RISK

MANAGEMENT
Project Timeline

Initiation Planning Execution Closure

02 Sep’19 – 23 Sep’19 24 Sep’19 – 21 Oct’19 22 Oct’19 – 25 Dec’19 26 Dec’19 – 09 Jan’ 20

Business Case Communication Platforms Roles and Responsibilities Handover

Project Charter Constraints Communication Management Client Satisfaction

Stakeholders Project Scope Risk Responses Achievements

Schedule Milestones Checklist Archival of Records

Resources Design of Process (BFD, SuperPro, PFD, P&ID) Key Takeaways

Risk Identification Financial Control

Cost Estimation Quality Control

Quality Management

Procurement Strategy

Formal Approval
Risk Management Process

Risk
Risk Evaluation Risk Strategies Risk Monitoring
Identification

 Identify possible  Rate probability and  Response Matrix  Evaluate risk strategies
risks for each work impact of each risk
package  Brainstorm strategies  Weekly meeting
 Risk Value = f to tackle risks updates
 Identify potential (Probability x Impact)
consequences for  Periodic consultation
each risk  Classify each risk
 Regular checks
 2 Risks to Highlight:
2 Risks to Highlight:
 Legal Risk
 Technical Knowledge Risk
 Technical Knowledge Risk
 Skill-set Risk

Initiation Planning Execution Closure

2 Risks to Highlight: 1 Risk to Highlight:

 Technical Knowledge Risk  Handover Risk

 Vendor Quality Risk

Initiation Phase – 1st Risk

Differences in Regional 1 – Full research on Singapore’s regulations

Regulatory Requirement 2 – Consult trustworthy pharmaceutical
Overall partners in Singapore
Objectives France VS Singapore

Work Potential Risk

Trigger Consequence Monitoring
Package Risk Strategies

Assigned team member to

Country’s Legal
Rules that are optional in France may be closely monitor & update
Requirement
required in Singapore & vice versa team on new/amended
rules upon notice
REDUCE

P × I = Risk No adherence = Mael Pharmaceuticals get sued

3 × 8 = 24
 Initiation Phase – 2nd Risk 1 – Team must have Subject Matter Expert (SME)
2 – Team must have seniors with experience
3 – Contact external consultants
4 – Every team member must carry out prior research before
assumption meeting

Assumption Log Lack of experience in

the entire team

Work Potential Risk

Trigger Consequence Monitoring
Package Risk Strategies

Lack of technical Wrong calculations

knowledge to establish Wrong assumptions Ensure entire team is
valid assumptions agreeable with all
REDUCE assumptions made &
 Safety at risk respective SMEs analyse the
assumption log frequently
 Plant hazard
before project handover to
P × I = Risk  Equipment failure sponsor
2 × 8 = 16  Disaster – Mael Pharmaceuticals &
Design company Reputation
 Planning Phase – 1st Risk 1 – All SME to be present in all risk meetings
2 – Use Historical risk registries that has similar scope as reference
3 – Entire team to do research on manufacturing risks prior to meeting
Risk Identification 4 – Allocate sufficient risk meetings to cover all aspects thoroughly
5 – Purchase Insurance for all personnel & facility

 Absence of SME in risk identification discussions

 Insufficient risk meetings to cover all aspects of risk

Work Potential Risk

Trigger Consequence Monitoring
Package Risk Strategies

 No risk response to handle the unidentified

Failure to identify all risk when it occurs
potential safety &
hazard risks  No relevant skills-set / technical knowledge to
handle the surfaced unidentified risk Carry out re-evaluation risk
meetings prior to project
 REDUCE
Safety of personnel handover to review list of
identified risks
 Plant hazard
P × I = Risk  Equipment failure
3 × 9 = 27  Disaster
 Mael & design company’s Reputation
Planning Phase – 2nd Risk
1 – Seek assistance from France parent plant on key things to note
2 – Use same supplier/vendor company
3 – Consult experts on material handling
Procurement
Strategy

Different vendor/suppliers used

from France parent plant

Work Potential Risk

Trigger Consequence Monitoring
Package Risk Strategies

Quality Risks  Source of materials/ utilities/ packaging

- Utilities different from parent plant
- Materials  Quality of tablets are compromised Carry out thorough
- Packaging analysis tests to ensure
- Transport REDUCE
quality of tablets are
 Stability study / documentation required equivalent to France
 Minor difference in manufacturing process parent plant tablets
P × I = Risk  Product recall
2 × 9 = 18  Mael & design company’s Reputation
 Execution Phase – 1st Risk

1 – All team members are to undergo comprehensive training

Assignment of Roles by external equipment vendors prior to project
& Responsibilities 2 – Team members are to speak up and clarify all doubts

Lack of technical expertise

Work Potential Risk

Trigger Consequence Monitoring
Package Risk Strategies

Insufficient knowledge  Longer time is required to finish assigned task

to handle given task  All aspects of the task may not be thoroughly
covered Training checklist are to be
REDUCE signed off by external
trainers/ vendors upon
completion
 Significant impact on safety & quality aspects
P × I = Risk
4 × 8 = 32
Execution Phase – 2nd Risk
1 – Ensure technical expert is present during the meeting for PFD
draft evaluation
2 – Finalized PFD have to be approved by all team members, SMEs
Design of & P&ID technical experts prior to start of P&ID draft
Process Flow
Diagram (PFD)
 Insufficient literature research /
experience on process
 Lack of technical expertise

Work Potential Risk

Trigger Consequence Monitoring
Package Risk Strategies

Lack of technical  Missing PFD details will be missed in P&ID  Take down minutes to ensure
knowledge to draft
 Cost estimation will not be accurate all concerns raised by P&ID
accurate & detailed
expert has been fully
PFD REDUCE addressed
 Safety of personnel  Carry out multiple
evaluation to ensure all
 Plant hazard & Equipment failure
P × I = Risk aspects are covered
 Cost exceeds budget
3 × 10 = 30  Mael & design company’s reputation
Closure Phase – 1 Risk 1 – Establish detailed documentation system & logbook
2- Ensure entire team is aware of the documentation practice
3 – Project Manager to check the filed documents after each
milestone is completed
Handover to
Sponsor
Poor documentation practice

Work Potential Risk

Trigger Consequence Monitoring
Package Risk Strategies

Poor handover: Appoint a team member to

- Missing document  Sponsor will have many questions & doubts keep track of all
- Disordered documents that must be
document filed & project manager is
REDUCE
to verify bi-weekly
 Sponsor will be dissatisfied
 Design company’s reputation affected
P × I = Risk
3 × 8 = 24