Actionable requirements | External Onsite Audit | Sampling & Test | Traditional Food Safety Records | Supplier food safety records by fsma SaaS | fsma SaaS Advantages |
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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 |
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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 |
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