To develop a business subsystem fulfilling International Organization for Standardization 15189 nonconformance management regulatory standard, facilitating employee engagement in problem identification and resolution to effect quality improvement and risk mitigation.
From 2012 to 2016, the integrated laboratories of the Henry Ford Health System used a quality technical team to develop and improve a management subsystem designed to identify, track, trend, and summarize nonconformances based on frequency, risk, and root cause for elimination at the level of the work.
Programmatic improvements and training resulted in markedly increased documentation culminating in 71,641 deviations in 2016 classified by a taxonomy of 281 defect types into preanalytic (74.8%), analytic (23.6%), and postanalytic (1.6%) testing phases. The top 10 deviations accounted for 55,843 (78%) of the total.
Deviation management is a key subsystem of managers' standard work whereby knowledge of nonconformities assists in directing corrective actions and continuous improvements that promote consistent execution and higher levels of performance.