ISO 9001:2015

1. Risk &
Opportunity
Analysis
(ISO 9001:2015)
By: Ghiru

2. RISK ASSESMENT
• Systematic Investigation & Analysis of potential risk
• To assign severities of probabilities & consequences
• Rate the risk to prioritize action proportionate to potential
impact
By: Ghiru

3. RISK & Opportunity
Analysis
• Business processes in Quality Management System
 Sales & Marketing
 Purchasing / External Providers
 Production
 Warehousing & Logistics
 Quality Control
 Document Control
 Human Resources
• Manufacturing Processes
 As in Control Plan / Process Flow Chart
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4. • External & Internal issues
• Interested Parties Requirement
RISK & Opportunity
Analysis
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5. Step 1: Choose Risk & Analysis
Tool
• Various analysis tools are available
 FMEA
 SWOT
 HIRARC
 Others
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6. Business Risk & opportunity Analysis
Process &
Function of
the process
Identifying current
Risk & Control
New Actions to handle
the risk that has high
score
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7. Step 2: Define Ranking Method
• Develop Severity and probability rating scores
• Develop Risk Matrix & define rating to take action
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8. Severity Table
Severity Situation Rating
Disastrous
Risk or Opportunity that if not addressed, may cause the Organization to cease
bankrupt 5
Major
Risk or Opportunity that if not addressed, may :-
 Seriously affecting the organization's reputation & credibility
 May cause lost of future customers
 A loss of about ½ year revenue
 Causing the production to shut down for 10 days or more
4
Serious
Risk or Opportunity that if not addressed, may :-
 Affecting the organization image / function / requirement
 May completely loss the customer
 A loss of about ¼ year revenue
 Causing the production to shut down for 5 ~ 9 days
3
Moderate
Risk or Opportunity that if not addressed, may :-
 Slightly impacting the organization image / function / requirement
 Required explanation to the affected interested parties
 May cause revenue loss of RM10K ~ 50K
 Causing the production to stop for 1 ~ 3 days
2
Minor
Risk or Opportunity that if not addressed, may :-
 Causing discomfort to the interested parties
 Causing the production stop less than 24 hrs.
1By: Ghiru

9. Probability Table
Probability Situation Rating
Very Likely
• Risk that has occurred based on previous record in the organization
• Opportunity that has been adopted and proven with beneficial result 5
Possible
• Risk that has not occurred in the Organization but based on previous record in similar
industry or competitor
• Opportunity that has not been adopted by the Organization but has been adopted by
similar industry or competitor with proven good result
4
Likely
• Risk that may occur if situation is not properly managed due to carelessness,
ignorance or inexperience
• Opportunity that may be implemented but with intangible beneficial result
3
Remote
• Risk that has not been known to occur after many years
• Opportunity that might not be viable due to requirement of high capability and
investment for implementation
2
Unlikely Almost not possible to happen or implement 1
By: Ghiru

10. Risk Matrix
Severity
Probability of
Occurrence
1 2 3 4 5
5 5 10 15 20 25
4 4 8 12 16 20
3 3 6 9 12 15
2 2 4 6 8 10
1 1 2 3 4 5
By: Ghiru

11. Trigger Level
RISK LEVEL GUIDELINES FOR ACTION
HIGH
[15~ 25 Points]
• Immediate intervention from the top management is needed to
ensure that a concrete controls is in place to avoid occurrence
• Control established must be able to reduce the Risk to at least
Medium Level
MEDIUM
[5~12 Points]
• For 10 points and above, must be given with additional control to
reduce the risk level
• For below 10 points additional control may be taken if there are any
opportunity to do so
• Medium Risks shall be reviewed periodically to ensure that they are
not turned into High Risk
LOW
[1~4 Points]
• Not compulsory to have additional control but it may be done
voluntary
• Shall be reviewed regularly to ensure that they are not turned into
High Risk
• Reduce the risk to as low as possible & practical
By: Ghiru

12. Step 3: Define The interested
Parties, Their need & expectation
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13.  Complying to International
Standards
 Implement & Maintain ISO
Certifications
 Quality & Reliability of Product
 On time delivery of the parts
 Effective communication & Good
CAR handling practices
 Fulfill legal & safety requirement
 Reasonable product cost &
dependable services
 Complying to legal requirement
 Maintaining business licenses
 No pollution or Public
nuisance
 Profitable business
 Salary on Time
 Taken care of the welfare
 Business continuation
 Good payment terms
By: Ghiru

14. Step 4 : Identify process
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15. Step 5 : Carry out Risk &
Opportunity Analysis
Carry out for identified processes
Include interested parties expectation
Include past experience
By: Ghiru

16. By: Ghiru