Quality Management 2017

Recommendations on risk management

For proactive risk assessment , the following is recommended as the minimum approach : • Potential failures or hazards are identified with peer experts ’ advice, analysis of feedback data or making use of checklists available of published risk assessment studies • Evaluation of consequencies is carried out by deductive (bottom up approach) and qualitative methods using either Failure Mode and Effect Analysis ( FMEA or FMECA) or Preliminary Hazard and Risk Analysis ( PRA ) In both methods, an additional step of the criticality (C) evaluation is carried out. Criticality data is then used to evaluate if the situation is acceptable or not , and actions taken to reduce the risk