[Sterilization business continuity and recovery plan: How is it integrated into the quality management system?]

The business continuity and recovery plan (BCRP) ensures continuity of services when situations arise that impact a process's activity. It is important that the BCRP be integrated into the sterilization quality management system (QMS). A six-month project was conducted at the sterilization facility in four stages: QMS and risk management assessment, knowledge/perception survey, development of an action plan for the BCRP, and its simulation. Among the 253 documents (39 procedures, 132 operating procedures, and 82 associated documents) counted in three different recording systems, three belonged to the BCRP, a 2004 map, and a procedure in the event of non-functionality of each business software. The survey conducted among 29 professionals showed that 56% of them were unaware of the actions to take during a cyberattack, and 41% were partially familiar with them. As the latter is one of the most complex situations, a working group developed an action plan that included the creation of 17 documents dealing with degraded process modes. The simulation of the proposed organization estimated the increase in time at 23hours per day compared to the usual procedure. The documentary inventory showed a lack of anticipation of exceptional situations, confirmed by the knowledge/perception survey. The establishment of a working group, the definition of an action plan, and above all, the simulation of a BCRP raised awareness of the importance of these organizations, improved mobilization, and also current practices by strengthening the QMS.