FSSC v 6.0 - Allergen Verification
Hi there, what's the difference between validation and verification of Allergen? Can we do allergen test internally?
I think if the lab is acceradiated approved then test can be done internally
Say that the production line produce all products with allergen as per raw material used (gluten, fish product, tree nuts, soy beans, egg and dairy), how to conduct validation?
Hi there, what's the difference between validation and verification of Allergen? Can we do allergen test internally?
Hi Shaf03,
For the FSSC 22000 Certification Scheme the requirements for the allergen management, validation and verification are covered in 3 documents as outlined below.
Validation and verification are prescribed in International ISO Standard 22000 2018 Food safety management systems — Requirements for any organization in the food chain.
Section 8.5.3 Validation of control measure(s) and combinations of control measures
Section 8.8 Verification related to PRPs and the hazard control plan - 8.8.1 Verification
ISO 22000 isn’t particularly specific in what validation and verification is required.
Technical ISO/TS Specification 22002-1 Prerequisite programmes on food safety —
Part 1: Food manufacturing has requirements in Section 10.3 Allergen management but does not refer to validation and verification.
FSSC 22000 Certification Scheme Part 2 | Requirements for Organization to be Audited Section 2.5.6 Management of Allergens (ALL FOOD CHAIN CATEGORIES) covers allergens validation and verification:
The organization shall have a documented allergen management plan that includes:
c) Identification and implementation of control measures to reduce or eliminate the risk of cross-contamination, based on the outcome of the risk assessment; and
d) Validation and verification of these control measures shall be implemented and maintained as documented information. Where more than one product is produced in the same production area that have different allergen profiles, verification testing shall be conducted at a frequency based on risk, e.g., surface testing, air sampling and/or product testing;
So although there are requirements for validation and verification, there is only limited guidance.
So, if there is a risk of cross-contamination of allergen between one product and another then measures must be in place to prevent or reduce the hazard to an acceptable level. When this is achieved by cleaning then the cleaning procedures need to be validated and verified. Validation can be achieved by using an ELISA test or specialist product testing to detect residual allergen content in “first off product” after the clean. For verification I would use ATP swabs but Proteins Swabs are also and option. Here are some extracts from previous SQF Guidance which is applicable to this situation:
Validation
The purpose of validation is to prove that the cleaning process employed is effective in removing the allergen of concern. This proof requires evidence that the specific allergen was in fact removed, or reduced to an acceptable level by the cleaning procedure. Therefore, only an allergen specific test will provide that evidence.
The acceptable validation testing methods involve the use of a test specific to the allergen being removed. These generally require the use of a test method which uses an antigen (the allergen) and an antibody specific to the antigen. One example of the antigen and antibody test is the enzyme linked immuno-assay or ELISA method.
Verification
Once a validated cleaning method has been shown to remove the allergenic material of concern, the facility must verify that the validated procedures were used each time. This verification must be documented by a responsible person from the site who has been trained in the validated cleaning method. The most common method used is direct observation of the validated cleaning procedure during the sanitation process. Another acceptable verification method is the use of highly sensitive swabs that test for proteins. These recently developed swabs will detect total protein at approximately 20 ppm. Since these devices only test for total protein and not specific allergens, they are not acceptable for validation but will serve to verify that equipment has been thoroughly cleaned. There are also sensitive ATP test swabs available however the presence of ATP does not indicate the presence of protein which is the allergenic material. The use of these total protein swabs or the ATP sensitive swabs must be calibrated with the validated cleaning procedure by using them immediately after the validated method is used and recording the results of both the allergen specific test and the protein or ATP swab test.
Kind regards,
Tony
Validation is applied prior to an activity and provides information about the capability to deliver intended results
Verification is a confirmation that specified requirements have been fulfilled
Hi Shaf03,
For the FSSC 22000 Certification Scheme the requirements for the allergen management, validation and verification are covered in 3 documents as outlined below.
Validation and verification are prescribed in International ISO Standard 22000 2018 Food safety management systems — Requirements for any organization in the food chain.
Section 8.5.3 Validation of control measure(s) and combinations of control measures
Section 8.8 Verification related to PRPs and the hazard control plan - 8.8.1 Verification
ISO 22000 isn’t particularly specific in what validation and verification is required.
Technical ISO/TS Specification 22002-1 Prerequisite programmes on food safety —
Part 1: Food manufacturing has requirements in Section 10.3 Allergen management but does not refer to validation and verification.
FSSC 22000 Certification Scheme Part 2 | Requirements for Organization to be Audited Section 2.5.6 Management of Allergens (ALL FOOD CHAIN CATEGORIES) covers allergens validation and verification:
The organization shall have a documented allergen management plan that includes:
c) Identification and implementation of control measures to reduce or eliminate the risk of cross-contamination, based on the outcome of the risk assessment; and
d) Validation and verification of these control measures shall be implemented and maintained as documented information. Where more than one product is produced in the same production area that have different allergen profiles, verification testing shall be conducted at a frequency based on risk, e.g., surface testing, air sampling and/or product testing;
So although there are requirements for validation and verification, there is only limited guidance.
So, if there is a risk of cross-contamination of allergen between one product and another then measures must be in place to prevent or reduce the hazard to an acceptable level. When this is achieved by cleaning then the cleaning procedures need to be validated and verified. Validation can be achieved by using an ELISA test or specialist product testing to detect residual allergen content in “first off product” after the clean. For verification I would use ATP swabs but Proteins Swabs are also and option. Here are some extracts from previous SQF Guidance which is applicable to this situation:
Validation
The purpose of validation is to prove that the cleaning process employed is effective in removing the allergen of concern. This proof requires evidence that the specific allergen was in fact removed, or reduced to an acceptable level by the cleaning procedure. Therefore, only an allergen specific test will provide that evidence.
The acceptable validation testing methods involve the use of a test specific to the allergen being removed. These generally require the use of a test method which uses an antigen (the allergen) and an antibody specific to the antigen. One example of the antigen and antibody test is the enzyme linked immuno-assay or ELISA method.
Verification
Once a validated cleaning method has been shown to remove the allergenic material of concern, the facility must verify that the validated procedures were used each time. This verification must be documented by a responsible person from the site who has been trained in the validated cleaning method. The most common method used is direct observation of the validated cleaning procedure during the sanitation process. Another acceptable verification method is the use of highly sensitive swabs that test for proteins. These recently developed swabs will detect total protein at approximately 20 ppm. Since these devices only test for total protein and not specific allergens, they are not acceptable for validation but will serve to verify that equipment has been thoroughly cleaned. There are also sensitive ATP test swabs available however the presence of ATP does not indicate the presence of protein which is the allergenic material. The use of these total protein swabs or the ATP sensitive swabs must be calibrated with the validated cleaning procedure by using them immediately after the validated method is used and recording the results of both the allergen specific test and the protein or ATP swab test.
Kind regards,
Tony
Dear tony, this is really helpful! Thanks!
Dear tony, this is really helpful! Thanks!
Hi Shaf03,
For the FSSC 22000 Certification Scheme the requirements for the allergen management, validation and verification are covered in 3 documents as outlined below.
Validation and verification are prescribed in International ISO Standard 22000 2018 Food safety management systems — Requirements for any organization in the food chain.
Section 8.5.3 Validation of control measure(s) and combinations of control measures
Section 8.8 Verification related to PRPs and the hazard control plan - 8.8.1 Verification
ISO 22000 isn’t particularly specific in what validation and verification is required.
Technical ISO/TS Specification 22002-1 Prerequisite programmes on food safety —
Part 1: Food manufacturing has requirements in Section 10.3 Allergen management but does not refer to validation and verification.
FSSC 22000 Certification Scheme Part 2 | Requirements for Organization to be Audited Section 2.5.6 Management of Allergens (ALL FOOD CHAIN CATEGORIES) covers allergens validation and verification:
The organization shall have a documented allergen management plan that includes:
c) Identification and implementation of control measures to reduce or eliminate the risk of cross-contamination, based on the outcome of the risk assessment; and
d) Validation and verification of these control measures shall be implemented and maintained as documented information. Where more than one product is produced in the same production area that have different allergen profiles, verification testing shall be conducted at a frequency based on risk, e.g., surface testing, air sampling and/or product testing;
So although there are requirements for validation and verification, there is only limited guidance.
So, if there is a risk of cross-contamination of allergen between one product and another then measures must be in place to prevent or reduce the hazard to an acceptable level. When this is achieved by cleaning then the cleaning procedures need to be validated and verified. Validation can be achieved by using an ELISA test or specialist product testing to detect residual allergen content in “first off product” after the clean. For verification I would use ATP swabs but Proteins Swabs are also and option. Here are some extracts from previous SQF Guidance which is applicable to this situation:
Validation
The purpose of validation is to prove that the cleaning process employed is effective in removing the allergen of concern. This proof requires evidence that the specific allergen was in fact removed, or reduced to an acceptable level by the cleaning procedure. Therefore, only an allergen specific test will provide that evidence.
The acceptable validation testing methods involve the use of a test specific to the allergen being removed. These generally require the use of a test method which uses an antigen (the allergen) and an antibody specific to the antigen. One example of the antigen and antibody test is the enzyme linked immuno-assay or ELISA method.
Verification
Once a validated cleaning method has been shown to remove the allergenic material of concern, the facility must verify that the validated procedures were used each time. This verification must be documented by a responsible person from the site who has been trained in the validated cleaning method. The most common method used is direct observation of the validated cleaning procedure during the sanitation process. Another acceptable verification method is the use of highly sensitive swabs that test for proteins. These recently developed swabs will detect total protein at approximately 20 ppm. Since these devices only test for total protein and not specific allergens, they are not acceptable for validation but will serve to verify that equipment has been thoroughly cleaned. There are also sensitive ATP test swabs available however the presence of ATP does not indicate the presence of protein which is the allergenic material. The use of these total protein swabs or the ATP sensitive swabs must be calibrated with the validated cleaning procedure by using them immediately after the validated method is used and recording the results of both the allergen specific test and the protein or ATP swab test.
Kind regards,
Tony
Hi Tony,
I have question on the validation. We cannot conduct validation on product testing as our product has all 8 major allergens and it's residues. So how can we conduct validation?