The scope of this study is to explore the understanding of Optimizing Manufacturing Operations in Pharmaceutical Industry including manufacturing structure, empowering employees, staffing for fluctuations and managing change along with Manufacturing Excellence and Process Efficiency Optimization.By maintaining and analyzing all these points one will be able to compare company’s manufacturing operations and management structure against those of the benchmark class, spot areas for improvement and utilize the best practices to develop a plan of action to implement performance enhancing activities.
Optimizing Manufacturing OperationsWhile optimizing manufacturing operations; Rapid Delivery, Uncertain Demand and Around-the-clock Operations are to be considered. The key insights in benchmarking manufacturing operations are:
1) Restructure positions that do not directly impact productivity to establish a lean management structure – Design lean management structure by restructuring positions that are accountable for productivity goals which are not empowered to impact production. Establish a lean management hierarchy to oversee facility operations, processes, shifts and production departments to increase accountability and cross-functional sharing of ideas.
2) Reduce management layers and establish a flat organizational structure through individual employee empowerment – Flattered organizational structure enables its leaders to react to problems more quickly. Include training and empowering employees, continuous process improvement and outsourcing complex tasks.
3) Staff below expected demand and augment the workforce with part-time employees to optimize staffing levels during periods of fluctuating demand – Fluctuating demand is a challenge for managers since facilities are forced to increase or decrease its workforce to demand levels. Manage uncertain demand by staffing full time work forces below forecasted demand and having additional staff available to quickly support demand fluctuations.
4) Anticipate and respond to the impact of structural changes on the facility’s and workflow – Structural changes are aimed at improving efficiencies and will result in a more productive workforce in the long run, but companies must also anticipate the short-term impact of structural reorganization on the culture and workflow.Manufacturing ExcellenceFor benchmarking manufacturing operations analyze manufacturing performance measures including Finished Goods inventory, work-in-progress inventory, manufacturing cycle-time, on-time delivery rate and customer lead time.
The key insights in manufacturing excellence are:
1) Combine distribution mechanisms with lean manufacturing techniques to excel in total inventory management – Finished good turns are an indication of a company’s proficiency in managing finished product inventories and are closely linked to distribution mechanism. The organizations focusing on work-in-progress inventory management and low customer lead times makes strong finished goods inventory management difficult.
2) Manage customer lead time and manufacturing cycle time to address market pressure and lean manufacturing efforts – Manufacture a range of complex products so that major cycle differences rely on unit degrees of customization in combination with ability to manage inventory.
3) Provide adequate support for productivity driven initiatives – Productivity driven programs are clearly responsible for high performance when they are aligned with company operations and implemented well across the organization.
4) Complaints Management – Manage complaints through a defined resolution process and trigger the appropriate corrective action/preventive action (CAPA) procedures. To address this issue, companies need to adopt a system that is capable of configuring process flows and enables easy tracking of complaints.
5) Training – Pharmaceutical manufacturing necessitates a methodical process of factory floor employees training and skill set tracking on production equipments. Extensive documentation including training manuals, standard operating procedures and regulatory guidelines need to be maintained and also closely controlled for accuracy of revisions and updates.Process Efficiency OptimizationThe nature of Pharma Industry demands the highest standard of production precision, detailed product and process reviews. Optimizing the existing manufacturing process is achieved by making additional development batches at laboratory scale, pilot scale and possibly even at production scale.
The following points can be considered during process efficiency optimization
1) Ensure Quality – Follow strict manufacturing processes that should be adhered in order to minimize any variability in product characteristics.2) Design of Experiments – Use Quality-by-Design approach to product development for systematic evaluation, understanding and refining of the formulation and manufacturing process including:
a) Identify the material attributes and process parameters that can have an effect on product Critical Quality Attributes by using knowledge, experimentation and risk assessment.
b) Determine the functional relationship that link material attributes and process parameters to product Critical Quality Attributes.
c) Assessing the impact of parameters on the product.ConclusionThe manufactured products if not delivered to customers, what will happen? Does the organization survive?
The answer is NO.
Thus, the products manufactured should be delivered rapidly to the customers along with managing uncertain demand.
Establish lean management hierarchy and flattered organizational structure to react to problems more quickly. To achieve manufacturing excellence concentrate on Finished Goods inventory, Work-in-Progress inventory, manufacturing cycle time, on-time delivery rate and customer lead time.
Follow strict manufacturing process in order to minimize variability in product characteristics.
