Planning for assessments

AEA. 2001c. Engineering Design Study Plan for Assessment of Technologies for Assembled Chemical Weapon Demilitarization, April. Pittsburgh, Pa. AEA Technology Engineering Services, Inc. 

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. ... 

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. 

D) the submission to the Secretary by the manufacturer or the sponsor of the investigation of a new drug of a statement of intent regarding whether the manufacturer or sponsor has plans for assessing pediatric safety and efficacy. 

Table 1 provides a useful context in which to discuss typictd measurement problems. There are two classes of problems of interest. The first class is planning too late, where, for example, failure to plan for assessing acceptability can preclude measurement prior to putting a product into use. The second class of problems is executing too early, where, for instance, demonstrations are executed prior to resolving test and verification issues, and potentitilly lead to negative initial impressions of a product or system. 

Action plan for assessing manual handling and sources of OOS... 

Solid-wa.ste-filling plan. The specific method of filling will depend on the characteristics of the site, such as the amount of available cover material, the topography, and local hydrology and geology. To assess future development plans, it will be necessary to prepare a detailed plan for the layout of the individual solid-waste cells. On the basis of the characteristics of the site or the method of operation (e.g., gas recovery), it may be necessaiy to incorporate special features for the control of the movement of gases and leachate from the landfill. 

An aetion plan for risk assessment is given in Figure 6.2. 

Figure 6.2 Action plan for fire risk assessment...

Consultation distances (in relation to major hazard and other sites, e.g. LPG, chlorine, for land use planning) HSE assessments for consultation distances for major hazard installations. Chapter 5 in Safety Cases (Lees and Ang, 1989)... 

The entire quality system shall be assessed at a minimum of once every three years. The audit plan for a supplier has to cover all requirements, all sites, all locations, all operations, all functions, all customers, all processes, all procedures at least once in a three-year cycle, unless it is an upgrade certification (see clause 4.6). Hence the sample of operations taken on each audit has to cover at least Veth of the whole. 

A failure modes and effects analysis is a systematic analytical technique for identifying potential failures in a design or a process, assessing the probability of occurrence and likely effect, and determining the measures needed to eliminate, contain, or control the effects. Action taken on the basis of an FMEA will improve safety, performance, reliability, maintainability and reduce costs. The outputs are essential to balanced and effective quality plans for both development and production as it will help focus the controls upon those products, processes, and characteristics that are at risk. It is not the intention here to give a full appreciation of the FMEA technique and readers are advised to consult other texts. 

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. 

Program Plan for an Integrated Risk Assessment Data Acquisition Program. U. S. Nuclear Regulatory Commission, September 1982. 

As piirt of each haz, irdous waste remedial action, the contamination at the site must be assessed. The options for remedial action to remo c or otherwise deal with hazardous materials will depend on the nature of the coutamiiuition lliat will be allowed to remain on site tifter cletmup. Thus there must be plans for site remediation to cover any accidental or emergency discharges to land or soils that might develop. 

Mr. York has been prescribed clofazimine daily to manage his leprosy. Discuss what preadministration assessments the nurse should make. Explain what information you would include in a teaching plan for Mr. York. 

Ms. Parker, age 72 years, is prescribed celecaxib for osteoarthritis. She is confused at times and has difficulty hearing. In developing a teaching plan for Ms. Parker, discuss what assessments would be important. Identify points to include in her teaching plan. 

Mr. Garcia wasprescribed labetalol (Normodyne) 100 mg orally twice daily for hypertension. The health care provider wants him to monitor his blood pressure once daily. Determine what assessments you would make. Develop a teaching plan for Mr. Garcia that would help him in monitoring his blood pressure and taking labetalol. 

A patient is prescribed tacrine (Cognex) for mild dementia related to AD. The nurse has a meeting with the patient and family. What patient assessments would you need to make before discussing the drug regimen with the patient What would you include in a teaching plan for the patient and family ... 

Judy Cowan, age 28 years, has been prescribed clomiphene to induce ovulation and pregnancy. Judy is very anxious and wants desperately to become pregnant. Her husband, Jim, has come to the clinic with her. Discuss assessments the nurse would consider important before initiating treatment with clomiphene. Discuss information the nurse would include in a teaching plan for Jim and Judy. 

Ms. Stone, age 76 years, has glaucoma and is prescribed timolol (Timoptic) eye drops. Your initial assessment reveals that she has severe arthritis and appears to have difficulty following instructions. Discuss any further investigations you feel are important to make before developing a teaching plan for this patient. 

Finally, the diagnostic instrument may be administered before commencing a particular topic in order to gauge students prior rmderstanding of the associated concepts. At the same time, the use of the instrument as a formative assessment tool will enable the teacher to take appropriate measttres to challenge ary students conceptions that may become evident dttring the lesson or plan for remediation with small groups of students that experience difficulties. 

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