Self-assessment

This questionnaire addresses all the key requirements of ISO/TS 16949 and will help you determine the margin between where you are now and where you need to be to achieve ISO/TS 16949 registration. If your business is the provision of services rather than products, replace the word product with service in the following questions. 

1 Have the quality policy, quality objectives, and commitment to quality been defined and documented by executive management  

1 Is the quality policy understood, implemented, and maintained at all levels in the organization  

1 Has a process been established for determining customer satisfaction  

1 Are continuous improvement measures and methodologies employed and do these cover all aspects of the quality system  

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The Test Bank and Online Learning Center with self assessments quizzes and review aids are available m the various course management systems Please ask your sales representative for details if you are interested... 

Online Learning Center—is the doorway to ac cess almost all of the media for Organic Chem istry Fifth Edition The OLC includes self assessment quizzes resources... 

Responsible Care Management System - Self Assessment (1998)... 

Questionnaires can be used by a facility to conduct a self-assessment or can be administered by an outside evaluator, by phone or in person. In any case the questionnaire typically focuses on identifying PSM activities and program content based on the requirements of the PSM model selected, and assessing condensed criteria for the effectiveness of management systems (as shown in Figure 4-2, page 78). 

CengageNOW s online self-assessment tools give you the choices and resources you need to study smarter. You can explore a variety of tutorials, exercises, and simulations (cross-referenced throughout the text by margin annotations) or take chapter-specific Pre-Tests and get a Personalized Study plan that directs you to specific interactive materials that can help you master areas where you need additional work. Access to CengageNOW for two semesters may be included with your new textbook, or can be purchased at www.ichapters.com using ISBN 0-495-39431-9. 

Different conformity assessment options are available, depending on the type of device and the level of associated risk. For lotv-risk devices, the manufacturer can make a declaration of conformity based solely on self-assessment, without the need for the involvement of a Notified Body. For all other devices Notified Bodies are required to perform one or more of the tasks outlined in Table 10.2. HIV and hepatitis tests and blood grouping tests represent the highest risk devices, as they are critical to ensuring the safety of blood and blood products. For example, a defective HIV test device could result in widespread infection in an unsuspecting population, whereas the detrimental effects ofan AIMD or a Class III device failure will just be confined to the individuals treated by the device. At this end of the risk spectrum. Notified Bodies are required to verify the applied quality system, the specific device design, and the... 

For low-risk devices the manufacturer may make a declaration of conformity with the essential requirements on the basis of a self-assessment, without any input from a Notified Body. In the case of Clas s I devices that are sterile or have a measuring function. Notified Body involvement is required, to provide assurance as to the effectiveness of the sterilisation process or the meteorological traceability of values as appropriate. 

Low (I) Usually possible to justify Proceed unless CA raise Not required, if can be used Self assessment by manufacturer... 

The identification of development needs through, for example, self-assessment questionnaires and/or careful reflective questioning. 

Preliminary assessment of the mentee s learning and development needs. Creating an initial development plan will be one of the most invaluable types of data with regard to matching mentors and mentees. Data regarding the mentee s development needs could initially be collated from, for example, the mentee s self-assessment and/or the assessment of his or her immediate supervisor or manager. 

Filling out a self-assessment questionnaire such as the Myers-Briggs-Type Indicator. This personality inventory provides insights into a person s Jimgian type, which has been found to be a useful basis for purposes such as self-development, career development and career counselling. 

Reporting and oversight Although the dmg regulatory authorities in all the countries publish reports, these focus more on the structure and process than on the outcomes of regulation. Self-assessment by the authorities of the effectiveness and the efficiency of... 

Self-assessment Self-assessment can help an organization to learn about its own strengths and weaknesses. Transforming a DRA into a learning organization which routinely conducts self-assessment and continuous quality improvement can be a powerful approach to enhancing dmg regulatory performance. 

Reference lists and self-assessment questions and answers are available at www.ChrsholmPharmacotherapy.com. 

Algorithm adapted with permission from Tisdale JE, Moser LR. Tachyarrhythmias. In Mueller BA, Bertch KE, Dunsworth TS, et al. (eds.) Pharmacotherapy Self-Assessment Program, 4th ed. Kansas City American College of Clinical Pharmacy 2001 21 7—267.)50... 

FIGURE 6-6. Decision algorithm for long-term ventricular rate control with oral drug therapy for patients with paroxysmal or permanent atrial fibrillation, bpm, beats per minute CCB, calcium channel blocker (diltiazem or verapamil) HF, heart failure LV, left ventricular function LVEF, left ventricular ejection fraction. (Algorithm adapted with permission from Tisdale JE, Moser LR. Tachyarrhythmias. In Mueller BA, Bertch KE, Dunsworth TS, et al. (eds.) Pharmacotherapy Self-Assessment Program, 4th ed. Kansas City American College of Clinical Pharmacy 2001 ... 

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