Risk Analysis

QMS: risk assessment 2 Definitions: Risk = the probability that quality is jeapordised With that, risk refers to both the probability and to the seriousness of its impact on quality. Formula: Risk = Probability x Impact

SGC: Riesgos 3 Presentación: Ilustrar el análisis de los riesgos con el diagrama de flujo de los huevos fritos del día 2.

QMS: risk assessment 4 Exercise: Make a risk analysis for each activity of the mapped process : 1.The frequency with which it may happen 2.The impact when it happens Low- L Medium- M High- H

QMS: risk assessment 5 Process analysis part 2: critical limits

QMS: risk assessment 6 Critical limits Preventive action Correction Critical limit: A criterion which separates acceptability from unacceptability, when monitoring a Control Point Preventive action: action to eliminate the cause of a potential nonconformity or other undesirable potential situation Correction: action to eliminate a detected nonconformity

QMS: risk assessment 7 Exercise: 1.Define critical limits by activity for risks higher than LL, LM, ML. 2.Define preventive actions and corrections

QMS: risk assessment 8 Risk assessment form Number your activities in the flow charts: Copy the numbers, and Note risks, critical limits, CA, PA and Corrections in the risk assessment form in excelrisk assessment form

QMS: risk assessment 9 Process Risk Frequency Impact Critical Limit Preventive Action Correction Corrective Action Work Instruction HighLowDescription Medium Decision tree LowMedium Designs photos LowHighetc. Product Quality Service Quality Organic FLO etc. Customer / User: Customer /User Requirements: Objective(s): target(s): Continual improvement (annual targets for critical limits) By Process: