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

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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

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Process analysispart 2: critical limits

QMS: risk assessment

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Critical limitsPreventive action

CorrectionCritical 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

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Exercise:

1. Define critical limits by activity for risks higher than LL, LM, ML.

2. Define preventive actions and corrections

QMS: risk assessment

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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 excel

QMS: risk assessment

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ProcessRisk

Frequency Impact

Critical Limit

Preventive Action

CorrectionCorrective

Action Work

Instruction

High Low Description

Medium Medium Decision tree

Low MediumDesigns

photos

Low High etc.

• 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: