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10. What is the name of the mandate that restricts the usage of six hazardous substances?
Answer
Correct Answer:
Restriction of Hazardous Substances
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11. In the phase of product development focused on product innovation based on data from market research, product data and consumer feedback, what is considered the driving force behind advancements?
Answer
Correct Answer:
R&D
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12. What is the term used to describe the process of R&D?
Answer
Correct Answer:
Research and development
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13. Quality management system is a collection of business processes and applications that maintain the standards and specifications of what?
Answer
Correct Answer:
Production process
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14. What is the critical component for both safety and customer satisfaction?
Answer
Correct Answer:
Quality Management System
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15. What type of inspection process involves a product or production process to determine if it fulfills specifications and complies with regulations?
Answer
Correct Answer:
Quality control
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16. Quality control refers to the inspection process of a product or production process to determine whether it fulfills what?
Answer
Correct Answer:
Specifications
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17. What is the inspection process of a product or production process to determine whether it fulfills specifications and complies with regulations?
Answer
Correct Answer:
Quality control
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18. What is a term used to indicate a system or process performed to determine whether a product meets specified requirements or complies with regulations?
Answer
Correct Answer:
Quality assurance
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19. Quality assurance is any system or business process performed to determine whether a product meets specified requirements or to comply with regulations in order to maintain standards set by what?
Answer
Correct Answer:
Governing bodies
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20. What is the name of the PVM platform developed by Propel Software?
Answer
Correct Answer:
Product Value Management
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21. Who created Product Value Management?
Answer
Correct Answer:
Propel Software
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22. What integrates people and business processes into core development?
Answer
Correct Answer:
Product Lifecycle Management
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23. What does PLM integrate into the core development of a product?
Answer
Correct Answer:
People and business processes
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24. What integrates people and business processes into the core development of a product?
Answer
Correct Answer:
Product Lifecycle Management
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25. What can a product company do in a PIM software?
Answer
Correct Answer:
Create a full product catalog directly
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26. What is the purpose of a product information management platform?
Answer
Correct Answer:
Provides a single source for product information
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27. In a PIM platform, a company can distribute product information and assets to multiple channels from where?
Answer
Correct Answer:
ECommerce and sales
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28. What is a PIM platform also known as?
Answer
Correct Answer:
Product Information Management
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29. What is a PIM platform considered?
Answer
Correct Answer:
A critical facet of product value management software
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30. What is a critical facet of product value management software?
Answer
Correct Answer:
Product Information Management
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31. What is used to house all current and approved CAD files, parts and assembly, models, and product drawings?
Answer
Correct Answer:
Product Data Management system
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32. The PDMS is used in product value management to house all what?
Answer
Correct Answer:
CAD files, parts and assembly, models, and product drawings
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33. What is the PDMS used for?
Answer
Correct Answer:
Product value management
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34. What is the term for the company that produces the original product?
Answer
Correct Answer:
Original Equipment Manufacturer
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35. An OEM is another company that produces what?
Answer
Correct Answer:
A product or part
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36. What are the primary reasons for using an ODM?
Answer
Correct Answer:
Efficiency and reduced costs
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37. What does an original design manufacturer do?
Answer
Correct Answer:
Design and manufacture a product based on another firm’s specifications
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38. What does an ODM do?
Answer
Correct Answer:
Design and manufacture a product based on another firm’s specifications
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39. What does the term "Overall Equipment Effectiveness" mean?
Answer
Correct Answer:
A best practice that measures the utilization of raw materials, time, and machinery
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40. What is the name of the process that measures the utilization of raw materials, time, and machinery in the overall manufacturing process?
Answer
Correct Answer:
Overall Equipment Effectiveness
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41. What is the process NPI stands for?
Answer
Correct Answer:
New Product Introduction
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42. What is included in the NPD process?
Answer
Correct Answer:
All the phases of conceptualizing, research, designing, planning, supplier management, and manufacturing
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43. What is NPD called when a new product is to be brought to market?
Answer
Correct Answer:
New Product Development
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44. New Product Development encompasses all phases of what?
Answer
Correct Answer:
Conceptualizing, research, designing, planning, supplier management, and manufacturing
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45. What can be submitted at any time of the material's life cycle?
Answer
Correct Answer:
Non-Conforming Material Report
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46. What is the acronym for a Non-Conforming Material Report?
Answer
Correct Answer:
NCMR
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47. What is the process of preparing, scheduling, and controlling inventory and raw materials to be purchased for use in the manufacturing process?
Answer
Correct Answer:
Material requirements planning
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48. What is the process of preparing, scheduling, and controlling inventory and raw materials?
Answer
Correct Answer:
MRP
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49. In what kind of platform is MRP implemented?
Answer
Correct Answer:
A computer-based platform
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50. What are manufacturing execution systems?
Answer
Correct Answer:
Digital manufacturing programs used to document and trace the conversions of raw materials into finished products
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51. What type of program documents the conversion of raw materials into finished products?
Answer
Correct Answer:
Manufacturing Execution Systems
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52. What is the name of the process implemented by the FDA to perform benefit-risk assessment?
Answer
Correct Answer:
Medical Device Reporting
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53. What is another term for Medical Device Reporting?
Answer
Correct Answer:
MDR
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54. What does an MCR propose?
Answer
Correct Answer:
A change to the manufacturing process
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55. What is the acronym for a Manufacturing Change Request?
Answer
Correct Answer:
MCR
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56. What does the acronym MCR stand for?
Answer
Correct Answer:
Manufacturing Change Request
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57. What term is commonly used in conjunction with an Engineering Change Order?
Answer
Correct Answer:
Manufacturing Change Order
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58. Manufacturing Change Order is a change order used specifically to make a manufacturing change to a product, as opposed to a change in what?
Answer
Correct Answer:
Design
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59. Just-In-Time improves efficiency by minimizing what?
Answer
Correct Answer:
Inventory on hand
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60. What is the purpose of Just-in-Time manufacturing?
Answer
Correct Answer:
Reducing production time and improving efficiency
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61. The internet of things refers to an interrelated set of what?
Answer
Correct Answer:
Computing devices, machines, and technologies
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62. The internet of things increases efficiency and reduces what?
Answer
Correct Answer:
Development time
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63. What does the acronym IoT mean?
Answer
Correct Answer:
Internet of things
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64. What kind of devices, machines, and technologies comprise the internet of things?
Answer
Correct Answer:
Computing devices, machines, and technologies
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65. What is a set of guidelines and best practices for managing each aspect of production?
Answer
Correct Answer:
Good Manufacturing Practices
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66. GMP is a set of guidelines and best practices for what?
Answer
Correct Answer:
Managing each aspect of production
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67. GMP guidelines and best practices are intended to ensure that what is met?
Answer
Correct Answer:
Standards and regulations
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68. What type of practices does GMP represent?
Answer
Correct Answer:
Guidelines and best practices
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69. What type of engineers look up parts and compare them to the products?
Answer
Correct Answer:
Form, Fit and Function Engineers
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70. The FFF framework enables flexibility by allowing changes to be made without requiring what as long as the changes align with the form, fit, and function of the product?
Answer
Correct Answer:
Documentation
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71. What type of Engineers use the FFF framework?
Answer
Correct Answer:
Form, Fit and Function
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72. What are engineers using the FFF framework to match to the needs of?
Answer
Correct Answer:
Products
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73. What does "Failed Field Request" mean?
Answer
Correct Answer:
A particular type of change request detailing a problem or non-conformity with the product
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74. What is a FFR also known as?
Answer
Correct Answer:
Field Failure Request
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75. What type of request details a problem or non-conformity with the product?
Answer
Correct Answer:
Field Failure Request
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76. What is an approach to supply chain management that considers the nonfinancial impact of production processes?
Answer
Correct Answer:
Environmental, Social, and Governance
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77. What sort of issues are being considered by companies?
Answer
Correct Answer:
Climate change and sociopolitical issues
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78. What are other terms for Environmental, Social, and Governance?
Answer
Correct Answer:
ESG
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79. What is an approach to supply chain management that considers social and environmental issues?
Answer
Correct Answer:
Environmental, Social, and Governance
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80. ESG is an approach to supply chain management that considers the what?
Answer
Correct Answer:
Non-financial impact of production processes
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81. What type of company uses ERP?
Answer
Correct Answer:
Product
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82. What is the hub of business processes for product companies?
Answer
Correct Answer:
Enterprise Resource Planning
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83. What does ERP model and analyze?
Answer
Correct Answer:
Data
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84. What's an example of a business process that an ERP system can track?
Answer
Correct Answer:
Purchasing
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85. Most commonly, what are Electronic Instructions for Use?
Answer
Correct Answer:
Relating most commonly to medical device or medical technology products
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86. What are eIFU commonly used for?
Answer
Correct Answer:
Medical device or medical technology products
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87. What is a common use for EDA?
Answer
Correct Answer:
Computer chip manufacturers
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88. What is also known as electronic computer-aided design?
Answer
Correct Answer:
Electronic Design Automation
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89. What is commonly used by computer chip manufacturers?
Answer
Correct Answer:
Electronic Design Automation
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90. What type of company uses EDA?
Answer
Correct Answer:
Computer chip manufacturers
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91. What is an ECR a request to propose improvements or problems with components or assemblies?
Answer
Correct Answer:
Engineering Change Request
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92. What is an Engineering Change Request?
Answer
Correct Answer:
A request to propose improvements or problems with components or assemblies
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93. What is the term for a proposed change to a design in the engineering phase of a product?
Answer
Correct Answer:
Engineering Change Order
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94. What is the Engineering Change Order called?
Answer
Correct Answer:
ECO
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95. What does the Engineering Change Order or ECO request from the manufacturers?
Answer
Correct Answer:
Review and approval
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96. What document outlines proposed change to the design?
Answer
Correct Answer:
Engineering Change Order
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97. What is an example of a reason a change order may be issued?
Answer
Correct Answer:
Fixing
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98. What documents are issued by the ECN process?
Answer
Correct Answer:
Engineering Change Notice
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