5.4.05 Creating a risk matrix for clinical treatment patterns (FMEA) Estimated reading: 1 minute 228 views Authors Purpose and goal A risk analysis is carried out for individual treatment patterns. The risks are identified according to the phases of a treatment, their probability, the severity of the consequences and the probability of timely detection are estimated and summarised in a risk indicator. Measures are introduced to reduce the risk and the expected risk reduction is then estimated. The results of the risk analysis are stored in the product documentation (configuration documents). DIN EN ISO 9001:2015 and DIN EN 15224:2017 6.1.2 Note; DIN EN ISO 14971:2012 4 Risk analysis; QM-RL:2015 § 4 (1) - Risk management sentence 1 - 3 Area of application Treatment patterns for which a risk matrix is to be created in order to analyse a particular hazard situation Description of the To the text of the VA Download Attachments Appendix 1 Risk matrixDownload Appendix 2 Questions to identify characteristics of a treatment procedureDownload Appendix 3 Examples of hazardsDownload Appendix 4 Assessment of the acceptability of hazards Appendix 5 Example of the risks of hernia operationsDownload Appendix 6 Example of hazards in arthroplastyDownload 5.4 Improvement measures - Previous 5.4.04 Individual case analysis of a UE Next - 5.4 Improvement measures 5.4.06 Problem-solving and improvement techniques
