Risk Based Thinking For HLS - Praneet Surti
Risk Based Thinking For HLS - Praneet Surti
Risk Based Thinking For HLS - Praneet Surti
RISK-DEFINITION
ISO 9001:2015 defines risk as THE EFFECT OF
UNCERTAINTY ON AN EXPECTED RESULT.
Or
an uncertain event or condition which if happens
affects mission objective.
ISSUE
RISK
OPPORTUNITY
PREVENTIVE ACTION
Clause 8.5.3
ISO 9001:2008
Organization shall take action to eliminate the
causes of POTENTIAL NONCONFORMITIES
in order to prevent their OCCURRENCE.
RISK APPROACH IN ISO 9001:2015
QUALITY MANAGEMENT SYSTEM
RISK APPROACH IN ISO 9001:2015
• Clause 4 (Context) the organization is required to
DETERMINE THE RISKS WHICH MAY AFFECT THIS
CONTEXT. The organization is also required to determine its
QMS processes and to ADDRESS its risks and opportunities
Options to address risks can include avoiding risk, taking risk in order to
pursue an opportunity, eliminating risk source, changing likelihood or
consequences, sharing risk or retaining risk by informed decision
EXTREMELY
HIGH HIGH
MODERATE
FMEA
FAILURE MODE EFFECTS ANALYSIS
A modified model of the previously discussed model
used in different segments of manufacturing and
service industries
Widely used for
• Design
• Product
• Process
• System
• Equipment
FMEA - TEMPLATE
FORM NO.
ISSUE NO.
PROCESS FMEA
REV. NO.
SUPPLIER CODE
DRG. REV. NO. A CUSTOMER VEHICLE DOC. NO.
PART NO.
PART NAME PERFORATED INNER PIPE DATE (ORG.)
C POTENTIAL CAUSE
CURRENT PROCESS CONTROLS ACTION RESULTS
OPN. NO.
3. Component feeding
c) Poor appearance Operator training.
Improper
Welding Missing a) Weak welding Before each set up
1. Improper welding
ensure for welding
b) Assembly problem parameters.
parameters. I st pc approval
4 4 and Patrol 3 48
c) Poor performance /
inspection
Functional problem
d) Poor appearance
1. Improper welding Before each set up I st pc approval
Pin Holes a) Weak welding
parameters. ensure for welding and Patrol
b) Assembly problem parameters. inspection
4 4 3 48
c) Poor performance /
Functional problem
d) Poor appearance
Over Burning of 1. Improper welding Before each set up I st pc approval
a) Weak welding
component parameter ensure for welding and Patrol
b) Assembly problem parameters. inspection
4 4 4 64
c) Poor performance /
Functional problem
d) Poor appearance
PRANEET SURTI
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