FDA investigators will determine if a design is appropriate, or safe and effective by evaluating the design control process, make recommendations based on whether the manufacturer has the required checks and balances in place, and verify implementation of the design control guidelines . Organizations should be remain creative, meet schedule team action and documentation are highlighted in the design control flowchart because of the critical part they play in obtaining compliance to QSR. s, and stay compliant in order to have efficient Design control system. controls. Organizations shall establish and maintain the proper documentation to ensure the specified design requirements are met.When reviewing the design control requirements. Risk analysis is also an important part of design control for which FDA will look for. FDA reviewers will verify the safety and effectiveness of the device. It is therefore essential that any risks and hazards are mitigated to acceptable levels.