ASC CONSULTANTS (PTY) LTD – Page 1 of 6

LOGO Doc No: APR 8.8

Food Safety Management System

Subject: Validation Procedure

1. PURPOSE
To determine and demonstrate whether control measures are capable of controlling food safety
hazards to intended appropriate levels and these levels of control can be achieved consistently.
2. SCOPE
This procedure covers all validations of control measures used to control microbiological, chemical,
physical and allergen hazards in the processing of starch and glucose products.
3. REFERENCES
ISO 22000:2018
4. RESPONSIBILITY

QA Manager  Ensuring that validation exercises are done

 Recording results from validation exercises
 Maintain records for validation exercises

HACCP Team  Assist the QA Manager with conducting validation exercises

whenever assistance is sought

4.1. DEFINITIONS
Control measure – Any action and activity that can be used to prevent or eliminate a food safety
hazard to an acceptable level.
Food safety control system – The combination of control measures that when taken as a whole,
ensures that food is safe for its intended use.
Monitoring – The act of conducting a planned sequence of observations or measurements of control
parameters to assess whether a control measure is under control.
Validation – Obtaining evidence that a control measure or combination of control measures if
properly implemented is capable of controlling the hazard to a specified outcome.
Verification – The application of methods, procedures, tests and other evaluations in addition to
monitoring to determine whether a control measure is or has been operating as intended.
5. METHODS
5.1 PREREQUISITE STEPS TO VALIDATION
Identification of the hazards that are intended to be controlled (relevant information including risk
assessment to be utilized.
Factors that should be considered includes: The importance of the control measure as it relates to
achieving the expected outcome for the control of the hazard.
Whether a control measure can be validated by itself or whether combination of control measures
should be validated together.
5.2. PRIORITY OF VALIDATION TAKES INTO ACCOUNT:
Approved by Food Safety Manager Issued on 13 Jan 2020 Last revised on 26 May 2020 Rev
1
ASC CONSULTANTS (PTY) LTD – Page 2 of 6
LOGO Doc No: APR 8.8
Food Safety Management System

Subject: Validation Procedure

 Adverse health effect

 Historical experience
 Ability to monitor and verify the control measure
 Scientific and technical feasibility
 Resources
 Identification of the food safety outcome required
 Approaches for Validating control measures
 Reference to scientific and technical literature, previous validation studies or historical
knowledge of the performance of the control measure(s).
 Scientifically valid experimental data that demonstrate the adequacy of the control measure
(s).
 Collection of data during normal operating conditions in the food operation.
 Mathematical Modelling
 Surveys
5.3 STEPS INVOLVED IN THE VALIDATION PROCESS
1) Complete the prerequisite steps to validation.
2) Decide the approach or combination of approaches.
3) Define the parameters and decision criteria that would demonstrate that a control measure or
combination of control measures if properly implemented is capable of consistently
controlling the hazard to the specified outcome.
4) Assemble relevant validation information and conduct the studies if necessary.
5) Analyze the results
6) Document and review the validation
7) Reference all sources of data
8) Results of validation studies will either
9) Indicate that the hazard can be adequately controlled and thus the measure can be
implemented or
10) Indicate that the measure is not adequate to achieve the necessary level of control and should
not be implemented. This may lead to re-evaluation of process parameters, control measures
or product formulation.
5.4 NEED FOR RE-VALIDATION
There are many changes that can lead to a need to re-validate control measure, combination of control
measures or the entire food safety control system. The examples include:

Approved by Food Safety Manager Issued on 13 Jan 2020 Last revised on 26 May 2020 Rev
1
ASC CONSULTANTS (PTY) LTD – Page 3 of 6
LOGO Doc No: APR 8.8
Food Safety Management System

Subject: Validation Procedure

5.4.1 Process Changes: The introduction in the food control system of a new control measure,
technology or a piece of equipment that impacts the control of the hazard means that the system or
part of it may need to be revalidated, similarly changes made to product formulation or the application
of current control measures may result in the need to revalidate control measures. While minor
changes are less likely to require revalidation, multiple minor changes will almost certainly result in
the requirement for revalidation.
5.4.2 New scientific or regulatory information: The hazard(s) associated with the food or ingredient
changes as a result of (i) higher concentrations of pathogens than originally encountered and
accounted for in the design, (ii) a change in response of a hazard control (eg adaptation),(iii)
emergence of previously unidentified hazard or (iv) new information indicating that the hazard is not
being controlled to the level specified (v) a new food safety outcome .
5.4.3 System Failure: If monitoring and verification identifies failures above pre-established rate for
which a process deviation cause cannot be identified, revalidation may be needed. Non-compliance
with monitoring or verification criteria may indicate changes in parameters (the selection and
specification of control measures) on which the design of the food safety control system is based.
5.5 PERFORMANCE MEASURES & REPORTING
Number of Complete validation studies.
Number of audit findings related to validations
Number of audit findings related to failure of validated control measures.
5.6 VALIDATION
The validation of the effectiveness of CCP controls shall be obtained from internal monitoring and
trials done over a period of time. Should the trials/monitoring show that the measures are effective,
the evidence will be used as the proof of effectiveness.
5.6.1. Shelf life Studies

Shelf life studies shall be conducted for unpreserved and preserved mango for a period of 12 months
and 24 months respectively. A full scientific shelf life study shall be conducted. Trend analysis as
well as scientific data is available for the two periods.

5.6.2. Microbiological testing challenge

Microbiological challenge testing has been and continues to be a useful tool for determining the
ability of a food to support the growth of spoilage organisms or pathogens. Microbiological challenge
tests also play an important role in the validation of processes that are intended to deliver some degree
of lethality against a target organism or group of target organisms. Quite often, with this latter
purpose, there is an associated performance standard that the process must deliver (for example, a 5
log reduction of Escherichia coli O157:H7 for fermented meats).
An appropriately designed microbiological challenge test will validate that a specific process is in
compliance with the predetermined performance standard. The design, implementation, and
Approved by Food Safety Manager Issued on 13 Jan 2020 Last revised on 26 May 2020 Rev
1
ASC CONSULTANTS (PTY) LTD – Page 4 of 6
LOGO Doc No: APR 8.8
Food Safety Management System

Subject: Validation Procedure

assessment of microbiological challenge studies is a complex task that depends on factors related to
how the product is formulated, manufactured, packaged, distributed, prepared, and consumed.
An expert microbiologist must consider the relevant factors and design a study that best assesses the
food safety of the product. Failure to account for specific product and environmental factors in the
design of the test could result in flawed conclusions. Microbiological challenge studies are also useful
in determining the potential shelf life of certain refrigerated or ambient-stored foods.
The determination of whether challenge studies are appropriate or useful must be made by
considering such factors as the likelihood of the product to support growth of spoilage organisms or
pathogens, or a knowledge of the previous history of the product. For example, it is not useful to
conduct challenge studies on frozen foods that would not support growth under proper storage
conditions; nor would it be especially useful to conduct challenge tests on commercially sterile
retorted canned foods.
However, in the canned food example, it may be appropriate to conduct inoculated pack studies as
part of the protocol for process validation. Microbiological challenge testing is very useful for food
products that may sustain the growth of pathogenic organisms and that are stored under refrigeration,
elevated temperature, or at ambient temperature and vulnerable to the growth of microorganisms.
When conducting a microbiological challenge study, a number of factors must be considered
(Vestergaard 2001). These include (1) the selection of appropriate pathogens or surrogates, (2) the
level of challenge inoculum, (3) the inoculum preparation and method of inoculation, (4) the duration
of the study, (5) formulation factors and storage conditions, and (6) sample analyses. The
interpretation of the data and pass/fail criteria are critical in evaluating whether a food needs
time/temperature control for safety. While microbiological challenge testing is useful for determining
the spoilage potential of a product formulation, the remainder of the discussion in this chapter will
focus on pathogens relevant to foods that need time/temperature control for safety.
5.6.3 Allergen Cleaning Validation
The same variables must be considered for allergen cleaning validation as with any type of cleaning
validation. The difference, however, is how much is at stake. Undeclared allergens are a life-
threatening contaminant and incomplete validation data or inaccurate data could put lives at risk. In
addition, there may be some “trial and error” in determining which cleaning methods are effective.
During this period, production lines may be down, product may need to be destroyed, and potentially
costly testing must be performed. 

I. Testing

There are two approaches to testing. One is to test the cleaned surface, and the other is to test the
product that is produced after the surface has been cleaned. Both testing methods have limitations,
primarily from the nature of sampling. By conducting both types of testing, the most variables are
addressed.
The steps involved in testing are as follows:
1. Run a product with an allergen.
2. Clean the line/equipment with the established method.

Approved by Food Safety Manager Issued on 13 Jan 2020 Last revised on 26 May 2020 Rev
1
ASC CONSULTANTS (PTY) LTD – Page 5 of 6
LOGO Doc No: APR 8.8
Food Safety Management System

Subject: Validation Procedure

3. Swab the surface(s) after cleaning and test for the allergen in question
and/or
4. Sample the first bit of product from the subsequent run (not containing the same allergen) and
test it for the allergen in question.
5. Hold all product produced in the subsequent run until results have been obtained.
 If the results indicate the absence of detectable allergen, the line may be used and any held
product may be released.
 If the results indicate allergen carryover: The held product must be destroyed (or used in a
formula that declares all carryover ingredients).
The line must be re-cleaned (with a different method, which could be a modification of time,
temperature, and/or chemical, etc.).

II. Frequency

As with most validation programs, the best approach is to revisit it at least annually and when there
are any significant changes. Changes would include changes to soil type, surface type, or cleaning
method. It may also include a more sensitive test methodology that has been developed and has
become available. The annual assessment would include all the variables in the soil x surface type x
method table. The ongoing validation of allergen cleaning typically involves a combination of the
following after each allergen changeover:
1) Visual inspection (this is a minimum requirement).
2) ATP swabs (not directly related to allergens, but can be used as a general indicator).
3) Allergen surface swabs.
4) Allergen testing of product

6. VERIFICATION SCHEDULE

ASPECT PURPOSE METHOD FREQUEN RESPONSIBI RECORD

CY LITY FORM
Cleaning Verification Visual inspection Daily QC Master
of cleaning cleaning
schedules
Cleaning Verification Surface swabs Monthly Microbiologist Micro-
and of testing results from
sanitation effectiveness lab
Final Product Microbiological Per batch Microbiologist SAP
Approved by Food Safety Manager Issued on 13 Jan 2020 Last revised on 26 May 2020 Rev
1
ASC CONSULTANTS (PTY) LTD – Page 6 of 6
LOGO Doc No: APR 8.8
Food Safety Management System

Subject: Validation Procedure

product release testing

PRP/GMP Verification Internal GMP Quarterly QA Manager GMP audit
s of process audits checklist
effectiveness
PRPs/GM Verification Procedure audits At least Food safety Procedure
Ps of once a year team audit
procedures implementati based on checklist
on risk
OPRPs Verification Internal Audits Quarterly Food safety CCP/OPRP
and CCPs of team audit
implementati checklist
on

7. Records Schedule
Retention
Record Title Doc No Authority for Disposal
Location Period
Change Request Form LF 8.2.1 Admin 3 QA Manager
office

Approved by Food Safety Manager Issued on 13 Jan 2020 Last revised on 26 May 2020 Rev
1