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## 

## United States

## Department of

**Agriculture**

### Food Safety

and Inspection

Service

September 1999

### HACCP-3 

## Generic HACCP

## Model for Raw, 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>

United States Food Safety Washington,
D.C.![](media/image2.png){width="0.4979166666666667in"
height="0.48819444444444443in"}

> Department of and Inspection 20250

Agriculture Service

> September 8, 1999

**[TO THE USERS OF THESE VOLUMES]{.underline}**

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

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.

# 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

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

# 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]{.underline}. (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 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.

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.

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]{.underline}. Procedures to be followed when a
deviation occurs.*

> *[Critical control point]{.underline}. 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]{.underline}. 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]{.underline}. Any biological, chemical, or
> physical property that may cause a food to be unsafe for human
> consumption.*

*[HACCP System]{.underline}. The HACCP plan in operation, including the
HACCP plan itself.*

*[Hazard]{.underline}. SEE Food Safety Hazard.*

> *[Preventive measure]{.underline}. Physical, chemical, or other means
> that can be used to control an identified food safety hazard.*
>
> *[Process‑monitoring instrument]{.underline}. An instrument or device
> used to indicate conditions during processing at a critical control
> point.*
>
> *[Responsible establishment official]{.underline}. 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.

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.***
>
> *(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.

**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 12^th^ 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/index.htm](http://www.fsis.usda.gov/OPPDE/NIS/index.htm).**

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 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]{.underline}. 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 be performed, that the establishment will use in
> accordance with § 417.4 of this part.*
>
> *(d) [Signing and dating the HACCP plan]{.underline}. (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.

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 position to check the temperatures in the storage
areas. They decided that the temperature checks should be performed
every [two]{.underline} 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) 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:*
>
> *(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.

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;*
>
> *(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 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.

### 

### 

### 

### **APPENDIX A**

# 

# 

# 

# 

# 

# 

# 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
>
> Chapter 11 -- canned ham, pp. 238-242

11. International Commission on Microbiological Specification for Foods.
    *Microorganisms in Foods 4. Application of Hazard Analysis and
    Critical Control Point (HACCP) Systems to Ensure Microbiological
    Safety and Quality*. Blackwell Scientific Publications, Boston, 1989

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

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

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

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

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

Useful sections in particular are:

###  Chapter 4 -- microbiological hazards, pp. 72-103

## Chapter 9 -- raw meat, pp. 193-199

##  Chapter 9 -- processed meats, pp. 199-216

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

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

> Useful sections in particular are:
>
> Chapter 4 -- meat and poultry slaughter, pp. 58-71
>
> Chapter 5 -- processed meats, pp. 72-107
>
> Chapter 7 -- risk analysis, pp. 134-154
>
> Chapter 13 -- predictive modeling, pp. 330-354

19. Pierson, M.D. and Corlett, D.A., Jr. Editors. *HACCP Principles and
    Applications*. Van 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, 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.

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-

78, 1988.

11\. Mermelstein, N. H. *Controlling E. coli 0157:H7 in meat*. Food
Technol. 47(4):90-91, 993.

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 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 31^st^
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.

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.* (81^st^ 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.

### **APPENDIX B** 

#### PROCESS FLOW DIAGRAM Figure 1

**PROCESS CATEGORY: RAW PRODUCT, GROUND**

##### PRODUCT: FRESH PORK SAUSAGE

> **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?                                                       |
+-----------------------------------------------------------------------+

**HAZARD ANALYSIS -- RAW PRODUCT, GROUND -- Fresh Pork Sausage**

+-----------+-----------+--------+-----------+-------------+----------+
| Process   | **Food    | **Reas | **Basis** | **If Yes in | **       |
| Step      | Safety    | onably |           | Column 3,   | Critical |
|           | Hazard**  | Likely |           | What        | Control  |
|           |           | to     |           | Measures    | Point**  |
|           |           | Oc     |           | Could be    |          |
|           |           | cur?** |           | Applied to  |          |
|           |           |        |           | Prevent,    |          |
|           |           |        |           | Eliminate,  |          |
|           |           |        |           | or Reduce   |          |
|           |           |        |           | the Hazard  |          |
|           |           |        |           | to an       |          |
|           |           |        |           | Acceptable  |          |
|           |           |        |           | Level?**    |          |
+-----------+-----------+--------+-----------+-------------+----------+
| **        | **Bi      | *      | ***Sa     | **Ce        | **1B**   |
| Receiving | ological: | *Yes** | lmonella* | rtification |          |
| -- Meat** | Pathogens |        | may be    | from        |          |
|           | --***S    |        | present   | suppliers   |          |
|           | almonella |        | on        | that        |          |
|           | **and***  |        | incoming  | product has |          |
|           |           |        | raw       | been        |          |
|           | **Other   |        | p         | sampled for |          |
|           | pathogens |        | roduct.** | *           |          |
|           | in pork   |        |           | Salmonella* |          |
|           | tr        |        |           | and meets   |          |
|           | immings** |        |           | performance |          |
|           |           |        |           | s           |          |
|           |           |        |           | tandards.** |          |
+-----------+-----------+--------+-----------+-------------+----------+
|           | *         |        |           |             |          |
|           | *Chemical |        |           |             |          |
|           | -- None** |        |           |             |          |
+-----------+-----------+--------+-----------+-------------+----------+
|           | *         | **No** | **Plant   |             |          |
|           | *Physical |        | records   |             |          |
|           | --        |        | show that |             |          |
|           | Foreign   |        | there has |             |          |
|           | ma        |        | been no   |             |          |
|           | terials** |        | incidence |             |          |
|           |           |        | of        |             |          |
|           |           |        | foreign   |             |          |
|           |           |        | materials |             |          |
|           |           |        | in        |             |          |
|           |           |        | products  |             |          |
|           |           |        | received  |             |          |
|           |           |        | into the  |             |          |
|           |           |        | plant.**  |             |          |
+-----------+-----------+--------+-----------+-------------+----------+
| **        | **B       |        |           |             |          |
| Receiving | iological |        |           |             |          |
| --        | -- None** |        |           |             |          |
| Nonmeat   |           |        |           |             |          |
| Ing       |           |        |           |             |          |
| redients/ |           |        |           |             |          |
| Packaging |           |        |           |             |          |
| Ma        |           |        |           |             |          |
| terials** |           |        |           |             |          |
+-----------+-----------+--------+-----------+-------------+----------+
|           | *         | **No** | **Letters |             |          |
|           | *Chemical |        | of        |             |          |
|           | -- Not    |        | guaranty  |             |          |
|           | a         |        | are       |             |          |
|           | cceptable |        | received  |             |          |
|           | for       |        | from all  |             |          |
|           | intended  |        | suppliers |             |          |
|           | use**     |        | of        |             |          |
|           |           |        | nonmeat   |             |          |
|           |           |        | in        |             |          |
|           |           |        | gredients |             |          |
|           |           |        | and       |             |          |
|           |           |        | packaging |             |          |
|           |           |        | mat       |             |          |
|           |           |        | erials.** |             |          |
+-----------+-----------+--------+-----------+-------------+----------+
|           | *         | **No** | **Plant   |             |          |
|           | *Physical |        | records   |             |          |
|           | -- metal, |        | de        |             |          |
|           | glass,    |        | monstrate |             |          |
|           | wood**    |        | that      |             |          |
|           |           |        | foreign   |             |          |
|           |           |        | material  |             |          |
|           |           |        | cont      |             |          |
|           |           |        | amination |             |          |
|           |           |        | has not   |             |          |
|           |           |        | occurred  |             |          |
|           |           |        | during    |             |          |
|           |           |        | the past  |             |          |
|           |           |        | several   |             |          |
|           |           |        | years.**  |             |          |
+-----------+-----------+--------+-----------+-------------+----------+

######## Figure 3 

**HAZARD ANALYSIS -- RAW PRODUCT, GROUND**

+-----------+-----------+--------+-----------+-------------+-----------+
| **Process | **Food    | **Reas | **Basis** | **If Yes in | *         |
| Step**    | Safety    | onably |           | Column 3,   | *Critical |
|           | Hazard**  | Likely |           | What        | Control   |
|           |           | to     |           | Measures    | Point**   |
|           |           | Oc     |           | Could be    |           |
|           |           | cur?** |           | Applied to  |           |
|           |           |        |           | Prevent,    |           |
|           |           |        |           | Eliminate,  |           |
|           |           |        |           | or Reduce   |           |
|           |           |        |           | the Hazard  |           |
|           |           |        |           | to an       |           |
|           |           |        |           | Acceptable  |           |
|           |           |        |           | Level?**    |           |
+-----------+-----------+--------+-----------+-------------+-----------+
| **Storage | **B       | *      | **        | **Maintain  | **2B**    |
| (Cold) -  | iological | *Yes** | Pathogens | product     |           |
| Meat**    | --        |        | are       | temperature |           |
|           | Pa        |        | r         | at or below |           |
|           | thogens** |        | easonably | a level     |           |
|           |           |        | likely to | sufficient  |           |
|           | ***Salm   |        | grow in   | to preclude |           |
|           | onella*** |        | this      | pathogen    |           |
|           |           |        | product   | growth.**   |           |
|           |           |        | if        |             |           |
|           |           |        | te        |             |           |
|           |           |        | mperature |             |           |
|           |           |        | is not    |             |           |
|           |           |        | m         |             |           |
|           |           |        | aintained |             |           |
|           |           |        | at or     |             |           |
|           |           |        | below a   |             |           |
|           |           |        | level     |             |           |
|           |           |        | s         |             |           |
|           |           |        | ufficient |             |           |
|           |           |        | to        |             |           |
|           |           |        | preclude  |             |           |
|           |           |        | the       |             |           |
|           |           |        | growth.** |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | *         |        |           |             |           |
|           | *Chemical |        |           |             |           |
|           | -- None** |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | *         |        |           |             |           |
|           | *Physical |        |           |             |           |
|           | -- None** |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
| **Storage | **B       |        |           |             |           |
| --        | iological |        |           |             |           |
| Nonmeat   | -- None** |        |           |             |           |
| Ing       |           |        |           |             |           |
| redients/ |           |        |           |             |           |
| Packaging |           |        |           |             |           |
| Ma        |           |        |           |             |           |
| terials** |           |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | *         |        |           |             |           |
|           | *Chemical |        |           |             |           |
|           | -- None** |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | **P       |        |           |             |           |
|           | hysical - |        |           |             |           |
|           | None**    |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
| **        | **B       |        |           |             |           |
| Assemble/ | iological |        |           |             |           |
| Pre-weigh | -- None** |        |           |             |           |
| Nonmeat   |           |        |           |             |           |
| Ingr      |           |        |           |             |           |
| edients** |           |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | **        |        |           |             |           |
|           | Chemical- |        |           |             |           |
|           | None**    |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | *         |        |           |             |           |
|           | *Physical |        |           |             |           |
|           | -- None** |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
| **        | **B       |        |           |             |           |
| Assemble/ | iological |        |           |             |           |
| Weigh     | -- None** |        |           |             |           |
| Meat**    |           |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | *         |        |           |             |           |
|           | *Chemical |        |           |             |           |
|           | -- None** |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | *         |        |           |             |           |
|           | *Physical |        |           |             |           |
|           | -- None** |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+

> Figure 3

**HAZARD ANALYSIS -- RAW PRODUCT, GROUND**

+-----------+-----------+--------+-----------+-------------+-----------+
| **Process | **Food    | **Reas | **Basis** | **If Yes in | *         |
| Step**    | Safety    | onably |           | Column 3,   | *Critical |
|           | Hazard**  | Likely |           | What        | Control   |
|           |           | to     |           | Measures    | Point**   |
|           |           | Oc     |           | Could be    |           |
|           |           | cur?** |           | Applied to  |           |
|           |           |        |           | Prevent,    |           |
|           |           |        |           | Eliminate,  |           |
|           |           |        |           | or Reduce   |           |
|           |           |        |           | the Hazard  |           |
|           |           |        |           | to an       |           |
|           |           |        |           | Acceptable  |           |
|           |           |        |           | Level?**    |           |
+-----------+-----------+--------+-----------+-------------+-----------+
| **Grin    | **Bio     |        |           |             |           |
| d/Blend** | logical - |        |           |             |           |
|           | None**    |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | *         |        |           |             |           |
|           | *Chemical |        |           |             |           |
|           | -- None** |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | *         | *      | **Plant   | **          |           |
|           | *Physical | *Yes** | records   | Maintenance |           |
|           | -- Metal  |        | show that | of grinder  |           |
|           | contam    |        | during    | blades and  |           |
|           | ination** |        | the       | plates can  |           |
|           |           |        | grinding  | preclude    |           |
|           |           |        | process   | metal       |           |
|           |           |        | metal     | co          |           |
|           |           |        | cont      | ntamination |           |
|           |           |        | amination | .**         |           |
|           |           |        | may       |             |           |
|           |           |        | occur.**  | **Routine   |           |
|           |           |        |           | examination |           |
|           |           |        |           | during      |           |
|           |           |        |           | equipment   |           |
|           |           |        |           | b           |           |
|           |           |        |           | reakdown.** |           |
|           |           |        |           |             |           |
|           |           |        |           | **There     |           |
|           |           |        |           | will be a   |           |
|           |           |        |           | metal       |           |
|           |           |        |           | detector at |           |
|           |           |        |           | p           |           |
|           |           |        |           | ackaging.** |           |
+-----------+-----------+--------+-----------+-------------+-----------+
| **Sausage | **B       |        |           |             |           |
| Stuffer** | iological |        |           |             |           |
|           | -- None** |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | *         |        |           |             |           |
|           | *Chemical |        |           |             |           |
|           | -- None** |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | **P       |        |           |             |           |
|           | hysical - |        |           |             |           |
|           | None**    |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
| *         | **B       | *      | **Use of  | **Rework    |           |
| *Rework** | iological | *Yes** | rework    | left at the |           |
|           | --        |        | can       | end of the  |           |
|           | Pa        |        | provide a | day is      |           |
|           | thogens** |        | medium    | condemned   |           |
|           |           |        | for       | or used in  |           |
|           | *Staph    |        | pathogen  | a cooked    |           |
|           | ylococcus |        | growth.** | product at  |           |
|           | aureus*   |        |           | the         |           |
|           |           |        |           | plant.**    |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | **        |        |           |             |           |
|           | Chemical- |        |           |             |           |
|           | None**    |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | *         |        |           |             |           |
|           | *Physical |        |           |             |           |
|           | -- None** |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+

> Figure 3

**HAZARD ANALYSIS -- RAW PRODUCT, GROUND**

+-----------+-----------+--------+-----------+-------------+-----------+
| **Process | **Food    | **Reas | **Basis** | **If Yes in | *         |
| Step**    | Safety    | onably |           | Column 3,   | *Critical |
|           | Hazard**  | Likely |           | What        | Control   |
|           |           | to     |           | Measures    | Point**   |
|           |           | Oc     |           | Could be    |           |
|           |           | cur?** |           | Applied to  |           |
|           |           |        |           | Prevent,    |           |
|           |           |        |           | Eliminate,  |           |
|           |           |        |           | or Reduce   |           |
|           |           |        |           | the Hazard  |           |
|           |           |        |           | to an       |           |
|           |           |        |           | Acceptable  |           |
|           |           |        |           | Level?**    |           |
+-----------+-----------+--------+-----------+-------------+-----------+
| **Pa      | **Bi      | *      | ***       | **Labels    | **3B**    |
| ckaging/L | ological: | *Yes** | Trichina* | that        |           |
| abeling** | Pathogens |        | has       | clearly     |           |
|           | --        |        | his       | indicate    |           |
|           | parasitic |        | torically | this is a   |           |
|           | (*Tri     |        | occurred  | raw         |           |
|           | china*)** |        | in raw    | product,    |           |
|           |           |        | pork      | along with  |           |
|           |           |        | pr        | cooking     |           |
|           |           |        | oducts.** | in          |           |
|           |           |        |           | structions, |           |
|           |           |        |           | and the     |           |
|           |           |        |           | safe food   |           |
|           |           |        |           | handling    |           |
|           |           |        |           | s           |           |
|           |           |        |           | tatement.** |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | *         |        |           |             |           |
|           | *Chemical |        |           |             |           |
|           | -- None** |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | *         | *      | **Metal   | *           | **4P**    |
|           | *Physical | *Yes** | cont      | *Functional |           |
|           | -- Metal  |        | amination | metal       |           |
|           | contam    |        | that may  | detector is |           |
|           | ination** |        | have come | on-line in  |           |
|           |           |        | into the  | the         |           |
|           |           |        | esta      | packagi     |           |
|           |           |        | blishment | ng/labeling |           |
|           |           |        | with raw  | area to     |           |
|           |           |        | product   | remove      |           |
|           |           |        | or        | product     |           |
|           |           |        | occurred  | with metal  |           |
|           |           |        | during    | conta       |           |
|           |           |        | the       | mination.** |           |
|           |           |        | grinding  |             |           |
|           |           |        | and       |             |           |
|           |           |        | stuffing  |             |           |
|           |           |        | p         |             |           |
|           |           |        | rocess.** |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
| *         | **B       | *      | **        | **Maintain  | **5B**    |
| *Finished | iological | *Yes** | Pathogens | product     |           |
| Product   | --        |        | are       | temperature |           |
| Storage   | Pa        |        | r         | at or below |           |
| (Cold)**  | thogens** |        | easonably | a level     |           |
|           |           |        | likely to | sufficient  |           |
|           | *Sa       |        | grow in   | to preclude |           |
|           | lmonella* |        | this      | pathogen    |           |
|           |           |        | product   | growth.**   |           |
|           | *Staph    |        | if        |             |           |
|           | ylococcus |        | te        |             |           |
|           | aureus*   |        | mperature |             |           |
|           |           |        | is not    |             |           |
|           |           |        | m         |             |           |
|           |           |        | aintained |             |           |
|           |           |        | at or     |             |           |
|           |           |        | below a   |             |           |
|           |           |        | level     |             |           |
|           |           |        | s         |             |           |
|           |           |        | ufficient |             |           |
|           |           |        | to        |             |           |
|           |           |        | preclude  |             |           |
|           |           |        | their     |             |           |
|           |           |        | growth.** |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | *         |        |           |             |           |
|           | *Chemical |        |           |             |           |
|           | -- None** |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+
|           | **P       |        |           |             |           |
|           | hysical - |        |           |             |           |
|           | None**    |        |           |             |           |
+-----------+-----------+--------+-----------+-------------+-----------+

> **Figure 3**

**HAZARD ANALYSIS -- RAW PRODUCT, GROUND**

  -------------- -------------- -------------- ------------ -------------- ------------
  **Process      **Food Safety  **Reasonably   **Basis**    **If Yes in    **Critical
  Step**         Hazard**       Likely to                   Column 3, What Control
                                Occur?**                    Measures Could Point**
                                                            be Applied to  
                                                            Prevent,       
                                                            Eliminate, or  
                                                            Reduce the     
                                                            Hazard to an   
                                                            Acceptable     
                                                            Level?**       

  **Shipping**   **Biological                                              
                 -- None**                                                 

                 **Chemical-                                               
                 None**                                                    

                 **Physical --                                             
                 None**                                                    
  -------------- -------------- -------------- ------------ -------------- ------------

> **Figure 3**

+------+------+---------+-------+-----------------+-----------------+
| # HA |      |         |       |                 |                 |
| CCP  |      |         |       |                 |                 |
| PLAN |      |         |       |                 |                 |
|      |      |         |       |                 |                 |
| *    |      |         |       |                 |                 |
| *PRO |      |         |       |                 |                 |
| CESS |      |         |       |                 |                 |
| C    |      |         |       |                 |                 |
| ATEG |      |         |       |                 |                 |
| ORY: |      |         |       |                 |                 |
| RAW  |      |         |       |                 |                 |
| PROD |      |         |       |                 |                 |
| UCT, |      |         |       |                 |                 |
| GROU |      |         |       |                 |                 |
| ND** |      |         |       |                 |                 |
|      |      |         |       |                 |                 |
| *    |      |         |       |                 |                 |
| *PRO |      |         |       |                 |                 |
| DUCT |      |         |       |                 |                 |
| EXAM |      |         |       |                 |                 |
| PLE: |      |         |       |                 |                 |
| F    |      |         |       |                 |                 |
| RESH |      |         |       |                 |                 |
| PORK |      |         |       |                 |                 |
| S    |      |         |       |                 |                 |
| AUSA |      |         |       |                 |                 |
| GE** |      |         |       |                 |                 |
+------+------+---------+-------+-----------------+-----------------+
| *    | **   | **Mon   | **    | **Verification  | **Corrective    |
| *CCP | Crit | itoring | HACCP | Procedures and  | Actions**       |
| \#   | ical | Pro     | Reco  | Frequency**     |                 |
| and  | Limi | cedures | rds** |                 |                 |
| Lo   | ts** | and     |       |                 |                 |
| cati |      | Freq    |       |                 |                 |
| on** |      | uency** |       |                 |                 |
+------+------+---------+-------+-----------------+-----------------+
| 1B   | Supp | Re      | Rece  | Every two       | Will not        |
|      | lier | ceiving | iving | months QA will  | receive product |
| R    | c    | pe      | Log   | request FSIS    | unaccompanied   |
| ecei | erti | rsonnel |       | *Salmonella*    | by *Salmonella* |
| ving | fica | will    |       | data results    | certification.  |
| --   | tion | check   |       | from the        |                 |
| Meat | that | each    |       | company for at  | If product does |
| *Sal | pro  | s       |       | least 2         | not have        |
| mone | duct | hipment |       | suppliers.      | certification,  |
| lla* | m    | for     |       |                 | it is rejected  |
| and  | eets | *Salm   |       |                 | or returned.    |
| o    | FSIS | onella* |       |                 |                 |
| ther | per  | certifi |       |                 | Assure that     |
| p    | form | cation. |       |                 | procedures for  |
| atho | ance |         |       |                 | only guaranteed |
| gens | stan |         |       |                 | supplier list   |
| in   | dard |         |       |                 | is kept current |
| raw  | for  |         |       |                 | and guaranty on |
| pork | *Sal |         |       |                 | file in         |
| t    | mone |         |       |                 |                 |
| rimm | lla* |         |       |                 | shipping        |
| ing. | must |         |       |                 | /receiving log. |
|      | a    |         |       |                 | If supplier     |
|      | ccom |         |       |                 | does not meet   |
|      | pany |         |       |                 | FSIS            |
|      | s    |         |       |                 | performance     |
|      | hipm |         |       |                 | standards       |
|      | ent. |         |       |                 | product will    |
|      |      |         |       |                 | not be          |
|      |      |         |       |                 | purchased from  |
|      |      |         |       |                 | them until they |
|      |      |         |       |                 | can maintain    |
|      |      |         |       |                 | bacterial       |
|      |      |         |       |                 | levels meeting  |
|      |      |         |       |                 | performance     |
|      |      |         |       |                 | standard.       |
+------+------+---------+-------+-----------------+-----------------+
| 2B   | Raw  | Main    | Room  | Maintenance     | QA will reject  |
|      | pro  | tenance | T     | supervisor will | or hold meat    |
| Sto  | duct | pe      | emper | verify accuracy | until           |
| rage | sto  | rsonnel | ature | of the Room     | t               |
| -    | rage | will    | Log   | Temperature Log | ime/temperature |
|      | area | record  |       | once per shift  | deviation and   |
| (C   | s    | raw     | Corre | and observe     | its             |
| old) | hall | product | ctive | plant employee  | implications    |
| Meat | not  | storage | A     | performing      | are reviewed.   |
|      | ex   | area    | ction | monitoring.     | Product         |
|      | ceed | temp    | Log   |                 | disposition     |
|      | 40°  | erature |       | QA will check   | will depend on  |
|      | F.   | every 2 | T     | all             | this expert     |
|      |      | hours,  | hermo | thermometers    | review.         |
|      |      | initial | meter | used for        |                 |
|      |      | / sign  | C     | monitoring      | QA will         |
|      |      | and     | alibr | devices for     | identify the    |
|      |      | date    | ation | their accuracy  | cause of the    |
|      |      | log.    | Log   | and verify to   | deviation and   |
|      |      |         |       | within 2° F on  | devise measures |
|      |      |         |       | a daily basis.  | to prevent      |
|      |      |         |       |                 | reoccurrence.   |
|      |      |         |       |                 |                 |
|      |      |         |       |                 | Maintenance     |
|      |      |         |       |                 | will adjust     |
|      |      |         |       |                 | scheduled       |
|      |      |         |       |                 | cooler upkeep & |
|      |      |         |       |                 | review if       |
|      |      |         |       |                 | necessary or    |
|      |      |         |       |                 | repair any      |
|      |      |         |       |                 | malfunctioning  |
|      |      |         |       |                 | equipment.      |
+------+------+---------+-------+-----------------+-----------------+

####### 

####### Signature : \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Figure 4 

+------+------+---------+-------+-----------------+-----------------+
| # HA |      |         |       |                 |                 |
| CCP  |      |         |       |                 |                 |
| PLAN |      |         |       |                 |                 |
|      |      |         |       |                 |                 |
| *    |      |         |       |                 |                 |
| *PRO |      |         |       |                 |                 |
| CESS |      |         |       |                 |                 |
| C    |      |         |       |                 |                 |
| ATEG |      |         |       |                 |                 |
| ORY: |      |         |       |                 |                 |
| RAW  |      |         |       |                 |                 |
| PROD |      |         |       |                 |                 |
| UCT, |      |         |       |                 |                 |
| GROU |      |         |       |                 |                 |
| ND** |      |         |       |                 |                 |
|      |      |         |       |                 |                 |
| *    |      |         |       |                 |                 |
| *PRO |      |         |       |                 |                 |
| DUCT |      |         |       |                 |                 |
| EXAM |      |         |       |                 |                 |
| PLE: |      |         |       |                 |                 |
| F    |      |         |       |                 |                 |
| RESH |      |         |       |                 |                 |
| PORK |      |         |       |                 |                 |
| S    |      |         |       |                 |                 |
| AUSA |      |         |       |                 |                 |
| GE** |      |         |       |                 |                 |
+------+------+---------+-------+-----------------+-----------------+
| *    | **   | **Mon   | **    | **Verification  | **Corrective    |
| *CCP | Crit | itoring | HACCP | Procedures and  | Actions**       |
| \#   | ical | Pro     | Reco  | Frequency**     |                 |
| and  | Limi | cedures | rds** |                 |                 |
| Lo   | ts** | and     |       |                 |                 |
| cati |      | Freq    |       |                 |                 |
| on** |      | uency** |       |                 |                 |
+------+------+---------+-------+-----------------+-----------------+
| 3B   | Pro  | Pa      | Corre | QA will observe | QA will         |
|      | duct | ckaging | ctive | packaging line  | segregate and   |
| Pa   | must | line    | A     | supervisor      | hold all        |
| ckag | cle  | sup     | ction | perform         | affected        |
| ing/ | arly | ervisor | Log   | monitoring      | product.        |
|      | be   | will    |       | activity once   |                 |
| Labe | lab  | select  | Lab   | per shift.      | QA will ensure  |
| ling | eled | 2       | eling |                 | that proper     |
| (*Tr | as   | p       | Log   | QA will select  | labeling is     |
| ichi | raw  | ackages |       | 3 labels        | applied to all  |
| na*) | --   | of      |       | intended for    | affected        |
|      | Cook | product |       | use from label  | product prior   |
|      | be   | hourly  |       | storage area    | to shipment.    |
|      | fore | and     |       | twice weekly to |                 |
|      | ea   | ensure  |       | ensure label    | QA will         |
|      | ting | l       |       | accuracy.       | determine cause |
|      |      | abeling |       |                 | of deviation    |
|      | Coo  | requi   |       | QA will check   | and institute   |
|      | king | rements |       | labels once a   | preventive      |
|      | inst | are     |       | day on packaged | action.         |
|      | ruct | met.    |       | product to      |                 |
|      | ions |         |       | ensure accurate |                 |
|      | that |         |       | labels are      |                 |
|      | s    |         |       | placed on       |                 |
|      | tate |         |       | packaged        |                 |
|      | "    |         |       | product.        |                 |
|      | cook |         |       |                 |                 |
|      | to   |         |       |                 |                 |
|      | 14   |         |       |                 |                 |
|      | 5°F" |         |       |                 |                 |
|      | must |         |       |                 |                 |
|      | be   |         |       |                 |                 |
|      | on   |         |       |                 |                 |
|      | pack |         |       |                 |                 |
|      | age. |         |       |                 |                 |
|      |      |         |       |                 |                 |
|      | Safe |         |       |                 |                 |
|      | food |         |       |                 |                 |
|      | hand |         |       |                 |                 |
|      | ling |         |       |                 |                 |
|      | s    |         |       |                 |                 |
|      | tate |         |       |                 |                 |
|      | ment |         |       |                 |                 |
|      | must |         |       |                 |                 |
|      | be   |         |       |                 |                 |
|      | part |         |       |                 |                 |
|      | of   |         |       |                 |                 |
|      | la   |         |       |                 |                 |
|      | bel. |         |       |                 |                 |
+------+------+---------+-------+-----------------+-----------------+

**Signature :
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Date:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_** **Figure
4**

+------+------+---------+-------+-----------------+-----------------+
| # HA |      |         |       |                 |                 |
| CCP  |      |         |       |                 |                 |
| PLAN |      |         |       |                 |                 |
|      |      |         |       |                 |                 |
| *    |      |         |       |                 |                 |
| *PRO |      |         |       |                 |                 |
| CESS |      |         |       |                 |                 |
| C    |      |         |       |                 |                 |
| ATEG |      |         |       |                 |                 |
| ORY: |      |         |       |                 |                 |
| RAW  |      |         |       |                 |                 |
| PROD |      |         |       |                 |                 |
| UCT, |      |         |       |                 |                 |
| GROU |      |         |       |                 |                 |
| ND** |      |         |       |                 |                 |
|      |      |         |       |                 |                 |
| *    |      |         |       |                 |                 |
| *PRO |      |         |       |                 |                 |
| DUCT |      |         |       |                 |                 |
| EXAM |      |         |       |                 |                 |
| PLE: |      |         |       |                 |                 |
| F    |      |         |       |                 |                 |
| RESH |      |         |       |                 |                 |
| PORK |      |         |       |                 |                 |
| S    |      |         |       |                 |                 |
| AUSA |      |         |       |                 |                 |
| GE** |      |         |       |                 |                 |
+------+------+---------+-------+-----------------+-----------------+
| *    | **   | **Mon   | **    | **Verification  | **Corrective    |
| *CCP | Crit | itoring | HACCP | Procedures and  | Actions**       |
| \#   | ical | Pro     | Reco  | Frequency**     |                 |
| and  | Limi | cedures | rds** |                 |                 |
| Lo   | ts** | and     |       |                 |                 |
| cati |      | Freq    |       |                 |                 |
| on** |      | uency** |       |                 |                 |
+------+------+---------+-------+-----------------+-----------------+
| 4P   | No   | Pa      | Metal | QA, outside the | Packaging       |
|      | m    | ckaging | Dete  | packaging unit, | supervisor will |
| Pa   | etal | line    | ction | will verify     | control and     |
| ckag | p    | sup     | Co    | that the metal  | segregate       |
| ing/ | arti | ervisor | ntrol | detector is     | affected        |
|      | cles | will    | Log   | functioning as  | product.        |
| Labe | to   | check   |       | intended by     |                 |
| ling | ex   | the     | Corre | running the     | Maintenance     |
|      | ceed | metal   | ctive | seeded sample   | personnel will  |
|      | 1/32 | d       | A     | through the     | identify and    |
|      | i    | etector | ction | metal detector  | eliminate any   |
|      | nch. | using a | Log   | twice per shift | problems with   |
|      |      | seeded  |       | (once AM, once  | the metal       |
|      | All  | sample  |       | PM).            | detector or     |
|      | cont | every   |       |                 | kick out        |
|      | amin | two     |       |                 | mechanism.      |
|      | ated | hours   |       |                 | Preventive      |
|      | pro  | to      |       |                 | maintenance     |
|      | duct | de      |       |                 | program will be |
|      | is   | termine |       |                 | implemented.    |
|      | rem  | limits  |       |                 |                 |
|      | oved | are not |       |                 | QA will run     |
|      | from | ex      |       |                 | seeded sample   |
|      | sy   | ceeded. |       |                 | through         |
|      | stem |         |       |                 | detector after  |
|      | by   |         |       |                 | repair.         |
|      | fun  |         |       |                 |                 |
|      | ctio |         |       |                 | All potentially |
|      | ning |         |       |                 | contaminated    |
|      | kick |         |       |                 | product will be |
|      | out  |         |       |                 | run through     |
|      | me   |         |       |                 | functional      |
|      | chan |         |       |                 | metal detector  |
|      | ism. |         |       |                 | prior to        |
|      | All  |         |       |                 | shipment.       |
|      | kick |         |       |                 |                 |
|      | out  |         |       |                 | All product     |
|      | pro  |         |       |                 | rejected by     |
|      | duct |         |       |                 | detector will   |
|      | will |         |       |                 | be reworked.    |
|      | be   |         |       |                 |                 |
|      | visu |         |       |                 |                 |
|      | ally |         |       |                 |                 |
|      | exam |         |       |                 |                 |
|      | ined |         |       |                 |                 |
|      | and  |         |       |                 |                 |
|      | any  |         |       |                 |                 |
|      | m    |         |       |                 |                 |
|      | etal |         |       |                 |                 |
|      | remo |         |       |                 |                 |
|      | ved. |         |       |                 |                 |
+------+------+---------+-------+-----------------+-----------------+

**Signature :
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Date:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_** **Figure
4**

+------+------+---------+-------+-----------------+-----------------+
| # HA |      |         |       |                 |                 |
| CCP  |      |         |       |                 |                 |
| PLAN |      |         |       |                 |                 |
|      |      |         |       |                 |                 |
| *    |      |         |       |                 |                 |
| *PRO |      |         |       |                 |                 |
| CESS |      |         |       |                 |                 |
| C    |      |         |       |                 |                 |
| ATEG |      |         |       |                 |                 |
| ORY: |      |         |       |                 |                 |
| RAW  |      |         |       |                 |                 |
| PROD |      |         |       |                 |                 |
| UCT, |      |         |       |                 |                 |
| GROU |      |         |       |                 |                 |
| ND** |      |         |       |                 |                 |
|      |      |         |       |                 |                 |
| *    |      |         |       |                 |                 |
| *PRO |      |         |       |                 |                 |
| DUCT |      |         |       |                 |                 |
| EXAM |      |         |       |                 |                 |
| PLE: |      |         |       |                 |                 |
| F    |      |         |       |                 |                 |
| RESH |      |         |       |                 |                 |
| PORK |      |         |       |                 |                 |
| S    |      |         |       |                 |                 |
| AUSA |      |         |       |                 |                 |
| GE** |      |         |       |                 |                 |
+------+------+---------+-------+-----------------+-----------------+
| *    | **   | **Mon   | **    | **Verification  | **Corrective    |
| *CCP | Crit | itoring | HACCP | Procedures and  | Actions**       |
| \#   | ical | Pro     | Reco  | Frequency**     |                 |
| and  | Limi | cedures | rds** |                 |                 |
| Lo   | ts** | and     |       |                 |                 |
| cati |      | Freq    |       |                 |                 |
| on** |      | uency** |       |                 |                 |
+------+------+---------+-------+-----------------+-----------------+
| 5B   | Fini | Main    | Room  | Maintenance     | If a deviation  |
|      | shed | tenance | T     | supervisor will | from a critical |
| Fini | pro  | pe      | emper | verify the      | limit occurs,   |
| shed | duct | rsonnel | ature | accuracy of the | the following   |
| Pro  | sto  | will    | Log   | room            | corrective      |
| duct | rage | check   |       | temperature log | actions will be |
| Sto  | area | f       | Corre | once per shift. | taken:          |
| rage | s    | inished | ctive |                 |                 |
| (C   | hall | product | A     | QA will check   | 1.  Product     |
| old) | not  | storage | ction | all             |     which may   |
|      | ex   | area    | Log   | thermometers    |     not have    |
| **(C | ceed | temp    |       | used for        |     met CL will |
| onti | 40°  | erature | T     | monitoring and  |     be          |
| nued | F.   | every   | hermo | verification    |     identified  |
| on   |      | two     | meter | activities for  |     and held.   |
| next |      | hours.  | C     | accuracy daily  |                 |
| pag  |      |         | alibr | and calibrate   | 2.  The cause   |
| e)** |      |         | ation | to within 2° F  |     of the      |
|      |      |         | Log   | accuracy as     |     temperature |
|      |      |         |       | necessary.      |     exceeding   |
|      |      |         |       |                 |     40° F will  |
|      |      |         |       | QA will observe |     be          |
|      |      |         |       | maintenance     |     identified  |
|      |      |         |       | personnel check |     and         |
|      |      |         |       | finished        |     eliminated. |
|      |      |         |       | product storage |                 |
|      |      |         |       | area once per   | 3.  The CCP     |
|      |      |         |       | shift.          |     will be     |
|      |      |         |       |                 |     monitored   |
|      |      |         |       |                 |     hourly      |
|      |      |         |       |                 |     after the   |
|      |      |         |       |                 |     corrective  |
|      |      |         |       |                 |     action is   |
|      |      |         |       |                 |     taken to    |
|      |      |         |       |                 |     ensure that |
|      |      |         |       |                 |     it is under |
|      |      |         |       |                 |     control.    |
|      |      |         |       |                 |                 |
|      |      |         |       |                 | 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**

+------+------+---------+-------+-----------------+-----------------+
| # HA |      |         |       |                 |                 |
| CCP  |      |         |       |                 |                 |
| PLAN |      |         |       |                 |                 |
|      |      |         |       |                 |                 |
| *    |      |         |       |                 |                 |
| *PRO |      |         |       |                 |                 |
| CESS |      |         |       |                 |                 |
| C    |      |         |       |                 |                 |
| ATEG |      |         |       |                 |                 |
| ORY: |      |         |       |                 |                 |
| RAW  |      |         |       |                 |                 |
| PROD |      |         |       |                 |                 |
| UCT, |      |         |       |                 |                 |
| GROU |      |         |       |                 |                 |
| ND** |      |         |       |                 |                 |
|      |      |         |       |                 |                 |
| *    |      |         |       |                 |                 |
| *PRO |      |         |       |                 |                 |
| DUCT |      |         |       |                 |                 |
| EXAM |      |         |       |                 |                 |
| PLE: |      |         |       |                 |                 |
| F    |      |         |       |                 |                 |
| RESH |      |         |       |                 |                 |
| PORK |      |         |       |                 |                 |
| S    |      |         |       |                 |                 |
| AUSA |      |         |       |                 |                 |
| GE** |      |         |       |                 |                 |
+------+------+---------+-------+-----------------+-----------------+
| *    | **   | **Mon   | **    | **Verification  | **Corrective    |
| *CCP | Crit | itoring | HACCP | Procedures and  | Actions**       |
| \#   | ical | Pro     | Reco  | Frequency**     |                 |
| and  | Limi | cedures | rds** |                 |                 |
| Lo   | ts** | and     |       |                 |                 |
| cati |      | Freq    |       |                 |                 |
| on** |      | uency** |       |                 |                 |
+------+------+---------+-------+-----------------+-----------------+
| 5B   |      |         |       |                 | If a deviation  |
|      |      |         |       |                 | from a critical |
| Fini |      |         |       |                 | limit occurs,   |
| shed |      |         |       |                 | the following   |
| Pro  |      |         |       |                 | corrective      |
| duct |      |         |       |                 | actions will be |
| Sto  |      |         |       |                 | taken:          |
| rage |      |         |       |                 |                 |
| (C   |      |         |       |                 | 5.  If room     |
| old) |      |         |       |                 |     temperature |
|      |      |         |       |                 |     exceeds the |
|      |      |         |       |                 |     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**

**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

                                                        

                                                        

                                                        

                                                        
  ----------------- ----------------- ----------------- -----------------

+----+-----+------------+-----------------------+-----------+--------+
| ## |     |            |                       |           |        |
| ## |     |            |                       |           |        |
|  G |     |            |                       |           |        |
| EN |     |            |                       |           |        |
| ER |     |            |                       |           |        |
| IC |     |            |                       |           |        |
|  E |     |            |                       |           |        |
| ST |     |            |                       |           |        |
| AB |     |            |                       |           |        |
| LI |     |            |                       |           |        |
| SH |     |            |                       |           |        |
| ME |     |            |                       |           |        |
| NT |     |            |                       |           |        |
|  X |     |            |                       |           |        |
| :  |     |            |                       |           |        |
| Ro |     |            |                       |           |        |
| om |     |            |                       |           |        |
|  T |     |            |                       |           |        |
| em |     |            |                       |           |        |
| pe |     |            |                       |           |        |
| ra |     |            |                       |           |        |
| tu |     |            |                       |           |        |
| re |     |            |                       |           |        |
|  L |     |            |                       |           |        |
| og |     |            |                       |           |        |
|    |     |            |                       |           |        |
| R  |     |            |                       |           |        |
| oo |     |            |                       |           |        |
| m: |     |            |                       |           |        |
| \_ |     |            |                       |           |        |
| \_ |     |            |                       |           |        |
| \_ |     |            |                       |           |        |
| \_ |     |            |                       |           |        |
| \_ |     |            |                       |           |        |
| \_ |     |            |                       |           |        |
| \_ |     |            |                       |           |        |
| \_ |     |            |                       |           |        |
| \_ |     |            |                       |           |        |
| \_ |     |            |                       |           |        |
| D  |     |            |                       |           |        |
| at |     |            |                       |           |        |
| e: |     |            |                       |           |        |
| \_ |     |            |                       |           |        |
| \_ |     |            |                       |           |        |
| \_ |     |            |                       |           |        |
| \_ |     |            |                       |           |        |
| \_ |     |            |                       |           |        |
| \_ |     |            |                       |           |        |
| \_ |     |            |                       |           |        |
| \_ |     |            |                       |           |        |
| \_ |     |            |                       |           |        |
+----+-----+------------+-----------------------+-----------+--------+
| ** | **  | *          | **If Yes,**           | **        | **Ve   |
| TI | TEM | *Deviation |                       | Monitored | rified |
| ME | P** | from CL?   | **Action?**           | by:**     | by:**  |
| ** |     | (Check if  |                       |           |        |
|    |     | yes)**     |                       |           |        |
+----+-----+------------+-----------------------+-----------+--------+
| 6: | 3   |            |                       | PS        |        |
| 36 | 4°F |            |                       |           |        |
| AM |     |            |                       |           |        |
+----+-----+------------+-----------------------+-----------+--------+
| 8: | 3   |            |                       | PS        |        |
| 30 | 3°F |            |                       |           |        |
| AM |     |            |                       |           |        |
+----+-----+------------+-----------------------+-----------+--------+
| 1  | 3   |            |                       | PS        | CB     |
| 0: | 4°F |            |                       |           |        |
| 32 |     |            |                       |           |        |
| AM |     |            |                       |           |        |
+----+-----+------------+-----------------------+-----------+--------+
| 1  | 4   |           | Notify maintenance    | PS        |        |
| 2: | 9°F |            | supervisor, CB & QA   |           |        |
| 30 |     |            |                       |           |        |
| PM |     |            |                       |           |        |
+----+-----+------------+-----------------------+-----------+--------+
|    |     |            |                       |           |        |
+----+-----+------------+-----------------------+-----------+--------+

**TIME/TEMPERATURE CRITICAL LIMIT \-\-- 40°F**

+---+----+-------+--------+---------+-------+-------+----+-----------+
| # |    |       |        |         |       |       |    |           |
| # |    |       |        |         |       |       |    |           |
| # |    |       |        |         |       |       |    |           |
| # |    |       |        |         |       |       |    |           |
|   |    |       |        |         |       |       |    |           |
| T |    |       |        |         |       |       |    |           |
| H |    |       |        |         |       |       |    |           |
| E |    |       |        |         |       |       |    |           |
| R |    |       |        |         |       |       |    |           |
| M |    |       |        |         |       |       |    |           |
| O |    |       |        |         |       |       |    |           |
| M |    |       |        |         |       |       |    |           |
| E |    |       |        |         |       |       |    |           |
| T |    |       |        |         |       |       |    |           |
| E |    |       |        |         |       |       |    |           |
| R |    |       |        |         |       |       |    |           |
|   |    |       |        |         |       |       |    |           |
| C |    |       |        |         |       |       |    |           |
| A |    |       |        |         |       |       |    |           |
| L |    |       |        |         |       |       |    |           |
| I |    |       |        |         |       |       |    |           |
| B |    |       |        |         |       |       |    |           |
| R |    |       |        |         |       |       |    |           |
| A |    |       |        |         |       |       |    |           |
| T |    |       |        |         |       |       |    |           |
| I |    |       |        |         |       |       |    |           |
| O |    |       |        |         |       |       |    |           |
| N |    |       |        |         |       |       |    |           |
|   |    |       |        |         |       |       |    |           |
| L |    |       |        |         |       |       |    |           |
| O |    |       |        |         |       |       |    |           |
| G |    |       |        |         |       |       |    |           |
|   |    |       |        |         |       |       |    |           |
| C |    |       |        |         |       |       |    |           |
| r |    |       |        |         |       |       |    |           |
| i |    |       |        |         |       |       |    |           |
| t |    |       |        |         |       |       |    |           |
| e |    |       |        |         |       |       |    |           |
| r |    |       |        |         |       |       |    |           |
| i |    |       |        |         |       |       |    |           |
| a |    |       |        |         |       |       |    |           |
| W |    |       |        |         |       |       |    |           |
| i |    |       |        |         |       |       |    |           |
| t |    |       |        |         |       |       |    |           |
| h |    |       |        |         |       |       |    |           |
| i |    |       |        |         |       |       |    |           |
| n |    |       |        |         |       |       |    |           |
|  |    |       |        |         |       |       |    |           |
| 1 |    |       |        |         |       |       |    |           |
| ° |    |       |        |         |       |       |    |           |
| F |    |       |        |         |       |       |    |           |
| o |    |       |        |         |       |       |    |           |
| f |    |       |        |         |       |       |    |           |
| C |    |       |        |         |       |       |    |           |
| o |    |       |        |         |       |       |    |           |
| n |    |       |        |         |       |       |    |           |
| t |    |       |        |         |       |       |    |           |
| r |    |       |        |         |       |       |    |           |
| o |    |       |        |         |       |       |    |           |
| l |    |       |        |         |       |       |    |           |
| T |    |       |        |         |       |       |    |           |
| h |    |       |        |         |       |       |    |           |
| e |    |       |        |         |       |       |    |           |
| r |    |       |        |         |       |       |    |           |
| m |    |       |        |         |       |       |    |           |
| o |    |       |        |         |       |       |    |           |
| m |    |       |        |         |       |       |    |           |
| e |    |       |        |         |       |       |    |           |
| t |    |       |        |         |       |       |    |           |
| e |    |       |        |         |       |       |    |           |
| r |    |       |        |         |       |       |    |           |
+---+----+-------+--------+---------+-------+-------+----+-----------+
| D | Ti | Depar | Therm  | Control | Per   | Adjus | In | Comments  |
| a | me | tment | ometer | Ther    | sonal | tment | it |           |
| t |    | or    | ID#    | mometer | T     | Req   | ia |           |
| e |    |       |        | Reading | hermo | uired | ls |           |
|   |    | Area  |        |         | meter | (Yes  |    |           |
|   |    |       |        |         | Re    | or    |    |           |
|   |    |       |        |         | ading | No)   |    |           |
+---+----+-------+--------+---------+-------+-------+----+-----------+
| 6 | 1: | Ch    | 2A     | 32°F    | 32°F  | No    | HK |           |
| / | 00 | iller |        |         |       |       |    |           |
| 1 | PM |       |        |         |       |       |    |           |
| 5 |    |       |        |         |       |       |    |           |
+---+----+-------+--------+---------+-------+-------+----+-----------+
|   |    |       |        |         |       |       |    |           |
+---+----+-------+--------+---------+-------+-------+----+-----------+
|   |    |       |        |         |       |       |    |           |
+---+----+-------+--------+---------+-------+-------+----+-----------+
|   |    |       |        |         |       |       |    |           |
+---+----+-------+--------+---------+-------+-------+----+-----------+
|   |    |       |        |         |       |       |    |           |
+---+----+-------+--------+---------+-------+-------+----+-----------+
|   |    |       |        |         |       |       |    |           |
+---+----+-------+--------+---------+-------+-------+----+-----------+
|   |    |       |        |         |       |       |    |           |
+---+----+-------+--------+---------+-------+-------+----+-----------+

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

Verified by: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Date/Time: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**GENERIC ESTABLISHMENT X: METAL DETECTION LOG**

  -------- ---------- ------ --------- -------- ------ ----------- -------------
  Date     Product    Lot \# Results   Seeded   Time   Monitored   Verified By
                                       Sample          By          

                                                                   

                                                                   

                                                                   

                                                                   
  -------- ---------- ------ --------- -------- ------ ----------- -------------

+-----------+-------+-------------------+---------+----------+-------+
| ## CORR   |       |                   |         |          |       |
| ECTIVE AC |       |                   |         |          |       |
| TIONS LOG |       |                   |         |          |       |
|           |       |                   |         |          |       |
| *         |       |                   |         |          |       |
| *Product: |       |                   |         |          |       |
| \_\_\     |       |                   |         |          |       |
| _\_\_\_\_ |       |                   |         |          |       |
| \_\_\_\_\ |       |                   |         |          |       |
| _\_\_\_\_ |       |                   |         |          |       |
| \_\_\_\_\ |       |                   |         |          |       |
| _\_\_\_\_ |       |                   |         |          |       |
| \_\_\_\_\ |       |                   |         |          |       |
| _\_\_\_\_ |       |                   |         |          |       |
| \_\_\_\_\ |       |                   |         |          |       |
| _\_\_\_\_ |       |                   |         |          |       |
| Lot \#    |       |                   |         |          |       |
| \         |       |                   |         |          |       |
| _\_\_\_\_ |       |                   |         |          |       |
| \_\_\_\_\ |       |                   |         |          |       |
| _\_\_\_\_ |       |                   |         |          |       |
| \_\_\_\_\ |       |                   |         |          |       |
| _\_\_\_** |       |                   |         |          |       |
+-----------+-------+-------------------+---------+----------+-------+
| **CCP**   | **De  | **Corrective      | **Disp  | **Respo  | **T   |
|           | viati | Action            | osition | nsible** | ime** |
|           | on/** | Pro               | of      |          |       |
|           |       | cedures/Explain** | Pr      | **       |       |
|           | *     |                   | oduct** | Person** |       |
|           | *Prob |                   |         |          |       |
|           | lem** |                   |         |          |       |
+-----------+-------+-------------------+---------+----------+-------+
|           |       |                   |         |          |       |
+-----------+-------+-------------------+---------+----------+-------+
|           |       |                   |         |          |       |
+-----------+-------+-------------------+---------+----------+-------+
|           |       |                   |         |          |       |
+-----------+-------+-------------------+---------+----------+-------+

**SIGNATURE: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ DATE:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

# 

# PRE-SHIPMENT REVIEW LOG 

# 

# 

# Date:\_\_\_\_\_\_\_\_\_\_\_\_\_\_

  ---------- ------------ ------------- ---------------- --------------------
  **LOT ID** **Time       **By Whom**   **Lot Released   **COMMENTS**
             Records                    for 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