Process implementation planning

The basis for your program plan should be your team s assessment of the current PSM status (Figure 4-11), which will have yielded a list of deficiencies compared with the required PSM elements. These gaps must now be translated into statements of required tasks, which in turn suggest work products for inclusion in your implementation plan. For example, your assessment shows that the process knowledge and documentation management system needs improvement. To address this gap you need to plan a series of tasks. 

At pulp and paper mills, air emissions from both process and combustion units are regulated under the National Ambient Air Quality Standards (NAAQS) and the State Implementation Plans (SIP) that enforce the standards. States may implement controls to limit emissions of particulate matter (PM), nitrogen oxides (NO ), volatile organic compounds (VOCs), and sulfur dioxide (S02). 

The retention of experienced and knowledgeable personnel during facility operation and closure is an important management issue. Personnel staffing and retention plans need to be addressed early in the facility planning process. Implementation of a suitable personnel retention, transfer, and release program is essential to the successful closure of JACADS. The Army s contractor for JACADS has recognized this issue and has developed a staff retention plan. 

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

To facilitate adoption or approval of a PAT process, manufacturers may request a preoperational review of a PAT manufacturing facility and process by the PAT team by contacting the FDA Process Analytical Technology Team at PAT cder.fda. gov. ft should be noted that when certain PAT implementation plans neither affect the current process nor require a change in specifications, several options can be considered. Manufacturers should evaluate and discuss with the agency the most appropriate option for their situation. 

In line with reasons developed by Baker and Carapinha, Kinsley Wilson and colleagues also accept the premise that the state is primarily responsible for ensuring access to essential medicines. They suggest that countries should develop a National Drug Policy (NDP) and accompanying implementation plans. Countries need to establish adequate processes as far as the registration, selection, procurement, and distribution of drugs are concerned. 

REGULATORY AGENCIES - CHEMICAL PROCESS INDUSTRY] (Vol21) State implementation plan (SIP)... 

Stratospheric Processes and their Role in Climate (SPARC) Implementation Plan (1998). World Climate Research Program Report No. 105, SPARC Office, Verrieres-le-Buisson, France. 

Review and approval process—The plan should address the review and approval process for all protocols and other documentation created as a result of the validation process. This would also include deviations occurring during the implementation of the validation protocols and any failures of data to meet acceptance criteria. 

During the design, specify and procure stage, preliminary process control and implementation plans are developed. These plans lay out the basic timing/milestones for each effort, as well as define the roles necessary to complete all the given tasks. It is expected... 

Validation plan A multidisciplinary strategy from which each phase of a validation process is planned, implemented, and documented to ensure that a facility, process, equipment, or system does what it is designed to do. May also be known as a system or software Quality Plan. 

The implementation plan prepared by the Department of Environmental Affairs and Tourism proposed that an interim expert group will be appointed by the Minister of the National Department of Environmental Affairs and Tourism to assess project proposals and bioprospecting applications and review requests for access. It is too early to make any comment on whether the review process is working because the procedures are not yet fully operational. There is no indication in the regulations as to how long the assessment of the application may take, especially as the applicant may be required to conduct a risk assessment. 

With over three years invested in the development and qualification of the supercritical cleaning process, the next phase of the implementation plan was cleaning of production hardware. The two key operations which had been identified early on as potential applications were the cleaning of end housings and the removal of bulk amounts of damping fluids from fill system fixturing. 

The three primary considerations to be addressed during an effective technology transfer are the plan, the persons involved, and the process. A plan must be devised to organize the personnel and the process steps. Once prepared, the plan must be communicated to the involved parties in research, at the corporate level, and at the production site. The success of any program is highly dependent on the effectiveness of the communication preceding its implementation. Therefore, identifying the parties involved in the development process is one of the most important tasks to be confronted and must be completed early in the transfer process. 

Each particular market must be analyzed to assess its particular needs, timing and other characteristics. The Federal action that is effective with one industry is not necessarily effective with another. The planning of commercialization starts with the beginning of the project and the market potential is a key factor in the project selection process. The planning of commercialization that steurts with the beginning of each project is inclusive of the commercialization actions required during development cind, ultimately, to implement the project. 

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. 

The Agency s implementation plan is expected to describe ways to Implement the recommendations of the NAS. The legal obstacles, however, have been highlighted in the NAS report in some cases. For example, the first recommendation points out current laws are inconsistent with treating residues in raw and processed foods the same. Furthermore, the use of scientific evidence to demonstrate that a risk is "negligible" is Inconsistent with a strict interpretation of the Delaney clause. The Implementation of the recommendations will pose legal risks for EPA, and a consistent standard may not be attained without congressional action. 

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