didumconsult safety examination Welcome to your didumconsult safety examination Name Email 1. The manufacturer is in a position to_____ Except Control the sources of product quality variation Ensure the correct and most appropriate manufacturing and packaging practices Assure that the testing results are not in compliance with the standards or specifications Assure product stability None 2. Product failures causing rejections or recalls after market introduction are serious and can be easily detected and minimized by an effectively administered quality testing program. True False None 3. Validation of a process is the demonstration that controlling the critical steps of a process results in products of repeatable attributes or causes a reproducible event. True False None 4. This record specifies the packaging materials to be used, operations to be performed, and the quantity to be packaged. Validation control System control Specification control Packaging control None 5. The records, such as Master Formula and Batch production records, should be prepared and maintained in accordance with established procedures. True False None 6. A packaging record bearing an identification number is not issued to the packaging section. True False None 7. Important parts for successful personnel include the following Except? Proper selection Training Motivation of life style Packaging None 8. Report on product, process and system risks is… To keep management informed To keep staff informed To keep QA/QC officer informed To be independent None 9. The following are Roles of a QA in the industry Except? To establish Quality Audit To audit compliance to the Quality System To establish manufacturing controls To inspect laboratory tests None 10. The set of activities for ensuring quality in products is referred to as? Quality assurance Quality management Quality control Quality process None 11. The set of activities for ensuring quality in the processes by which products are developed. Quality management Quality assurance Quality control Quality process None 12. The goal of QA is to improve development and test processes so that defects do not arise when the product is being developed. True False None 13. The goal of QC is to identify defects after a product is developed and before it's released. True False None 14. Quality control conduct in-process testing when required, perform environmental monitoring, and inspect operations for compliance. True False None 15. Following variables may affect ultimate quality of product Packaging material Finish product Manual Error All of the above None 16. Monitoring of personnel is a Manufacturing Variation Control? True False None 17. The regulatory requirement to capture all sorts of deviations evolves in your systems in order to maintain the continuous improvement to your processes and systems is called? Control report system Deviation control system Control regulatory requirement Deviation regulatory requirement None 18. The process of striving to produce a perfect product by a series of measures requiring an organized effort at every stage in production. Total quality management Total quality control Total quality assurance None of the above None 19. In products and process designing, it considers many parameters like: Materials In-process and product control All of the above None 20. Major Keywords of Quality Assurance includes the following Except? Calibration Validation Qualification Specification None 21. Which is the operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties (of the calibrated instrument or secondary standard) and, in a second step, uses this information to establish a relation for obtaining a measurement result from an indication. Calibration Validation Qualification Specification None 22. The process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in production or testing maintains the desired level of compliance at all stages is referred to? Calibration Validation Qualification Specification None 23. The field of validation is divided into a number of subsections including the following: Process Validation, Analytical method validation and Computer system validation. Packaging validation, Cold chain validation and equipment validation. None of the above All of the above None 24. These are the types of Validation Except? Prospective Validation Concurrent Validation Retrospective Validation Progressive Validation None 25. The validation that is carried out during normal production is referred to as? Prospective Validation Concurrent Validation Retrospective Validation Progressive Validation None 26. The validation that involves the examination of past experience of production on the assumption that composition, procedures, and equipment remain unchanged is called? Prospective Validation Concurrent Validation Retrospective Validation Repeated Validation None 27. The following are the cost of quality Except? Prevention costs Approval costs Internal failure costs External failure costs None 28. Trying to manage all aspects of the organization in order to excel in all dimensions that are important to “customers” refers to? Total quality management Quality management Quality Control Quality Assurance None 29. Quality is “fitness for use” is credited to who? Edward Deming Joseph Juran Malcolm Baldridge Tai-ichi Ohno None 30. Tools used for continuous improvement includes the following Except? Process flowchart Run chart Control chart Manual chart None 31. Pareto analysis is a tool used for continuous improvement? True False None 32. The integration of all functions and processes within an organization in order to achieve continuous improvement of the quality of goods and services is refers to? Quality management Quality management system Total quality management Management processes None 33. Total Quality Management is aimed at: Customers business Customers plan Customers satisfaction None of the above None 34. The three Quality Gurus includes the following except? Edward Deming Joseph Juran Philip Crosby Al-Quaan None 35. Quality is “uniformity and dependability” is credited to? Edward Deming Joseph Juran Philip Crosby Al-Quaan None 36. Quality is free is credited to? Edward Deming Joseph Juran Philip Crosby Al-Quaan None 37. Involvement of leadership and top management is essential to the necessary culture of commitment to quality. True False None 38. Quality is first and schedules are second. True false None 39. Factual Approach to Decision Making is a list among the quality management principles? True False None 40. How many are the quality management principles? 7 9 8 6 None 41. The Customer Satisfaction Three Part System includes the following Except? Human Resource Management Company Operations Customer Expectations Human capital development None 42. Indicators for Customer Satisfaction includes the following? Quality requirements of market segment and Commitment to customers Understanding customer requirements and Service standards meeting customers requirements. None of the above All of the above None 43. Proactive customer service system is a part of Indicators for Customer Satisfaction? True False None 44. The views for the cost of quality are how may? 1 4 3 2 None 45. Higher stock prices is a benefit of TQM? True False None 46. The following are the benefits of TQM Greater customer loyalty and Market share improvement. Higher stock prices and Reduced service calls. Higher prices and Greater productivity. All of the above None 47. What is the primary objective of a Quality Assurance program? Strong support system Decrease liability Enhance patient care Boost staff confidence None 48. What is involved in the Quality Control of X-ray equipment? Visual Inspection Performance Testing Environmental Testing All of the Above None 49. Fishbone diagram is a Tool used for continuous improvement? True False None 50. According to Edward Deming, Quality is defined as conformance to requirements, not “goodness” True False None 1 out of 5 Please fill in the comment box below.
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