According to the report ” The Top Ten cGMP Citations for FY 2018″ created by cGMP trends, there is a need to approach the root causes of those citations differently. In other words, we need to have a different relationship with the problem.

It is a reality that getting forms 483 from the FDA can affect the organization revenues; however, it will not change the public image of the company as a recall will do.

Another element to add to this scenario is the rapid digital transformation of the industry especially the pharmaceutical and medical device industries; and the behaviours of our people because of the technological revolution.

Form 483 is the warning sign of having potentially a recall in the future; however, the question to answer in this article is:

How can we improve our quality management systems to predict non-conformances scenarios?

Many companies in these industries frequently focus on the technical aspects of QA, FDA, quality risk, compliance and quality management. However, in this fourth industrial revolution, building relationships with people and look for new ways of involvement with the problems such as creativity, sharing ideas are becoming critical to develop to identify and predict non-conformance scenarios.

In occupational health and safety, we call it a human approach.

Any quality risk management program needs to have the human element to succeed.

The ICH-Q9 standard is very similar to the old process safety management program but focuses on quality risk.

Consequently, the PSM program has progressed to 20 elements; the six new are all about commitment and human approach.

Here are the four steps to add the human approach element to your quality risk management program to prevent non-conformance scenarios.

Step 1.  Top senior management involvement.

The first step is critical. It has found information published by some consultant experts in this topic such as McKenzie and Company that there is little involvement from top senior management in the quality risk management programs.  Frequently, expert leaders in lean manufacturing, QA and other specialists do have low or no power to make decisions in their teams to achieve these goals.

Some questions arise to measure involvement from top management:

  • Do you have transformational indicators to measure culture?
  • Do you measure the involvement of top management in the company’s culture?
  • Have you defined the culture of your company?
  • Have you developed leaders through the organization?
  • Do you set a path to follow or do you establish directions?
  • Have you set your transformational goals to satisfy the hierarchy of Maslow’s pyramid?

Step 2. As an organization, it is imperative to understand what type of culture you have. Is it a culture that set directions or paths?

Frequently, organizations are used to set directions. Therefore, you can ask yourself the following:

  • Do I understand the experiences, ideas and skills of people?
  • Are you capable of optimizing the ideas, experiences and skills of people?
  • Do your employees feel that they are contributing to the quality risk management program to identify non-conformance scenarios?

Step 3. At this step, the organization knows the current state of its culture. Therefore, they see what culture want to set for the future.

The organization is ready to establish transformation indicators that will help management to measure the effectiveness of the new culture in place.

Step 4.  At this stage, the organization will start setting the boundaries to set values, rules and policies. A question comes up to this stage:

What are those boundaries?

The boundaries are safety, quality, compliance and other disciplines involved to have a healthy operation.

All the codes, standards and regulations come into a place to start designing the boundaries of the different operational aspects of the organization.

At this stage, many companies in the pharmaceutical, food and medical device industries have already implemented standards such as ICH-Q7, ICH-Q9 and ICH-Q10.

However, at this stage, some companies have not been able to prevent those same non-conformance scenarios occurred again and again.

For example, do you have a key performance indicator to measure the effectiveness of the non-conformance scenarios predictability?

  • Do you measure how many times have the same scenario occurred?

Organizations need to have these KPIs to measure effectiveness and be able to adjust to specific scenarios that can lead to having forms 483.

There is no doubt that in the pharmaceutical, food and medical device industries have many experts with vast knowledge of QA standards, cGMPs, FDA or Health Canada regulations, that is not what this article tries to point.

There are two main issues in these industries that are leading to having the same non-conformance scenarios year by year:

  1. The lack of knowledge of their own company culture.
  2. The lack of transformational indicators that will allow organizations to identify and measure the effectiveness of the fundamental aspects such as meetings effectiveness, people involvement, optimization and understanding of ideas, skills and experiences to find solutions that will fit the organization to succeed in the cGMP programs and have successful audits from health government agencies.

In conclusion, the human approach to succeed is paramount in this fourth industrial revolution.

Organizations need to review the following three aspects:

  • Corporate resources are deployed to meet customer needs.
  • The way of formal structures and processes are used to manage technical systems and achieve business objectives.
  • The idea that people think and feel about their work and conduct themselves in the workplace.


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