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Decoding Food Safety Validation & Verification

Posted by Tony-C, in Food Safety Standards 21 January 2015 · 3,606 views

validation verification
Decoding Food Safety Validation & Verification This subject of validation and verification is right up there in the list of food safety areas which cause the most confusion among members and the variety and often conflicting definitions and requirements in food safety certification standards as to what should be validated, what should be verified and what should be done to meet the criteria for validation and verification only adds to the confusion.

In this blog post I review what the main texts and food safety certification standards say about the subject of validation and verification comparing and contrasting their ideas whilst hopefully removing some of the confusion.

I’m going to start off with the principle that generally prerequisite programs are verified and control measures in HACCP/Food Safety plans are validated and verified.

So let’s look at prerequisite programs; prerequisite programs are implemented to provide sound environment and fundamental operating conditions that are necessary for the production of safe food.

Examples of prerequisite programs include

• Building fabric
• Calibration
• Chemical controls
• Cleaning and sanitation
• Consumer education
• Control of brittle material
• Control of raw materials
• Control of non-conforming product
• Control of operations
• Control of visitors and contractors
• Control of wood
• Corrective action and preventative action
• Dispatch and transport
• Documentation and records
• Employee awareness and responsibilities
• Equipment standards
• External standards
• Facilities
• Foreign body detection and removal
• Health status
• Housekeeping and hygiene
• Identification and traceability
• Instruction and supervision
• Labelling and pack control
• Layout, product flow and segregation
• Location
• Lot identification
• Maintenance
• Management and supervision
• Management of allergens
• Management of customer complaints
• Management of emergencies/incidents
• Medical screening
• Metal contamination control
• Personal behaviour
• Personal cleanliness
• Personal hygiene
• Pest control systems
• Product design & development
• Product information
• Product inspection
• Product labelling
• Product packaging
• Product recall procedures
• Product release
• Protective clothing
• Site security
• Specifications
• Staff facilities
• Storage
• Supplier approval and monitoring
• Training programmes
• Transport
• Utilities - water and air
• Waste & waste disposal

General requirements require prerequisite programs to be verified as implemented and effective.

For arguments sake let’s use a CODEX take on verification:

‘Verification is an ongoing activity used to determine that the control measures have been implemented as intended. Verification occurs during or after operation of a control measure through a variety of activities…’

Examples of such verification techniques are:

• External audits
• Inspections
• Internal audits
• Observation of monitoring activities
• Review of records
• Test results

On to validation

Validation is an assessment of control measure(s) that should be conducted prior to operation and is a process of gaining objective evidence to demonstrate that a control measure (or combination of control measures), when operating correctly, is capable of achieving the intended level of control, ensuring the hazard is eliminated or reduced to a defined acceptable level (within critical limits).

Validation methods include:

• Scientific literature
• Peer-reviewed published research
• Reference to legally defined CCP’s, such as for the pasteurization of milk
• In-house challenge studies
• Mathematical modelling

In some cases it may be that prerequisite programs control a specific hazard that needs to be controlled as identified during hazard analysis. When a prerequisite programme is used to manage a specific hazard there needs to be a documented validation that the prerequisite controls the identified hazard.

The most common example of where this is likely to occur is cleaning where effective cleaning is critical to ensure pathogens or allergens are eliminated or reduced to an acceptable level.

Some useful guidance on allergen cleaning is provided in SQF Module 2 Guidance Appendix 1: Allergen Cleaning and Sanitation Guide.

Following CODEX guidelines for Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application - Annex to CAC/RCP 1-1969 as per Principle 6 there is a requirement to establish procedures for verification to confirm that the HACCP system is working effectively. So as stated previously control measures in HACCP/Food Safety plans should be validated and verified.

So why the confusion?

We have seen quite a lot of confusion from members looking to achieve SQF certification, some of which seems to have originated from the requirements of the SQF 2000 Code - Ed 6 August '08 amended July '10 such as in clauses:

4.4.2.5 ‘Pre-requisite Programs shall be validated and verified as described in 4.5.’ and 4.5.2 Validation:

‘4.5.2.1 The methods, responsibility and criteria for validating Pre-requisite Programs and critical food safety limits to ensure they achieve their intended purpose shall be documented and implemented.’

As discussed previously the cause of this confusion is that generally prerequisite programs are verified.

The requirement for validating pre-requisite programs was replaced with ensuring the effectiveness of pre-requisite programs in the 7th Edition of the SQF Code July 2012 and subsequent editions:

SQF Code - A HACCP-Based Supplier Assurance Code for the Food Industry 7th Edition July 2012

2.5.2 Validation & Effectiveness (M)

2.5.2.1 The methods, responsibility and criteria for ensuring the effectiveness of pre-requisite programs, and validating critical food safety limits to ensure they achieve their intended purpose shall be documented and implemented.

The methods applied shall ensure that:

i. Pre-requisite programs are confirmed to ensure they achieve the required result.

There is further clarification of the revised requirements in General Guidance for Developing, Documenting, Implementing, Maintaining, and Auditing an SQF System Module 2: System Elements SQF Code, Edition 7.2 July 2014 where potential methods for confirming the effectiveness of specific pre-requisite programs are given and examples of validation methods for CCP’s or CQP’s to demonstrate that the hazard is adequately controlled. Unfortunately there are still some references to validation that may still cause confusion.

We also see quite a lot of confusion amongst members seeking ISO 22000 and FSSC 22000, usually this is related to the principle of categorizing control measures into operational prerequisite programmes and those controlled in the HACCP plan either way these control measures require validation. Clarification of the concepts of validation and verification are provided in TECHNICAL SPECIFICATION ISO/TS 22004:2005(E) Food safety management systems - Guidance on the application of ISO 22000:2005:

7.8 Verification planning

The concepts of validation, verification and monitoring are often confused.
  • Validation is an assessment prior to operation, the role of which is to demonstrate that individual (or a combination of) control measures are capable of achieving the intended level of control
  • Verification is an assessment carried out during and after the operation, the role of which is to demonstrate that the intended level of control has actually been achieved.
  • Monitoring is a procedure to detect any failures in the control measure.
Another source of confusion can be when referring to CODEX and NACMCF definitions and principles. Referring to NATIONAL ADVISORY COMMITTEE ON MICROBIOLOGICAL CRITERIA FOR FOODS HACCP Principles & Application Guidelines (3) validation is described as an element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan, when properly implemented, will effectively control the hazards.

Appendix G gives Examples of Verification Activities which include references to validation.

A. Verification procedures may include:

Validation of critical limits to confirm that they are adequate to control significant hazards.

Validation of HACCP plan, including on-site review.

B. Verification should be conducted:
When there are emerging concerns about the safety of the product.

When foods have been implicated as a vehicle of foodborne disease.

To assess whether a HACCP plan should be modified due to a change in the process, equipment, ingredients, etc.

C. Verification reports may include information on the presence and adequacy of:

Certification that monitoring equipment is properly calibrated and in working order.
Validation activities.

So we can see how people following NACMCF HACCP Guidelines could be confused by validation and verification requirements in food safety management certification standards.

Looking at the GFSI definitions and references to validation, the GFSI Guidance Document Sixth Edition Version 6.3 gives the following definitions:

Validation - An activity to obtain evidence that a requirement is controlled effectively.

Verification - A confirmation, through the review of objective evidence that requirements have been fulfilled.

There are a number of references to validation in the guidance document requirements:

The management system shall:

g) validate packaging design and development to ensure food safe and legal manufacture.

The measuring and monitoring equipment required shall have an adequate degree of accuracy and methods recognised and validated.

The standard shall require that equipment is suitably designed and validated for the intended purpose and be used and stored so as to minimise food safety risks from packaging materials.

The standard shall require that appropriate standards of housekeeping, cleaning and hygiene be maintained at all times and throughout all the stages with validation and recording of the effectiveness of the cleaning.

Food Sector Categories EI, EII, EIII, EIV & L (food processing categories) are required to have HACCP Systems where in all cases, the 7 Codex Alimentarius HACCP principles and the 12 step logic sequence for application of HACCP specified in the document, Recommended International Code of Practice – General Principles of Food Hygiene CAC/ RCP 1-1969, Rev. 4 -2003, shall apply.

Going back to the SQF Code Guidance for Developing, Documenting, Implementing, Maintaining and Auditing an SQF System SQF Code, Edition 7.2 – Module 2: SQF System Elements states:

2.5 SQF System Verification

Definitions of validation and verification differ slightly from standard to standard. The GFSI Guidance Document version 6.2 defines validation as “an activity to obtain evidence that a requirement is controlled effectively” and verification as “a confirmation through the review of effective evidence that requirements have been fulfilled.” SQF uses the Codex definition. In other words, validation applies to scientific authentication that the critical limits set for each CCP and CQP will achieve the intended results (refer 2.5.2). Verification applies to the entire SQF System and includes methods such as sampling, internal audit and re-validation to demonstrate that the SQF System is working and is effective.

Whilst the GFSI Guidance Document Sixth Edition Version 6.3 requirements for the food safety management systems section refers to CODEX 16 times, NACMCF is also referred to in Hazard Analysis and Critical Control Point (HACCP) clauses 3 times. This section in the guidance refers to validation 4 times, by comparison in ISO 22000:2005 there are 5 references to validation, in IFS Food V6 there are 8 references to validation and in both the SQF Code (Modules 2 & 11) and BRC Food Standard there are 17 references to validation.


Summary

If in doubt consult CODEX guidelines for Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application - Annex to CAC/RCP 1-1969 which is referred to in GFSI requirements, BRC Global Standard for Food Safety, the SQF Code, IFS Food and ISO 22000.

Codex GUIDELINES FOR THE VALIDATION OF FOOD SAFETY CONTROL MEASURES CAC/GL 69 - 2008 is also very useful and contains examples of validation of food safety control measures.

This PDF document includes references to validation UNDERLINED and areas that may cause confusion in RED


I’ll finish off with this simple example

‘The following example for uncooked fermented sausages illustrates the interrelationship of validation, verification and monitoring:

- Validation: The competent authority established the need for control measure(s) that achieve a specified log reduction in pathogenic Escherichia coli. The validation process indicated that industry could consistently achieve a specified log reduction through ensuring a specific decrease in pH during fermentation and a specific decrease in water activity during maturation, coupled with ensuring that the raw materials have less than a specified level of pathogenic E. coli based on statistically-based microbiological testing.

- Monitoring: Measuring pH drop during fermentation and weight loss (or water activity) during maturation.

- Verification: Periodic process control testing for pathogenic E. coli to verify that incoming levels in the raw materials are within specification and that fermentation and maturation achieve the intended outcome in the semi-finished or finished product. Examination of monitoring records to check for continuous control over time.’


References
  • NATIONAL ADVISORY COMMITTEE ON MICROBIOLOGICAL CRITERIA FOR FOODS HACCP Principles & Application Guidelines
  • BRC Global Standard for Food Safety Issue 7 Interpretation Guideline
  • BRC Global Standard for Food Safety Issue 7
  • SQF Code - A HACCP-Based Supplier Assurance Code for the Food Industry Edition 7.2 MARCH 2014
  • Guidance for Developing, Documenting, Implementing, Maintaining and Auditing an SQF System SQF Code, Edition 7.2 – Module 2: SQF System Elements
  • Guidance for Developing, Documenting, Implementing, Maintaining and Auditing an SQF System SQF Code, Edition 7.2 – Module 11: Food Safety Fundamentals – Good Manufacturing Practices for Processing of Food Products
  • SQF 2000 Code - Ed 6 August '08 amended July '10 A mended July ‘10
  • SQF Code - A HACCP-Based Supplier Assurance Code for the Food Industry 7th Edition July 2012
  • IFS Standard for auditing quality and food safety of food products Version 6 January 2012
  • ISO 22000:2005
  • TECHNICAL SPECIFICATION ISO/TS 22004:2005(E) Food safety management systems - Guidance on the application of ISO 22000:2005
  • GFSI Guidance Document Sixth Edition Version 6.3
  • CODEX guidelines for Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application - Annex to CAC/RCP 1-1969
  • Codex GUIDELINES FOR THE VALIDATION OF FOOD SAFETY CONTROL MEASURES CAC/GL 69 - 2008


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Dear Tony,

 

Excellent effort to clarify the situation but I fear it’s a lost cause. This boat may well have sailed.

 

Even some (many?) FS auditors seem to be baffled as to what their standards actually require.

The occasional, contrarial, use of the Va-Ve words as simple English verbs often doesn’t help either.

 

It would be certainly be nice IMO if Food Standards included in their glossary a reasonably unambiguous statement of tthe Standards practical interpretation of the chosen reference definition. The difficulty is that, in the absence of specific examples which have often become (Standard) abhorred due fears of misused plagiarism, brevity is near impossible. (cf your blog, ILSI’s Va/Ve Report 2001, FSIS’s meat process document 2013).

 

It’s also, implicitly/explicitly acknowledged that from a modern POV, Va may include a pilot study which then potentially overlaps (Codex) Verification. This effectively (and necessarily?) introduces a deferrable zigzag.

 

Perhaps the food industry  might consider some of the alternative Va-Ve methods used in other areas, but then again, better the devils we know ......?  –

 

http://programmers.s...ation-if-so-whi

    • 0

Superb work again tony, well researched and a great reference for members. :clap:

    • 0

Hi Tony

 

Thank you very much for  the explaination, it really helped.

 

 Question : (Milk Powder production)

1)I have G4 & F8 filters as an OPRP how does one validate this?

2) I have pasteurazition as a CCP -they want us to validate this as well (We are pasteurizing at 75 degrees celsius for 15 seconds.I have a calculation that proves that my holding time with 15000 l/h (worst case scenario)  is 15.29 seconds-that takes into consideration the lenght of the holding tube ,bends etc. according to the auditors I need proof that microbiologically this time/ temperature combination is really a kill step.How do I go about doing that.

3) Metal detection - Can I use the test strips that I verify with to validate this CCP.For instance take the stainless steel test piece put it inside the milk powder bag and test it at least 20 times, if it consistently pick it up then I can conclude that the metal detector can control the hazard.

 

Thanking you  in advance for your  help.

KB

    • 0

Hi KB,

 

1. I'm going to post a few useful links on this one. You can validate yourself using an air sampler or using a validation service. I would use a validation service annually and monitor using an air sampler:

 

RECOMMENDED INTERNATIONAL CODE OF HYGIENIC PRACTICE FOR DRIED MILK CAC/RCP 31 1983
4.4.4 Air
An adequate supply of air should be provided for the drying, conveying, cooling or air sweeping of the product. Where necessary, precautions should be taken to remove oil, moisture, dirt, microorganisms, insects, odours and all other objectionable matter, from such air. Compressed air which comes into contact with milk products or product contact surfaces should also conform to these requirements.


http://www.dairyaust...D3AD8C70F97.pdf
Specifies G 1-4 prefilter H 11-13

http://www.inspectio...52333841?chap=2

http://www.foodsafet...ndards_Bulk.pdf Page 31

http://www.foodprote...lin/Fischer.pdf
Specifies EU 10 filtraion

http://en.wikipedia.org/wiki/HEPA

http://www.freudenbe...sting-services/
Validation services

http://www.mbv.ch/ma...-eco_29-en.html
Air sampler

 

2. For Validation you could refer to PMO
Page 82 & Appendix H

Your plant should have been validated on commissioning to ensure it kills pathogens. You can do this by comparing raw and pasteurized milk samples. Your routine testing should verify the plant is working correctly. You want to ensure that your process reduces the maximum specified level of pathogen in your raw materials to the level specified for your finished product.

 

3. For MD validate by putting test strips inside bags as you have stated ensuring the strip is detected/rejected in the least sensitive area of the detector as per manufacturers instructions (Check that you get the same result with the test strips outside the bag also at this stage). Verification can be carried out by checks that the test strip is rejected before during and at the end of production.

 

Regards,

 

Tony

    • 0

Very good read. Thank you.

    • 0