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## 

## United States

## Department of

**Agriculture**

### Food Safety

and Inspection

Service

May 1999

### HACCP-8 

## Generic HACCP

## Model for Irradiated, Raw 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

> 2

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

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

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

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

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

We hope that these documents are helpful.

# Table of Contents

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

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

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

Hazard
Analysis.......................................................................................
8

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

Identifying
CCPs......................................................................................
12

Appendix A

References for all HACCP Model
Teams................................................ 19

References for Irradiated, Raw Meat and Poultry
Products............................ 21

##  Appendix B

Process Flow Diagram (Figure
1).......................................................... 25

Product Description Form (Figure
2)...................................................... 26

Hazard Analysis Form (Figure
3).......................................................... 27

HACCP Plan Form (Figure
4).............................................................. 32

Form letter requesting Salmonella data
(1)............................................... 37

Form letter requesting Salmonella data
(2)................................................ 38

Generic Establishment X: Product Temperature Log
................................... 39

Generic Establishment X: Room Temperature
Log...................................... 40

Thermometer Calibration
Log............................................................... 41

Generic Establishment X: Irradiation/Dose Mapping Log
............................. 42

Corrective Actions
Log......................................................................
43

Pre-Shipment Review
Log.................................................................. 44

# GENERIC HACCP MODEL

# FOR

# IRRADIATED, RAW 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.*

(x) This generic model is designed for use with the process subcategory:
    Irradiated, raw product.

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

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

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

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

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

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

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

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

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

# Using This Generic Model

This generic model is designed to be used by establishments that produce
irradiated, raw product(s). The model can be used for all irradiated,
raw meat and poultry products.

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

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

Since this generic model entails the use of ionizing radiation, at least
one team member must be trained in quality control, food technology,
irradiation processing, and radiation health and safety. This team
member must have a working knowledge of FSIS regulations on irradiation
(e.g. 9 CFR 381.135, 381.147, and 381.149 for poultry), and other
requirements set forth by the FDA, National Regulatory Commission, and
the Office of Safety and Health Administration.

It would be beneficial for other team members to have reviewed any of
the various guidance materials available on how to develop a HACCP plan
for your company, including several useful videos, handbooks, or
computer programs. Once the HACCP team has prepared itself as thoroughly
as possible in general HACCP principles and how to use them, this model
should be helpful.

**Note**: This generic model includes a number of forms that can be used
to record various types of required information. The forms themselves
are samples; a company HACCP team can develop whatever forms it finds
most useful. All the forms mentioned in this document are included in
Appendix B; they appear in the order in which they are discussed in the
text.

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

> ***§ 417.1 Definitions.***
>
> *For purposes of this part, the following definitions shall apply:*

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

> *[Critical control point]{.underline}. A point, step, or procedure in
> a food process at which control can be applied and, as a result, a
> food safety hazard can be prevented, eliminated, or reduced to
> acceptable levels.*
>
> *[Critical limit]{.underline}. The maximum or minimum value to which a
> physical, biological, or chemical hazard must be controlled at a
> critical control point to prevent, eliminate, or reduce to an
> acceptable level the occurrence of the identified food safety hazard.*
>
> *[Food safety hazard]{.underline}. Any biological, chemical, or
> physical property that may cause a food to be unsafe for human
> consumption.*

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

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

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

# Process Flow Diagram and Product Description

To begin using this model, the company\'s HACCP team should first
describe the product(s), which are part of this process category and
covered by this HACCP plan. The product(s) should be described in two
ways:

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

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

In this generic model, there is an example for irradiated, raw product -
fresh poultry. 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 irradiated fresh poultry in generic establishment X. Figure 2 is an
example of a **PRODUCT DESCRIPTION** for the production of irradiated
fresh poultry produced by generic establishment X.

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

**Note**: In this generic model, it is assumed that packaged poultry
will be transported to another facility for the irradiation process. If
in your process, irradiation is to be done in the same establishment
that the poultry is received and packaged, then the transporting step
may be omitted. 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 "Receiving-Raw Poultry" on the first page of the
six column form; the HACCP team has determined that *Salmonella* may be
present at high levels in incoming raw product, so it has put a "Yes" in
the third column. Column four explains the basis for the team's
determination. In the fifth column, the HACCP team has described the
preventive measures it will use to make sure that each hazard has been
prevented, eliminated, or reduced to an acceptable level. For the
*Salmonella* hazard, the HACCP team decided to tell its suppliers that
product could not be accepted unless it was accompanied by the most
recent *Salmonella* performance standard sampling results which
demonstrated that the supplier had not failed two consecutive
*Salmonella* performance standard sets. FSIS does not consider safe
handling instructions on labels alone to be an adequate CCP for any
pathogenic microorganisms such as bacteria and viruses.

You will notice that in our generic hazard analysis for irradiated fresh
poultry, there are five safety hazards in which the HACCP team has
identified a point in the process at which a food safety hazard is
reasonably likely to occur. For each one of these they have identified a
measure which can be used to control the hazard.

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

**Note**: If you are using this generic model to produce a different raw
irradiated product or if you use a different process flow, you may have
different hazards which are reasonably likely to occur. For these
different hazards, there may be different measures that could be used
for control purposes.

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

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

# Developing Your HACCP Plan

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

*(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 irradiated fresh
poultry 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 are five points on the
hazard analysis form where food safety hazards reasonably likely to
occur were identified: Salmonella on raw poultry at receiving, pathogen
proliferation at packaging and labeling, pathogen proliferation at
storage (cold)/transporting, pathogen survival and/or proliferation
after irradiation, and pathogen proliferation at finished product
storage(cold).

The establishment HACCP team has chosen to have five CCPs to address
these five hazards: *Salmonella* certification, use of approved
packaging material for irradiation and clear product label features to
indicate the product is irradiated, raw, and must be fully cooked,
proper temperature maintenance during transport and storage, compliance
with FSIS/FDA requirements for the process of irradiation, and proper
temperature maintenance at finished product storage (cold).

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.

The team was aware of regulatory requirements for the packaging material
and labeling of irradiated products as stated in 9 CFR 381.135 and 21
CFR 179.45. For their critical limit, the HACCP team decided that air
permeable packaging material, and a label with features to indicate a
raw, irradiated product has the irradiation logo, the radura, along with
the statement "Treated with radiation" or "Treated by Irradiation",
handling statement, clear cooking instructions, and safe handling
instructions.

.

The team set the critical limits for the minimum and maximum absorbed
dose for irradiation of poultry as found in 9 CFR 381.147. For
developing a HACCP plan for irradiation of pork, the required absorbed
dose will be different.

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

The HACCP team decided that receiving personnel check the packaging and
labeling materials for irradiated products at Receiving-packaging
materials. At this location, receiving personnel also routinely check
all letters of guarantee and incoming packaging materials to make sure
they met specifications. Since labels are manufactured in large lots by
a single company, the receiving clerks would randomly sample each
arriving lot. Some packaging materials do not have their labels and safe
handling instructions printed on them and therefore these need to be
applied to the packaging material later in the process. Monitoring at
the packaging and labeling step ensures that the necessary pressure
sensitive sticker labels are applied to the package.

For the CCP on the irradiation process, the HACCP team decided that the
production supervisor would be in the best position to assure that the
irradiation unit was functioning properly by checking the data log
printout from the irradiation control board or "process monitoring
instrument" as the product goes through the irradiation process. The
irradiation control board shows all function movement which take place
within the irradiation chamber during the irradiation process. It will
indicate whether the unit is functioning properly, and will alert the
operator for any abnormal movements.

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 that they could verify the raw poultry
irradiation step through the following procedures and frequency:

1.  QA will verify the irradiation data log printout.

2.  QA will verify the letter of guarantee for calibration of the
    dosimeter every 12 months.

3.  QA will verify that absorbed doses received by product are within
    the minimum and maximum limits from results of dose mapping.

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 three records were necessary: Irradiation Data Log,
Irradiation/Dose Mapping Log, and Letter of guarantee for dosimeter
calibration.

The forms(logs) were designed to provide spaces for all entries
necessary for the monitoring and verification activities at the raw
poultry irradiation 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
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 4:

1\. QA supervisor takes control of and segregates all products processed
when the irradiation unit was not functioning properly.

2\. QA condemns affected products and dispose according to standard
operating procedures.

3\. Certified irradiation maintenance personnel identify problem with
the irradiation unit and repair it so that the integrity of the unit is
restored and the same problem does not recur.

4\. QA implements preventive maintenance checks.

The HACCP team also develops planned corrective actions for each of the
other CCPs and attaches them to the HACCP plan. Whenever a deviation
from a critical limit occurs, company employees follow the corrective
action plan and use the Corrective Action Log to create a record of
their actions. The Corrective Action Log forms are available at CCPs, so
they can be used immediately when an employee performing a monitoring
check discovers and records a deviation. All Corrective Action Logs,
which have been used during the day, are turned in to the HACCP
coordinator.

There is one final verification/recordkeeping requirement which the
company must perform; it is found at 417.5(c):

(c) Prior to shipping product, the establishment shall review the
    records associated with the production of that product, documented
    in accordance with this section, to ensure completeness, including
    the determination that all critical limits were met and, if
    appropriate, corrective actions were taken, including the proper
    disposition of product. Where practicable, this review shall be
    conducted, dated, and signed by an individual who did not produce
    the record(s), preferably by someone trained in accordance with §
    417.7 of this part, or the responsible establishment official.

In generic establishment X, product is shipped out, often in small lots,
throughout the day. This means that pre-shipment verification checks
must be as complete as possible when finished product is in storage, so
that a shipment can be made up quickly and moved into distribution
channels.

The establishment uses a half day lotting system and a midshift cleanup.
While the midshift cleanup is being performed, QA personnel or the HACCP
coordinator review results of monitoring and verification checks applied
to that lot; if there were deviations from critical limits, they review
the Corrective Action Logs to make sure all appropriate planned
responses were carried out. If everything is in order and there are
complete records showing that the establishment has controlled
production of this product through its HACCP system, the HACCP
coordinator will sign the pre-shipment review form which the HACCP team
devised for this purpose.

**Note:** It is not a regulatory requirement that a separate form be
used for pre-shipment review; in addition, FSIS has indicated that it
will be very flexible in accepting a variety of arrangements for
accomplishing pre-shipment review to reflect the variety of commercial
practices which it has encountered in the industry. It is, however,
important to remember that pre-shipment review is a regulatory
requirement that must be met, as it indicates that the establishment is
taking full responsibility for the product having been produced under a
well-functioning HACCP system.

The HACCP team believes it has now completed preparation of the
documents which are necessary to meet regulatory requirements for a
Hazard Analysis and a HACCP Plan for their irradiated, raw 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 all HACCP Model 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 (beef slaughter, roaster beef, ham,
> chicken slaughter, etc.)

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 R.F. Steir. *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 Specifications 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
    (NACMCF). *March 20, 1992 -- Hazard Analysis and Critical Control
    Point System*. Int. J. Food Micr. 16: 1-23, 1993.

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

14. 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

15\. Notermans, S., et al. *The HACCP concept: Identification of
potentially hazardous*

*microorganisms*. Food Microbiol. 11:203-214, 1994.

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

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

17. Pierson, M.D. and Corlett, D.A., Jr. Editors. *HACCP/Principles and
    Applications*. Van Nostrand Reinhold, 1992.

18. 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 section in particular is:
>
> Chapter 11 -- forms for hazard analysis, CCP, limits, HACCP master
> sheet, example HACCP for breaded chicken

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

20. 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 (HACCP) in Meat,
    Poultry and Seafoods*. Chapman & Hall, 1995.

#### References for Irradiated, Raw Meat and Poultry Products

1.  American Meat Institute. *Palatability, Color, and Shelf life of
    Low-Dose Irradiated Beef.* AMI, Washington, DC, 1995.

2.  American Society for Tests and Measures. *Standard Guide for
    Selection and Application of Dosimetry Systems for Radiation
    Processing of Food.* In Annual Book of ASTM Standards. ASTM.
    Washington, DC, 12.02: 785-788, 1989.

3.  Clavero, M. Rocelle S. *Inactivation of* *Escherichia coli* 0157:H7,
    Salmonellae, *and* *Campylobacter jejuni in Raw Ground Beef by Gamma
    Irradiation.* App. Environ. Microbiol. June 1994: 2069-2075, 1994.

4.  Codex. Codex General Standard for Irradiated Foods (Annex 2)(and
    other sections regarding irradiation). In Codex Alimentarius, Vol.
    XV, 1984.

5.  FDA. *Irradiation in the Production, Processing and Handling* *of
    Food* (Part 179). In Code of Federal Regulations. National Archives
    and Records Administration. Washington, DC 21:179.2: 411-415, 1977.

6.  FDA. *Irradiation in the Production, Processing and Handling of
    Food.* In Federal Register/Rules and Regulations*.* Food and Drug
    Administration. Washington, DC, 55:18538-18533, 1990.

7.  FSIS, USDA. *Irradiation of Pork for Control of Trichinella
    spiralis* (Part 318). In Federal Register/Rules Regulations. U.S.
    Department of Agriculture, Washington, DC, 51:1769-1771, 318.7 p.
    257, 1999.

8.  Hashim, I. B., et al. *Consumer Attitudes Toward Irradiated
    Poultry.* Food Technol. March 1996: 77-80, 1996.

9.  Monk, J. David., et al. *Irradiation Inactivation of* *Listeria
    monocytogenes* *and Staphylococcus aureus in Low-and High-fat,
    Frozen and Refrigerated Ground Beef.* J. Food Protect. 57:969-974,
    1994.

10. Murano, Elsa A. *Irradiation of Fresh Meats.* Food Technol. December
    1995: 52-54, 1995.

11. Murano, E. A., Editor. *Irradiation Processing* (Chapter 1). In Food
    Irradiation A Sourcebook. Iowa State University Press. Ames, IA,
    1995.

12. Patterson, Margaret. *Sensitivity of Bacteria to Irradiation of
    Poultry Meat Under Various Atmospheres.* Letters in Appl. Microbiol.
    7: 55-58, 1988.

13. Radomyski, Tomasz., et al. *Elimination of Pathogens of Significance
    in Food by Low-dose Irradiation: A Review.* J. Food Protect. 57:
    73-86, 1994.

14. Renwick, Stephen P., et al. The RF Linear Accelerator in In-Lear
    E-Beam Processing of Beef and Poultry. Dairy Food Environ. Sanit.
    16: 214-221, 1996.

15. Robeck, Mark R. *Product Liability Issues Related to Food
    Irradiation.* Food Technol. February 1996: 78-82, 1996.

16. Rodriguez, H. Ricardo, et al. *Low-dose Gamma Irradiation and
    Refrigeration to Extend Shelf Life of Aerobically Packed Fresh Beef
    Round.* J. Food Protect. 56: 505-509, 1993.

17. Tarte, R. R., et al. *Survival and Injury of* *Listeria
    monocytogenes. Listeria innocua and* *Listeria ivanovii in Ground
    Pork Following Electron Beam Irradiation.* J. Food Protect. 59:
    596-600, 1996.

18. Thayer, D. W. *Use of Irradiation to Kill Pathogens on Meat and
    Poultry.* J. Food Science. 15: 181-192, 1995.

19. Thayer, D. W., et al. *Extending Shelf Life of Poultry and Red Meat
    by Irradiation Processing.* J. Food Protect. 56: 831-833, 1993.

20. Thayer, D. W., et al. *Elimination of Escherichia coli 0157:H7 in
    Meats by Gamma Irradiation.* Appl. Environ. Microbiol. April 1993:
    1030-1034, 1993.

21. USDA. *Irradiation of Poultry Products* (Part 381). In Federal
    Register/Rules and Regulation. U.S. Department of Agriculture.
    Washington, DC 57:43588-43600, 1992.

### **APPENDIX B** 

#### PROCESS FLOW DIAGRAM Figure 1

####### PROCESS CATEGORY: IRRADIATED, RAW PRODUCT

##### PRODUCT: FRESH POULTRY

> **PRODUCT DESCRIPTION** **Figure 2**

+-----------------------------------------------------------------------+
| PROCESS CATEGORY: IRRADIATED, RAW PRODUCT                             |
|                                                                       |
| PRODUCT: FRESH POULTRY                                                |
+-----------------------------------------------------------------------+
| 1\. COMMON NAME? FRESH POULTRY                                        |
|                                                                       |
| 2\. HOW IS IT TO BE USED? COOKED AND CONSUMED                         |
|                                                                       |
| 3\. TYPE OF PACKAGE? BULK-PACK/RESEALABLE POUCH OR RETAIL             |
| PACKAGE(with air permeable and approved packaging material for        |
| irradiation)                                                          |
|                                                                       |
| 4\. LENGTH OF SHELF LIFE, APPROX. 1-3 WEEKS AT 27-40° F AT WHAT       |
| TEMPERATURE?                                                          |
+-----------------------------------------------------------------------+
| 5\. WHERE WILL IT BE SOLD? RETAIL AND HRI, WHOLESALE                  |
|                                                                       |
| CONSUMERS? GENERAL PUBLIC                                             |
|                                                                       |
| INTENDED USE?                                                         |
+-----------------------------------------------------------------------+
| 6\. LABELING INSTRUCTIONS? RADURA SIGN, "TREATED WITH RADIATION" OR   |
| "TREATED BY IRRADIATION"; KEEP REFRIGERATED ; COOKING INSTRUCTIONS;   |
| SAFE HANDLING INSTRUCTIONS.                                           |
+-----------------------------------------------------------------------+
| 7\. IS SPECIAL DISTRIBUTION KEEP REFRIGERATED                         |
|                                                                       |
| CONTROL NEEDED?                                                       |
+-----------------------------------------------------------------------+

**HAZARD ANALYSIS -- IRRADIATED, RAW PRODUCT**

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

  **Receiving   **Biological:      **Yes**        ***Salmonella*   **Certification   **1B**
  -- Raw        Pathogens                         may be present   from suppliers    
  Poultry**     -microbial                        on incoming raw  that product has  
                (*Salmonella*)**                  product.**       been sampled for  
                                                                   *Salmonella* and  
                                                                   passed            
                                                                   standards.**      

                **Chemical --                                                        
                None**                                                               

                **Physical --      **No**         **Plant records                    
                Foreign                           show that there                    
                materials**                       has been no                        
                                                  incidence of                       
                                                  foreign                            
                                                  materials in                       
                                                  products                           
                                                  received into                      
                                                  the plant.**                       
  ------------- ------------------ -------------- ---------------- ----------------- ------------

######## Figure 3 

**HAZARD ANALYSIS -- IRRADIATED, RAW PRODUCT**

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

  **Receiving   **Biological                                                  
  -- Packaging  -- None**                                                     
  Materials**                                                                 

                **Chemical --  **No**         **Letters of                    
                Not acceptable                guarantee for                   
                for intended                  air permeable                   
                use**                         direct food                     
                                              contact                         
                                              packaging                       
                                              material and                    
                                              labels with                     
                                              required                        
                                              features                        
                                              approved for                    
                                              irradiation.**                  

                **Physical --  **No**         **Plant records                 
                Foreign                       demonstrate that                
                materials                     foreign material                
                (insects,                     contamination                   
                dirt, etc.)**                 has not occurred                
                                              during the past                 
                                              several years.**                
  ------------- -------------- -------------- ---------------- -------------- ------------

######## Figure 3 

**HAZARD ANALYSIS -- IRRADIATED, RAW PRODUCT**

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

  **Storage (Cold)- Raw    **Biological -   **No**         **Temperature                  
  Poultry**                Pathogens**                     of product and                 
                                                           storage area                   
                                                           will be                        
                                                           maintained                     
                                                           below a level                  
                                                           to prevent                     
                                                           pathogen                       
                                                           growth.**                      

                           **Chemical --                                                  
                           None**                                                         

                           **Physical --                                                  
                           None**                                                         

  **Storage --Packaging    **Biological --                                                
  Materials**              None**                                                         

                           **Chemical --                                                  
                           None**                                                         

                           **Physical -                                                   
                           None**                                                         

  **Packaging/Labeling**   **Biological -   **Yes**        **Improper      **Plant will   **2B**
                           Pathogens**                     packaging       use approved   
                                                           materials and   packaging      
                                                           labeling may    materials for  
                                                           allow pathogen  irradiation.   
                                                           growth          Labels with    
                                                           including       radura, and    
                                                           anaerobes.**    required       
                                                                           features will  
                                                                           clearly        
                                                                           indicate an    
                                                                           irradiated,    
                                                                           raw product.** 

                           **Chemical -                                                   
                           None**                                                         

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

> Figure 3

**HAZARD ANALYSIS -- IRRADIATED, RAW PRODUCT**

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

  **Storage        **Biological -   **Yes**        **Pathogens   **Maintain     **3B**
  (Cold)/          Pathogens**                     are           product        
  Transporting**                                   reasonably    temperature at 
                                                   likely to     or below a     
                                                   grow in this  level          
                                                   product if    sufficient to  
                                                   temperature   prevent        
                                                   is not        pathogen       
                                                   maintained at growth.**      
                                                   or below a                   
                                                   level                        
                                                   sufficient to                
                                                   prevent                      
                                                   growth.**                    

                   **Chemical --                                                
                   None**                                                       

                   **Physical --                                                
                   None**                                                       

  **Raw Poultry    **Biological --  **Yes**        **Improper    **Correct dose **4B**
  Irradiation**    Pathogens**                     use of        range as per   
                                                   irradiation   FSIS           
                                                   may not       regulation     
                                                   reduce/kill   (according to  
                                                   pathogens as  approved       
                                                   intended.**   treatment      
                                                                 protocol in 9  
                                                                 CFR 381.147,   
                                                                 381.149) will  
                                                                 be used.**     

                   **Chemical-                                                  
                   None**                                                       

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

> Figure 3

**HAZARD ANALYSIS -- IRRADIATED, RAW PRODUCT**

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

  **Finished     **Biological   **Yes**        **Pathogens    **Maintain     **5B**
  Product        -- Pathogens**                are reasonably product        
  Storage                                      likely to grow temperature at 
  (Cold)**                                     in this        or below a     
                                               product if     level          
                                               temperature is sufficient to  
                                               not maintained prevent        
                                               at or below a  pathogen       
                                               level to       growth.**      
                                               maintain                      
                                               process                       
                                               integrity.**                  

                 **Chemical --                                               
                 None**                                                      

                 **Physical --                                               
                 None**                                                      

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

                 **Chemical --                                               
                 None**                                                      

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

> **Figure 3**

+------+------+---------+-------+-----------------+-----------------+
| # HA |      |         |       |                 |                 |
| CCP  |      |         |       |                 |                 |
| PLAN |      |         |       |                 |                 |
|      |      |         |       |                 |                 |
| *    |      |         |       |                 |                 |
| *PRO |      |         |       |                 |                 |
| CESS |      |         |       |                 |                 |
| C    |      |         |       |                 |                 |
| ATEG |      |         |       |                 |                 |
| ORY: |      |         |       |                 |                 |
| IRR  |      |         |       |                 |                 |
| ADIA |      |         |       |                 |                 |
| TED, |      |         |       |                 |                 |
| RAW  |      |         |       |                 |                 |
| P    |      |         |       |                 |                 |
| RODU |      |         |       |                 |                 |
| CT** |      |         |       |                 |                 |
|      |      |         |       |                 |                 |
| *    |      |         |       |                 |                 |
| *PRO |      |         |       |                 |                 |
| DUCT |      |         |       |                 |                 |
| EXAM |      |         |       |                 |                 |
| PLE: |      |         |       |                 |                 |
| F    |      |         |       |                 |                 |
| RESH |      |         |       |                 |                 |
| P    |      |         |       |                 |                 |
| OULT |      |         |       |                 |                 |
| RY** |      |         |       |                 |                 |
+------+------+---------+-------+-----------------+-----------------+
| *    | **   | **Mon   | **    | **Verification  | **Corrective    |
| *CCP | Crit | itoring | HACCP | Procedures and  | Actions**       |
| \#   | ical | Pro     | Reco  | Frequency**     |                 |
| and  | Limi | cedures | rds** |                 |                 |
| Lo   | ts** | and     |       |                 |                 |
| cati |      | Freq    |       |                 |                 |
| on** |      | uency** |       |                 |                 |
+------+------+---------+-------+-----------------+-----------------+
| 1B   | Supp | Re      | Rece  | Every two       | Will not        |
|      | lier | ceiving | iving | months QA will  | receive product |
| R    | c    | pe      | Log   | request         | unaccompanied   |
| ecei | erti | rsonnel |       | *Salmonella*    | by *Salmonella* |
| ving | fica | will    | Corre | testing results | certification.  |
| --   | tion | check   | ctive | from FSIS for   |                 |
| Raw  | that | each    | Ac    | at least 2      |                 |
| Pou  | pro  | s       | tions | suppliers.      |                 |
| ltry | duct | hipment | Log   |                 |                 |
|      | has  | for     |       |                 |                 |
|      | been | *Salm   |       |                 |                 |
|      | sam  | onella* |       |                 |                 |
|      | pled | certifi |       |                 |                 |
|      | for  | cation. |       |                 |                 |
|      | *Sal |         |       |                 |                 |
|      | mone |         |       |                 |                 |
|      | lla* |         |       |                 |                 |
|      | must |         |       |                 |                 |
|      | a    |         |       |                 |                 |
|      | ccom |         |       |                 |                 |
|      | pany |         |       |                 |                 |
|      | s    |         |       |                 |                 |
|      | hipm |         |       |                 |                 |
|      | ent. |         |       |                 |                 |
+------+------+---------+-------+-----------------+-----------------+

####### 

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

####### 

+------+------+---------+-------+-----------------+-----------------+
| # HA |      |         |       |                 |                 |
| CCP  |      |         |       |                 |                 |
| PLAN |      |         |       |                 |                 |
|      |      |         |       |                 |                 |
| *    |      |         |       |                 |                 |
| *PRO |      |         |       |                 |                 |
| CESS |      |         |       |                 |                 |
| C    |      |         |       |                 |                 |
| ATEG |      |         |       |                 |                 |
| ORY: |      |         |       |                 |                 |
| IRR  |      |         |       |                 |                 |
| ADIA |      |         |       |                 |                 |
| TED, |      |         |       |                 |                 |
| RAW  |      |         |       |                 |                 |
| P    |      |         |       |                 |                 |
| RODU |      |         |       |                 |                 |
| CT** |      |         |       |                 |                 |
|      |      |         |       |                 |                 |
| *    |      |         |       |                 |                 |
| *PRO |      |         |       |                 |                 |
| DUCT |      |         |       |                 |                 |
| EXAM |      |         |       |                 |                 |
| PLE: |      |         |       |                 |                 |
| F    |      |         |       |                 |                 |
| RESH |      |         |       |                 |                 |
| P    |      |         |       |                 |                 |
| OULT |      |         |       |                 |                 |
| RY** |      |         |       |                 |                 |
+------+------+---------+-------+-----------------+-----------------+
| *    | **   | **Mon   | **    | **Verification  | **Corrective    |
| *CCP | Crit | itoring | HACCP | Procedures and  | Actions**       |
| \#   | ical | Pro     | Reco  | Frequency**     |                 |
| and  | Limi | cedures | rds** |                 |                 |
| Lo   | ts** | and     |       |                 |                 |
| cati |      | Freq    |       |                 |                 |
| on** |      | uency** |       |                 |                 |
+------+------+---------+-------+-----------------+-----------------+
| 2B   | Appr | Pa      | Packa | QA will observe | QA will         |
|      | oved | ckaging | ging/ | packaging line  | segregate and   |
| Pa   | p    | line    | Lab   | supervisor      | hold            |
| ckag | acka | sup     | eling | perform         | incorrectly     |
| ing/ | ging | ervisor | Log   | monitoring      | packaged and/or |
| Labe | mate | will    |       | activity once   | labeled         |
| ling | rial | r       | Corre | per shift.      | product. Follow |
|      | li   | andomly | ctive |                 | SOPs for        |
|      | sted | sample  | Ac    | QA will sample  | product         |
|      | in   | p       | tions | labels intended | disposition.    |
|      | 21   | ackages | Log   | for use from    |                 |
|      | CFR  | of      |       | label storage   | QA will         |
|      | 17   | product |       | area twice      | identify the    |
|      | 9.45 | once    |       | weekly to       | cause of the    |
|      | and  | per     |       | ensure label    | deviation and   |
|      | 9    | shift   |       | accuracy.       | prevent         |
|      | CFR  | and     |       |                 | reoccurrence.   |
|      | 381. | ensure  |       | QA will check   |                 |
|      | 149. | pa      |       | labels once a   |                 |
|      |      | ckaging |       | day on packaged |                 |
|      | L    | m       |       | product to      |                 |
|      | abel | aterial |       | ensure label    |                 |
|      | with | and     |       | accuracy on     |                 |
|      | rad  | l       |       | packaged        |                 |
|      | ura, | abeling |       | product.        |                 |
|      | "Tre | requi   |       |                 |                 |
|      | ated | rements |       |                 |                 |
|      | with | are     |       |                 |                 |
|      | rad  | met.    |       |                 |                 |
|      | iati |         |       |                 |                 |
|      | on", |         |       |                 |                 |
|      | or   |         |       |                 |                 |
|      |      |         |       |                 |                 |
|      | "Tre |         |       |                 |                 |
|      | ated |         |       |                 |                 |
|      | by   |         |       |                 |                 |
|      | irra |         |       |                 |                 |
|      | diat |         |       |                 |                 |
|      | ion" |         |       |                 |                 |
|      | Hand |         |       |                 |                 |
|      | ling |         |       |                 |                 |
|      | St   |         |       |                 |                 |
|      | atem |         |       |                 |                 |
|      | ent, |         |       |                 |                 |
|      |      |         |       |                 |                 |
|      | Coo  |         |       |                 |                 |
|      | king |         |       |                 |                 |
|      | I    |         |       |                 |                 |
|      | nstr |         |       |                 |                 |
|      | ucti |         |       |                 |                 |
|      | ons, |         |       |                 |                 |
|      | Safe |         |       |                 |                 |
|      | Hand |         |       |                 |                 |
|      | ling |         |       |                 |                 |
|      | I    |         |       |                 |                 |
|      | nstr |         |       |                 |                 |
|      | ucti |         |       |                 |                 |
|      | ons. |         |       |                 |                 |
+------+------+---------+-------+-----------------+-----------------+

####### 

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

####### 

+------+------+---------+-------+-----------------+-----------------+
| # HA |      |         |       |                 |                 |
| CCP  |      |         |       |                 |                 |
| PLAN |      |         |       |                 |                 |
|      |      |         |       |                 |                 |
| *    |      |         |       |                 |                 |
| *PRO |      |         |       |                 |                 |
| CESS |      |         |       |                 |                 |
| C    |      |         |       |                 |                 |
| ATEG |      |         |       |                 |                 |
| ORY: |      |         |       |                 |                 |
| IRR  |      |         |       |                 |                 |
| ADIA |      |         |       |                 |                 |
| TED, |      |         |       |                 |                 |
| RAW  |      |         |       |                 |                 |
| P    |      |         |       |                 |                 |
| RODU |      |         |       |                 |                 |
| CT** |      |         |       |                 |                 |
|      |      |         |       |                 |                 |
| *    |      |         |       |                 |                 |
| *PRO |      |         |       |                 |                 |
| DUCT |      |         |       |                 |                 |
| EXAM |      |         |       |                 |                 |
| PLE: |      |         |       |                 |                 |
| F    |      |         |       |                 |                 |
| RESH |      |         |       |                 |                 |
| P    |      |         |       |                 |                 |
| OULT |      |         |       |                 |                 |
| RY** |      |         |       |                 |                 |
+------+------+---------+-------+-----------------+-----------------+
| *    | **   | **Mon   | **    | **Verification  | **Corrective    |
| *CCP | Crit | itoring | HACCP | Procedures and  | Actions**       |
| \#   | ical | Pro     | Reco  | Frequency**     |                 |
| and  | Limi | cedures | rds** |                 |                 |
| Lo   | ts** | and     |       |                 |                 |
| cati |      | Freq    |       |                 |                 |
| on** |      | uency** |       |                 |                 |
+------+------+---------+-------+-----------------+-----------------+
| 3B   | Tem  | QA      | Pr    | QA supervisor   | QA will reject  |
|      | pera | pe      | oduct | will check      | or hold product |
| Sto  | ture | rsonnel |       | Product         | until           |
| rage | of   | will    | T     | Temperature Log | temperature is  |
| (Co  | prod | check   | emper | and Room        | achieved:       |
| ld)/ | uct, | raw     | ature | Temperature Log | dependent on    |
| Tran | sto  | product | Log   | twice per       | time and        |
| spor | rage | temp    |       | shift.          | temperature     |
| ting | and  | erature | Room  |                 | deviation.      |
|      | t    | every   | T     | Maintenance     | Follow standard |
|      | rans | two     | emper | supervisor will | operating       |
|      | port | hours.  | ature | verify accuracy | procedures for  |
|      | at   |         | Log   | of the Room     | product         |
|      | 27   | Main    |       | Temperature Log | disposition.    |
|      | -38° | tenance | T     | once per shift. |                 |
|      | F.   | pe      | hermo |                 | QA and          |
|      |      | rsonnel | meter | QA will check   | maintenance     |
|      |      | will    | C     | all             | personnel will  |
|      |      | check   | alibr | thermometers    | identify the    |
|      |      | storage | ation | used for        | cause of the    |
|      |      | area    | Log   | monitoring and  | deviation and   |
|      |      | temp    |       | verification    | prevent         |
|      |      | erature | Corre | for accuracy    | reoccurrence.   |
|      |      | every   | ctive | daily and       |                 |
|      |      | two     | Ac    | calibrate to    |                 |
|      |      | hours.  | tions | within 1° F     |                 |
|      |      |         | Log   | accuracy as     |                 |
|      |      |         |       | necessary.      |                 |
+------+------+---------+-------+-----------------+-----------------+

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

+------+------+---------+-------+-----------------+-----------------+
| # HA |      |         |       |                 |                 |
| CCP  |      |         |       |                 |                 |
| PLAN |      |         |       |                 |                 |
|      |      |         |       |                 |                 |
| *    |      |         |       |                 |                 |
| *PRO |      |         |       |                 |                 |
| CESS |      |         |       |                 |                 |
| C    |      |         |       |                 |                 |
| ATEG |      |         |       |                 |                 |
| ORY: |      |         |       |                 |                 |
| IRR  |      |         |       |                 |                 |
| ADIA |      |         |       |                 |                 |
| TED, |      |         |       |                 |                 |
| RAW  |      |         |       |                 |                 |
| P    |      |         |       |                 |                 |
| RODU |      |         |       |                 |                 |
| CT** |      |         |       |                 |                 |
|      |      |         |       |                 |                 |
| *    |      |         |       |                 |                 |
| *PRO |      |         |       |                 |                 |
| DUCT |      |         |       |                 |                 |
| EXAM |      |         |       |                 |                 |
| PLE: |      |         |       |                 |                 |
| F    |      |         |       |                 |                 |
| RESH |      |         |       |                 |                 |
| P    |      |         |       |                 |                 |
| OULT |      |         |       |                 |                 |
| RY** |      |         |       |                 |                 |
+------+------+---------+-------+-----------------+-----------------+
| *    | **   | **Mon   | **    | **Verification  | **Corrective    |
| *CCP | Crit | itoring | HACCP | Procedures and  | Actions**       |
| \#   | ical | Pro     | Reco  | Frequency**     |                 |
| and  | Limi | cedures | rds** |                 |                 |
| Lo   | ts** | and     |       |                 |                 |
| cati |      | Freq    |       |                 |                 |
| on** |      | uency** |       |                 |                 |
+------+------+---------+-------+-----------------+-----------------+
| 4B   | Min  | Pro     | I     | QA will verify  | QA supervisor   |
|      | imum | duction | rradi | irradiation     | will segregate  |
| Raw  | abso | sup     | ation | data log        | and hold        |
| Pou  | rbed | ervisor | Data  | printout.       | affected        |
| ltry | d    | will    | Log   |                 | products.       |
| Irr  | ose: | monitor | pri   | QA will verify  |                 |
| adia | 1.5  | the     | ntout | letter of       | QA will condemn |
| tion | kilo | data    |       | guarantee for   | affected        |
|      | gray | log     | I     | calibration of  | products.       |
|      | (150 | p       | rradi | the dosimeter   | Follow standard |
|      | k    | rintout | ation | every 12        | operating       |
|      | ilor | from    | /Dose | months.         | procedures for  |
|      | ads) | the     | Ma    |                 | disposition of  |
|      | Max  | irra    | pping | QA will verify  | irradiated      |
|      | imum | diation | Log   | that absorbed   | products.       |
|      | abso | control |       | doses received  |                 |
|      | rbed | board   | L     | by product are  | Certified       |
|      | d    | for     | etter | within the      | irradiation     |
|      | ose: | each    | of    | minimum and     | maintenance     |
|      | 3.0  | irr     | guar  | maximum limits  | personnel will  |
|      | kilo | adiated | antee | from results of | identify and    |
|      | gray | batch.  | for   | dose mapping.   | correct the     |
|      | (300 |         | dosi  |                 | problem with    |
|      | k    | Pro     | meter |                 | the irradiation |
|      | ilor | duction | c     |                 | unit and ensure |
|      | ads) | sup     | alibr |                 | no reocurrence  |
|      | as   | ervisor | ation |                 | of the problem. |
|      | f    | will    |       |                 |                 |
|      | ound | take    | Corre |                 | QA will         |
|      | in 9 | do      | ctive |                 | implement a     |
|      | CFR  | simeter | Ac    |                 | preventive      |
|      | 381  | r       | tions |                 | maintenance     |
|      | .147 | eadings | Log   |                 | program.        |
|      | and  | for     |       |                 |                 |
|      | 381  | each    |       |                 |                 |
|      | .149 | irr     |       |                 |                 |
|      |      | adiated |       |                 |                 |
|      |      | batch   |       |                 |                 |
+------+------+---------+-------+-----------------+-----------------+

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

+------+------+---------+-------+-----------------+-----------------+
| # HA |      |         |       |                 |                 |
| CCP  |      |         |       |                 |                 |
| PLAN |      |         |       |                 |                 |
|      |      |         |       |                 |                 |
| *    |      |         |       |                 |                 |
| *PRO |      |         |       |                 |                 |
| CESS |      |         |       |                 |                 |
| C    |      |         |       |                 |                 |
| ATEG |      |         |       |                 |                 |
| ORY: |      |         |       |                 |                 |
| IRR  |      |         |       |                 |                 |
| ADIA |      |         |       |                 |                 |
| TED, |      |         |       |                 |                 |
| RAW  |      |         |       |                 |                 |
| P    |      |         |       |                 |                 |
| RODU |      |         |       |                 |                 |
| CT** |      |         |       |                 |                 |
|      |      |         |       |                 |                 |
| *    |      |         |       |                 |                 |
| *PRO |      |         |       |                 |                 |
| DUCT |      |         |       |                 |                 |
| EXAM |      |         |       |                 |                 |
| PLE: |      |         |       |                 |                 |
| F    |      |         |       |                 |                 |
| RESH |      |         |       |                 |                 |
| P    |      |         |       |                 |                 |
| OULT |      |         |       |                 |                 |
| RY** |      |         |       |                 |                 |
+------+------+---------+-------+-----------------+-----------------+
| *    | **   | **Mon   | **    | **Verification  | **Corrective    |
| *CCP | Crit | itoring | HACCP | Procedures and  | Actions**       |
| \#   | ical | Pro     | Reco  | Frequency**     |                 |
| and  | Limi | cedures | rds** |                 |                 |
| Lo   | ts** | and     |       |                 |                 |
| cati |      | Freq    |       |                 |                 |
| on** |      | uency** |       |                 |                 |
+------+------+---------+-------+-----------------+-----------------+
| 5B   | Fini | QA      | Pr    | QA supervisor   | QA will reject  |
|      | shed | pe      | oduct | will check      | or hold product |
| Fini | pro  | rsonnel | T     | Product         | until           |
| shed | duct | will    | emper | Temperature Log | temperature is  |
| Pro  | and  | check   | ature | and Room        | achieved:       |
| duct | sto  | raw     | Log   | Temperature Log | dependent on    |
| Sto  | rage | product |       | twice per       | time and        |
| rage | area | temp    | Room  | shift.          | temperature     |
| (C   | s    | erature | T     |                 | deviation.      |
| old) | hall | every   | emper | Maintenance     | Follow standard |
|      | be   | two     | ature | supervisor will | operating       |
|      | ma   | hours.  | Log   | verify accuracy | procedures for  |
|      | inta |         |       | of the Room     | product         |
|      | ined | Main    | T     | Temperature Log | disposition.    |
|      | at   | tenance | hermo | once per shift. |                 |
|      | 27   | pe      | meter |                 | QA and          |
|      | -38° | rsonnel | C     | QA will check   | maintenance     |
|      | F.   | will    | alibr | all             | personnel will  |
|      |      | check   | ation | thermometers    | identify the    |
|      |      | storage | Log   | used for        | cause of the    |
|      |      | area    |       | monitoring and  | deviation and   |
|      |      | temp    | Corre | verification    | prevent         |
|      |      | erature | ctive | for accuracy    | reoccurrence.   |
|      |      | every   | Ac    | daily and       |                 |
|      |      | two     | tions | calibrate to    |                 |
|      |      | hours.  | Log   | within 1° F     |                 |
|      |      |         |       | accuracy as     |                 |
|      |      |         |       | necessary.      |                 |
+------+------+---------+-------+-----------------+-----------------+

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

**FORM LETTER requesting *Salmonella* Data**

Date

To: FSIS

FOIA Coordinator

USDA

This is to request results of any *Salmonella* performance standard
sample sets completed during the past two months from establishments
listed below.

Thank you.

  ----------------- ----------------- ----------------- -----------------
  File Copy         Date Results      Two Consecutive   If Yes, Remarks
                    Received          Failed Sets?      

  Est. YYY                                              

  Est. ZZZ                                              

  Est. AAA                                              

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

**FORM LETTER requesting *Salmonella* Data**

To: FSIS

FOIA Coordinator

USDA

This is to request results of any *Salmonella* performance standard
sample sets completed during the past two months from establishments
listed below.

Thank you.

Est. YYY

Est. ZZZ

Est. AAA

+-----+------+----------+-----------------------+-----------+--------+
| ##  |      |          |                       |           |        |
| ##  |      |          |                       |           |        |
| GEN |      |          |                       |           |        |
| ERI |      |          |                       |           |        |
| C E |      |          |                       |           |        |
| STA |      |          |                       |           |        |
| BLI |      |          |                       |           |        |
| SHM |      |          |                       |           |        |
| ENT |      |          |                       |           |        |
|  X: |      |          |                       |           |        |
|  pr |      |          |                       |           |        |
| odu |      |          |                       |           |        |
| ct  |      |          |                       |           |        |
| Tem |      |          |                       |           |        |
| per |      |          |                       |           |        |
| atu |      |          |                       |           |        |
| re  |      |          |                       |           |        |
| Log |      |          |                       |           |        |
|     |      |          |                       |           |        |
| pr  |      |          |                       |           |        |
| odu |      |          |                       |           |        |
| ct: |      |          |                       |           |        |
| \_\ |      |          |                       |           |        |
| _\_ |      |          |                       |           |        |
| \_\ |      |          |                       |           |        |
| _\_ |      |          |                       |           |        |
| \_\ |      |          |                       |           |        |
| _\_ |      |          |                       |           |        |
| \_\ |      |          |                       |           |        |
| _\_ |      |          |                       |           |        |
| \_\ |      |          |                       |           |        |
| _\_ |      |          |                       |           |        |
| \_\ |      |          |                       |           |        |
| _\_ |      |          |                       |           |        |
| \_\ |      |          |                       |           |        |
| _\_ |      |          |                       |           |        |
| \_\ |      |          |                       |           |        |
| _\_ |      |          |                       |           |        |
| \_\ |      |          |                       |           |        |
| _\_ |      |          |                       |           |        |
| \_\ |      |          |                       |           |        |
| _\_ |      |          |                       |           |        |
| Da  |      |          |                       |           |        |
| te: |      |          |                       |           |        |
| \_\ |      |          |                       |           |        |
| _\_ |      |          |                       |           |        |
| \_\ |      |          |                       |           |        |
| _\_ |      |          |                       |           |        |
| \_\ |      |          |                       |           |        |
| _\_ |      |          |                       |           |        |
+-----+------+----------+-----------------------+-----------+--------+
| **  | **TE | **D      | **If Yes,**           | **        | **Ve   |
| TIM | MP** | eviation |                       | Monitored | rified |
| E** |      | from CL? | **Corrective          | by:**     | by:**  |
|     |      | (Check   | Action?**             |           |        |
|     |      | if       |                       |           |        |
|     |      | yes)**   |                       |           |        |
+-----+------+----------+-----------------------+-----------+--------+
| 6   | 34°F |          |                       | PS        |        |
| :36 |      |          |                       |           |        |
| AM  |      |          |                       |           |        |
+-----+------+----------+-----------------------+-----------+--------+
| 8   | 33°F |          |                       | PS        |        |
| :30 |      |          |                       |           |        |
| AM  |      |          |                       |           |        |
+-----+------+----------+-----------------------+-----------+--------+
| 10  | 34°F |          |                       | PS        | CB     |
| :32 |      |          |                       |           |        |
| AM  |      |          |                       |           |        |
+-----+------+----------+-----------------------+-----------+--------+
| 12  | 36°F |         | Notify maint. supv.,  | PS        |        |
| :30 |      |          | CB & QA               |           |        |
| PM  |      |          |                       |           |        |
+-----+------+----------+-----------------------+-----------+--------+
|     |      |          |                       |           |        |
+-----+------+----------+-----------------------+-----------+--------+

**TIME/TEMPERATURE CRITICAL LIMIT:**

+-----+------+----------+-----------------------+-----------+--------+
| ##  |      |          |                       |           |        |
| ##  |      |          |                       |           |        |
| GEN |      |          |                       |           |        |
| ERI |      |          |                       |           |        |
| C E |      |          |                       |           |        |
| STA |      |          |                       |           |        |
| BLI |      |          |                       |           |        |
| SHM |      |          |                       |           |        |
| ENT |      |          |                       |           |        |
|  X: |      |          |                       |           |        |
|  ro |      |          |                       |           |        |
| om  |      |          |                       |           |        |
| Tem |      |          |                       |           |        |
| per |      |          |                       |           |        |
| atu |      |          |                       |           |        |
| re  |      |          |                       |           |        |
| Log |      |          |                       |           |        |
|     |      |          |                       |           |        |
| S   |      |          |                       |           |        |
| tor |      |          |                       |           |        |
| age |      |          |                       |           |        |
| r   |      |          |                       |           |        |
| oom |      |          |                       |           |        |
| :\_ |      |          |                       |           |        |
| \_\ |      |          |                       |           |        |
| _\_ |      |          |                       |           |        |
| \_\ |      |          |                       |           |        |
| _\_ |      |          |                       |           |        |
| \_\ |      |          |                       |           |        |
| _\_ |      |          |                       |           |        |
| \_\ |      |          |                       |           |        |
| _\_ |      |          |                       |           |        |
| \_\ |      |          |                       |           |        |
| _\_ |      |          |                       |           |        |
| \_\ |      |          |                       |           |        |
| _\_ |      |          |                       |           |        |
| \_\ |      |          |                       |           |        |
| _\_ |      |          |                       |           |        |
| \_\ |      |          |                       |           |        |
| _\_ |      |          |                       |           |        |
| Da  |      |          |                       |           |        |
| te: |      |          |                       |           |        |
| \_\ |      |          |                       |           |        |
| _\_ |      |          |                       |           |        |
| \_\ |      |          |                       |           |        |
| _\_ |      |          |                       |           |        |
| \_\ |      |          |                       |           |        |
| _\_ |      |          |                       |           |        |
+-----+------+----------+-----------------------+-----------+--------+
| **  | **TE | **D      | **If Yes,**           | **        | **Ve   |
| TIM | MP** | eviation |                       | Monitored | rified |
| E** |      | from CL? | **Corrective          | by:**     | by:**  |
|     |      | (Check   | Action?**             |           |        |
|     |      | if       |                       |           |        |
|     |      | yes)**   |                       |           |        |
+-----+------+----------+-----------------------+-----------+--------+
| 6   | 34°F |          |                       | PS        |        |
| :36 |      |          |                       |           |        |
| AM  |      |          |                       |           |        |
+-----+------+----------+-----------------------+-----------+--------+
| 8   | 33°F |          |                       | PS        |        |
| :30 |      |          |                       |           |        |
| AM  |      |          |                       |           |        |
+-----+------+----------+-----------------------+-----------+--------+
| 10  | 34°F |          |                       | PS        | CB     |
| :32 |      |          |                       |           |        |
| AM  |      |          |                       |           |        |
+-----+------+----------+-----------------------+-----------+--------+
| 12  | 36°F |         | Notify maint. supv.,  | PS        |        |
| :30 |      |          | CB & QA               |           |        |
| PM  |      |          |                       |           |        |
+-----+------+----------+-----------------------+-----------+--------+
|     |      |          |                       |           |        |
+-----+------+----------+-----------------------+-----------+--------+

**TIME/TEMPERATURE CRITICAL LIMIT:**

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

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

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

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

**GENERIC ESTABLISHMENT X: IRRADIATION/ DOSE MAPPING LOG**

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

+-------------+-----------+-------------+---------------+-------------+
| **Lot or**  | **Do      | **A         | **Dose        | **Verified  |
|             | simeter** | bsorption** | (KGY)**       | By:**       |
| **          |           |             |               |             |
| Irradiation | **Po      |             |               |             |
| ID**        | sitions** |             |               |             |
+-------------+-----------+-------------+---------------+-------------+
|             |           |             |               |             |
+-------------+-----------+-------------+---------------+-------------+
|             |           |             |               |             |
+-------------+-----------+-------------+---------------+-------------+
|             |           |             |               |             |
+-------------+-----------+-------------+---------------+-------------+
|             |           |             |               |             |
+-------------+-----------+-------------+---------------+-------------+

+---------+-------+---------+------------+---------+--------+-------+
| ## C    |       |         |            |         |        |       |
| ORRECTI |       |         |            |         |        |       |
| VE ACTI |       |         |            |         |        |       |
| ONS LOG |       |         |            |         |        |       |
|         |       |         |            |         |        |       |
| **P     |       |         |            |         |        |       |
| roduct: |       |         |            |         |        |       |
| \_\_    |       |         |            |         |        |       |
| \_\_\_\ |       |         |            |         |        |       |
| _\_\_\_ |       |         |            |         |        |       |
| \_\_\_\ |       |         |            |         |        |       |
| _\_\_\_ |       |         |            |         |        |       |
| \_\_\_\ |       |         |            |         |        |       |
| _\_\_\_ |       |         |            |         |        |       |
| \_\_\_\ |       |         |            |         |        |       |
| _\_\_\_ |       |         |            |         |        |       |
| \_\_\_\ |       |         |            |         |        |       |
| _\_\_\_ |       |         |            |         |        |       |
| \_\_\_\ |       |         |            |         |        |       |
| _\_\_** |       |         |            |         |        |       |
+---------+-------+---------+------------+---------+--------+-------+
| **CCP** | **De  | **Disp  | **         | **M     | *      | **T   |
|         | viati | osition | Corrective | easures | *Respo | ime** |
|         | on/** | of      | Action     | to      | nsible |       |
|         |       | Pr      | Procedures | Prevent | Pe     |       |
|         | *     | oduct** | /Explain** | Recur   | rson** |       |
|         | *Prob |         |            | rence** |        |       |
|         | lem** |         |            |         |        |       |
+---------+-------+---------+------------+---------+--------+-------+
|         |       |         |            |         |        |       |
+---------+-------+---------+------------+---------+--------+-------+
|         |       |         |            |         |        |       |
+---------+-------+---------+------------+---------+--------+-------+
|         |       |         |            |         |        |       |
+---------+-------+---------+------------+---------+--------+-------+

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

# 

# Pre-Shipment Review Log Date:\_\_\_\_\_\_\_\_\_\_\_\_\_\_

  -------- -------------------- --------- ---------------------------------
  **Lot    **Time Records       **By      **Lot Released for Shipment?
  ID**     Reviewed**           Whom**    Signature**

  11:10                                   
  a.m.                                    

  11:10                                   
  p.m.                                    

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