Corrective Actions to Reestablish Control

5.1 Introduction
The primary goal of a food safety system is to prevent, eliminate or reduce hazards to the extent
feasible by existing technology. Food safety systems are based on knowledge of the potential hazards
that can occur in food operations, through the process of hazard analysis. Control measures are then
selected and applied to ensure the food will comply with requirements established by the manufacturer,
customers and control authorities. It is in the interest of manufacturers to produce foods that
consumers can rely upon as being safe.
Many countries require food safety systems that incorporate the principles of Good Hygiene
Practices (GHP) and Hazard Analysis Critical Control Point (HACCP) programs (Codex Alimentarius

1997a, b). Evidence may reveal that the food operation is not or has not been in control and that corrective
action is needed. This evidence may be from an on-site inspection, monitoring GHP, monitoring
or verifying a critical control point (CCP), sample analysis, consumer complaints or epidemiologic
information implicating the food operation.
In the context of HACCP, corrective action is “any action to be taken when the results of monitoring
at the CCP indicate a loss of control” (Codex Alimentarius 1997a). Furthermore, principle 5 of the
Codex document on HACCP states:
Specific corrective actions must be developed for each CCP in the HACCP system in order to deal with deviations
when they occur. The actions must ensure that the CCP has been brought under control. Actions taken
must also include proper disposition of the affected product. Deviation and product disposition procedures must
be documented in the HACCP record keeping.
In this chapter the focus is on microbiological hazards and corrective actions for deficiencies in
GHP and from the marketplace are also considered.
5.2 Good Hygiene Practices
GHP can be viewed as the basic hygienic conditions and practices that must be maintained to produce
safe foods. Effective application of GHP provides the foundation upon which a HACCP plan
can be developed and implemented. Collectively, GHP and the HACCP plan constitute the food
safety system for a food operation. Failure to maintain and implement effective pathogen controls
Chapter 5
Corrective Actions to Reestablish Control
48 5 Corrective Actions to Reestablish Control
through implementation of GHP can result in production of unsafe food and invalidate the HACCP
plan. Spoilage and quality defects may also be more prevalent when GHP is not effectively
applied.
The General Principles of Food Hygiene (Codex Alimentarius 1997b) describe the major components
of GHP as:
• Design and facilities (location, premises and rooms, equipment facilities)
• Control of operation (control of food hazards, key aspects of food hygiene control, incoming material
requirements, packaging, water, management and supervision, documentation and records)
• Maintenance and cleaning (maintenance and cleaning, cleaning programs, pest control systems,
waste management, monitoring effectiveness)
• Personal hygiene (health status, illness and injuries, personal cleanliness and behavior, visitors)
• Transportation (general, requirements, use and maintenance)
• Product information and consumer awareness (lot identification, product information, labeling,
consumer education, handling/storage instructions)
• Training (awareness and responsibilities, training programs, instruction and supervision, refresher
training)
The components of GHP do not carry equal weight for pathogen control. It is necessary to consider
the microbial hazards that are most likely to occur in each facility and identify those elements of
GHP that contribute most to controlling the pathogens and spoilage microorganisms of concern.
Certain elements of GHP may require modification from traditional practice to increase their effectiveness
for controlling a specific pathogen. The principles of GHP are intended to provide a certain
level of control for a wide variety of microbiological quality and safety concerns. Application of
HACCP is targeted towards specific microbial hazards which, if not controlled, can lead to foodborne
disease.
The result of verification activities may also indicate a deviation occurred in the implementation
or application of GHP requiring the application of corrective actions.
5.3 HACCP
HACCP plans are developed following a stepwise process in which:
1. A team of individuals knowledgeable about the food operation is assembled.
2. The food being produced is described.
3. The intended use of the food is described.
4. A flow diagram that describes the steps in the process that are under the manufacturer’s control is
prepared.
5. An on-site confirmation of the flow diagram is conducted.
6. All potential hazards are listed and a hazard analysis is conducted.
7. CCPs are determined.
8. Critical limits are established for each CCP.
9. A monitoring system is established for each CCP.
10. Corrective actions are established.
11. Verification procedures are established.
12. Documentation and record keeping procedures are established.
The results of monitoring (step 9) may indicate a deviation occurred at a CCP and corrective actions
(step 10) are necessary (Codex Alimentarius 1997a).
5.4 Assessing Control of GHP and the HACCP Plan 49
5.4 Assessing Control of GHP and the HACCP Plan
Control means “the state wherein correct procedures are being followed and criteria are being met” and
“to take all necessary actions to ensure and maintain compliance with criteria established in the HACCP
plan” (Codex Alimentarius 1997a). The latter definition incorporates several aspects of the food safety
system: establishing critical limits, monitoring to ensure compliance and making adjustments to maintain
compliance with the criteria. Chap. 3 addresses verifying compliance with GHP and HACCP plans. This
chapter addresses corrective actions to reestablish control. In an ideal food operation:
• Criteria are supported by research and technical literature.
• Criteria are specific, quantifiable and provide a yes/no response.
• The technology for controlling microbial hazards is readily available and at reasonable cost.
• Monitoring is continuous and provides immediate results, while the operation is automatically
adjusted to maintain control.
• There is a favorable history of control.
• The potential hazard is prevented or eliminated completely.
Ideal food operations, however, do not exist in the real world. Unfortunately, criteria cannot always
be clearly defined and assessments of whether the food operation is in compliance with criteria must
be based on the judgment and experience of an observer. In many cases, it may be possible to reduce
but not prevent a hazard (e.g., enteric pathogens on raw seafood and agricultural commodities).
Control frequently does not rely on a single measure but on a set of measures embedded in GHP and/
or HACCP that all need to be functioning as designed during the course of operation. In some cases
small changes to the product or processing may impact the effectiveness of control measures. Also,
the effectiveness of control measures can range from partial reduction of certain hazards (e.g., salmonellae
on raw poultry) to significant reductions of highly resistant hazards (e.g., Clostridium botulinum
in low acid canned foods). Assessment of whether an operation is under control may vary among
individuals with different backgrounds unless there is a common understanding (e.g., guideline, regulation)
that clearly defines how to assess control.
5.4.1 Assessing Control of GHP
Many food operations establish written procedures to assess control of the GHP factors listed in Sect. 5.2.
The two most common methods to assess control are visual inspection and microbiological sampling.
Visual inspection is normally assigned to one or more trained experienced employees in the food operation.
Inspections can also be performed by control authorities or third party auditors (ICMSF 2002).
The time of at which inspections are carried out is important and depends on their purpose.
Preoperational inspection is performed after the facility and equipment have been cleaned and sanitized
to determine whether the equipment and processing environment are acceptable for the subsequent
production. Attention may also be given to maintenance activities to be certain personnel
follow procedures and do not contaminate the equipment during equipment maintenance, reassembly
and start-up. Inspections during production should cover activities that can lead to product contamination,
such as employee practices, product flow, build-up of residues, etc. Inspections that address
plant construction and layout are less frequent, but are also important.
Results from inspections are recorded and made available for review by those who need the information
to respond appropriately. Organizing and evaluating the data for trend analysis can identify
situations of improved or reduced control (ICMSF 2002). Timely review is essential so adjustments
can be made in a timely manner and a deviation can be avoided.
50 5 Corrective Actions to Reestablish Control
Visual inspections provide one means of assessing GHP control but in many instances
microbiological
sampling can provide greater insight and a more accurate assessment of microbial
control. For many facilities, it may be relevant to maintain a program of sampling equipment before
production commences, as well as collecting samples from the equipment or the food during
production.
The samples may be tested for indicators (e.g., aerobic colony count, coliforms,
Enterobacteriaceae)
that reflect the hygienic conditions during processing. Additional tests for pathogens may be performed
for certain products. Extensive guidance on microbiologicalsampling
of the processing
environment and food has been provided (ICMSF 2002), as well as in this book (see Chap. 4, and
product chapters).
For certain food operations the likelihood of resident pathogens and harborage sites must be considered
(ICMSF 2002). If this is likely to occur, it may be necessary to establish an environmental
sampling program to verify the effectiveness of the GHP procedures (ICMSF 2002). This information
could be used to make adjustments in GHP to control one, or more, target pathogens that could
become established in the food production environment and lead to contamination of the food.
The basic components of a monitoring program to assess control of persistent pathogens in the
processing environment include the following strategies:
1. Preventing the establishment and growth of pathogens in harborage sites that can lead to the contamination
of food.
2. Implementing a sampling program that can assess in a timely manner whether the environment
where the food is exposed is under control.
3. Detecting the source or route of pathogen transfer that leads to contaminated food.
4. Applying appropriate corrective actions in response to each positive finding of a target pathogen.
5. Verifying, by follow-up sampling, that the source has been detected and corrected.
6. Providing a short-term assessment (e.g., involving the last four to eight samplings) to facilitate the
detection of problems and trends.
7. Providing a longer-term assessment (e.g., quarterly, annually) to detect widely scattered incidents
of pathogen detection and to measure overall progress toward continuous improvement.
An inherent weakness in industry’s ability to detect and respond to pathogens in harborage sites is
the difficulty and time needed to collect the samples and perform the analytical tests needed to detect
the source(s) of contamination. A common issue is that all the investigational samples may test negative
for the target pathogen and a clear direction for appropriate corrective actions is lacking.
Furthermore, the pathogen may be detected again at some later date after the routine monitoring
program has been resumed.
Microbiological data should be recorded and made available for review by others who need to
know the results so they can respond appropriately. In addition, the data should be organized and
evaluated for trends toward improved or reduced control (ICMSF 2002). As with visual inspections,
this information is essential so appropriate corrective actions can occur in a timely manner.
5.4.2 Assessing Control of the HACCP Plan
HACCP plans are formal, structured documents that are based on the seven principles of HACCP
(Codex Alimentarius 1997a). The size and type of food operation will influence the content of the
HACCP plan. Food operations that do not have a CCP that can prevent, eliminate or reduce the hazards
of concern may not have a HACCP plan. Smaller operations, such as street food vendors, may
rely more on regulations or guidelines from health authorities that emphasize GHP.
For larger operations that have HACCP plans, control is assessed through the monitoring and verification
activities stated in the HACCP plan. The HACCP plan should include corrective actions for
the deviations that are likely to occur (step 10 in Sect. 5.3).
5.5 Corrective Actions 51
5.5 Corrective Actions
5.5.1 Corrective Actions for GHP
Information about how microbial hazards can be introduced is necessary to design a food operation
and implement appropriate control procedures. It is not unusual to occasionally detect weaknesses in
the design and implementation of GHP, which requires corrective action. Typical corrective actions
associated with GHP involve the factors listed in Sect. 5.2. For example, microbiological data might
indicate improvements are needed in how processing rooms or equipment are cleaned and sanitized.
This could involve training individuals on the correct procedures, changing the method or frequency
of cleaning and sanitizing, or performing maintenance and repair on equipment. When food operations
increase production or add new products, this may result in an unacceptable increase in risk that
the food may become contaminated and may require a change in the plant layout. Another common
corrective action for GHP is retraining employees who have not followed established procedures for
personal hygiene, food handling or following the traffic pattern that separates raw ingredient processing
and areas where ready-to-eat foods are handled.
When equipment is suspected to be a persistent source of contamination, corrective action may
include complete dismantling of the equipment to allow more thorough cleaning and sanitizing of the
parts before reassembling. For small equipment with many parts, cleaning in a recirculating bath of
hot water with detergent (e.g., Clean Out of Place (COP) tank) is effective. COP cleaning requires
placement of parts in a way that assures adequate circulation of the cleaning solution for optimum
results. These procedures are normally adequate and the preferred corrective action. As equipment is
being dismantled, sampling sites suspected of harboring microbial contaminants can provide useful
information that can be used to change maintenance and cleaning procedures. For example, the
equipment may need to be modified for more effective cleanability. In some situations, lubricants
may be a potential harborage site for contamination, and use of food-grade antimicrobial lubricants
may be an appropriate corrective action.
Occasionally, even extensive dismantling and cleaning will prove ineffective. For equipment that
can be moved, heating with moist heat in a chamber, after sensitive electronics, oil, and grease are
removed, can be effective. If this is not possible, the equipment can be covered with a heat-resistant
tarpaulin and steam can be introduced from the bottom. When these moist heating techniques are
used, an internal temperature of 71°C for 20–30 min is recommended to eliminate vegetative cells.
The temperature can be monitored with thermocouples placed within the equipment or thermometers
that pierce through the tarpaulin. Of course, equipment such as drying towers for dried milk products
and many closed systems must be cleaned and sanitized in-place.
To regain control, it is helpful to determine the source of the contamination so that appropriate
corrective actions can be taken. Investigational samples are analyzed individually rather than as composites,
samples are collected more frequently (e.g., every four hours) and additional sites are
included. A simple map showing the layout of the rooms and the equipment can be beneficial.
Positive sites are marked on the map with the dates and times of collection. A very simple schematic
drawing or a blueprint of the facility can be used. By organizing the results to show which sites test
positive more frequently and where the positive samples first occur, the source of contamination can
be more easily located. In an environment that has been in control, this will often identify specific
equipment that is a harborage for the contaminant. In general, contamination flows down along or
through processing equipment with the flow of product. Fingerprinting isolates can be a very useful
tool for identifying the source and pathways of contamination.
Exposed surfaces of equipment may be transfer points but generally are not sources of contaminants
due to their ease of cleaning and sanitizing. Of greater concern are enclosed areas (e.g., within
a hollow roller for a conveyor) where food deposits and moisture accumulate and cannot be removed
52 5 Corrective Actions to Reestablish Control
by normal cleaning, scrubbing, and sanitizing. These harborage sites are not necessarily biofilms per
se, but rather sites in which a variety of bacteria become established and multiply.
To achieve continuous improvement and long-term control, corrective actions may involve
changes in the plant layout, equipment design or maintenance, replacing floors or walls, or changing
the procedures for cleaning and sanitizing. In the event construction is required, extra precautions
must be taken to control the pathogen and prevent food from becoming contaminated during the
construction process.
5.5.2 Corrective Actions for HACCP
Seven possible corrective actions are appropriate to consider when a deviation occurs at a CCP within
the HACCP plan:
1. If necessary, stop the operation
2. Place all suspect product on hold
3. Provide a short-term resolution or “fix” so that production can be safely resumed and additional
deviations will not occur
4. Verify that the short-term fix has been effective and recurrences do not occur
5. Identify and correct the root cause for failure to prevent future deviations
6. Collect the necessary information to decide what to do with suspect product
7. Record what happened and the actions taken
8. If necessary, review and improve the HACCP Plan
The corrective actions must bring the food operation into compliance with established criteria and
ensure safe disposition of the product involved. Corrective actions should be considered in advance
for each CCP in the HACCP plan; however, it is unrealistic to anticipate and prepare for all the possible
deviations that can occur.
5.5.3 Response to Epidemiologic Evidence and Complaints
When an epidemiologic investigation implicates a specific food as the likely cause of illness or when
consumer complaints provide such an implication, the root cause(s) leading to disease may not be
immediately apparent. While removal of the implicated food may prevent additional consumer exposure,
the corrective actions necessary to prevent future cases of disease may be unclear. Detailed
review of the relevant operations before and during the period of likely contamination along with
extensive microbiological evaluation of the environment, ingredients and finished foods may reveal
information about the root cause(s). Food and environmental isolates should be compared with
human clinical isolates to confirm, as clearly as possible, the source(s) of the pathogen and root
causes. When the location within the food chain is identified as the likely source, every effort should
be made to determine the important factors involved so adjustments can be made to existing control
measures (i.e., GHP, HACCP) to prevent additional outbreaks.
It is possible that a thorough evaluation of the food implicated by the epidemiologic investigation
will correctly reveal a food system under good control without obvious defects in GHP and HACCP
plans or their implementation, despite the presence of pathogens at a frequency and concentration
sufficient to cause disease. This scenario is more likely to occur when raw agricultural commodities
are involved and existing technology and food safety controls can reduce but not prevent or eliminate
the hazard. While it remains appropriate to prevent additional exposures to the implicated food, this
situation may require issuance of a consumer advisory for persons at risk. A consumer advisory on
5.6 Options for Disposition of Questionable Product 53
the retail package to properly store, prepare and cook raw meat and poultry products is one such
example. Information from public health agencies to physicians and other health care providers who
advise high risk patients is another example.
5.6 Options for Disposition of Questionable Product
If control is lost and a deviation occurs, several options may be considered for disposition of suspect
product:
1. Determine whether the suspect product complies with existing criteria for safety and can be used
as intended. To assess the acceptability, a sampling plan can be applied, keeping in mind the limitations
of the sampling plan to detect lots with defects that are of very low prevalence (Appendix A
and ICMSF 2002). In some situations dividing the lot(s) into smaller portions (e.g., pallet, hourly)
may be considered, with sampling and testing of each portion or sub-lot as separate entities. This
increases the number of samples across the total production and also provides information about
distribution of the defect. Testing sub-lots should be evaluated carefully. See Sect. 5.6.1 for further
considerations.
2. The suspect product can be diverted to a safe use. For example, eggs or cooked chicken contaminated
with salmonellae could be used as ingredients in the manufacture of a commercial product
that will receive a kill step that can ensure the food will be safe.
3. The suspect food could be reprocessed, if reprocessing will destroy the hazard.
4. The suspect food could be destroyed.
Reaching a decision on the appropriate disposition of non-compliant product is influenced by a number
of factors. First is the severity or the seriousness of the hazard. For example, does the potential
defect consist of spoilage or could it be a severe hazard such as botulinum toxin? Second is the type
of microbial hazard. For example, staphylococcal enterotoxin is very heat stable and its presence in
a food would render the food unacceptable for human consumption in any manner. Third is the likelihood
of the hazard being present in the food. Is it one chance in a million or is it likely to occur every
time the deviation occurs? Fourth is how the food will be stored, shipped, and prepared. Fifth is who
will prepare the food. Sixth is whether the intended consumers include highly susceptible individuals.
Each of these factors and, perhaps, others should be considered before reaching a recommendation
on the disposition of the product.
5.6.1 Sub-Lot Testing Considerations
No sampling plan, other than one that tests the entire lot, can prove that the lot is not contaminated.
Thus, while the term “zero tolerance” is often used, in actuality sampling to assess compliance can only
provide a certain level of confidence that the contamination level is below some mean concentration.
That concentration depends on the size and number of analytical units tested, and the variance
in the
concentration of the pathogen in the lot. From statistical standpoint the size of a lot does not influence
the performance of a sampling plan. An example from probability statistics can help explain why this
is true. If a die is tossed 100 times and the numbers are recorded and then 3 random numbers from 1 to
6 are determined, there is a certain probability of having a “1” in the set of 3. If the die is tossed 1,000
times, the probability of having a “1” in the set of three random numbers is the same as that for tossing
the die 100 times.
If contaminating cells are distributed randomly throughout a lot, creating five sub-lots is equal to
taking 5 times the number of samples from the lot, and the average concentration of a microbial population
would remain valid for the whole lot and not just the sub-lots. However, in many instances
54 5 Corrective Actions to Reestablish Control
microorganisms are not randomly distributed. Examples of situations that may alter distribution of
contamination during processing include introduction of water from a leaking roof or a drain back-up
at one point in time, a change in raw materials, equipment being inserted into the process, mechanical
breakdown of equipment, production interruptions for cleaning, a function of production time, and
other specific events. In such cases, it is not a good assumption to define this as a uniform lot, and
sub-lotting may assist in identifying trends and defective portions of the lot.
The application of testing sub-lots should be evaluated very carefully. Elements to consider are:
• Readily available microbiological data on pathogens as well as indicator organisms from the lot
in question
• Data for lots manufactured before and after as well as in-process and/or environmental samples
• Data on processing parameters
• The type of microbiological hazard, its severity and its fate during further handling, i.e., the likelihood
that it could increase or decrease prior to consumption, as well as the sensitivity of the
consumer, etc.
5.7 Repetitive Loss of Control
The HACCP concept has gained wide acceptance because it provides a logical, structured approach
to prevent, eliminate or reduce hazards in foods. The system is designed to detect loss of control and,
thereby prevent suspect food from reaching consumers. This is an essential component of the food
safety system because deviations can and will occur during the normal course of operation. Preventing
repetitive deviations for GHPs and CCPs is a desirable goal but may be difficult to achieve in some
food operations. Each food operation should strive to prevent repetitive loss of control by implementing
a continuous improvement program to achieve greater reliability for controlling GHPs and CCPs
within the food safety system.