Risk Quiz

Risk Quiz

ISO-9001:2015 has changed the definition of risk.
ISO 9001:2015 defines risk as “the effect of uncertainty on an expected result. Please familiarize yourself with this definition and answer the following questions.


Choose the word that best describes the opposite meaning of “risk” from the following group of words.

  1. “Peace of mind.”
  2. “Safety.”
  3. “Certainty.”
  4. “Opportunity.”
  5. “Returns.”


The correct answer is 3. “Certainty.

This is because risk is “uncertain.

In addition, we would like you to answer the following questions


Which of the following examples is the least risky?

Conversely, which of the following would be considered the most risky?

  1. The centerpiece of the museum’s exhibit is a necklace from the Egyptian dynasty. There are rumors that international thieves are targeting it. It is valued at 1 billion yen in market value and is insured for the same amount.
  2. Mr. A is a shareholder of a pharmaceutical company. It has been confirmed within the company that a drug from that pharmaceutical company has a serious side effect. Since that information has not been made public, Mr. A does not know about it.
  3. A telecommunications equipment manufacturer has hit the jackpot with a new information terminal that is selling extremely well.
    In its earnings announcement, the company announced that it expects sales for the next fiscal year to increase fivefold over the current fiscal year.
  4. A small company is on the verge of bankruptcy unless it can raise 10 million yen by the end of the day.
    The company has only 5 million yen in cash on hand, which it has scraped together through all possible means.
  5. I happened to be ready early that day, so I took a train that was one train earlier than the commuter train I usually take.
    When I arrived at the office, I learned that my usual commuter train had been involved in a derailment accident.


The correct answer is,

The least risky is 4. This is because bankruptcy is a “certainty. For this company, bankruptcy is certain, not uncertain.

The least risky is 3. This is because “sales in the next fiscal year are expected to increase five-fold over the current fiscal year, but this is uncertain.

The two questions above show that “what has happened (a certainty) is not a risk.” This is what is meant by “what has happened (what is certain) is not a risk.

Events that have occurred are called “problems.

The “problem” requires a CAPA to be implemented to prevent recurrence.

The author conducts risk management consultations and audits for many pharmaceutical and medical device companies, and often sees cases where risk analysis (severity x probability of occurrence) is conducted for problems that have occurred.

This is a mistake.

It is not a risk analysis for problems that occur, but rather corrective actions must be implemented to prevent recurrence.

For problems that do occur, only severity is an issue for consideration. The probability of occurrence is generally not sought.

For example, let’s say there was a train accident or an aircraft accident. What would you think if the accident investigation committee decided, “Although this accident was serious, the probability of its recurrence is extremely small (rare), so we will not prevent its recurrence. What would you think if the accident investigation committee decided that, although the accident was serious, the probability of its recurrence was extremely small (rare).

It is obvious that such a response is not possible.

In economics, uncertainty with gain is called upside risk and uncertainty with loss is called downside risk. In other words, there are Positive and Negative risks.

Positive risk is, for example, “If we had manufactured more beer, we would have sold more.” etc.

Product safety areas such as the pharmaceutical and medical device industries are only subject to Negative risks.

Negative risks only refer to those that negatively impact the company, and positive impacts are generally not in view. Only hazard-related risks are covered. In other words, the definition of “risk” = “uncertainty” is inappropriate for the pharmaceutical and medical device industries.

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