As companies in pharma continue to grow, the way in which they operate and manage their sites needs to adapt with increasing demands – how can a business process management system be useful in facilitating these adaptations?
The biotech and pharma sector is growing steadily. Many companies have full order books for the next few years and expect growth. This is the basis for new investments in assets and infrastructure. These growing structures often expose vulnerabilities and challenges for the business. Therefore, companies need to increase the stability and efficiency of their processes.
With companies that are currently expanding to serve the needs of the biotech and pharma market, there is often a drive to significantly increase manufacturing capacity at production sites. As there are incredibly high standards for GMP-compliant CDMOs to adhere to, the challenge for most organisations is the transfer of currently efficient processes to new facilities or at larger scales.
There needs to be a drive to continuously improve and standardise the processes of the entire company, in order for the CDMO to differentiate itself from the competition and respond more flexibly to the needs of its customers.
Business process management as the key to growth
Business process management (BPM) is the structured approach to gaining transparency of activities, responsibilities and interfaces within an organisation. Implementation begins with the documentation of business processes. This is the basis for later analysis and optimisation. It is recommended to start with a top-down definition of the most important processes. These are divided into three areas: management, core and support.
Core processes represent the value chain of the company’s services. They typically start with the customer’s order and end with the delivery or fulfilment. Support processes are necessary for the core processes to operate, for example, to provide materials, personnel, equipment or assets.
Management processes ensure that these processes are carried out. They include strategy definition and control or measures to ensure compliance.
The key for a successful BPM implementation is to take the right approach based on the needs and culture of the organisation. There are two main types: top-down or bottom-up. The top-down
approach requires the support of the top management. They need to understand the benefits and provide the respective resources. The bottom-up approach requires the employees to recognise the advantages for their daily work. Considering the effort and time required for a full BPM implementation, the topdown approach is more efficient and should be prioritised.
Figure 1: Example of a process landscape
Regardless of the approach, the company needs to nominate (top-down) or organise (bottom-up) a core team. This core team should be made up by experts from every business area (three to five people are recommended).
First, they have to identify all business activities from customer order until delivery or fulfilment. Afterwards the management and support process can be defined. The results of these activities are the main processes of the company, which are represented in the process and business landscape (as shown in Figure 1). The finished draft should be released by the top management.
In the next step, every main process can be detailed. Therefore, SIPOC is a common method for the initial documentation. It is important that each sub-process has between four and seven steps.
The initial SIPOC can afterwards be modelled by the Business Process Modelling Notation (BPMN 2.0). This is a worldwide standard, which is used by most of the companies. Therefore, the introduction of a BPM software is recommended to simplify the modelling of the whole process landscape (as shown in Figure 2).
Establishing a BPM organisation
The modelling of the detailed processes shouldn’t be done by the core team alone. The core team needs to involve further experts from each department. In the end, every process needs one (process) owner and at least one (process) manager. The process owner is responsible for the process and has to release it. The process manager is the operational part and prepares the initial process or implements changes. All process owners and managers need a basic BPM qualification within their responsibilities.
This shall enable them to continuously improve the process modelling by the user feedback. They have to ensure that the described activities help all employees to perform the processes in the correct way.
The detailed process shall include some important information. Every step and task should contain the responsibilities who execute them. This can be represented by RACI Logic:
R = Responsible
A = Accountable
C = Consulted/Cooperation
I = Informed
Transparency of responsibilities clarifies the interface between different departments, especially in new facilities. Everyone knows how to work and who to involve. The effect of this clarity is to reduce waste in finding the right person to talk to and to improve quality by involving the necessary experts. Another important piece of information is the input and output of each step and the whole process. The input shows all the information, documents or products required to start the task or process and the output represents the result. An example is an empty template that is filled in. If processes have no output,they are not needed for the business because the output is the input for other processes or a result to meet customer requirements.
Quick hits for process improvement
During the modelling companies with several locations often face the problem that their processes work differently. Different executions of the same process can lead to variations in the quality of the products delivered to the customer. This may affect the reputation of the company and the customer satisfaction. So, the first step should be the standardisation to increase the efficiency of the process and the quality of the output. In this way, sites can learn from each other and adopt best practice.
At first glance, this may seem like a simple quick win, but it requires very good change management to get everyone on board. It is therefore important to involve representatives from impacted sites as early as possible.
Otherwise, the standardisation will only be valid on paper, but won’t be implemented. It is also important not to force standardisation on every process. Different legal requirements or different site sizes can prevent compatibility. In these cases, local variations are necessary and required.
In addition to quick hits for process improvement, Key performance indicators (KPIs) are an important requirement for increasing efficiency. The definition of KPIs makes the process measurable and shows the status of the process. Basically, KPIs can be divided into three areas: quality, time and cost (including effort). Ideally, each process will have one KPI in each category, but no more than five in total.
Figure 2: Scheme for a SIPOC
The necessary information for a KPI is a precise description of the purpose, the stakeholders and the calculation. The target value and ranges can then be defined. In some cases, it is necessary to collect data beforehand to get an idea of a suitable target. When the KPIs are recorded, a traffic light system can provide a quick overview of the performance of each process.
Figure 3: Maturity levels
Increasing the maturity of BPM
The implementation of BPM is an ongoing process to continuously improve the maturity of the organisation. Based on the previous steps, the company has established BPM and reached maturity level two.
The next level will be ‘Managed’. For this, other management systems such as risk management have to be integrated and linked to the processes, and each process must have key performance indicators. The North Star is the achievement of ‘Level 5: ‘Optimisation’ (Figure 3). This level is never finished, because process improvement doesn’t stop. It is always assumed that the current process is the worst process and must be improved.
