From non-conformity to improvement

To enable laboratory technicians to identify and document a non-conformity, help understand its causes, and then carry out, follow up and trace effectively the CAPA actions entrusted to them, under the supervision of the quality manager and the biologist.

QA5 helps technicians go beyond simply reporting a deviation. Participants learn to contribute to the analysis, then to organise and carry out effectively the actions entrusted to them.

• recognise a non-conformity in the different phases of the process
• make the situation safe immediately and preserve useful evidence
• write a factual and usable description of the deviation
• assess the potential consequences and escalate the alert to the right level
• contribute to root-cause analysis with reliable information from the field
• distinguish between correction, corrective action and preventive action
• understand the tasks, responsibilities, deadlines and evidence of a CAPA plan
• organise one’s time and track the progress of one’s actions
• update a dashboard and produce the expected deliverables
• use digital tools and artificial intelligence with caution for reporting