The FDA inspections reveal the following violations from companies in 2020
FSVP Development 514
|Fee Category||Fee rates for FY 2022|
|Hourly rate if domestic travel is required||$277|
|Hourly rate if foreign travel is required||$330|
Other methods of verification are identified besides onsite audits. The current practices do not yield ongoing compliance, as evidence by the FDA violations. Audits are not making entities demonstrate compliance. The infrastructure format for managing food process flow chart is based on the traditional discipline silos, which are attempting to facilitate FSMA’s risk based requirements. The dissonance suggests an alternate format is needed for operationalizing the law. The point is – the present and traditional management tools methodology are not designed to enable ongoing compliance – especially with paper.
fsma SaaS offers harmonious technology that systematically covers all the requirements for FSMA digitally, with appropriate management controls, with the supplier’s seamless interface with the importer. Its digital intuitive flow facilitates ongoing compliance, paperlessly.
The importer can meet the verification responsibilities through the seamless interface. It is direct method for 100 % verification – rather than depend on a third party auditor results, which can be as old as one year. The information that can be presented to the customs and the FDA inspections.
fsma SaaS presents more certainty for verification outcomes rather than risking the results of a sampling exercise. Moreover, because of its design, the importer is assured of the supplier compliance.
Which is preferred? the risk of violations because of sampling which could lead to reinspection fees and the possible disruption of the supply chain or ongoing compliance?
Because of continuing FDA inspections violations – it is necessary to consider other verification options that are within the law because audit sampling is unreliable and the traditional operating methods are not conducive to producing the desirable outcomes.
Food Safety is subject to regulatory compliance. Software is the most efficient method to effectively manage compliance. ‘fsma SaaS’ is a food safety software application.
The Principal of ‘fsma SaaS’ spent 15 years in food manufacturing. His involvement was both in production and maintenance management and his experience also included ISO Standards consulting for California state. The experiences led to the design of food safety software. As a PCQI, his familiarity led to the design of food safety software. The mechanics of ‘fsma SaaS’ operate as a system.
The ‘fsma SaaS’ application consists of a Cloud and two apps – Shecklist and Sheca.
‘Shecklist’ manages Hazard Analysis and Risk-Based Preventive Controls. The scheduled download is available at each process step from the cloned process.
‘Sheca’ manages the corrective actions at each process step.
The applications employ ISO standard techniques for control. The construct of ‘fsma SaaS’ enables end to end control in one software program. Layered controls and verifications enable compliance. Operator decisions are limited to either yes or no. The software acts as a manager making logical decisions. After the operator decides yes/no, the software directs the next action. The action follows a controlled process of clauses for regulatory compliance. Paper or more than one software program cannot automate error-proofing. A gap exists if disciplines are not all-inclusive.
LOWEST FSMA COMPLIANCE COST
FASTEST FOOD SAFETY RECORDS