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 | Traditional Food Safety Records | Supplier food safety records by fsma SaaS | fsma SaaS Advantages |
|---|---|---|---|---|---|
| Process flow chart | Traditional audit modes are not risk based | Paper – multiple checklists from independent departments | Process Flow chart – Paper limiting and disciplines not integrated | Digital in the cloud and available for scheduled download as one electronic document at point of use | Applied manufacturing controls of related disciplines |
| Cost | Audit Sampling exercise not effective for verification | Significant | Cost – Subject to collating and storing records | $0 to Importer | Least expensive for supplier and importer |
| Compliance Effectiveness | Audit records are typically whether an activity was carried out – does not address risk | Does not satisfy all verification requirements | Compliance effectiveness – no control in ensure compliance is maintained – trust dependent | Ongoing compliance framework, which satisfies all FSMA requirements | Risk of FDA Violation and reinspection fees minimized |
| Records - time to reach importer | Auditor may not be expert on all related disciplines associated with the process | Delayed for independent lab results | Records time to reach importer – Collected by discipline with risk of not reaching importer in timely manner for example – trained personnel | Real time prior to shipping | Supplier provides original records as is required by FDA |
| Media | Yes | Paper by each discipline and function | Media – Paper by discipline | Digital -holistic integration of disciplines and functions | Enables Management by Exception by Supplier, including denial of access unless trained |
| Risk of FDA violations | FDA can find violations after External Audit completed – see 2020 violations | Yes | Risk of FDA violations – 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 | Only able to determine if a checklist activity was conducted | FDA can find violations, even as sampling and test is accepted by importer | Verification status – lots of work for importer to review individual documents | 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 | Auditor not trained in risk based auditing and its relationship with corrective actions | Standalone disciplines with Paper are employee trust dependent | Manufacturing control 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) | Auditor unable to audit full supply chain for traceability. Limited to audit facility. | Delay or uncertainty on when to open a corrective action – takes a longer time to resolve | Corrective Action – does not pinpoint loss of control or resource in process |
|
Supplier- Alerts to management of corrective action required Importer- Provides earlier time for meeting 7 day response time limit after the non-conformance |
| Traceability | Auditor can be bogged down resolving the recall activities | Manual input | Traceability – non digital or bar code – subject to manual input error | 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 | Recall – manual records requiring several actions, which are not intuitive manually | One click to all importers | Digital enables recall response emails of the specific lot |