World Accreditation Day 2020 – 9th June

WAD2020 - Celebrations….

Validation and
Webinar # 6 Verification
Process
 About CCC

Consultants Consortium of Chennai (CCC) is an Association of Management Systems Consultants, registered under the
Tamilnadu Societies Registration Act, 1975. The Key Objective of CCC is to work in alignment with the National
Quality Mission launched by the Government of India by educating the industry about the role and importance of
Standards, Certifications and Regulations in the country as well as in the global markets.
CCC strives to encourage Responsible Consulting through Members of its Association and focus is to Standardize
Consulting Practices in alignment with changing market and industry needs in a dynamic manner.
The focus is also to identify areas and industries in which the consultants in the profession of Management Systems
Consulting can contribute to the betterment of the society and the country and to promote Management Systems
Consulting in such areas or industries.
One of the core objectives is to collaborate with various Industry platforms, Trade Associations, Chambers of
Commerce, Management Associations, Apex Bodies of Government or Quasi Government Organization to contribute to
the betterment of the industry initiatives, which will in turn contribute to the betterment of the society.
 About WAD 2020

World Accreditation Day is a global initiative established by ILAC and IAF. This year’s
theme is How Accreditation Improves Food Safety.

Accreditation has an important role in food safety, by ensuring competent and impartial
inspection, certification and testing services in all parts of local, national and international
food chains. In doing so, accreditation supports the United Nations’ Sustainable
Development Goals (SDGs), in particular, the Good Health and Well-being Goal (SDG 3).

Accreditation can be applied to a wide variety of assessment, approval or evaluation tasks

and is used by business, government and regulators to help deliver a safer world.
Alok Jain, Director & Head, TCB
Ph. +919811352698, Mail: ajain@nabl.qcin.org
4
 About today’s webinar: Verification and Validation Process

● Validation and Verification process plays important role in various aspects of Food
Safety
● We need to
○ Validate Control Measure Combination for the critical limits

○ Verify the compliance of process as per the critical limits

○ Verify the process flow whether all steps are covered – so that no step which
might have food safety risk is left out
○ Verify implementation of various system elements like PRP checking, OPRP and
CCP checking, Internal Audit, other records
 About the presenter and co-presenter

Yogesh Jain, B.E., M. S. (BITS, Pilani), M. Tech.

Total 27 years experience, 4 years in Industry , 23 years in Mgmt System Consulting,
Certified LA for FSSC 22000, BRC Food, besides ISO 9001, 14001, 45001, etc.
Consulting done for Dairy, Brewery, Distillery, Soya Plants, Flour Mill, Spice Processing,
FIBC, Animal Feed

Sonia Sawhney, Food Technologist

Total 24yrs exp.12 years in Industry ,12years in Management System Consultancy,
Auditing and Trainings, QCI -NBQP and APEDA Approved FSMS Consultant, NLRP/Trainer
of FSSAI
 Verification and Validation Process

Definition:
Validation: As regards to food safety - obtaining evidence that a control
measure for combination of control measures will be capable of effectively
controlling the significant food safety hazards.

Validation is performed at the time a control measure combination is designed, or whenever

changes are made to the implemented control measures.
 Verification and Validation Process

Definition:
Verification: confirmation, through the provision of objective evidence, that
specified requirements have been fulfilled.
 Verification and Validation Process

● validation is applied prior to an activity and provides

information about the capability to deliver intended results;

● monitoring is applied during an activity and provides

information for action within a specified time frame;

● verification is applied after an activity and provides

information for confirmation of conformity.
 Objectives of Validation and Verification

V&V is 6th Principle of HACCP

Two Objectives:
(1) to determine if the plan is valid, i.e., that it is adequate to
control hazards associated with the product when the
plan is properly implemented, and
(2) to verify that the HACCP system is operating according
to the plan, i.e., that the plan is being followed.

Since it is part of Food Safety System and System promotes preventive approach – that
remains hallmark of V&V over reactive approach.
 FST Limitation in understanding V&V

(1) the distinction between monitoring procedures and verification

activities and;

(2) the differences between validation and verification activities

and actions.
VALIDATION
 Verification and Validation Process

Validation: Say e.g. microbiological hazard of presence of pathogen

Kill step in process like baking, roasting, extruding, or frying

Need
Scientific, technical or regulatory back-up so that not all lots of products
require conformity testing of step (kill ) effectiveness.

Validation then is essentially a collection of proof that a process involving

chemical, physical, and biological inputs is consistently delivering a
desired effect to ensure the destruction of pathogenic microorganisms
generally measured as “log reduction”
 Verification and Validation Process

Validation is the application

of the methods to ensure
critical food safety limits,
prerequisite programmes
and control measures are
achieving intended purposes
and are effective in
controlling the hazard to the
appropriate level
 Verification and Validation Process

Validation:
So for Milk pasteurisation process as per Dr. Louis Pasteur :
Pathogenic bacteria in milk get killed at 72°C if heated for 15 seconds
OR 63°C for 30 minutes

For In Bottle Sterilisation - Bacteria kill temperature required is 105-110°C

for 30-45 min.

UHTS (Ultra High Temperature Short Time) or aseptic method: Packaging is

done after heat treatment. Requires 135-150 for 1-20 Seconds
 Verification and Validation Process

Validation:
Is validation only for Microbiological hazards?
 Verification and Validation Process

Validation:
Applicable to Chemical and Physical Hazards through
historically or scientifically proven limits.

e.g.
MRL of Pesticides & Heavy Metals as per Regulation.

Ensure: Through Finished Product Testing

 Verification and Validation Process

Validation:
Chemical and Physical Hazards are also possible to control and any
historically proven limits are considered good for those as well.
e.g.
Metal presence (Ferrous or non Ferrous)  Limits prescribed by
USFDA of < 7mm. But for grounded iron – ppm allowed in Food Laws
can be referred.
Analysis: Metal detectors available to detect Non Ferrous upto 3.5
mm. For flour etc. where metal detection is not employed, ppm
calculation in which prescribed iron ppm limit in FSSAI specification
forms the basis.
 Verification and Validation Process

Validation:
- Only for Control Measures appearing in the process?

Validation: is also for

- PRP i.e. Cleaning Validation  How – Swab Testing, Rinse Analysis

Any monitoring whose measure affects food safety can

be validated.
 Verification and Validation Process

So Validation:
Is to establish Limits to control at controls of PRP
AND Process.

Perform validation again:

• If there is any change in process
• Change in scientific and technical finding
• Change in regulatory requirement
VERIFICATION
 Verification and Validation Process

Definition:
Verification: confirmation, through the provision of objective evidence, that
specified requirements have been fulfilled.
 Verification and Validation Process

Requirements: Need or expectation that is stated, generally implied or obligatory.

Note: Generally implied means that it is customer or common practice for the
organisation and interested parties that the need or expectation under
consideration is implied.
Note: A specified requirement is one that is stated, for example in documented
information.
● validation is applied prior to an activity and provides information about the
capability to deliver intended results;
● monitoring is applied during an activity and provides information for action
within a specified time frame;
● Verification is applied after an activity and provides information for
confirmation of conformity.
 Verification and Validation Process
Verification of Hazard Control Plan :

Verification:
● Is the flow diagram right and complete?
● Are the control measures working
○ PRP (Reviewing monitoring of PRP done) and Effectiveness of HRM & Training
○ Hazard Control Plan (or HACCP Plan):
■ OPRP / CCP point physically and related record (with value)
● Are records kept?
● Are the process schedules validated?
● Is the documentation appropriate to operational processes?
 Verification and Validation Process

Verification:
ensure that verification activities are not carried out by the person responsible for
monitoring the same activities
- e.g. Operator monitors sieve integrity after every lot, Verifier (HOD) may
cross check it once a week
- e.g. magnet catch weighment done every 2 hours, Verifier (HOD) may
witness it once a day / week
 Verification and Validation Process

Verification: Also include:

● Supplier Audits Evaluation, Review of Chemical Preparation Register
● Process specific audit, Systems internal audit
● Reviewing monitoring and deviation procedures
● Result of Verification for monitoring and measuring methods and equipment
● Customer complaint analysis and MRM results
And as per Appaji Rao Sir – this may additionally include
● Mock Withdrawal, Mock Drill
 Verification and Validation Process

Verification resulting into failure - Include:

● OPRP, CCP thru parameter or testing  Potentially unsafe product
● Systems internal audit  System Non-Conformity
● Reviewing monitoring and deviation procedures  Subject product may
become potentially unsafe, re-establish system requirement
● Verification of MME Potentially unsafe product
 Verification and Validation Process

Verification: Management System demands: Defining

○ Purpose
○ Method
○ Frequencies  Depending upon Risk associated with CCP / OPRP, result
of previous audits, Customer Complaints
○ Responsibilities
○ Record reference
 Verification and Validation Process

Verification:
○ Is not record cross verification alone

But
○ As well involves cross verifying process parameter sometime
○ And also analysis
 Verification and Validation Process

Verification:
○ FST to conduct analysis of Verification Activities  Input to FSMS
performance, MRM
○ Verification of the actions taken post internal audit non-conformity

● Output of analysis of Verification  Updation of FSMS

 DISCUSSION ON
Responsibility
Activity
Dos and Don’ts
Summarise
Continual Improvement
3
Who should be responsible for V&V
 Responsibilities of Managers in V&V

Those responsible for Validation

● Literature study  Must for good manger to understand, document and defend limits
● Testing  To validate literature and develop equivalence in environment conditions
● To review correction and corrective actions and check for the food in question
● To revalidate limits periodically
● To ask management for literature support, advanced equipment as needed
Those responsible for Verification
● To verify process, quality outcome at designated time
● To verify record of parameters
● To review the process and process output (i.e. food material) if NC observed
● To bring back the system on track through Training, counseling, etc.
 Actions after Validation and Verification

Validation Verification
1. Continue as it is 1. Continue as it is
2. As per advancement in tech ask for 2. Confidence on system is improved,
better processing equipment may review testing frequency /
3. Ask for better laboratory equipment verification frequency
4. Re-fix limits as per changes in 3. If the verification result throws non
scientific findings / regulation compliance look for reasons in
practice, behaviour, tradition, culture
and address that methodically
4. Sometimes reward and punishment
may also be resorted to
 Verification and Validation Process

Do!
● Divide validation and verification into separate tasks
● Think of validation as your scientific evidence and proof the system
controls the hazards
● Think of verification as an audit process
● Use science-based information to support the initial validation
● Use management to participate in validation development and
operations of verification
● Use lessons from near misses and corrections to adjust and improve the
food safety system.
Source: http://www.foodprotection.org/files/food-protection-trends/NovDec-14-Brackett.pdf
 Verification and Validation Process

Don’t!
● Confuse the activities of verification with those of routine monitoring
● Rely on literature or studies that are unlike your process / product to prove
controls are valid
● Conduct audit processes and then not review the results
● Perform corrective actions without determining if a system change may be
needed to fix a problem
● Forget, reanalysis is done every 3 years or sooner if new information or problems
suggest.
Source: http://www.foodprotection.org/files/food-protection-trends/NovDec-14-Brackett.pdf
To summarise

● Scientist / Professor / Expert / consultant

● Manager – May not be member of FST

● Manager – May be member of FST

● Operators perform day to day activity under

supervision of supervisors. Verification is but done
by Manager
Verification and Validation Process

THANK YOU
Presenter Co-Presenter
Yogesh Jain Sonia Sawhney
+91 9303205440 +91 92140 69690
yogesh@nicheqs.com sonia@vrwservices.com