Select people with the required core values and then nurture those values by creating a conducive environment. But it is only possible to nurture something that already exists, cautions Vishalakshi Naik, Founder, Quality Solutions. She gives a few examples and tips to build a culture of cGMP compliance
GMP is like oxygen for the pharma industry and a culture of compliance has to be in the blood of the organisation so that every part or process or system or document in an organisation will breath GMP. Building a culture of GMP compliance is the need of the industry and the human aspect is the most essential thing in the culture. To build a culture, the most important thing is a motivated leader and a team with specific core values. Selection of people based on their core values and nurturing those values at every important decision-making stage are two most important aspects of building culture of GMP compliance. The driving force and motivation to achieve this status must come from top management and it has to be retained by middle management.
What is culture? Culture is a sum effect of social behavioural pattern. Culture creates unwritten rules and they are followed. Principles, ethics, moral values play very important role. There are many scholarly articles about its impact of social and organisational behaviour as well as its impact on businesses. Many life coaches in the US and Europe are now teaching meditation, reflection and gratitude. Industry in the 21st century is evolving at a pace which we could not have thought of earlier. Artificial intelligence, machine learning, big data and block chain are the buzz words. With increasing order of automation and digitalisation, we will be realising the importance of human mind and creativity. Thus, we will need expert inputs to check and verify machine generated results. Importance of human values will be increasing to great extent. To understand human aspects, let us read this story written by Stephen Covey (Author of “The 7 Habits of Highly Effective People”). He has shared an experience, he had in a subway ride in New York.
“People were sitting quietly; few reading newspapers, few lost in thought, few resting with their eyes closed. It was a calm, peaceful scene. Then suddenly, a man and his children entered the subway. The children were so loud that instantly the whole climate changed. The children were yelling back and forth, throwing things. It was very disturbing. And yet, the man sitting next to me did nothing. It was difficult not to feel irritated. I could not believe that he could be so insensitive to let his children run wild like that and do nothing about it, taking no responsibility at all. It was easy to see that everyone else on the subway felt irritated, too. So finally, with what I felt was unusual patience and restraint, I turned to him and said, “Sir, your children are really disturbing a lot of people. I wonder if you couldn’t control them a little more. The man lifted his gaze as if to come to a consciousness of the situation for the first time and said softly, “Oh, you’re right. I guess, I should do something about it. We just came from the hospital where their mother died about an hour ago. I don’t know what to think, and I guess they don’t know how to handle it either.” Can you imagine what I felt at that moment? My paradigm shifted. Suddenly I saw things differently, I felt differently, I behaved differently. My irritation vanished. I didn’t have to worry about controlling my attitude or my behaviour; my heart was filled with the man’s pain. Feelings of sympathy and compassion flowed freely. “Your wife just died? Oh, I’m so sorry. Can you tell me about it? What can I do to help?” Everything changed in an instant. In the process of building a culture of GMP compliance, we need to first understand technical aspects. Let us understand, how can the above story help us in conducting a better investigation and finding the correct root cause analysis (RCA).
Example 1: In a manufacturing section, an entry was found missing in the logbook during self-inspection. After an investigation, the reason noted was “human error.” After the suggested action of “re-training” was completed, the corrective and preventive action (CAPA) was closed. It was decided that no global action was required. Using the same example, can we look at a paradigm shift and investigate deeper?
In the process of investigation, it is required to go in to details by talking to the person concerned. The reasons could range from the following:
- The entry register is not nearby.
- The person is uneducated.
- People keep changing daily.
Now, with above reasons, global verification may be required. Since we are focusing on systems, every member of a team will contribute to nullify the cause of mistake. The whole process will become positive and energetic.
Example 2 Consider a formulation company receiving a market complaint of empty pocket in a strip. For a while, imagine this in your company and think of how you will go about finding RCA? Can you assure that being part of the system, you will not blame any person and go deep into the system to find the root cause?
Example 3 In an API unit, imagine that the most important vendor audit is in process and one of your workers happens to pass by without wearing safety goggles and head gear. What will be your reaction?
Discuss this with your team as a theoretical example. Give five minutes to list out all possible reasons, without worrying about right or wrong. Once they do this exercise, you can give a few actual examples of your own department or organisation and repeat this process. Assure them that we are in the process of building a strong culture of GMP compliance.
I believe that no person will make a mistake with the intention of making a mistake. Things go wrong and some of the reasons could be:
1. Lack of awareness – He does not know it’s a mistake or he does not know the difference between right and wrong.
2. He does not know the impact of his action. He does not know the big picture.
3. He doesn’t know changed circumstances.
4. He is too lazy to act.
At the next stage of investigation, after finding RCA, you will proceed to CAPA. All observations related to non-compliance related to staff ends with training. Once again, pause and think. If at all training was a solution, this was done earlier so why did that mistake happen? Therefore, there is something much beyond training.
Process of building a culture of GMP compliance
Let us accept that building a culture is long process. We cannot plan today and have a change in culture from tomorrow. The most important thing is, if we want to build a culture of GMP compliance, we need to essentially focus on educating every person. Education cannot be just by induction or on-job training or the traditional process but also at every stage of growth and every stage of failure or mistake. Every Standard Operating Procedure (SOP) must be followed (with an understanding of the importance of it and not mere as a formality). And essentially have a top to bottom approach in management. The selection process must be elaborate, and should include, assessing human needs (http://six-human-needs-test.herokuapp.com/ members/ new), personality testing (https://www.tonyrobbins.com/disc/). People must be selected with required core values by asking few questions. In pharma or healthcare industry, ‘humanity’ is the most important characteristic. And if one is aware of the fact that the whole business is about serving humanity, GMP and need of compliance need not be realised at every stage. And then nurture those things which will ultimately raise the culture of GMP compliance in the organisation.
Challenges in building culture
Every person working in the pharma sector as an individual understands and tries his best to follow GMP. What then are the challenges in building a culture of GMP compliance? The important thing here is, it is only possible to nurture something that already exists. There are certain principles, ethics and core values which are primarily essential in the person if he needs to be part of a culture of GMP compliance. A few of them are most important like attitude, quality, humanity, sharing, transparency, truth and empathy.
Building a culture is a long- term process. As part of this process, once the right person is selected based on values, those values are to be nurtured with a conducive environment. Culture is a reflection of social behaviour. A challenging situation may cause an individual to behave differently. The same person under observation may react in one way to a certain situation as an individual and differently as part of a team, even if the situation is the same. Even work pressure or performance pressure will make a difference in the reaction pattern. In our industry, our managers are technical experts most of the time, but not always experts in managerial skills. So development of managerial skill plays a very important role in the process of building a culture.
Once we give the authority to execute a responsibility, that person needs to be empowered with the needed authority. Every individual is a great resource to achieve a culture of GMP compliance. The quality assurance department should evolve to handhold everyone to reach a GMP-compliant organisation. Internal inspection team should simultaneously try reaching to the root cause and help the organisation assess possible non-compliances in other departments and units and make CAPA global as required time to time.
- What are the expectations for building a culture of compliance?
- Communication – Open honest transparent communication
- Feel of we, us and our. A strong team–sense of togetherness
- System-based approach – No blame game
- Information – Sharing with all concerned at every stage.
- Learning and growing – everything should be taken as a learning and growing opportunity.
These are very basic things, but we need to give importance to them and take some effort. This is not difficult at all. We can work on individuals to inculcate good habits. But a lot of dedication and efforts are required for this process. This can be done for a few top or middle management individuals, with personal coaching sessions and effective follow up. Selecting the right person for the right job with good character and good attitude, core values and nurturing these values in a conducive environment will be the ‘mantra’ to build a culture of GMP compliance in the organisation.
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