Root cause analysis (RCA) ensures safety, quality, and compliance in the medical device industry. However, a common pitfall is relying on a single RCA method across all scenarios. This paper explores the need fora tailored RCA approach across the product lifecycle, offering insights into specific tools that different departments can use for optimal outcomes.
Importance of root cause analysis in the medical device industry
RCA addresses issues that compromise product quality, patient safety, or regulatory compliance. An absence or misapplication of RCA can have a domino effect that may be unseen for long periods. An incorrect evaluation of a product specification during the design stages that is then transferred to manufacturing can end up being released to the market in a faulty state and only as field complaints start to filter in does it become a known issue. This, in turn, may be a threat (or cause harm) to public safety that may require a recall, leading to extended downtime, and reparations to both the product and the user population.
Click here to read more about root cause analysis for medical devices.
