Plan development elements

The second volume and CD-ROM are designed for individuals specifically involved in writing and execution of master validation plans, development of protocols, and applicable procedures. This book provides a complete, single-source reference detailing conceptual design elements and 139 explicit procedures to provide sterility assurance. 

Development, review, and/or revision of the Incident Action Plan, or elements of the Incident Action Plan... 

The centerpiece of the Laboratory Standard is the Chemical Hygiene Plan. This is a written plan developed by the employer (e.g., university or research organization) and has the following major elements ... 

Having determined the overall program objectives and having created an organization, the next step is to develop a detailed SEMS plan. Key elements in the plan are ... 

Prolonging the patency of an access circuit is a key element for patient safety. It starts with optimal access planning utilizing DUS and surgical techniques that minimize hemodynamic stress responsible for the development of MIH. Monitoring, surveillance and timely interventions play a key role in prolonging the access patency. It is important that the access plan developed and communicated to the patient gets reinforced by all personnel involved in patient care activities. 

List several elements important to developing a meaningful indoor air quality management plan. 

An OSHA emergency response plan (ERP) is a written plan to prepare for and handle anticipated emergencies prior to the emergency. If employees are expected to respond to spills or releases requiring an emergency response, OSHA requires the development of an ERP that contains required elements as outlined in 29 CFR 1910.120 (q)(2) and (l)(3)(iv). The following are the minimum type of procedures ... 

Employers shall develop a written action plan that implements employee participation in developing and conducting process hazards analyses and other elements of process safety. management. 

Risk-based information provides a foundation for regulation of severe accidents. Early PRAs, with large uncertainties, indicated risk that was above or below the Safety Goals depending on containment performance. Consequently the NRC developed an Integration Plan for Closure of Severe Accident Issues (SECY-88-47) with six main elements to this plan 1) individual plant examinations (IPE), 2) containment performance improvements, 3) improved plant oper itions, 4) severe accident research, 5) external event considerations, and 6) accident management. 

If an element has no system at all, it may indicate that the facility manager does not fully understand what the element requires, or is for some reason unable to cany his/her responsibilities. In addition, a weakness in corporate oversight, direction, or resource allocation may contribute to the problem. Either way, the plan you develop must take these gaps into account. 

The best approach is to begin by developing a plan for each PSM element. The summary of those plans represents an overall plan for the PSM program. The steps required to prepare a plan are the same whether your approach is centralized or decentralized. 

As you near completion of each PSM element s modification or redesign, it s useful to check results against the criteria you established as part of developing your plan. You may find it helpful to review the plan at intervals, and to revisit Section 3.2, which discusses PSM criteria. Similarly, you will want to assure that the modifications you devise address the priorities you identified as part of the planning process (see Section 5.3). 

As part of developing the PSM implementation plan (Chapter 5), you and the team identified benefits unique to the approach you selected, using them to help win management s approval. For example, your plan may focus on priority elements because the assessment you conducted suggests that this method will yield the greatest overall improvement in safety performance. And, as part of the pilot test described in this chapter, you focused on facility-specific benefits to enlist the support of local management and staff. 

Once the order in which you plan to develop management processes, programs, and elements has been established, you must assign responsibilities for the work. These will be shared between the project team and local managers and staff. Generally, small development teams will be established to work on particular processes, programs, and elements. Ideally each team should include the following ... 

The team should also measure the success of the pilot project itself— compared with the plan how long did each activity take, or how many new processes were developed, or how many programs and elements needed to be developed or upgraded compared with your plan This will allow you to reconsider the overall project cost estimate and revise it if necessary. 

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