plan shall describe the
corrective action to be taken,and assign responsibility for taking corrective action,to
ensure,
(1) The cause of the deviation is identified and eliminated;
(2) The CCP will be under control after the corrective action is taken;
(3) Measures to prevent recurrence are established; and
(4) No product that is injurious to health or otherwise adulterated as a result of the
deviation enters commerce,
The HACCP team has developed a specific corrective action plan which will be followed
whenever there is a deviation from a critical limit at a CCP; each of the planned corrective
actions meets the four regulatory requirements of 417.3(a),
Planned Corrective Action for CCP 1,
Receiving personnel will not receive product unaccompanied by Salmonella certification,
12
Raw,Not Ground Model
The HACCP team also develops planned corrective actions for each of the other CCPs and
attaches them to the HACCP plan,Whenever a deviation from a critical limit occurs,company
employees follow the corrective action plan and use the Corrective Action Log to create a record
of their actions,The Corrective Action Log forms are available at CCPs,so they can be used
immediately when an employee performing a monitoring check discovers and records a
deviation,All Corrective Action Logs,which have been used during the day,are turned in to the
HACCP coordinator,
There is one final verification/recordkeeping requirement which the company must perform; it is
found at 417.5(c),
(c) Prior to shipping product,the establishment shall review the records associated with
the production of that product,documented in accordance with this section,to ensure
completeness,including the determination that all critical limits were met and,if
appropriate,corrective actions were taken,including the proper disposition of product,
Where practicable,this review shall be conducted,dated,and signed by an individual
who did not produce the record(s),preferably by someone trained in accordance with §
417.7 of this part,or the responsible establishment official,
In generic establishment X,product is shipped out,often in small lots,throughout the day,This
means that pre-shipment verification checks must be as complete as possible when finished
product is in storage,so that a shipment can be made up quickly and moved into distribution
channels,
The establishment uses a half day lotting system and a midshift cleanup,While the midshift
cleanup is being performed,QA personnel or the HACCP coordinator review results of
monitoring and verification checks applied to that lot; if there were deviations from critical
limits,they review the Corrective Action Logs to make sure all appropriate planned responses
were carried out,If everything is in order and there are complete records showing that the
establishment has controlled production of this product through its HACCP system,the HACCP
coordinator will sign the pre-shipment review form which the HACCP team devised for this
purpose,
Note,It is not a regulatory requirement that a separate form be used for pre-shipment review; in
addition,FSIS has indicated that it will be very flexible in accepting a variety of arrangements
for accomplishing pre-shipment review to reflect the variety of commercial practices which it
has encountered in the industry,It is,however,important to remember that pre-shipment review
is a regulatory requirement that must be met,as it indicates that the establishment is taking full
responsibility for the product having been produced under a well-functioning HACCP system,
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
raw,not ground production process,They have secured a copy of FSIS Directive 5000.1,
13
Raw,Not Ground Model
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,
14
Raw,Not Ground Model
APPENDIX A
15
Raw,Not Ground Model
References for HACCP Teams
1. Agriculture Canada,Food Safety Enhancement Program – HACCP Implementation Manual,
Camelot Drive,Nepean,Ontario,Canada,1996,
2. American Meat Institute Foundation,HACCP,The Hazard Analysis and Critical Control
Point System in the Meat and Poultry Industry,Washington,D.C.,1994,
Useful sections in particular are,
Chapter 3 – microbiological hazards,pp,15-26
Chapter 4 – chemical hazards,pp,27-32
Chapter 5 – physical hazards,pp,33-35
Appendix A – NACMCF HACCP
Appendix C – Model HACCP plans
3. Baker,D.A,Application of Modeling in HACCP Plan Development,Int,J,Food Microbiol,
25:251-261,1995,
4. Corlett,D.A.,Jr,and Stier,R.F,Risk Assessment within the HACCP System,Food Control
2:71-72,1991,
5. Council for Agriculture Science and Technology,Risks Associated with Foodborne
Pathogens,February 1993,
6. Easter,M.C.,et al,The Role of HACCP in the Management of Food Safety and Quality,J,
Soc,Dairy Technol,47:42-43,1994,
7. Environmental Protection Agency,Tolerances for Pesticides in Foods,Title 40,Code of
Federal Regulations,Part 185,U.S,Government Printing Office,Washington,D.C.,1998,
8. Food and Drug Administration,The Food Defect Action Levels,FDA/CFSAN,
Washington,D.C.,1998,
9. Food and Drug Administration,Fish and Fishery Products Hazards and Control Guide --
Get Hooked on Seafood Safety,Office of Seafood,Washington,D.C.,1994,
10,International Commission on Microbiological Specification for Foods,HACCP in
Microbiological Safety and Quality,Blackwell Scientific Publications,Oxford,1988,
Useful sections in particular are,
Chapter 10 – raw meat and poultry,pp,176-193
Chapter 11 – roast beef,pp,234-238
16
Raw,Not Ground Model
Chapter 11 – canned ham,pp,238-242
11,International Commission on Microbiological Specification for Foods,Microorganisms in
Foods 4,Application of Hazard Analysis and Critical Control Point (HACCP) Systems to
Ensure Microbiological Safety and Quality,Blackwell Scientific Publications,Boston,1989
12,National Advisory Committee on Microbiological Criteria for Foods,March 20,1992 --
Hazard Analysis and Critical Control Point System,Int,J,Food Microbiol,16,1-23,1993,
13,National Advisory Committee on Microbiological Criteria for Foods,Adopted August 14,
1997-- Hazard Analysis and Critical Control Point Principles and Application Guidelines,J,
Food Protect,61(9),1246-1259,1998,
14,National Advisory Committee on Microbiological Criteria for Foods,DRAFT document -
FSIS Microbiological Hazard Identification Guide for Meat and Poultry Components of
Products Produced by Very Small Plants,1-22,August 1999,
15,National Advisory Committee on Microbiological Criteria for Foods,June 1993 -- Report
on Generic HACCP for Raw Beef,Food Microbiol,10,449-488,1994,
16,National Research Council,An Evaluation of the Role of Microbiological Criteria for Foods
and Food Ingredients,National Academy Press,Washington,D.C.,1985,
Useful sections in particular are,
Chapter 4 – microbiological hazards,pp,72-103
Chapter 9 – raw meat,pp,193-199
Chapter 9 – processed meats,pp,199-216
17,Notermans,S.,et al,The HACCP Concept,Identification of Potentially Hazardous
Microorganisms,Food Microbiol,11:203-214,1994,
18,Pierson M.D,and Dutson,T,Editors,HACCP in Meat,Poultry,and Fish Processing,
Blackie Academic & Professional,Glasgow,1995,
Useful sections in particular are,
Chapter 4 – meat and poultry slaughter,pp,58-71
Chapter 5 – processed meats,pp,72-107
Chapter 7 – risk analysis,pp,134-154
Chapter 13 – predictive modeling,pp,330-354
17
Raw,Not Ground Model
19,Pierson,M.D,and Corlett,D.A.,Jr,Editors,HACCP Principles and Applications,Van
Nostrand Reinhold,New York,1992,
20,Stevenson,K.E,and Bernard,D.T,Editors,HACCP,Establishing Hazard Analysis Critical
Control Point Programs.,A Workshop Manual,The Food Processors Institute,Washington,
D.C.,1995,
Useful sections in particular are,
Chapter 11 – forms for hazard analysis,CCPs,critical limits,HACCP master
sheet,example HACCP for breaded chicken
21,Stevenson,K.E,and Bernard,D.T,Editors,HACCP,A Systematic Approach to Food
Safety,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 Raw,Not Ground Meat and Poultry Products
1,American Meat Science Association,Flowchart for fresh meat,AMSA,Chicago,IL,1995,
2. Blair,I.S.,et al,Microbiological examination of pre-storage and post-storage intervention
beef,Meat Sci,38,155-161,1994,
3. Coates,K.J.,et al,The contribution of carcass contamination and the boning process to
microbial spoilage of aerobically stored pork,Food Microbiol,12,49-54,1995,
4. Gill,C.O.,et al,Changes in the microflora on commercial beef trimmings during their
collection,distribution and preparation for retail sale as ground beef,Int,J,Food
Microbiol,18,321-332,1993,
5. Gill,C.O.,et al,Hygienic effects of trimmings and washing operations in beef –carcass-
dressing process,J,Food Protect,59,666-669,1996,
6. Kotula K.L.,et al,Microbiological and sensory attributes of retail cuts of beef treated with
acetic acid and lactic acid solutions,J,Food Protect,57,665-670,1994,
18
Raw,Not Ground Model
7. Miller,M.F.,et al,Microbiology of hot-fat-trimmed beef,Staphylococcus by lactic acid
bacteria in country-style hams,J,Anim,Sci,1368-1371,1995,
19
Raw,Not Ground Model
APPENDIX B
20
Raw,Not Ground Model
PROCESS FLOW DIAGRAM Figure 1
PROCESS CATEGORY,RAW PRODUCT,NOT GROUND
PRODUCT,BEEF TRIMMINGS,TENDERIZED (MECHANICALLY) BEEF CUTS
RECEIVING
PACKAGING
MATERIALS
RECEIVING
CARCASSES
STORAGE
PACKAGING
MATERIALS
STORAGE
(COLD)
CARCASSES
FABRICATION OF
BEEF
TRIMMINGS
AND/OR
BEEF CUTS
PACKAGING/
LABELING
FINISHED PRODUCT STORAGE
(COLD)
BEEF TRIMMINGS
BEEF CUTS
TENDERIZING
(MECHANICAL)
SHIPPING
21
Raw,Not Ground Model
PRODUCT DESCRIPTION Figure 2
PROCESS CATEGORY,RAW PRODUCT,NOT GROUND
PRODUCT,BEEF TRIMMINGS,TENDERIZED (MECHANICALLY) BEEF
CUTS
1,COMMON NAME? BEEF TRIMMINGS,TENDERIZED
(MECHANICALLY) BEEF CUTS
2,HOW IS IT TO BE USED? BEEF TRIMMINGS – FOR FURTHER
PROCESSING INTO GROUND OR
PROCESSED PRODUCTS,
TENDERIZED BEEF CUTS – FOR
FURTHER PROCESSING INTO
BREADED PRODUCTS OR SOLD AS
RAW TENDERIZED BEEF CUTS
3,TYPE OF PACKAGE? BULK-PACKED (E.G.,PLASTIC
BAG,VACUUM PACKED)
4,LENGTH OF SHELF LIFE,3-6 MONTHS AT 0° F OR
AT WHAT TEMPERATURE? BELOW;7 DAYS AT 40° F
5,WHERE WILL IT BE SOLD? WHOLESALE TO DISTRIBUTORS
CONSUMERS? ONLY
INTENDED USE?
6,LABELING INSTRUCTIONS? KEEP FROZEN; KEEP
REFRIGERATED
7,IS SPECIAL DISTRIBUTION KEEP FROZEN; KEEP
CONTROL NEEDED? REFRIGERATED
22
Raw,Not Ground Model
HAZARD ANALYSIS – RAW PRODUCT,NOT GROUND - Beef Trimmings/Beef Cuts
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 – Carcasses Biological,Pathogens
– microbial
Salmonella,
Escherichia coli
0157:H7
Yes Salmonella and Escherichia
coli 0157:H7 may be
present on incoming raw
product,
Certification from suppliers
that product has been
sampled for Salmonella and
meets standard set by FSIS,
and that it has been
subjected to E,coli
sampling without
presumptive positive
results,
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,
Receiving – 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
No Plant records demonstrate
that foreign material
contamination has not
occurred during the past
several years,
Figure 3
23
Raw,Not Ground Model
HAZARD ANALYSIS – RAW PRODUCT,NOT GROUND
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
Storage –Packaging
Materials
Biological – None
Chemical – None
Physical – None
Storage (Cold) –
Carcasses
Biological – Pathogens
Salmonella
Escherichia 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
Fabrication of Beef
Trimmings and/or
Beef Cuts; Tenderizing
(Mechanical) Beef
Cuts
Biological – None
Chemical – None
Physical – Metal
contamination from
injection needles and
machine wear,
Yes Plant records show that
during the fabrication and
tenderizing process metal
contamination is likely to
occur,
Metal detector prior to
packaging and/or visual
examination and
maintenance of tenderizers
Figure 3
24
Raw,Not Ground Model
HAZARD ANALYSIS – RAW PRODUCT,NOT GROUND
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
Packaging/Labeling Biological – None
Chemical – None
Physical – Metal
contamination
Yes Metal contamination that
may have come into the
establishment with raw
product or occurred during
the fabrication process,
Functional metal detector is
on-line in the
packaging/labeling area to
remove product with metal
contamination,
3P
Finished Product
Storage (Cold)
Biological – Pathogens
Salmonella E,coli
0157: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,
4B
Chemical – None
Physical – None
Shipping Biological – None
Chemical – None
Physical – None
Figure 3
25
Raw,Not Ground Model
HACCP PLAN
PROCESS CATEGORY,RAW PRODUCT,NOT GROUND
PRODUCT EXAMPLE,BEEF TRIMMINGS,TENDERIZED (MECHANICALLY) BEEF CUTS
CCP# and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP Records Verification Procedures and
Frequency
Corrective Actions
1B
Receiving –
Carcasses
Supplier
certification
that product
meets FSIS
performance
standard 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
the most recent FSIS Salmonella
data results from at least 2 suppliers,
Product not meeting specifications will not
be accepted for entry and supplier history
examined, If supplier has exceeded
specifications,the source will no longer be
used until performance standards are met,
2B
Storage
(Cold) –
Carcasses
Raw product
storage area
shall not
exceed 40° F,
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 1° F accuracy as necessary,
QA will reject or hold product,&
dependent on time/temperature deviation
will make a disposition,Maintenance will
review cooler service records and
placement of carcasses,
Product > 50°F for 2 hours will be diverted
to a cooking process,Determination on
product < 50°F for < 2 hours will be made
using Process Authority or pathogen
growth modeling,
QA will identify the cause of the deviation
and prevent reoccurrence,
Cooler unit will be repaired if necessary,
26
Raw,Not Ground Model
Signature,__________________________________ Date,__________________________ Figure 4
27
Raw,Not Ground Model
HACCP PLAN
PROCESS CATEGORY,RAW PRODUCT,NOT GROUND
PRODUCT EXAMPLE,BEEF TRIMMINGS,TENDERIZED (MECHANICALLY) BEEF CUTS
CCP# and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP Records Verification Procedures and
Frequency
Corrective Actions
3P
Packaging/
Labeling
No metal
particles to
exceed 1/32
inch,
All
contaminated
product is
removed from
system by
functioning
kick out
mechanism,
Packaging line
supervisor will
check the metal
detector using a
seeded sample
every 2 hours to
determine limits
are not exceeded,
Metal Detection
Control Log
Corrective Action
Log
QA,outside the packaging unit,will
verify that the metal detector is
functioning as intended by running
the seeded sample through the metal
detector twice per shift (once AM,
once PM),QA will observe
monitoring to assure that product
from kick out is placed on hold,
Packaging supervisor will control and
segregate affected product,
Maintenance personnel will identify and
eliminate any problems with the metal
detector or kick out mechanism,Preventive
maintenance program will be implemented,
QA will run seeded sample through
detector after repair,
All potentially contaminated product will
be run through functional metal detector
prior to shipment,
All product rejected by detector will be
reworked after visual examination,
Signature,__________________________________ Date,__________________________ Figure 4
28
Raw,Not Ground Model
HACCP PLAN
PROCESS CATEGORY,RAW PRODUCT,NOT GROUND
PRODUCT EXAMPLE,BEEF TRIMMINGS,TENDERIZED (MECHANICALLY) BEEF CUTS
CCP#
and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP Records Verification Procedures and
Frequency
Corrective Actions
4B
Finished
Product
Storage
(Cold)
(Continued
on next
page)
Finished
product
storage areas
will not
exceed 40° F,
Maintenance
personnel will
check finished
product storage
areas temperatures
every 2 hours,
Room Temperature
Log
Thermometer
Calibration Log
Corrective Action
Log
Maintenance supervisor will verify
the accuracy of the room
temperature log once per shift,
QA will check all thermometers
used for monitoring and verification
activities for accuracy daily and
calibrate to within 1° F accuracy as
necessary,
QA will observe maintenance
personnel check finished product
storage area once per shift,
If a deviation from a critical limit occurs,
the following corrective actions will be
taken,
1,The cause of the temperature
exceeding 40° F will be identified and
eliminated,
2,The CCP will be monitored hourly
after the corrective action is taken to
ensure that it is under control,
3,When the cause of the deviation is
identified,measures will be taken to
prevent it from recurring e.g.,if the
cause is equipment failure,preventive
maintenance program will be reviewed
and revised,if necessary,
Signature,__________________________________ Date,__________________________ Figure 4
29
Raw,Not Ground Model
HACCP PLAN
PROCESS CATEGORY,RAW PRODUCTS,NOT GROUND
PRODUCT EXAMPLE,BEEF TRIMMINGS,TENDERIZED (MECHANICALLY) BEEF CUTS
CCP# and
Location
Critical
Limits
Monitoring
Procedures
and Frequency
HACCP
Records
Verification Procedures and
Frequency
Corrective Actions
4B
Finished
Product
Storage
(Cold)
If a deviation from a critical limit occurs,
the following corrective actions will be
taken,
4,If room temperature exceeds the
critical limit,the processing authority
will evaluate the product temperature
to ensure the temperature is sufficient
to preclude pathogen growth before
release for shipment,If temperature is
not sufficient to preclude pathogen
growth,product will be cooked in the
establishment to ensure destruction of
pathogens or condemned,
Signature,__________________________________ Date,__________________________ Figure 4
30
Raw,Not Ground 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
31
Raw,Not Ground Model
THERMOMETER CALIBRATION LOG
Calibrate to 32
0
F while thermometer is in slush ice water
Date Time Department
or
Area
Thermometer
ID#
Personal
Thermomete
r 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,_______________________
32
Raw,Not Ground Model
GENERIC ESTABLISHMENT X,ROOM TEMPERATURE LOG
ROOM,______________
TIME TEMP Deviation from CL?
(Check if yes)
If Yes,
Action?
Monitored by,Verified by,
DATE,_________________
TIME/TEMPERATURE CRITICAL LIMIT ---- 40o F
33
Raw,Not Ground Model
GENERIC ESTABLISHMENT X,METAL DETECTION LOG
Date Product Lot # Results Seeded
Sample
Time Monitored By Verified By
34
Raw,Not Ground Model
CORRECTIVE ACTIONS LOG
Product,___________________________________________ Lot # ______________________________
CCP/ Deviation/
Problem
Corrective Action
Procedures/Explain
Disposition of
Product
Responsible
Person
Time
SIGNATURE,__________________________ DATE,______________________
35
Raw,Not Ground Model
PRE-SHIPMENT REVIEW LOG
Date:______________
LOT ID TIME RECORDS
REVIEWED
BY
WHOM
LOT RELEASED FOR
SHIPMENT?
SIGNATURE
COMMENTS *
*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
36
