## United States

## Department of

**Agriculture**

### Food Safety

and Inspection

Service

September 1999

### HACCP-11

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## 

## ![](media/image1.jpeg){width="1.179861111111111in" height="0.8138888888888889in"}Generic HACCP

**Model for Heat Treated But Not Fully Cooked, Not Shelf Stable Meat and
Poultry Products**

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## 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.............................................................................................
2

Using This Generic
Model............................................................................
4

Process Flow Diagram and Product
Description................................................... 5

Hazard
Analysis........................................................................................6

Developing Your HACCP
Plan.......................................................................
8

Identifying
CCPs.......................................................................................
9

Appendix A

References for HACCP
Teams.............................................................15

References for Heat Treated But Not Fully Cooked, Not Shelf Stable

Meat and Poultry
Products..................................................................17

##  

## Appendix B

Process Flow Diagram (Figure1) Smoked Sausage, Partially Cooked

Chicken Patties
.............................................................................
19

Product Description (Figure
2)........................................................... 20

Hazard Analysis Form (Figure
3)......................................................... 21

HACCP Plan Form (Figure
4)............................................................. 26

Form Letter Confirming *Salmonella* Compliance with

Performance Standards
.....................................................................32

Thermometer Calibration
Log.............................................................33

Generic Establishment X: Room Temperature Log
....................................34

Generic Establishment X: Metal Detection
Log.........................................35

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

Pre-Shipment Review
Log.................................................................37

**GENERIC HACCP MODEL**

**FOR**

## HEAT TREATED BUT NOT FULLY COOKED, NOT SHELF STABLE 

## 

##  MEAT AND POULTRY PRODUCTS

**Introduction**

The Hazard Analysis Critical Control Point (HACCP) system is a
scientific approach to process control. It is designed to prevent the
occurrence of problems by assuring that controls are applied at any
point in a food production system where hazardous or critical situations
could occur. Hazards include biological, chemical, or physical
contamination of food products.

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 process category: Heat
treated but not fully cooked\--not shelf stable.

The purpose of the process category listing in 417.2 is to set out the
circumstances under which a HACCP team may develop a single HACCP plan
for multiple products. This may be done when products are in the same
process category, and food safety hazards, critical control points, and
other features are essentially the same. There is a generic model for
each process category, plus two for subcategories which present special
issues: irradiated products and mechanically separated products.

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

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

2\) For processed products, make a list of all products produced in the
plant.

3\) Examine the list and group like products, considering common
processing steps and equipment used.

4\) Compare the grouped products with the list of processes in the
regulations; this step should reveal how many and which of the generic
models might be useful.

Deciding on a generic model and which products can be covered by a
single plan is an important achievement. If the team does it well, it
can save a lot of unnecessary effort and paperwork.

Selecting an inappropriate generic model reduces its potential benefits.
However, often the HACCP team will discover they have made this error
when they develop their process flow diagram or during their hazard
analysis. These are early stages in the process when it is relatively
easy to make changes.

In any case, establishments must meet all regulatory requirements for
their products.

**Using This Generic Model**

This generic model is designed to be used by establishments that produce
heat treated but not fully cooked, not shelf stable product(s), the
eighth process category. The model can be used for all heat treated but
not fully cooked, not shelf stable products: either meat or poultry. The
generic model is not suitable for products that fall into any of the
other process categories.

The model will be most useful to a HACCP team that includes access to
one trained individual, as specified in 417.7(b).

> *(b)The individual performing the functions listed in paragraph (a) of
> this section shall have successfully completed a course of instruction
> in the application of the seven HACCP principles to meat or poultry
> product processing, including a segment on the development of a HACCP
> plan for a specific product and on record review.*

It would be beneficial for other team members to have reviewed any of
the various guidance materials available on how to develop a HACCP plan
for your company, including several useful videos, handbooks, or
computer programs. 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 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 heat treated but not
fully cooked, not shelf stable -- smoked sausage and partially cooked
chicken patties. 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 smoked sausage and partially cooked chicken patties in generic
establishment X. Figure 2 is an example of a **PRODUCT DESCRIPTION** for
the smoked sausage and partially cooked chicken patties produced in
generic establishment X.

Once the company HACCP team in your establishment has prepared your
Process Flow Diagram, they should verify it by walking through the
establishment following the flow of product and making sure that all the
steps of the process are included in the flow diagram. The team should
also review the information provided on the Product Description to make
sure all the key facts are included, such as identifying consumers,
especially those with particular health problems or known to be at risk.

**Note**: If your process includes steps not included in this example,
those steps should be added. Also, if your process does not include all
the steps identified in this example, those steps would be omitted when
conducting the hazard analysis. That is generally, how you use these
generic model examples\--just omit the features which do not apply to
your operation or if your operation includes features not included in
this example, they should be added.

By completing a Process Flow Diagram and a Product Description, you have
met the requirements of 417.2(a)(2). You can use the Process Flow
Diagram in particular to help you complete the rest of the hazard
analysis. Use the flow diagram to systematically review each step in the
process and ask the question, \"Is there a food safety hazard which is
reasonably likely to occur which may be introduced at this step?\" In
answering the question, your HACCP team needs to consider biological
(including microbiological), chemical, and physical hazards.

**Hazard Analysis**

Once your product(s) are accurately described through the flow diagram
and product description, the HACCP team should begin work on the
**HAZARD ANALYSIS**. The hazard analysis is fundamental to developing a
good HACCP plan and one that meets regulatory requirements. The
regulatory requirements for a hazard analysis are found at 417.2(a).

***§ 417.2 Hazard Analysis and HACCP Plan*.**

> *(a) Hazard analysis. (1) Every official establishment shall conduct,
> or have conducted for it, a hazard analysis to determine the food
> safety hazards reasonably likely to occur in the production process
> and identify the preventive measures the establishment can apply to
> control those hazards. The hazard analysis shall include food safety
> hazards that can occur before, during, and after entry into the
> establishment. A food safety hazard that is reasonably likely to occur
> is one for which a prudent establishment would establish controls
> because it historically has occurred, or because there is a reasonable
> possibility that it will occur in the particular type of product being
> processed, in the absence of those controls.*
>
> *(2) A flow chart describing the steps of each process and product
> flow in the establishment shall be prepared, and the intended use or
> consumers of the finished product shall be identified.*

Generic establishment X, which we are using for our example, is
capturing these regulatory requirements on a 6-column **Hazard Analysis
Form (See Figure 3)**. A good way to use a form like this is to create
the first column by using the Process Flow Diagram and the second by
answering the question. Once the HACCP team has considered all the steps
in the flow diagram and determined if a food safety hazard could be
introduced, it needs to consider whether the hazard is \"reasonably
likely to occur\", using the meaning of this phrase included in
417.2(a). On the 6-column form used by generic establishment X, the
third and fourth columns address this issue. If the establishment\'s
HACCP team has decided that the hazard is not reasonably likely to
occur, they enter \"No\" in column three, explain the basis for their
determination in column four, and do not need to further consider
activity at this point in the process.

If, however, the team has determined there is a \"food safety hazard
reasonably likely to occur\" introduced at a certain point in the
process, column five is used to describe a measure which could be
applied to \"prevent, eliminate, or reduce to acceptable levels\" the
food safety hazard identified in column three. Column six is used when a
critical control point (CCP) is identified based upon the decision made
in the hazard analysis. Each CCP has a number -- the order corresponds
to steps in the process. For example, 1 is the first CCP in the process
flow, 2 the next, etc. The letter indicates whether the hazard is
biological -- B; chemical -- C; or physical -- P.

Look at the entries for "Receiving -- Raw Meat/Poultry" on the first
page of the six column form for heat treated but not fully cooked, not
shelf stable; the HACCP team has determined that *Salmonella* may be
present at high levels in incoming raw product, so it has put a "Yes" in
the third column. Column four explains the basis for the team's
determination. In the fifth column, the HACCP team has described the
preventive measures it will use to make sure that each hazard has been
prevented, eliminated, or reduced to an acceptable level. For the
*Salmonella* hazard, the HACCP team decided to tell its suppliers that
product could not be accepted unless it was accompanied by the most
recent *Salmonella* performance standard sampling results which
demonstrated that the supplier had not failed two consecutive
*Salmonella* performance standard sets. FSIS does not consider safe
handling labels alone to be an adequate CCP for any pathogenic
microorganisms such as bacteria and viruses.

**Note**: Look at the entries for "Storage -- (Cold --
Frozen/Refrigerated) -- Raw Meat/Poultry" on the second page of the
six-column form: the HACCP team has determined that there is a food
safety hazard reasonably likely to occur at this step in the process.
Column four contains the reason for their thinking: pathogenic organisms
can grow in this product if it is not kept sufficiently cool. Column
five contains their description of a measure that will prevent the
growth of pathogenic organisms: temperatures that are sufficiently low
to preclude growth.

You will notice that on our generic hazard analysis for smoked sausage
and partially cooked chicken patties, there are six food safety hazards
in which the HACCP team has identified a point in the process at which a
food safety hazard is reasonably likely to occur. For each one of these
they have identified a measure which can be used to control the hazard.

When your HACCP team has completed their hazard analysis (whether they
use this format or not), it is a good idea to review the flow diagram,
the product description and the hazard analysis itself to make sure they
are complete. Part 417.2(a)(3) includes a list of sources from which
food safety hazards might be expected to arise. Reviewing that list
could help the HACCP team check for completeness.

**Note**: If you are using this generic model to produce a different
heat treated but not fully cooked, not shelf stable product or if you
use a different process flow, you may have different hazards which are
reasonably likely to occur. For these different hazards, there may be
different measures which could be used for control purposes.

This, and all other FSIS generic models, contains a list of references
which can help your HACCP team in making sure the hazard analysis is
complete. These references are found in Appendix A. A member of your
HACCP team might want to review at least some of the references to make
sure hazards have not been omitted from the hazard analysis.

Completing the hazard analysis is a very significant and important
element in developing your HACCP system. Your HACCP team should feel a
real sense of accomplishment when they get this far; this is like
completing the foundation of a house.

**Developing Your HACCP Plan**

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

*(c) [The contents of the HACCP plan]{.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 smoked sausage
and partially cooked chicken patties 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 six points on the
hazard analysis form for smoked sausage and partially cooked chicken
patties where food safety hazards reasonably likely to occur were
identified: *Salmonella* on raw meat/poultry at receiving, pathogen
proliferation at cold storage, metal contamination during mechanical
processing, *trichina* in finished product being packaged and labeled,
pathogen proliferation at chilling, and pathogen proliferation at
finished product storage (cold). The establishment HACCP team has chosen
to have six CCPs to address these six hazards: *Salmonella*
certification, proper cold storage of raw meat/poultry, metal detectors
prior to packaging and labeling, clear product labeling to show product
is raw and must be fully cooked to prevent any *trichina* survival,
proper chilling of finished product, and proper maintenance of finished
product temperatures during storage.

After identifying its CCPs, the HACCP team proceeded to consider
critical limits, monitoring procedures and their frequencies, and
verification procedures and their frequencies, and HACCP records.

In deciding what would be the critical limits, the HACCP team first
considered whether there were any regulatory requirements which had to
be met and would function as critical limits.

They found no regulatory requirements for receiving raw meat/poultry,
but realized that *Salmonella* coming into the plant could result in
cross-contamination with other product. The HACCP team knew that
*Salmonella* may be present on incoming raw product, so they set the
critical limit at requiring the supplier of the carcass parts to send a
*Salmonella* certificate with each shipment stating that the product has
been sampled for *Salmonella*.

Once they had decided on their critical limits, they needed to identify
how the monitoring procedures would be carried out and at what
frequency.

For their receiving -- raw meat/poultry step, the establishment had the
receiving personnel check each shipment for *Salmonella* certification.

These decisions by the HACCP team regarding critical limits, plus
monitoring procedures and their frequencies are written up in columns
two and three of the HACCP Plan.

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

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

*(i) The calibration of process-monitoring instruments;*

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

> *(iii) The review of records generated and maintained in accordance
> with §417.5(a)(3) of this part.*

The HACCP team decided they could verify the suppliers' *Salmonella*
certifications by requesting *Salmonella* data results from FSIS for at
least two suppliers every two months.

The HACCP team described the verification procedures and their
frequencies in the fifth column of their HACCP plan.

The HACCP team for generic establishment X knew that their HACCP Plan
needed to provide for a recordkeeping system. They wanted their records
to be easy to create and understand. They wanted to be sure their
records met regulatory requirements, so they reviewed part 417.5(a) and
(b):

***§ 417.5 Records.***

> *(a) The establishment shall maintain the following records
> documenting the establishment\'s HACCP plan:*
>
> *(1) The written hazard analysis prescribed in § 417.2(a) of this
> part, including all supporting documentation;*
>
> *(2) The written HACCP plan, including decision making documents
> associated with the selection and development of CCPs and critical
> limits, and documents supporting both the monitoring and verification
> procedures selected and the frequency of those procedures.*
>
> *(3) Records documenting the monitoring of CCPs and their critical
> limits, including the recording of actual times, temperatures, or
> other quantifiable values, as prescribed in the establishment\'s HACCP
> plan; the calibration of process‑monitoring instruments; corrective
> actions, including all actions taken in response to a deviation;
> verification procedures and results; product code(s), product name or
> identity, or slaughter production lot. Each of these records shall
> include the date the record was made.*
>
> *(b) Each entry on a record maintained under the HACCP plan shall be
> made at the time the specific event occurs and include the date and
> time recorded, and shall be signed or initialed by the establishment
> employee making the entry.*

The HACCP team decided that their records would be kept on some simple
forms, some of which the team itself devised.

The HACCP team decided that since receiving personnel had a form that
they had been using for receiving product, that they would modify that
form. The form was modified to provide spaces for all entries necessary
for the monitoring and verification activities at the receiving -- raw
meat/poultry step.

On its HACCP Plan, generic establishment X has listed the names of the
forms it will be using for monitoring and verification records.

There is one other form included in column four, where the establishment
has described its recordkeeping system. That is the Corrective Actions
Log; it is used to create the records of any corrective actions taken
because of deviations from critical limits at CCPs. Column six of the
HACCP plan references the planned corrective actions for each CCP. The
HACCP team carefully reviewed the regulatory requirements for planned
corrective actions found at 417.3(a):

***§ 417.3 Corrective actions.***

> *(a) The written HACCP plan shall identify the corrective action to be
> followed in response to a deviation from a critical limit. The HACCP
> plan shall describe the corrective action to be taken, and assign
> responsibility for taking corrective action, to ensure:*

*(1) The cause of the deviation is identified and eliminated;*

*(2) The CCP will be under control after the corrective action is
taken;*

*(3) Measures to prevent recurrence are established; and*

> *(4) No product that is injurious to health or otherwise adulterated
> as a result of the deviation enters commerce.*

The HACCP team has developed a specific corrective action plan which
will be followed whenever there is a deviation from a critical limit at
a CCP; each of the planned corrective actions meets the four regulatory
requirements of 417.3(a).

Planned Corrective Action for CCP 1:

Receiving personnel will not receive product unaccompanied by
*Salmonella* certification.

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

### 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 Heat Treated But Not Fully Cooked, Not Shelf Stable Meat
and Poultry Products

1.  American Meat Science Association. *Flowchart for uncooked, cured
    summer sausage.* AMSA, Chicago, IL, 1995.

2.  Bushway, A.A., et al. *Residual nitrite concentration and total
    plate counts in white and dark chicken patties.* J. Food Protect.
    47: 119-121, 1984.

3.  Marcy, J.A., et al. *Effect of acid and neutral pyrophosphates on
    the natural bacterial flora of a cooked meat system.* J. Food Sci.
    52: 1183-1185, 1987.

4.  Stevenson, K.E. and Bernard, D.T. Editors. *Process flow diagram for
    battered and breaded chicken pieces. In HACCP Establishing Hazard
    Analysis Critical Control Point Programs., A Workshop Manual.*
    Chapter 11: 14-15, The Food Processors Institute, Washington, DC,
    1995.

5.  Yen, L.C., et al. *Effect of meat curing ingredients on thermal
    destruction of Listeria monocytogenes in ground pork.* J. Food
    Protect. 54: 408-412.

6.  Yi, Y.H., et al. Yields, color, moisture and microbial contents of
    chicken patties as affected by frying and internal temperatures. J.
    Food Sci. 52: 1183-1185, 1987.

**APPENDIX B**

> **PROCESS FLOW DIAGRAM Figure 1**

## PROCESS CATEGORY: HEAT TREATED BUT NOT FULLY COOKED, 

##  NOT SHELF STABLE

#### 

#### PRODUCT: SMOKED SAUSAGE, PARTIALLY COOKED CHICKEN PATTIES

####  

####   {#section-23 .unnumbered}

#### PRODUCT DESCRIPTION Figure 2

+-----------------------------------------------------------------------+
| ####### PROCESS CATEGORY: HEAT TREATED BUT NOT FULLY COOKED,          |
|                                                                       |
| #######  NOT SHELF STABLE                                             |
|                                                                       |
| ####### PRODUCT: SMOKED SAUSAGE, PARTIALLY COOKED CHICKEN PATTIES     |
+-----------------------------------------------------------------------+
| 1\. COMMON NAME? SMOKED SAUSAGE, PARTIALLY COOKED CHICKEN PATTIES     |
|                                                                       |
| 2\. HOW IS IT TO BE USED? ENTREES, NUGGETS, SNACK FOODS, SALADS       |
|                                                                       |
| 3\. TYPE OF PACKAGE? BULK-PACKED (E.G., PLASTIC BAG, VACUUM PACKED)   |
|                                                                       |
| 4\. LENGTH OF SHELF LIFE, 3-6 MONTHS AT 0° F OR                       |
|                                                                       |
| AT WHAT TEMPERATURE? BELOW;7 DAYS AT 40° F                            |
|                                                                       |
| 5\. WHERE WILL IT BE SOLD? WHOLESALE TO DISTRIBUTORS                  |
|                                                                       |
| CONSUMERS? ONLY                                                       |
|                                                                       |
| INTENDED USE?                                                         |
|                                                                       |
| 6\. LABELING INSTRUCTIONS? KEEP FROZEN; KEEP REFRIGERATED             |
|                                                                       |
| 7\. IS SPECIAL DISTRIBUTION KEEP FROZEN; KEEP                         |
|                                                                       |
| CONTROL NEEDED? REFRIGERATED                                          |
+-----------------------------------------------------------------------+

**HAZARD ANALYSIS -- HEAT TREATED BUT NOT FULLY COOKED, NOT SHELF STABLE
-**

**Smoked Sausage, Partially Cooked Chicken Patties**

+-----------+-----------+-------+-------------+-------------+---------+
| **Process | **Food    | **    | ###         | **If Yes in | **C     |
| Step**    | Safety**  | Reaso | ##### Basis | Column 3,   | ritical |
|           |           | nably |             | What        | Control |
|           | *         | L     |             | Measures    | Point** |
|           | *Hazard** | ikely |             | Could be    |         |
|           |           | to    |             | Applied to  |         |
|           |           | Occ   |             | Prevent,    |         |
|           |           | ur?** |             | Eliminate,  |         |
|           |           |       |             | or Reduce   |         |
|           |           |       |             | the Hazard  |         |
|           |           |       |             | to an       |         |
|           |           |       |             | Acceptable  |         |
|           |           |       |             | Level?**    |         |
+-----------+-----------+-------+-------------+-------------+---------+
| **        | #### Biol | ###   | ***         | **Ce        | #####   |
| Receiving | ogical: P | ##### | Salmonella* | rtification | #### 1B |
| -- Raw    | athogens  | # Yes | may be      | from        |         |
| Meat/     |           |       | present on  | suppliers   |         |
| Poultry** | #### *Sa  |       | incoming    | that        |         |
|           | lmonella* |       | raw         | product has |         |
|           |           |       | product.**  | been        |         |
|           | *         |       |             | sampled for |         |
|           | Trichina* |       |             | *           |         |
|           |           |       |             | Salmonella* |         |
|           |           |       |             | meets       |         |
|           |           |       |             | performance |         |
|           |           |       |             | standards** |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       |       |             |             |         |
|           | # Chemica |       |             |             |         |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ###   | **Bone/bone | **Supplier  |         |
|           | *Physical | ##### | fragments   | sp          |         |
|           | --        | # Yes | (           | ecification |         |
|           | Foreign   |       | size/shape) | that all    |         |
|           | materials |       | that would  | product     |         |
|           | such as   |       | represent a | must have   |         |
|           | broken    |       | hazard to   | been run    |         |
|           | needles,  |       | consumers   | through a   |         |
|           | bone/     |       | have been   | bone        |         |
|           | bone      |       | found in    | de          |         |
|           | fr        |       | incoming    | tector/bone |         |
|           | agments** |       | product.**  | collector   |         |
|           |           |       |             | in process  |         |
|           |           |       |             | or if whole |         |
|           |           |       |             | muscle      |         |
|           |           |       |             | product     |         |
|           |           |       |             | received    |         |
|           |           |       |             | use of a    |         |
|           |           |       |             | bone        |         |
|           |           |       |             | de          |         |
|           |           |       |             | tector/bone |         |
|           |           |       |             | collector   |         |
|           |           |       |             | in          |         |
|           |           |       |             | process.**  |         |
+-----------+-----------+-------+-------------+-------------+---------+
| **        | ####      |       |             |             |         |
| Receiving | Biologica |       |             |             |         |
| --        | l -- None |       |             |             |         |
| Nonmeat/N |           |       |             |             |         |
| onpoultry |           |       |             |             |         |
| Food      |           |       |             |             |         |
| Ing       |           |       |             |             |         |
| redients; |           |       |             |             |         |
| Packaging |           |       |             |             |         |
| Ma        |           |       |             |             |         |
| terials** |           |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ##    | **Letters   |             |         |
|           | *Chemical | ##### | of guaranty |             |         |
|           | -- Not    | ## No | are         |             |         |
|           | a         |       | received    |             |         |
|           | cceptable |       | from all    |             |         |
|           | for       |       | suppliers   |             |         |
|           | intended  |       | of          |             |         |
|           | use**     |       | packaging   |             |         |
|           |           |       | m           |             |         |
|           |           |       | aterials.** |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ##    | **Plant     |             |         |
|           | *Physical | ##### | records     |             |         |
|           | --        | ## No | demonstrate |             |         |
|           | Foreign   |       | that        |             |         |
|           | materials |       | foreign     |             |         |
|           | (wood,    |       | material    |             |         |
|           | metal,    |       | co          |             |         |
|           | glass,    |       | ntamination |             |         |
|           | etc.)**   |       | has not     |             |         |
|           |           |       | occurred    |             |         |
|           |           |       | during the  |             |         |
|           |           |       | past        |             |         |
|           |           |       | several     |             |         |
|           |           |       | years.**    |             |         |
+-----------+-----------+-------+-------------+-------------+---------+

**Figure 3**

**HAZARD ANALYSIS -- HEAT TREATED BUT NOT FULLY COOKED, NOT SHELF
STABLE - Smoked Sausage, Partially Cooked Chicken Patties**

+-----------+-----------+-------+-------------+-------------+---------+
| **Process | **Food    | **    | ###         | **If Yes in | **C     |
| Step**    | Safety**  | Reaso | ##### Basis | Column 3,   | ritical |
|           |           | nably |             | What        | Control |
|           | *         | L     |             | Measures    | Point** |
|           | *Hazard** | ikely |             | Could be    |         |
|           |           | to    |             | Applied to  |         |
|           |           | Occ   |             | Prevent,    |         |
|           |           | ur?** |             | Eliminate,  |         |
|           |           |       |             | or Reduce   |         |
|           |           |       |             | the Hazard  |         |
|           |           |       |             | to an       |         |
|           |           |       |             | Acceptable  |         |
|           |           |       |             | Level?**    |         |
+-----------+-----------+-------+-------------+-------------+---------+
| **Storage | ####      | ##### |             |             |         |
| --        | Biologica | ####  |             |             |         |
| Nonmeat/N | l -- None |       |             |             |         |
| onpoultry |           |       |             |             |         |
| Food      |           |       |             |             |         |
| Ing       |           |       |             |             |         |
| redients; |           |       |             |             |         |
| Packaging |           |       |             |             |         |
| Ma        |           |       |             |             |         |
| terials** |           |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       | ##### |             |             |         |
|           | # Chemica | ####  |             |             |         |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       | ##### |             |             |         |
|           | # Physica | ####  |             |             |         |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
| **Storage | #### Bi   | ###   | **Pathogens | **Maintain  | #####   |
| (Cold --  | ological  | ##### | are         | product     | #### 2B |
| Fr        |           | # Yes | reasonably  | temperature |         |
| ozen/Refr | *Sa       |       | likely to   | at or below |         |
| igerated) | lmonella* |       | grow in     | a level     |         |
| -- Raw    |           |       | this        | sufficient  |         |
| Meat/     | *Listeria |       | product if  | to preclude |         |
| Poultry** | monoc     |       | temperature | or abate    |         |
|           | ytogenes* |       | is not      | pathogen    |         |
|           |           |       | maintained  | growth.**   |         |
|           |           |       | at or below |             |         |
|           |           |       | a level     |             |         |
|           |           |       | sufficient  |             |         |
|           |           |       | to preclude |             |         |
|           |           |       | their       |             |         |
|           |           |       | growth and  |             |         |
|           |           |       | coolers are |             |         |
|           |           |       | not         |             |         |
|           |           |       | maintained  |             |         |
|           |           |       | to hold     |             |         |
|           |           |       | temp        |             |         |
|           |           |       | eratures.** |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       |       |             |             |         |
|           | # Chemica |       |             |             |         |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ##### |             |             |         |
|           | *Physical | ####  |             |             |         |
|           | -- None** |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
| **        | ####      | ##### |             |             |         |
| Tempering | Biologica | ####  |             |             |         |
| Frozen    | l -- None |       |             |             |         |
| Meat/     |           |       |             |             |         |
| Poultry** |           |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ##### |             |             |         |
|           | *Chemical | ####  |             |             |         |
|           | -- None** |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ##### |             |             | ###     |
|           | *Physical | ####  |             |             | ######  |
|           | -- None** |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
| *         | ####      | ##### |             |             | ###     |
| *Weighing | Biologica | ####  |             |             | ######  |
| Nonmeat/N | l -- None |       |             |             |         |
| onpoultry |           |       |             |             |         |
| Food      |           |       |             |             |         |
| Ingr      |           |       |             |             |         |
| edients** |           |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ##### |             |             | ###     |
|           | *Chemical | ####  |             |             | ######  |
|           | -- None** |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ##### |             |             | ###     |
|           | *Physical | ####  |             |             | ######  |
|           | -- None** |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+

**Figure 3**

**HAZARD ANALYSIS -- HEAT TREATED BUT NOT FULLY COOKED, NOT SHELF
STABLE - Smoked Sausage, Partially Cooked Chicken Patties**

+-----------+-----------+-------+-------------+-------------+---------+
| **Process | **Food    | **    | ###         | **If Yes in | **C     |
| Step**    | Safety**  | Reaso | ##### Basis | Column 3,   | ritical |
|           |           | nably |             | What        | Control |
|           | *         | L     |             | Measures    | Point** |
|           | *Hazard** | ikely |             | Could be    |         |
|           |           | to    |             | Applied to  |         |
|           |           | Occ   |             | Prevent,    |         |
|           |           | ur?** |             | Eliminate,  |         |
|           |           |       |             | or Reduce   |         |
|           |           |       |             | the Hazard  |         |
|           |           |       |             | to an       |         |
|           |           |       |             | Acceptable  |         |
|           |           |       |             | Level?**    |         |
+-----------+-----------+-------+-------------+-------------+---------+
| *         | ####      | ##### |             |             |         |
| *Weighing | Biologica | ####  |             |             |         |
| Raw       | l -- None |       |             |             |         |
| Meat/     |           |       |             |             |         |
| Poultry** |           |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       | ##### |             |             |         |
|           | # Chemica | ####  |             |             |         |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       | ##### |             |             |         |
|           | # Physica | ####  |             |             |         |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
| **Combine | ####      | ##### |             |             | ###     |
| Ingr      | Biologica | ####  |             |             | ######  |
| edients** | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       |       |             |             |         |
|           | # Chemica |       |             |             |         |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ##### |             |             |         |
|           | *Physical | ####  |             |             |         |
|           | -- None** |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
| **M       | ####      | ##### |             |             |         |
| echanical | Biologica | ####  |             |             |         |
| Process** | l -- None |       |             |             |         |
|           |           |       |             |             |         |
| **\* See  |           |       |             |             |         |
| list on   |           |       |             |             |         |
| flow      |           |       |             |             |         |
| chart on  |           |       |             |             |         |
| page 21** |           |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ##### |             |             |         |
|           | *Chemical | ####  |             |             |         |
|           | -- None** |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ###   | **Plant     | **Metal     | #####   |
|           | *Physical | ##### | records     | detectors   | #### 3P |
|           | -- Metal  | # Yes | show that   | are         |         |
|           | Contam    |       | during      | installed   |         |
|           | ination** |       | mechanical  | prior to    |         |
|           |           |       | processing  | p           |         |
|           |           |       | metal       | ackaging.** |         |
|           |           |       | co          |             |         |
|           |           |       | ntamination |             |         |
|           |           |       | is likely   |             |         |
|           |           |       | to occur.** |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
| **Smokin  | ####      | ##### |             |             | ###     |
| g/Partial | Biologica | ####  |             |             | ######  |
| Cooking** | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ##### |             |             | ###     |
|           | *Chemical | ####  |             |             | ######  |
|           | -- None** |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ##### |             |             | ###     |
|           | *Physical | ####  |             |             | ######  |
|           | -- None** |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
| #######   | #         | ##    | **Rework at |             | ###     |
| ## Rework | ### Biolo | ##### | the end of  |             | ######  |
|           | gical --  | ## No | the day is  |             |         |
|           | Pathogens |       | c           |             |         |
|           |           |       | ondemned.** |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ##### |             |             | ###     |
|           | *Chemical | ####  |             |             | ######  |
|           | -- None** |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ##### |             |             | ###     |
|           | *Physical | ####  |             |             | ######  |
|           | -- None** |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+

**Figure 3**

**HAZARD ANALYSIS -- HEAT TREATED BUT NOT FULLY COOKED, NOT SHELF
STABLE - Smoked Sausage, Partially Cooked Chicken Patties**

+-----------+-----------+-------+-------------+-------------+---------+
| **Process | **Food    | **    | ###         | **If Yes in | **C     |
| Step**    | Safety**  | Reaso | ##### Basis | Column 3,   | ritical |
|           |           | nably |             | What        | Control |
|           | *         | L     |             | Measures    | Point** |
|           | *Hazard** | ikely |             | Could be    |         |
|           |           | to    |             | Applied to  |         |
|           |           | Occ   |             | Prevent,    |         |
|           |           | ur?** |             | Eliminate,  |         |
|           |           |       |             | or Reduce   |         |
|           |           |       |             | the Hazard  |         |
|           |           |       |             | to an       |         |
|           |           |       |             | Acceptable  |         |
|           |           |       |             | Level?**    |         |
+-----------+-----------+-------+-------------+-------------+---------+
| **Pa      | #         | ###   | *           | **Labels    | #####   |
| ckaging/L | ### Biolo | ##### | **Trichina* | that        | #### 4B |
| abeling** | gical --  | # Yes | has         | clearly     |         |
|           | Pathogens |       | h           | indicate    |         |
|           |           |       | istorically | this is a   |         |
|           | **-       |       | occurred in | raw         |         |
|           | parasitic |       | raw pork    | product,    |         |
|           | (*Tri     |       | products.** | along with  |         |
|           | china*)** |       |             | cooking     |         |
|           |           |       |             | i           |         |
|           |           |       |             | nstructions |         |
|           |           |       |             | and a safe  |         |
|           |           |       |             | food        |         |
|           |           |       |             | handling    |         |
|           |           |       |             | s           |         |
|           |           |       |             | tatement.** |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       | ##### |             |             |         |
|           | # Chemica | ####  |             |             |         |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       | ##### |             |             |         |
|           | # Physica | ####  |             |             |         |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
| **C       | #### Biol | ###   | **Pathogens | **Proper    | #####   |
| hilling** | ogical -  | ##### | are         | chilling    | #### 5B |
|           | Pathogens | # Yes | reasonably  | procedures  |         |
|           |           |       | likely to   | are used.** |         |
|           |           |       | grow if     |             |         |
|           |           |       | improper    |             |         |
|           |           |       | chilling    |             |         |
|           |           |       | procedures  |             |         |
|           |           |       | are used.** |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       | ##### |             |             | ###     |
|           | # Chemica | ####  |             |             | ######  |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       | ##### |             |             | ###     |
|           | # Physica | ####  |             |             | ######  |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+

**Figure 3**

**HAZARD ANALYSIS -- HEAT TREATED BUT NOT FULLY COOKED, NOT SHELF
STABLE - Smoked Sausage, Partially Cooked Chicken Patties**

+-----------+-----------+-------+-------------+-------------+---------+
| **Process | **Food    | **    | ###         | **If Yes in | **C     |
| Step**    | Safety**  | Reaso | ##### Basis | Column 3,   | ritical |
|           |           | nably |             | What        | Control |
|           | *         | L     |             | Measures    | Point** |
|           | *Hazard** | ikely |             | Could be    |         |
|           |           | to    |             | Applied to  |         |
|           |           | Occ   |             | Prevent,    |         |
|           |           | ur?** |             | Eliminate,  |         |
|           |           |       |             | or Reduce   |         |
|           |           |       |             | the Hazard  |         |
|           |           |       |             | to an       |         |
|           |           |       |             | Acceptable  |         |
|           |           |       |             | Level?**    |         |
+-----------+-----------+-------+-------------+-------------+---------+
| *         | #         | ###   | **Pathogens | **Maintain  | #####   |
| *Finished | ### Biolo | ##### | are         | product     | #### 6B |
| Product   | gical --  | # Yes | reasonably  | temperature |         |
| Storage   | Pathogens |       | likely to   | at or below |         |
| (Cold)**  |           |       | grow in     | a level     |         |
|           |           |       | this        | sufficient  |         |
|           |           |       | product if  | to preclude |         |
|           |           |       | temperature | pathogen    |         |
|           |           |       | is not      | growth.**   |         |
|           |           |       | maintained  |             |         |
|           |           |       | at or below |             |         |
|           |           |       | a level     |             |         |
|           |           |       | sufficient  |             |         |
|           |           |       | to preclude |             |         |
|           |           |       | their       |             |         |
|           |           |       | growth.**   |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       |       |             |             |         |
|           | # Chemica |       |             |             |         |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ##### |             |             |         |
|           | *Physical | ####  |             |             |         |
|           | -- None** |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
| **S       | #### B    | ##### |             |             |         |
| hipping** | iological | ####  |             |             |         |
|           |  -- None  |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ##### |             |             |         |
|           | *Chemical | ####  |             |             |         |
|           | -- None** |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ##### |             |             |         |
|           | *Physical | ####  |             |             |         |
|           | -- None** |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+

**Figure 3**

+-----+------+--------+---------+----------------+-------------------+
| *   |      |        |         |                |                   |
| *HA |      |        |         |                |                   |
| CCP |      |        |         |                |                   |
| PLA |      |        |         |                |                   |
| N** |      |        |         |                |                   |
|     |      |        |         |                |                   |
| ### |      |        |         |                |                   |
| ### |      |        |         |                |                   |
| # * |      |        |         |                |                   |
| *PR |      |        |         |                |                   |
| OCE |      |        |         |                |                   |
| SS  |      |        |         |                |                   |
| CAT |      |        |         |                |                   |
| EGO |      |        |         |                |                   |
| RY: |      |        |         |                |                   |
|  HE |      |        |         |                |                   |
| AT  |      |        |         |                |                   |
| TRE |      |        |         |                |                   |
| ATE |      |        |         |                |                   |
| D B |      |        |         |                |                   |
| UT  |      |        |         |                |                   |
| NOT |      |        |         |                |                   |
|  FU |      |        |         |                |                   |
| LLY |      |        |         |                |                   |
|  CO |      |        |         |                |                   |
| OKE |      |        |         |                |                   |
| D,  |      |        |         |                |                   |
| NOT |      |        |         |                |                   |
|  SH |      |        |         |                |                   |
| ELF |      |        |         |                |                   |
|  ST |      |        |         |                |                   |
| ABL |      |        |         |                |                   |
| E** |      |        |         |                |                   |
|     |      |        |         |                |                   |
| ##  |      |        |         |                |                   |
|  PR |      |        |         |                |                   |
| ODU |      |        |         |                |                   |
| CT  |      |        |         |                |                   |
| EXA |      |        |         |                |                   |
| MPL |      |        |         |                |                   |
| E:  |      |        |         |                |                   |
| SMO |      |        |         |                |                   |
| KED |      |        |         |                |                   |
|  SA |      |        |         |                |                   |
| USA |      |        |         |                |                   |
| GE, |      |        |         |                |                   |
|  PA |      |        |         |                |                   |
| RTI |      |        |         |                |                   |
| ALL |      |        |         |                |                   |
| Y C |      |        |         |                |                   |
| OOK |      |        |         |                |                   |
| ED  |      |        |         |                |                   |
| CHI |      |        |         |                |                   |
| CKE |      |        |         |                |                   |
| N P |      |        |         |                |                   |
| ATT |      |        |         |                |                   |
| IES |      |        |         |                |                   |
+-----+------+--------+---------+----------------+-------------------+
| #   | #### | **Moni | ####    | **Verification | ######### C       |
| ### |  Cri | toring |  HACCP  | Procedures and | orrective Actions |
|  CC | tica | Proc   | Records | Frequency**    |                   |
| P#  | l Li | edures |         |                |                   |
| and | mits | and    |         |                |                   |
|  Lo |      | Frequ  |         |                |                   |
| cat |      | ency** |         |                |                   |
| ion |      |        |         |                |                   |
+-----+------+--------+---------+----------------+-------------------+
| 1B  | Supp | Rec    | Re      | Every two      | Will not receive  |
|     | lier | eiving | ceiving | months QA will | product           |
| Rec | c    | per    | Log     | request FSIS   | unaccompanied by  |
| eiv | erti | sonnel |         | *Salmonella*   | *Salmonella*      |
| ing | fica | will   | Cor     | data results   | certification.    |
| --  | tion | check  | rective | from company   |                   |
| Raw | that | each   | Action  | for at least 2 | Product found not |
| Mea | pro  | sh     | Log     | suppliers.     | meeting           |
| t/P | duct | ipment |         |                | *Salmonella*      |
| oul | has  | for    |         |                | performance       |
| try | been | *Salmo |         |                | standards will    |
|     | sam  | nella* |         |                | not be accepted.  |
|     | pled | ce     |         |                | If supplier has   |
|     | for  | rtific |         |                | failed 2          |
|     | *Sal | ation. |         |                | consecutive sets  |
|     | mone |        |         |                | of *Salmonella*   |
|     | lla* |        |         |                | tests, the        |
|     | must |        |         |                | supplier will not |
|     | a    |        |         |                | be used until     |
|     | ccom |        |         |                | they certify that |
|     | pany |        |         |                | the results of a  |
|     | s    |        |         |                | sample set meets  |
|     | hipm |        |         |                | baseline          |
|     | ent. |        |         |                | standard.         |
+-----+------+--------+---------+----------------+-------------------+
| 2B  | Raw  | Maint  | Room    | Maintenance    | Product internal  |
|     | pro  | enance | Temp    | supervisor     | temperature will  |
| S   | duct | per    | erature | will verify    | be determined. QA |
| tor | sto  | sonnel | Log     | accuracy of    | will reject or    |
| age | rage | will   |         | the Room       | hold product      |
|     | a    | check  | Ther    | Temperature    | dependent on      |
| (C  | reas | raw    | mometer | Log once per   | time/temperature  |
| old | s    | p      | Cali    | shift and      | deviation. Volume |
| --F | hall | roduct | bration | observe        | or manner of      |
| roz | not  | s      | Log     | temperature    | storage will be   |
| en/ | ex   | torage |         | checks.        | adjusted if       |
|     | ceed | area   | Cor     |                | determined to     |
| Ref | 40°  | tempe  | rective | QA will check  | contribute to the |
| rig | F.   | rature | Action  | all            | deviation.        |
| era |      | every  | Log     | thermometers   | Cooling curve or  |
| ted |      | two    |         | used for       | Process Authority |
| --  |      | hours. |         | monitoring and | will be used to   |
| Raw |      |        |         | verification   | make product      |
| Mea |      |        |         | for accuracy   | disposition       |
| t/P |      |        |         | daily and      | determination.    |
| oul |      |        |         | calibrate to   |                   |
| try |      |        |         | within 2°F     | QA will identify  |
|     |      |        |         | accuracy as    | the cause of the  |
|     |      |        |         | necessary.     | deviation and     |
|     |      |        |         |                | prevent           |
|     |      |        |         |                | reoccurrence.     |
|     |      |        |         |                | Cooler will be    |
|     |      |        |         |                | repaired &        |
|     |      |        |         |                | maintenance       |
|     |      |        |         |                | schedule revised  |
|     |      |        |         |                | if necessary.     |
+-----+------+--------+---------+----------------+-------------------+

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

+------+-----+--------+---------+----------------+-------------------+
| **H  |     |        |         |                |                   |
| ACCP |     |        |         |                |                   |
| PL   |     |        |         |                |                   |
| AN** |     |        |         |                |                   |
|      |     |        |         |                |                   |
| *    |     |        |         |                |                   |
| *PRO |     |        |         |                |                   |
| CESS |     |        |         |                |                   |
| C    |     |        |         |                |                   |
| ATEG |     |        |         |                |                   |
| ORY: |     |        |         |                |                   |
| HEAT |     |        |         |                |                   |
| TRE  |     |        |         |                |                   |
| ATED |     |        |         |                |                   |
| BUT  |     |        |         |                |                   |
| NOT  |     |        |         |                |                   |
| F    |     |        |         |                |                   |
| ULLY |     |        |         |                |                   |
| COO  |     |        |         |                |                   |
| KED, |     |        |         |                |                   |
| NOT  |     |        |         |                |                   |
| S    |     |        |         |                |                   |
| HELF |     |        |         |                |                   |
| STAB |     |        |         |                |                   |
| LE** |     |        |         |                |                   |
|      |     |        |         |                |                   |
| *    |     |        |         |                |                   |
| *PRO |     |        |         |                |                   |
| DUCT |     |        |         |                |                   |
| EXAM |     |        |         |                |                   |
| PLE: |     |        |         |                |                   |
| SM   |     |        |         |                |                   |
| OKED |     |        |         |                |                   |
| SAUS |     |        |         |                |                   |
| AGE, |     |        |         |                |                   |
| P    |     |        |         |                |                   |
| ARTI |     |        |         |                |                   |
| ALLY |     |        |         |                |                   |
| CO   |     |        |         |                |                   |
| OKED |     |        |         |                |                   |
| CHI  |     |        |         |                |                   |
| CKEN |     |        |         |                |                   |
| P    |     |        |         |                |                   |
| ATTI |     |        |         |                |                   |
| ES** |     |        |         |                |                   |
+------+-----+--------+---------+----------------+-------------------+
| ##   | ##  | **Moni | ####    | **Verification | ######### C       |
| ## C | ##  | toring |  HACCP  | Procedures and | orrective Actions |
| CP#  | Cri | Proc   | Records | Frequency**    |                   |
| and  | tic | edures |         |                |                   |
| Loca | al  | and    |         |                |                   |
| tion | Lim | Frequ  |         |                |                   |
|      | its | ency** |         |                |                   |
+------+-----+--------+---------+----------------+-------------------+
| 3P   | No  | Maint  | Metal   | Maintenance    | Mechanical        |
|      | me  | enance | De      | supervisor     | separation line   |
| Me   | tal | per    | tection | will verify    | supervisor will   |
| chan | par | sonnel | Log     | metal detector | control and       |
| ical | tic | will   |         | is functioning | segregate         |
| P    | les | check  | Cor     | and perform    | affected product. |
| roce | to  | the    | rective | routine        |                   |
| sses | exc | metal  | Action  | maintenance as | Maintenance       |
|      | eed | de     | Log     | required by    | personnel will    |
|      | 1   | tector |         | manufacturer.  | identify and      |
|      | /32 | with a |         |                | eliminate the     |
|      | i   | seeded |         | QA will verify | problem with the  |
|      | nch | sample |         | that the metal | metal detector.   |
|      | es. | once   |         | detector is    |                   |
|      |     | per    |         | functioning as | Preventive        |
|      |     | shift  |         | intended by    | maintenance       |
|      |     | &      |         | observing      | program will be   |
|      |     | det    |         | maintenance    | implemented and   |
|      |     | ermine |         | test with      | revised as        |
|      |     | that   |         | seeded sample  | required.         |
|      |     | kick   |         | once every     |                   |
|      |     | out    |         | other day.     | QA will run       |
|      |     | device |         |                | seeded sample     |
|      |     | is     |         |                | through metal     |
|      |     | funct  |         |                | detector after    |
|      |     | ioning |         |                | repair.           |
|      |     | as     |         |                |                   |
|      |     | int    |         |                | All potentially   |
|      |     | ended. |         |                | contaminated      |
|      |     |        |         |                | product will be   |
|      |     |        |         |                | visually examined |
|      |     |        |         |                | & metal removed.  |
|      |     |        |         |                | Product will be   |
|      |     |        |         |                | x-rayed prior to  |
|      |     |        |         |                | rework or         |
|      |     |        |         |                | shipment.         |
+------+-----+--------+---------+----------------+-------------------+

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

##  

+------+-----+--------+---------+----------------+-------------------+
| **H  |     |        |         |                |                   |
| ACCP |     |        |         |                |                   |
| PL   |     |        |         |                |                   |
| AN** |     |        |         |                |                   |
|      |     |        |         |                |                   |
| *    |     |        |         |                |                   |
| *PRO |     |        |         |                |                   |
| CESS |     |        |         |                |                   |
| C    |     |        |         |                |                   |
| ATEG |     |        |         |                |                   |
| ORY: |     |        |         |                |                   |
| HEAT |     |        |         |                |                   |
| TRE  |     |        |         |                |                   |
| ATED |     |        |         |                |                   |
| BUT  |     |        |         |                |                   |
| NOT  |     |        |         |                |                   |
| F    |     |        |         |                |                   |
| ULLY |     |        |         |                |                   |
| COO  |     |        |         |                |                   |
| KED, |     |        |         |                |                   |
| NOT  |     |        |         |                |                   |
| S    |     |        |         |                |                   |
| HELF |     |        |         |                |                   |
| STAB |     |        |         |                |                   |
| LE** |     |        |         |                |                   |
|      |     |        |         |                |                   |
| *    |     |        |         |                |                   |
| *PRO |     |        |         |                |                   |
| DUCT |     |        |         |                |                   |
| EXAM |     |        |         |                |                   |
| PLE: |     |        |         |                |                   |
| SM   |     |        |         |                |                   |
| OKED |     |        |         |                |                   |
| SAUS |     |        |         |                |                   |
| AGE, |     |        |         |                |                   |
| P    |     |        |         |                |                   |
| ARTI |     |        |         |                |                   |
| ALLY |     |        |         |                |                   |
| CO   |     |        |         |                |                   |
| OKED |     |        |         |                |                   |
| CHI  |     |        |         |                |                   |
| CKEN |     |        |         |                |                   |
| P    |     |        |         |                |                   |
| ATTI |     |        |         |                |                   |
| ES** |     |        |         |                |                   |
+------+-----+--------+---------+----------------+-------------------+
| ##   | ##  | **Moni | ####    | **Verification | ######### C       |
| ## C | ##  | toring |  HACCP  | Procedures and | orrective Actions |
| CP#  | Cri | Proc   | Records | Frequency**    |                   |
| and  | tic | edures |         |                |                   |
| Loca | al  | and    |         |                |                   |
| tion | Lim | Frequ  |         |                |                   |
|      | its | ency** |         |                |                   |
+------+-----+--------+---------+----------------+-------------------+
| 4B   | P   | Pac    | L       | QA will        | QA will segregate |
|      | rod | kaging | abeling | observe        | and hold all      |
| Pa   | uct | line   | Log     | packaging line | affected product. |
| ckag | m   | supe   |         | supervisor     |                   |
| ing/ | ust | rvisor | Cor     | perform        | QA will ensure    |
|      | c   | will   | rective | monitoring     | that proper       |
| Labe | lea | select | Action  | activity once  | labeling is       |
| ling | rly | 2      | Log     | per shift.     | applied to all    |
|      | be  | pa     |         |                | affected product  |
| *(Tr | l   | ckages |         | QA will select | prior to          |
| ichi | abe | of     |         | 3 labels       | shipment.         |
| na)* | led | each   |         | intended for   |                   |
|      | as  | type   |         | use from label | Labeling          |
|      | raw | of     |         | storage area   | equipment will be |
|      | or  | p      |         | twice weekly   | adjusted if       |
|      | par | roduct |         | to ensure      | required. Label   |
|      | tia | pr     |         | label          | manufacturer will |
|      | lly | oduced |         | accuracy.      | provide           |
|      | coo | at the |         |                | certification     |
|      | ked | start  |         | QA will check  | that all required |
|      | and | &      |         | labels once a  | features are      |
|      | req | finish |         | day on         | printed properly. |
|      | uir | of     |         | packaged       | Incoming labels   |
|      | ing | each   |         | product to     | will examined to  |
|      | co  | lot    |         | ensure label   | assure they are   |
|      | oki | and    |         | accuracy on    | correct.          |
|      | ng. | ensure |         | packaged       |                   |
|      |     | la     |         | product.       |                   |
|      | C   | beling |         |                |                   |
|      | ook | requir |         |                |                   |
|      | ing | ements |         |                |                   |
|      | ins | are    |         |                |                   |
|      | tru | met.   |         |                |                   |
|      | cti |        |         |                |                   |
|      | ons |        |         |                |                   |
|      | m   |        |         |                |                   |
|      | ust |        |         |                |                   |
|      | be  |        |         |                |                   |
|      | on  |        |         |                |                   |
|      | the |        |         |                |                   |
|      | pa  |        |         |                |                   |
|      | cka |        |         |                |                   |
|      | ge. |        |         |                |                   |
|      |     |        |         |                |                   |
|      | S   |        |         |                |                   |
|      | afe |        |         |                |                   |
|      | f   |        |         |                |                   |
|      | ood |        |         |                |                   |
|      | ha  |        |         |                |                   |
|      | ndl |        |         |                |                   |
|      | ing |        |         |                |                   |
|      | sta |        |         |                |                   |
|      | tem |        |         |                |                   |
|      | ent |        |         |                |                   |
|      | m   |        |         |                |                   |
|      | ust |        |         |                |                   |
|      | be  |        |         |                |                   |
|      | p   |        |         |                |                   |
|      | art |        |         |                |                   |
|      | of  |        |         |                |                   |
|      | the |        |         |                |                   |
|      | lab |        |         |                |                   |
|      | el. |        |         |                |                   |
+------+-----+--------+---------+----------------+-------------------+

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

##  

+------+-----+--------+---------+----------------+-------------------+
| **H  |     |        |         |                |                   |
| ACCP |     |        |         |                |                   |
| PL   |     |        |         |                |                   |
| AN** |     |        |         |                |                   |
|      |     |        |         |                |                   |
| *    |     |        |         |                |                   |
| *PRO |     |        |         |                |                   |
| CESS |     |        |         |                |                   |
| C    |     |        |         |                |                   |
| ATEG |     |        |         |                |                   |
| ORY: |     |        |         |                |                   |
| HEAT |     |        |         |                |                   |
| TRE  |     |        |         |                |                   |
| ATED |     |        |         |                |                   |
| BUT  |     |        |         |                |                   |
| NOT  |     |        |         |                |                   |
| F    |     |        |         |                |                   |
| ULLY |     |        |         |                |                   |
| COO  |     |        |         |                |                   |
| KED, |     |        |         |                |                   |
| NOT  |     |        |         |                |                   |
| S    |     |        |         |                |                   |
| HELF |     |        |         |                |                   |
| STAB |     |        |         |                |                   |
| LE** |     |        |         |                |                   |
|      |     |        |         |                |                   |
| *    |     |        |         |                |                   |
| *PRO |     |        |         |                |                   |
| DUCT |     |        |         |                |                   |
| EXAM |     |        |         |                |                   |
| PLE: |     |        |         |                |                   |
| SM   |     |        |         |                |                   |
| OKED |     |        |         |                |                   |
| SAUS |     |        |         |                |                   |
| AGE, |     |        |         |                |                   |
| P    |     |        |         |                |                   |
| ARTI |     |        |         |                |                   |
| ALLY |     |        |         |                |                   |
| CO   |     |        |         |                |                   |
| OKED |     |        |         |                |                   |
| CHI  |     |        |         |                |                   |
| CKEN |     |        |         |                |                   |
| P    |     |        |         |                |                   |
| ATTI |     |        |         |                |                   |
| ES** |     |        |         |                |                   |
+------+-----+--------+---------+----------------+-------------------+
| ##   | ##  | **Moni | ####    | **Verification | ######### C       |
| ## C | ##  | toring |  HACCP  | Procedures and | orrective Actions |
| CP#  | Cri | Proc   | Records | Frequency**    |                   |
| and  | tic | edures |         |                |                   |
| Loca | al  | and    |         |                |                   |
| tion | Lim | Frequ  |         |                |                   |
|      | its | ency** |         |                |                   |
+------+-----+--------+---------+----------------+-------------------+
| 5B   | In  | QA     | Product | Once per shift | QA will reject or |
|      | ter | tech   | C       | the QA         | hold product      |
| Chil | nal | nician | hilling | supervisor     | dependent on time |
| ling | p   | will   | Log     | will review    | and temperature   |
|      | rod | o      |         | the Product    | deviation.        |
|      | uct | bserve | Product | Chilling Log   | Internal product  |
|      | t   | ch     | Coolers | and observe    | time/temperature  |
|      | emp | illing | Temp    | temperature    | curve will be     |
|      | era | ha     | erature | monitoring     | determined & used |
|      | tur | ndling | Re      | activity.      | to make product   |
|      | e\< | proc   | cording |                | disposition.      |
|      | 7   | edures | Charts  | Maintenance    | Product will be   |
|      | 0°F | to     |         | supervisor     | condemned or      |
|      | wit | ensure | Ther    | will verify    | fully cooked.     |
|      | hin | cr     | mometer | accuracy of    |                   |
|      | 3   | itical | Cali    | the product    | QA will identify  |
|      | ho  | limits | bration | cooler         | the cause of the  |
|      | urs | are    | Log     | temperature    | deviation and     |
|      | and | met.   |         | recording      | prevent           |
|      | w   |        | Cor     | charts once    | reoccurrence.     |
|      | ill | P      | rective | per shift.     |                   |
|      | re  | roduct | Action  |                | Cooler will be    |
|      | ach | c      | Log     | QA will check  | repaired if       |
|      | \<  | oolers |         | all            | required &        |
|      | 4   | will   |         | thermometers   | maintenance       |
|      | 1°F | be     |         | used for       | schedule revised  |
|      | wit | mon    |         | monitoring and | if required.      |
|      | hin | itored |         | verification   |                   |
|      | an  | and    |         | for accuracy   |                   |
|      | a   | re     |         | daily and      |                   |
|      | ddi | corded |         | calibrate to   |                   |
|      | tio | contin |         | within 2°F     |                   |
|      | nal | uously |         | accuracy as    |                   |
|      | 6   | on     |         | necessary.     |                   |
|      | ho  | tempe  |         |                |                   |
|      | urs | rature |         |                |                   |
|      | af  | rec    |         |                |                   |
|      | ter | ording |         |                |                   |
|      | re  | c      |         |                |                   |
|      | ach | harts. |         |                |                   |
|      | ing |        |         |                |                   |
|      |     | QA     |         |                |                   |
|      | \<  | tech   |         |                |                   |
|      | 70  | nician |         |                |                   |
|      | °F  | will   |         |                |                   |
|      | (To | ra     |         |                |                   |
|      | tal | ndomly |         |                |                   |
|      | ch  | select |         |                |                   |
|      | ill | 5      |         |                |                   |
|      | ing | s      |         |                |                   |
|      | t   | amples |         |                |                   |
|      | ime | of     |         |                |                   |
|      | of  | each   |         |                |                   |
|      | 9   | type   |         |                |                   |
|      | h   | of     |         |                |                   |
|      | our | p      |         |                |                   |
|      | s). | roduct |         |                |                   |
|      |     | at 3   |         |                |                   |
|      |     | and 9  |         |                |                   |
|      |     | hours  |         |                |                   |
|      |     | from   |         |                |                   |
|      |     | start  |         |                |                   |
|      |     | of     |         |                |                   |
|      |     | ch     |         |                |                   |
|      |     | illing |         |                |                   |
|      |     | and    |         |                |                   |
|      |     | det    |         |                |                   |
|      |     | ermine |         |                |                   |
|      |     | in     |         |                |                   |
|      |     | ternal |         |                |                   |
|      |     | temper |         |                |                   |
|      |     | ature. |         |                |                   |
+------+-----+--------+---------+----------------+-------------------+

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

##  

## 

+-----+------+--------+---------+----------------+-------------------+
| *   |      |        |         |                |                   |
| *HA |      |        |         |                |                   |
| CCP |      |        |         |                |                   |
| PLA |      |        |         |                |                   |
| N** |      |        |         |                |                   |
|     |      |        |         |                |                   |
| **P |      |        |         |                |                   |
| ROC |      |        |         |                |                   |
| ESS |      |        |         |                |                   |
| CAT |      |        |         |                |                   |
| EGO |      |        |         |                |                   |
| RY: |      |        |         |                |                   |
| H   |      |        |         |                |                   |
| EAT |      |        |         |                |                   |
| T   |      |        |         |                |                   |
| REA |      |        |         |                |                   |
| TED |      |        |         |                |                   |
| BUT |      |        |         |                |                   |
| NOT |      |        |         |                |                   |
| FU  |      |        |         |                |                   |
| LLY |      |        |         |                |                   |
| C   |      |        |         |                |                   |
| OOK |      |        |         |                |                   |
| ED, |      |        |         |                |                   |
| NOT |      |        |         |                |                   |
| SH  |      |        |         |                |                   |
| ELF |      |        |         |                |                   |
| ST  |      |        |         |                |                   |
| ABL |      |        |         |                |                   |
| E** |      |        |         |                |                   |
|     |      |        |         |                |                   |
| **P |      |        |         |                |                   |
| ROD |      |        |         |                |                   |
| UCT |      |        |         |                |                   |
| EX  |      |        |         |                |                   |
| AMP |      |        |         |                |                   |
| LE: |      |        |         |                |                   |
| SMO |      |        |         |                |                   |
| KED |      |        |         |                |                   |
| SA  |      |        |         |                |                   |
| USA |      |        |         |                |                   |
| GE, |      |        |         |                |                   |
| PAR |      |        |         |                |                   |
| TIA |      |        |         |                |                   |
| LLY |      |        |         |                |                   |
| COO |      |        |         |                |                   |
| KED |      |        |         |                |                   |
| C   |      |        |         |                |                   |
| HIC |      |        |         |                |                   |
| KEN |      |        |         |                |                   |
| PAT |      |        |         |                |                   |
| TIE |      |        |         |                |                   |
| S** |      |        |         |                |                   |
+-----+------+--------+---------+----------------+-------------------+
| #   | #### | **Moni | ####    | **Verification | ######### C       |
| ### |  Cri | toring |  HACCP  | Procedures and | orrective Actions |
|  CC | tica | Proc   | Records | Frequency**    |                   |
| P#  | l Li | edures |         |                |                   |
| and | mits | and    |         |                |                   |
|  Lo |      | Frequ  |         |                |                   |
| cat |      | ency** |         |                |                   |
| ion |      |        |         |                |                   |
+-----+------+--------+---------+----------------+-------------------+
| 6B  | Fini | Maint  | Room    | Maintenance    | If a deviation    |
|     | shed | enance | Temp    | supervisor     | from a critical   |
| Fi  | pro  | per    | erature | will verify    | limit occurs, the |
| nis | duct | sonnel | Log     | the accuracy   | following         |
| hed | sto  | will   |         | of the room    | corrective        |
| P   | rage | check  | Ther    | temperature    | actions will be   |
| rod | a    | fi     | mometer | log once per   | taken:            |
| uct | reas | nished | Cali    | shift.         |                   |
| S   | will | p      | bration |                | 1.  The cause of  |
| tor | not  | roduct | Log     | QA will check  |     the           |
| age | ex   | s      |         | all            |     temperature   |
| (Co | ceed | torage | Cor     | thermometers   |     exceeding 40° |
| ld) | 40°  | areas  | rective | used for       |     F will be     |
|     | F.   | temper | Action  | monitoring and |     identified    |
| **( |      | atures | Log     | verification   |     and           |
| Con |      | every  |         | activities for |     eliminated.   |
| tin |      | two    |         | accuracy daily |                   |
| ued |      | hours. |         | and calibrate  | 2.  The CCP will  |
| on  |      |        |         | to within 2° F |     be monitored  |
| n   |      |        |         | accuracy as    |     hourly after  |
| ext |      |        |         | necessary.     |     the           |
| p   |      |        |         |                |     corrective    |
| age |      |        |         | QA will        |     action is     |
| )** |      |        |         | observe        |     taken to      |
|     |      |        |         | maintenance    |     ensure that   |
|     |      |        |         | personnel      |     it is under   |
|     |      |        |         | check finished |     control.      |
|     |      |        |         | product        |                   |
|     |      |        |         | storage area   | 3.  When the      |
|     |      |        |         | once per       |     cause of the  |
|     |      |        |         | shift.         |     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 |      |        |         |                |                   |
| PLA |      |        |         |                |                   |
| N** |      |        |         |                |                   |
|     |      |        |         |                |                   |
| **P |      |        |         |                |                   |
| ROC |      |        |         |                |                   |
| ESS |      |        |         |                |                   |
| CAT |      |        |         |                |                   |
| EGO |      |        |         |                |                   |
| RY: |      |        |         |                |                   |
| H   |      |        |         |                |                   |
| EAT |      |        |         |                |                   |
| T   |      |        |         |                |                   |
| REA |      |        |         |                |                   |
| TED |      |        |         |                |                   |
| BUT |      |        |         |                |                   |
| NOT |      |        |         |                |                   |
| FU  |      |        |         |                |                   |
| LLY |      |        |         |                |                   |
| C   |      |        |         |                |                   |
| OOK |      |        |         |                |                   |
| ED, |      |        |         |                |                   |
| NOT |      |        |         |                |                   |
| SH  |      |        |         |                |                   |
| ELF |      |        |         |                |                   |
| ST  |      |        |         |                |                   |
| ABL |      |        |         |                |                   |
| E** |      |        |         |                |                   |
|     |      |        |         |                |                   |
| **P |      |        |         |                |                   |
| ROD |      |        |         |                |                   |
| UCT |      |        |         |                |                   |
| EX  |      |        |         |                |                   |
| AMP |      |        |         |                |                   |
| LE: |      |        |         |                |                   |
| SMO |      |        |         |                |                   |
| KED |      |        |         |                |                   |
| SA  |      |        |         |                |                   |
| USA |      |        |         |                |                   |
| GE, |      |        |         |                |                   |
| PAR |      |        |         |                |                   |
| TIA |      |        |         |                |                   |
| LLY |      |        |         |                |                   |
| COO |      |        |         |                |                   |
| KED |      |        |         |                |                   |
| C   |      |        |         |                |                   |
| HIC |      |        |         |                |                   |
| KEN |      |        |         |                |                   |
| PAT |      |        |         |                |                   |
| TIE |      |        |         |                |                   |
| S** |      |        |         |                |                   |
+-----+------+--------+---------+----------------+-------------------+
| #   | #### | **Moni | ####    | **Verification | ######### C       |
| ### |  Cri | toring |  HACCP  | Procedures and | orrective Actions |
|  CC | tica | Proc   | Records | Frequency**    |                   |
| P#  | l Li | edures |         |                |                   |
| and | mits | and    |         |                |                   |
|  Lo |      | Frequ  |         |                |                   |
| cat |      | ency** |         |                |                   |
| ion |      |        |         |                |                   |
+-----+------+--------+---------+----------------+-------------------+
| 6B  |      |        |         |                | If a deviation    |
|     |      |        |         |                | from a critical   |
| Fi  |      |        |         |                | limit occurs, the |
| nis |      |        |         |                | following         |
| hed |      |        |         |                | corrective        |
| P   |      |        |         |                | actions will be   |
| rod |      |        |         |                | taken:            |
| uct |      |        |         |                |                   |
| S   |      |        |         |                | 4.  If room       |
| tor |      |        |         |                |     temperature   |
| age |      |        |         |                |     exceeds the   |
| (Co |      |        |         |                |     critical      |
| ld) |      |        |         |                |     limit, the    |
|     |      |        |         |                |     processing    |
|     |      |        |         |                |     authority     |
|     |      |        |         |                |     will evaluate |
|     |      |        |         |                |     the product   |
|     |      |        |         |                |     temperature   |
|     |      |        |         |                |     to ensure the |
|     |      |        |         |                |     temperature   |
|     |      |        |         |                |     is sufficient |
|     |      |        |         |                |     to preclude   |
|     |      |        |         |                |     pathogen      |
|     |      |        |         |                |     growth before |
|     |      |        |         |                |     release for   |
|     |      |        |         |                |     shipment. If  |
|     |      |        |         |                |     temperature   |
|     |      |        |         |                |     is not        |
|     |      |        |         |                |     sufficient to |
|     |      |        |         |                |     preclude      |
|     |      |        |         |                |     pathogen      |
|     |      |        |         |                |     growth,       |
|     |      |        |         |                |     product will  |
|     |      |        |         |                |     be cooked in  |
|     |      |        |         |                |     the           |
|     |      |        |         |                |     establishment |
|     |      |        |         |                |     to ensure     |
|     |      |        |         |                |     destruction   |
|     |      |        |         |                |     of pathogens  |
|     |      |        |         |                |     or condemned. |
+-----+------+--------+---------+----------------+-------------------+

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

**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 Failed
                 Received                        Tests

                                                 

                                                 

                                                 

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

+----+----+-------+---------+-------+-------+----+-------------------+
| *  |    |       |         |       |       |    |                   |
| *T |    |       |         |       |       |    |                   |
| HE |    |       |         |       |       |    |                   |
| RM |    |       |         |       |       |    |                   |
| OM |    |       |         |       |       |    |                   |
| ET |    |       |         |       |       |    |                   |
| ER |    |       |         |       |       |    |                   |
| C  |    |       |         |       |       |    |                   |
| AL |    |       |         |       |       |    |                   |
| IB |    |       |         |       |       |    |                   |
| RA |    |       |         |       |       |    |                   |
| TI |    |       |         |       |       |    |                   |
| ON |    |       |         |       |       |    |                   |
| L  |    |       |         |       |       |    |                   |
| OG |    |       |         |       |       |    |                   |
| ** |    |       |         |       |       |    |                   |
|    |    |       |         |       |       |    |                   |
| C  |    |       |         |       |       |    |                   |
| al |    |       |         |       |       |    |                   |
| ib |    |       |         |       |       |    |                   |
| ra |    |       |         |       |       |    |                   |
| te |    |       |         |       |       |    |                   |
| to |    |       |         |       |       |    |                   |
| 3  |    |       |         |       |       |    |                   |
| 2^ |    |       |         |       |       |    |                   |
| 0^ |    |       |         |       |       |    |                   |
| F  |    |       |         |       |       |    |                   |
| w  |    |       |         |       |       |    |                   |
| hi |    |       |         |       |       |    |                   |
| le |    |       |         |       |       |    |                   |
| t  |    |       |         |       |       |    |                   |
| he |    |       |         |       |       |    |                   |
| rm |    |       |         |       |       |    |                   |
| om |    |       |         |       |       |    |                   |
| et |    |       |         |       |       |    |                   |
| er |    |       |         |       |       |    |                   |
| is |    |       |         |       |       |    |                   |
| in |    |       |         |       |       |    |                   |
| s  |    |       |         |       |       |    |                   |
| lu |    |       |         |       |       |    |                   |
| sh |    |       |         |       |       |    |                   |
| i  |    |       |         |       |       |    |                   |
| ce |    |       |         |       |       |    |                   |
| w  |    |       |         |       |       |    |                   |
| at |    |       |         |       |       |    |                   |
| er |    |       |         |       |       |    |                   |
+----+----+-------+---------+-------+-------+----+-------------------+
| Da | Ti | Depar | Ther    | Per   | Adjus | In | Comments          |
| te | me | tment | mometer | sonal | tment | it |                   |
|    |    | or    | ID#     | T     | Req   | ia |                   |
|    |    |       |         | hermo | uired | ls |                   |
|    |    | Area  |         | meter | (Yes  |    |                   |
|    |    |       |         | Re    | or    |    |                   |
|    |    |       |         | ading | No)   |    |                   |
+----+----+-------+---------+-------+-------+----+-------------------+
|    |    |       |         |       |       |    |                   |
+----+----+-------+---------+-------+-------+----+-------------------+
|    |    |       |         |       |       |    |                   |
+----+----+-------+---------+-------+-------+----+-------------------+
|    |    |       |         |       |       |    |                   |
+----+----+-------+---------+-------+-------+----+-------------------+
|    |    |       |         |       |       |    |                   |
+----+----+-------+---------+-------+-------+----+-------------------+
|    |    |       |         |       |       |    |                   |
+----+----+-------+---------+-------+-------+----+-------------------+
|    |    |       |         |       |       |    |                   |
+----+----+-------+---------+-------+-------+----+-------------------+
|    |    |       |         |       |       |    |                   |
+----+----+-------+---------+-------+-------+----+-------------------+
|    |    |       |         |       |       |    |                   |
+----+----+-------+---------+-------+-------+----+-------------------+

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

Reviewed by:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

+-----+-----+----------+-----------------------+---------+----------+
| **G |     |          |                       |         |          |
| ENE |     |          |                       |         |          |
| RIC |     |          |                       |         |          |
| E   |     |          |                       |         |          |
| STA |     |          |                       |         |          |
| BLI |     |          |                       |         |          |
| SHM |     |          |                       |         |          |
| ENT |     |          |                       |         |          |
| X:  |     |          |                       |         |          |
| R   |     |          |                       |         |          |
| oom |     |          |                       |         |          |
| Te  |     |          |                       |         |          |
| mpe |     |          |                       |         |          |
| rat |     |          |                       |         |          |
| ure |     |          |                       |         |          |
| Lo  |     |          |                       |         |          |
| g** |     |          |                       |         |          |
|     |     |          |                       |         |          |
| **  |     |          |                       |         |          |
| Roo |     |          |                       |         |          |
| m** |     |          |                       |         |          |
| :\_ |     |          |                       |         |          |
| \_\ |     |          |                       |         |          |
| _\_ |     |          |                       |         |          |
| \_\ |     |          |                       |         |          |
| _\_ |     |          |                       |         |          |
| \_\ |     |          |                       |         |          |
| _\_ |     |          |                       |         |          |
| **D |     |          |                       |         |          |
| ate |     |          |                       |         |          |
| **: |     |          |                       |         |          |
| \_\ |     |          |                       |         |          |
| _\_ |     |          |                       |         |          |
| \_\ |     |          |                       |         |          |
| _\_ |     |          |                       |         |          |
| \_\ |     |          |                       |         |          |
| _\_ |     |          |                       |         |          |
+-----+-----+----------+-----------------------+---------+----------+
| T   | T   | D        | If Yes,               | Mo      | Verified |
| IME | EMP | eviation |                       | nitored | by:      |
|     |     | from CL? | Action?               | by:     |          |
|     |     | (Check   |                       |         |          |
|     |     | if yes)  |                       |         |          |
+-----+-----+----------+-----------------------+---------+----------+
|     |     |          |                       |         |          |
+-----+-----+----------+-----------------------+---------+----------+
|     |     |          |                       |         |          |
+-----+-----+----------+-----------------------+---------+----------+
|     |     |          |                       |         |          |
+-----+-----+----------+-----------------------+---------+----------+
|     |     |          |                       |         |          |
+-----+-----+----------+-----------------------+---------+----------+
|     |     |          |                       |         |          |
+-----+-----+----------+-----------------------+---------+----------+

  --------------- ---------- ------ --------- -------- ------ ----------- -------------
  **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       | Devia | Corrective Action | Disp    | Res      | Date  |
|           | tion/ | P                 | osition | ponsible | /Time |
|           |       | rocedures/Explain | of      |          |       |
|           | Pr    |                   | Product | Person   |       |
|           | oblem |                   |         |          |       |
+-----------+-------+-------------------+---------+----------+-------+
|           |       |                   |         |          |       |
+-----------+-------+-------------------+---------+----------+-------+
|           |       |                   |         |          |       |
+-----------+-------+-------------------+---------+----------+-------+
|           |       |                   |         |          |       |
+-----------+-------+-------------------+---------+----------+-------+
|           |       |                   |         |          |       |
+-----------+-------+-------------------+---------+----------+-------+

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

+---------+--------+--------+--------+----------------+---------------+
| # PR    |        |        |        |                |               |
| E-SHIPM |        |        |        |                |               |
| ENT REV |        |        |        |                |               |
| IEW LOG |        |        |        |                |               |
|         |        |        |        |                |               |
| # Date: |        |        |        |                |               |
| \_\_\_\ |        |        |        |                |               |
| _\_\_\_ |        |        |        |                |               |
| \_\_\_\ |        |        |        |                |               |
| _\_\_\_ |        |        |        |                |               |
+---------+--------+--------+--------+----------------+---------------+
| **PR    | *      | **Time | **By** | **Lot Released | **COMMENTS    |
| ODUCT** | *Lot** | R      |        | for            | \***          |
|         |        | ecords | **     | Shipment?**    |               |
|         | **ID** | Revi   | Whom** |                |               |
|         |        | ewed** |        | **Signature**  |               |
+---------+--------+--------+--------+----------------+---------------+
|         |        |        |        |                |               |
+---------+--------+--------+--------+----------------+---------------+
|         |        |        |        |                |               |
+---------+--------+--------+--------+----------------+---------------+
|         |        |        |        |                |               |
+---------+--------+--------+--------+----------------+---------------+

\*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.