MDSAP Audit Approach (MDSAP AU P0002) C3-T12: Gather and evaluate post-production experience, including complaints and post-market surveillance, feed it into improvement and risk management, and (for Australia) pass serious problem and proposed recall information to the TGA or sponsor as soon as practicable

What does C3-T12 require?

The organisation must make effective arrangements to learn from the post-production phase (post-market surveillance, complaint handling, investigation of causes behind advisory notices) with feedback into measurement, analysis and improvement, and must consider production and post-production data when updating the product risk analysis. Australia: the post-marketing system must systematically review experience from sources such as user groups, surveys, complaints, warranty and service data, literature, post-market studies and adverse event reports, and investigate promptly so that information about malfunction or deterioration, design, labelling, instruction or advertising inadequacies, or any use that could cause, or could have caused, death or a serious decline in health, and information on technical or medical reasons that led the manufacturer to start a recall, reaches the TGA or the sponsor once the manufacturer becomes aware (Sch 3 Pt 1 cl 1.4(3) and (3A)); contact should not wait until a recall is finished. Japan: the Registered Manufacturing Site must have effective arrangements to share customer feedback, complaints and advisory notice information with the marketing authorization holder (MO169 Art 29). Clauses: ISO 13485:2016 4.2.1, 7.2.3, 7.5.4(a), 8.2.1, 8.2.2, 8.5.1.