Planned Changes

Before any planned changes are made, including organizational and safety control structure changes, their impact on safety must be evaluated. Whether this process is expensive depends on how the original hazard analysis was performed and particularly how it was documented. Part of the rationale behind the design of intent specifications was to make it possible to retrieve the information needed. 

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A test run involving the actual raw materials for the toll or the initial startup that follows a water batch and PSSR is an appropriate time to evaluate any planned changes necessary for increasing production later in the toll. 

Planned changes should be documented as part of a formal change monitoring process (for example via a quality assurance system). Unplanned changes should be identified during the accident investigation process. 

Beginning on July 1, the company will institute some changes to our policies and procedures (P P). Please take time before that date to familiarize yourself with both the existing P P and the planned changes. The P P can be found on the company website under the P/P link. 

Schizophrenia is arguably the most devastating of all mental illnesses. It typically takes a young vibrant person just entering adulthood full of hopes and aspirations and devastates his/her life. Education is interrupted. Career plans change. Family life is disrupted. Often a shell of the former person is all that remains. 

During the development of the closure plan, changes were identified that necessitated a change to the JACADS RCRA permit. Table 3-2 lists six permit modifications submitted by the Army to EPA to support closure. 

Materials for this year s open enrollment are in Please come to the Human Resources Department to pick up your packet. There are several changes in the Medical and Dental plans we will be offering next year. You ll need to make your selections by December 15. Plan changes will be effective January 1,2003. 

One of the primary problems to be encountered in energy conversion facilities will be the variability of the feedstock. A coal or oil shale facility will probably see greater variability, day-by-day, than experienced in planned changes in oil refinery crude runs. Even with extensive blending in the feed stockpile, the variation in feed characteristics will be significant. 

Planned changes that could affect the quality management system... 

The agenda of the management review meetings is based on follow-up actions from previous reviews, proposed and planned changes to inculcate further improvement, customer feedback resulted through effective communication and results of the previous audits, and the corrective and preventive action taken. 

The quality system requirements specified in clause 4.1 are achieved through proactive planning. Changes made to the system are documented and controlled. 

Adaptive planning—changing the project plan based on the feedback from each iteration Please note that it is perfectly OK to cither add new features or remove already planned features in the forthcoming iterations. This... 

Gentle but increasing anxiety occurs as you approach retirement. This anxiety can be healthy if it produces sound planning. The more planned changes the better, so long as you do not lose interest in your work role and become less productive. 

Planned change An intentional change to a validated system for which an implementation and evaluation program is predetermined. 

Guerrero RM, Nickman NA, Bair JN. 1990. Using pharmacists perceptions in planning changes in pharmacy practice. Am JHosp Pharm 47 2026. 

Communication with the FDA contact can take a variety of forms most will accept telephone calls and e-mails and will request formal, written communications when significant issues arise. But regardless of the format, keep your contact in the loop if schedules or plans change. 

Study Plan Amendment A study plan amendment should be issued to document a planned change in study design before the event occurs. An amendment also may be issued as a result of unexpected occurrences during the study that will require significant action. Amendments should indicate the reason for the change and be sequentially numbered, dated, signed, and distributed to all recipients of the original study plan by the study director. 

Studies are conducted to evaluate the adverse effects of chemicals and drugs, and are usually based on an earlier study plan. Deviations from study plans are not common. However, such deviations cannot be anticipated or totally ignored. In such a situation, there is a need for documentary evidence. Whereas an amendment is a planned change to the study plan, a deviation is an unplanned change that occurs during the study. Study information, such as a deviation from the study plan, should be noted in documentation. Such notes may be initiated by other personnel involved in the study but should be acknowledged by the study director who must approve any corrective action taken. The study director should consider whether to consult with other scientists to determine the impact of any such information on the study and should report (and discuss where necessary) these deviations in the final report. 

Thus the second set of comparisons to be made evaluates alternative preclinical development plans to support the lack of a relevant species and planned changes to the cell line, manufacturing process, formulation, or route of administration during development. 

Organizational charts Training records Validation Master Plans Change control records Problem logs... 

Step 3 Observation stage (collect information on the effect of the planned changes which have been implemented)... 

Step 1 Planning stage (identify objectives, define data which may be available, define new data needs, plan change or test)... 

Virtually all the needs of Brasilia s future residents were reflected in the plan. It is just that these needs were the same abstract, schematic needs that produced the formulas for Le Corbusier s plans. Although it was surely a rational, healthy, rather egalitarian, state-created city, its plans made not the slightest concession to the desires, history, and practices of its residents. In some important respects, Brasilia is to Sao Paulo or Rio as scientific forestry is to the unplanned forest. Both plans are highly legible, planned simplifications devised to create an efficient order that can be monitored and directed from above. Both plans, as we shall see, miscarry in comparable respects. Finally, both plans change the city and the woods to conform to the simple grid of the planner. 

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