Systematic quality management responds to any deviation analysing the root cause and implementing appropriate measures. Deviations from the accepted quality standard can trigger corrections adapting existing procedures, running production or manufacturing processes or design changes to products and services. The preventative measures avoid a repetition by modifying the set up to make the occurrence of the same deviation impossible.
All signs possibly leading to deviations or areas must be collected and analysed down to the root cause. The input channels include own measurements and observations, audits or reports of regulatory bodies, user/customer claims or complaints..
All deviations are permanently monitored, evaluated and prioritised.
The analysis must be documented with a proper audit trail to create reliable, reproducible and for stakeholders accessible results. Guideline can be an FMEA (Failure Mode and Effects Analysis) performed beforehand: the sequence of analytic tasks can depend on the risk of failure and cost associated with the investigated object.
Once the corrections and preventions are planned, they must be examined of their effectiveness, budgeted/financed and approved. Only then, the implementation starts under close monitoring. The importance, complexity and/or cost of the measure might require another authorisation of the project results at closure or even a revisit of the project some given period after closure providing assurance on the effectivity of the implemented measures.