Adv Topics quality assurance

QC-Which of the following elements must be present to empower employees?

Authority Empowered employees have the authority to maximize their contribution.

BoQ-What quality tool can be used to select projects with the highest payback?

Pareto analysis The Pareto principle (analysis) allows an organization to identify the vital few projects

QIT-What quality tool would an organization use to measure the relevance of three different types of processing errors to a total effect?

Pareto chart A Pareto chart is used to compare many errors to a total effect

Guru-Known for the principle of "Do It Right The First Time" and promoting the standard of zero defects

Philip Crosby

CS-Which survey method provides a great amount of insight while keeping costs to a minimum?

Phone interviewing Phone interviewing obtains good insight from the client with a more personal touch while keeping costs to a minimum

CI-The improvement process developed by Kaoru Ishikawa was named PDCA. This acronym stands for:

Plan, do, check, act

QIT-What basic flowchart symbol is used to link one point in a flowchart to another?

Line with arrow The line and arrow connects one point in a flowchart to another

QC-A process operator is primarily focused on continuously improving his process. According to Juran, the operator is focused on which for the following quality terms?

Little q An operator at the process level is focused on the technological matter or little q of quality

Once the SIPOC linkages have been identified, which component would management measure?

Output Output of the process is what is measured to determine the need for improvement.

Process Performance and Product Quality Monitoring System

a system for the monitoring of process performance and product quality to ensure a state of control is maintained

QRM: Quality Risk Management

a systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle

Risk Assessment

a systematic process of organizing information to support a risk decision to be made within a risk management process. It consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards

PAT: Process Analytical Technologies

system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of assuring final product quality

Qp-Juran believed

that implementing quality improvement would raise quality to higher and higher levels

DS: Design Space

the multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality

Qp-Crosby developed the four absolutes of quality:

1.Conformance to requirements is the only definition of quality 2.What causes quality is prevention, not appraisal 3.Zero defects is the only acceptable performance standard 4.The price of nonconformance is how quality should be measured

PI-A lean tool that encompasses the idea that waste is hidden in dirt and clutter is called:

5S 5S stands for sort, set, shine, standardize, and sustain. It is intended to create a clean and organized workplace that will include visual control and benefit lean production

Which of the following tools would be most appropriate for collecting data to student the symptoms of a problem?

A check sheet

Quality Improvement Tools- What symbol represents the continuation of a process flow from one page to another on a completed multipage process flowchart?

A circle with a letter inside Placing a circle with a letter inside it at the edge of a page and then a corresponding circle with the same letter in it on the following page to indicate the continuation of a process flow

CS-A field services manager is responsible for handling customer resolutions. Which type of customer will typically call to file a complaint?

A customer who has a problem and wants it solved A customer who has a problem with a service or a broken product will want resolution. This type of customer is more likely to file a complaint.

A product audit is best described as

A detailed examination of a finished product

RR-What distinguishes a good team leader from other team members?

A good team leader creates and maintains channels that enable team members to do their work The team leader serves as the hub for team communication and makes sure that the other team members and management are informed. All team members perform the other tasks listed here

QIT-What quality tool would a manufacturing manager use to verify that three different operators running the same part of the same machine were running the process with the same consistency in terms of part length?

A histogram Histograms are a graphic representation of frequency distribution in dat. If there were a difference in the product between the three operators, multiple peaks would appear on the histogram, indicating different processes.

Kaizen

A philosophy or practices that focus upon continuous improvement of processes which aims to eliminate waste, humanize the workplace, eliminate hard work and teach the scientific method as applied to daily work.

Kaizen blitz

A rapid improvement of a limited process area, for example, a production cell. Part of the improvement team consists of workers in that area. The objectives are to use innovative thinking to eliminate non-value-added work and to immediately implement the changes within a week or less. Ownership of the improvement by the area work team and the development of the team's problem-solving skills are additional benefits.

PAT: Process Analytical Technology

A system for designing, analyzing, and controlling manufacturing through timely measurements(i.e., during processing) of critical quality and performance attributes of raw an in-process materials and processes with the goal of assuring final product quality

CAPA :Corrective Action Preventative Action

A system for implementing corrective actions and preventative actions resulting from investigation of complaints, products rejections, non-conformances, recalls, deviations, audits, regulatory inspections and findings, and trends from process performance and product quality monitoring

Process Performance and Product Quality Monitoring System

A system for the monitoring of process performance and products quality to ensure a state of control.

CMS: Change Management System

A systematic approach to proposing, evaluating, approving, implementing and reviewing changes

Team Organization-Which of the following situations would make the best use of a team?

Addressing business problems across multiple departments A team is needed when cross-functional knowledge and skills from multiple departments is required for a comprehensive solution

CI-Brainstorming is generally the first step when using which quality tool?

Affinity Diagram Brainstorming is typically used to generate ideas for an affinity diagram. The ideas are then organized into categories based on their relationship with each other

CI-ABC management group has just finished brainstorming ideas for a new product line. What improvement tool is the best to use to group the diverse ideas?

Affinity diagram Affinity diagrams are used to help groups organize ideas. Brainstorming responses are separated into categories based on their relationship to each other.

CI-Which of the following quality management tools best helps team to organize and summarize the natural grouping of a large number of ideas and issues

Affinity diagram An affinity diagram helps teams logically group many brainstorming concepts into higher-level buckets for further analysis

BoQ-Which of the following is a prominent measure of customer satisfaction?

American Customer Satisfaction Index (ACSI) The American Customer Satisfaction Index (ACSI) is a domestic and international economic indicator of customer satisfaction with the quality of goods and services available to consumers world-wide.

Root Cause Analysis

An analytical technique used to determine the basic underlying reason that causes a variance or a defect or a risk. A root cause may underlie more than one variance or defect or risk.

CI-Costs of poor quality expended to assess and approve the suppliers of products and services are:

Appraisal costs Appraisal costs come from measuring and monitoring activities related to quality. These costs are associated with the supplier's and customers' evaluation of purchased materials, processes, products, and services to ensure that they conform to specifications, and can include verification, quality audits, and supplier rating.

Roles and Responsibilities- What is the responsibility of the team sponsor?

Approve objectives for the team and provide political support A sponsor is responsible for defining objectives and provides resources and support to remove obstacles to completing the assigned task

Continuous Improvement- Which tool would a process improvement team use to generate a large number of ideas by utilizing an open, freewheeling technique that has little structure or order?

Brainstorming •Generating ideas is the goal of brainstorming. Participants verbalize ideas at random with no structure or order. This is done until the group runs out of ideas. The freewheeling nature of this technique can help stimulate creativity in team members as ideas feed from each other, generating a large number of ideas for consideration.

QIT-A customer returned a recent shipment of cereal because the boxes did not contain enough cereal. The plant manager where the cereal was produced gathered a cross-functional team to solve the problem.

Cause and effect diagram A cause and effect diagram is used to find the underlying root causes of an identified problem by looking at possible causes by categories.

QIT-A pencil manufacturer has put together a cross-functional team to solve the problem of producing pencils that are too short. To help understand the possible root cause of the problem, the team could elect to use which quality tool?

Cause and effect diagram A cause and effect diagram organizes the factors that are thought to be the root cause of a problem or issue

RR-Which member of management is responsible for supporting the vision of the team?

Champion The champion is a member of management who specifically supports the team and the completion of the project

Qp-Modify implementation plan if necessary is an activity of which PDCA phase?

Check The three activities under "check are monitor progress of the implementation plan, modify implementation plan if necessary, and monitor results of countermeasures

Which of the following SIPOC components would a dry cleaners measure to ensure the process is effective?

Clean and undamaged clothing Clean and undamaged clothing is an output of the process and would be measured to ensure its effectiveness.

RR-What is the most important role of a team member?

Completing assigned tasks between meetings Completing assignments between meetings moves the project to completion and is the most important function of a team member

QP-What is the goal of the Shewhart cycle?

Continually look for a better method of doing things The goal of the PDCA cycle is to continuously search for ways to improve the way things are done

PI-A manufacturing process has been changed as a result of a particular project. The assigned Six Sigma team decides to implement a final product inspection procedure in the updated process. What stage of the DMAIC process are they in?

Control stage A final inspection process is one tool that can be used during the control stage

CI-Which of the following cost of poor-quality categories is the largest cost to incur?

Cost to recall defective products from retail outlets By the time that this cost is incurred, all other costs of poor quality have accrued, plus damage to reputation and lost sales

Qp-Management commitment, education and training, measurements, cost of quality, quality awareness, corrective action, zero defects, goal setting, and recognition are steps to quality improvement proposed by which quality guru?

Crosby

Qp-The four absolutes of quality are part of which quality guru's contribution to the philosophy of quality?

Crosby

TQ-Jenny, the plant quality assurance manager, has formed an on-site quality improvement team with members from accounting, production, and logistics. The team will perform a specific task with the final decisions being made by Jenny. What type of team is this?

Cross-functional team Cross-functional teams are made of members from several different, yet contributory, areas.

Quality is best defined as

Customer needs

QC-Which of the following conditions will help employees become empowered?

Dedicated training and invitation to participate in projects Employee empowerment is introduced by dedicated training and empowering the workforce to participate in planning and improvement, including the concept of self-directed teams.

Process Improvement-Which Six Sigma method allows a great deal of information to be analyzed through a minimum number of tests?

Design of experiments Design of Experiments is a Six Sigma method that allows for a great deal of information to be analyzed with a minimum number of experiments

Tf&GD-Why do teams sometimes fail to become effective at problem solving despite having a committed group of process experts supported by management?

Differences between individuals are not well understood and capitalized upon Failure to manage interaction styles can render an otherwise well-chosen team ineffective

QC-A quality plan starts with establishing the project and identifying the customer. What is the next step in the quality planning process?

Discovering customer needs The other steps are important later, but after the project has been established and the customer has been identified, discovering customers needs is the next step in the quality planning process.

QP-Which of the following statements best explains Phillip B. Crosby's claim that "quality is free"?

Doing it right the first time is less expensive than cost incurred in detecting and dealing with defects Doing it right the first time is Crosby's rationale for quality

QP-The quality philosophy based on planning, control, and breakthrough (quality improvement) is associated with which person?

Dr. Joseph Juran In Juran's trilogy, quality planning provides a system that is capable of meeting quality standards. Quality control is used to determine when corrective action is required. Quality improvement (breakthrough) seeks better ways of doing things

QP-Which of the following quality professionals developed the cause and effect diagram?

Dr. Kaoru Ishikawa Dr. Kaoru Ishikawa developed the diagram in the 1950s. It is also referred to as an Ishikawa diagram or a fishbone diagram.

A credit card company has implemented a new program that would allow managers and processors to work together on process and product improvement initiatives. Which of the following stakeholders will most benefit from the new program?

Employees In a traditional organization, processors report to managers but rarely work together to achieve a goal. The employees within an organization will most benefits from working in an employee-empowered organization that allows processors and managers to work side-by-side. This can result in better products, services, and processes, which in turn will benefit the customer supplier, and community.

BQ-Quality can benefit many organizational stakeholders. A feeling of accomplishment is a benefit for which stakeholder group?

Employees Producing high-quality products that the customer desires provide employees of the producing company with a high level of personal satisfaction.

BoQ-Each month, a furniture manufacturer receives several product returns due to defects. In an effort to improve the outgoing product, the company should take which of the following actions?

Establish a quality improvement process and implement it across the organization Providing a quality product or service starts with all parts of the organization having a shared focus on continuous process improvement and quality improvement. Quality improvement should be a way of life for a quality organization. If defective products are being returned, quality improvement processes should be established and applied to business processes as well as individual functions

PI-Benchmarking is a structured approach for companies to:

Examine similar process operations to identify best practices Benchmarking is a technique in which an organization compares its own performance for a specific process with the "best practice" performance of a recognized leader in a comparable process.

CSR-A shopping mall purchases its cleaning service. What is the relationship of the shopping mall to the cleaning service?

External customer External customers receive product or services but are not part of the organization supplying it. The shopping mall received a service from an outside organization, therefore it is an external customer

CRS- Which of the following groups can provide the best feedback regarding the quality of a final product?

External customer External customers typically use the product. These customers are in the best position top provide feedback regarding the quality of a final product.

CI-Warranty claims are classified into which cost of poor quality category?

External failure costs The cost of warranty claims, field repairs, servicing, complaints, and returns are all part of external failure costs

CSR-An original equipment manufacturer (OEM) purchases products and services from Design Supply Plus, an office supply distributor. What is the relationship of Design Supply Plus to the manufacturer?

External supplier Design Supply Plus is an external supplier because it provides products and services to the manufacturer and is not part of the manufacturer's organization

BQ-Reduced costs in inspections may result from a quality organization's establish partnership with which of the following stakeholders?

External suppliers An established partnership with external suppliers ensures the supplier understands the requirements and the organization understands the supplier's capabilities. This allows the organization to reduce inspections on material.

QP- A quality tool that can be used to identify possible causes of a problem or effect, and sort them into useful categories, is called a:

Fishbone diagram Dr. Ishikawa developed the fishbone diagram, also referred to the Ishikawa diagram and the cause and effect diagram. Utilizing brainstorming to identify possible causes of an event or program, and then sorting them into categories that aid in analysis. It is a useful tool for root-cause analysis.

Groupthink is best described as

Focusing on reaching any decision rather than the best decision

QIT-What does the vertical axis on a histogram represent?

Frequency of occurrence Histograms graphically demonstrate the frequency of an occurrence. The y-axis, or vertical axis, is always used to represent frequency.

BQ-Organizations with focus on continuous improvement usually possess which of the following characteristics?

Higher probability of survival High-quality organizations that focus on continuous improvement have a higher probability of survival

CI-What is the primary purpose of an internal audit?

Identify improvement opportunities An internal audit evaluates a process in terms of inputs, work being done correctly, and outputs. The audit will identify a breakdown in any of these areas so that a corrective action can be implemented and the process performance improved.

SM-What is the primary reason to measure a supplier's performance?

Improve the organization's products and services Helping suppliers to improve material and services helps the organization to improve its own products and services

TQ-Other than successfully completing an assigned task, what would be the additional benefit of using a team?

Improved attitudes of both management and team members A sense of accomplishment increases pride and motivation of team members and builds confidence in management to support future projects

TQ-Which activity would be better accomplished using a cross-functional team approach?

Improving and redefining a process that spans multiple departments With a process that spans multiple departments, inputs from those departments will provide a broader approach so that all stakeholder interests are addressed

CS-Which customer feedback method is typically the most expensive but provides great insights?

In-person interview In-person interviews are the most expensive form of feedback, but the personal contact involved often yields great insights.

BQ-Which of the following is a well-defined goal statement that ensures the benefit of quality improvement are achieved?

Increase on-time deliveries from 85 to 95 percent by the end of the current fiscal year

PI-What is process improvement that is achieved gradually and in small steps?

Incremental Improvement Incremental improvement is referred to as kaizen. It is based upon the premise that gradual changes become more integrated into how an organization operates.

CS-Which of the following statements provides the best definition of feedback?

Information used to improve a process or product Feedback is best described as information used to improve processes and products

Continuous improvement- What aspect of the brainstorming technique contributes to a large number of ideas being generated?

Letting ideas flow freely Freewheeling and not holding back is encouraged

PI-Which of the following terms is defined as "benchmarking between similar operations within an organization?"

Internal Benchmarking Identification of common internal processes that continually achieve high levels of performance enables a company to create a benchmark. This can be used to increase the performance level of other processes without having to benchmark outside the organization

CRS-Which of the following describes a person or department that receives a product or service from another person or department within an organization?

Internal customer Internal customers receive products or services from other person or departments within the same organization

BQ-Which of the following stakeholders usually receives a more immediate sense of accomplishment as a result of working with a quality?

Internal customers Employees usually receive a quick sense of achievement through working in a quality organization and by knowing they have provided a quality product to the best of their abilities.

RR-As a team matures, how does the involvement of the facilitator change?

Involvement decreases because the team is now familiar with the team process As the team becomes more familiar with the team process, the role of the facilitator diminishes and is assumed by the leader

QIT- What tool would a quality improvement team use to create a picture of the various contributing factors to the problem?

Ishikawa (fishbone) diagram The Ishikawa or fishbone diagram shows in graphic form the causes and sub-causes of a problem

Qp-Which of the following quality tools can be used to find and organize the causes of variation and identify possible relationship between them?

Ishikawa diagram

BoQ-What is the benefit to an organization that has a high quality image, positive reputation, and stature?

It is easier to recruit new employees Reputation, stature, and image of a high-quality organization make it easier to recruit new employees

QC-Which of the following statements best describes common cause variation?

It requires management intervention to correct The majority of common cause variation requires management action to provide inputs that will correct the issue

Guru-Developed the idea of considering two elements of quality: "Big Q," quality in transactional or business processes, and "little q," quality in operational or production processes.

Joseph Juran

Guru-Promoted the idea of "the Cost of Quality," which really referred to the cost to an organization of not conforming to quality principles.

Joseph Juran

PI-What method would a company use if it wanted rapid, short-term, incremental improvements to decrease defects in its assembly department?

Kaizen-blitz A kaizen-blitz is a tool designed for incremental process improvement. Kaizen results in the implementation of small, incremental improvement steps over a period of time.

•Which of the following is a Japanese word that means "visual card" and describes an activity used to allow demand signals to trigger action like production or re-ordering supplies?

Kanban

Guru-Developed the cause-and-effect "fishbone" diagram that bears his name. This diagram identifies and displays the factors that are thought to affect an output and is used to find a root cause of an effect.

Kaoru Ishikawa

Qp-Who is credited with implementing the seven quality tools?

Kaoru Ishikawa

BQ-Benefits of quality improvement can be inhibited by several principal factors that include:

Lack of management support Management commitment is key to the success of any quality improvement activity. Success is dependent upon the application of needed time and resources. If management is not willing to supply those resources, the improvement activity will ultimately fail.

RR-Every team must have a

Leader •A leader is absolutely necessary for a team to be successful. The others are nice to have, but not necessarily essential

PI-Eliminating waste is a primary focus of which activity?

Lean manufacturing Lean manufacturing's primary focus is the elimination of waste through the application of a set of tools designed to eliminate activities that do not add value to the final product.

BQ-Upper management responds best when there is a:

Major threat to the business It's not uncommon for upper management to become complacent with its current success. However, change is inevitable and often a successful organization needs to be faced with a major threat before it is willing to take action and make the changes necessary to meet that threat.

QC-When developing a quality plan, who is responsible for properly allocating resources between short- and long-term requirements?

Management Management is responsible for ensuring resources are balanced between short- and long- term requirements.

SM-Which of the following is a primary reason to assist suppliers with improving their products and services?

Material and services from suppliers can substantially impact the quality of the product, customer satisfaction, and profitability The primary reason to assist suppliers is because their materials and services can substantially impact quality of the product, customer satisfaction, and profitability

Tf&GD-Describe the norming stage of team evolution

Members reconcile competing loyalties and responsibilities This describes the norming stage of team development

TQ-Which type of team would best describe the human resource department of an organization?

Natural team A natural team is made up of individuals who have responsibility for a specific process or function and work together in a participative environment.

QIT-What does a narrow band of points extending from the upper left to the lower right on a scatter diagram represent?

Negative correction Points extending from the upper left to the lower right would indicate a negative correlation

CI-Which of the following is a rule of brainstorming?

No idea is evaluated during the idea generation part of brainstorming Evaluating ideas during the idea generation part of brainstorming takes up a great deal of time and will reduce the time available for generating new ideas. Additionally, if an idea is submitted, then discussed and discarded, the person submitting the idea may be reluctant to contribute again.

Tf&GD-What should be done prior to initiating a team?

Obtain support from upper management Without support from upper management there is little point in initiating a team

Which of the following pairs of factors describes more special cause variation?

Occurs sporadically and is the result of a single variable

The three phases of organizational planning include strategic planning and tactical planning. Which of the following is the third phase?

Operational Planning

Benefits of Quality- •The use of quality tools and philosophies to establish the productive and profitable use of resources directly benefits which stakeholder?

Organization The organization directly benefits from the productive and profitable use of its resources. (The key word is directly)

Quality philosophies-What are the steps of the process improvement cycle developed by Walter Shewhart?

Plan, do, check, act Plan, do, check, act (PDCA) was developed by Walter Shewhart

Which of the following describes the Deming method for continuous improvement?

Plan-do-check-act cycle

CI-A brainstorming session where anyone can call out an idea, in no particular order, until all ideas are shared, is which brainstorming technique?

Popcorn The popcorn technique is a freewheeling method of idea generation. It is used when the group is comfortable expressing ideas in front of others. It encourages creative thinking.

BoQ- Which of the following is an unwanted side effect of changes due to quality improvement?

Possible loss of jobs or a change in job status that results in lower pay As a result of some changes, costs can be reduced. IN some instances the reduced costs are obtained from job eliminations or restructuring of jobs that can result in lower pay for some employees. The goal of process improvement is not to eliminate jobs but to put good people into jobs where they can make more of a significant contribution to the organization without adding unneeded costs.

Deming advocates ceasing dependence on mass inspection through the use of

Process improvement

QC-Which of the following is a basic component of all business system models?

Processes All business systems have inputs, processes, and customers.

QC-In addition to all internal departments being customers and suppliers, what other role do they play?

Processor •Internal departments have everyone inside an organization playing three roles: customer, supplier, and processor

Supplier Management-A customer has requested that their supplier provide a report containing information about a product's test parameters and results. The test report is which type of supplier feedback?

Product data Product data is a form of verification that is analyzed to ensure suppliers are complying with specifications. The test report is a form of product data

Which of the following is NOT one of the quality elements in the Juran Trilogy

Quality Audits

Which of the following is NOT one of the quality elements in the Juran Trilogy?

Quality audits

Qp-Juran's trilogy is a road map for organizations to follow as they work to achieve quality objectives. The key components of the trilogy are quality planning, quality control, and

Quality improvement

BoQ-Which of the following approaches should be part of a quality improvement initiative?

Quality improvement should be built into the system Quality improvement should be built into the system for the organization to have it embedded into the culture. It must become a way of life

QP-What are the universal processes that make up the Juran trilogy?

Quality planning, quality management, and quality improvement Quality planning, quality control, and quality improvement are the three interrelated processes of the Juran trilogy

BoQ-The quality professional drives improvement in his/her organization through the application and use of:

Quality tools Quality tools consist of those charts, diagrams, and technques that are designed for a specific purpose and contribute to identifying and implementing desired change. They also confirm the results of that change

TQ-A team is going through the storming stage and members are presenting opinions as facts. What should the facilitator do to get them back on track?

Question opinions and assumptions and ask for supporting data Some members may have difficulty distinguishing facts from opinions. Questing assumption and asking for supporting data will help them learn this distinction and get back on track.

In order for a problem to be understood and solved correctly, which of the following must occur first?

Recognizing the problem

BQ-Quality benefits the supplier by doing which of the following?

Reducing inspection costs A supplier with a consistent record of delivering quality products can achieve lower inspection costs because the frequency of those inspections can be reduced.

CRS-Which kind of customer has a limited choice of suppliers for a product or service?

Service user A service user has a limited choice of suppliers for a product or service such as water, sewage, and waste disposal

BoQ-The use of quality improvement efforts to increase profitability begins with which of the following actions?

Setting new goals Improving quality in an effort to increase income starts by setting new goals, such as new product features, shorter cycle time, and one-stop shopping

Quality Philosophies-What did Dr. Deming call the PDCA cycle?

Shewhart cycle Since Deming was an apprentice to Shewhart, he referred to his improvement cycle of PDCA as the Shewhart cycle.

QC- Which of the following events is relatively easy to detect and resolve

Special cause Common (nonassignable) causes are typically chronic and usually have their origin in the interplay among multiple minor variations. Special cause events are typically sporadic, which makes it realtively easy to detect and correct.

Forming, storming, norming, and performing" are terms that describe

Stages of team growth

CI-Within the PDCA cycle, which of the following would fall under the Act phase?

Standardize improvement action In the Act phase, once corrective action is implemented, the team needs to consider if the corrective actions taken would be beneficial on similar processes

Quality planning is part of all three

Strategic, tactical, and operational planning are the three phases of organizational planning. Financial planning is part of the first two.

SM-Which index should be used to track the performance of a supplier who provides several components to the organization?

Supplier performance index Supplier performance index tracks the overall quality and delivery performance of a supplier

PI-In a Six Sigma project, which of the following tools is used in the Define DMAIC to identify customer needs and wants?

Suppliers-Inputs-Process-Outputs-Customers SIPOC is a structured method of identifying customer needs and the inputs and processes that interact to supply them

Which of the following terms best explains multiple sets of interrelated or interconnected activities that transforms inputs into outputs?

System A system is a set of interrelated or interconnected processes; thus, it is multiple sets of interrelated or interconnected activities.

Tf&GD-Which is an example of storming within the phases of team development?

Team members feel more comfortable expressing their opinions Storming is the phase when team members fell more comfortable expressing their opinions. They may challenge the team leader's authority and recommendations

RR-A team is collecting data to justify a process improvement, but the process owner is reluctant to grant access to the financial data which includes sensitive information on employee labor rates. Who should help the team gain access to the required information?

Team sponsor The sponsor supports the work of the team and should work with the finance manager and department manager to give the team access to the appropriate data while still protecting sensitive employee information

Team formation and Group Dynamics What is most critical to team success?

The active support of management Management support is critical to member participation and having time to work on team activities outside of meetings

Tf&GD-Which factor is most important when determining team size?

The complexity of the task that the team has to perform The complexity of the task is the primary determining factor for the resources needed and the team size required to successfully accomplish the task. The more complex the task, the larger number of people that will be needed to make sure all aspects are covered and sufficiently resourced.

CQIA: A hotel prides itself in the quality of its service. Which of the following best describes what its approach to quality should be?

The hotel should anticipate customer needs in advance

CS-Before an organization can accept an order from their client, customer requirements should be clarified by:

The organization The organization must know what to build; therefore, the organization must ensure the requirements are clear

According to Crosby, quality is measured by

The price of nonconformance

BQ-For a project to have a significant and noticeable positive impact upon the organization, the best criteria for project selection should include:

The project's ability to align with the strategic objectives of the organization Projects that are not aligned with the strategic objectives are unlikely to increase the performance of the organization in area that are strategically significant

QP-Which of the following is a part of the "profound knowledge" system developed by Deming?

The psychology of change The "psychology of change" is a component of profound knowledge. Deming's ideas are based on 14 points of management including working with joy, managing without fear, and knowledge of variation.

SPC: Statistical Process Control

The use of metrics (monitoring and measurement) to ensure that a process operates in a state of control - within predetermined control limits

BoQ-What does the phrase "higher quality costs more" mean?

The way to improve quality is to increase inspection so fewer defects escape Higher quality costs more is based on the outdated belief that the way to improve quality is to increase inspection so fewer defects escape

QIT-What is the best way to use a check sheet?

To determine the root cause of a problem Check sheets are used for tallying the frequency in which events occur. They are used to create histograms and Pareto charts

Process audits serve which of the following functions?

To ensure standardized quality practices.

TQ-At the start of an improvement project, what is a sufficient timeframe to allow team members to develop their skills while building and maintaining management support for the program?

Two to four months A two- to four-month timeframe gives adequate time to investigate and correct the problem and deliver positive results that will sustain management support and enable the team to tackle additional, more difficult problems during the year

VOC:

Voice of the Customer

Guru-Developed "14 points of management" that advocated a reorganization of companies to embrace quality.

W. Edwards Deming

Guru-Developed the idea of "seven deadly diseases" of organizations that undermine their quest for quality.

W. Edwards Deming

Guru-Considered to be the "father" of statistical quality control, he first applied mathematics and the scientific process to the assurance of quality.

Walter Shewhart

Qp-To what concept is Crosby's book Quality Is Free devoted?

Zero defects

Design of Experiments (DoE) refers to:

a formalized structure for discovering how to optimize a process

CQA: Critical Quality Attribute

a physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure product quality

QA: Quality Attribute

a physical, chemical, or microbiological property or characteristic that directly or indirectly relates to pre-defined product quality (safety, identity, strength, purity, and marketability of the product).

CS: Control Strategy

a planned set of controls, derived from current product and process understanding that ensures process performance and product quality. The controls can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring or control.

CPP: Critical Process Parameter

a process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces desired quality

PP: Process Parameter

a process variable (e.g., temperature, compression force) that can be assigned values to be used as control levels or operating limits.

QTPP: Quality Target Product Profile

a prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the drug product.

Qp-Ishikawa diagrams

are used to organize and display the interrelationship of various theories of the root cause of the problem

Crosby defined quality

as conformance to requirements. He believed quality could be measured by determining the cost of not conforming to requirements

Qp-Crosby

believed that each of his proposed steps for quality improvement were critical to the successful implementation of a quality improvement system in an organization

Quality is best defined as meeting

customer needs

One benefit of quality is that a reduction in errors can result in increased downtime

down-town

A customers definition of quality sometimes differs from a supplier's definition. A customer's primary expectation is:

fitness for use

Quality Concepts-A customers definition of quality sometimes differs from a supplier's definition. A customer's primary expectation is:

fitness for use Fitness for use indicates that a product, service, or process fits the customer's defined purpose for that product, service, or process

Qp-Ishikawa is credited

for organizing the seven quality tools

5S

for sort, set, shine, standardize, and sustain. It is intended to create a clean and organized workplace that will include visual control and benefit lean production

Qp-Quality is free

is Crosby's first book devoted to the concept of zero defects

Process mapping

is a lean tool to define the steps in the current process so they can be investigated for waste. Process maps focus on process steps.

Six Sigma

is a method of utilizing statistical tools to improve process capability by reducing process variation

QFD: Quality function deployment

is a method used to turn customer wants and needs into product specifications

SIPOC: Suppliers-Inputs-Process-Outputs-Customers

is a structured method of identifying customer needs and the inputs and processes that interact to supply them

Benchmarking

is a technique in which an organization compares its own performance for a specific process with the "best practice" performance of a recognized leader in a comparable process.

Quality

is anticipating customer needs and expectations and delivering them. Any quality organization should strive to anticipate customer needs.

One of the fundamental definitions of quality

is making customer service available. The customer have expressed dissatisfaction with long wait lines and a quality response should include making customer service available through opening and staffing additional checkout lanes.

DoE :Design of Experiments

method of experimenting with the complex interactions among parameters in a process or product with the objective of optimizing the process or product

Poke-Yoke

•"mistake proofing"

Value-Added Analysis

process of evaluating all work activities, materials flows, and paperwork to determine the value that they add for customers

The objective of a Lean

• approach is to provide more value to the customer •The goal is to give them what they want, when and where they want it, in the desired quality and variety, with quality and a competitive price •Organizations that embrace Lean as part of their culture make it a priority to achieve this goal of improving customer satisfaction.

Benefits of Lean

•A Lean mindset also makes it easier to identify and eliminate waste. •With a clear understanding of the sources of waste, an organization can take a realistic look at how things are done and eliminate process steps that are not needed, or move steps to other processes where they are more appropriate

CSR-Which of the following best describes an internal supplier?

•A process improvement team that provides audit data to its senior quality engineers. The process improvement team is providing a product or service within its organization; therefore it is an internal supplier

CI-Testing and inspections are examples of which type of cost of poor quality?

•Appraisal costs Appraisal costs come from measuring and monitoring activities related to quality. Testing and inspections are measuring and monitoring activities

Principles of Lean - People, Teamwork

•At the heart of a successful Lean culture is a sincere respect for people •Leaders in a Lean culture are encouraged to nurture an environment in which all individuals inside and outside the organization are respected and inspired to improve each day. •Everyone learns from one another, and individuals become experts in their areas. •Respect for People = successful Lean culture •Environment of Respect

QC-Which of the following best explains the importance of using a process approach when implementing continuous improvement efforts within an organization?

•Changing one process may negatively impact another.* Processes are interactive and changing a process or the system as a whole, negating the improvement made in the first process.

Types of Benchmarking

•Competitive Benchmarking •Functional Benchmarking •Internal Benchmarking - Identification of common internal processes that continually achieve high levels of performance enables a company to create a benchmark. This can be used to increase the performance level of other processes without having to benchmark outside the organization •Generic Benchmarking

DMAIC

•Define-Measure-Analyze-Improve-Control •Pronounced Da-May-Ick

SM-Which index measures supplier performance by comparing stated requirements to total number of days early and total days late?

•Delivery performance index Delivery performance index measures a supplier's performance based on delivery requirements

Benefits of Lean

•Eliminating waste and streamlining processes is critical for obtaining consistent, quality results that meet customer demands. •Knowing about the pricings of Lean and understanding the sources of waste are important first steps toward integrating Lean into any organization. •These topics will be covered in more detail later in this course.

Customer Supplier Relations-The use of a "mystery shopper" approach in the retail industry is geared toward understanding the experience of which kind of customers?

•End-users A mystery shopper is an end-user who documents the experience and provide feedback to the organization; thus, this approach targets the end-user experience.

What's the first step of quality planning?

•Establish the project The first logical step is to establish the project

CI-Determining conformance or non-conformance is part of which step in the audit process?

•Evaluate The evaluate stage is where it is determined if the facts that have been collected demonstrate conformance to the process under scrutiny

SM-Which of the following tools is essential in helping suppliers to improve their products, services, and processes?

•Feedback Similar to an employee's performance review, suppliers need feedback to help them in identifying their strengths and opportunities for improvement

ISO: International Organisation for Standards

•ISO 9000 focuses on driving consistency through standardization of processes

History of Lean

•In 1990, the term "lean manufacturing" was introduced in The Machine that Changed the World," a book by James Womack, Daniel Jones, and Daniel Roos. •In it, the authors laid out the key concepts of Lean, including value, waste reduction, flow, pull, and time. •Today, the success of companies like Toyota has sparked an increasing interest in Lean methodologies. •All over the world, companies are seeking to generate profit while meeting rapidly changing market demands and keeping costs under control. •Although Lean was first developed for use in manufacturing, Lean principles and methods have been adopted by organizations in the service, healthcare, construction, government, and other industries.

History of Lean

•In its history, Lean has been driven by a need for improvement •Knowing Lean's history is just as important to understanding its power as knowing its core principles •Evolution •DOWNTIME •In the late 1700s, Eli Whitney, who invented the cotton gin, was a pioneer in the use of interchangeable parts for manufacturing. •With this approach, he was able to mass produce guns for the U. S. Army at a very low price. •In the 1800s, early industrial engineers like Frederick W. Taylor and Frank and Lillian Gilbreth began to study workers and processes, including the links between worker motivations and process outcomes. •Their work caught the attention of later pioneers who incorporated better working conditions into quality initiative, resulting in improved workforce relationships.

History of Lean

•In the early 1900s, Henry Ford pioneered the manufacturing assembly line to reduce cycle times during the production of his popular Model T Ford automobile. •His system, however, was limited to one model without any options for color or style. •As the economy changed, Ford did not change his system. •General Motors (GM) learned from Ford and built a variety of automobiles while continuing to use mass production to keep costs under control. •With this change, GM was able to dominate the market. •At Toyota, Taichii Ohno and Shigeo Shingo developed the Toyota Production system (TPS), which became a model for efficiency by removing waste. •TPS used elements of Ford's approach, but incorporated improvements that increased its flexibility and was more respectful of workers. Changes like greater product variety, small-batch processing, just-in-time inventory flow, better workforce relationships, and better labor conditions gave Toyota a competitive edge. •TPS was developed as a way to achieve higher levels of safety, quality, productivity, and flexibility with minimal investment.

A quality-focused retail store receives several complaints of long checkout lines. Which of the following actions would be the best first step towards immediately addressing the customers' concerns?

•Increase the number of open and staffed checkout lanes.

CS-Which of the following quality methods is used to analyze customer satisfaction data?

•Kano model The Kano model is one of the methods used by organizations to analyze customer satisfaction data

Which of the following is defined as a set of functions or activities that work together for the benefit of the organization?

•Management

When starting an employee involvement program, which of the following presents the greatest risk?

•Management inaction on suggestions for improvement. Management must be prepared to act on improvement suggestions provided, otherwise it will kill any initiative that the program generates.

What is the department called (typically) that devotes itself to continuous improvement?

•Operational Excellence

CI-Stan's Manufacturing has put a plan in place to correct a defective product. It verified the change was effective in eliminating the problem, then made the correction a permanent part of the manufacturing process. This is an example of:

•Plan, Do, Check, Act (PDCA)* PDCA is a process improvement methodology that involves identifying a problem, testing a corrective action to see if it solves the problem, then, if the corrective action is effective, making that a permanent part of the new process

CI-What is an effective tool for assessing the performance of a process being reviewed during an internal audit?

•Plan, do, check, act (PDCA) PDCA is well suited to assess process performance as it helps the auditor understand the input, work performed, and expected outputs of a process.

Business quality-Business functions managed through a systems organizational structure generally tend to create:

•Positive attitudes and behavior within the organization. System's organizational structure creates a culture where employees think about the interworking relationships of the organization as opposed to only focusing on their processes, they are more engaged, and they are encouraged to think and discuss challenges freely within the organization.

Customer Satisfaction-Which customer feedback method collects data that is used to analyze the customer's purchasing decision?

•Product warranty registration cards The types of questions asked and answered on the product warranty cards provide insight into customers' purchasing decisions

Quality and Regulatory Compliance

•Quality Systems lead to Regulatory Compliance •Pharmaceutical Quality System - ICH Q10 •Quality systems flow out of the quality movement - changes in management systems that emphasize quality •The principles of quality can and are applied to pharmaceutical manufacturing •These quality principles lead to compliance •American Society for Quality - CQIA - Certified Quality Improvement Associate Body of Knowledge

PI-The objective of a lean project is to eliminate activities that add waste to the system and do not enhance the product or output What tool can be used to identify these types of activities?

•Root cause analysis - determines the underlying cause of a problem Value-added analysis In a value-added analysis, the team looks at each step of a process to determine which ones truly add value and which a customer would be willing to pay for

Which scenario is an example of common cause variation?

•Routine rush hour has increased scheduled delivery time by 20 minutes. Rush hour is inherent to the process though it was not present when the process was first developed. Variation inherent to the process is considered common cause variation.

ISO 9001

•The International Organization for Standardization (ISO), a non-governmental organization based in Geneva, Switzerland, consists of a network of national standards institutes from countries across the world. The organization publishes a wide range of international standards for business, government, and society in general. Organizations adhere to ISO standards for various reasons (consistency across facilities/units/processes, vendor requirements, quality efforts, market advantages, efficiency improvements, requirements imposed by regulatory bodies and agencies, etc.).

Principles of Lean

•The core principles of Lean define the values and intentions behind every action and decision made in a Lean approach to quality. •They are •Maintain respect for people and support teamwork •Define value from the customer's perspective •Indentify the value stream •Make value flow through the system without interruptions •Improve efficiency; reduce product variation and develop standard work •Let customers pull value through the system •Pursue perfection

One Factor at a Time

•The experimental approach at contrasts with DoE where one parameter of a process is varied at a time.

Benefits of Lean

•The fast pace of the marketplace means customers continuously demand better products and service at affordable prices. •Their expectations increase with each new innovation. •Customers want more, faster, better, cheaper... and they want it now. Lean makes it easier to keep up with industry standards like ISO and regulatory requirements for quality

QC-The measure of variation between the upper process limit and the lower process limit is necessary to determine what?

•The range of natural variation in the process. The range between the upper and lower limits of the process are established by recording actual measurements of the process variables and using this information to determine the inherent or natural variation of the process. (Outside of the range of these limits would be special cause variation.)

PDCA• Plan Do Check Act:

•These phases occur within the Deming circle of continuous process improvement

Benefits of Lean

•While the primary focus of Lean is on creating value for the customer, embracing a Lean mindset benefits an organization in other ways. •A Lean mindset encourages leaders to empower workers and make processes better so they improve safety, reduce errors, improve efficiency, and increase productivity - all of which help the organization be more competitive in today's global economy.

QbD: Quality-by-Design:

•a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management

What is Lean

•is an approach to improve safety and quality, increase productivity, reduce costs, and increase customer satisfaction by eliminating waste and creating value. •Waste, also known the Japanese term muda, is any activity that consumes resources like time, space, and materials, but does not add value to a product or service.