Transcript 5. Risk analysis & critical limits

Risk Analysis
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
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QMS: risk assessment
Presentación:
Ilustrar el análisis de los riesgos con el
diagrama de flujo de los huevos fritos del
día 2.
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SGC: Riesgos
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
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QMS: risk assessment
Process analysis
part 2: critical limits
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QMS: risk assessment
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
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Exercise:
1. Define critical limits by activity for risks
higher than LL, LM, ML.
2. Define preventive actions and corrections
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QMS: risk assessment
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
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QMS: risk assessment
• Product Quality
Customer / User:
By Process:
Customer /User
Requirements:
• Service Quality
• Organic
Objective(s):
Continual
improvement
target(s):
• FLO
• etc.
(annual targets for
critical limits)
Process
Risk
Frequency
Impact
Critical
Limit
Preventive
Action
Correction
Corrective
Action
Work
Instruction
High
Low
Description
Medium
Medium
Decision tree
Low
Medium
Designs
photos
Low
High
etc.
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QMS: risk assessment