Step 5 Implementation Plan

build a task list to include all of the actions required to get to the future state condition. Each task should have a defined owner and a target date. The value of this step is the accountability and task management it provides. With the future state clearly in mind, the team can be turned loose to accomplish the identified tasks. When all tasks have been accomplished and the future state process has been in use for some period of time, the final step of the A3 process can be completed. 

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Having agreed on PSM goals and objectives, your next step is to conduct a more detailed assessment of the present status of PSM activities within your company, to form the basis for your implementation plan. This baseline assessment works against both the model you have selected for PSM and the characteristics that describe a sound management system, such as those described by CCPS. 

SIPs are intended to prevent air pollution emergency episodes. The phms are directed toward preventing excessive buildup of air pollutants tliat me known to be harmful to the population and the enviroiunent when concentrations exceed certain limits. The compounds affected under the implementation plans are sulfur dioxide, particulate matter, ctirbon monoxide, nitrogen dioxide, and ozone. A contingency plan, which will outline the steps to be taken in tlie event tliat a particular pollutant concentration reaches tlie level at wliich it can be considered to be hannful, must be included in each implementation plan. The implementation plans are solely based on tlie continuous emission of tlie previously stated air pollutants. They do not mandate any actions to be taken in tlie event of an accidental toxic release. 

Slates are required to propose implementation plans, SIPs, for tlie prevention of air pollution emergency episodes. Each implementation plan must include a contingency plan, wlrich will outline tlie steps to be taken in tlic event tliat a particular pollutiuit concentration reaches the level at wliich it can be considered to be liarmful. 

Final decision. The ability to arrive at a final decision regarding the acceptability of a material for use will depend on the degree to which each of the aforementioned steps were planned and implemented. The establishment of a stepwise framework with specific objectives, procedures, and criteria is critical to implementing an evaluation approach that will address all necessary issues. 

The overall program design consisted of a five-step process leading to State Implementation Plan revisions ... 

Instruments to be used in a GMP environment have to be validated prior to regular use. It is useful to develop the instrument implementation plan as a plan to outline the steps necessary to validate the instrument and to support the use of the instrument through its functional life in the laboratories. The implementation plan should highlight the activities in the validation of the system and will be the guiding document of the project. Typically, the validation plan includes ... 

By 1999, 108 countries had developed an NDP while 69 had yet to draft an implementation plan (WHO 2004a). Each country should take careful steps to plan and prioritize its implementation in correspondence with national priorities (WHO 2001). Prioritization is often based on balancing the severity of the problem, the likelihood in achieving the objective, and the potential impact possible with existing resources (WHO 2001). In the context of good governance, Cohen, Cercone, and Macaya (2002) suggest that resources should be funneled to the weakest link in the pharmaceutical system, to decrease the likelihood of poor investments. 

When the implementation plan has been developed, the next step is to start implementing the plan by preparing the organization for a full rollout of the metrics program. 

In both regions, the vision and roadmap documents stress an integral and connected approach for research and development, but are less clear about market development. The European Union did not address market issues early on, although a May 2003 EU directive does promote alternative fuels for transport (European Commission, 2003). That directive is planned to be a stepping-stone aimed to stimulate a market pull for alternative fuels. The U.S. implementation programs address market issues, but actual policies and programs have not been proposed. My preliminary characterization of the U.S. implementation plans would be high priority for research and development and low priority for market development. 

All software and computer systems used in accredited and GLP- and GMP-regulated analytical laboratories for the generation and analysis of critical data should be retrospectively evaluated and formally validated. As a first step, the user should list all systems in the laboratory, assess the need for validation for each system and develop an implementation plan. For validation of individual systems, the validation plan should describe user requirements and specific validation steps. It should also list the person or persons responsible for each step as well as the criteria that must be met to achieve validated status. 

During the whole process it is important to involve stakeholders, to ensure that dieir interests and views are correctly understood in the problem identification and problem solution phases. They must also share the conceptual understanding of the system and have confidence in the scientific basis of the assessments of the programme of measures. Furthermore, it is important to evaluate the uncertainty in the different steps and tools used, for instance in the model simulations and in the data collected. Other factors such as social aspects, socioeconomics and restrictions in terms of economy, etc. have to be taken into account in the implementation plan. Stakeholder involvement and uncertainty assessments are not shown as individual steps in die flow chart in Figure 4.1.1, because they should be considered through the whole process. 

Recommend a design and implementation plan for the shift and separation steps for the Phase 3 demonstration in Georgia in 2003. 

Step 4, plan and implement solution, is a statement of how the team intends to solve the problem. It is important that the team understand the limits of its authority, so that it will develop local solutions that are very focused on the root cause(s) identified in Step 3. They are not authorized to change the entire system. The team needs to analyze the problem and identify different alternatives to solving the problem. It is valuable for the team to assign the tasks of implementing the solution using the 4 Ws and 1 H who, when, where, what, and how. 

Step 5 Planning and implementation of appropriate strategies for anticipating and preventing error occurrence, or for minimizing the potential for harm. The action plan incorporates within its framework a shared vision of appropriate goals that are focused, measurable, and simple. 

In the PDCA process, planning is the first step. This section requires that processes be established to identity hazards, risks, and shortcomings in safety management systems and to establish and implement plans for continual improvement. Measurable objectives are to be established to achieve the greatest probable risk reduction. 

In the Plan-Do-Check-Act (PDCA) model, the Plan step requires that problems be identified and analyzed. In some PDCA models, the first action to be taken in applying the Do step is to develop solutions for the problems identified. Establishing and implementing the processes set forth in the planning section of ZIO will serve problem identification and analysis purposes as well as the development of solutions and implementation plans with respect to the problems identified. 

In the planning processes, occupational health and safety management systems issues are identified, analyzed, and prioritized. Those issues are defined in the standard as hazards, risks, management system deficiencies and opportunities for improvement. After the identification and analysis process, objectives are then to be established that offer the greatest opportunities for improvement. The following steps are to draft a documented implementation plan to achieve the objectives and to allocate the necessary resources. 

Value Stream Mapping is the written or computer-based identification of the sequence of activities and information flows to produce a product or deliver a service. This represents a vital step in the lean concept because it provides the opportunity for team brainstorming to identify activities that do not add value. Lean practitioners use value stream mapping to identify major sources of non-value-added time in a value stream envision a less wasteful future state and develop an implementation plan for future lean activities. An Addendum providing a Simplified Initial Value Stream Map appears at the end of this chapter. 

As the implementation plan proceeds, a score for each step is calculated by multiplying the level achieved by its weighting. A copy of the chart can be provided to senior managers each month from which the pace of progress can easily be seen. This can assist in decisions regarding the allocation of resources to maintain progress. 

The TQM project implementation steps are as follows identify problems (opportunities) prioritize these problems select the biggest bang-for-the-buck project develop an implementation plan use operations research and MIS tools where appropriate develop guideposts and an appropriate measurement system conduct training carry out implementation perform feedback— monitoring— control—change after successful project implementation and ongoing status, repeat cycle. 

The next step is implementation. The implementation should be a trivial process, if all the planning and training steps are performed carefully. Part of the implementation involves installing feedback, monitoring, and control mechanisms, as laid out in the implementation plan. Careful monitoring allows corrective changes to occur whenever necessary. 

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