Guidebook for HACCP：HACCP-6.PDF

United States
Department of
Agriculture
Food Safety
and Inspection
Service
September 1999
HACCP-7
Generic HACCP
Model for
Thermally
Processed,
Commercially
Sterile 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
Thermally Processed,Commercially Sterile
Table of Contents
Introduction………………………………………….……………………………………,3
Using This Generic Model………………………….…………………………………….,5
Process Flow Diagram and Product Description….………………………………………,7
Hazard Analysis…………………………………………………………………………… 8
Developing Your HACCP Plan………..………………………………………………….,10
Identifying CCPs…………………………………….……………………………………,11
Appendix A
References for HACCP Teams……………………………………….………….,19
References for Thermally Processed,Commercially Sterile
Meat and Poultry Products………………………………………….………….....,21
Part I – Epidemiology of Foodborne Illness…………..………….…….….,21
Part II – Product Spoilage ………………………………….……………… 22
Part III – Physical and Chemical Contamination ………….…..…………….23
Appendix B
Process Flow Diagram (Figure 1) Beef Stew…………………………………….,26
Product Description Form (Figure 2)……………………………………………… 27
Hazard Analysis Form (Figure 3)…………………………………………………,28
HACCP Plan Form (Figure 4)..…………………………………………………… 33
Thermometer Calibration Log…………………………………………………….,40
1
Thermally Processed,Commercially Sterile
Generic Establishment X,Metal Detection Log…………………………………,41
Generic Establishment X,Process Operating Log………………………………… 42
Generic Establishment X,Process Deviation Log……………....………………… 43
Corrective Actions Log……………………………………………………………,44
Pre-Shipment Review Log………………………………………………………… 45
2
Thermally Processed,Commercially Sterile
GENERIC HACCP MODEL
FOR
THERMALLY PROCESSED,COMMERCIALLY STERILE 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),
3
Thermally Processed,Commercially Sterile
(b) The HACCP plan,(1) Every establishment shall develop and implement a written
HACCP plan covering each product produced by that establishment whenever a hazard
analysis reveals one or more food safety hazards that are reasonably likely to occur,
based on the hazard analysis conducted in accordance with paragraph (a) of this
section,including products in the following processing categories,
(i) Slaughter--all species,
(ii) Raw product--ground,
(iii) Raw product--not ground,
(iv) Thermally processed--commercially sterile,
(v) Not heat treated--shelf stable,
(vi) Heat treated--shelf stable,
(vii) Fully cooked--not shelf stable,
(viii) Heat treated but not fully cooked--not shelf stable,
(ix) Product with secondary inhibitors--not shelf stable,
This generic model is designed for use with the fourth process category,Thermally processed --
commercially sterile,
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,
4
Thermally Processed,Commercially Sterile
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 thermally processed,
commercially sterile product(s),the fourth process category,The model can be used for all
thermally processed,commercially sterile products,either meat or poultry; with or without cure;
whether low-acid or acidified low-acid product,The model can be used for those products
generally referred to as canned,The generic model is not suitable for products that fall into any
of the other process categories,
The model will be most useful to a HACCP team that includes access to one trained individual,
as specified in 417.7(b),
(b) The individual performing the functions listed in paragraph (a) of this section shall
have successfully completed a course of instruction in the application of the seven
HACCP principles to meat or poultry product processing,including a segment on the
development of a HACCP plan for a specific product and on record review,
It would be beneficial for other team members to have reviewed any of the various guidance
materials available on how to develop a HACCP plan for your company,including several useful
videos,handbooks,or computer programs,Once the HACCP team has prepared itself as
thoroughly as possible in general HACCP principles and how to use them,this model should be
helpful,
5
Thermally Processed,Commercially Sterile
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,Procedures to be followed when a deviation occurs,
Critical control point,A point,step,or procedure in a food process at which control can
be applied and,as a result,a food safety hazard can be prevented,eliminated,or reduced
to acceptable levels,
Critical limit,The maximum or minimum value to which a physical,biological,or
chemical hazard must be controlled at a critical control point to prevent,eliminate,or
reduce to an acceptable level the occurrence of the identified food safety hazard,
Food safety hazard,Any biological,chemical,or physical property that may cause a
food to be unsafe for human consumption,
HACCP System,The HACCP plan in operation,including the HACCP plan itself,
Hazard,SEE Food Safety Hazard,
Preventive measure,Physical,chemical,or other means that can be used to control an
identified food safety hazard,
Process-monitoring instrument,An instrument or device used to indicate conditions
during processing at a critical control point,
Responsible establishment official,The individual with overall authority on-site or a
higher level official of the establishment,
6
Thermally Processed,Commercially Sterile
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 thermally processed,commercially sterile - beef
stew,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 thermally
processed,commercially sterile beef stew in generic establishment X,Figure 2 is an example of
a PRODUCT DESCRIPTION for the thermally processed,commercially sterile beef stew
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,
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),
7
Thermally Processed,Commercially Sterile
§ 417.2 Hazard Analysis and HACCP Plan,
(a) Hazard analysis,(1) Every official establishment shall conduct,or have conducted
for it,a hazard analysis to determine the food safety hazards reasonably likely to occur
in the production process and identify the preventive measures the establishment can
apply to control those hazards,The hazard analysis shall include food safety hazards
that can occur before,during,and after entry into the establishment,A food safety
hazard that is reasonably likely to occur is one for which a prudent establishment would
establish controls because it historically has occurred,or because there is a reasonable
possibility that it will occur in the particular type of product being processed,in the
absence of those controls,
(2) A flow chart describing the steps of each process and product flow in the
establishment shall be prepared,and the intended use or consumers of the finished
product shall be identified,
Generic establishment X,which we are using for our example,is capturing these regulatory
requirements on a 6-column Hazard Analysis Form (See Figure 3),A good way to use a form
like this is to create the first column by using the Process Flow Diagram and the second by
answering the question,Once the HACCP team has considered all the steps in the flow diagram
and determined if a food safety hazard could be introduced,it needs to consider whether the
hazard is "reasonably likely to occur",using the meaning of this phrase included in 417.2(a),On
the 6-column form used by generic establishment X,the third and fourth columns address this
issue,If the establishment's HACCP team has decided that the hazard is not reasonably likely to
occur,they enter "No" in column three,explain the basis for their determination in column four,
and do not need to further consider activity at this point in the process,
If,however,the team has determined there is a "food safety hazard reasonably likely to occur"
introduced at a certain point in the process,column five is used to describe a measure which
could be applied to "prevent,eliminate,or reduce to acceptable levels" the food safety hazard
identified in column three,Column six is used when a critical control point (CCP) is identified
based upon the decision made in the hazard analysis,Each CCP has a number – the order
corresponds to steps in the process,For example,1 is the first CCP in the process flow,2 the
next,etc,The letter indicates whether the hazard is biological – B; chemical – C; or physical –
P,
Look at the entries for,Receiving-Non-meat Food Ingredients” on the first page of the six
column form; the HACCP team has determined that even though bacterial spore loads may be
present at high levels in incoming product,they put a,No” in the third column,Column four
explains the basis for the team’s determination,The bacterial spore load which is introduced
into the product either at the producer or supplier operations,can be controlled at the canning
8
Thermally Processed,Commercially Sterile
establishment,Therefore,the team decided that the hazard can be controlled by the thermal
process or by using irradiated spices,
You will notice that on our generic hazard analysis for thermally processed,commercially sterile
beef stew,there are seven food safety hazards in which the HACCP team has identified a point
in the process at which a food safety hazard is reasonably likely to occur,For each one of these
they have identified a measure which can be used to control the hazard,
When your HACCP team has completed their hazard analysis (whether they use this format or
not),it is a good idea to review the flow diagram,the product description and the hazard analysis
itself to make sure they are complete,Part 417.2(a)(3) includes a list of sources from which food
safety hazards might be expected to arise,Reviewing that list could help the HACCP team
check for completeness,
Note,If you are using this generic model to produce a different thermally processed,
commercially sterile 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 thermally
processed,commercially sterile 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,The HACCP plan shall,at a minimum,
9
Thermally Processed,Commercially Sterile
(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,(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;
10
Thermally Processed,Commercially Sterile
(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 thermally processed,commercially
sterile beef stew on a six column form (See Figure 4),You do not need to use this form,
although some kind of a form is probably the easiest way to present your HACCP plan,
Identifying CCPs
The first column on this particular form is used to enter information developed and contained on
the hazard analysis form,Part 417.2(c)(1) and (2) require that the food safety hazards identified
in the hazard analysis be listed on the HACCP plan and that there be a CCP for each identified
hazard,You will notice that there were seven process steps on the hazard analysis form where
food safety hazards reasonably likely to occur were identified,microbial growth on incoming
meat; presence of foreign material on non-meat food ingredients; presence of foreign materials
in cans and packaging materials; presence of foreign materials after can washing; improper
product formulation; improper filling of can; and,improper application of the thermal process
and cooling,
The establishment HACCP team has chosen to have seven CCPs to address these seven hazards,
temperature monitoring of incoming meat; visual inspection of incoming meat; letter of guaranty
for non-meat food ingredients; visual inspection of non-meat food ingredients; visual inspection
of cans and packaging on receipt; visual inspection of cans after exiting washer; and the
processing authority specifications for product formulation,filling of cans,and the process
schedule,
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,If
the plant decided to use the current regulations for thermally processed,commercially sterile
product to address bacterial hazards,only physical and chemical hazards would have to be
addressed in the HACCP Plan,However,the team decided to address bacterial hazards in their
plan and set limits that met or exceeded regulatory requirements,
Although meat would remain frozen below 32°F,the team decided that 10°F or below would be
11
Thermally Processed,Commercially Sterile
more conservative and protective of the frozen product,There would be less chance of the
product reaching thaw temperature before use and,thus,reducing the chance for temperature
abuse,
In addition to the critical limit regarding metal in the packaging and non-metal containers,the
team decided that any other visible hazardous non-food material,such as glass,was unacceptable
not only at receipt of packaging materials and containers but also during the washing of the cans,
For non-meat ingredients,the bacterial spore load in spices is the bacteriological concern,
However,the bacteriological load is incorporated before the non-meat ingredients reach the
thermal processing establishment,The team therefore decided that purchase specifications and/or
letters of guarantee would be the best method for controlling the bacterial hazards,
With respect to metal contamination,the team knew that their detector was capable of
identifying particles as small as 1/32 of an inch,as long as it was working well,Therefore,they
decided that their critical limit would be the capability of a properly functioning metal detector,
The processing authority determines the formulation,container filling,and thermal process and
cooling specifications that will produce a safe and stable product,Therefore,the critical limits
for these steps in processing are those specified by the processing authority for the specific
product,
Once they had decided on their critical limits,they needed to identify how the monitoring
procedures would be carried out and at what frequency,
For their Receiving – Frozen Cooked Diced Beef and Non-meat Food Ingredient controls on
incoming product,they decided the operational personnel who normally checked arriving
products would check product temperature for each load,This individual would also visually
inspect each load of frozen cooked diced beef,non-meat ingredients,and packaging in addition
to checking letters of guarantee and ensuring that all goods are from approved suppliers,The
team determined that this might be an excessive frequency for suppliers with good performance,
and decided that when they validated their HACCP plan (by actually trying it out and recording
results),they would consider whether another frequency should be used,
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,
12
Thermally Processed,Commercially Sterile
(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 determined that since receiving personnel were performing the temperature
checks on incoming meat,their supervisor would be a good person to involve in verification,He
will review the temperature logs and receiving logs,and may either observe the employee taking
the temperature or take a temperature of his own,once per shift,
There is a regulatory requirement (Part 417.4(a)(2)(i)) for including as a verification,the
calibration of process-monitoring instruments; the thermometers being used to take the
temperature checks are obviously process monitoring instruments,so someone outside the
maintenance unit,in this case the Quality Assurance unit,will check those thermometers for
accuracy on a daily basis,and calibrate them to within 1 degree as necessary,
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
13
Thermally Processed,Commercially Sterile
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 team created a separate form to be used by the QA personnel
who were checking the thermometers and calibrating them as necessary,Each employee who
was performing a temperature check had a thermometer assigned to him,which was identifiable
by its serial number,QA personnel picked up thermometers from employees throughout the day
when employees were not using them,and checked them against a known standard; recalibration
was performed immediately if it was necessary,There were only four different employees and
different thermometers being used in the HACCP monitoring and verification activities,and they
were to be checked once a day,so the HACCP team decided that this form could be used by QA
for more than one day,QA personnel were located in a different part of the plant; employees
delivered their thermometers to QA once a day immediately after they had performed a
temperature check,QA checked the thermometer and returned it to the employee with a copy of
the record showing results; in addition,QA e-mailed the results to the HACCP coordinator at the
end of each day,and each time there was a variation of more than 2° F noted when the
thermometer was checked,
The HACCP team also created a form to be used by employees with assigned tasks concerning
the functioning of the metal detector,The Metal Detector Performance Log includes both
monitoring and verification checks results; the form has entries from both the packaging
supervisor and from QA personnel,The form is kept near the metal detector and is turned in to
the HACCP coordinator at the end of each day,
The Process Operating Log was designed to include all the information required by the
regulations Part 318.306,The team also designed a form to be used in the event of a deviation in
processing,The Process Deviation Log includes date of the deviation,product information,and
disposition of the product after evaluation by the processing authority,
14
Thermally Processed,Commercially Sterile
On its HACCP Plan,generic establishment X has listed the names of the forms it will be using
for monitoring and verification records,
Another form is included in column four,where the establishment has described its
recordkeeping system,That is the Corrective Actions Log; it is used to create the records of any
corrective actions taken because of deviations from critical limits at CCPs,Column six
references the planned corrective actions for each CCP,The HACCP team carefully reviewed
the regulatory requirements for planned corrective actions,found at 417.3(a),
§ 417.3 Corrective actions,
(a) The written HACCP plan shall identify the corrective action to be followed in
response to a deviation from a critical limit,The HACCP plan shall describe the
corrective action to be taken,and assign responsibility for taking corrective action,to
ensure,
(1) The cause of the deviation is identified and eliminated;
(2) The CCP will be under control after the corrective action is taken;
(3) Measures to prevent recurrence are established; and
(4) No product that is injurious to health or otherwise adulterated as a result of the
deviation enters commerce,
The HACCP team has developed a specific corrective action plan which will be followed
whenever there is a deviation from a critical limit at a CCP; each of the planned corrective
actions meets the four regulatory requirements of 417.3(a),For example,this is the
establishment's planned corrective action whenever there is a deviation from the thermal
processing and cooling critical limit,i.e.,an improper application of the process schedule as
specified by the processing authority,
Planned Corrective Actions for CCP 9,
1,The plant designee will apply a filed alternate process schedule appropriate for the situation
or
2,The plant designee will place product on hold pending evaluation of the process deviation by
the processing authority,
15
Thermally Processed,Commercially Sterile
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,
16
Thermally Processed,Commercially Sterile
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
thermally processed,commercially sterile beef stew 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,
17
Thermally Processed,Commercially Sterile
APPENDIX A
18
Thermally Processed,Commercially Sterile
References for HACCP Teams
1. Agriculture Canada,Food Safety Enhancement Program – HACCP Implementation Manual,
Camelot Drive,Nepean,Ontario,Canada,1996,
2. American Meat Institute Foundation,HACCP,The Hazard Analysis and Critical Control
Point System in the Meat and Poultry Industry,Washington,D.C.,1994,
Useful sections in particular are,
Chapter 3 – microbiological hazards,pp,15-26
Chapter 4 – chemical hazards,pp,27-32
Chapter 5 – physical hazards,pp,33-35
Appendix A – NACMCF HACCP
Appendix C – Model HACCP plans
3. Baker,D.A,Application of Modeling in HACCP Plan Development,Int,J,Food Microbiol,
25:251-261,1995,
4. Corlett,D.A.,Jr,and Stier,R.F,Risk Assessment within the HACCP System,Food Control
2:71-72,1991,
5. Council for Agriculture Science and Technology,Risks Associated with Foodborne
Pathogens,February 1993,
6. Easter,M.C.,et al,The Role of HACCP in the Management of Food Safety and Quality,
J,Soc,Dairy Technol,47:42-43,1994,
7. Environmental Protection Agency,Tolerances for Pesticides in Foods,Title 40,Code of
Federal Regulations,Part 185,U.S,Government Printing Office,Washington,D.C.,1998,
8. Food and Drug Administration,The Food Defect Action Levels,FDA/CFSAN,
Washington,D.C.,1998,
9. Food and Drug Administration,Fish and Fishery Products Hazards and Control Guide --
Get Hooked on Seafood Safety,Office of Seafood,Washington,D.C.,1994,
10,International Commission on Microbiological Specification for Foods,HACCP in
Microbiological Safety and Quality,Blackwell Scientific Publications,Oxford,1988,
Useful sections in particular are,
19
Thermally Processed,Commercially Sterile
Chapter 10 – raw meat and poultry,pp,176-193
Chapter 11 – roast beef,pp,234-238
Chapter 11 – canned ham,pp,238-242
11,International Commission on Microbiological Specification for Foods,Microorganisms in
Foods 4,Application of Hazard Analysis and Critical Control Point (HACCP) Systems to
Ensure Microbiological Safety and Quality,Blackwell Scientific Publications,Boston,1989
12,National Advisory Committee on Microbiological Criteria for Foods,March 20,1992 --
Hazard Analysis and Critical Control Point System,Int,J,Food Microbiol,16,1-23,1993,
13,National Advisory Committee on Microbiological Criteria for Foods,Adopted August 14,
1997-- Hazard Analysis and Critical Control Point Principles and Application Guidelines,
J,Food Protect,61(9),1246-1259,1998,
14,National Advisory Committee on Microbiological Criteria for Foods,DRAFT document -
FSIS Microbiological Hazard Identification Guide for Meat and Poultry Components of
Products Produced by Very Small Plants,1-22,August 1999,
15,National Advisory Committee on Microbiological Criteria for Foods,June 1993 -- Report
on Generic HACCP for Raw Beef,Food Microbiol,10,449-488,1994,
16,National Research Council,An Evaluation of the Role of Microbiological Criteria for Foods
and Food Ingredients,National Academy Press,Washington,D.C.,1985,
Useful sections in particular are,
Chapter 4 – microbiological hazards,pp,72-103
Chapter 9 – raw meat,pp,193-199
Chapter 9 – processed meats,pp,199-216
17,Notermans,S.,et al,The HACCP Concept,Identification of Potentially Hazardous
Microorganisms,Food Microbiol,11:203-214,1994,
18,Pierson M.D,and Dutson,T,Editors,HACCP in Meat,Poultry,and Fish Processing,
Blackie Academic & Professional,Glasgow,1995,
Useful sections in particular are,
Chapter 4 – meat and poultry slaughter,pp,58-71
Chapter 5 – processed meats,pp,72-107
Chapter 7 – risk analysis,pp,134-154
20
Thermally Processed,Commercially Sterile
Chapter 13 – predictive modeling,pp,330-354
19,Pierson,M.D,and Corlett,D.A.,Jr,Editors,HACCP Principles and Applications,Van
Nostrand Reinhold,New York,1992,
20,Stevenson,K.E,and Bernard,D.T,Editors,HACCP,Establishing Hazard Analysis Critical
Control Point Programs,A Workshop Manual,The Food Processors Institute,Washington,
D.C.,1995,
Useful sections in particular are,
Chapter 11 – forms for hazard analysis,CCPs,critical limits,HACCP master
sheet,example HACCP for breaded chicken
21,Stevenson,K.E,and Bernard,D.T,Editors,HACCP,A Systematic Approach to Food
Safety,3
rd
Edition,The Food Processors Institute,Washington,D.C.,1999,
22,Tompkin,R.B,The Use of HACCP in the Production of Meat and Poultry Products,
J,Food Protect,53(9),795-803,1990,
23,Tompkin,R.B,The Use of HACCP for Producing and Distributing Processed Meat and
Poultry Products,In Advances in Meat Research,Volume 10,Hazard Analysis Critical
Control Point in Meat,Poultry and Seafoods,Chapman & Hall,1995,
References for Thermally Processed,
Commercially Sterile Meat and Poultry Products
Part I – Epidemiology of Foodborne Illness
1. Barker,W,H.,Jr.,J,B,Weissman,V,R,Dowell Jr.,L,Gutmann,and D,A,Kautter,Type B
botulism outbreak caused by a commercial food product,West Virginia and Pennsylvania,
1973,JAMA 237(5):456-459,1977,
2. Billon,J.,A,Perpezat,and M,Charrier,[Studies on 114 cases of food poisoning.] Medecine
et Nutrition 13(4):277-280,1977,
3. Blake,P,A.,M,A,Horwitz,L,Hopkins,G,L,Lombard,J,E,McCroan,J,C,Prucha,J.C,
and M,H,Merson,Type A botulism from commercially canned beef stew,South,Med,J,
70(1):5-7,1977,
21
Thermally Processed,Commercially Sterile
4. Gilbert,R,J.,J,L,Kolvin,and D,Roberts,Canned foods – the problems of food poisoning
and spoilage,Health and Hygiene 4(2/3/4):41-47,1982,
5. Guilfoyle,D,E,and J,F,Yager,Survey of infant foods for Clostridium botulinum spores,J,
Association Official Analytical Chemists 66(5):1302-1304,1983,
6. Odlaug,T,E,and I,J,Pflug,Clostridium botulinum and acid foods,J,Food Protect,
41(7):566-573,1978,
7. Osherhoff,B,J.,G,G,Slocum,and W,M,Decker,Status of botulism in the United States,
Public Health Reports 79(10):871-878,1964,
8. Sours,H,E,and D,G,Smith,Outbreaks of foodborne disease in the United States,1972-
1978,J,Infect,Dis,142(1):122-125,1980,
9. Stersky,A.,E,Todd,and H,F,Pivnick,Food poisoning associated with post-process
leakage (PPL) in canned foods,J,Food Protect,43(6):465-476,483,1980,
10,Terranova,W.,J,G,Breman,R,P,Locey,S,B,Speck,Botulism type B,epidemiologic
aspects of an extensive outbreak,Am,J,Epidemiol,108(2):150-156,1978,
11,Thompson,R,C,A tin of salmon had but a tiny hole,FDA Consumer 16(5).7-9,1982,
Part II – Product Spoilage
1. Ashton,D,H,Thermophilic organisms involved in food spoilage,thermophilic anaerobes
not producing hydrogen sulfide,J,Food Protect,44(2):146-148,1981,
2. Davidson,P,M.,I,J,Pflug,and G,M,M,Smith,Microbiological analysis of food product
in swelled can of low-acid foods collected from supermarkets,J,Food Protect,44(9):686-
691,1981,
3. Howitz,M,A.,J,S,Marr,M,H,Merson,V,R,Dowell,and J,M,Ellis,A continuing
common-source outbreak of botulism in a family,Lancet 2(7940):861-863,1975,
22
Thermally Processed,Commercially Sterile
4. Lake,D,E.,R,R,Graves,R,S,Lesniewski,and J,E,Anderson,Post-processing spoilage of
low-acid canned foods by mesophilic sporeformers,J,Food Protect,48(3):221-226,1985,
5. Lynt,R,K.,D,A,Kautter,and R,B,Read,Jr,Botulism in commercially canned foods,J,
Milk Food Technol,38(9):546-550,1975,
6. Matsuda,N.,M,Komaki,R,Ichikawa,and S,Gotoh,[Cause of microbial spoilage of canned
foods analysed during 1968-1980.] J,Japanese Society Food Science Technology 32(6):444-
449,1985,
7. McDaniel,M,R.,R,Diamant,E,R,Loewen,and D,H,Berg,Dangerous canning practices
in Manitoba,Canadian J,Public Health 72(1):58-62,1981,
8. Pflug,I,J.,P,M,Davidson,and R,G,Holcomb,Incidence of canned food spoilage at the
retail level,J,Food Protect,44(9):682-685,1981,
9. Rhodehamel,E,J.,N,R,Reddy,and M,D,Pierson,Botulism,the causative agent and its
control in foods,Food Control 3(3):125-143,1992,
10,Tsai,S,J.,Y,C,Chang,J,D,Wang,and J,H,Chou,Outbreak of type A botulism caused by
a commercial food product in Taiwan,clinical and epidemiological investigations,Chung
Hua I Hsueh Tsa Chih,46(1):43-48,1990,
11,United States of America,National Food Processors Association/Can Manufacturing
Institute,Container Integrity Task Force,Botulism risk from post-processing contamination
of commercially canned foods in metal containers,NFPA/CMI container integrity task
force,microbiological assessment group report,J,Food Protect,47(10):801-816,1984,
Part III – Physical and Chemical Contamination
1. Andres,C,Food processors benefit from 2-piece vs,3-piece can technology race,Food
Processing 42(6):124-126,1981,
2. Barbieri,G,[Tinplate cans for foods,soldered with Pb/Sn alloys.] Rivista della Societa
Italiana de Scienza dell’Alimentazione 12(2):125-126,1983,
3. Biffoli,R,et al,[Contamination of canned foods with metals.] Rivista della Societa Italiana
de Scienza dell’Alimentazione 9(4):241-246,1980,
4,Brand,N,G,[Broken glass in bottles.] Brygmesteren 35(2):55-56,1978,
23
Thermally Processed,Commercially Sterile
5. Gibson,R,[Food contamination is not an isolated occurrence.]
Voedingsmiddelentechnologie 26(24):23,1993,
6. Jorhem,L,and S,Slorach,[Less lead and tin in canned foods.] Var Foeda 43(6):312-316,
337,1991,
7. Lopez-Martinez,C.,et al,[Levels of Pb contamination in canned foods,meat,sea-foods,
vegetables and prepared dishes.] Anales de Bromatologia 39(2):239-246,1987,
8. Ludwigsen,R,J,Container contribution to lead in canned foods,Rivista della Societa
Italiana de Scienza dell’Alimentazione 11(6):369-382,1982,
9. Prosic,Z.,et al,[Organochlorine pesticides in canned meat.] Hrana I Ishrana 28(4):199-202,
1987,
10,Renesse,R,L.,van and J,W,Klumper,[Glass in foods,prevention is not always possible.]
Voedingsmiddelentechnologie 26(24):31-34,1993,
11,Sanchez-Saez,J,J.,et al,[Pb and Cu contents of canned cooked meals.] Boletin del Centro
Nacional de Alimentacion y Nutricion No,5,14-17,1981,
12,Thomas,G,[Measures for prevention of contamination of canned foods.] Revue Francaise
de Dietetique 18(71):27-31,1974,
13,Yokomizo,Y,[Contamination of processed foods with pesticide residues.] Boletin del
Centro Nacional de Alimentacion y Nutricion 16(1):41-51,1979,
24
Thermally Processed,Commercially Sterile
APPENDIX B
25
Thermally Processed,Commercially Sterile
PROCESS FLOW DIAGRAM Figure 1
PROCESS CATEGORY,THERMALLY PROCESSED,COMMERCIALLY STERILE
PRODUCT,BEEF STEW
RECEIVING
CANS/PACKAGING
MATERIALS
STORAGE
CANS/
MATERIALS
NON-MEAT
FOOD
ING
NON-MEAT FOOD
ING
ASSEMBLE / PRE-WEIG
CUT-UP / PRE-M
NON-MEAT FOOD
ING
RECEIVING
FROZEN COOKED
DICED BEEF
FORMULATION
CLEANING
CANS
PROCESSING &
PACKAGING
REDIENTS
RECEIVING
STORAGE
REDIENTS
H
IX
REDIENTS
STORAGE
FROZEN COOKED
DICED BEEF
ASSEMBLE/ WEIGH
PRE-GRIND / RE-WORK
FINAL GRIND
COOKED DICED BEEF
FILLING
SEALING
SHIPPING
THERMAL
COOLING
LABELING
AND
CASING
STORAGE
26
Thermally Processed,Commercially Sterile
PRODUCT DESCRIPTION Figure 2
PROCESS CATEGORY,THERMALLY PROCESSED,COMMERCIALLY STERILE
PRODUCT,BEEF STEW
1,COMMON NAME? BEEF STEW
2,HOW IS IT TO BE USED? PRODUCT IS READY-TO-EAT; TYPICALLY
HEATED BEFORE CONSUMPTION,INTENDED
FOR PERSONS WITHOUT SPECIAL DIETARY
REQUIREMENTS OR PROBLEMS
3,TYPE OF PACKAGE? METAL,DOUBLE-SEAMED(“SANITARY”) CAN
4,LENGTH OF SHELF LIFE,2-3 YEARS UNDER COOL (e.g.,75°F OR
AT WHAT TEMPERATURE? LOWER),DRY CONDITIONS; MUST BE
PROTECTED FROM FREEZING
5,WHERE WILL IT BE SOLD? RETAIL
CONSUMERS? GENERAL PUBLIC
INTENDED USE? HEAT AND CONSUME
6,LABELING INSTRUCTIONS? NO SPECIAL INSTRUCTIONS
7,IS SPECIAL DISTRIBUTION NONE REQUIRED
CONTROL NEEDED?
27
Thermally Processed,Commercially Sterile
HAZARD ANALYSIS – THERMALLY PROCESSED,COMMERCIALLY STERILE – Beef Stew
Process Step Food Safety
Hazard
Reasonably
Likely to
Occur?
Basis If Yes in Column 3,
What Measures Could
be Applied to Prevent,
Eliminate,or Reduce
the Hazard to an
Acceptable Level?
Critical Control
Point
Receiving – Frozen
Cooked Diced Beef
Biological,
Listeria monocytogenes
Yes Growth of pathogens due
to improper temperature
and handling,
Measure and record temper-
ature of incoming lots,Check
container integrity,
1B
Chemical – Antibiotic
and pesticide residues,
No Supplied by inspected
establishments,
Physical – Foreign
materials
No Pieces of broken glass,
metal,or plastic has been
found in product in the
past,
Visual examination 2P
Receiving – Non-meat
Food Ingredients
Biological – Bacterial
spores
Clostridium botulinum
No The bacterial spore load
is controlled at the
establishment by the
thermal process sufficient
to destroy > 10
12
spores of
Clostridium botulinum,
Proper application of the
thermal process
Chemical –Pesticides No Plant records show that
there has not been a
problem in the past,
Physical – wood,metal
in dried beans,potatoes,
etc,
Yes Pieces of broken glass,
metal,or plastic have
been found in ingredients
in the past,
Visual examination and
metal detectors used at
receiving,
3P
Figure 3
28
Thermally Processed,Commercially Sterile
HAZARD ANALYSIS – THERMALLY PROCESSED,COMMERCIALLY STERILE – Beef Stew
Process Step Food Safety
Hazard
Reasonably
Likely to
Occur?
Basis If Yes in Column 3,
What Measures Could
be Applied to Prevent,
Eliminate,or Reduce
the Hazard to an
Acceptable Level?
Critical Control
Point
Receiving – Cans/
Packaging Materials
Biological – None
Chemical – None
Physical –Foreign
Material
Yes Wood,metal,or glass
may get on the cans
during storage and
shipping if protective
packaging or
containers are
damaged,
Control can be applied most
effectively at process steps
where cans are inverted and
cleaned,
Storage -Frozen
Cooked Diced Beef
Biological - Pathogens No Pathogens are not
reasonably likely to
grow in this product if
temperature is
maintained at or below
a level sufficient to
preclude their growth,
Chemical – None
Physical – None
Storage – Non-meat
Food Ingredients
Biological – None
Chemical – None
Physical - None
Figure 3
29
Thermally Processed,Commercially Sterile
HAZARD ANALYSIS – THERMALLY PROCESSED,COMMERCIALLY STERILE – Beef Stew
Process Step Food Safety
Hazard
Reasonably
Likely to
Occur?
Basis If Yes in Column 3,
What Measures Could
be Applied to Prevent,
Eliminate,or Reduce
the Hazard to an
Acceptable Level?
Critical Control
Point
Storage – Cans/
Packaging Materials
Biological - None
Chemical – Chemicals No Packing materials
stored in a location that
does not allow chemical
contamination,
Physical – Foreign
Material
No Packing materials
stored in a location that
does not allow foreign
material
contamination,
Assemble /Weigh
Pre-grind / Re-work
Final Grind – Cooked
Diced Beef
Biological – None
Chemical – None
Physical - None
Assemble / Pre-weigh
Cut-up / Pre-mix
Non-meat Food
Ingredients
Biological – None
Chemical- None
Physical – None
Figure 3
30
Thermally Processed,Commercially Sterile
HAZARD ANALYSIS – THERMALLY PROCESSED,COMMERCIALLY STERILE – Beef Stew
Process Step Food Safety
Hazard
Reasonably
Likely to
Occur?
Basis If Yes in Column 3,
What Measures Could
be Applied to Prevent,
Eliminate,or Reduce
the Hazard to an
Acceptable Level?
Critical Control
Point
Cleaning Cans Biological --None
Chemical – None
Physical – Foreign
Material
Yes Foreign material in
container,
Control of cleaning
operation,Use of removable
can twists,
4P
Formulation Biological – Improper
formulation may allow
survival of Clostridium
botulinum spores,
Yes Improper application
of thermal process may
allow the survival of
Clostridium botulinum
spores,
Operational formulation
controls as defined by a
Process Authority,
5B
Chemical – None
Physical - None
Filling Biological – Improper
Fill
Yes If the containers are
not filled per the
processing authority’s
recommendations,the
thermal process may be
inadequate,
Operational filling controls,6B
Chemical- None
Physical – None
Figure 3
31
Thermally Processed,Commercially Sterile
HAZARD ANALYSIS – THERMALLY PROCESSED,COMMERCIALLY STERILE – Beef Stew
Process Step Food Safety
Hazard
Reasonably
Likely to
Occur?
Basis If Yes in Column 3,
What Measures Could
be Applied to Prevent,
Eliminate,or Reduce
the Hazard to an
Acceptable Level?
Critical Control
Point
Sealing Biological – None
Chemical- None
Physical – None
Thermal Processing
and Cooling
Biological – Survival of
Clostridium botulinum
spores due to
inadequate process,
Yes
Improper application of
thermal process may
allow the survival of
Clostridium botulinum
spores,
Operational thermal
processing controls,
7B
Chemical- None
Physical – None
Labeling and Casing Biological – None
Chemical- None
Physical – None
Storage Biological – None
Chemical- None
Physical – None
Shipping Biological – None
Chemical- None
Physical – None
Figure 3
32
Thermally Processed,Commercially Sterile
HACCP PLAN
PROCESS CATEGORY,THERMALLY PROCESSED,COMMERCIALLY STERILE
PRODUCT EXAMPLE,BEEF STEW
CCP # and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP
Records
Verification Procedures and
Frequency
Corrective Actions
1B
Receiving –
Frozen
Cooked
Diced Beef
Temperature
within plant
specifications,
Meat must be
received at
10°F or
below to
maintain in
frozen state,
Receiver will check
the temperature of
each load of meat
received,
Results will be
recorded,initialed,
signed & dated in the
Product Temperature
Receiving Log,
Product
Temperature
Receiving Log
Thermometer
Calibration Log
Corrective
Action Log
Receiving supervisor will observe
receiving employee taking product
temperature or will take product
temperature once per shift
Receiving supervisor will review
Product Temperature Receiving Log,
Corrective Action Log,Calibration Log
& Verification records once per shift,
QA will check all thermometers used
for monitoring and verification for
accuracy daily and calibrate to within
2° F accuracy as necessary,
Receiver will hold meat that exceeds
10°F and notify supervisor,Any
rejected meat will be returned to
supplier,
Supplier history will be reviewed,
Condemned meat will be denatured at
the plant,
Signature, _______________________________ Date:___________________________ Figure 4
33
Thermally Processed,Commercially Sterile
HACCP PLAN
PROCESS CATEGORY,THERMALLY PROCESSED,COMMERCIALLY STERILE
PRODUCT EXAMPLE,BEEF STEW
CCP # and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP
Records
Verification Procedures and
Frequency
Corrective Actions
2P
Receiving –
Frozen
Cooked
Diced Beef
No visible
hazardous
foreign
material (e.g.,
glass); no
visible metal
contamination,
Receiver will
visually examine a
random sample from
each lot received for
foreign material,
Receiving Log
Corrective
Action Log
QA supervisor will review Receiving
Log twice per shift,
QA supervisor will observe visual
inspection of incoming product by
receiver once per shift,
Receiver will ensure that all meat
received is from establishments on
company approved list,
Supplier history will be reviewed and if
there is a trend in supplier inability to
meet the critical limit,the supplier will
no longer be used,
If hazardous foreign material is
detected in or on the meat,QA will
identify and control affected product
for disposition; condemn or return
controlled product to supplier,
QA will take action to prevent
reoccurrence,
Signature, ________________________________ Date:___________________________ Figure 4
34
Thermally Processed,Commercially Sterile
HACCP PLAN
PROCESS CATEGORY,THERMALLY PROCESSED,COMMERCIALLY STERILE
PRODUCT EXAMPLE,BEEF STEW
CCP # and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP
Records
Verification Procedures and
Frequency
Corrective Actions
3P
Receiving -
Non-meat
Food
Ingredients
No visible
hazardous
foreign
material (e.g.,
glass); no
metal
contamination
1/32 inch,
Receiver will
examine each lot for
foreign material
using metal detector
and visual
examination,
QA will examine a
random sample from
each lot for foreign
material using metal
detector and visual
examination,
Receiving Log
Metal Detector
Log
Corrective
Action Log
Maintenance supervisor will verify
metal detectors are functioning,
QA will verify that the metal detectors
are functioning as intended by running
a seeded sample through the metal
detectors twice per shift (once in the
AM and once in the PM),
Receiving supervisor will control and
segregate affected product,
Maintenance personnel will identify
and eliminate the problems with the
metal detectors,
Preventive maintenance program will
be implemented,
QA will run a seeded sample through
the metal detectors after repair,
Signature, ________________________________ Date:___________________________ Figure 4
35
Thermally Processed,Commercially Sterile
HACCP PLAN
PROCESS CATEGORY,THERMALLY PROCESSED,COMMERCIALLY STERILE
PRODUCT EXAMPLE,BEEF STEW
CCP # and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP
Records
Verification Procedures and
Frequency
Corrective Actions
4P
Cleaning
Cans
No visible
hazardous
foreign
material (e.g.,
glass,metal),
Can washer operator
will visually examine
cans as they exit
washer to ensure unit
is operating properly
and cans are
adequately cleaned,
QA will randomly
visually check cans
as they exit washer at
a frequency
determined using a
statistical
randomization chart,
Daily check to
determine that can
twists are installed &
working properly,
Can Washer Log
Corrective
Action Log
QA supervisor will review Can Washer
Log and Corrective Action Log twice
per shift,
QA supervisor will observe can washer
operator,Maintenance will verify can
twists are properly installed and
operating on a weekly basis,
If can washer or can twist malfunctions,
operator will stop line,remove
uncleaned cans,and notify plant
designee,When proper functioning is
restored,cans removed will be
examined by QA,then recycled through
washer,
QA will take action to prevent
reoccurrence,
Maintenance will make appropriate
repairs to cleaners or twists and alter
maintenance schedule as required,
Signature, ________________________________ Date:___________________________ Figure 4
36
Thermally Processed,Commercially Sterile
HACCP PLAN
PROCESS CATEGORY,THERMALLY PROCESSED,COMMERCIALLY STERILE
PRODUCT EXAMPLE,BEEF STEW
CCP # and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP
Records
Verification Procedures and
Frequency
Corrective Actions
5B
Formulation
Criteria as
specified by
the
Processing
Authority
(e.g,
maximum
sauce
viscosity
value),
Head formulation cook
will check ingredient
characteristics,
quantities,sauce
viscosity and
conformance with
specified formulation
procedure for each
batch prepared,
Plant designee will
check the time elapsed
from assembly to
commercial
sterilization for each
batch to determine that
it meets limits
specified by the
processing authority,*
Formulation Log
Process
Deviation Log
Corrective
Action Log
QA will review the formulation log
twice a week to verify that every batch
is properly formulated,
QA will audit to verify sampling
techniques and accuracy of records;
determine if the critical limit
corresponds to the plant records; check
to see if critical limits are adequate for
hazard; assure corrective actions are
adequate,document findings,
Head formulation cook will not pass
batch for transfer to the filler that has
not been formulated correctly or has
exceeded the time specification,If
possible,rejected batches will be
reformulated,Otherwise,the product
will be condemned,
QA will take action to prevent
reoccurrence,
* Time elapsed will not always be specified as critical factor by a Processing Authority,
Signature, ________________________________ Date:___________________________ Figure 4
37
Thermally Processed,Commercially Sterile
HACCP PLAN
PROCESS CATEGORY,THERMALLY PROCESSED,COMMERCIALLY STERILE
PRODUCT EXAMPLE,BEEF STEW
CCP # and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP
Records
Verification Procedures and
Frequency
Corrective Actions
6B
Filling
Criteria as
specified by
the
Processing
Authority
(e.g,
maximum fill
weight),
Fill operator will
ensure that filled
containers are run
through an automatic
over/under check
weigher set to reject
above the weight
limit once per hour,
Also,the,toppers”
on the seamer will be
set to produce
headspace in excess
of prescribed
minimum,
Weight /
Headspace Log
Process
Deviation Log
Corrective
Action Log
QA will review the records and twice
weekly verify the accuracy and
measure sample weights and
headspaces daily to ensure that weight
and headspace standards are met,
QA will audit to verify sampling
techniques and accuracy of the records;
determine if the critical limit
corresponds to the plant records; check
to see if critical limits are adequate for
hazard; assure corrective actions are
adequate,document findings,Weekly
calibration of filler,
Production foreman and QA will ensure
that all rejected containers are emptied
and contents reworked or condemned,
QA will take action to prevent
reoccurrence,
Signature, ________________________________ Date:___________________________ Figure 4
38
Thermally Processed,Commercially Sterile
HACCP PLAN
PROCESS CATEGORY,THERMALLY PROCESSED,COMMERCIALLY STERILE
PRODUCT EXAMPLE,BEEF STEW
CCP # and
Location
Critical
Limits
Monitoring
Procedures and
Frequency
HACCP
Records
Verification Procedures and
Frequency
Corrective Actions
7B
Thermal
Processing
and Cooling
Criteria as
specified by
the
Processing
Authority
(e.g,
minimum
product initial
temperature,
minimum
retort
temperature,
minimum
process time,
etc.),
Retort operator will
monitor and record
thermal processing
conditions at intervals
determined to be
sufficient by the
processing authority
to ensure that the
process schedule is
properly applied,
including process
application,venting
procedures,
Process
Operating Log
Recorder Charts
Process
Deviation Log
Corrective
Action Log
QA will review the logs and charts
within one working day after the
thermal process,
QA will audit to verify sampling
techniques and accuracy of records;
determine if the critical limit
corresponds to the plant records; check
to see if critical limits are adequate for
hazard; assure corrective actions are
adequate,document findings,Quarterly
calibration of retort,
If a process deviation occurs,the plant
designee will apply a filed alternate
process schedule appropriate for the
situation or hold the product pending a
processing authority’s evaluation,
QA will take action to prevent
reoccurrence,
Product will be reworked if applicable
using the alternate process schedule,
Signature, ________________________________ Date:___________________________ Figure 4
39
Thermally Processed,Commercially Sterile
THERMOMETER CALIBRATION LOG
Calibrate to 32
0
F while thermometer is in slush ice water,
Date Time Department or
Area
Thermometer ID# Personal
Thermometer
Reading
Adjustment
Required (Yes
or No)
Initials Comments
If a thermometer is broken or taken out of service,document this in the comment column,
Reviewed by,_______________________ Date,_______________________
40
Thermally Processed,Commercially Sterile
GENERIC ESTABLISHMENT X,METAL DETECTION LOG
Date Product Lot # Results Seeded
Sample
Time Monitored By Verified By
41
Thermally Processed,Commercially Sterile
GENERIC ESTABLISHMENT X,PROCESS OPERATING LOG
Product ______________________ Retort Operator ___________
Code ________________________ Date ____________________
Can Size _____________________
No,Cans/Retort _______________
Min,Product Int,Temp,_________
Process Time/Temperature ______/________
Batch No,Retort No,Int
Temp
Time
Steam
On
Time
Vent
Closed
Retort
Temp at
End of
Vent
Actual Process Time
Start Stop Total
Temperature
MIG Chart
Initial
42
Thermally Processed,Commercially Sterile
GENERIC ESTABLISHMENT X,PROCESS DEVIATION LOG
Date of
Deviation
Retort No,Product Product Code Product Disposition Reviewed
by,
43
Thermally Processed,Commercially Sterile
CORRECTIVE ACTIONS LOG
Product,___________________________________________ Lot # ______________________
CCP Deviation/
Problem
Corrective Action
Procedures/Explain
Disposition of
Product
Responsible
Person
Date/Time
SIGNATURE,__________________________ DATE,______________________
44
Thermally Processed,Commercially Sterile
PRE-SHIPMENT
Date:______________
PRODUCT LOT
ID
TIME
RECORDS
REVIEWED
BY
WHOM
LOT RELEASED FOR
SHIPMENT?
SIGNATURE
COMMENTS *
LOG REVIEW
*Monitoring frequency as per plan; Critical limits met; Certification (if applicable) as per plan; Deviations if occurred were reviewed
for appropriate corrective actions; Records complete and accurate,
45