Process owner

Other organizations present their policies and procedures in a less formal marmer and/or with considerable variation. In some companies, each functional area, division, or business unit may have its own preferred format in others, the format depends on the topic presented. In cases such as these, it is particularly important to identify the "process owner," since this determination may drive the form of the team s work product. 

The organization mnst consider all management and operational activities as processes and measnre their efficiency and effectiveness. The process owner and process cnstomer of each process as well as management responsible for the processes must be clearly defined. Within each process the responsibilities of management and process owner mnst be conveyed to the persotmel that perform such processes. 

The needs and expectations of customers and process owners must be identified. The performance of each process is measured and monitored and opporturuties for improvement are sought, the aim being the continual improvement. 

Management and process owners will have the ability to focus their efforts on the key processes. 

What education is needed for participants, innovators, engineers, and process owners, such as line management and operators, to reduce or prevent failures ... 

Identification of the process owner who will maintain and update the process... 

Robust processes will have owners that have defined roles, responsibilities, and accountabilities. These process owners must be fully dedicated to their process. They must know their process capabilities and expectations, the interrelationship between their process and other processes and manage them like a business unto themselves. Functional management must support process owners, and leadership must understand and lead the QMS effort as an ongoing program, treating it as the integral part of the business that it is. 

Staff empowerment allows pride in workmanship. Well-designed quality systems make clear to staff where decision authority and process accountability lies, provide clear expectations of the process and process owners, and provide personnel a clear development path to process ownership. 

Clearly identified process attributes provide organizations more than tribal knowledge to pass onto the next process owner.They provide clear structure, process, and other attributes critical to the ongoing success of the enterprise. The organization becomes reliant on their system and processes not people s personal knowledge, which can be lost with staff turnover. 

The QMS and the processes that comprise it must be custom designed for the needs of the business. One size does not fit all situations. The requirements of an enterprise vary across sites and the phases of a product life cycle. A comprehensive system will ensure a holistic programmatic approach in its support to the enterprise. This does not mean that every phase of the product life cycle (discovery, development, commercial manufacturing) will utilize all the processes that comprise the system. Nor does it require that all commercial manufacturing sites will necessarily implement all processes. It does, however, provide a common platform and expectation for all processes, owners, metrics review programs, continuous improvement efforts, and the like when they are implemented. 

This comprehensive approach allows for efficient integration between processes, different phases of product life cycle, and integration between different sites in the supply chain. This integration provides opportunity for efficiency in that process owners are integrated with each other s needs and expectations. Duplication of effort is avoided and efficiencies gained. Quality outputs from one process become reliable inputs into the next process. Management and leadership will have access and insight into compliance, infrastructure, and performance metrics of all processes on a comparable basis. This provides leadership the opportunity for risk-based resource allocation to appropriate areas of the enterprise. 

Complex processes may need to be managed as distinct subprocesses in order to provide process owners the ability to accomplish their work with specific focus and expertise. Management and leadership may require data and metrics on specific areas of the process that are not available if the process is too complex and large. Dividing a complex process into simpler, more manageable processes also allows for scalability and transferability throughout the organization. 

Once processes have been defined for the enterprise, sufficient system resolution should be determined. This is accomplished by evaluating the ability of the process owner to manage and execute the process requirements. Another factor in this determination is the data and metrics needed from the process by management and leadership. An example of a complex process that benefits the organization by being managed through distinct subprocesses is validation. 

Documented process structure provides rapid employee assimilations when transferring employees between sites. New employees, replacing existing process owners, are enabled to rapidly execute process responsibilities due to the abbreviated learning curve when processes have been well defined and documented. Systems designed as described here provide meaningful and comparable metrics for leadership to evaluate progress, compliance, and performance. 

Process owners need to be dedicated to their process. They must be empowered and held accountable for all the attributes listed in their roles and responsibilities. Process owners may have ownership of more than one process and may have other job responsibilities, but it must be clear throughout the organization as to who has full authority for the process. 

Process owners require a defined set of responsibilities to maintain a vibrant and effective process that continues to support product quality deliverables. Having roles and responsibilities defined provides owners with the structure and parameters... 

Including the key stakeholders in decisions affecting process design or changes ensures efforts by the process owner are applied correctly. Process robustness is dependent upon meeting business and customer needs, and the process owners require input and support from the stakeholder group. 

Each process owner requires a defined level of decision authority. This authority level delineates the bounds of decision making granted by the organization to the process owner. Business needs and risk assessment must be incorporated into the design of the decision authority granted to a process owner. Table 6 is an example of a decision authority matrix design for a process owner. It requires cross-functional management support to be effective. 

Site projects All projects related to the existing process or the projected improved state of the process at a specific site Site head Process owner Leadership team Site project portfolio manager Process stakeholders Corporate quality assurance counterpart QMS office... 

Often, the best examples of process efficiency can be found outside the pharmaceutical and biopharmaceutical industries. Other fields such as electronics, space, and software industries have evolved their documentation, training, quality, and change control systems to the point of best in class. These industries are more time sensitive to get product to market and have often evolved their processes to be efficient and decision processes to be very quick. Process owners may expand their knowledge by investigating other industries to find best practices and apply them internally. 

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