Any effective quality management system (including the subsystems) works as a control process, which has the ability to detect deviations and nonconforming products and assures that the corrective and preventive action measures are effective. The regulatory auditor should check that all subsystems and processes of the quality management system are structured as self-regulating control processes. For example Deming’s PDCA cycle demonstrates such a process with the following components:
i) Plan – Has the manufacturer established the objectives and processes to enable the quality system to deliver the results in accordance with the regulatory requirements?
ii) Do – Has the manufacturer implemented the quality system and the processes?
iii) Check – Has the manufacturer checked process monitoring and measurement results against the objectives and the regulatory requirements? Does the manufacturer evaluate the effectiveness of thequality system periodically through internal audits and management reviews?
iv) Act – Has the manufacturer implemented effective corrective and preventive actions? Confirm that the company is committed to providing high quality safe and effective medical devices, and that the company is conforming with applicable laws and regulations.
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