ASTM E2590-23

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: E2590 − 23
Standard Guide for
Conducting Hazard Analysis-Critical Control Point (HACCP)
Evaluations
This standard is issued under the fixed designation E2590; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope part of the HACCP process. A list of general references is
provided for HACCP and implementation of HACCP and
1.1 This guide describes a stepwise procedure for using
similar methods, as those apply to environmental hazard
existing information, and if available, supporting field and
evaluation, natural resource management, and environmental
laboratory data concerning a process, materials, or products
engineering practices (11-26).
potentially linked to adverse effects likely to occur in the
environment as a result of an event associated with a process
1.4 This guide does not describe or reference detailed
such as the dispersal of a potentially invasive species or the
procedures for specific applications of HACCP, but describes
release of material (for example, a chemical or a physical
how existing information or other empirical data should be
substance) or its derivative products to the environment.
used when assessing the hazards and identifying CCPs poten-
Hazard Analysis-Critical Control Point (HACCP) evaluations
tially of use in minimizing or eliminating specific hazards.
were historically linked to food safety (Hulebak and Schlosser
Specific applications of HACCP evaluation are included as
W. 2002 (1); Mortimer and Wallace 2013 (2)), but the process
annexes to this guide, which include implementation of
has increasingly found application in planning processes such
HACCP in resource management practices related to control
as those occurring in health sciences ; Quattrin et al. 2008 (3);
and mitigation of invasive species or disease agents primarily
Hjarno et al. 2007 (4); Griffith 2006 (5) or; Noordhuizen and
of concern for managing fish and wildlife.
Welpelo 1996 (6)), in natural resource management (US Forest
1.5 HACCP evaluation has a well developed literature in,
Service 2014 a,b,c (7, 8, 9), (US EPA, 2006 (10); see also
for example, food science and technology, and in engineering
http://www.waterboards.ca.gov/water_issues/programs/swamp/ais/prevention_
applications (see, for example, (11, 12, 13, 15, 17)). As a
planning.shtml; (last accessed October 16, 2023)
resource management tool, HACCP is relatively recent in
or in supporting field operations wherein worker health and
application to the analysis of hazards to aquatic, wetland, and
natural resource management issues intersect.
terrestrial habitats and the organisms occupying those habitats.
1.2 HACCP evaluation is a simple linear process or a
(see, for example, US Forest Service 2014 a,b,c (7, 8, 9); see
network of linear processes that represents the structure of any
also http://www.haccp-nrm.org/ last accessed June 16, 2014).
event; the hazard analysis (HA) depends on the data quality
Most of the guidance provided herein is qualitative rather than
and data quantity available for the evaluation process, espe-
quantitative, although quantitative methods should be applied
cially as that relates to critical control points (CCPs) charac-
to any hazard analysis when possible. Uncertainties associated
terized in completing HACCP. Control measures target CCPs
with the analysis should also be characterized and incorporated
and serve as limiting factors or control steps in a process that
into the HACCP evaluation when possible (see, for example,
reduce or eliminate the hazards that initiated the HACCP
(11, 27-38)).
evaluation. The main reason for implementing HACCP is to
prevent problems associated with a specific process, practice,
1.6 This standard provides guidance for assessing hazard
material, or product.
within a generalized framework that may be extended to
specific environmental settings, such as that detailed in E1023
1.3 This guide assumes that the reader is knowledgeable in
for aquatic habitats (Guide for Assessing the Hazard of a
specific resource management or engineering practices used as
Material to Aquatic Organisms and Their Uses). This standard
does not provide guidance on how to account for socio-
This guide is under the jurisdiction of ASTM Committee E50 on Environmental
economic or political considerations that influence the specifi-
Assessment, Risk Management and Corrective Action and is the direct responsibil-
cation of the acceptability of risk associated with the hazard,
ity of Subcommittee E50.47 on Biological Effects and Environmental Fate.
Current edition approved Dec. 1, 2023. Published December 2023. Originally
particularly when HACCP is implemented and CCPs are
approved in 2008. Last previous edition approved in 2015 as E2590–15. DOI:
considered within contemporary risk-based decision-making
10.1520/E2590-23.
processes. Judgments concerning acceptability are outside the
The boldface numbers in parentheses refer to the list of references at the end of
this standard. scope of this guide, but available guidance from ASTM is
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E2590 − 23
applicable to this process (see E2348 Standard Guide for 3.1.4 corrective action, v—any action to be taken when the
Framework for a Consensus-based Environmental Decision- results of monitoring at the CCP indicate a loss of control.
making Process).
3.1.5 critical control point (CCP), n—a step at which
control can be applied and is essential to prevent or eliminate
1.7 This guide is arranged as follows:
a hazard or reduce it to an acceptable level.
Section
Scope 1
3.1.6 critical limit, n—a criterion which separates accept-
Referenced Documents 2
ability from unacceptability.
Descriptions of Terms Specific to This Standard 3
Summary of Guide 4
3.1.7 deviation, n—failure to meet a critical limit.
Significance and Use 5
Basic Concepts of HACCP and Detailed Characterization 6 3.1.8 flow diagram, n—a systematic representation of the
of HACCP
sequence of steps or operations of a system or process,
HACCP Applied to Prevention and Control of Invasive Species Annex A1
including the production or manufacture of a materials or
HACCP-Derived Decontamination Procedures Mitigating Annex A2
Equipment-Mediated Transfers of Invasive Aquatic Biota,
products.
Principally Mussel Species
3.1.9 HACCP (Hazard Analysis-Critical Control Point),
HACCP-Derived Decontamination Procedures for Controlling Annex A3
Equipment-Mediated Transfers of Disease Agents of Aquatic
n—a system which identifies, evaluates, and controls hazards
Biota, Principally Infectious Amphibian Diseases
which are significant for a wide range of natural resource
1.8 This standard does not purport to address all of the
management and environmental engineering applications.
safety concerns, if any, associated with its use and the
3.1.10 HACCP plan, n—a document prepared in accordance
implementation of HACCP. It is the responsibility of the user of
with the principles of HACCP to ensure control of hazards.
this standard to establish appropriate safety, health, and
3.1.11 hazard, n—a biological, chemical or physical agent
environmental practices and determine the applicability of
or condition with the intrinsic capacity to cause an unwanted or
regulatory limitations prior to use.
adverse effect in an exposed system.
1.9 This international standard was developed in accor-
dance with internationally recognized principles on standard- 3.1.12 hazard analysis (HA), n—the process of collecting
ization established in the Decision on Principles for the
and evaluating data and information on hazards and conditions
Development of International Standards, Guides and Recom- leading to their presence and necessary to include in a HACCP
mendations issued by the World Trade Organization Technical
plan.
Barriers to Trade (TBT) Committee.
3.1.13 monitor, v—the act of conducting a planned sequence
of observations or measurements of control parameters to
2. Referenced Documents
assess whether a critical control point is under control.
2.1 ASTM Standards:
3.1.14 step, n—a point, procedure, operation or stage in a
E943 Terminology Relating to Biological Effects and Envi-
process.
ronmental Fate
3.1.15 validation, n—obtaining evidence that the elements
E1023 Guide for Assessing the Hazard of a Material to
of the HACCP plan are effective.
Aquatic Organisms and Their Uses
3.1.16 verification, n—the application of methods,
E1391 Guide for Collection, Storage, Characterization, and
procedures, tests and other evaluations, in addition to monitor-
Manipulation of Sediments for Toxicological Testing and
ing to determine compliance with the HACCP plan.
for Selection of Samplers Used to Collect Benthic Inver-
tebrates
3.2 For definitions of other terms used in this guide, refer to
E2348 Guide for Framework for a Consensus-based Envi-
Terminology E943 and references cited herein.
ronmental Decision-making Process
4. Summary of Guide
3. Terminology
4.1 Hazard Analysis-Critical Control Point (HACCP) evalu-
3.1 Definitions of Terms Specific to This Standard:
ation has become increasingly applied to natural resource
3.1.1 control, v—to take all necessary actions to ensure and
management and environmental engineering problems, par-
maintain compliance with criteria established in the HACCP
ticularly as hazards may be managed, for example, with respect
plan.
to the safety of processes or release of materials or products to
the environment. HACCP should be an integral part of man-
3.1.2 control, n—a state wherein correct procedures are
agement practices focused on engineering or resource manage-
being followed and criteria are being met.
ment practices used to develop aquatic, wetland, and terrestrial
3.1.3 control measure, v—any action and activity that can be
habitats for human use (for example, agriculture or construc-
used to prevent or eliminate a hazard or reduce it to an
tion activities) or to enhance habitats for fish and wildlife.
acceptable level.
HACCP is a systematic and preventive approach that addresses
biological, chemical and physical hazards through anticipation
and prevention, rather than through end-product inspection and
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
testing or retrospective engineering solutions necessitated be-
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
cause of previous undertakings. The HACCP system is in-
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. tended for assessing and managing risks and safety concerns
E2590 − 23
associated with a wide range of materials, products, and in this annex. Additionally, in recognizing the dynamic process
management practices with an emphasis on a total systems associated with species invasions, users of this stand-alone
approach to improve environmental quality. This standard
annex would benefit from consultation with online resources
could be used in conjunction with existing ASTM standards that directly complement this implementation of HACCP
such as Guides E1023 and E2348. HACCP emphasizes control
(http://www.haccp-nrm.org/ last accessed June 16, 2014).
of a process as far upstream in the processing system as
4.3.2 Annex A2 continues implementation of HACCP
possible by utilizing operator control or continuous monitoring
linked to invasive-species management issues with a particular
techniques, or a combination of both, at critical control points.
focus on decontamination procedures intended to mitigate or
The HACCP system uses the approach of controlling critical
reduce hazards associated species transfers stemming from
points in any process to reduce or eliminate risks and prevent
field operations. Given the increasing occurrence of dispersal
safety problems from developing. The identification of specific
and establishment of invasive species in previously unoccupied
hazards and measures for their control to ensure the safety of
terrestrial or aquatic habitats, various organizations have de-
a process, material, or product through prevention and reduces
veloped procedures for managing unintended human-aided
the reliance on end-product inspection and testing (for
dispersal events. For aquatic invasive species (AIS) HACCP or
example, for agrichemicals), remedial measures (for example,
principals characteristic of the HACCP process reflected in this
related to construction practices), or mitigation measures as
annex guides the development of mitigation practices intended
part of a control program (for example, quarantine or disinfec-
to prevent the spread of AIS with a primary focus on New
tion for control of invasive species) are integral components of
Zealand mudsnail (Potamopyrgus antipodarum), quagga mus-
any HACCP system. Any HACCP system should be capable of
sel (Dreissena rostriformis bugensis) or zebra mussel (Dreis-
accommodating change, such as advances in equipment design
sena polymorpha). These invasive molluscs are not easily
or developing alternative resource management practices,
observed in field settings; hence, unintended transport to new
changes in processing procedures, or technological develop-
locations on equipment or other materials used in the field
ments.
serve as potential vectors mediating transfers from occupied
4.2 This guide describes an iterative procedure for assessing habitats to previously unoccupied habitats when equipment or
hazard and characterizing CCPs. Unavailable, yet necessary other materials are deployed in areas that are geographically
information concerning the hazard and the process generating separated, yet potentially linked through management actions
that hazard should be identified and characterized through a mediated by their use. To prevent their unintended spread
stepwise evaluation that details the hazard and specifies critical between field-work locations, procedures for decontaminating
points that may serve to control the process, and minimize or equipment and other materials are considered in this annex
eliminate hazard. At the end of any iteration of the HACCP which serves to mitigate and reduce species transfers linked to
process, specific CCPs that reduce likelihood of hazard may be
use of this equipment or other materials in waterbodies at
identified, or the available data related to the hazard and the different locations. Procedures listed in this annex may be used
process generating that hazard may be judged as being insuf-
to establish mitigation practices implemented through the
ficient to adequately characterize hazard or CCPs. In the latter
decontamination process.
instance, additional data or information should be identified
4.3.3 Annex A3 applied HACCP to natural resource man-
and obtained, so that HA and CCPs can be reassessed. The
agement issues related to disease agents, particularly the
process is repeated until the hazard is adequately characterized
transfer of pathogens between and among different locations
and CCPs are characterized in order to reduce likelihood that
within aquatic systems—lentic or lotic. A wide range of disease
hazard is realized.
agents are capable of entering previously unoccupied habitats
through actions of biological vectors or other transfer agents
4.3 Three annexes are also included with this standard
that assure their potential passage through numerous pathways.
guide.
In the wild and in absence of human intervention, little direct
4.3.1 Annex A1 focuses on implementation of HACCP
control can be exerted over most of these pathways where
within the context of natural resource management, principally
waterfowl or shore birds, other migratory birds, foraging
that process developed for control of invasive species;
ungulates and other wildlife such as beavers may be critical
principally, prevention of species invasions, but also
components in completed pathways. In managed habitats or in
mitigation, reduction, or eradication if such events have
managed field investigations, however, transfers of disease
occurred. This annex summarizes extension of the general
agents may be enabled when these disease-specific biological
guidance contained within the standard guide to a specific
vectors or tools and other equipment serve as mediating agents;
application of the HACCP process that may serve as a “stand
alone” document to support the development of species- vectors for a wide array of pathogenic microorganisms are
many, yet common attributes of biological or physical transfer
specific or practice-specific HACCP plans linked to invasive
species. The relationships between the generalized HACCP agents benefit development of countermeasures that potentially
mitigate transfers by interrupting pathways at CCPs in the
process summarized in the standard guide and its specific
implementation in this annex should be considered in adapting chain-of-events required for successful species invasions or
transfers of disease agents from one area to another, oftentimes
HACCP plans to changing environmental conditions that might
develop and alter hazards through time. Tasks outlined in the previously unoccupied area. This annex focuses on a disease
standard guide have been variously incorporated into the agent of amphibians—chytrid fungus, Batrachochytrium
implementation-specific five-step HACCP process summarized dendrobatidis—which calls for countermeasures that would
E2590 − 23
also mitigate disease agent transfers coincident with manage- control to ensure the safety of any process, but especially those
ment of other aquatic biota. involving engineering or management practices that manipu-
late materials, products, or systems potentially associated with
5. Significance and Use
adverse effects directly or indirectly associated with those
5.1 HACCP is a proactive management tool that serves to
manipulations. HACCP is a tool to assess hazards and establish
reduce hazards potentially expressed as adverse biological or
control systems that focus on prevention rather than relying
environmental effects, for example, associated with chemical
mainly on end-product testing and inspection. Any HACCP
releases, changes in natural resource or engineering practices
system is capable of accommodating change, such as advances
and their related impacts, and accidental or intentional releases
in equipment design, processing procedures or technological
of biological stressors such as invasive species.
developments. This section reviews the 12 tasks in the appli-
cation of HACCP, including the seven HACCP principles. It
5.2 Sequential implementation of HACCP and feedback in
emphasizes the importance of standards and guidelines as a
the iterative HACCP process allows for technically-based
basis for developing the HACCP plan.
judgments concerning, for example, natural resources or the
use of natural resources. Implementing the HACCP process
6.2 Principles of the HACCP System—The HACCP system
serves to reduce adverse effects potentially associated with a
consists of seven principles that guide any evaluation.
particular material or process, and provides guidance for
6.2.1 Conduct a hazard analysis. Identify the potential
testing and evaluation of products or processes, through a
hazard(s) associated with at all stages or steps within a system
pre-emptive procedure focused on information most pertinent
or process of concern within a system. Assess the likelihood of
to a system’s characterization. For example, identification of
occurrence of the hazard(s) and identify the measures for their
CCPs assure that processes and practices can be managed to
control.
achieve hazard reduction. For different processes and
6.2.2 Determine the Critical Control Points (CCPs). Deter-
situations, HA may be based on substantially different amounts
mine the points, procedures or operational steps that can be
and kinds of, for example, biological, chemical, physical, and
controlled to eliminate the hazard(s) or minimize its (their)
toxicological data, but the identification of CCPs serving to
likelihood of occurrence. A “step” means any stage in the
reduce hazard is key to successful implementation of HACCP.
system, including materials or processes that are part of the
system or contribute to the systems form or function, for
5.3 HACCP should never be considered complete for all
example, exogenous inputs should have specifications that can
time, and continuing reassessment is a characteristic of
be incorporated into HACCP.
HACCP evaluations, especially if there should be changes in,
6.2.3 Establish critical limit(s). Critical limit(s), also re-
for example, production volumes of a material, or its use or
ferred to as control limit(s), must be established to ensure the
disposal increases, new uses are discovered, or new informa-
CCP is under control.
tion on biological, chemical, physical, or toxicological proper-
6.2.4 Establish a system to monitor control of the CCP.
ties becomes available. Similarly, HACCP should be consid-
Establish a system to monitor control of the CCP by scheduled
ered an ongoing process serving as a key component in
testing or observations.
engineering practices, for example, related to construction
6.2.5 Establish the corrective action to be taken when
activities and land-use changes, and natural resource manage-
monitoring indicates that a particular CCP is not under control.
ment practices, for example, related to habitat use,
6.2.6 Establish procedures for verification to confirm that
enhancement, and species introductions such as fish-stocking
the HACCP system is working effectively.
programs. Periodic review of a system’s performance will help
6.2.7 Establish documentation concerning all procedures
assure that new circumstances and information receive prompt
and records appropriate to these principles and their applica-
and appropriate attention.
tion.
5.4 In many cases, consideration of adverse effects should
6.3 Implementation of the HACCP System—Management
not end with completion of the HA and identification of CCPs
commitment is necessary for implementation of an effective
key to the development of control measures. Additional steps
HACCP system. During hazard identification, evaluation, and
may subsequently include risk assessment, and decisions
subsequent operations in designing and applying HACCP
concerning acceptability of identified hazards and risks, and
systems, consideration must be given to existing technical
mitigation actions potentially applicable to the process or
practices, the role of processes to control hazards, likely
practice that initially motivated HACCP.
end-use of the product (for example, if hazards are associated
6. Basic Concepts of Hazard Analysis-Critical Control
with manufacturing process), categories of users of concern,
Point (HACCP) Evaluation
and data suggestive of a system being out of control (for
6.1 Overview of HACCP Evaluation—The basic principle of example, observation of system failure). The intent of the
HACCP relies on system characterization and a repetitive or HACCP system is to focus control at CCPs. Redesign of the
iterative evaluation of that system and its attendant outcomes. operation should be considered if a hazard which must be
When available data to characterize a system are inadequate controlled is identified but no CCPs are found. In complex
and CCPs can not be adequately characterized, data needs are systems, HACCP should be applied to each specific operation
identified and HACCP reiterated. The process is repeated until separately. CCPs identified in any given specific implementa-
HA is adequate and CCPs are clearly identified. The HACCP tion might not be the only ones identified for a specific
system systematically identifies hazards and measures for their application or might be of a different nature; hence, HACCP
E2590 − 23
will vary as a function of the system. The HACCP application
should be reviewed and necessary changes made when any
modification is made in the product, process, or any step. It is
important when applying HACCP to be flexible where
appropriate, given the context of the application, taking into
account the nature and the size of the operation.
6.3.1 Application of HACCP Principles—Implementation of
HACCP principles is captured in the Logic Sequence for
Application of HACCP (Fig. 1).
6.3.1.1 Assemble HACCP team. Appropriate process-
specific or material-specific knowledge and expertise must be
available for the development of an effective HACCP plan.
Optimally, this may be accomplished by assembling a multi-
disciplinary team. Where such expertise is not available on site,
expert advice should be obtained from other sources. The
scope of the HACCP plan should be identified, including the
general classes of hazards to be addressed (for example does it
cover all classes of hazards or only selected classes).
6.3.1.2 Describe product or process. A full description of the
product or process of concern should be developed.
6.3.1.3 Identify intended use. The intended use should be
based on the expected uses of the product or services that will
result from completion of an engineering project that may
variously affect end users or consumers. In specific cases,
vulnerable groups should be considered.
6.3.1.4 Construct flow diagram. The flow diagram should be
constructed by the HACCP team. The flow diagram should
cover all steps in the operation, for example, associated with a
product, material, or engineering activity. When applying
HACCP to a given operation, consideration should be given to
steps preceding and following the specified operation.
6.3.1.5 On-site verification of flow diagram. The HACCP
team should confirm the processing operation against the flow
diagram during all stages of operation and amend the flow
diagram where appropriate.
6.3.1.6 List all potential hazards associated with each step,
conduct a hazard analysis, and consider any measures to
control identified hazards as supported by Principle 1. The
HACCP team should list all hazards that may be expected to
occur at each step of the process, for example, from primary
production, processing, manufacture, and distribution until the
point of use. The HACCP team should next conduct a hazard
analysis to identify and describe for the HACCP plan which
hazards are of such a nature that their elimination or reduction
to acceptable levels is essential to the production of product or
to the engineering process. In conducting the hazard analysis,
the following should be included whenever possible: the likely
occurrence of hazards and severity of their adverse effects; the
qualitative or quantitative evaluation, or both, of the presence
of hazards; and conditions leading to the above. The HACCP
team must then consider what control measures, if any, exist
which can be applied for each hazard. More than one control
measure may be required to control a specific hazard(s) and
FIG. 1 Overview of HACCP Process
more than one hazard may be controlled by a specified control
measure.
6.3.1.7 Determine Critical Control Points (CCP). There may system can be facilitated by the application of a decision tree
be more than one CCP at which control is applied to address which indicates a logic reasoning approach, as illustrated in
the same hazard. The determination of a CCP in the HACCP Annex A1. Application of a decision tree should be flexible,
E2590 − 23
given whether the operation production or outcomes of the 6.3.1.12 Establish documentation and record keeping. Effi-
process being evaluated. The decision tree could be used for cient and accurate record keeping is essential to the application
guidance when determining CCPs, although a decision tree of an HACCP system. HACCP procedures should be docu-
may not be applicable to all situations. Other approaches may mented. Documentation and record keeping should be appro-
priate to the nature and size of the operation. Documentation
be used, and training in the application of the decision tree is
recommended, if that approach to HACCP is pursued. If a examples are hazard analysis; CCP determination; Critical
limit determination. Record examples are: CCP monitoring
hazard has been identified at a step where control is necessary
for safety, and no control measure exists at that step, or any activities; Deviations and associated corrective actions; Modi-
fications to the HACCP system.
other, then the product or process should be modified at that
step, or at any earlier or later stage, to include a control
6.4 Expanded Characterization of HACCP Process—The
measure.
first task in the application of HACCP is to assemble a team
6.3.1.8 Establish critical limits for each CCP. Limits must
having the knowledge and expertise to develop an HACCP
be specified and validated if possible for each CCP. In some
plan. The team should be multidisciplinary and should repre-
cases more than one critical limit will be elaborated at a
sent a blend of expertise and experience. The assembled team
particular step. Criteria may capture upper and/or lower bounds
will collect, collate and evaluate technical data and identify
of acceptable performance, and may be specified by indicators
hazards and critical control points. One person may fulfill
benchmarked on past performance.
several roles or even constitute the whole team, in which case
the use of external consultants or advice may be necessary. The
6.3.1.9 Establish a monitoring system for each CCP. Moni-
team should include personnel who are directly involved in
toring is the scheduled measurement or observation of a CCP
daily activities related to the hazards of concern, since these
relative to its critical limits. The monitoring procedures must
individuals will be more familiar with the specific variability
be able to detect loss of control at the CCP. Further, monitoring
and limitations of the operation or materials in question. The
should ideally provide data in real-time to make adjustments to
HACCP team may require independent outside experts to
ensure control of the process to prevent violating the critical
advise on identified issues or problem areas; however, com-
limits. Where possible, process adjustments should be made
when monitoring results indicate a trend towards loss of plete reliance on outside sources is not recommended in
developing the HACCP plan. Ideally the team should not be
control at a CCP. The adjustments should be taken before a
deviation occurs. Data derived from monitoring must be larger than six, although for some implementations of HACCP,
it may be necessary to develop larger teams.
evaluated by a designated person with knowledge and authority
to carry out corrective actions when indicated. If monitoring is
6.4.1 Team Composition—When selecting the team, the
not continuous, then the amount or frequency of monitoring coordinator should focus on those who will be involved in
must be sufficient to guarantee the CCP is in control. Most
hazard identification, those who will be involved in determi-
monitoring procedures for CCPs will need to be done rapidly nation of critical control points, those who will monitor critical
because they relate to on-line processes or real-time activities
control points, those who will verify operations at critical
that may not allow for lengthy analytical testing. All records control points, those who will examine samples and perform
and documents associated with monitoring CCPs must be
verification procedures.
signed by the person(s) doing the monitoring and by a
6.4.2 Knowledge Required—In addition to knowledge of
responsible reviewing official(s).
HACCP principles and techniques, personnel participating as
part of the HACCP team should have a basic understanding of
6.3.1.10 Establish corrective actions. Specific corrective
actions must be developed for each CCP in the HACCP system technology and procedures characteristic of the process or
material that initiated the HACCP evaluation, as well as a basic
in order to deal with deviations when they occur. The actions
must ensure that the CCP has been brought under control, understanding of the particular hazard(s) that the plan will
address.
including actions that must be taken for proper disposition of
the affected product, for example, in the food industry. Devia-
6.4.3 Scope—One of the first tasks of the HACCP team
tion and product disposition procedures must be documented in
should be to identify the scope of the HACCP plan. The team
the HACCP record keeping similar in practice to establishing
should limit the study to a specific material and process, define
risk management practices wherein acceptable risk is charac-
the type(s) of hazards to be included (for example biological,
terized.
chemical, physical), define the system or part of the system to
be studied.
6.3.1.11 Establish verification procedures. Establish proce-
dures for verification. Verification and auditing methods, pro- 6.4.4 Coordinator—The team must include a coordinator
cedures and tests, including random sampling and analysis, can (chairperson) whose role is to ensure that the composition of
be used to determine if the HACCP system is working the team meets the needs of the study, suggest changes to the
correctly. The frequency of verification should be sufficient to team if necessary, coordinate the team’s work, ensure that the
confirm that the HACCP system is working effectively. Ex- agreed established plan is followed, share the work and
amples of verification activities include: review of the HACCP responsibilities, ensure that a systematic approach is used,
system and its records; review of deviations and product ensure that the scope of the study is met, chair meetings so that
dispositions; confirmation that CCPs are kept under control. team members can freely express their ideas, represent the
Where possible, validation activities should include actions to team before management, provide management with an esti-
confirm the efficacy of all elements of the HACCP plan. mate of the time, money and labor required for the study.
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6.4.5 Develop a Flow Diagram—It is easier to identify and chemical measurements or visual observations, which may
hazards and CCPs to suggest methods of control and to discuss be done rapidly, are often preferred as monitoring tools. If
these among the HACCP team if there is a flow diagram of the
analytical instrumentation is used in a monitoring program, it is
system linked to the hazard of interest. The review of the flow essential that all monitoring equipment be properly calibrated
of materials or the process in the system from the beginning to for accuracy. Monitoring procedures performed during the
end is the feature that makes HACCP a specific and important operation should result in written documentation which will
tool for the identification and control of potential hazards. A serve as an accurate record of the operating conditions.
process flow diagram should be constructed following Monitoring records provide information on conditions during
interviews, observation of operations and other sources of the operation and allow for action to be taken in the event of a
information, for example, such as engineering design or field loss of control or for a process adjustment to be made if there
operations manuals. The process flow diagram will identify the is a trend towards a loss of control. Accurate monitoring
important process steps used in the production of the specific procedures and associated records provide information to the
material or specific operation being assessed. There should be operator and allow for decisions to be made on the acceptabil-
enough detail to be useful in hazard identification, but not so ity of the lot at a particular stage in the process. To complete
much as to overburden the plan with less important points. the monitoring process, data derived from monitoring should
be reviewed and evaluated by a designated person or persons
6.4.6 Hazard Analysis—Hazard analysis is the first HACCP
with knowledge and authority to carry out corrective actions
principle, and is one of the most important tasks of HACCP. An
when indicated. The worst scenario is that in which monitoring
inaccurate hazard analysis would inevitably lead to the devel-
procedures indicate that any one of the critical limits is
opment of an inadequate HACCP plan. Hazard analysis re-
exceeded, which indicates loss of control of a CCP. This lack
quires technical expertise and scientific background in various
of control is considered to be a deviation resulting in the
domains for proper identification of all potential hazards.
production of a hazardous or unsafe product. The situation
6.4.7 Critical Control Points and Critical Limits—At each
requires immediate identification and control of the affected
CCP critical limits are established and specified. Critical limits
product and corrective action. Responsibility for monitoring
are defined as criteria that separate acceptability from unac-
should be clearly defined, and individuals must be adequately
ceptability. A critical limit represents the boundaries that are
trained in the monitoring procedures for the CCP for which
used to judge whether a process is producing materials or
they are responsible. They must also fully understand the
conducting specific operations in a safe manner. Critical limits
purpose and importance of monitoring. The individual should
may be set for factors, for example, such as temperature, time
have ready access to the monitoring activity, must be unbiased
(minimum time exposure), physical dimensions, as these
in monitoring and must accurately report the monitoring
attributes affect system performance. These parameters, if
activity.
maintained within boundaries, will confirm the safety of the
6.4.9 Design of a Monitoring System and Establishing
system of interest.
Corrective Actions—Loss of control is considered as a devia-
6.4.8 Monitoring—Monitoring is the process that users rely
tion from a critical limit for a CCP. Deviation procedures are a
upon to show that the HACCP plan is being followed. It
predetermined and documented set of actions to be imple-
provides the user with accurate records that demonstrate that
mented when a deviation occurs. All deviations must be
the conditions of system are in compliance with the HACCP
controlled by taking action(s) to control the non-compliant
plan. Ideally, monitoring should provide information in time to
product or process and to correct the cause of non-compliance.
allow any adjustments to the process, thus preventing loss of
Product or process control includes proper identification,
control of the process and critical limits being exceeded. In
control and disposition of the variance. The control and
practice, operating limits are often used to provide a safety
disposition of the variance and the corrective action(s) taken
margin which allows extra time to adjust the process before the
must be recorded and filed. The diversity of possible deviations
critical limit is exceeded. There are many ways to monitor the
at each CCP means that more than one corrective action may
critical limits of a CCP. Monitoring can be done on a
be necessary at each CCP. When a deviation occurs, it will
continuous (100 percent) or batch basis. When feasible, con-
most likely be noticed during the routine monitoring of the
tinuous monitoring is preferred, since it is more reliable.
CCP. Deviation and corrective action procedures are prescribed
Continuous monitoring is designed to detect shifts around
so that employees responsible for CCP monitoring understand
target levels, thus allowing correction of these shifts and
and are able to perform the appropriate corrective action(s) in
preventing deviation beyond the critical limits. When monitor-
the event of a deviation. Process adjustments should also be
ing is not continuous, the amount and frequency of monitoring
made when monitoring results indicate a trend towards loss of
should be sufficient to provide an acceptable level of assurance
control at a CCP. Action should be taken to bring the process
that the CCP is under control. The higher the frequency of
within the operating limits before a deviation occurs. The
monitoring (that is, the less time between each instance of
deviation procedures at each CCP should be recorded.
monitoring), the less system performance will be affected when
there is a loss of control at the CCP. A further consideration 6.4.10 Deviation and Corrective Action Procedures—Since
the main reason for implementing HACCP is to prevent
when establishing a monitoring system is the time taken to
achieve a result from the monitoring procedure. Most moni- problems from occurring, corrective action should be taken to
toring procedures will need to be rapid, since time for lengthy prevent deviation at a CCP. Corrective action should be taken
analytical testing may not be practical. For this reason, physical following any deviation to ensure the safety of the product or
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process, and to prevent recurrence of the deviation. Corrective the HACCP plan is based on methods and information suffi-
action procedures are necessary to determine the cause of the cient to identify hazards and identify CCPs, and is appropriate
problem, take action to prevent recurrence and follow up with
for the system of interest. A technical review should be
monitoring and reassessment to ensure that the action taken is performed to ensure that there is a scientific and technical basis
effective. If the corrective action does not address the root for decisions regarding which hazards are being controlled,
cause of the deviation, the deviation could recur. Reassessment which hazards are not being controlled and how identified
of the hazard analysis or modification of the HACCP plan may hazards are being controlled. This review could incorporate the
be necessary to eliminate further occurrence. use of information and data gathered for the purpose of the
verification, and should be periodically updated. The process of
6.4.11 Deviation and Corrective Action Records—Records
validating an existing HACCP plan should also include review
should be available to demonstrate the control of products
of HACCP audit reports, review of changes to the HACCP plan
affected by the deviation and the corrective action taken.
and the reasons for those changes, review of past validation
Adequate records permit verification that the producer has
reports, review of deviation reports, assessment of corrective
deviations under control and has taken effective corrective
action effectiveness, review of information on consumer
action.
complaints, review of linkages between the HACCP plan and
6.4.12 Deviation Procedures and Verification—Verification
good management practice (GMP) programs. HACCP plan
is embodied in HACCP principles, and serve to determine
validation is an ongoing, periodic procedure. Validations may
compliance with the HACCP plan by using methods,
be scheduled at a pre-set frequency. However, other factors
procedures, tests and other evaluations as needed, in addition to
may trigger a review of the plan to determine if changes are
monitoring. Verification and auditing methods, procedures and
necessary. These factors could include changes to the raw
tests, including random sampling and analysis, can be used to
materials, product or process; adverse audit findings; recurring
determine if the HACCP system is working correctly. Careful
deviations; new scientific information about potential hazards
preparation of the HACCP plan with clear definition of all the
or control measures; and user complaints and/or failures or
necessary items does not guarantee the plan’s effectiveness.
under performance of the system.
Verification procedures are necessary to assess the effective-
6.4.15 HACCP System Audits—As part of verification, au-
ness of the plan and to confirm that the HACCP system adheres
dits are performed to compare the actual practices and proce-
to the plan. Verification allows the producer to challenge the
dures of the HACCP system with those written in th
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