Challenges in practice
Deviations are documented in the various areas of your company and their causes identified as far as possible. Whether deviations in the initial sample process with your suppliers, failures in your SPC inspections in the production area or quality deficiency reported by your customers: the prerequisite for a quick and systematic root cause analysis is the use of common cause analyses. Standardised, comprehensible presentations of the associated risk analysis for the correction and preventive elimination of deviations, such as the 8D report, are often required by your customers. Particularly in the GxP environment, special regulations and standards for handling error analyses in the form of CAPA (Corrective and Preventive Action) processes are essential for a corrective and preventive action system.
Solution QS1
Failure analyses in accordance with IATF 16949 or CAPA in accordance with ISO 13485 - QS1 offers you the tools to efficiently identify, analyse and permanently eliminate failures in products, services and processes. You can analyse the causes of faults for actual faults that have occurred or potential faults from internal audits or your FMEAs using common methods such as Ishikawa or the 5-Why method. You can plan, control and monitor your error analyses and CAPA processes using the integrated action and workflow management. If required, the functions for validating the analysis processes and digital signatures for your ‘Qualified Person’ are available to you for checking the effectiveness of the measures and the corresponding success evaluation.
