Processes, owners defined

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. 

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. 

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 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... 

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. 

A well-designed QMS will include identified process owners with defined roles and responsibilities. Process owners require support from management, their customers, stakeholders, and quality assurance. Accountability and decision-making parameters will empower process owners to drive execution and improvements to their process, delivering the business results expected. Without these process owner attributes and support, minimal results will be achieved, and functional management will be burdened with and assume the responsibility for making decisions that should be in the hands of capable process owners. 

Process improvements may be conducted by the completion of a task or a project. A task is an activity that can be completed by the process owner with minimal cost and/or resources over a short period of time. A project is defined as temporary work to provide a product or service that is beyond the process owner s support. In general, a project requires more than one full-time equivalent (FTE), crosses over multiple functional organizations, and the duration of the effort spans over a longer period of time. Improvement status, updates, and issues should be discussed on a regular basis by a management forum or steering committee. Tasks and projects should be prioritized based on the risk against patient safety and efficacy and compliance. 

Therefore, it is the first task of the business process owner to define which records under his area of responsibility are electronic records and which not. The best approach is to have a defined and documented business process. Then the records growing out of this process can be determined. In the next step, systems supporting the process are identified, and records in the system assessed. The business process definition will also be needed as a basis for the record risk assessment and validation activities of a system. An example on how this can be documented is given in Fig. 2. 

Quality cf relationships pertains to the quality of interaction and relationship among suppliers, process owners, customers, teams, work units, labor and management, and functional business areas. It also involves the quality of outputs and outcomes produced as a result of a defined relationship among suppliers, process owners and customers. 

Process owner Each defined business process should have an individual assigned to monitor and direct that process. Often when business processes are ineffective or produce poor results, it is due to the fact that process ownership is unclear. 

All working processes are stable and shared between the process owners. The processes are homogeneous and consistent. Interfaces are well defined and understood. There exists a common practice of revising processes and the related IT tools. There will be small changes only in the future. 

Step 1 begins with selecting the areas to improve — injury reductions, product improvement, inventory management, etc. A well-defined scope is established that will validate the business issues under review. The scope and objective can be established by a designated team, the process owner, and/ or a member of the leadership team. 

If the RFA or other information has indicated a release of hazardous constituents, then from the owner/operator s perspective, the Corrective Action process truly begins. The first step in the process, the RCRA Facility Investigation (RFI), is directed toward development of the engineering information about the site necessary to permit selection and evaluation of remedial alternatives. The main engineering thrust of the RFI is the characterization of site conditions by defining the nature and extent of the problem. 

The gap between the process risk and the owner/operator s risk criteria establishes the requirements for risk reduction. The risk gap can be managed by a single safety function or by multiple functions allocated to protection layers. The team defines the risk reduction that must be provided by each safety function and allocates the safety function to a protection layer that is designed and managed to achieve the allocated risk reduction. 

Owner - A person who has defined responsibility for a proposal, a function, a work process, specific data or an idea. Use of the term owner needs to also clearly identify what is owned and what is the responsibility of that ownership. ... 

The Keystone of the Reactive Chemicals Program is the concept of Owner Responsibility. (When all the advice and consultation is gathered relative to an issue, it is the process or facility owner s responsibility to make the appropriate decisions. It is recommended that the Owner be defined as the person who approves the highest level of Management of Change for the facility.)... 

Risk is defined as the probability of an undesirable event occurring and the impact of that event if it does occur. The result of this analysis will influence the degree to which the system development, implementation, and maintenance activities are performed and documented. By evaluating the system risk analysis, the system owner may uncover potential problems, which can be avoided during the development process. The chances of a successful, if not perfect, system implementation are improved. 

The System Owner/User role is responsible for defining and approving requirements. It should be possible to describe in overview the system to be implemented from this information. The System Owner/User should then agree with Quality and Compliance what functionality within the computer system is GxP critical. This is used to help select the supplier to develop the system. The System Owner/User should lead a Design Review to verify that what is being developed meets the requirements, with feedback to the design and development group(s) as required. The User Qualification Process should take account of GxP Assessment of critical functions, the capability... 

Environmental stewardship, with quality, health and safety, are all definable processes that can yield immense benefits from management systems. Academia, owner and contractor companies and suppliers will be judged not only on the value they deliver but also on their ability to protect and improve the world. No longer are chemical engineers just working on a finite task they must broaden their view and set the benchmark for global responsibility. 

The SPCC addresses owners or operators that drill, produce, gather, store, use, process, refine, transfer, distribute, or consume oil and oil products. With such a broad classification, de minimis standards are established that set maximum vessel or throughput quantities. The SPCC defines threshold EPA reportable event levels as ... 

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