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Activities included in the design phase are meant to determine if the equipment, process inputs and the environment can meet the intended FS outcomes. Documentation that the HACCP plan and the PRPs are operating as planned during actual in-plant production operating conditions. FSIS Compliance Guideline HACCP Systems Validation May 2013. The objective is to use continuous process verification to ensure that critical FS attributes are controlled throughout the process.
Outputs of this process include but are not limited to: • Identifying hazards • Identifying the expected level of hazard reduction or prevention that must be achieved • Identifying critical operating parameters, including control limits • Identifying the process steps that will achieve the needed reduction or prevention of the hazards • Identifying the processing steps that will be monitored • Ensuring the establishment and verification of PRPs needed to maintain the environment for processing under safe conditions • Conducting microbial validation studies under worst-case conditions • Establishing that the equipment in the process can operate within the established operating parameters • Demonstrating that the critical control equipment and instrumentation can operate within the prescribed parameters for the process equipment • Initially determining that the processing equipment is properly installed and can achieve the required objectives FS system execution ensures that three activities take place: 1. Basic questions that need to be answered include: • Does the FS team have confidence in the manufacturing process? Meat and Poultry Hazards and Controls Guide: usda.gov/OPPDE/rdad/FSISDirectives/5100.2/Meat_and_Poultry_Hazards_Controls_Guide_10042005 USDA Food Safety Inspection Service: usda.gov/shared/PDF/HACCP_Systems_ The plant needs to identify key indicators, including the following measures: • PRPs • Ingredients • Product attributes (both in-process and finished product) • Key process measures • Facility inspection results • Internal audit reports • Effectiveness of corrective actions • Employee competency assessments • Updating the HACCP plan • Other procedures required by the plant to have an effective FS system These results should be statistically analyzed for important trends to identify actions that need to be taken to build a more robust FS system.
Verification is a process of evaluating the intermediary work products of a software development lifecycle to check if we are in the right track of creating the final product.
Now the question here is : What are the intermediary products?
V&V Tasks – Maintenance Phase – Evaluation of the anomalies – Assessment of migration – Assessment of the retrial features – Assessment of proposed change. V&V processes determine whether products of a given activity confirm to requirements and are fit for its use.
In a very simpler terms ( to avoid any kind of confusion), we just remember that Verification means the review activities or the static testing techniques and validation means the actual test execution activities or the dynamic testing techniques.
Validation, verification and monitoring are critical components of food safety and quality management programs.
Table 1[1-3] provides some definitions for validation, verification and monitoring.
• Do lessons learnt activities and collect the improvement information. V&V tasks during different phases of development lifecycle: A development phase has different phase.In my food safety seminars, I ask food safety professionals to define validation and verification.This allows for meaningful conversation on the subject. Validation of GMP programs: mb.ca/agriculture/food-safety/at-the-food-processor/ National Advisory Committee on Microbiological Criteria for Foods. Requisite scientific parameters for establishing the equivalence of alternative methods of pasteurization.Well, These can include the documents which are produced during the development phases like, requirements specification, design documents, data base table design, ER diagrams, test cases, traceability matrix etc.We sometimes tend to neglect the importance of reviewing these documents but we should understand that reviewing itself can find out many hidden anomalies when if found or fixed in the later phase of development cycle, can be very costly.