“Process Simplification”

When Rancho was asked to define a machine, his answer was “Machine is anything which reduces human efforts”. If you remember the movie 3 Idiots, you may also remember the simple and complicated definition of a machine. In the same way if I have to write a google definition of the term “process simplification”, I will write it as “Process Simplification?is a?process?design technique that lets make a?process?more feasible and manageable through dividing this?process?into relatively simple tasks, so that every task is carefully observed to detect and remove redundant or wasteful actions and to estimate precise time necessary for implementing”. And if someone asks me a Rancho definition, it will be “To make a process or a task simpler”.

Whether it is as meek as talking to someone or as challenging as documenting core research as GXP, I have observed many men and women prefer showing to the world that the work which they are doing is complicated. As of now let us not go into that direction, we can discuss this later.

Since I am working in Research & Development, my thoughts will be more or less inclined towards my function. But I am sure, those who are in other streams will also find it relevant. Each function is governed through SOPs (standard operating procedures) and in certain functions the adherence to these SOPs is of utmost important. When we prepare these procedures, during the course of time, complications do arise. There are multiple reasons which lead to complication of the processes and I am going to discuss some of the probable reasons with some possible solutions in this article. But before we do that, let me start with a very short story.

Many years back, I had a friend Ajay (name changed to hide his identity) who was our neighbour as well. My uncle was at a very high post in one of the government departments and fortunately he was posted in our district during those days. Ajay was not good in his studies, so his father approached my uncle for adjusting him somewhere. Initially my uncle was very reluctant but then my father got involved, thus pressurizing my uncle to help Ajay. Ajay was then given a contractual job with low salary and he seemed very happy, at least for a couple of months. During this tenure he saw clerks and peons taking tips from anyone who was approaching my uncle. Since the flow of visitors was enormous, he became desirous. He started coming to my father every day convincing him to have a word with my uncle. He wanted to get a tip of ?10 from every visitor.?My father somehow persuaded my uncle and Ajay was told to take ? 10 as tip from anyone wanting to take an appointment with my uncle.

After sometime we had to leave our native place and I lost contact with Ajay. Recently during a casual discussion with my elder brother, he told me about Ajay. I was keen to know, what Ajay was doing now. Was he promoted and what was his profile? I was surprised to know that Ajay was still in the same office, on contractual job and taking tips for appointments. The only difference was that, earlier the tip was ?10 but now it was much higher!

In one of the surveys reported online about the complexity of their workplace, 25% respondents mentioned very complex, 49% mentioned complex and 22% mentioned somewhat complex. And when respondent’s simplification programs and plans were surveyed, 10% mentioned that major programs were in place, 44% mentioned some activities were in place, 22% mentioned they were considering simplification programs and 25% mentioned that there was no plan for simplification.

It is interesting to comprehend the reasons which are the probable reasons for the transition of a simple process to a complex one. Once we understand the core issue, it becomes easy to look for probable solutions. Most of us do have intentions of starting the process as a simple one, but then over a period of time, intentionally or unintentionally, it takes a non-linear path towards complications. Let us discuss some of the probable reasons which lead to process complications.

·???????Unwanted additional step/additional review: Remember Ajay and his story. Some of you might have thought about my intention to put this short story in this article. That short story explains this point very skilfully. In my opinion, adding unwanted steps or adding additional review steps is one of the major reasons for making our processes complicated. In the story, Ajay was indeed not required. But even if Ajay was added (because of some or other reason), he remained unnoticed there for many years. There was no one who could challenge Ajay or re-evaluate the process. This is exactly what happens in our routine processes. Sometimes because of one or the other reason, an additional step or an additional review is incorporated in the system. If it remains unnoticed for years, it will have major impact on cost and productivity. If Ajay remains in the system for long time, it gets near to impossible to remove him from the system. I strongly believe that there should be a mechanism of routinely revisiting each process and management should then ensure to remove that additional step or additional review from the process.

·???????Citation by a regulatory inspectors: While working on process simplification in one of my sub-functions, there were few complicated steps which were hurdles in the entire process. In certain cases I observed these as duplicate steps. When I asked the team to start removing these unwanted duplicate steps, I was shown a very old inspection report and the responses provided by the team to the inspectors at that time. Honestly speaking I am not saying that we should not accept the citations from regulatory agencies and I am also not saying that once we submit responses, we should revisit our processes quickly. But my concern is that inspection was done 10 years back by a regulatory body in a particular setup who cited some improvement areas and responses were provided to the agency with some corrective and preventive actions. After that inspection, multiple other changes happened in the overall process in the function. The systems improved and actually addressed the concerns raised 10 years back by the agency, but the team was reluctant to change the process/document which was submitted to the agency as part of a response. It was simply a duplication in the process. Regulatory guidelines and regulatory requirements keep on evolving. Then why should we stick to the response provided 10 years back. That response was applicable with respect to expectations at the time of inspection and should be revisited keeping in perspective current regulatory requirements and the overall improvement in the systems and processes of the function.

·???????Suggestion by an ex-senior person: I have faced this ample number of times. There are situations wherein some step/process was suggested by an ex-HOD or an ex-senior person. Please, for God sake, it is not necessary that anything suggested by a senior person is sacrosanct. During re-evaluation of processes, make a change if it does not makes any sense with respect to current standards, even if it was suggested by an ex- senior or current senior-most person.

·???????Internal quality control or quality assurance teams: Listen to them, but again, it is not inviolable to implement each suggestion as such. There are alternate processes, discuss and come-up with best possible simpler solutions without impacting quality standards.

·???????Previous discussions: Sometimes we feel that a process was discussed long back and we should not spend time on it now. I do not endorse this. Guidelines evolve, our experience evolves and technology evolves. Re-discuss a complicated process again and again over a period of time and come up with simpler innovative solutions.

·???????Technology: We are in tech era and technology development is at its peak. Many of the times our management and even regulatory bodies expect us to use electronic applications. Implementing these systems is easier said than done. Whether it is the development part, it’s IQ/OQ/PQ or even after its implementation, complications arise from these applications. It is always better to have electronic applications in the system as it enhances compliance levels. But re-evaluate and do make necessary changes in due course of time in these electronic applications and check if they are user friendly or have become a burden for the task.

·???????Global regulatory requirements: We are working for the global world and have to comply with global requirements. Each regulatory body has its own specific requirements and to incorporate all of these, makes our processes complex.

·???????Last but not the least, there are people who either love complexity or want to impress others by making the processes more complex. In the long run, this definitely hurts.

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Technology, globalization, and compliance requirements continuously add complication to work. These complications, if left unaddressed, this can lead to an organizational atmosphere that damages employee engagement, lowers quality, and reduces innovation. More than 7 out of 10 surveyed organizations rated the need to simplify work as an “important problem,” with more than 25 percent citing it as “very important.”

Each organization should make it an objective to simplify processes or at least get feedback from its employees for any change required in the processes. I have ample experience in working on process simplifications and most of the times it was a success. Besides increase in productivity, it helps in employee motivation.

Let us discuss the process which in my opinion, if implemented, will help organizations towards process simplification.

·???????First and foremost step towards process simplification is creating an environment for the same. The team should understand the objective and should be ready to adapt the changes. Management and people down the line, need to be on the same page.

·???????List down the processes/steps which are complicated. It is always better that these complicated steps/processes should come from the doer. Manager or management cannot make assumptions what is complex and what needs to be changed. Discuss each step, its complexity and its benefits. Before taking a decision of modifying any step, it is vital to ensure that it should not lead to non-compliance. Avoid taking multiple steps/processes at a time for revision.

·????????Give responsibilities to team members with positive attitude. The intent and competence is important without which, either things will not move or will move in the wrong direction. Management should guide and support, wherever required.

·???????Discuss budget, compliance, timelines and overall impact of each step/process which has been taken for modification. It is imperative to involve all stakeholders from the beginning. It is also necessary to start and execute through a proper plan.

·???????Train the doers and implement the change. It is utmost important that the revised process should be simpler than the previous one, sometimes it may get more complicated. Management should also keep a close watch on its adaptability.

·???????It will be totally wrong to say that once a change is done, it cannot be reversed. It can be. There will be exceptional cases where in after implementation, it is observed that the change has either further complicated the process or the change needs supplementary modifications, these should be re-looked into. The chances of reversing the change will only decrease if a proper due diligence is done before taking a decision.

·???????As soon as any changed step/process is implemented, start work on the next one.

A vital question which usually is being asked by employees is that, whether everything can be simplified. During process simplification programs, some doers expect that each step and each process should be simplified. Principally a simple process may look challenging because of ineffective training processes. It is the responsibility of management to ensure personnel are well trained. Some organizations have complex training programs, in those scenarios, people are reluctant to attend trainings. They look for short-cuts even for the training sessions.

There are certain principles which should be followed while preparing SOPs. Foremost is to ask the doer to prepare the SOP. Use simplest possible text, preferably with bullet points and evade mentioning tasks/steps just for name sake. Ensuring an effective SOP and training management program is the first and most vital step to process simplification.

Process simplification has many advantages and some of these are:

·???????It makes job/task easier for the doer.

·???????Believe me, it increases productivity in many ways.

·???????It enhances quality.

·???????Cost reduction is definitely there, depending on the number and nature of process(s) simplified.

·???????It eases burden on supervision and document review.

·???????Work-life balance is improved.

·???????Significant improvements can be seen in the turnaround time of projects.

·???????Management can take this as an opportunity for enhancing employee engagement.

I will conclude by saying that simplifying the processes should be one of the core agenda of the management, it will not only percolate a positive message down the line but will also help in enhancing quality and reducing cost.

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By

Dr. Arshad H Khuroo

Head Bioavailability and Bioequivalence