Be accountable for compiling and analyzing information to identify unacceptable trends and benefit risk conclusions with the goal of driving suitable corrective actions needed to maintain safe and effective products.

More Uses of the ISO 14971 Toolkit:

  • Ensure you train; are organized and process oriented as a skilled project management, you can balance a wide range of projects and tasks to your predetermined timelines.
  • Ensure product specification, material specification, and process specification are fully defined, unambiguous, and practical in production environment.
  • Orchestrate: human system capabilities and limitations are accurately reflected in the system requirements and human system performance and safety risks are appropriately addressed in program baseline.
  • Collaborate with the Design Team to support the design of QMS Modules to understand interactions and expected operation to incorporate with Validation efforts.
  • Provide statistical support to analyze manufacturing processes and to recommend appropriate process controls for ensuring product conformance to specification.
  • Initiate and lead project teams on non conformance investigations regarding component failures, finished goods failures, and product returns.
  • Establish that your organization develops effective verification strategies and test protocols for each system test, oversees testing and generates verification test reports.
  • Provide continual regulatory updates to the Management Team to ensure that processes needed for the quality system regulation are established, implemented and maintained.
  • Provide consultation to end users and process owners with regard to data collection, analysis and creation of design verification and validation protocols and reports.
  • Identify and implement effective process control systems to support the development, qualification, and on going manufacturing of products to meet or exceed internal and external requirements.
  • Provide oversight and guidance to equipment and process validation team members during the development and execution of validation and qualification plans, protocols, and reports.
  • Confirm your organization communicates all observed defects to the technical lead, updates test cases based on the discovered defects and re executes test cases accordingly.
  • Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders.
  • Establish that your organization supports the technical development of automated and manual assembly techniques, tooling, and identifies electro/mechanical testing development to improve product manufacturability.
  • Collaborate constructively with other functional group Core Team or Change Team members in defining performance requirements, conducting risk analysis, and verification test plan execution.
  • Govern: people who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
  • Evaluate process risks and ensures appropriate production and process controls are identified, qualified and implemented throughout the product manufacturing lifecycle.
  • Warrant that your organization plans, designs, and /or implements methods and procedures for inspecting, testing, and evaluating the precision and reliability of products and/or production and/or test equipment.
  • Identify any existing deviations, perform risk and root cause analysis and implement Corrective Action and Preventive Action to reduce the deviation from the actual process.
  • Confirm your organization provides engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with organizations procedures.
  • Facilitate and ensure that complex, high value Business Unit projects are properly scoped, resourced, and communicated to minimize risk, deliver on time and on budget.
  • Drive: monitor and advising the performance of IT quality management system, producing data, and measuring quality operations against set standards.
  • Assure your organization serves as a technical consulting resource for integration, subsystem and system verification activities updating plans, protocols, and reports, as necessary.
  • Make sure that your organization provides solutions to highly complex, significant, and complex issues; develops solutions based on in depth technical knowledge, organization policies, or defined process paths.
  • Confirm your organization plans, lead, monitors, and/or controls progress of projects to ensure sound application of engineering principles are used, and design intent is being achieved.


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