PTIL/PSA

PTIL/PSA

PTIL/PSA

6th Annual International Regulatory Affairs Symposium

“Risk Governance in Regulation”Historical review – how old are the conception of “risk”?

“The origin of our species – Chris Stringer”• The easy answers is where and when,

the difficult one is why?Nonetheless he is bringing aspects of:• Risk reduction

- Modern humans spread risk for survival through better technology, provisioning and mutual support

• Risk taking - “Necessity is the mother of invention”- Innovation or imitation

PTIL/PSA

Basic knowledge about risk• Any human activity implies a risk• Uncertainty about the consequences of an activity will always exist• There is always something we do not know• Zero risk can be achieved only by zero activity• Zero uncertainty can be achieved only by zero activity

From a regulators perspective - How to govern risk?What does a risk based approach mean?

PTIL/PSA

Command and control Self regulation

You need to balance a regulatory role which encompasses:

And

From a regulators perspective – how to govern risk?

PTIL/PSA

Command and control Self regulation

Risk taking and risk reduction is about the interrelationship between

From a regulators perspective – how to govern risk?

PTIL/PSA

Technological systemMutual influence

Human needs and behaviour• Career planning • Job satisfaction (content and variation in the job)• On the job training/learning • Empowerment and decision-making • Execution of power• Reputation/prestige (support, trust etc)• Integrity and autonomy

Systemic characteristics - Rationality• Scientific approach to ensure rational and effective production• Specialisation• Clarified roles (who das what)• Standardisation• Automation

Social system- individuals- groups- needs

Risk and rationality in a Human – Technology - Organisation-perspective

PTIL/PSA

8

System perspectives

PTIL/PSA9

Specialisation around similar work tasks- standardisation- common procedures

Elimination of overlapping work Synergy of large-scale operations

- Optimal investments- low unit costs

Management tool- hierarchy- instructions and procedures

Depended on internal and externalstability

Development and utilisation of knowledge and knowledge systems

Development of strategic expertise platforms with greater width anddepthThe empowered employee

- autonomy- integrity

Management tool- team (virtual)- network

Adaptive to uncertainty in the market

Communicationtools

Data quantityand quality

System boundariesand interfaces

System organization

Real-time data

Analyticalmodels

Data re-presentation

Communicationtools

Data quantityand quality

System boundariesand interfaces

System organization

Real-time data

Analyticalmodels

Data re-presentation

Activities in a high risk environment

New intelligent and virtualtools

How to utilize tacit knowledge?

PTIL/PSA

Quality

Experience/competence

Know what?

Know how?

Know why?

Care why?

How to develop knowledge in a risk based regulatory context?

A C

DEFG

B A C

DEFG

B

PTIL/PSA

Care why – demands focus on values, people and leadership

Guiding our behaviour and discuss what we expect from

our fellow colleagues, our companies and our leaders