1 Risk

 

1.1 History and references

History, disastrous risk management cases

risk

The word risk could come from the Latin word resecum “that which cuts, reef” hence the maritime origin “steep rock” or could derive from the ancient Italian risicare, which means “to dare.”

Opportunities and threats are two sides of the same coin called risk. When the outcome is favorable we speak of an opportunity, when the outcome is unfavorable we speak of a threat.

About 5,200 years ago in the Euphrates region, a group called Asipu were consultants in risk analysis for making risky or uncertain decisions.

Every decision involves risk. Peter Barge

In Mesopotamia, around 3,900 years ago insurance began as one of the oldest risk management strategies. The risk premium for ship and cargo losses in basic contracts was formalized in the Hamurabi Code.

More than 2,400 years ago Pericles spoke about taking risks and evaluating them before carrying out an action. His compatriot Socrates defines eikos (possible, probable) as “likelihood of truth”.

Blaise Pascal and Pierre de Fermat laid the foundations of probability theory in the 1650s, which opened the door to quantitative risk assessment.

Pierre Simon de Laplace developed a risk analysis in 1792 with his calculations of the probability of death with and without smallpox vaccination.

Risk management is relatively recent. For example, the Basel II agreement on risk management requirementsexplicit or implicit need or expectation (see also ISO 9000, 3.1.2) in the banking sector dates from 2004. Some prescriptive (non-certifiable) standards on risk appeared at the beginning of the 21st century (see § 2.2).

In 1997, the European Committee for Standardization (ECS) published the standard EN 1441 “Medical devices – Risk analysis”.

In 1998, the ISO (International Organization for Standardization) published ISO 14971-1 – “Medical devices — Risk management — Part 1: Application of risk analysis” which became ISO 14971 in 2000. The second edition was released in 2007 and the third in 2019 (see § 2.2).

The ability to identify a hazard, analyze the risk, evaluate it, and then act accordingly is the basis of risk management.

A difficulty in risk management arises from the fact that the event concerned (the harm) takes place in the future. You have to imagine an event that may never take place.

Zero risk does not exist

For several decades, the majority of companies in the medical sector have become aware that the costs of implementing risk management are insignificant compared to the unfavorable consequences or even the insurance to take out.

The main objective of risk management is to ensure the survival of the company in all circumstances.

Risk management has been considered in the past by some managers as something superfluous, cf. annex 01. These people believed that the main goal was to avoid risk. Since then, many have understood that risk is inevitable and intrinsic to any activity but must be reduced to an acceptable level. instruction

Risk cannot be eliminated

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1.2 Scope

Scope of the ISO 14971 standard, what can be excluded, areas

scope 

The scope of this module applies to risk management of medical devices (MDs). This concern:

The risk scope includes:

This module does not specifically include risks related to:

Risk management is used in many areas:

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1.3 Benefits

Benefits, root causes of failures, cost versus life cycle

benefits

Expected benefits of risk management of MDs:

The biggest risk is not taking any!

Root causes of failures:

Applying risk management upstream costs 10 times less than managing a crisis

The cost of managing risk over the life of a productany outcome of a process or activity (see also ISO 9000, 3.4.2) is shown in figure 1-1.

cost 
Figure 1-1. The cost and product cycle life

 

He who excuses himself, accuses himself

Common excuses for failure:

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