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70 Cards in this Set
- Front
- Back
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What is ISO? |
ISO is a independent non/governmental international organization with a membership of 162 national standard bodies |
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How many members are there in ISO? |
Full members (or member bodies), correspondent members and subscriber members |
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What do full members do? |
They influence ISO standards and strategy by attending ISO technical and policy meetings as observers. |
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What do correspondent members do? |
They observe the development of ISO standards and strategy by attending ISO technical and policy meetings as observers. Correspondent members can sell and adopt ISO international standards nationally |
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What do subscriber members do? |
They keep up to date on ISO work but can not participate in it. They do not sell or adopt ISO international standards nationally |
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What kind membership does Mexico have? |
México is a member body |
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Which organism coordinates the National Standardization, Metrology and Conformity Assessment System? |
Dirección general de normas (DGN) of the Ministry of Economy |
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What does the assessment system consist of? |
It consist of three fundamental activities; standardization national (including regulations) and international, Metrology and accreditation, and Conformity Assessment. To maximize the efficiency and effectiveness of these functions |
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What is DGN in charge of doing? |
-participates in the international organizations and other relevant to represent the interests of our national sectors -coordinates the development of national regulations and standards under its competence and registers national standardization bodies to issue standards. -authorizes the accreditation entity and oversees it's work as well as the compliance of the regulations under DGN responsability -provides training to enhance human resources, provides publicly available information (online catalogue of Mexican standards and regulations) and promotes the system as a whole trough participating and giving conferences, seminars and workshops |
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What are standard? |
International standards make things work. They give world-class specifications for products, services and systems, to ensure quality, safety and efficiency. They are instrumental in facilitating international trade |
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What are benefits of ISO international standards? |
ISO international standards ensure that products and services are safe, reliable and of good quality. For business, they are strategic tools that reduce costs by minimizing waste and errors and increasing productivity. They help companies to access new markets , level the playing field for developing countries and facilitate free and fair global trade |
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How does ISO develop standards ? |
Our standards are developed by the people that need them, through a consensus process. Experts from all over the world develop the standards that are required by their sector. This means they reflect a wealth of international experience and knowledge |
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What does quality control stand for? |
Quality control or QC for short , is a process by Wich entities review the quality of all factors involved in production |
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How does ISO 9000 define quality control? |
It defines quality control as "A part of quality management focused on fulfilling quality requirements" |
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What are the three aspects enshrined in standards such as ISO 9001? |
-Elements such as controls, job management, defined and well managed processes, performance and integrity criteria, and identification of records
-Competence , such as knowledge, skills , experience, and qualifications
-Soft elements, such as personnel, integrity, confidence, organizational culture, motivation, team spirit , and quality relationship |
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What is inspection? |
It is a major component of quality control , where physical product is examined visually (or the end results of a service are analyzed). Product inspectors will be provided whit lists and descriptions of unacceptable product defects such as cracks or surface blemishes for example |
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What is first article inspection (FAI)? |
Is a design verification and design history file and a formal method of providing a reported measurement for a given manufacturing process |
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Who is in charge of performing the first article? |
Both the supplier and purchaser perform the first article on the ordered product. |
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What does the evaluation method consist for? |
The evaluation method consists of comparing supplier and buyers results from measuring the properties and geometry of an initial sample item against given specifications, for example a drawing |
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What does quality control requires in project management? |
Quality control requires the project manager and/or the project team to inspect the accomplished work to ensure its alignment with the project scope |
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Can you explain how items are checked by the supplier and purchaser? |
They are wide and varied and may include distances between edges, positions of holes , diameters and shapes of holes , weight , density, siffness, color or surface finish |
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What type of industries is FAI applied for? |
Non-military industries , particularly aerospace, automotive and medical manufacturing |
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What's good manufacturing practices GMP? |
They are practices required in order to conform to the guidelines recommend by agencies that control authorization and licensing for manufacture and sale of food, pharmaceutical products, etc. And the assure that the products are of high quality and do no pose any risk to the consumer or public |
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What does quality assurance (QA) stand for? |
It is a way of preventing mistakes or defects in manufactured products and avoiding problems when delivering solutions or services to customers |
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How does ISO 9000 defines QA? |
It defines it as part of quality management focused on providing confidence that quality requirements will be fulfilled |
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Are the terms "quality assurance" and "quality control" used in the same way? |
They are often used interchangeably to refer to ways of ensuring the quality of a service or product |
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What does DMAIC stand for? |
Define, measure, analyze, improve and control |
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Wich company describes implementation of inspections and structured testing as a measure of quality assurance and he term "control" , however, is used to describe the fifth phase of the DMAIC model. DMAIC is a data-driven quality strategy used to improve process. |
Philips semiconductors |
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It includes the following principles: "Fit for purpose" (the product should be suitable for the intended purpose); and "right first time" (mistakes should be eliminated). includes management of the quality of raw materials, assemblies, products and components, services related to production, and management, production and inspection processes. The two principles also manifest before the background of developing (engineering) a novel technical product: The task of engineering is to make it work once, while the task of quality assurance is to make it work all the time. |
Quality assurance |
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Is QA límited to manufacturing? |
It can be applied to any business or non-business activity, including: design, consulting, banking, insurance, computer software development, retailing, investment, transportation, education, and translation.
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Why QA is important in the medical field? |
Because it helps to identify the standards of medical equipments and services |
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is often used instead of quality assurance and is, alongside project management and engineering, one of the three primary project functions. Quality assurance is seen as one part of product assurance. Due to the sometimes catastrophic consequences a single failure can have for human lives, the environment, a device, or a mission, product assurance plays a particularly important role here. It has organizational, budgetary and product developmental independence meaning that it reports to highest management only, has its own budget, and does not expend labor to help build a product. |
The term product assurance (PA) |
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It consists of a means of monitoring the software engineering processes and methods used to ensure quality. The methods by which this is accomplished are many and varied, and may include ensuring conformance to one or more standards, such as ISO 9000 or a model such as CMMI. |
Software quality assurance |
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They are sometimes employed when introducing new quality practices and methods, particularly where the relevant skills and expertise are not available within the organization or when allocating the available internal resources are not available. They will often employ Quality Management Systems (QMS), auditing and procedural documentation writing CMMI, Six Sigma, Measurement and systems Analysis (MSA), Quality Function Deployment (QFD), Failure Mode and Effects Analysis (FMEA), and Advance Product Quality Planning (APQP). |
Consultants and contractors |
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What does acceptance number stand for? |
The maximum number of defects or defectives allowable in a sampling lot to be acceptable |
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What does acceptance quality limit (AQL) stand for? |
In a continuing of lots a quality level that , for the purpose of sampling inspection, is the limit of a satisfactory process average |
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What does accreditation body stand for? |
It is an organization with authority to accredit other organizations to perform services such as quality system certification |
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What does accuracy stand for? |
The characteristic of measure |
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What does audit stand for? |
The on-site verification activity, such as inspection or examination, of process or quality system, to ensure compliance to requirements. An audit can apply to an entire organization or might be specific to a function, process or production step. |
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It is a Japanese term for manufacturing technique for preventing mistakes by designing the manufacturing process, equipment and tools so an operation literally cannot be performed incorrectly. In addition to prevent incorrect operation, the technique usually provides a warning signal of some sort for incorrect performance.
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Baka-yoke or poka-yoke |
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What does benefic-cost analysis stand for? |
An examination of the relationship between the monetary cost of implementing an improvement and the monetary value of the benefits achieved by the improvement, both within the same time period. |
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Full time team leader responsible for implementing process improvement projects-define, measure, analyze, improve and control DMAIC or define, measure, analyze, design and verify DMADV-within a business to drive up customer satisfaction and productivity levels. |
Black belt |
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What does business process reengineering (BPR) stand for? |
The concentration on improving business processes to deliver outputs that will achieve results meeting the firms objectives, priorities and mission. |
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What does defective stand for? |
A unit of product that contains one or more defects with respect to the quality characteristics under consideration |
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The degree to which a product is operable an capable of performing its required function at any randomly chosen time during its specified operating time. Provided that the product is available at the start of a period. (Nonoperation related influences are not included)? |
Dependability it can be expressed by the ratio: time available + time required).
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What does improvement stand for? |
The positive effect of a process change effort |
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What does inspection lot stand for? |
A collection of similar units or a specific quantity of similar material offered for inspection and acceptance at one time |
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What does ISO 9000 stand for? |
It is a set of international standards on quality management and quality assurance developed to help companies effectively document the quality system elements to be implemented to maintain an efficient quality system |
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What does leadership stand for? |
It’s an essential part of a quality improvement effort. Organization leaders must establish a vision, communicate that vison to those in the organization and provide the tools and knowledge necessary to accomplish the vision. |
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What does lean stand for? |
Producing the maximum sellable products or services at the lowest operational cost while optimizing inventory levels |
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It is an initiative focused on eliminating all waste in manufacturing processes. Principles of lean manufacturing include zero waiting time, zero inventory, scheduling (internal customer pull instead of push system), batch to flow (cut batch sizes), line balancing and cutting actual process times. The production systems are characterized by optimum automation, just-in time supplier delivery disciplines, quick changeover times, high levels of quality and continuous improvement. |
Lean production or lean manufacturing |
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What does lean migration stand for? |
It is the journey from traditional manufacturing methods to one in wish all forms of waste are systematically eliminated |
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What does mistake proofing stand for? |
Use of production or design features to prevent the manufacture or passing downstream a nonconforming product, also known as "error proofing " |
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What's ISO 9001:2015 quality management systems? |
ISO 9001 is the international standard that specifies requirements for a quality management system (QMS). ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO) an international agency composed of the national standards bodies of more than 160 countries. The current version of ISO 9001 was released in September 2015. |
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Who should use 9001:2015 quality management systems revision? |
It applies to any organization , regardless of size or industry |
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Why do organizations of all types find that using the ISO 9001:2015 standard helps them? |
-organize process -improve the efficiency of process -continually improve |
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What topic does ISO 9001:2015 cover? |
- Requirements for a quality management system, including documented information, planning and determining process interactions- Responsibilities of management- Management of resources, including human resources and organization’s work environment- Product realization, including the steps for design to delivery- Measurement, analysis, and improvement of the QMS through activities like internal audits and corrective and preventive action. |
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What are the benefits of ISO 9001:2015? |
-Organize QMS -Create satisfied customers, management, and employees -Continually improve |
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What does this figure represent? |
ISO 9001 timeline |
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It is a fact-based, data-driven philosophy or improvement that values defect prevention over defect detection. It drives customer satisfaction and bottom-line results by reducing variation, waste, and cycle time. While promoting the use of work standardization and flow, thereby creating a competitive advantage. It applies anywhere variation and waste exist, and every employee should be involved. |
Lean six sigma |
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What is scientific management also known as scientific approach? |
It is a term referring to the intent to find and use the best way to perform tasks to improve quality, productivity and efficiency. |
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This word is the name of a Japanese management practice which means manufacturing and number and is assigned to all parts, materials and purchase orders associated with a particular customer job, projector or anything else. This enables a manufacturer to track everything related to a particular product, project or customer, and facilitates setting aside inventory for specific projects or priorities. That makes it an effective practice to project and buildto-order manufacturing. |
Seiban |
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What are the seven tools of quality? |
- cause and effect diagram - Check sheet - control chart - flowchart - histogram - pareto chart - scatter diagram |
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What does this figure stand for? |
This a check list, a tool that contains items important or relevant to an issue or situation |
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What does this figure stand for? |
Control chart. Whit upper and lower limits on Wich values of some satisfical measure for a series of samples or subgroups are plotted |
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What does this figure represent? |
Histogram. A graphic summary of variation in a set of data |
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What is the name of this chart? |
Pareto chart. A graphical tool for ranking causes from most significant to least significant |
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What does this figure represent? |
Scatter diagram. A graphical technique to analyze the relationship between two variables |
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What does this figure represent? |
Run chart. Collected from a process running over time. A chart showing a line connecting numerous data points |
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What does this figure represent? |
Flowchart. A graphical representation of the steps in a process |
