Monitoring, Verification, and

Validation of Cleaning Processes

Sanitation programs must encompass monitoring, verification and validation practices
that ensure cleaning procedures are effective. The broader effort to control pathogens
such as Listeria monocytogenes (Lm) is inseparably linked to recognizing, defining
and implementing these critical processes. Monitoring is generally defined as a
surveillance mechanism to evaluate ongoing cleaning procedures, with a focus
on achieving success in the present. Verification typically involves activities that
determine if cleaning procedures are delivering expected results, so the focus here
is on past actions. Finally, validation is an endorsement of a cleaning procedure,
which, when followed delivers a predictable outcome. The focal point of validation
is on the capability of a cleaning procedure to deliver future successes. So, any
changes in cleaning procedures that potentially deviate from the expectations of
the original validation must be carefully reviewed to determine if it will be necessary
to revalidate the procedures.

Monitoring: Successful and effective monitoring steps include:

• Success criteria for the sanitation standard operating procedure (SSOP)
must be mutually agreed upon by all stakeholders in the facility.
• An SSOP must be developed to deliver on pre-determined success criteria
• All employees must be trained to safely and effectively perform the SSOP
• A formalized procedure for monitoring activities is strongly recommended
which include:
° V
 isual observation while clean-in-place (CIP) processes are occurring
(pressure, conductivity, flow, temperature, time, etc.).
° V isual observations of sanitation personnel during cleaning operations
° Titration tests
° Inspection of equipment and areas while sanitation personnel are still cleaning
or shortly thereafter
° U
 se and perform rapid tests and methodologies such as ATP, protein tests, etc.

AFFIFoodSafety.org
1
 Verification:
All food cleaning and sanitation processes should be verified on a regular basis to
establish these operations were effective. Verification as an effectiveness check
is essentially a data collection activity and it is important to outline key data and
collection requirements (for instance, the “who”, “what” and “where” are critical)
pertaining to the sanitation program. Ideally, all the collected data and information
are representative of the fitness of specified cleaning procedures and verify the
success of executing defined SSOPs. Individuals conducting verification activities
must be properly trained and it is recommended they apply a formal procedure for
performing verification to ensure consistency.

Annual verification of cleaning procedures is recommended to confirm that

established SSOPs are being followed and related success criteria are consistently
being met. Most food quality programs that are linked to food safety procedures
require at least an annual verification. A recommended method for this approach
is to conduct records review as well as successfully repeat a trial that was part of
the original validation. All verification activities should be recorded and available
for review. These verification records are invaluable when they are carefully
analyzed and monitored for trends that reflect on the level of pathogen and
microbial control in the food facility. Examples of verification records include:
• CIP charts
• Historical pre-operational/post-sanitation inspection results and trends
• Cleaning documentation records reviews
• Historical rapid testing results and trends (ATP, protein tests, etc.)
• Routine environmental monitoring results and trends
• Finished product testing results and trends
• Consumer complaint data that may point to potential cleaning deficiencies
in the facility

When a validated cleaning process is being verified in real-time, the focus is essen-
tially on the original validation of the cleaning procedure, its execution as described
in the SSOP and ability to deliver on established success criteria. Documentation of
this process demonstrates that the validated SSOP is still being followed as written.

AFFIFoodSafety.org
2
 Validation:
A fully developed SSOP must be developed prior to a validation test. Personnel
tasked with validation activities must be properly trained and it is recommended they
use a formalized procedure to conduct their validation studies. Validation of a process
in the absence of a defined SSOP, may reflect merely on the cleaning performance
of the operator rather than the process itself. SSOPs are critical to driving consistency
across the facility and company as no two individuals are likely to follow the same
cleaning process if they are not well-defined. When differences in operator performance
are significant, the outcomes of the cleaning will also likely be inconsistent and
unpredictable. Furthermore, personnel are likely to change their cleaning practices
over time and can potentially impact outcomes in unforeseen ways. Similarly,
employee turnover or poor knowledge transfer tend to alter cleaning practices
significantly over time.

An example of a validation exercise, is where the observer watches a sanitor execute

an SSOP. When the SSOP is executed precisely and in its entirety, from beginning to
end, it can be confidently evaluated against stated success criteria. If results meet
these criteria, then the validation is considered a successful trial. On the other hand,
if the sanitor does not follow the steps outlined in the SSOP properly, the validation
exercise should be stopped, and stakeholders should discuss and agree whether
the SSOP needs modification or if the performance of the operator needs correction.
More information on developing an SSOP is available here (see example of an SSOP
here), but it is important that any success criteria for the SSOP should be practical
and achievable by the facility.

One approach to making the validation more efficient is to group similar equipment
together for this purpose. Grouping is a common tactic used in food facilities and
is acceptable for validation purposes, however, one should determine and clearly
describe how one equipment is ‘like’ another in the facility. When multiple pieces
of equipment are deemed ‘alike’ and their SSOPs are identical, then it is possible
to validate the cleaning of all by validating the equipment that is the most complex
or challenging among them. The concept of validation is to challenge the SSOP
with the most conservative scenario.

AFFIFoodSafety.org
3
 When SSOPs are executed accurately and results from this validation exercise
do not meet the success criteria, then the SSOP should be modified appropriately.
Lowering standards of success criteria to satisfy a sanitation process, may be
considered, but only as a last resort.

Facilities should decide if a single successful trial is sufficient to validate the

SSOP or if multiple trials are needed. Statistically, a sample size of one is likely
not defensible. When multiple trials are deemed appropriate, the facility should
also determine whether all or consecutive trials should be successful to indicate
validation. If SSOP validation trials were not successful across consecutive trials,
then the repeatability of the SSOP may be challenged. Regardless, all validation
exercises should be clearly documented and made available as needed.

Validation of a sanitation procedure should be retained until a significant change

in sanitation processes, processing, formulation, or equipment warrants a review
and potential revalidation of the procedure. Policies outlined by the facility’s change
management program and consultation with the broader food safety team may
help determine the need for a revalidation. Examples of significant changes that
can elicit SSOP revalidation include:

• Product formulation changes such as a more complex ingredient matrix

• Processing parameters such as longer production runs between cleanings
• Equipment modifications
• Alterations in cleaning time, temperature, detergent concentrations/types,
or cleaning agitation

AFFIFoodSafety.org
4