Verification

Verification is the application of methods, procedures, tests and other evaluations, in addition to monitoring to determine whether a control measure or a combination of control measures is or is operating as intended and to establish the validity of the food safety plan. 21 cfr 117.3

Verification

Verification is the application of methods, procedures, tests and other evaluations, in addition to monitoring to determine whether a control measure or a combination of control measures is or is operating as intended and to establish the validity of the food safety plan. 21 cfr 117.3

Comparison - Foreign Supplier Verification Methods

Actionable requirements	External Onsite Audit	Sampling & Test	Supplier food safety records by fsma SaaS	fsma SaaS Advantages
Process flow chart	Paper multiple checklists from independent departments	Paper – multiple checklists from independent departments	Digital in the cloud and available for scheduled download as one electronic document at point of use	Applied manufacturing controls of related disciplines
Cost	Collating paper records greater than $1	Significant	$0 to Importer	Least expensive for supplier and importer
Compliance Effectiveness	Frequency of audits - annual– no assurance of completed desired controls	Does not satisfy all verification requirements	Ongoing compliance framework, which satisfies all FSMA requirements	Risk of FDA Violation and reinspection fees minimized
Records - time to reach importer	Delayed for collating documents	Delayed for independent lab results	Real time prior to shipping	Supplier provides original records as is required by FDA
Media	Paper by each discipline and function	Paper by each discipline and function	Digital -holistic integration of disciplines and functions	Enables Management by Exception by Supplier, including denial of access unless trained
Risk of FDA violations	Yes	Yes	No- Framework of Error proofing and alerts when scheduled activities are not completed	Violations are not about the food, but compliance to FSMA.
Verification status	FDA can find violations after External Audit completed – see 2020 violations	FDA can find violations, even as sampling and test is accepted by importer	100% verification because of framework for on-going compliance	Intuitive – no knowledge of the legal requirements – all FSMA requirements embedded in the technology
Manufacturing control	Standalone disciplines with Paper are employee trust dependent	Standalone disciplines with Paper are employee trust dependent	Integrated Controls at point of use	Digitizing the operations – enables controls and not trust dependent due to error proofing and alerts within the technology
Corrective action decision making (when to open)	Delay or uncertainty on when to open a corrective action -takes a longer time to resolve	Delay or uncertainty on when to open a corrective action – takes a longer time to resolve	Suppliers - Automated corrective action due to binary configuration and opened when conditions not met Importer -Available box for checking each lot, if required	Supplier- Alerts to management of corrective action required Importer- Provides earlier time for meeting 7 day response time limit after the non-conformance
Traceability	Manual input	Manual input	Ingredient Bar code scan at point of use or digital manual input	Less risk of errors in recording bar code or manual digits
Recall	Manual	Manual	One click to all importers	Digital enables recall response emails of the specific lot

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