Organizations need to be ready to tear themselves away from conventional thinking to tackle the top ten citations from the FDA or improve their recordable incident rates in we are speaking about safety.

It is common to find the following scenario in the pharmaceutical and food industries:

•   You have people from ten to twenty-five years working at your organization. All of them have been exposed to audits from the FDA at least twice in their working life.

Why do we see the same citations every FDA audit cycle?

Why are we experiencing much injuring each year?

I am sure you have done everything in your hands to answer the past two question positively as a manager, director, VP or CEO.

I am sure that you have heard the word transformation many times.

What do you think about this word?

Do you think this word is overrated, overused, new or exciting?

I think it is overrated because the transformation word is also used in technology as well, for example, digital transformation, technological transformation.

Therefore, the meaning of the word of transformation shall mean how you as an organization encourage to perform to generate solutions that will fit only your company to succeed.

Currently, management systems such as ISO are introducing the element of culture and leadership, but the system does not encourage organizations to transform.

If we use the meaning for transformation to:

•   increase performance, production,

•   to reduce cost,

•   to excel in compliance,

•   to excel in cGMPs

•    to stop people getting injured,

•   To innovate

•   to grow capital, and,

•   to adapt faster, quicker and effective.

In the end, having the same type of citations in the last ten years, the same RIRs, LTR, and the top ten safety violations for the previous 15 years means that is not a technical issue.

It is a humanistic approach issue to find creative, and fit solutions for your organization; in other words, tackle the challenge from a different angle.

What do we have to do in other to immerse our company in the real meaning of transformation?

Here are the seven steps to start a meaningful transformation in your organization.

  1. Develop a governance structure led by the Chief Transformation Officer (CTrO).

The organization shall designate a full-time CTrO to lead, plan, execute and measure the transformation strategy.

2.   Transform the old behaviours by developing soft skills into your organization.

It is essential to develop a leader at all levels to use them as sponsors of transformation.

Organizations would train the experts in soft skills such as problem-solving, creativity, emotional intelligence, service oriented to mention a few of them.

For example, one of the top FDA citations is making manual changes by hand and not updating the master document.

One of the priority projects to eliminate this behaviour of lack of updating master documents, the sponsors in conjunction with management shall come with solutions by using the problem-solving skills to eradicate this behaviour.

How do the experts eradicate this issue?


By communicating the new behaviour and coaching the peers to make sure that was understood. Also, management shall track this effort through a critical performance indicator.

3.   Build leaders (experts) everywhere.

4.   Define what experts and leaders do every day. Define activities and behaviours to perform their daily activities. It includes top management as well. For example, set a goal per month to assess a potential citation in your quality management system.

For safety, the organization can start promoting safety talks and measure its effectiveness by creating key performance indicators.

5. Help expert to manage their time. Help expert to manage their time. In this step, it is not saying to freeze time for the experts in other to participate or execute specific tasks.

I am going to use an example in the safety area because this step causes many arguments inside companies. If the organization wats to reduce injuries, assess hazards to predict scenarios which can cause injuries, the organization shall set no more than three objectives.

The organization XYZ wants to reduce the RIR from 1.7 to 1.0. This is the main goal.

a. According to that goal, you set the activities to achieve the results.

i.   Identify the work stations that had been identifying where workers are getting injured.

ii.   Evaluate the current hazard assessments to determine if they are accurate or not with the current state of the work station.

iii.   Perform kaizen blitz to those stations to determine if the current state helps to reduce injuries.

iv.   Determine three possible solutions that will help to achieve the goal.

Establishing goals will help the transformation process to determine activities, allocate resources and time.

6. Measure the progress. Organizations typically measure big goals or objectives to measure the progress, cost reduction, sales to mention a few aspects of the business.

However, organizations do not measure necessary activities that are so important to achieve transformation; in fact, they are basic that impact your business activates gratefully.

For example, I was having a conversation with a top manager. In his organization, they started measuring how many times do their worker have at one safety conversation a week? He started measuring respect through punctuality.

Organization tend to measure significant achievements before measure that basic tasks to reach the goal; therefore, the transformation has been so difficult because of that reason.

By measuring the basic tasks that have a significant impact on the culture of the organization, managers will have an accurate picture of the current culture of the organization. For example, having not structured morning meeting will impact your quality management systems, especially in the pharmaceutical, food and medical device industries where some of those companies are submitted to comply with the FDA.

7.     Set incentives. Financial and non-monetary incentives are essential to establish to empower an innovation culture.

I want to conclude this article by saying something I read in a column of Mckenzie and Company, “Change is not for everyone else – It is for you.”

In my opinion, that statement says a lot on what we want to achieve realistically, for example, in the safety area, we always say, “Safety is the number one priority” Really it is? The reality is not, the number one priority for an organization is to produce, to bring revenue, that is a fact. However, the organization will choose how it wants to bring that revenue, what culture they want to have, what type of reputation they want to have. Therefore, safety is not for everyone – It is for you.

The human approach through a transformation in the cGMPs and safety is the key to success, to comply with innovating to eliminate the same citations year by year.


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