Doc. Title: Validation and Verification Doc. No.

IAC/HC/PR17
Prepared By Reviewed By Approved by
Revision No. 01
AM - JA- IK FSTL GM

Document No. : IAC/HC/PR17

Original Issue Date : 15-12-2016

Revision : 01

Revision Date : 10-05-2017

Reviewed By : __________________ Plant/Quality Assurance Manager / FSTL

Dr. Asif Meraj

Approved By : __________________ (General Manager)

Ghufran Subhan

Distribution List
CE

FSTL

GM

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 Doc. Title: Validation and Verification Doc. No.
IAC/HC/PR17
Prepared By Reviewed By Approved by
Revision No. 01
AM - JA- IK FSTL GM

DOCUMENT CHANGE RECORD

Rev. Original Revision

Brief Description Of Changes
No. Date of Issue Date

01 15-12-2016 10-05-2017 Document number revised from FSMS to FSSC 22000

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 Doc. Title: Validation and Verification Doc. No.
IAC/HC/PR17
Prepared By Reviewed By Approved by
Revision No. 01
AM - JA- IK FSTL GM

1. Purpose
The purpose of this procedure is to provide guidelines for validation and
verification of control measures
2. Scope

This procedure is applicable to full range of control measures (PRP, OPRP, CCP
and HCP) intended to control microbiological, chemical or physical hazards
within processing, production, packing, storage, handling and distribution.

3. Responsibility

FSTL along with Food safety and Halal team members is responsible for the
implementation of this procedure.

4. Concept And Nature of Validation:

Validation process is one that demonstrates that the selected control measures
actually are capable, on consistent basis, of achieving the intended level of hazard
control. Prior to implementation of control measures to be included in OPRP and
the HC and HAACP plan and after alterations into food safety management
system, validation ensure that:

The selected control measures are effective and capable of achieving the intended
control of the food safety hazard(s) for which they are designed.
The control measures are effective and capable of, in combination, ensuring
control of the identified food safety hazard(s) to obtain end products that meet
defined acceptable levels.
The validation process provides assurance that the combination will deliver
products that meet identified acceptable levels.
The range of control measures is extensive and broadly categorized into three
groups:

 To control initial hazard levels

 Prevent increase of hazard levels
 Reduce hazard levels

4.1 Pre requisites To Validation

 Identification of hazards that can be controlled and assessment of their

severity and probability of occurrence (hazard analysis)
 Identify control measures to be validated. The Control measures to be
managed by OPRP and HAACP plan are those that require validation.
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Prepared By Reviewed By Approved by
Revision No. 01
AM - JA- IK FSTL GM

 Factors that should be considered include:

 Whether a control measure can be validated by itself or whether combination
of certain control measures should be validated together.
 The feasibility of conducting the validation
 To what extent the levels of food safety hazards are affected (qualitatively,
semi- quantitatively or quantitatively)
 Identify the step or location where the control measure is intended to be
applied.
 Identify the food safety outcome required. The factors to consider include:
 Appropriate targets should be identified by the competent authority or by
industry as appropriate.
 Identify whether (set of) control measure(s) has previously been appropriately
validated or whether its performance is so well established for the application
under consideration that validation should be considered complete.
 Identify the appropriate approach to be used for validation.
 Validate and verify your food safety system.

4.2 Approaches for Validating Control Measures

 The following approaches to validation may be used individually or in

combination as appropriate.
 Reference to previous validation studies or historical knowledge of the
performance of the control measure(s)
 Scientific or technical information needed to validate control measures may,
in many instances, be available from many sources including; Scientific
Literature, Government Regulations, Guidelines on Good Hygiene Practices
and HACCP,MS 1500, International Standards or Guidelines (eg; Codex
Alimentarius) etc.
 Scientifically valid experimental trail that document the adequacy of control
measure(s)
 Lab challenge testing designed to mimic process conditions is such an
approach as are pilot tests of particular aspects of a food processing system

 Collection of data during normal operating conditions in the food operation

 In order to validate control measure(s) it may be necessary to collect

appropriate biological, chemical or physical data relating to the hazard(s) of
concern during normal operating conditions in the food operation. Sampling
should be based on the use of appropriate statistical sampling plans,
validated testing methodology. Sufficient data should be collected that

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IAC/HC/PR17
Prepared By Reviewed By Approved by
Revision No. 01
AM - JA- IK FSTL GM

appropriate statistical analysis can be carried out to assess the effectiveness

of control measure being validated.

 Statistically designed surveys

These can be used to document control measures that cannot otherwise be

measured.

 Mathematical modeling

Mathematical modeling can be used to estimate the predicted performance of a

control measure or combination of control measure, including taking into account
variation of individual control measure.

4.3 The Validation Process

a. Validation demonstrates that the combination of control measures is capable

of achieving the intended level of control.
b. Where a control measure cannot be validated, it cannot be included within
HACCP plan or operational PRP’s, but can be applied within PRP’s.
c. Validation shall be carried out even when all control measures are to be
managed through OPRP’s.
d. The process of validating control measure includes the following steps:
e. Validation shall be carried out before formal implementation of control
measures and in case of any changes to food safety management system.
The need for validation shall be assessed and if required shall be planned
and carried out accordingly.
f. Complete the pre-requisite steps to validation.
g. Assemble documentation as supporting evidence for the selection of
significant hazards and effectiveness of the proposed control measures.
h. Evidence must be gathered for both the inclusion and exclusion of all
relevant hazards considered during hazard analysis.
i. Reconcile or crosscheck the hazard analysis sheet and the process flow
diagrams to ensure that control measures to be managed by OPRP’s and
HACCP plan have been correctly identified and that the established target
values, critical limits and monitoring procedures are adequate.
j. OPRP’s and HACCP plans must be available including information on
methodology, frequency, acceptable levels, actions to be taken if values are
outside critical limits (in case of CCP’s) and responsibilities.
k. Validation of control measures must ensure that corrective actions taken in
case of process deviations will result in the adequate segregation of non-
conforming products to ensure that it does not reach the consumers.
Responsibility for taking corrective actions and decisions lies with the and
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Food Safety Management Representative in correspondence with food

safety team
l. Document the findings of validations studies using “Checklist for Validation
of Control Measures” IAC/FM12
m. FSTL shall communicate the findings and their interpretations among the
members of food safety team.
n. Results of validation will either;
o. Indicate that the hazards can be adequately controlled and, thus, the control
measures can be implemented, or
p. Indicate that the control measure is not adequate to achieve the necessary
level of control and should not be implemented
q. In this case, re- evaluation of process parameters, control measures, food
safety control design, and corrective actions shall be taken.

4.4. Concept And Nature of Verification

 Verification is the ongoing demonstration that the selected control measures

are being delivered appropriately.
 Monitoring and verification take place only after the validated control
measures have been implemented.
 Verification is used to determine that the control measures have been
appropriately implemented (eg; that monitoring is being conducted and
documented as specific) and thus are achieving the level of hazard control
required.
 Verification occurs during or after operation through a variety of activities
including observations or monitoring activities and review of records to
confirm that implementation of control measures is according to design.
 Monitoring activities are typically focused on “real-time” measurements and
are generally focused on the performance of a specific control measure.
 Validation: Will the system work when put into practice?
 Verification: Are we doing what we have planned to do?
 Verification of control measures includes two distinct activities:
 Demonstrating conformity with PRP/ OPRP/ HACCP plan: A key objective
of conformity is to raise confidence in the competence of manufacturing
unit. The records shall include:
 Operations (including calibrations)
 Deviations, corrective actions and other measures taken with regards to
product
 Internal audits
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Prepared By Reviewed By Approved by
Revision No. 01
AM - JA- IK FSTL GM

 Changes to the system

 Gathering of information: Verification should ensure that plans are
applicable and are being implemented to the processes, products, cleaning
protocols, factory layout, environment, distribution, storage, raw and
packaging material and that it incorporates the latest hazards and product
end use.
 Common ways of gathering information include trend analysis on:
 Data recorded as CCP’s
 Results of online testing
 Consumer/ customer complaints
 Hygiene testing analysis
 Equipment calibration checking
 These trends need to be analyzed and results should be used to identify root
cause of problems and potential improvements to food safety.
4.5 Verification planning

 A schedule of verification activities is developed as part of the food safety

management system. This schedule shall include the procedures or
methods to be utilized, the frequency and the person(s) responsible for
performing the activity.

 Ongoing verification: Examples of verification activities that should be

considered as part of the system include
 Reviewing monitoring records
 Reviewing deviations and their corrective actions, including handling of
affected product
 Calibrating thermometers or other critical measuring equipments
 Visually inspecting operations to observe if control measures are under
control
 Analytically testing or auditing monitoring procedures
 Randomly collecting and analyzing samples of in- process or end product
 Reviewing consumer/ customer complaints
 Periodic verification: The periodic verification activities involve overall
assessment of the system. This is usually performed during management
review meeting, and all the above evidences over the period of time are
reviewed to ascertain if the system is functioning as planned and if
updating or improvement is necessary.

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Prepared By Reviewed By Approved by
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 Verification reports: These should include:

a. The system
b. The persons administering and updating it
c. Certification that monitoring equipment is properly calibrated
d. Results of record review and any samples analyzed
e. Review of training records of personnel
4.6 Responsibility

Manager is responsible for the implementation of verification activity and

maintaining the records of verification activities.

FSTL along with food safety team members is responsible for assessing and
evaluating the results of verification.

4.7 Verification Process

Verification plan shall be established defining the purpose, methods, frequencies

and responsibilities for the verification activities using “Plan for Verification of
Control Measures” IAC/FM13 as under:

a. Verify that PRP’s have been implemented

b. Verify that hazard analysis inputs are updated
c. Verify that hazard levels are acceptable
d. Verify that OPRP’s are implemented and effective
e. Verify that HACCP plan is implemented and is effective.
f. Verify that procedures are implemented and effective.
g. Record the results of verification activities
h. Food safety team shall evaluate the results of individual verification
activities on quarterly basis in review meeting for verification of control
measures.
i. If verification does not conform with the planned arrangements, review
shall be done for:

 Existing procedures and communication channels

 Conclusion of hazard analysis, the established OPRP’s and HACCP
plan
 The PRP’s Effectiveness of human resource and training activities
 Apart from above areas, appropriate corrective actions shall be
identified to met planned arrangements.
 Results of verification activities shall be analyzed in order to meet the
requirements as below:

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Prepared By Reviewed By Approved by
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a. To identify the need for updating or improving the food safety management
system
b. To identify trends which indicate higher incidence of potentially unsafe
products
c. To provide evidence that corrections and corrective actions that have been
taken are effective.
d. FSTL shall communicate the results to the food safety team
e. The verification results shall be analyzed for their adequacy and effectiveness
f. To confirm that the overall performance of system and requirements of FSMS
g. Identify the need for updating and improving the FSMS
h. Identify trends
i. Establish information or planning of internal audits
j. Provide evidences that corrections and corrective actions are effective
k. Results of analysis of verification activities and subsequent actions shall be
recorded and presented as inputs to management review meeting for updating
food safety management system.

If verification is based on testing of end product samples and where those show non-
conformance with acceptable levels of food safety hazard, the affected lots shall be
handled as potentially unsafe products.

5. RELATED RECORDS

Checklist for Validation of Control Measures IAC/FM12

Verification Plan for Control Measures IAC/FM13

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