##  ![](media/image1.jpeg){width="1.1770833333333333in" height="0.80625in"}

## United States

## Department of

> **Agriculture**

### Food Safety

> and Inspection
>
> Service
>
> September 1999
>
> HACCP-15

### Generic HACCP

Model for Not Heat Treated, Shelf Stable

Meat and Poultry Products

> Additional copies of the Guidebook for the Preparation of HACCP Plans
> and the Generic HACCP Models are available from:
>
> U.S. Department of Agriculture
>
> Food Safety and Inspection Service (FSIS)
>
> Office of Policy, Program Development,
>
> and Evaluation (OPPDE)
>
> Inspection Systems Development Division
>
> Room 202, Cotton Annex Building
>
> 300 12^th^ Street SW
>
> Washington, D.C. 20250-3700
>
> Phone: (202) 720-3219
>
> Fax: (202) 690-0824
>
> This material is also available on the FSIS Homepage:
>
> <http://www.fsis.usda.gov/index.htm>

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

Department of and Inspection 20250

Agriculture Service

> September 8, 1999

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

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

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

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

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

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

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

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

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

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

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

We hope that these documents are helpful.

# Table of Contents

Introduction.............................................................................................
3

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

Process Flow Diagram and Product
Description................................................... 6

Hazard
Analysis........................................................................................
7

Developing Your HACCP
Plan.......................................................................
9

Identifying
CCPs.......................................................................................
10

Appendix A

References for HACCP
Teams.............................................................. 16

References for Not Heat Treated, Shelf Stable Meat and Poultry
Products........... 19

##  Appendix B

Process Flow Diagram (Figure1) Pepperoni,
Salami.....................................21

Product Description Form (Figure
2)....................................................... 22

Hazard Analysis Form (Figure
3)............................................................23

HACCP Plan (Figure
4)......................................................................
28

Form Letter Confirming *Salmonella* Compliance with Performance

Standards
.......................................................................................
33

Thermometer Calibration
Log............................................................\.... 34

Generic Establishment X: Room Temperature Log
...................................... 35

Generic Establishment X: Metal Detection
Log.........................................\...36

Fermentation
Log...........................................................................\...
37

MPR
Log.......................................................................................38

Sanitizer Usage
Log...........................................................................
39

Corrective Actions
Log........................................................................40

Pre-Shipment Review
Log....................................................................
41

**GENERIC HACCP MODEL**

**FOR**

## NOT HEAT TREATED, 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: Not
heat treated\--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
not heat treated, shelf stable product(s), the fifth process category.
The model can be used for all not heat treated, 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 not heat treated, shelf
stable -- pepperoni and salami. 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 pepperoni and salami in generic establishment X. Figure 2 is an
example of a **PRODUCT DESCRIPTION** for the pepperoni and salami
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.

Look at the entries for "Slicing/Peeling" on the fifth page of the six
column form for not heat treated, shelf stable; the HACCP team has
determined that *Listeria monocytogenes* may be present, so it has put a
"Yes" in the third column. Column four explains the basis for the team's
determination. In the fifth column, the HACCP team has described the
preventive measures it will use to make sure that each hazard has been
prevented, eliminated, or reduced to an acceptable level. For this
hazard, the HACCP team decided that a sanitizer known to be effective
against *Listeria monocytogenes* would be applied every two hours on
product contact equipment. FSIS does not consider safe handling labels
alone to be an adequate CCP for any pathogenic microorganisms such as
bacteria and viruses. 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.

**Note**: Look at the entries for "Storage -- (Cold --
Frozen/Refrigerated) -- Raw Meat" on the second page of the six-column
form: the HACCP team has determined that there is a food safety hazard
reasonably likely to occur at this step in the process. Column four
contains the reason for their thinking: pathogenic organisms 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 pepperoni and
salami, 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 not
heat treated, 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 pepperoni and
salami 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 pepperoni and salami 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, pathogen proliferation at
fermentation, pathogen proliferation at drying, and *Listeria
monocytogenes* contamination at slicing/peeling. The establishment HACCP
team has chosen to have six CCPs to address these six hazards:
*Salmonella* certification, proper cold storage of raw meat, metal
detectors prior to packaging and labeling, correct pH reached after the
fermentation process is done, proper moisture: protein ratio (MPR) is
reached after drying, and proper sanitizer is used at slicing/peeling.

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

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

They did find FSIS regulatory requirements and guidelines for
slicing/peeling, so they set the critical limit(s) using criteria as
specified by FSIS for the control of pathogens.

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

For their slicing/peeling step, the establishment had Quality Assurance
monitor the application and record the time of sanitizer application.

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

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

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

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

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

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

The HACCP team decided they could verify through the following
procedures and frequency:

Quality Assurance will conduct a *Listeria* sampling program (both
environmental and end product) as detailed in the FSIS issuance
"*Listeria* Guidelines for Industry" to verify effectiveness of the
sanitizer and its method of usage.

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 six forms would be used: Sanitizer Usage
Log, Thermometer Calibration Log, Room Temperature Log, Metal Detection
Log, Fermentation Log, and MPR Log. The form was designed to provide
spaces for all entries necessary for the monitoring and verification
activities at the slicing/peeling 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 in 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 Actions for CCP 6:

1.  QA will address positive *Listeria* samples as detailed in the FSIS
    issuance "*Listeria* Guidelines for Industry".

2.  QA will stop slicing/peeling operations if time since the last
    application of sanitizer exceeds 2 hours.

3.  All end product produced after the 2 hour limit is exceeded will be
    held until *Listeria monocytogenes* test results are final. If
    positive, product will be condemned and additional environmental and
    end product testing will be done until the source is determined.
    Further corrective actions will be done as detailed in FSIS
    regulations 417.3.

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 Actions 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 not heat treated, 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 Not Heat Treated, Shelf Stable Meat and Poultry Products

1.  American Meat Institute. *Interim good manufacturing practices for
    fermented dry and semi-dry sausage products.* Washington, DC, 1995.

2.  Campanini, M. et al. *Behavior of Listeria monocytogenes during the
    maturation of naturally and artificially contaminated salami: effect
    of lactic-acid bacteria starter cultures.* Int. J. Food Microbiol.
    20: 169-175, 1993.

3.  Collins-Thompson, D.L., et al. *The effect of nitrite on the growth
    of pathogens during manufacture of dry and semi-dry sausage.* Can.
    Inst. Food Sci. Technol. J. 17: 102-106, 1984.

4.  Glass, K.A. and Doyle, M.P. *Fate and thermal inactivation of
    Listeria monocytogenes in beaker sausage and pepperoni.* J. Food
    Protec. 52: 226-231, 1989.

5.  Hinkens, J.C., et al. *Validation of pepperoni processes for control
    of Escherichia coli O157:H7.* J. Food Protec. 1996.

6.  Johnson, J.L., et al. *Fate of Listeria monocytogenes in tissues of
    experimentally infected cattle and in hard salami.* Appl. Environ.
    Microbiol. 54: 497-501, 1988.

7.  Leistner, F. *The essentials of producing stable and safe raw
    fermented sausages.* In New Technologies for Meat and Meat Products.
    ECCEAMST, Utrecht, pp.1-17, 1992.

8.  Martinez, E.J., et al. *Combined effect of water activity, pH and
    additives on growth of Staphylococcus aureus in model salami
    systems.* Food Microbiol. 3: 321-329, 1986.

9.  Nicholson, R., et al. *Dry fermented sausage and Escherichia coli
    O157:H7.* National Cattlemen's Beef Association, Research Report No.
    11-316, Chicago, IL, 1996.

10. Papa, F., et al. *Production of Milano style salami of good quality
    and safety.* Food Microbiol. 12: 9-12, 1995.

11. Raccach, M. *Some aspects of meat fermentation.* Food Microbiol. 9:
    55-65, 1992.

12. Smith, H.J., et al. *Destruction of Trichinella spiralis during the
    preparation of dry cured pork products procuitto, procuittini and
    Genoa salami.* Can. J. Vet. Res. 53: 80-83, 1989.

**APPENDIX B**

> **PROCESS FLOW DIAGRAM Figure 1**

## PROCESS CATEGORY: NOT HEAT TREATED, SHELF STABLE

#### PRODUCT: PEPPERONI AND SALAMI

####  

####   {#section-3 .unnumbered}

#### PRODUCT DESCRIPTION Figure 2

+-----------------------------------------------------------------------+
| ####### PROCESS CATEGORY: NOT HEAT TREATED, SHELF STABLE              |
|                                                                       |
| ####### PRODUCT: PEPPERONI AND SALAMI                                 |
+-----------------------------------------------------------------------+
| 1\. COMMON NAME? PEPPERONI                                            |
|                                                                       |
| SALAMI                                                                |
|                                                                       |
| 2\. HOW IS IT TO BE USED? CONSUMED AS PURCHASED (READY TO EAT)        |
|                                                                       |
| 3\. TYPE OF PACKAGE? BULK-PACKED (E.G., PLASTIC BAG, VACUUM PACKED)   |
|                                                                       |
| 4\. LENGTH OF SHELF LIFE, VARIES WITH PACKAGING AND AT WHAT           |
| TEMPERATURE? STORAGE TEMPERATURE: MAY LAST 3 MONTHS NON- REFRIGERATED |
| & 12 MONTHS UNDER REFRIGERATION                                       |
|                                                                       |
| 5\. WHERE WILL IT BE SOLD? WHOLESALE TO DISTRIBUTORS                  |
|                                                                       |
| CONSUMERS? ONLY                                                       |
|                                                                       |
| INTENDED USE?                                                         |
|                                                                       |
| 6\. LABELING INSTRUCTIONS? KEEP REFRIGERATED                          |
|                                                                       |
| 7\. IS SPECIAL DISTRIBUTION KEEP REFRIGERATED                         |
|                                                                       |
| CONTROL NEEDED?                                                       |
+-----------------------------------------------------------------------+

**HAZARD ANALYSIS -- NOT HEAT TREATED, SHELF STABLE -- Pepperoni,
Salami**

+-----------+-----------+-------+-------------+-------------+---------+
| **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?**    |         |
+-----------+-----------+-------+-------------+-------------+---------+
| **        | ###       | ###   | ***         | **Ce        | #####   |
| Receiving | # Biologi | ##### | Salmonella* | rtification | #### 1B |
| -- Raw    | cal: Path | # Yes | &** *E.     | from        |         |
| Meat**    | ogens *Sa |       | coli* **may | suppliers   |         |
|           | lmonella* |       | be present  | that        |         |
|           |           |       | on incoming | product has |         |
|           | *E. coli  |       | raw         | been        |         |
|           | O157:H7*  |       | product.    | sampled for |         |
|           |           |       | Incoming    | *           |         |
|           | *Listeria |       | presence of | Salmonella* |         |
|           | monoc     |       | Lm may      | &** *E.     |         |
|           | ytogenes* |       | impact      | coli        |         |
|           |           |       | process     | O157:H7*    |         |
|           |           |       | control &   | **meets     |         |
|           |           |       | growth.**   | FSIS        |         |
|           |           |       |             | performance |         |
|           |           |       |             | standards.  |         |
|           |           |       |             | F           |         |
|           |           |       |             | ermentation |         |
|           |           |       |             | & drying or |         |
|           |           |       |             | use of post |         |
|           |           |       |             | processing  |         |
|           |           |       |             | kill step   |         |
|           |           |       |             | could       |         |
|           |           |       |             | effectively |         |
|           |           |       |             | control     |         |
|           |           |       |             | level.**    |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       |       |             |             |         |
|           | # Chemica |       |             |             |         |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ##    | **Plant     |             |         |
|           | *Physical | ##### | records     |             |         |
|           | --        | ## No | show that   |             |         |
|           | Foreign   |       | there has   |             |         |
|           | materials |       | been no     |             |         |
|           | such as   |       | incidence   |             |         |
|           | broken    |       | of foreign  |             |         |
|           | needles** |       | materials   |             |         |
|           |           |       | in products |             |         |
|           |           |       | received    |             |         |
|           |           |       | into the    |             |         |
|           |           |       | plant.**    |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
| **        | ####      |       |             |             |         |
| Receiving | Biologica |       |             |             |         |
| --        | l -- None |       |             |             |         |
| R         |           |       |             |             |         |
| estricted |           |       |             |             |         |
| and       |           |       |             |             |         |
| Unr       |           |       |             |             |         |
| estricted |           |       |             |             |         |
| Nonmeat   |           |       |             |             |         |
| Food      |           |       |             |             |         |
| Ing       |           |       |             |             |         |
| redients; |           |       |             |             |         |
| Starter   |           |       |             |             |         |
| Cultures  |           |       |             |             |         |
| /Casings; |           |       |             |             |         |
| Packaging |           |       |             |             |         |
| Ma        |           |       |             |             |         |
| terials** |           |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ##    | **Letters   |             |         |
|           | *Chemical | ##### | of guaranty |             |         |
|           | -- Not    | ## No | are         |             |         |
|           | a         |       | received    |             |         |
|           | cceptable |       | from all    |             |         |
|           | for       |       | suppliers   |             |         |
|           | intended  |       | of starter  |             |         |
|           | use**     |       | cultures,   |             |         |
|           |           |       | casings,    |             |         |
|           |           |       | and         |             |         |
|           |           |       | packaging   |             |         |
|           |           |       | m           |             |         |
|           |           |       | aterials.** |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ##    | **Plant     |             |         |
|           | *Physical | ##### | records     |             |         |
|           | --        | ## No | demonstrate |             |         |
|           | Foreign   |       | that        |             |         |
|           | materials |       | foreign     |             |         |
|           | (metal,   |       | material    |             |         |
|           | glass,    |       | co          |             |         |
|           | wood,     |       | ntamination |             |         |
|           | etc.)**   |       | has not     |             |         |
|           |           |       | occurred    |             |         |
|           |           |       | during the  |             |         |
|           |           |       | past        |             |         |
|           |           |       | several     |             |         |
|           |           |       | years.**    |             |         |
+-----------+-----------+-------+-------------+-------------+---------+

**Figure 3**

**HAZARD ANALYSIS -- NOT HEAT TREATED, SHELF STABLE - Pepperoni,
Salami**

+-----------+-----------+-------+-------------+-------------+---------+
| **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 | ####  |             |             |         |
| R         | l -- None |       |             |             |         |
| estricted |           |       |             |             |         |
| &         |           |       |             |             |         |
| Unr       |           |       |             |             |         |
| estricted |           |       |             |             |         |
| Nonmeat   |           |       |             |             |         |
| Food      |           |       |             |             |         |
| Ing       |           |       |             |             |         |
| redients; |           |       |             |             |         |
| Starter   |           |       |             |             |         |
| C         |           |       |             |             |         |
| ultures** |           |       |             |             |         |
|           |           |       |             |             |         |
| **asings; |           |       |             |             |         |
| Packaging |           |       |             |             |         |
| Ma        |           |       |             |             |         |
| terials** |           |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       | ##### |             |             |         |
|           | # Chemica | ####  |             |             |         |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       | ##### |             |             |         |
|           | # Physica | ####  |             |             |         |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
| **Storage | #### Bi   | ###   | *Salmonella | **Maintain  | #####   |
| (Cold --  | ological  | ##### | & E.coli    | product     | #### 2B |
| Fr        |           | # Yes | O157:H7*    | temperature |         |
| ozen/Refr | *Sa       |       | **are       | at or below |         |
| igerated) | lmonella* |       | reasonably  | a level     |         |
| -- Raw    |           |       | likely to   | sufficient  |         |
| Meat**    | *E.coli   |       | grow in     | to preclude |         |
|           | O157:H7*  |       | this        | pathogen    |         |
|           |           |       | product if  | growth.**   |         |
|           |           |       | temperature |             |         |
|           |           |       | is not      |             |         |
|           |           |       | maintained  |             |         |
|           |           |       | at or below |             |         |
|           |           |       | a level     |             |         |
|           |           |       | sufficient  |             |         |
|           |           |       | to preclude |             |         |
|           |           |       | their       |             |         |
|           |           |       | growth.**   |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       |       |             |             |         |
|           | # Chemica |       |             |             |         |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ##### |             |             |         |
|           | *Physical | ####  |             |             |         |
|           | -- None** |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
| **        | #         | ###   | *           | **Control   |         |
| Tempering | ### Biolo | ##### | *Pathogenic | of          |         |
| Frozen    | gical --  | # Yes | mic         | time/       |         |
| Meat**    | Pathogens |       | roorganisms | temperature |         |
|           |           |       | present are | during      |         |
|           |           |       | likely to   | thawing     |         |
|           |           |       | grow if     | process. No |         |
|           |           |       | time/       | water       |         |
|           |           |       | temperature | t           |         |
|           |           |       | is not      | empering.** |         |
|           |           |       | maintained  |             |         |
|           |           |       | at or below |             |         |
|           |           |       | a level     |             |         |
|           |           |       | sufficient  |             |         |
|           |           |       | to preclude |             |         |
|           |           |       | growth.**   |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ##### |             |             |         |
|           | *Chemical | ####  |             |             |         |
|           | -- None** |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ##### |             |             | ###     |
|           | *Physical | ####  |             |             | ######  |
|           | -- None** |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+

**Figure 3**

**HAZARD ANALYSIS -- NOT HEAT TREATED, SHELF STABLE - Pepperoni,
Salami**

+-----------+-----------+-------+-------------+-------------+---------+
| **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 Meat | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       | ##### |             |             |         |
|           | # Chemica | ####  |             |             |         |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       | ##### |             |             |         |
|           | # Physica | ####  |             |             |         |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
| *         | ####      | ##### |             |             |         |
| *Weighing | Biologica | ####  |             |             |         |
| R         | l -- None |       |             |             |         |
| estricted |           |       |             |             |         |
| &         |           |       |             |             |         |
| Unr       |           |       |             |             |         |
| estricted |           |       |             |             |         |
| Nonmeat   |           |       |             |             |         |
| Food      |           |       |             |             |         |
| Ing       |           |       |             |             |         |
| redients; |           |       |             |             |         |
| Preparing |           |       |             |             |         |
| Starter   |           |       |             |             |         |
| Cultures/ |           |       |             |             |         |
| Casings** |           |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       | ##### |             |             |         |
|           | # Chemica | ####  |             |             |         |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       | ##### |             |             |         |
|           | # Physica | ####  |             |             |         |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
| **Combine | ####      | ##### |             |             |         |
| Ing       | Biologica | ####  |             |             |         |
| redients/ | l -- None |       |             |             |         |
| P         |           |       |             |             |         |
| rocessing |           |       |             |             |         |
| (Includes |           |       |             |             |         |
| one or    |           |       |             |             |         |
| more of   |           |       |             |             |         |
| the       |           |       |             |             |         |
| f         |           |       |             |             |         |
| ollowing: |           |       |             |             |         |
| grinding, |           |       |             |             |         |
| chopping, |           |       |             |             |         |
| mixing,   |           |       |             |             |         |
| stuffing, |           |       |             |             |         |
| forming,  |           |       |             |             |         |
| and       |           |       |             |             |         |
| s         |           |       |             |             |         |
| licing)** |           |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ##### |             |             |         |
|           | *Chemical | ####  |             |             |         |
|           | -- None** |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ###   | **Plant     | **Visual    | #####   |
|           | *Physical | ##### | records     | inspection  | #### 3P |
|           | -- Metal  | # Yes | show that   | prior to    |         |
|           | Contam    |       | during      | stuffing    |         |
|           | ination** |       | mechanical  | and/or      |         |
|           |           |       | processing  | metal       |         |
|           |           |       | metal       | detectors   |         |
|           |           |       | co          | are         |         |
|           |           |       | ntamination | installed   |         |
|           |           |       | is likely   | prior to    |         |
|           |           |       | to occur.** | p           |         |
|           |           |       |             | ackaging.** |         |
+-----------+-----------+-------+-------------+-------------+---------+

**Figure 3**

**HAZARD ANALYSIS -- NOT HEAT TREATED, SHELF STABLE - Pepperoni,
Salami**

+-----------+-----------+-------+-------------+-------------+---------+
| **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?**    |         |
+-----------+-----------+-------+-------------+-------------+---------+
| #######   | #         | ##    | **Rework at |             | ###     |
| ## Rework | ### Biolo | ##### | the end of  |             | ######  |
|           | gical --  | ## No | the day is  |             |         |
|           | Pathogens |       | c           |             |         |
|           |           |       | ondemned.** |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       | ##### |             |             | ###     |
|           | # Chemica | ####  |             |             | ######  |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       | ##### |             |             | ###     |
|           | # Physica | ####  |             |             | ######  |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
| **F       | #         | ###   | **Potential | **pH        | #####   |
| ermenting | ### Biolo | ##### | growth and  | sufficient  | #### 4B |
| (Used for | gical --  | # Yes | subsequent  | to ensure   |         |
| flavor    | Pathogens |       | toxigenesis | correct pH  |         |
| de        |           |       | of          | reached     |         |
| velopment | ***(Staph |       | pathogens   | after       |         |
| and pH    | ylococcus |       | with the    | ferm        |         |
| red       | a         |       | failure of  | entation.** |         |
| uction)** | ureus*)** |       | the         |             |         |
|           |           |       | f           |             |         |
|           |           |       | ermentation |             |         |
|           |           |       | process.**  |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       | ##### |             |             |         |
|           | # Chemica | ####  |             |             |         |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       | ##### |             |             |         |
|           | # Physica | ####  |             |             |         |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
| *         | ##        | ###   | **Potential | **Room      | #####   |
| *Drying** | ## Biolog | ##### | growth and  | temperature | #### 5B |
|           | ical -- P | # Yes | subsequent  | can be      |         |
|           | athogens  |       | toxigenesis | controlled  |         |
|           | *Salmonel |       | of          | to assure   |         |
|           | la, Staph |       | pathogens   | the drying  |         |
|           | ylococcus |       | with the    | process is  |         |
|           |  aureus,  |       | failure of  | achieving   |         |
|           | Trichina* |       | the drying  | the desired |         |
|           |           |       | process.**  | goal of     |         |
|           |           |       |             | moisture    |         |
|           |           |       |             | protein     |         |
|           |           |       |             | ratio.**    |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       | ##### |             |             | ###     |
|           | # Chemica | ####  |             |             | ######  |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       | ##### |             |             | ###     |
|           | # Physica | ####  |             |             | ######  |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+

**Figure 3**

**HAZARD ANALYSIS -- NOT HEAT TREATED, SHELF STABLE - Pepperoni,
Salami**

+-----------+-----------+-------+-------------+-------------+---------+
| **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?**    |         |
+-----------+-----------+-------+-------------+-------------+---------+
| ########  | #         | ###   | **Potential | **Sanitizer | #####   |
| # Slicing | ### Biolo | ##### | co          | known to be | #### 6B |
| /Peeling  | gical --  | # Yes | ntamination | effective   |         |
|           | Pathogens |       | from        | against     |         |
|           |  (*Lister |       | en          | *Listeria   |         |
|           | ia monocy |       | vironmental | mon         |         |
|           | togenes*) |       | sources     | ocytogenes* |         |
|           |           |       | and/or      | will be     |         |
|           |           |       | employee    | applied     |         |
|           |           |       | handling.** | every 4     |         |
|           |           |       |             | hours on    |         |
|           |           |       |             | product     |         |
|           |           |       |             | contact     |         |
|           |           |       |             | e           |         |
|           |           |       |             | quipment.** |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       | ##### |             |             | ###     |
|           | # Chemica | ####  |             |             | ######  |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ##### |             |             | ###     |
|           | *Physical | ####  |             |             | ######  |
|           | -- None** |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
| **Pa      | ####      | ##### |             |             | ###     |
| ckaging/L | Biologica | ####  |             |             | ######  |
| abeling** | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       | ##### |             |             | ###     |
|           | # Chemica | ####  |             |             | ######  |
|           | l -- None |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | *         | ##### |             |             | ###     |
|           | *Physical | ####  |             |             | ######  |
|           | -- None** |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
| *         | ####      | ##### |             |             | ###     |
| *Finished | Biologica | ####  |             |             | ######  |
| Product   | l -- None |       |             |             |         |
| Storage   |           |       |             |             |         |
| (Cold)**  |           |       |             |             |         |
+-----------+-----------+-------+-------------+-------------+---------+
|           | ###       |       |             |             |         |
|           | # 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: |      |        |         |                |                   |
|  NO |      |        |         |                |                   |
| T H |      |        |         |                |                   |
| EAT |      |        |         |                |                   |
|  TR |      |        |         |                |                   |
| EAT |      |        |         |                |                   |
| ED, |      |        |         |                |                   |
|  SH |      |        |         |                |                   |
| ELF |      |        |         |                |                   |
|  ST |      |        |         |                |                   |
| ABL |      |        |         |                |                   |
| E** |      |        |         |                |                   |
|     |      |        |         |                |                   |
| #   |      |        |         |                |                   |
| # P |      |        |         |                |                   |
| ROD |      |        |         |                |                   |
| UCT |      |        |         |                |                   |
|  EX |      |        |         |                |                   |
| AMP |      |        |         |                |                   |
| LE: |      |        |         |                |                   |
|  PE |      |        |         |                |                   |
| PPE |      |        |         |                |                   |
| RON |      |        |         |                |                   |
| I A |      |        |         |                |                   |
| ND  |      |        |         |                |                   |
| SAL |      |        |         |                |                   |
| AMI |      |        |         |                |                   |
+-----+------+--------+---------+----------------+-------------------+
| #   | #### | **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      | Product without   |
|     | lier | eiving | ceiving | months QA will | certification     |
| Rec | c    | per    | Log     | request        | will not be       |
| eiv | erti | sonnel |         | *Salmonella*   | accepted if a     |
| ing | fica | will   | Cor     | data results   | supplier fails to |
| --  | tion | check  | rective | from company   | meet performance  |
| Raw | that | each   | Actions | for at least 2 | standards for 2   |
| M   | pro  | sh     | Log     | suppliers.     | sample set.       |
| eat | duct | ipment |         |                |                   |
|     | has  | for    |         |                | Supplier will not |
|     | been | *Salmo |         |                | be used until a   |
|     | sam  | nella* |         |                | full sample set   |
|     | pled | ce     |         |                | meets performance |
|     | for  | rtific |         |                | standards.        |
|     | *Sal | ation. |         |                |                   |
|     | mone |        |         |                |                   |
|     | lla* |        |         |                |                   |
|     | must |        |         |                |                   |
|     | a    |        |         |                |                   |
|     | ccom |        |         |                |                   |
|     | pany |        |         |                |                   |
|     | s    |        |         |                |                   |
|     | hipm |        |         |                |                   |
|     | ent. |        |         |                |                   |
+-----+------+--------+---------+----------------+-------------------+
| 2B  | Raw  | Maint  | Room    | Maintenance    | QA will reject or |
|     | pro  | enance | Temp    | supervisor     | hold product      |
| S   | duct | per    | erature | will verify    | dependent on time |
| tor | sto  | sonnel | Log     | accuracy of    | and temperature   |
| age | rage | will   |         | the Room       | deviation.        |
|     | a    | record | Ther    | Temperature    | Product           |
| (C  | reas | raw    | mometer | Log once per   | disposition will  |
| old | will | p      | Cali    | shift.         | be determined by  |
| --F | not  | roduct | bration |                | effects of        |
| roz | ex   | s      | Log     | QA will check  | deviation.        |
| en/ | ceed | torage |         | all            | Process Authority |
|     | 40°  | area   | Cor     | thermometers   | will be consulted |
| Ref | F in | tempe  | rective | used for       | or cooling curves |
| rig | refr | rature | Actions | monitoring and | will be used to   |
| era | iger | every  | Log     | verification   | make a            |
| ted | ated | two    |         | for accuracy   | determination.    |
| --  | r    | hours. |         | daily and      |                   |
| Raw | ooms |        |         | calibrate to   | QA will identify  |
| Mea | or   |        |         | within 2° F    | the cause of the  |
| t/P | ex   |        |         | accuracy as    | deviation and     |
| oul | ceed |        |         | necessary.     | prevent           |
| try | 30°  |        |         |                | reoccurrence by   |
|     | F in |        |         | QA will        | adjusting         |
|     | fre  |        |         | observe        | maintenance       |
|     | ezer |        |         | maintenance    | schedule &        |
|     | ro   |        |         | taking &       | repairing         |
|     | oms. |        |         | recording      | equipment as      |
|     |      |        |         | temperatures   | required.         |
|     |      |        |         | weekly.        |                   |
+-----+------+--------+---------+----------------+-------------------+

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

+------+-----+--------+---------+----------------+-------------------+
| **H  |     |        |         |                |                   |
| ACCP |     |        |         |                |                   |
| PL   |     |        |         |                |                   |
| AN** |     |        |         |                |                   |
|      |     |        |         |                |                   |
| *    |     |        |         |                |                   |
| *PRO |     |        |         |                |                   |
| CESS |     |        |         |                |                   |
| C    |     |        |         |                |                   |
| ATEG |     |        |         |                |                   |
| ORY: |     |        |         |                |                   |
| NOT  |     |        |         |                |                   |
| HEAT |     |        |         |                |                   |
| TREA |     |        |         |                |                   |
| TED, |     |        |         |                |                   |
| S    |     |        |         |                |                   |
| HELF |     |        |         |                |                   |
| STAB |     |        |         |                |                   |
| LE** |     |        |         |                |                   |
|      |     |        |         |                |                   |
| ## P |     |        |         |                |                   |
| RODU |     |        |         |                |                   |
| CT E |     |        |         |                |                   |
| XAMP |     |        |         |                |                   |
| LE:  |     |        |         |                |                   |
| PEPP |     |        |         |                |                   |
| ERON |     |        |         |                |                   |
| I AN |     |        |         |                |                   |
| D SA |     |        |         |                |                   |
| LAMI |     |        |         |                |                   |
+------+-----+--------+---------+----------------+-------------------+
| ##   | ##  | **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   |
| Com  | tal | per    | tection | will verify    | supervisor will   |
| bine | par | sonnel | Log     | metal          | control and       |
| Ingr | tic | will   |         | detectors are  | segregate         |
| edie | les | check  | Cor     | functioning.   | affected product. |
| nts/ | to  | the    | rective |                |                   |
|      | exc | metal  | Actions | QA will verify | Maintenance       |
| Pr   | eed | de     | Log     | that the metal | personnel will    |
| oces | 1   | tector |         | detectors are  | identify and      |
| sing | /32 | every  |         | functioning as | eliminate the     |
|      | i   | two    |         | intended by    | problem with the  |
|      | nch | hours  |         | running a      | metal detector.   |
|      | es. | to     |         | seeded sample  |                   |
|      |     | assure |         | through the    | Preventive        |
|      | All | the    |         | detector prior | maintenance       |
|      | k   | kick   |         | to start of    | program will be   |
|      | ick | out    |         | each shift.    | implemented.      |
|      | out | mec    |         |                |                   |
|      | p   | hanism |         | QA will        | QA will run       |
|      | rod | is     |         | observe        | seeded sample     |
|      | uct | w      |         | examination &  | through metal     |
|      | w   | orking |         | rework of kick | detector after    |
|      | ill | pro    |         | out product    | repair.           |
|      | be  | perly. |         | once per week. |                   |
|      | re  |        |         |                | All potentially   |
|      | wor | All    |         | Kick out       | contaminated      |
|      | ked | kick   |         | device will be | product will be   |
|      | to  | out    |         | tested each    | run through metal |
|      | m   | p      |         | shift to       | detector, X- ray, |
|      | eet | roduct |         | determine it   | or visually       |
|      | cr  | will   |         | is functioning | examined prior to |
|      | iti | be     |         | as intended.   | further           |
|      | cal | vi     |         |                | processing.       |
|      | lim | sually |         |                |                   |
|      | it. | ex     |         |                | No adulterated    |
|      |     | amined |         |                | product will be   |
|      |     | at the |         |                | shipped.          |
|      |     | end of |         |                |                   |
|      |     | the    |         |                |                   |
|      |     | shift  |         |                |                   |
|      |     | or     |         |                |                   |
|      |     | p      |         |                |                   |
|      |     | roduct |         |                |                   |
|      |     | line   |         |                |                   |
|      |     | and    |         |                |                   |
|      |     | r      |         |                |                   |
|      |     | esults |         |                |                   |
|      |     | rec    |         |                |                   |
|      |     | orded. |         |                |                   |
+------+-----+--------+---------+----------------+-------------------+

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

##  

+------+-----+--------+---------+----------------+-------------------+
| **H  |     |        |         |                |                   |
| ACCP |     |        |         |                |                   |
| PL   |     |        |         |                |                   |
| AN** |     |        |         |                |                   |
|      |     |        |         |                |                   |
| ##   |     |        |         |                |                   |
| PROC |     |        |         |                |                   |
| ESS  |     |        |         |                |                   |
| CATE |     |        |         |                |                   |
| GORY |     |        |         |                |                   |
| : NO |     |        |         |                |                   |
| T HE |     |        |         |                |                   |
| AT T |     |        |         |                |                   |
| REAT |     |        |         |                |                   |
| ED,  |     |        |         |                |                   |
| SHEL |     |        |         |                |                   |
| F ST |     |        |         |                |                   |
| ABLE |     |        |         |                |                   |
|      |     |        |         |                |                   |
| *    |     |        |         |                |                   |
| *PRO |     |        |         |                |                   |
| DUCT |     |        |         |                |                   |
| EXAM |     |        |         |                |                   |
| PLE: |     |        |         |                |                   |
| P    |     |        |         |                |                   |
| EPPE |     |        |         |                |                   |
| RONI |     |        |         |                |                   |
| AND  |     |        |         |                |                   |
| SALA |     |        |         |                |                   |
| MI** |     |        |         |                |                   |
+------+-----+--------+---------+----------------+-------------------+
| ##   | ##  | **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   | pH  | QA     | Ferme   | QA supervisor  | QA will segregate |
|      |    | tech   | ntation | will observe   | and hold all      |
| Fe   | 5.3 | nician | Log     | QA technician  | affected product  |
| rmen | wit | will   |         | perform pH     | until correct pH  |
| ting | hin | test   | pH Log  | test once per  | is achieved or    |
|      | 6   | pH of  |         | shift.         | other appropriate |
|      | hou | 10     | Cor     |                | disposition is    |
|      | rs. | sticks | rective | QA will check  | determined based  |
|      |     | from   | Actions | all pH meters  | on the nature of  |
|      |     | each   | Log     | used for       | the deviation,    |
|      |     | lot by |         | monitoring and | time at pH of     |
|      |     | probe  |         | verification   | product and food  |
|      |     | during |         | for accuracy   | safety            |
|      |     | the    |         | daily and      | parameters.       |
|      |     | fermen |         | calibrate for  |                   |
|      |     | tation |         | accuracy       | Starter culture   |
|      |     | p      |         | daily.         | will be checked   |
|      |     | rocess |         |                | for appropriate   |
|      |     | every  |         |                | amount used,      |
|      |     | 2      |         |                | dispersion, and   |
|      |     | hours  |         |                | storage           |
|      |     | and at |         |                | parameters. HACCP |
|      |     | compl  |         |                | plan and process  |
|      |     | etion. |         |                | controls will be  |
|      |     |        |         |                | changed as        |
|      |     |        |         |                | required.         |
|      |     |        |         |                |                   |
|      |     |        |         |                | QA will identify  |
|      |     |        |         |                | the cause of the  |
|      |     |        |         |                | deviation and     |
|      |     |        |         |                | prevent           |
|      |     |        |         |                | reoccurrence.     |
+------+-----+--------+---------+----------------+-------------------+

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

##  

## 

+-----+------+--------+---------+----------------+-------------------+
| *   |      |        |         |                |                   |
| *HA |      |        |         |                |                   |
| CCP |      |        |         |                |                   |
| PLA |      |        |         |                |                   |
| N** |      |        |         |                |                   |
|     |      |        |         |                |                   |
| **P |      |        |         |                |                   |
| ROC |      |        |         |                |                   |
| ESS |      |        |         |                |                   |
| CAT |      |        |         |                |                   |
| EGO |      |        |         |                |                   |
| RY: |      |        |         |                |                   |
| NOT |      |        |         |                |                   |
| H   |      |        |         |                |                   |
| EAT |      |        |         |                |                   |
| TR  |      |        |         |                |                   |
| EAT |      |        |         |                |                   |
| ED, |      |        |         |                |                   |
| SH  |      |        |         |                |                   |
| ELF |      |        |         |                |                   |
| ST  |      |        |         |                |                   |
| ABL |      |        |         |                |                   |
| E** |      |        |         |                |                   |
|     |      |        |         |                |                   |
| **P |      |        |         |                |                   |
| ROD |      |        |         |                |                   |
| UCT |      |        |         |                |                   |
| EX  |      |        |         |                |                   |
| AMP |      |        |         |                |                   |
| LE: |      |        |         |                |                   |
| PEP |      |        |         |                |                   |
| PER |      |        |         |                |                   |
| ONI |      |        |         |                |                   |
| AND |      |        |         |                |                   |
| SA  |      |        |         |                |                   |
| LAM |      |        |         |                |                   |
| I** |      |        |         |                |                   |
+-----+------+--------+---------+----------------+-------------------+
| #   | #### | **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 |      |        |         |                |                   |
+-----+------+--------+---------+----------------+-------------------+
| 5B  | R    | MPR    | Drying  | QA supervisor  | If a deviation    |
|     | each | checks | Room    | will review    | from a critical   |
| Dry | est  | will   | R       | MPR log and    | limit occurs, the |
| ing | abli | be     | ecorder | drying room    | following         |
|     | shed | done   | Charts  | recorder       | corrective        |
|     | M    | on     |         | charts once    | actions will be   |
|     | oist | each   | Ther    | per shift and  | taken:            |
|     | ure: | lot by | mometer | observe MPR    |                   |
|     |      | prod   | Cali    | check once per | 1.  The cause of  |
|     | Pro  | uction | bration | week.          |     the deviation |
|     | tein | emp    | Log     |                |     will be       |
|     | R    | loyee. |         | Maintenance    |     identified    |
|     | atio |        | Cor     | supervisor     |     and           |
|     | (    | Drying | rective | will verify    |     eliminated.   |
|     | MPR) | time   | Actions | the accuracy   |                   |
|     |      | /tempe | Log     | of the drying  | 2.  The CCP will  |
|     | P    | rature |         | room recorder  |     be monitored  |
|     | eppe | will   | MPR Log | once per       |     hourly after  |
|     | roni | be     |         | shift.         |     the           |
|     | 1.   | mon    |         |                |     corrective    |
|     | 6:1, | itored |         | QA will check  |     action is     |
|     |      | using  |         | all            |     taken to      |
|     | Sa   | room   |         | thermometers   |     ensure that   |
|     | lami | re     |         | used for       |     it is under   |
|     | 1    | corder |         | monitoring and |     control.      |
|     | .9:1 | c      |         | verification   |                   |
|     |      | harts. |         | activities for | 3.  When the      |
|     |      |        |         | accuracy daily |     cause of the  |
|     |      |        |         | and calibrate  |     deviation is  |
|     |      |        |         | to within 2° F |     identified,   |
|     |      |        |         | accuracy as    |     measures will |
|     |      |        |         | necessary.     |     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. |
|     |      |        |         |                |                   |
|     |      |        |         |                | 4.  QA will       |
|     |      |        |         |                |     reject or     |
|     |      |        |         |                |     hold product  |
|     |      |        |         |                |     dependent on  |
|     |      |        |         |                |                   |
|     |      |        |         |                |  time/temperature |
|     |      |        |         |                |     deviation.    |
+-----+------+--------+---------+----------------+-------------------+

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

+-----+------+--------+---------+----------------+-------------------+
| *   |      |        |         |                |                   |
| *HA |      |        |         |                |                   |
| CCP |      |        |         |                |                   |
| PLA |      |        |         |                |                   |
| N** |      |        |         |                |                   |
|     |      |        |         |                |                   |
| **P |      |        |         |                |                   |
| ROC |      |        |         |                |                   |
| ESS |      |        |         |                |                   |
| CAT |      |        |         |                |                   |
| EGO |      |        |         |                |                   |
| RY: |      |        |         |                |                   |
| NOT |      |        |         |                |                   |
| H   |      |        |         |                |                   |
| EAT |      |        |         |                |                   |
| TR  |      |        |         |                |                   |
| EAT |      |        |         |                |                   |
| ED, |      |        |         |                |                   |
| SH  |      |        |         |                |                   |
| ELF |      |        |         |                |                   |
| ST  |      |        |         |                |                   |
| ABL |      |        |         |                |                   |
| E** |      |        |         |                |                   |
|     |      |        |         |                |                   |
| **P |      |        |         |                |                   |
| ROD |      |        |         |                |                   |
| UCT |      |        |         |                |                   |
| EX  |      |        |         |                |                   |
| AMP |      |        |         |                |                   |
| LE: |      |        |         |                |                   |
| PEP |      |        |         |                |                   |
| PER |      |        |         |                |                   |
| ONI |      |        |         |                |                   |
| AND |      |        |         |                |                   |
| SA  |      |        |         |                |                   |
| LAM |      |        |         |                |                   |
| I** |      |        |         |                |                   |
+-----+------+--------+---------+----------------+-------------------+
| #   | #### | **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  | App  | QA     | Sa      | QA will        | QA will address   |
|     | lica | will   | nitizer | conduct a      | positive          |
| Sl  | tion | m      | Usage   | *Listeria*     | *Listeria*        |
| ici | e    | onitor | Log     | sampling       | samples as        |
| ng/ | very | the    |         | program (both  | detailed in the   |
|     | 2    | appli  | Cor     | environmental  | FSIS issuance     |
| P   | h    | cation | rective | and end        | "*Listeria*       |
| eel | ours | and    | Actions | product) as    | Guidelines for    |
| ing | of a | record | Log     | detailed in    | Industry".        |
|     | s    | the    |         | the FSIS       |                   |
|     | anit | time   |         | issuance       | QA will stop      |
|     | izer | of     |         | "*Listeria*    | slicing/peeling   |
|     | k    | san    |         | Guidelines for | operations if     |
|     | nown | itizer |         | Industry" to   | time since last   |
|     | to   | applic |         | verify         | application of    |
|     | be   | ation. |         | effectiveness  | sanitizer exceeds |
|     | e    |        |         | of the         | 2 hours.          |
|     | ffec |        |         | sanitizer and  |                   |
|     | tive |        |         | its method of  | All end product   |
|     | aga  |        |         | usage.         | produced after    |
|     | inst |        |         |                | the 2 hour limit  |
|     | *    |        |         |                | is exceeded will  |
|     | List |        |         |                | be held until     |
|     | eria |        |         |                | *Listeria         |
|     | mon  |        |         |                | monocytogenes*    |
|     | ocyt |        |         |                | test results are  |
|     | o-ge |        |         |                | final. If         |
|     | nes* |        |         |                | positive, product |
|     | on   |        |         |                | will be condemned |
|     | pro  |        |         |                | and additional    |
|     | duct |        |         |                | environmental and |
|     | con  |        |         |                | end product       |
|     | tact |        |         |                | testing will be   |
|     | eq   |        |         |                | done until the    |
|     | uipm |        |         |                | source is         |
|     | ent. |        |         |                | determined.       |
|     |      |        |         |                | Further           |
|     |      |        |         |                | corrective        |
|     |      |        |         |                | actions will be   |
|     |      |        |         |                | done as detailed  |
|     |      |        |         |                | in FSIS           |
|     |      |        |         |                | regulations       |
|     |      |        |         |                |                   |
|     |      |        |         |                | § 417.3.          |
+-----+------+--------+---------+----------------+-------------------+

**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   | Adju   | In | Comments       |
| te | me | tment | mometer | sonal | stment | it |                |
|    |    | or    | ID#     | T     | Re     | ia |                |
|    |    |       |         | hermo | quired | ls |                |
|    |    | Area  |         | meter | (Yes   |    |                |
|    |    |       |         | Re    | or No) |    |                |
|    |    |       |         | ading |        |    |                |
+----+----+-------+---------+-------+--------+----+----------------+
|    |    |       |         |       |        |    |                |
+----+----+-------+---------+-------+--------+----+----------------+
|    |    |       |         |       |        |    |                |
+----+----+-------+---------+-------+--------+----+----------------+
|    |    |       |         |       |        |    |                |
+----+----+-------+---------+-------+--------+----+----------------+
|    |    |       |         |       |        |    |                |
+----+----+-------+---------+-------+--------+----+----------------+
|    |    |       |         |       |        |    |                |
+----+----+-------+---------+-------+--------+----+----------------+
|    |    |       |         |       |        |    |                |
+----+----+-------+---------+-------+--------+----+----------------+
|    |    |       |         |       |        |    |                |
+----+----+-------+---------+-------+--------+----+----------------+
|    |    |       |         |       |        |    |                |
+----+----+-------+---------+-------+--------+----+----------------+

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

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

+------+-----+-------+-----------+--------------+----------+---------+
| *    |     |       |           |              |          |         |
| *GEN |     |       |           |              |          |         |
| ERIC |     |       |           |              |          |         |
| E    |     |       |           |              |          |         |
| STAB |     |       |           |              |          |         |
| LISH |     |       |           |              |          |         |
| MENT |     |       |           |              |          |         |
| X:   |     |       |           |              |          |         |
| ROOM |     |       |           |              |          |         |
| TEM  |     |       |           |              |          |         |
| PERA |     |       |           |              |          |         |
| TURE |     |       |           |              |          |         |
| L    |     |       |           |              |          |         |
| OG** |     |       |           |              |          |         |
|      |     |       |           |              |          |         |
| **R  |     |       |           |              |          |         |
| OOM: |     |       |           |              |          |         |
| \_   |     |       |           |              |          |         |
| \_\_ |     |       |           |              |          |         |
| \_\_ |     |       |           |              |          |         |
| \_\_ |     |       |           |              |          |         |
| \_\_ |     |       |           |              |          |         |
| \_\_ |     |       |           |              |          |         |
| \_\_ |     |       |           |              |          |         |
| \_\_ |     |       |           |              |          |         |
| \_\_ |     |       |           |              |          |         |
| \_\_ |     |       |           |              |          |         |
| \_\_ |     |       |           |              |          |         |
| \_\_ |     |       |           |              |          |         |
| \_\_ |     |       |           |              |          |         |
| D    |     |       |           |              |          |         |
| ATE: |     |       |           |              |          |         |
| \_   |     |       |           |              |          |         |
| \_\_ |     |       |           |              |          |         |
| \_\_ |     |       |           |              |          |         |
| \_\_ |     |       |           |              |          |         |
| \_\_ |     |       |           |              |          |         |
| \_\_ |     |       |           |              |          |         |
| \_\_ |     |       |           |              |          |         |
| \_\_ |     |       |           |              |          |         |
| \_\_ |     |       |           |              |          |         |
| \_\_ |     |       |           |              |          |         |
| \_\_ |     |       |           |              |          |         |
| \_\_ |     |       |           |              |          |         |
| \_\_ |     |       |           |              |          |         |
| \_\_ |     |       |           |              |          |         |
| \_\_ |     |       |           |              |          |         |
| \_** |     |       |           |              |          |         |
+------+-----+-------+-----------+--------------+----------+---------+
| Time | T   | Pr    | Deviation | If Yes,      | M        | V       |
|      | emp | oduct | from CL?  |              | onitored | erified |
|      |     |       | (Check if | Action?      | by:      | by      |
|      |     |       | yes)      |              |          |         |
+------+-----+-------+-----------+--------------+----------+---------+
|      |     |       |           |              |          |         |
+------+-----+-------+-----------+--------------+----------+---------+
|      |     |       |           |              |          |         |
+------+-----+-------+-----------+--------------+----------+---------+
|      |     |       |           |              |          |         |
+------+-----+-------+-----------+--------------+----------+---------+
|      |     |       |           |              |          |         |
+------+-----+-------+-----------+--------------+----------+---------+
|      |     |       |           |              |          |         |
+------+-----+-------+-----------+--------------+----------+---------+
|      |     |       |           |              |          |         |
+------+-----+-------+-----------+--------------+----------+---------+
|      |     |       |           |              |          |         |
+------+-----+-------+-----------+--------------+----------+---------+
|      |     |       |           |              |          |         |
+------+-----+-------+-----------+--------------+----------+---------+

+-------+---------+-----+-----+-------+-----+----------+------------+
| **GE  |         |     |     |       |     |          |            |
| NERIC |         |     |     |       |     |          |            |
| EST   |         |     |     |       |     |          |            |
| ABLIS |         |     |     |       |     |          |            |
| HMENT |         |     |     |       |     |          |            |
| X:    |         |     |     |       |     |          |            |
| METAL |         |     |     |       |     |          |            |
| DETE  |         |     |     |       |     |          |            |
| CTION |         |     |     |       |     |          |            |
| LOG** |         |     |     |       |     |          |            |
+-------+---------+-----+-----+-------+-----+----------+------------+
| **D   | **      | **  | **  | **S   | **  | **M      | **Verified |
| ate** | Product | Lot | Res | eeded | Tim | onitored | By**       |
|       | \***    | \   | ult | Sam   | e** | By**     |            |
|       |         | #** | s** | ple** |     |          |            |
|       |         |     |     |       |     |          |            |
|       |         |     | **  |       |     |          |            |
|       |         |     | \*\ |       |     |          |            |
|       |         |     | *** |       |     |          |            |
+-------+---------+-----+-----+-------+-----+----------+------------+
|       |         |     |     |       |     |          |            |
+-------+---------+-----+-----+-------+-----+----------+------------+
|       |         |     |     |       |     |          |            |
+-------+---------+-----+-----+-------+-----+----------+------------+
|       |         |     |     |       |     |          |            |
+-------+---------+-----+-----+-------+-----+----------+------------+
|       |         |     |     |       |     |          |            |
+-------+---------+-----+-----+-------+-----+----------+------------+
|       |         |     |     |       |     |          |            |
+-------+---------+-----+-----+-------+-----+----------+------------+

\* Note if kick out product

\*\* Kick out product to be reworked , results noted -- no metal \>1/32
inch.

**FERMENTATION LOG**

**CCP:**

**Critical Limit:**

**Corrective Action(s):**

**Instructions:** Record requested information. Time and temperature may
be recorded on log or taken from chart recorded.

+------+-----+-----+------+------+-------+------------+-------------+
| **Da | *   | **  | **   | **pH | *     | **         | **Operator  |
| te** | *Lo | Tim | Time | O    | *pH** | Comments** | Initials/** |
|      | t** | e** | O    | ut** |       |            |             |
|      |     |     | ut** |      | **@ 2 |            | **V         |
|      | **I | **I |      |      | & 4   |            | erification |
|      | D** | n** |      |      | h     |            | Date and**  |
|      |     |     |      |      | our** |            |             |
|      |     |     |      |      |       |            | *           |
|      |     |     |      |      |       |            | *Initials** |
+------+-----+-----+------+------+-------+------------+-------------+
|      |     |     |      |      |       |            |             |
+------+-----+-----+------+------+-------+------------+-------------+
|      |     |     |      |      |       |            |             |
+------+-----+-----+------+------+-------+------------+-------------+
|      |     |     |      |      |       |            |             |
+------+-----+-----+------+------+-------+------------+-------------+
|      |     |     |      |      |       |            |             |
+------+-----+-----+------+------+-------+------------+-------------+
|      |     |     |      |      |       |            |             |
+------+-----+-----+------+------+-------+------------+-------------+
|      |     |     |      |      |       |            |             |
+------+-----+-----+------+------+-------+------------+-------------+
|      |     |     |      |      |       |            |             |
+------+-----+-----+------+------+-------+------------+-------------+
|      |     |     |      |      |       |            |             |
+------+-----+-----+------+------+-------+------------+-------------+

+-----------+------------+------------+-------------+----------------+
| **MPR     |            |            |             |                |
| LOG**     |            |            |             |                |
+-----------+------------+------------+-------------+----------------+
| **DA      | **LOT ID** | **MPR**    | **MONITORED | **VERIFIED     |
| TE/TIME** |            |            | BY**        | BY**           |
|           |            |            |             |                |
|           |            |            | *           | **Initials**   |
|           |            |            | *Initials** |                |
+-----------+------------+------------+-------------+----------------+
|           |            |            |             |                |
+-----------+------------+------------+-------------+----------------+
|           |            |            |             |                |
+-----------+------------+------------+-------------+----------------+
|           |            |            |             |                |
+-----------+------------+------------+-------------+----------------+
|           |            |            |             |                |
+-----------+------------+------------+-------------+----------------+
|           |            |            |             |                |
+-----------+------------+------------+-------------+----------------+
|           |            |            |             |                |
+-----------+------------+------------+-------------+----------------+
|           |            |            |             |                |
+-----------+------------+------------+-------------+----------------+
|           |            |            |             |                |
+-----------+------------+------------+-------------+----------------+

+----------+-------+--------+--------+---------+--------+-----------+
| **S      |       |        |        |         |        |           |
| ANITIZER |       |        |        |         |        |           |
| USAGE    |       |        |        |         |        |           |
| LOG**    |       |        |        |         |        |           |
+==========+=======+========+========+=========+========+===========+
| **S      | *     | **TIME | ###### | **MO    | **VE   | **C       |
| ANITIZER | *DATE | APP    | ## EQU | NITORED | RIFIED | ORRECTIVE |
| USED**   | APPL  | LIED** | IPMENT | BY:**   | BY:**  | AC        |
|          | IED** |        |        |         |        | TION(S)** |
|          |       |        |        | **DATE  | *      |           |
|          |       |        |        | /TIME** | *DATE/ | **DA      |
|          |       |        |        |         | TIME** | TE/TIME** |
+----------+-------+--------+--------+---------+--------+-----------+
|          |       |        |        |         |        |           |
+----------+-------+--------+--------+---------+--------+-----------+
|          |       |        |        |         |        |           |
+----------+-------+--------+--------+---------+--------+-----------+
|          |       |        |        |         |        |           |
+----------+-------+--------+--------+---------+--------+-----------+
|          |       |        |        |         |        |           |
+----------+-------+--------+--------+---------+--------+-----------+
|          |       |        |        |         |        |           |
+----------+-------+--------+--------+---------+--------+-----------+
|          |       |        |        |         |        |           |
+----------+-------+--------+--------+---------+--------+-----------+
|          |       |        |        |         |        |           |
+----------+-------+--------+--------+---------+--------+-----------+
|          |       |        |        |         |        |           |
+----------+-------+--------+--------+---------+--------+-----------+
|          |       |        |        |         |        |           |
+----------+-------+--------+--------+---------+--------+-----------+

Critical Limit: Sanitizer applied every 2 hours.

+-----------+-------+-------------------+---------+----------+-------+
| ##        |       |                   |         |          |       |
|           |       |                   |         |          |       |
| ## 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.