Picture; Property of Siemens

In 2017, the Federal and Drug Administration issued around five hundred and fifty-five warning letters known as “Form 483” in the Pharmaceutical, food and cosmetic industries.

Most of these letters appoint the lack of risk identification in many stages of the manufacturing process.

Many investigations were ineffective of risk identification leading only to corrective actions but not preventive actions to avoid recurrence in all stages of the process.

In 2016, the FDA issued 350 warning letters. The root cause is indirectly and directly lack risk identification.

The pharmaceutical industry is still learning how to establish a systematic approach to assess risks. Although, the system already exists.

The ICH-Q9 “Pharmaceutical Risk Management” and the ICH-Q10 “The Pharmaceutical Quality System” are two standards that describe the goals and expectations from the pharmaceutical standpoint of view.

Why is risk assessment paramount in the fourth industrial revolution?

Risk has become critical in other areas of the industry, for example, market and product development.

There is a key understanding of this era of change that will help top management:

Risk assessment is the synonym of the data analysis.

When the FDA issues the warning letter, they are telling the organization they do not have a good data analysis system. In my professional experience, if a company is not good at data analysis, the areas that will have an immediate impact are quality and safety.

Why? Because is all about data.

For example, incident investigations, and CAPAs are sources of data to support the decision-making process.

Data analysis will help to predict failures in manufacturing and analytical processes.

Let’s see the risk from the blockchain perspective. This technology gives the advantage of tracking each step of the transaction. Technologies are being developed to emulate it.

According to the World Economic Forum, businesses that scale in categories will win the market. They will be able to predict approaches to take.

In my last article, I mentioned only 1 percent of the data is evaluated. Also, top management knows a small fraction of the tools used in other industries.

The ICH-Q9 collects the second and fourth pillar of the Risk-Based Process Safety program. The goals of the two pillars are to understand the risk and learn from past experiences. Therefore, the amount of data allocated will help managers to predict, identify and conduct accurate risk assessments.

Benefits of Risk Management for the Pharmaceutical Industry to Succeed in this Revolution.

First, identify your risks will help the business to innovate.

R&D plays a big role in developing new medications and processes.  However, changes in the market and technology will force top management to look outside where some organizations have implemented risk management to innovate.

Second, the decision-making process will be effective and efficient to allocate resources for monitoring and mitigation.

Third, technology will be interconnected. It is known as the Internet of Things (IoT). Cybersecurity will be a field to master to avoid losing data.

Fourth, the risk assessment generates a lot of data that the organization needs to use statistical techniques to determine causal factors to make decisions based on your own evidence.

Here are the 4 Steps to Succeed in this Industry Revolution.

  1. Started decoding your tacit Knowledge is critical.
  2. Use Create-Estimate-Aggregate and Manage model.
  3. Avoid duplication.
  4. Adopt a based Risk decision-making process



  1. McKenzie and Company
  2. World Economic Forum.
  3. Federal Drug and Administration (FDA)