By: Ghiru

Risk & Opportunity Analysis (ISO 9001:2015)

By: Ghiru

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

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

By: Ghiru

• External & Internal issues• Interested Parties Requirement

RISK & Opportunity Analysis

By: Ghiru

Step 1: Choose Risk & Analysis Tool• Various analysis tools are available

FMEA SWOT HIRARC Others

By: Ghiru

Business Risk & opportunity Analysis

Process & Function of the process

Identifying current Risk & Control

New Actions to handle the risk that has high score

By: Ghiru

Step 2: Define Ranking Method

• Develop Severity and probability rating scores• Develop Risk Matrix & define rating to take action

By: Ghiru

Severity TableSeverity 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

MinorRisk or Opportunity that if not addressed, may :- Causing discomfort to the interested parties Causing the production stop less than 24 hrs.

1

By: Ghiru

Probability TableProbability 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 implementation2

Unlikely Almost not possible to happen or implement 1

By: Ghiru

Risk MatrixSeverity

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

Trigger LevelRISK 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

Step 3: Define The interested Parties, Their need & expectation

By: Ghiru

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

Step 4 : Identify process

By: Ghiru

Step 5 : Carry out Risk & Opportunity Analysis

Carry out for identified processesInclude interested parties expectationInclude past experience

By: Ghiru