Generic HACCP

United States
Model for Raw,
Ground Meat
Department of
Agriculture

and Poultry
Food Safety
and Inspection
Service

September 1999 Products

HACCP-3
Additional copies of the Guidebook for the Preparation

of HACCP Plans and the Generic HACCP Models are

available from:

U.S. Department of Agriculture

Food Safety and Inspection Service (FSIS)

Office of Policy, Program Development,

and Evaluation (OPPDE)

Inspection Systems Development Division
Room 202, Cotton Annex Building
300 12th Street SW
Washington, D.C. 20250-3700
Phone: (202) 720-3219
Fax: (202) 690-0824

This material is also available on the FSIS Homepage:

http://www.fsis.usda.gov/index.htm
 United States Food Safety Washington, D.C.
Department of and Inspection 20250
Agriculture Service

September 8, 1999

TO THE USERS OF THESE VOLUMES

As some of you may know, the Food Safety and Inspection Service (FSIS) received a substantial
package of comments on its Guidebook for Hazard Analysis and Critical Control Point
(HACCP) Plan Development and the 13 Generic HACCP models, from a coalition of industry
and trade associations. This package represents a large and thoughtful effort on the part of these
organizations. FSIS intends to give it the careful attention and response that it deserves.

The comments included many technical suggestions for improvements in the FSIS documents. It
also included reiteration of longstanding differing policy viewpoints that have been frequently
discussed by the Agency and the regulated industry. For the first time, the comments revealed
substantially differing expectations on the part of these organizations and FSIS with respect to
the purpose of the FSIS documents and their intended use. We want to address some aspects of
this latter point.

When the Pathogen Reduction/Hazard Analysis and Critical Control Point systems (PR/HACCP)
final regulation was published on July 25, 1996, the DRAFT Guidebook was included as an
appendix. The Generic Models, developed for FSIS under contract, were available shortly
thereafter in April 1997. It was probably inevitable that there were significant differences
between the final regulatory language of CFR Part 417 and the DRAFT Generic Models as they
were developed independently. It would have been inappropriate for FSIS to discuss its final
regulatory language with any outside group. The contractor was appropriately proceeding from
what it knew best, the National Advisory Committee on Microbiological Criteria for Foods
(NACMCF) documents on the subject of HACCP. Therefore, FSIS accepted that work product
with full knowledge that significant revisions would be necessary.

As time passed, FSIS managers became increasingly uncomfortable with the situation in which
its major technical assistance documents did not appropriately and completely inform the
regulated industry of Agency expectations regarding regulatory compliance. Because the
intended audience for these technical assistance materials was primarily the very small
establishments, which the Agency believed to have the least HACCP-experience, the Agency
began the systematic revision of the documents to overcome this problem. We targeted the
summer of 1999 as the completion date for this effort.

FSIS now believes that others had very different ideas about the purpose and use of the
documents than it did. As is consistently reiterated in the documents themselves, they are not
designed to be used "as is." That is, they cannot be copied and used by an establishment to meet
all the regulatory requirements of 9 CFR Part 417. Nor were they designed to be the ultimate
teaching and training materials, as some would suggest. The development of ideal generic
models is left to others who may have an interest in doing so. The generic models are not

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

 2

designed to extend or further interpret existing regulations; rather, they are designed to send the
user back to the regulations so he/she can become familiar with the requirements as well as the
flexibility they permit. The generic models are not designed to present new or alternative
methods of producing and processing meat and poultry products. That is also left to others with
an interest in doing so.

FSIS envisioned that the generic models might be used in the following way: Suppose a HACCP
team leader of a three-person HACCP team in a very small establishment attended a training
course, but the others on his/her team were not able to do so. Suppose the HACCP training
course met all the requirements of 417.7 but did not provide participants with much in the way of
"take away materials" like workbooks, practical questions and answers, access to follow-up
resources, etc., which the Research Triangle Institute (RTI) needs assessment indicated were so
important to these establishments. The trained HACCP team leader returns to the establishment
and begins the process of attempting to develop HACCP plans for the company's products and
processes. He/she is quite confident that he/she has grasped the material presented in the training
course and begins to work with this team immediately, while the concepts are fresh in his/her
mind.

First, he/she has the rest of the team review the Canadian video and the Guidebook from FSIS so
that all members of his team have a basic level of information.

The team members begin their work, and as they proceed, some questions arise as to whether
what they have developed is appropriate. This is the point when FSIS expects the team to pick up
the appropriate generic model and get a sense of whether they are on the right track. They should
be able to determine whether the forms that they have developed, while different from the
various ones in the generic models and not the same as what other companies use, are acceptable
because they include the required information. They will also be able to discover what are some
typical food safety hazards that are reasonably likely to occur, as explicitly defined in 417.2, and
how to think through the problems that these hazards represent for their own products. They can
see how critical limits might arise from existing regulatory requirements like the ones for rapid
chilling of poultry products. They can also see that in the absence of settled regulatory
requirements, there may be several sources of scientific expertise, and they can choose to make a
conservative decision to provide a good margin of safety. They can find out the essential
differences between monitoring and verification and have a basis for making their choices about
verification activities and their frequencies. FSIS believes that these are useful, beneficial and
worthwhile functions for which its generic models can be used.

FSIS is publishing these updated revisions of the generic models, beginning with the Guidebook
and the Generic Model for Raw, Ground Product, because a large backlog of requests exists for
these two documents. FSIS intends to publish revisions of all the generic models no later than
September 30, 1999. Moreover, as a result of public consultation, it may publish an additional
revision of some of these models, but given the backlog and the impending HACCP
implementation date, we considered it important to get a version of these documents out now.

We hope that these documents are helpful.

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Table of Contents

Introduction………………………………………….……………………………………. 3

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

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

Hazard Analysis…………………………………………………………………………… 8

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

Identifying CCPs…………………………………….……………………………………. 11

Appendix A

References for HACCP Teams………………………………………….............. 21

References for Raw, Ground Meat and Poultry Products…..…………………….. 23

Part I – Prevalence of Pathogens Found in Ground Beef and Fresh Pork

Sausage…………………………………………..………………… 23

Part II – Effects of Processing Procedures on the Growth of

Pathogens……………………………………….………………… 25

Appendix B

Process Flow Diagram (Figure 1)…………………………………………………. 28

Product Description Form (Figure 2)……………………………………………… 29

Hazard Analysis Form (Figure 3)…………………………………………………. 30

HACCP Plan Form (Figure 4)..…………………………………………………… 35

FORM LETTER Confirming Salmonella Compliance

with Performance Standards……………………………………………………… 40

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Generic Establishment X: Room Temperature Log ……………………………… 41

Thermometer Calibration Log…………………………………………………….. 42

Generic Establishment X: Metal Detection Log……………………….................. 43

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

Pre-Shipment Review Log………………………………………………………… 45

Raw, Ground Model

GENERIC HACCP MODEL

FOR

RAW, 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).
(b) The HACCP plan. (1) Every establishment shall develop and implement a written

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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 second process category: Raw product--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 that present special issues: irradiated products and mechanically separated
products.

In order to select the model or models that will be most useful for the activities performed in any
specific plant, the following steps should be taken:

1) For slaughtering operations, select the model for the appropriate species.

2) For processed products, make a list of all products produced in the plant.
3) Examine the list and group like products, considering common processing steps and
equipment used.

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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, ground
product(s), the second process category. The model can be used for all raw, ground products:
either meat or poultry; with or without spices or condiments; whether fresh or frozen. The
generic model is not suitable for ground products with preservatives or secondary inhibitors or
for partially cooked ground products. The model can be used for those products generally
referred to as comminuted. Because mechanically separated products present some unique
issues, FSIS has prepared a separate generic model for these products.

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.

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All FSIS generic models are designed to assist establishments in applying the seven HACCP
principles to their meat and poultry processing operations AND to meet the regulatory
requirements of Part 417. Therefore, the definitions used in this and all other FSIS generic
models are those found in 417.1:

§ 417.1 Definitions.

For purposes of this part, the following definitions shall apply:

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

Critical control point. A point, step, or procedure in a food process at which control can
be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced
to acceptable levels.

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

chemical hazard must be controlled at a critical control point to prevent, eliminate, or
reduce to an acceptable level the occurrence of the identified food safety hazard.

Food safety hazard. Any biological, chemical, or physical property that may cause a
food to be unsafe for human consumption.

HACCP System. The HACCP plan in operation, including the HACCP plan itself.

Hazard. SEE Food Safety Hazard.

Preventive measure. Physical, chemical, or other means that can be used to control an
identified food safety hazard.

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

during processing at a critical control point.

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

higher level official of the establishment.

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:

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(1) by a simple diagram which shows the steps the company uses when it produces the product,

and

(2) in a brief written description which provides key facts about the product and its use.

In this generic model, there is an example for fresh pork sausage, one of the products in this

process category. 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 fresh pork

sausage in generic establishment X. Figure 2 is an example of a PRODUCT DESCRIPTION

for the fresh pork sausage produced by generic establishment X.

Once the company HACCP team in your establishment has prepared your Process Flow

Diagram, they should verify it by walking through the establishment following the flow of

product and making sure that all the steps of the process are included in the flow diagram. The

team should also review the information provided on the Product Description to make sure all

the key facts are included, such as identifying consumers, especially those with particular health

problems or known to be at risk.

Note: If you are producing a raw, ground product which does not have any non-meat ingredients,

such as raw, ground beef patties, you would not include the left side of the flow diagram i.e.,

receiving non-meat ingredients, storage of non-meat ingredients, etc. That is generally, how you

use these generic model examples--just omit the features which do not apply to your operation.

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.

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(a) Hazard analysis. (1) Every official establishment shall conduct, or have conducted
for it, a hazard analysis to determine the food safety hazards reasonably likely to occur
in the production process and identify the preventive measures the establishment can
apply to control those hazards. The hazard analysis shall include food safety hazards
that can occur before, during, and after entry into the establishment. A food safety
hazard that is reasonably likely to occur is one for which a prudent establishment would
establish controls because it historically has occurred, or because there is a reasonable
possibility that it will occur in the particular type of product being processed, in the
absence of those controls.

(2) A flow chart describing the steps of each process and product flow in the
establishment shall be prepared, and the intended use or consumers of the finished
product shall be identified.

Generic establishment X, which we are using for our example, is capturing these regulatory
requirements on a 6-column Hazard Analysis Form (See Figure 3). A good way to use a form
like this is to create the first column by using the Process Flow Diagram and the second by
answering the question of whether there is a food safety hazard. 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-Meat” on the first page of the six column form; 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 certification 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.

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Note: Look at the entries for "Storage-Meat" on the second page of the six-column form: the

HACCP team has determined that there is a food safety hazard reasonably likely to occur at this

step in the process. Column four contains the reason for their thinking: pathogenic organisms

(including Salmonella) 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 pork sausage, there are six 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, 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 that could be used for

control purposes.

This, and all other FSIS generic models, contains a list of references which can help your

HACCP team in making sure the hazard analysis is complete. The references for raw, ground

product are found in Appendix A. A member of your HACCP team might want to review at

least some of the references to make sure hazards have not been omitted from the hazard

analysis.

If you are using this generic model to develop a HACCP plan for raw, ground beef, you may find

the recently issued FSIS guidance material on producing this product to be useful. You may get

a copy from the FSIS Docket Clerk in Room 102, Cotton Annex Building, 300 12th Street, SW,

Washington, DC, 20250. An electronic version of the guidance material is available on line

through the FSIS web page located at http://www.fsis.usda.gov.

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.

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Developing Your HACCP Plan

The company HACCP team can now take the materials it developed while doing the hazard
analysis and use them to build the HACCP Plan. Remember that one of the important
objectives of the FSIS generic models is to provide examples that illustrate how to meet the
regulatory requirements of Part 417, as well as to correctly apply the principles of HACCP.
Part 417.2 (c) and (d) are the regulatory requirements:

The contents of the HACCP plan. The HACCP plan shall, at a minimum:

(1) List the food safety hazards identified in accordance with paragraph (a) of this
section, which must be controlled for each process.

(2) List the critical control points for each of the identified food safety hazards,
including, as appropriate:

(i) Critical control points designed to control food safety hazards that could be
introduced in the establishment, and

(ii) Critical control points designed to control food safety hazards introduced outside the
establishment, including food safety hazards that occur before, during, and after entry
into the establishment;

(3) List the critical limits that must be met at each of the critical control points. Critical
limits shall, at a minimum, be designed to ensure that applicable targets or performance
standards established by FSIS, and any other requirement set forth in this chapter
pertaining to the specific process or product, are met;

(4) List the procedures, and the frequency with which those procedures will be
performed, that will be used to monitor each of the critical control points to ensure
compliance with the critical limits;

(5) Include all corrective actions that have been developed in accordance with §417.3(a)
of this part, to be followed in response to any deviation from a critical limit at a critical
control point; and

(6) Provide for a recordkeeping system that documents the monitoring of the critical
control points. The records shall contain the actual values and observations obtained
during monitoring.

(7) List the verification procedures, and the frequency with which those procedures will

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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 pork sausage on a six column form
(See Figure 4). You do not need to use this form, although some kind of a form is probably the
easiest way to present your HACCP plan.

Identifying CCPs

The first column on this particular form is used to enter information developed and contained on
the hazard analysis form. Part 417.2(c)(1) and (2) require that the food safety hazards identified
in the hazard analysis be listed on the HACCP plan and that there be a CCP for each identified
hazard. You will notice that there were five process steps (six food safety hazards) on the hazard
analysis form where food safety hazards reasonably likely to occur were identified: presence of
Salmonella on incoming meat products; pathogen growth at the location where meat was stored;
metal shavings contamination at grinding; metal shavings contamination carried through into
packaged product; presence of trichina in finished product being packaged and labeled; and
pathogen growth in stored finished product.

The establishment HACCP team has chosen to have five CCPs to address these six hazards:
supplier Salmonella certification review at meat receiving; temperature controls in the raw meat
storage area, and temperature controls in the finished product storage area; a metal detector on
the packaging line overseen by the packaging line supervisor; and clear product labeling to show
the product is raw and must be fully cooked to prevent any trichina survival. The metal detector
is the control for metal shavings contamination whether introduced through the packaging
process or at some earlier point.

Determining what will be the CCPs requires knowledge of HACCP, the establishment processes,
and good practical judgment. When the team gets this done, it has passed an important
milestone.

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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 knew about the pathogen reduction performance standards for Salmonella on raw carcasses
and raw ground products (Part 310.25) because they would be subject to one themselves. The
team determined that if a supplier establishment had failed two consecutive sample sets, they
would not receive that product.

They did not find any specific temperature limits which applied to red meat storage areas. The
team members knew that the Food Code, which had recently been adopted in their state,
recommended a transport temperature of 41° F; and they knew that the European Union required
a 42° F temperature. They decided that in order to be within the recommended limits for food
safety and to assure that the thermometers used which measure in 2 degree increments assured
safety, the conservative 40° F critical limit was selected.

With respect to metal shavings, the team knew that their metal detector was capable of
identifying metal shavings as small as 1/32 of an inch, as long as it was working well. Therefore
they decided that their critical limit would be 1/32 inch.

They were aware of regulatory requirements to prevent consumer confusion about which pork
products were raw. Their product did not have any ingredients that would make it appear
cooked. For their critical limit, the HACCP team decided that a label that met regulatory
requirements for raw pork products, with clear cooking instructions, plus the FSIS safe handling
label, would be their critical limits.

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-Meat control on Salmonella prevalence on incoming products, they decided
the operational personnel who normally checked arriving products would also check each
shipment for the supplier certification about Salmonella results. The team determined that this
might be an excessive frequency for suppliers with good performance, and decided that when
they validated their HACCP plan (by actually trying it out and recording results), they would
consider whether another frequency should be used.

For their two temperature CCPs, they decided that maintenance personnel would be in the best

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position to check the temperatures in the storage areas. They decided that the temperature
checks should be performed every two hours. In making this decision, the team knew that if
there was a deviation from a critical limit at a CCP, they would need to perform corrective
actions on the product which had potentially been affected by the deviation; they determined that
two hours' worth of product was the most that they wanted to control and possibly rework at one
time.

For their metal detector CCP, the HACCP team decided that the packaging line supervisor would
be in the best position to assure that the metal detector was working well and that he could do so
by putting a seeded sample through the detector every two hours. Company personnel have
worked with this metal detector for about six months and have found that when it is properly
adjusted, it works very well and meets manufacturer's specifications. However, it can get out of
alignment relatively quickly, and there are no overt signs on the machine itself that it is working
less than optimally. Putting a seeded sample through is a reliable way to assure its proper
functioning. The team decided that putting the seeded sample through every two hours was a
good frequency because they did not want to have more than two hours worth of product
which they might need to rework if there were a deviation from the critical limit of 1/32 inch.

The HACCP team decided that the best way to monitor that their labeling specifications were
being met was at non-meat receiving; at this location receiving personnel routinely checked all
incoming non-meat materials to make sure they met specifications. Since labels were
manufactured in large lots by a single company, the receiving clerks would randomly sample
each arriving lot.

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. By using the six-
column form, the team members can see that they are making good progress on developing their
plan.

The team then went on to consider appropriate verification procedures; the team knew that there
were different types of verification and that Part 417.4(a)(2) included specific regulatory
requirements for each. The regulatory requirements for ongoing verification are:

(2) Ongoing verification activities. Ongoing verification activities include, but are not
limited to:

(i) The calibration of process-monitoring instruments;

(ii) Direct observations of monitoring activities and corrective actions; and

(iii) The review of records generated and maintained in accordance with § 417.5(a)(3)

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of this part.

The HACCP team decided that they could verify the Salmonella results forwarded by suppliers
by periodically seeking results directly from FSIS. Because the sample set for pork carcasses
consisted of 51 samples, the team decided that seeking the information from FSIS every two
months would be sufficient. QA staff would initiate these data requests.

The HACCP team determined that since maintenance personnel were performing the room
temperature checks, their supervisor would be a good person to involve in verification. He will
review the temperature logs, and may either observe the employee taking the temperature or take
a temperature of his own, once per shift.

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

calibration of process-monitoring instruments; the thermometers being used to take the
temperature checks are obviously process monitoring instruments, so someone outside the
maintenance unit, in this case the Quality Assurance unit, will check those thermometers for
accuracy on a daily basis, and calibrate them to within 1 degree as necessary.

To verify the functioning of the metal detector, a QA person who is outside the packaging unit,
will feed the seeded sample through the metal detector twice per shift, once in the morning and
once in the afternoon.

Finally, the HACCP team decided that verification of the accuracy, clarity, and appropriateness
of product labels could be handled by QA personnel, who routinely sampled packaged product to
assure customer satisfaction. In this case, QA would add a verification check once a day to make
sure the labeling met requirements.

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:

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Raw, Ground Model

(1) The written hazard analysis prescribed in § 417.2(a) of this part, including all
supporting documentation;

(2) The written HACCP plan, including decision making documents associated with the
selection and development of CCPs and critical limits, and documents supporting both
the monitoring and verification procedures selected and the frequency of those
procedures.

(3) Records documenting the monitoring of CCPs and their critical limits, including the
recording of actual times, temperatures, or other quantifiable values, as prescribed in the
establishment's HACCP plan; the calibration of process-monitoring instruments;
corrective actions, including all actions taken in response to a deviation; verification
procedures and results; product code(s), product name or identity, or slaughter
production lot. Each of these records shall include the date the record was made.

(b) Each entry on a record maintained under the HACCP plan shall be made at the time
the specific event occurs and include the date and time recorded, and shall be signed or
initialed by the establishment employee making the entry.

The HACCP team decided that their records would be kept on some simple forms, some of
which the team itself devised. To monitor supplier Salmonella data, the form now used at
Receiving-Meat, had an additional box added, which would be checked. A similar simple form
modification made it easy for receiving staff to check label correctness. For monitoring
temperatures during storage of raw product and storage of finished products, the maintenance
employees performing the checks would use a Room Temperature Log. Notice that this form
can be used for both monitoring and verification temperature checks performed by maintenance
personnel; the form can be used in both the raw meat storage room and in the finished products
storage room.

Since the QA staff were heavily involved with verification activities, as they had been before
HACCP, the HACCP team sometimes modified existing forms they used, and sometimes created
simple new forms. In requesting the Salmonella data from FSIS, QA staff used a form letter that
listed the establishment numbers of their suppliers. They retained a copy of the form letter, and
when results were received, noted if the supplier had failed two consecutive sample sets. If so,
they immediately notified operational staff receiving meat to refuse shipments from that supplier,
and initiated contacts with the supplier.

QA staff already had a checklist which they used when they sampled packaged product, so the
HACCP team just added an extra box, where the presence of complete, clear, and accurate
labeling was specifically noted.

15

Raw, Ground Model

The team created a separate form to be used by the QA personnel who were checking the
thermometers and calibrating them as necessary. Each employee who was performing a
temperature check had a thermometer assigned to him which was identifiable by its serial
number. QA personnel picked up thermometers from employees throughout the day when
employees were not using them, and checked them against a known standard; recalibration was
performed immediately if it was necessary. There were only four different employees and
different thermometers being used in the HACCP monitoring and verification activities, and they
were to be checked once a day, so the HACCP team decided that this form could be used by QA
for more than one day. QA personnel were located in a different part of the plant; employees
delivered their thermometers to QA once a day immediately after they had performed a
temperature check. QA checked the thermometer and returned it to the employee with a copy of
the record showing results; in addition, QA e-mailed the results to the HACCP coordinator at the
end of each day, and each time there was a variation of more than 2° F noted when the
thermometer was checked.

The HACCP team also created a form to be used by employees with assigned tasks concerning
the functioning of the metal detector. Like the Room Temperature Log, the form includes both
monitoring and verification checks results; the form has entries from both the packaging
supervisor and from QA personnel. The form is kept near the metal detector and is turned in to
the HACCP coordinator at the end of each day.

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
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;

16

Raw, Ground Model

(3) Measures to prevent recurrence are established; and

(4) No product that is injurious to health or otherwise adulterated as a result of the

deviation enters commerce.

The HACCP team has developed a specific corrective action plan which will be followed
whenever there is a deviation from a critical limit at a CCP; each of the planned corrective
actions meets the four regulatory requirements of 417.3(a). For example, this is the
establishment's planned corrective action whenever there is a deviation from the 1/32 inch
critical limit, i.e. whenever the packaging supervisor puts the seeded sample through the system
and the metal detector does not respond appropriately.

Planned Corrective Actions for CCP 5P

1. Packaging Supervisor takes control of and segregates all product which may have been
processed when metal detector not functioning, i.e. all product processed since the last
complying monitoring check;

2. Maintenance personnel identify problem with the metal detector and repair it so that the same
problem does not recur in the near future; maintenance personnel plan preventive maintenance
checks;

3. QA runs a seeded sample through the repaired system and verifies that it is functioning
correctly;

4. QA runs possibly adulterated product through the repaired system, and releases only that
which complies; other product is returned for rework/condemnation.

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

17

Raw, Ground Model

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
pork sausage production process. They have secured a copy of FSIS Directive 5000.1,
Enforcement of Regulatory Requirements in Establishments Subject to HACCP System
Requirements, the HACCP Basic Compliance Checklist which will be used by inspection
program personnel. The HACCP team has modified the inspection form to make the statements
into positives, and now has a checklist for its own use to make sure they have not omitted
anything in their plan development and preparation. When they are confident that they have done
what is necessary, they will turn their Hazard Analysis and HACCP Plan over to the
establishment owner for decisions about implementation.

18

Raw, Ground Model

APPENDIX A

19

Raw, 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:

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Raw, Ground Model

Chapter 10 – raw meat and poultry, pp. 176-193

Chapter 11 – roast beef, pp. 234-238

Chapter 11 – canned ham, pp. 238-242

11. International Commission on Microbiological Specification for Foods. Microorganisms in

Foods 4. Application of Hazard Analysis and Critical Control Point (HACCP) Systems to
Ensure Microbiological Safety and Quality. Blackwell Scientific Publications, Boston, 1989

12. National Advisory Committee on Microbiological Criteria for Foods. March 20, 1992 --
Hazard Analysis and Critical Control Point System. Int. J. Food Microbiol. 16: 1-23, 1993.

13. National Advisory Committee on Microbiological Criteria for Foods. Adopted August 14,
1997-- Hazard Analysis and Critical Control Point Principles and Application Guidelines. J.
Food Protect. 61(9): 1246-1259, 1998.

14. National Advisory Committee on Microbiological Criteria for Foods. DRAFT document -
FSIS Microbiological Hazard Identification Guide for Meat and Poultry Components of
Products Produced by Very Small Plants. 1-22, August 1999.

15. National Advisory Committee on Microbiological Criteria for Foods. June 1993 -- Report
on Generic HACCP for Raw Beef. Food Microbiol. 10: 449-488, 1994.

16. National Research Council. An Evaluation of the Role of Microbiological Criteria for Foods
and Food Ingredients. National Academy Press, Washington, D.C., 1985.

Useful sections in particular are:

Chapter 4 – microbiological hazards, pp. 72-103
Chapter 9 – raw meat, pp. 193-199
Chapter 9 – processed meats, pp. 199-216

17. Notermans, S., et al. The HACCP Concept: Identification of Potentially Hazardous
Microorganisms. Food Microbiol. 11:203-214, 1994.

18. Pierson M.D. and Dutson, T. Editors. HACCP in Meat, Poultry, and Fish Processing.
Blackie Academic & Professional. Glasgow, 1995.

Useful sections in particular are:

Chapter 4 – meat and poultry slaughter, pp. 58-71
Chapter 5 – processed meats, pp. 72-107
Chapter 7 – risk analysis, pp. 134-154

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Raw, Ground Model

Chapter 13 – predictive modeling, pp. 330-354

19. Pierson, M.D. and Corlett, D.A., Jr. Editors. HACCP Principles and Applications. Van
Nostrand Reinhold, New York, 1992.

20. Stevenson, K.E. and Bernard, D.T. Editors. HACCP: Establishing Hazard Analysis Critical
Control Point Programs., A Workshop Manual. The Food Processors Institute, Washington,
D.C., 1995.

Useful sections in particular are:

Chapter 11 – forms for hazard analysis, CCPs, critical limits, HACCP master
sheet, example HACCP for breaded chicken

21. Stevenson, K.E. and Bernard, D.T. Editors. HACCP: A Systematic Approach to Food
Safety. 3rd Edition. The Food Processors Institute, Washington, D.C., 1999.

22. Tompkin, R.B. The Use of HACCP in the Production of Meat and Poultry Products.
J. Food Protect. 53(9): 795-803, 1990.

23. Tompkin, R.B. The Use of HACCP for Producing and Distributing Processed Meat and
Poultry Products. In Advances in Meat Research. Volume 10. Hazard Analysis Critical
Control Point in Meat, Poultry and Seafoods. Chapman & Hall, 1995.

References for Raw, Ground Meat and Poultry Products

Part I – Prevalence of Pathogens Found in Ground Beef and Fresh Pork Sausage

1. Abdel-Rahman, H., El-Khateib, T.E. and El-Timmawy, A.K. Spoilage and food poisoning
organisms in frozen ground beef. Fleischwirtschaft 68(7):881-882, 1988.

2. Adesiyun, A. A. Prevalence of Listeria spp., Campylobacter spp., Salmonella spp., Yersinia

spp. and toxigenic Escherichia coli on meat and seafoods in Trinidad. Food Microbiology
10(5):395-403, 1993.

3. Chapman, P. A., et al. Cattle as a possible source of verocytotoxin-producing Escherichia

coli 0157 infections in man. Epidemiology and Infection 111(3):439-447, 1993.

4. Comi, G., et al. Listeria monocytogenes serotypes in Italian meat products. Letters-in-
Applied-Microbiology 15(4):168-171, 1992.

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Raw, Ground Model

5. Doyle, M. P. Escherichia coli 0157:H7 and its significance in foods. International J. Food
Microbiol. 12(4):289-301, 1991.

6. Duitschaever, C. L. and Buteau, C. I. Incidence of Salmonella in pork and poultry Products.

J. Food Protect. 42(8):662-663, 1979.

7. Johnston, R. W., et al. Incidence of Salmonella in fresh pork sausage in 1979 compared with
1969. J. Food Science 47(4):1369-1371, 1982.

8. Ladiges, W. C. and Foster, J.F. Incidence of Salmonella in beef and chicken. J. Milk Food
Technol. 37(4):213-214, 1974.

9. Lior, H. Escherichia coli 0157:H7 verotoxigenic Escherichia coli (VTEC). Dairy, Food and
Environmental Sanitation 14(7):378-382, 1994.

10. McLauchlin, J., et al. Listeriosis and food-borne transmission. Lancet I(8578):177-178,
1988.

11. Mermelstein, N. H. Controlling E. coli 0157:H7 in meat. Food Technol. 47(4):90-91, 1993.

12. Read, S. C., et al. Prevalence of verocytotoxigenic Escherichia coli in ground beef, pork,
and chicken in southwestern Ontario. Epidemiol. Infect. 105:11-20, 1990.

13. Rindi, S., Cerri, D., and Gerardo, B. Thermophilic Campylobacter in fresh pork sausages.
Industrie-Alimentari 25(241):648-650, 1986.

14. Riley, L. W. The epidemiologic, clinical, and microbiologic features of hemorrhagic colitis.
Ann. Rev. Microbiol. 41:383-407, 1987.

15. Samadpour, M., et al. Occurrence of Shiga-like toxin-producing Escherichia coli in retail
fresh seafood, beef, lamb, pork, and poultry from grocery stores in Seattle, Washington.
Appl. Environ. Microbiol. 60(3):1038-1040, 1994.

16. Schuchat, A., Swaminathan, B. and Broome, C. V. Epidemiology of human listeriosis. Clin.
Micro. Rev. 4(2):169-183, 1991.
17. Silas, J. C., et al. Update: prevalence of Salmonella in pork sausage. J. Animal Science
59(1):122-124, 1984.

18. Surkiewicz, B. F., et al. Bacteriological survey of fresh pork sausage produced at

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Raw, Ground Model

establishments under federal inspection. Appl. Microbiol 23(3):515-520, 1972.

19. Surkiewicz, B. F., et al. Bacteriological survey of raw beef patties produced at
establishments under federal inspection. Appl. Microbiol. 29(3):331-334, 1975.

20. Tarr, P. I. Review of 1993 Escherichia coli 0157:H7 outbreak: Western United States.
Dairy, Food and Environmental Sanitation 14(7):372-373, 1994.

21. Vorster, S. M., et al. Incidence of Staphylococcus aureus and Escherichia coli in ground
beef, broilers and processed meats in Pretoria, South Africa. J. Food Protect. 57(4):305-310,
1994.

22. Warnken, M. B., et al. Incidence of Yersinia species in meat samples purchased in Rio de
Janeiro, Brazil. J. Food Protect. 50(7):578-579, 1987.

23. Weissman, M. A. and Carpenter, J. A. Incidence of Salmonellae in meat and meat products.
App. Micro. 17(6):899-902, 1969.

Part II - Effects of Processing Procedures on the Growth of Pathogens

1. Ayres, J. C. Salmonella in meat products. Proceedings of the 31st Annual Reciprocal Meat
Conference. pp. 148-155, 1979.

2. Buchanan, R. L. and Klawitter, L. A. The effect of incubation temperature, initial pH, and
sodium chloride on the growth kinetics of Escherichia coli 0157:H7. Food Microbiol. 9:185-
196, 1992.

3. Conner, D. E., et al. Heat Resistance of Escherichia coli 0157:H7 in low-fat meat and
poultry products. Highlights of Agriculture Research 40:11, 1993.

4. Crespo, F. L. and Ockerman, H. W. Thermal destruction of microorganisms in meat by

microwave and conventional cooking. J. Food Protect. 40(7):442-444, 1977.

5. Doyle, M. P. and Schoeni, J. L. Isolation of Escherichia coli 0157:H7 from retail fresh
meats and poultry. Appl. Environ. Microbiol. 53(10):2394-2396, 1987.

6. Doyle, M.P. and Schoeni, J. L. Survival and growth characteristics of Escherichia coli
associated with hemorrhagic colitis. Appl. Environ. Microbiol. 48(4):855-856, 1984.

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Raw, Ground Model

7. El-Kest, S., et al. Fate of Listeria monocytogenes during freezing and frozen storage. J Food
Science 56(4):1068-1071, 1991.

8. Fain, A.R., et al. Lethality of heat to Listeria monocytogenes Scott A: D-value and z-value
determinations in ground beef and turkey. J. Food Protect. 54(10)756-761, 1991.

9. Goepfert, J.M., and Kim, H. U. Behavior of selected food-borne pathogens in raw ground
beef. J. Milk Food Technol. 38(8):449-452, 1975.

10. Harris, L.J., and Stiles, M. E. Reliability of Escherichia coli counts for vacuum-packaged
ground beef. J. Food Protect. 55(4):266-270, 1992.

11. Kotula, A.W., et al. Trichinella spiralis: Effect of high temperature on infectivity of pork.
Experimental Parasitol. 56:15-19, 1983.

12. Kotula, A.W., et al. Destruction of Trichinella spiralis during cooking. J. Food Science
48:765-768, 1983.

13. Line, J.E., et al. Lethality of heat to Escherichia coli 0157:H7: D-value and z-value
determinations in ground beef. J. Food Protect. 54(10):762-766, 1991.

14. Linton, R.H., Pierson, M. D. and Bishop, J. R. Increase in heat resistance of Listeria
monocytogenes Scott A by sublethal heat shock. J. Food Protect. 53(11):924-927, 1990.

15. Palumbo, S.A., et al. Influence of temperature on hemorrhagic Escherichia coli: Verotoxin
production and minimum temperature of growth. (81st Annual Meeting of IAMFES) Dairy
Food Environ. Sanitation pp. 612, 1994.

16. Schoeni, J.L., Brunner, K. and Doyle, M. P. Rates of thermal inactivation of Listeria
monocytogenes in beef and fermented beaker sausage. J. Food Protect. 54(5):334-337, 1991.

17. Todd, E., et al. E.C.C. Todd and J.M. MacKenzie (Ed.). Thermal resistance of verotoxigenic
Escherichia coli in ground beef – Initial work in Escherichia coli 0157:H7 and other
verotoxigenic E. coli in foods. pp. 93-109, 1991.

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Raw, Ground Model

APPENDIX B

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Raw, Ground Model

PROCESS FLOW DIAGRAM Figure 1

PROCESS CATEGORY: RAW PRODUCT, GROUND

PRODUCT: FRESH PORK SAUSAGE

RECEIVING RECEIVING
PACKAGING NONMEAT RECEIVING
MATERIALS INGREDIENTS MEAT

STORAGE STORAGE
NONMEAT MEAT (COLD)
INGREDIENTS

ASSEMBLE/
PREWEIGH GRIND/BLEND ASSEMBLE/
NONMEAT WEIGH MEAT
INGREDIENTS

STORAGE
PACKAGING SAUSAGE
MATERIALS STUFFER REWORK

PACKAGING/
LABELING

FINISHED
PRODUCT
STORAGE
(COLD)

SHIPPING

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PRODUCT DESCRIPTION Figure 2

PROCESS CATEGORY: RAW PRODUCT, GROUND

PRODUCT: FRESH PORK SAUSAGE

1. COMMON NAME? FRESH PORK SAUSAGE

2. HOW IS IT TO BE USED? COOKED AND CONSUMED

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? RETAIL AND HRI, WHOLESALE

CONSUMERS? GENERAL PUBLIC, NO
INTENDED USE? DISTRIBUTION TO SCHOOLS OR
HOSPITALS

6. LABELING INSTRUCTIONS? KEEP REFRIGERATED; COOKING

INSTRUCTIONS (MINIMUM
INTERNAL TEMPERATURE FOR
COOKING); SAFE FOOD
HANDLING LABEL

7. IS SPECIAL DISTRIBUTION KEEP REFRIGERATED

CONTROL NEEDED?

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Raw, Ground Model

HAZARD ANALYSIS – RAW PRODUCT, GROUND – Fresh Pork Sausage

Process Step Food Safety Reasonably Basis If Yes in Column 3, Critical Control
Hazard Likely to What Measures Could Point
Occur? be Applied to Prevent,
Eliminate, or Reduce
the Hazard to an
Acceptable Level?
Receiving – Meat Biological: Pathogens Yes Salmonella may be Certification from suppliers 1B
–Salmonella and present on incoming raw that product has been
Other pathogens in product. sampled for Salmonella and
pork trimmings meets performance
standards.
Chemical – None
Physical – Foreign No Plant records show that
materials there has been no
incidence of foreign
materials in products
received into the plant.
Receiving – Nonmeat Biological – None
Ingredients/Packaging Chemical – Not No Letters of guaranty are
Materials acceptable for received from all
intended use suppliers of nonmeat
ingredients and
packaging materials.
Physical – metal, No Plant records
glass, wood demonstrate that foreign
material contamination
has not occurred during
the past several years.
Figure 3

29

Raw, Ground Model

HAZARD ANALYSIS – RAW PRODUCT, GROUND

Process Step Food Safety Reasonably Basis If Yes in Column 3, Critical Control
Hazard Likely to What Measures Could Point
Occur? be Applied to Prevent,
Eliminate, or Reduce
the Hazard to an
Acceptable Level?
Storage (Cold) - Meat Biological – Pathogens Yes Pathogens are Maintain product 2B
Salmonella reasonably likely to temperature at or below a
grow in this product if level sufficient to preclude
temperature is not pathogen growth.
maintained at or below
a level sufficient to
preclude the growth.
Chemical – None
Physical – None
Storage – Nonmeat Biological – None
Ingredients/Packaging Chemical – None
Materials Physical - None
Assemble/Pre-weigh Biological – None
Nonmeat Ingredients Chemical- None
Physical – None
Assemble/ Weigh Meat Biological – None
Chemical – None
Physical – None
Figure 3

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Raw, Ground Model

HAZARD ANALYSIS – RAW PRODUCT, GROUND

Process Step Food Safety Reasonably Basis If Yes in Column 3, Critical Control
Hazard Likely to What Measures Could Point
Occur? be Applied to Prevent,
Eliminate, or Reduce
the Hazard to an
Acceptable Level?
Grind/Blend Biological - None
Chemical – None
Physical – Metal Yes Plant records show that Maintenance of grinder
contamination during the grinding blades and plates can
process metal preclude metal
contamination may contamination .
occur. Routine examination during
equipment breakdown.
There will be a metal
detector at packaging.
Sausage Stuffer Biological – None
Chemical – None
Physical - None
Rework Biological – Pathogens Yes Use of rework can Rework left at the end of the
Staphylococcus aureus provide a medium for day is condemned or used in
pathogen growth. a cooked product at the
plant.
Chemical- None
Physical – None
Figure 3

31

Raw, Ground Model

HAZARD ANALYSIS – RAW PRODUCT, GROUND

Process Step Food Safety Reasonably Basis If Yes in Column 3, Critical Control
Hazard Likely to What Measures Could Point
Occur? be Applied to Prevent,
Eliminate, or Reduce
the Hazard to an
Acceptable Level?
Packaging/Labeling Biological: Pathogens Yes Trichina has Labels that clearly indicate 3B
– parasitic (Trichina) historically occurred in this is a raw product, along
raw pork products. with cooking instructions,
and the safe food handling
statement.
Chemical – None
Physical – Metal Yes Metal contamination Functional metal detector is 4P
contamination that may have come on-line in the
into the establishment packaging/labeling area to
with raw product or remove product with metal
occurred during the contamination.
grinding and stuffing
process.
Finished Product Biological – Pathogens Yes Pathogens are Maintain product 5B
Storage (Cold) Salmonella reasonably likely to temperature at or below a
Staphylococcus aureus grow in this product if level sufficient to preclude
temperature is not pathogen growth.
maintained at or below
a level sufficient to
preclude their growth.
Chemical – None
Physical - None
Figure 3

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Raw, Ground Model

HAZARD ANALYSIS – RAW PRODUCT, GROUND

Process Step Food Safety Reasonably Basis If Yes in Column 3, Critical Control
Hazard Likely to What Measures Could Point
Occur? be Applied to Prevent,
Eliminate, or Reduce
the Hazard to an
Acceptable Level?
Shipping Biological – None
Chemical- None
Physical – None
Figure 3

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Raw, Ground Model

HACCP PLAN
PROCESS CATEGORY: RAW PRODUCT, GROUND
PRODUCT EXAMPLE: FRESH PORK SAUSAGE
CCP # and Critical Monitoring HACCP Verification Procedures and Corrective Actions
Location Limits Procedures and Records Frequency
Frequency
1B Supplier Receiving personnel Receiving Log Every two months QA will request Will not receive product
Receiving – certification will check each FSIS Salmonella data results from the unaccompanied by Salmonella
Meat that product shipment for company for at least 2 suppliers. certification.
Salmonella meets FSIS Salmonella If product does not have certification, it
and other performance certification. is rejected or returned.
pathogens in standard for Assure that procedures for only
raw pork Salmonella guaranteed supplier list is kept current
trimming. must and guaranty on file in
accompany shipping /receiving log. If supplier
shipment. does not meet FSIS performance
standards product will not be purchased
from them until they can maintain
bacterial levels meeting performance
standard.
2B Raw product Maintenance Room Maintenance supervisor will verify QA will reject or hold meat until
Storage - storage area personnel will record Temperature Log accuracy of the Room Temperature Log time/temperature deviation and its
(Cold) Meat shall not raw product storage once per shift and observe plant implications are reviewed. Product
exceed 40° F. area temperature Corrective employee performing monitoring. disposition will depend on this expert
every 2 hours, initial / Action Log review.
sign and date log. QA will check all thermometers used QA will identify the cause of the
Thermometer for monitoring devices for their deviation and devise measures to
Calibration Log accuracy and verify to within 2° F on a prevent reoccurrence.
daily basis. Maintenance will adjust scheduled
cooler upkeep & review if necessary or
repair any malfunctioning equipment.

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Signature : _______________________________ Date:___________________________ Figure 4

HACCP PLAN
PROCESS CATEGORY: RAW PRODUCT, GROUND
PRODUCT EXAMPLE: FRESH PORK SAUSAGE
CCP # and Critical Monitoring HACCP Verification Procedures and Corrective Actions
Location Limits Procedures and Records Frequency
Frequency
3B Product must Packaging line Corrective QA will observe packaging line QA will segregate and hold all affected
Packaging/ clearly be supervisor will select Action Log supervisor perform monitoring activity product.
Labeling labeled as 2 packages of product once per shift.
(Trichina) raw – Cook hourly and ensure Labeling Log QA will ensure that proper labeling is
before eating labeling requirements QA will select 3 labels intended for use applied to all affected product prior to
are met. from label storage area twice weekly to shipment.
Cooking ensure label accuracy.
instructions QA will determine cause of deviation
that state QA will check labels once a day on and institute preventive action.
“cook to packaged product to ensure accurate
145°F” must labels are placed on packaged product.
be on
package.

Safe food
handling
statement
must be part
of label.

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Signature : ________________________________ Date:___________________________ Figure 4

HACCP PLAN
PROCESS CATEGORY: RAW PRODUCT, GROUND
PRODUCT EXAMPLE: FRESH PORK SAUSAGE
CCP # and Critical Monitoring HACCP Verification Procedures and Corrective Actions
Location Limits Procedures and Records Frequency
Frequency
4P No metal Packaging line Metal Detection QA, outside the packaging unit, will Packaging supervisor will control and
Packaging/ particles to supervisor will check Control Log verify that the metal detector is segregate affected product.
Labeling exceed 1/32 the metal detector functioning as intended by running the
inch. using a seeded Corrective seeded sample through the metal Maintenance personnel will identify
sample every two Action Log detector twice per shift (once AM, once and eliminate any problems with the
All hours to determine PM). metal detector or kick out mechanism.
contaminated limits are not Preventive maintenance program will
product is exceeded. be implemented.
removed from
system by QA will run seeded sample through
functioning detector after repair.
kick out
mechanism. All potentially contaminated product
All kick out will be run through functional metal
product will detector prior to shipment.
be visually
examined and All product rejected by detector will be
any metal reworked.
removed.

Signature : ________________________________ Date:___________________________ Figure 4

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HACCP PLAN
PROCESS CATEGORY: RAW PRODUCT, GROUND
PRODUCT EXAMPLE: FRESH PORK SAUSAGE
CCP # Critical Monitoring HACCP Verification Procedures and Corrective Actions
and Limits Procedures and Records Frequency
Location Frequency
5B Finished Maintenance Room Maintenance supervisor will verify the If a deviation from a critical limit
Finished product personnel will check Temperature Log accuracy of the room temperature log occurs, the following corrective actions
Product storage area finished product once per shift. will be taken:
Storage shall not storage area Corrective
(Cold) exceed 40° F. temperature every Action Log QA will check all thermometers used 1. Product which may not have met
two hours. for monitoring and verification CL will be identified and held.
(Continued Thermometer activities for accuracy daily and 2. The cause of the temperature
on next Calibration Log calibrate to within 2° F accuracy as exceeding 40° F will be identified
page) necessary. and eliminated.
3. The CCP will be monitored hourly
QA will observe maintenance personnel after the corrective action is taken
check finished product storage area to ensure that it is under control.
once per shift. 4. 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

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HACCP PLAN
PROCESS CATEGORY: RAW PRODUCT, GROUND
PRODUCT EXAMPLE: FRESH PORK SAUSAGE
CCP # and Critical Monitoring HACCP Verification Procedures and Corrective Actions
Location Limits Procedures and Records Frequency
Frequency
5B If a deviation from a critical limit
Finished occurs, the following corrective actions
Product will be taken:
Storage 5. If room temperature exceeds the
(Cold) critical limit, the processing
authority will evaluate the product
temperature to ensure the
temperature is sufficient to
preclude pathogen growth prior to
shipment. If temperature is not
sufficient to preclude pathogen
growth, product will be cooked in
the establishment to ensure
destruction of pathogens.

Signature : ________________________________ Date:___________________________ Figure 4

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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 Test Results Two Consecutive

Received Failed Tests

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GENERIC ESTABLISHMENT X: ROOM TEMPERATURE LOG

ROOM:__________ DATE:_________

TIME TEMP Deviation from If Yes, Monitored by: Verified by:

CL? (Check if yes) Action?

6:36 AM 34°F PS

8:30 AM 33°F PS

10:32 34°F PS
AM
CB
12:30 PM 49°F  Notify maintenance supervisor, CB & QA PS

TIME/TEMPERATURE CRITICAL LIMIT --- 40°F

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THERMOMETER CALIBRATION LOG

Criteria Within ∀1 °F of Control Thermometer

Date Time Department or Thermometer ID# Control Personal Adjustment Initials Comments
Area Thermometer Thermometer Required (Yes
Reading Reading or No)
6/15 1:00 PM Chiller 2A 32°F 32°F No HK

* If a thermometer is broken or taken out of service, document this in the comment column.

Verified by: _______________________

Date/Time: _______________________

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GENERIC ESTABLISHMENT X: METAL DETECTION LOG

Date Product Lot # Results Seeded Time Monitored By Verified By

Sample

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CORRECTIVE ACTIONS LOG

Product: ___________________________________________ Lot # ______________________

CCP Deviation/ Corrective Action Disposition of Responsible Time

Problem Procedures/Explain Product Person

SIGNATURE: __________________________ DATE: ______________________

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PRE-SHIPMENT REVIEW LOG

Date:______________

LOT ID TIME BY WHOM LOT RELEASED FOR COMMENTS

RECORDS SHIPMENT?
REVIEWED SIGNATURE

11:10 a.m.

11:10 p.m.

*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

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