Machine / Monitoring Equipment/

Measuring Instruments/Work Env. Exercise-4 Process Approach Man/Skill/Competency/Awareness

Process Elements: MAN; Machine,Tool,

IMTE, Work Environment, Method,
Material, Monitoring & Measurement,
Objective.

Activities in the process/

Input from Previous process: Output from Previous process:
Value Addition
Product/Service/Semi finished Product/Service/Semi finished items/Decision
items/Decision

Method/Criteria/External
Document/CP/FMEA/Risk & opportunities Effectiveness & Efficiency

IRCLASS/TRG/QMS-2015/IA/Ex4/Rev00 – Dated Jan 2016

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 Process
Element

SL NO
Likelihood

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Issues
arising
from
Consequence – 1- Negligible

Conseque
nce (C)
Rating
3-Major

Likelihood
(L)Rating
RISK MODEL / Delegate can use FMEA Format.

RISK= C x
RISK ANALYSIS

L
- 1-Not happen 3-Moderate Changes

IRCLASS/TRG/QMS-2015/IA/Ex4/Rev00 – Dated Jan 2016

Current
Control
5-Catastrophic.
5- Definitely happen

Avoid Risk

Take Risk
to pursue
opportuni
ty

Eliminate
the Risk a
source

Change
Conseque
nce
RISK MITIGATION

Share the
Risk

New
Consequc
e ranking
New
likelihood
Ranking
Risk =
Cx L
 Consequences
1 3 5
5
5 15 25
Likhlihood
3
3 09 15
1
1 3 5
Low Risk
Medium Risk
High Risk

IRCLASS/TRG/QMS-2015/IA/Ex4/Rev00 – Dated Jan 2016

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