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.V&V tasks – Design Phase – Evaluation of software design – Evaluation / Analysis of the Interfaces (UI) – Generation of Integration test plan – Generation of Component test plan – Generation of test design#4.
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.• Test for boundry values, stress and the functionalities • Test for error messages and in case of any error, the application is terminated gracefully.• Test that the software meets the business requirements and is fit for use.• Validate that the products and its components are suitable for environment.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.In simple words the test execution which we do in our day to day life are actually the validation activity which includes smoke testing, functional testing, regression testing, systems testing etc…• Requirement verification Involves review of the requirements • Design Verification Involves reviews of all the design documents including the HLD and LDD • Code verification Code review • Documentation Verification Verification of user manuals and other related documents.• Prepare the test requirements documents, test cases, and other test specifications to analyze the test results.• Evaluate that these test requirements, test cases and other specifications reflects the requirements and is fit for use.Verification and validation are performed in each of the phases of the lifecycle. V & V tasks – Planning: – Verification of contract – Evaluation of Concept document – Performing risk analysis#2.V & V tasks- Requirement phase – Evaluation of software requirements – Evaluation / analysis of the interfaces – Generation of systems test plan – Generation of Acceptance test plan#3.When we carry out the V&V tasks, we have to concentrate both of these view of quality.To begin, let’s try to understand the terms first and try to explore them with different standards.