Written plans

Emergency response plan A written plan which addresses actions to take in case of plant fire, explosion or accidental chemical release. 

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 ... 

The primary contractor at Site A had identified clean zones, buffer zones, and related site control procedures in its written plan however, onsite implementation differed from those specified in the plan. For example, the exclusion zones identified in the plan at the upper pad of the wastewater treatment plant, the dredge area, and the solid waste storage area were marked with signs requiring PPE, but were not labeled with red banners as called for in the plan. In addition, the exclusion zones did not have controlled access through one point of entry as described in the plan, nor were the buffer zones established and demarcated with yellow banners. 

The contractors SSAHPs at Sites I and K required that safety and health program inspections be conducted however, these requirements were not effectively implemented at either of these sites. Both Site K contractors required the HSO to conduct daily inspections, and both stated in their written plans that hazards would be immediately corrected. Neither contractor, however, had established hazard abatement procedures to ensure the prompt correction of hazards, and site records for both contractors indicated that hazard abatement activities were either not documented or not completed. For example, the subcontractor s daily safety log contained several notations of safety hazards, including an unstable concrete well and storage of diesel cans near the propane tank however, later log entries and site records did not track the abatement of these hazards. 

Submit a written plan describing the hazards and control measures for the work to be done by the contractor, for each new contract or task. 

The plan you develop for implementing PSM will outline your approach to addressing the needs you have identified within your company. While the appearance of the written plan itself can take any of a num r of forms, the content should focus on ... 

The clinical trial protocol is a detailed written plan that outlines how the study procedures are to be carried out and how the data are to be collected and analyzed. It insures the quality and integrity of the trial, particularly when multiple research sites are participating in data collection (Chow and Liu, 1998). The purposes of the protocol are to outline ... 

For each regulatory study, a written plan must exist prior to initiation of the study. The study plan must be approved by dated signature of the Study Director and verified for GLP compliance by QA personnel. 

Study Protocol (160.120) an approved written plan that clearly indicates the objectives and all methods for the conduct of the study. 

Improvement Item Recovery plan not formally documented in a written plan. Reimbursement needs should be included in recovery plan (supplies, hours, equipment, etc.). Utilization of business cards or other quick reference needed to assist in identifying major players involved in recovery planning. Recovery plan should include animal con-trol/consideration of animal welfare. 

Develop a security program with written plans and train employees frequently. 

The FDA s dehnition of comparability protocol is a well-defined, written plan for assessing the effect of specific CMC changes in the identity, strength, purity, and potency of a specific drug product as these factors relate to the safety and effectiveness of the product. A comparability protocol describes changes that are covered under the protocol and specifies the tests and studies that will be performed, including analytical procedures that will be used, and acceptance criteria that will be achieved to demonstrate that specified CMC changes do not adversely affect the product. ... 

Following risk assessment, the next step is to draft a formal validation plan. This is a written plan that includes all the specific validation procedures, installation tasks, acceptance testing, documentation requirements, reviews and verification tasks that need to be followed for proper system validation. The plan should also define individual responsibilities for these tasks and include an expected timeline. The plan should be designed around the URS and take into account the risk assessment determinations performed earlier. 

If a Massachusetts plant produces more than 1000 kg (approximately 265 gal) of waste oil in a month, the plant s waste oil must be shipped within 90 days but the plant is not subject to certain written plans and reports under Massachusetts Management Requirements. The plant may, however, be classed as a small quantity generator (SQG) or very small quantity generator (VSQG) of other hazardous wastes. 

Written plan, verified for GLP compliance, approved by the study director and by the management... 

Is there a written plan for dealing with emergencies ... 

The written plan or SOP on vahdation should include the regulatory or expert review, identifying the approach as an appeal procedure to resolve issues relating to the three-tier system. 

A comparability protocol is a well-defined, detailed, written plan for assessing the effect of specific CMC changes in the identity, strength, quality, purity, and potency of a specific drug product as these factors relate to the safety and effectiveness of the product. 

Suppose that you put two people in a room in accordance with a written plan and designate one the sender and the other the receiver or percipient. In parapsychological literature, they are usually called agent and subject. The percipient and the sender sit back to back so that they cannot see each other. A third person, the experimenter, observes the procedure. The sender is asked to think of some simple thing, draw a sketch of it, and try to send the image mentally to the percipient. The percipient is asked to make a sketch of whatever impressions come to mind. When the percipient has sketched his impression as well as he can, you compare the two sketches. 

A written plan stating how validation will be conducted and defining acceptance criteria. For example, the protocol for a manufacturing process identifies process equipment, critical process parameters/operation ranges, product characteristics, sampling, and test data to be collected, number of validation runs, and acceptable test results [1],... 

The Generic Medical Implementation Plan also specifies that the systems contractor s quality assurance unit must conduct regular audits of the systems contractor s occupational health program and that an annual audit of the program must be conducted by PMCD-designated health care professionals. Reports of all audits are forwarded to the clinic medical director and the medical administrator for prompt action. Nonconformance requires a written plan for corrective action. 

As with strategic planning, the process of business planning produces a written plan. A key point to clarify here is that the business plan needs to be written with the audience in mind. If the decision maker is the chief executive officer (CEO) and/or chief financial officer (CFO), then the plan should be written so that it is applicable to and appropriate for that audience. Business plans that do not consider the audience are less likely to be acted on favorably. A common mistake by authors of business plans (including pharmacists) is to write in a manner that is too technical or detailed, thus failing to hold the attention of executives, who might be the decision makers. 

Employee Participation. Employers must develop a written plan of action for how they will implement employee participation requirements. Employers must consult with employees, affected contractors, and their representatives on the conduct and development of process hazard analyses and on other elements of the standard. They must have... 

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