Executive Action Steps

On the basis of the results described above, and using many suggestions derived from the group sessions, the safety-measures improvement team proposed the following five action steps at the senior executive level. 

A dialogue between levels of the organization should be developed. A dialogue is a two-way conversation, in which each party listens and attempts to understand the meaning the other is trying to convey. It is in the form of an informal conversation. Initial efforts would work best if supported by a facilitator experienced in this process. These conversations are initially difficult to develop in organizations that are relatively hierarchical. 

We recommended that each executive, from the leadership committee on down, participate in a two-hour facilitated dialogue at two plant sites during the year. In addition, we recommended that we share the results of the work of our safety management improvement team with the participants and at the annual health safety and environment (HSE) conference to 

We proposed to use the organization s established TQM process to define and implement a safety supervisory process. We would begin with an organizational unit that volunteered for the process. We would establish a team, including supervisors, hourly employees, and the plant manager. This team would develop, define, and document a process that could be rolled out across the organization. 

The supervisory process had to have the following characteristics it must be cost-effective and improve the overall efficiency of the organization it should be based on the principles of TQM and it must be flexible, so that sites with varying businesses and cultures can implement it. 

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In other words, what integrated and diversified chemical companies need now is bold action aimed at turning them into focused entrepreneurial organizations. Those seeking to make such a transition should first focus on key product or market segments, and then consolidate at the business unit level or below. Once companies have taken these steps, they should use their new platform as the basis for an ambitious growth plan. If they are to execute each step successfully, however, companies will also need to create a more entrepreneurial culture. The result will be an industry that looks very different from toda/s. 

Process design is the first action step in the execution of a project. Process design packages are normally prepared to serve as the starting point for more advanced design stages as well as the basis for the various types of cost estimates required to make progressive project decisions. For example ... 

Consider again a batch polymerization process where the process is characterized by the sequential execution of a number of steps that take place in the two reactors. These are steps such as initial reactor charge, titration, reaction initiation, polymerization, and transfer. Because much of the critical product quality information is available only at the end of a batch cycle, the data interpretation system has been designed for diagnosis at the end of a cycle. At the end of a particular run, the data are analyzed and the identification of any problems is translated into corrective actions that are implemented for the next cycle. The interpretations of interest include root causes having to do with process problems (e.g., contamination or transfer problems), equipment malfunctions (e.g., valve problems or instrument failures), and step execution problems (e.g., titration too fast or too much catalyst added). The output dimension of the process is large with more than 300 possible root causes. Additional detail on the diagnostic system can be found in Sravana (1994). 

At the time the hormone is introduced into the LBD (Fig. 1.4), a conformational change is produced in the three-dimensional structure of the receptor, a change that is key to the subsequent steps in hormonal action. This change is produced by a few contacts (between 6 or 7 and 15) of the receptor s amino acids with related groups from the hormone s structure. Some basic amino acid residues, particularly from arginine, which are preserved virtually intact among receptors, are critical in the execution of this function (Quingley et al. 1995). 

You can implement an action s specification by designing a refinement into a smaller set of actions—ultimately, in software, messages. Program code is the most detailed kind of action implementation. Implementations cannot be joined in the same way that specifications can be joined (see Figure 8.2). First, it isn t clear what anding two programs together would mean. The machine must follow one list of instructions or the other, which one should it execute Both In what order Therefore, your support tool should complain if you try to provide code for two operations with the same name in the same class or for two refinements of the same action into different sets of smaller steps. 

The heart of the system comprises the automatic units that carry out the basic operations. The individual steps of the operations are specified in a set of execution parameters, which are controlled and monitored by a microprocessor that also calculates the basic results. Apart from monitoring all operations for correct action, it is necessary to avoid the generation of incorrect analytical results and to signal the malfunctioning of any subsystem. The machine operation should allow the state of any procedure or module to be readily and easily visible. 

Rule-based At the middle level, these are performance tasks that involve actions governed by training and procedures that are executed consistently by different operators across a facility. These typically correspond to written procedures learned in operations and maintenance classrooms and on-the-job training. An example of a mistake associated with rule-based performance is the omission of a step in a formal written procedure. 

The respondent company has ten working days to provide a written undertaking that the promotional activity or use of the material in question (if not already discontinued or no longer in use) will cease forthwith and that all possible steps will be taken to avoid a similar breach of the Code in the future. This undertaking must be signed by the chief executive of the company or with his or her authority and must be accompanied by details of the actions taken by the company to implement the undertaking, including the date on which the promotional material was finally used or appeared and/or the last date on which the promotional activity took place. 

As part of the action of signing an electronic record, the purpose of the signature must be identified and be an element of each signed record. In the drag CGMP arena, there are relatively few purposes for a signature and these include authored by, reviewed by, and approved by The execution of an action such as a production step does not require an electronic signature, and can be documented via the audit trail. 

Sometimes interdepartmental roles and responsibilities for batch record development and review can become confused during the drive to bring a new product to the manufacturing floor. The information below intends to provide a guide for each department. Keep in mind that individual companies may have differences from what is written here therefore, it is imperative that these roles and responsibilities are included in SOPs dealing with batch record development, execution, and review. The goal is to make sure that all necessary steps, as listed in this chapter, are fulfilled. This list is by no means all inclusive of every department or of all actions necessary to meet specific internal requirements. 

Once the retesting protocol is executed successfully (i.e., no analytical deviations), the results will either support the OOS result and confirm a material failure or render the OOS result invalid and provide ample justification to pass the test specifications. If the OOS result is confirmed, the batch is rejected and the quality assurance department should take appropriate steps for batch disposal. Since confirmation of the OOS result strongly suggests an operator-related or process-related error, the onus is now placed on the formal or phase II investigation participants to identify a cause. If an operator-related error is found and batch rework is possible and prescribed in an approved batch record and approved regulatory submission, this may be the desired course of action. If no rework or reprocessing is possible, the batch is rejected and disposed of in an acceptable manner. 

Another magic besides that of the erotic emanates from the appearance and the actions of the Girls the magic of the military. Drilled, parallel, in step, correctly executing handholds and manoeuvres, obeying an unseen but inescapable command. .. it provides the same appeal that makes soldiers play so palatable to the spectator but of course only as a spectator.97... 

Hybrid audit trails electronically logging last changed by with date and link to related paper-based change records are acceptable for critical records so long as previous versions of the record are maintained. It may be possible in some cases to fulfill the audit trail requirements with a transaction database log. Some database designs require the user to execute a commit record step, while others commit the data as soon as the next field is tabbed to. In cases where a conscious decision to commit the record is required, data entered should not be defined as an electronic record until this action is taken, thus potentially simplifying the audit trail. In cases where there is no commit step, the audit trail should start as soon as each data item is entered. 

A work process model, in the following referred to as process model for short, contains the steps performed in a work process as well as their interdependencies, for example a sequence of several steps or their parallel execution. In this contribution, the steps are referred to as activities, in contrast to other terms which can be found in literature (e.g., action [880], function [949]), this term emphasizes the temporal dimension of an activity which can itself be decomposed in several sub-activities which form a work process in their own right. Depending on their purpose, process models can contain further information beyond the activities, for instance about the products of activities, the people performing the activities, or the tools required. 

Executive Session of Organizing Committee 12 15 Working lunch general discussion 1 00 Develop consensus findings 1 45 Develop consensus recommendations 2 30 Develop action items, follow-up steps, and assignments 3 30 Adjourn... 

In conclusion, we wish to once again emphasize the value of the context that surrounds the application of QSAR strategies in synthesis planning and in analysis of biological data including insights relative to mode of action studies. If the first steps of experimental design are done properly the benefits can include activity optimization as well as effective overall project execution. 

The evaluators are presented with the task under study and asked to woik through each individual action. The evaluator examinees the user interface and executes the next action they believe will progress towards the defined goal. At each step individuals are asked to note any difficulties or areas of concem. The evaluator records either a success or failure story depending on whether they were able to successfully progress. 

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