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Total Quality Management MCQ

What is Gage Management System used for?

Scheduling and managing gages

Controlling the gages

Controlling the output of gages

Monitoring, tracking, and calibrating gages

Measuring pressure

Answer

Correct Answer: Monitoring, tracking, and calibrating gages

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What is one important aspect of the documentaiton of processes?

Traceability

Timeliness

Transparency

Records

Accuracy

Answer

Correct Answer: Traceability

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What is the global food network called?

The Global Food Safety Initiative

The International Federation of Agricultural Producers

The World Food Program

The International Grain Council

Answer

Correct Answer: The Global Food Safety Initiative

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What type of chart shows planned work and finished work?

PERT chart

Venn diagram

Time-chart

Gantt chart

Answer

Correct Answer: Gantt chart

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A Gantt chart displays planned work and finished work in relation to what?

Date

Task

Steps

Efforts

Time

Answer

Correct Answer: Time

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What is a FMEA called that is related to the failure of a product or process?

Root cause analysis

Failure mode and impact analysis

Failure mode and effects analysis

Failure mode effects analysis

Answer

Correct Answer: Failure mode effects analysis

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What is an example of an area that may be problem sources or improvement opportunities?

Strategic planning

Teams

Processes

Flowcharts

Process improvement

Answer

Correct Answer: Flowcharts

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What are decision points called?

Cornstalks

Reacting to possible consequences

Rocks

Bridges

Diamonds

Answer

Correct Answer: Diamonds

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What is the common abbreviation for 21 CFR Part 820?

AEROSPACE EMERGENCY RESPONSE

REGULATION OF QUALITY SYSTEMS

QUALITY SYSTEM REGULATIONS

REGULATIONS OF QUALITY SYSTEMS

AIR TRAFFIC CONTROL

Answer

Correct Answer: QUALITY SYSTEM REGULATIONS

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What is the regulatory body that describes current good manufacturing processes?

OSHA

FDA

ISO

European Union

Answer

Correct Answer: FDA

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What part of the FDA's code of regulations describes the applicability of Hazard Analysis and Critical Control Point Systems to any juice sold as such or used as an ingredient in beverages?

21 CFR Part 175

21 CFR Part 111

21 CFR Part 114

21 CFR Part 120

Answer

Correct Answer: 21 CFR Part 120

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What does the 11th part of the FDA's regulation deal with?

Requirements for postmarket submissions

The proper handling of hazardous materials

Electronic document management records and signatures

Sanitation and safety procedures

Requirements for premarket submissions

Answer

Correct Answer: Electronic document management records and signatures

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What is the FDA's rule that defines the criteria under which electronic document management records and signatures are acceptable, i.e. equivalent to paper records?

FDA 21 CFR Part 11

The definition of electronic records in the Federal Records Act

Electronic signatures can be used for equivalent records

The FDA's Policy Statement on Electronic Records and Signature Authentication

Answer

Correct Answer: FDA 21 CFR Part 11

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What does the term enivironmental impacts mean?

Any adverse or beneficial change to the environment

The impact of human activity on natural ecosystems

The unintentional alteration of the Earth's climate

The impact of human activity on the environment

Answer

Correct Answer: Any adverse or beneficial change to the environment

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Any changes to the environment caused by a facility's activities, products, or services are called what?

Environmental concerns

Environmental considerations

Environmental impacts

Environmental harm

Answer

Correct Answer: Environmental impacts

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What does an element of a facility's activities, products, or services interact with?

The clients

The employees

Customers

Suppliers

The environment

Answer

Correct Answer: The environment

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What is the term used to describe how that element interacts with the environment?

Technology

Ecological aspects

Human aspects

Pollution

Environmental aspects

Answer

Correct Answer: Environmental aspects

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EMI stands for what?

Electronics Manufacturing Index

Electronics Manufacturing Industry

Enterprise Manufacturing Intelligence

Electronics Manufacturing Innovation

Electrical and Musical Instrument Manufacturing

Answer

Correct Answer: Enterprise Manufacturing Intelligence

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What is the area of EH&S concerned with?

Safety issues in the workplace

Infection control

Occupational health and safety

Infection Control and Epidemiology

Impact of the workplace

Answer

Correct Answer: Impact of the workplace

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What three areas are concerned with the impact of the workplace on employees, customers, and the environment?

Marketing - Marketing Strategies

Labor - Labor Relations, Employment Laws

Legal

EH&S - Environmental, Health and Safety

Social

Answer

Correct Answer: EH&S - Environmental, Health and Safety

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What is the acronym for Environmental, Health and Safety?

EH&S

EPA

ISO

S&T

OSHA

Answer

Correct Answer: EH&S

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What is a request that a department might make to an Engineering department?

Technical Support Request

Research Request

Engineering Change Request

Request for Proposal

Request for Quote

Answer

Correct Answer: Engineering Change Request

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What is the acronym for Engineering Change Request?

EHS

ECR

EPC

ESCR

ECORD

Answer

Correct Answer: ECR

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What is a request to an Engineering department for a change to a product design?

ECR - Engineering Change Request

PD - Product Development Request

PDR - Product Design Request

CAPA - Change Advisory Package

RFI - Request for Information

Answer

Correct Answer: ECR - Engineering Change Request

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What is a document requesting changes or improvements to a product?

SWG - Strategic Work Group

POC - Product Obsolescence Criteria

PPM - Process Plan Modification

SOW - Sustainability Office Work

ECO - Engineering Change Order

Answer

Correct Answer: ECO - Engineering Change Order

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What is the acronym for Engineering Change Order?

CHAOS

ECHO

ECO

Answer

Correct Answer: ECO

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What does lost production time mean?

Downtime

Reduced quality

Decreased productivity

Lost sales

Inefficiency

Answer

Correct Answer: Downtime

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What is a major part of document control?

Ensuring accuracy and completeness of documents

Managing, distributing, and controlling documents

Providing a secure means of document management

Ensuring accuracy of documents

Identifying changes to documents

Answer

Correct Answer: Managing, distributing, and controlling documents

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Documents are managed, distributed and controlled by what system?

Email system

Document control

Database

Paperless document system

File system

Answer

Correct Answer: Document control

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What is an example of a DMR?

Device Management Record

Digital Media Receiver

Dynamic Multi-Ring Protocol

Device Master Record

Dish Network

Answer

Correct Answer: Device Master Record

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What is required by the FDA?

Device Identification Number

Device History Record

Registered Device Application

Informed Consent Form

Written Agreement

Answer

Correct Answer: Device History Record

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What is required for each type of device or family of devices that are manufactured according to one DMR?

A RF transceiver

A DMR

A DHF

An MDM

A data service plan

Answer

Correct Answer: A DHF

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What is the abbreviation for Design History File?

DSF

DHF

DHF-X

DHP

Answer

Correct Answer: DHF

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What kind of improvement model is the Deming Cycle?

Continuous

Incremental

Radical

Progressive

Continuous Improvement

Answer

Correct Answer: Continuous

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Who created the Deming Cycle?

W. Edwards Deming

Dr. Deming

Edward Deming

Frederick Winslow Taylor

Answer

Correct Answer: Edward Deming

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How many classes of defects are there?

Four

Two

One

Five

Six

Answer

Correct Answer: Four

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What type of organization uses CRM?

Manufacturers

Human resources

Sales

Customers and prospective customers

Service organizations

Answer

Correct Answer: Customers and prospective customers

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What does a customer-supplier partnership involve?

Collaborating on pricing and delivery times

Consistent quality and timely delivery

Creating a product that meets customer's needs

Teamwork and mutual confidence

Cooperation and communication

Answer

Correct Answer: Teamwork and mutual confidence

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The buyer uses less suppliers because it gives what to its supplier?

More accurate forecasts

Improved supplier performance

Long-term contracts

Better quality

More efficiencies

Answer

Correct Answer: Long-term contracts

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What does a process that presents a serious potential danger to human life, health and the environment risk if it isn't stopped?

Damage to the environment

Loss of significant sums of money or customers

Loss of public confidence in the company

The potential for a major legal battle

The potential for harm to the environment

Answer

Correct Answer: Loss of significant sums of money or customers

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What property could the processes have that risk the loss of customers?

Quality

Time

Timing

Money

Answer

Correct Answer: Money

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What is an important communication tool that describes the long-term impact of quality effort?

Six Sigma

ISO 9000

Cost of Quality

Answer

Correct Answer: Cost of Quality

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What does COQ stand for?

Comprehensive Organization Development

Component Output Quality

Corporate Ordering Quality

Cost of Quality Methodology

Committee on Occupational Safety and Health

Answer

Correct Answer: Cost of Quality Methodology

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What does COSO stand for?

Critical Incident Stress Officer

Corporate Strategies

Control environment system

Committee of Sponsoring Organizations

Corporate Oversight Standards

Answer

Correct Answer: Committee of Sponsoring Organizations

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What framework shows organizations how to identify, assess, and manage risk?

ISO 27001

COSO ERM

ASEAN Risk Framework

ISO 14001

Answer

Correct Answer: COSO ERM

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What type of actions can be taken to remove a cause or causes of a problem?

Restorative action

Reactionary action

Corrective action

Preventative action

Preventive action

Answer

Correct Answer: Corrective action

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What is an example of a written description of an organization's systems that control part and process quality?

Control plan

Maintenance plan

Process specification

Process improvement plan

Process map

Answer

Correct Answer: Control plan

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How is the centerline on a control chart typically labeled?

Average value

Minimum value

Maximum value

Upper Limit

Lower Limit

Answer

Correct Answer: Average value

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What are the upper and lower control limits of a control chart?

Drawn symmetrically around the centerline

Drawn at right angles to the centerline

Drawn above and below the centerline

Drawn on the x-axis at ±1σ

Answer

Correct Answer: Drawn above and below the centerline

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Time related process variability is measured by what?

Process Maps

Process Improvement Plans

Control Charts

Control Limits

Answer

Correct Answer: Control Charts

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Control charts are used to measure what?

The presence of outliers

The effectiveness of process improvement interventions

The effect of changes in process parameters on product quality

Whether batches of products meet specification

Sequential or time-related process performance and variability

Answer

Correct Answer: Sequential or time-related process performance and variability

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What does "conformance" mean?

Functional

Regulatory

Technical

Specification

Behavior

Answer

Correct Answer: Regulatory

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What type of entity could be a regulatory body?

Authoritative

Regulator

Conformance

Regulatory

Enforcement

Answer

Correct Answer: Conformance

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What does the term "compliance" mean?

Coercive

Agreement

Complying

Complimentary

Regulatory

Answer

Correct Answer: Regulatory

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What is the act of conforming to prescribed specifications, regulations, or standards?

Following

Compliance

Obeying

Regulation

Standardization

Answer

Correct Answer: Compliance

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What is the purpose of complaint tracking?

The process of managing customer complaints

The process of resolving customer complaints

The management of complaints by the company

The identification of customer issues and the provision of feedback

The process of collecting customer complaint data

Answer

Correct Answer: The process of collecting customer complaint data

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What is the process of collecting customer complaint data known as?

Telephone survey

Complaint tracking

Handling customer complaints

Contact center management

Resolving customer complaints

Answer

Correct Answer: Complaint tracking

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What is the goal of improving processes by eliminating inefficiencies?

Increase speed

Reduce costs

Decrease costs

Decrease cycle time

Increase effectiveness

Answer

Correct Answer: Increase effectiveness

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What does it involve eliminating that don't add value?

Procedures

Positions

Ideas

Activities

Processes

Answer

Correct Answer: Activities

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What is the name of the simple form quality managers can use to collect data?

Sheets Forms

Questionnaires

Surveys

Answer

Correct Answer: Sheets Forms

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What type of process is change management?

The coordination and communication of efforts to achieve a common objective

The process of managing uncertainty

The process of requesting, evaluating, planning and implementing change

The process of transforming an organization

The management of relationships with others involved in change

Answer

Correct Answer: The process of requesting, evaluating, planning and implementing change

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What is the process of requesting, evaluating, planning and implementing change to a system or aspect of a business?

Change management

Change initiative

Change proposal

Organizational development

Process improvement

Answer

Correct Answer: Change management

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What is another name for a quality improvement associate?

CQIA

Quality Coordinator

CPA

Quality assurance associate

Quality Assurance Specialist

Answer

Correct Answer: CQIA

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What does the acronym CQIA stand for?

Commission on quaternary education

Congruent quality improvement approach

Cancer quality institute

Community quality of life index

Certified quality improvement associate

Answer

Correct Answer: Certified quality improvement associate

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A written statement from a quality management department states that the product being shipped meets the customer's specifications, what is known as?

Statement of quality

Certificate of compliance

Release

Written confirmation of product quality

Written assurance of quality

Answer

Correct Answer: Certificate of compliance

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What does the business process involving the recording and resolution of issues arising post-production involve?

Post-production coordinator

CCM

Production

Answer

Correct Answer: CCM

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What is the result of a cause and effect diagram also called?

Venn Diagram

Cause and Effect Chart

Cause and Effect Matrix

Ishikawa Diagram or a Fishbone Diagram

Answer

Correct Answer: Ishikawa Diagram or a Fishbone Diagram

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Calibration is to a standard of what?

Precision

Accuracy

Accuracy and Precision

Timing

Answer

Correct Answer: Accuracy

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What is the name of the framework for occupational health and safety practices in the United Kingdom?

OHSAS 18001

OSHWA

IOSH

BS8800

Answer

Correct Answer: BS8800

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What is a framework for managing occupational, health, and safety practices?

BS8800 British standard

NIOSH 8000

OSHA 1910

OH&S manual

NIOSH standard

Answer

Correct Answer: BS8800 British standard

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What is a common term used to describe breakthrough improvement?

A new way of doing things

A dynamic, decisive movement

A creative idea

Continuous learning

Continuous improvement

Answer

Correct Answer: A dynamic, decisive movement

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What is an example of a breakthrough improvement?

The development of a product that meets or exceeds customer expectations

A new way of thinking about an old problem

The implementation of an innovative process change

A dynamic, decisive movement to a new, higher level of performance

A quantum leap in technology

Answer

Correct Answer: A dynamic, decisive movement to a new, higher level of performance

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What process is used to generate ideas within a group or team?

Brainstorming

Ideation

Critique

Disscussion

Answer

Correct Answer: Brainstorming

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What is the best practice used to improve an organization's performance?

A method or practice of performing a business process

Allocating resources in an effective way

Making changes to the organization's structure

Implementing new technology

Answer

Correct Answer: A method or practice of performing a business process

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What is the process of performing a business process that is considered to be the best way to improve an organization's performance?

Process redesign

Best practice

Control

Process improvement

Execution

Answer

Correct Answer: Best practice

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What improvement technique involves comparing a company to other companies that are doing well?

Periodic review

Case study

Benchmarking

Peer pressure

Change management

Answer

Correct Answer: Benchmarking

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What is Basel II?

An international initiative

A currency

A banking regulation

A treaty

Answer

Correct Answer: An international initiative

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An international initiative that requires financial services companies to have a more risk sensitive framework for the assessment of regulatory capital requirements is called what?

Basel IV

Basel II

Basel III

Answer

Correct Answer: Basel II

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What type of intelligence is transferred?

Animal

Human

Robot

Answer

Correct Answer: Human

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What does eliminating overproduction do?

Prevents defects

Reduces costs

Reduces waste

Increases efficiency

Increases profits

Answer

Correct Answer: Prevents defects

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A quality system audit can be performed on an entire organization or a specific function, process or what?

Quality function

Function

Process or product

Process or production step

Quality assurance

Answer

Correct Answer: Process or production step

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What is the assessment, inspection, or examination of a quality system to determine compliance to requirements. Performed onsite?

Inspections

Audit

Performance audit

Inspection

Assessment

Answer

Correct Answer: Audit

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What helps companies measure the effectiveness of a quality system?

Tools

Assessments

Process improvement audits

Processes

Surveys

Answer

Correct Answer: Assessments

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A systematic process of collecting and analyzing data to determine the current, historical or projected compliance of an organization to a regulation or standard is known as what?

Compliance

Inspection

Assessment

Oversight

Answer

Correct Answer: Assessment

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What is the name of the non-profit organization that is responsible for developing and promoting quality related information, technology and training?

American Academy of Pediatrics

American Society for Quality

American Statistical Association

American Society for Testing and Materials

Answer

Correct Answer: American Society for Quality

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What is a standard that describes a seven step process for performing risk management?

AS/NZS 4360

PCI DSS

ISO27001

ISO 9001

ISO 27001

Answer

Correct Answer: AS/NZS 4360

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What type of standard is AS/NZS 4360?

Dutch standard

Australian standard

British standard

American standard

Answer

Correct Answer: Australian standard

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What type of process is APQP used for developing products?

A process used for making products

A quality assurance process

A quality process used for developing products

A process used for creating products

A process used for improving products

Answer

Correct Answer: A quality process used for developing products

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What is another name for APQP?

Advanced Project Quality Planning

Advanced Product Quality Planning

Advanced Project Quality Plan

Advanced Process Quality Planning

Actions and Procedures for Quality Planning

Answer

Correct Answer: Advanced Product Quality Planning

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ANSI/AIHA Z10-2005 is what type of standard?

A guidance

A coding

A coding standard

A regulatory

A performance standard

Answer

Correct Answer: A regulatory

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A regulatory standard from what organization helped companies create and maintain occupational, health and safety management systems?

Occupational Safety and Health Administration

European Community Standard

National Institute for Occupational Safety and Health

American Industrial Hygiene Association

Answer

Correct Answer: American Industrial Hygiene Association

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ANSI is the U.S. member body of what organization?

International Electrotechnical Commission

International Organization for Standardization

World Health Oragnization

American National Standards Institute

Answer

Correct Answer: International Organization for Standardization

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ANSI presides over the creation and use of thousands of what?

Norms and guidelines

Standards

Codes

Answer

Correct Answer: Norms and guidelines

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What is the name of the system that incorporates signal lights used in manufacturing settings to notify employees of a quality or process problem?

Indicator

Red light

Yellow light

Andon

Answer

Correct Answer: Andon

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What do alignment actions ensure a process or activity supports?

Strategy, goals and objectives

Communication and collaboration

Process, products and services

Process design

People, systems and processes

Answer

Correct Answer: Strategy, goals and objectives

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What are the actions to ensure that a process or activity supports the organization's strategy, goals and objectives?

Establishing and enforcing standards

Alignment

Culture

Defining and measuring success

Definition

Answer

Correct Answer: Alignment

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What type of diagram facilitates organization and consideration of a group of ideas?

Affinity Diagram

Hierarchy Chart

Venn Diagram

Answer

Correct Answer: Affinity Diagram

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What are used to organization verbal information into some type of visual pattern?

Venn diagram

Flowchart Allows

Tree Diagram

Tree Diagram Shows

Affinity Diagram Facilitates

Answer

Correct Answer: Affinity Diagram Facilitates

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What do adverse events not match?

Risk

Desired or usual outcome

Harm

Intent

Condition

Answer

Correct Answer: Desired or usual outcome

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What is the healthcare industry's term for a change or event that is not consistent with the desired or usual outcome?

Adverse event

Failure

Incident

Unplanned event

Answer

Correct Answer: Adverse event

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What is an acceptable level of risk for an organization to absorb?

Introducing new products

Increased risk of business failure

Current operations

Increased risk of cyber attacks

Reducing expenses

Answer

Correct Answer: Current operations

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What is a specific risk acceptable if it has been reduced?

A level that does not present a risk

A level that is too high

A level that the organization can absorb

A level that is lower than the original risk

A level that does not impose an unacceptable burden

Answer

Correct Answer: A level that the organization can absorb

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