Quality Management Short Answer – Flashcards

PRIMARY GOAL: detection of defects WAY OF REACHING QUALITY: solving quality problems THE AIM OF THE ACTIVITIES: homogenous products (everything is the same) METHODS: standardization and measurements TASKS OF QUALITY PROFESSIONALS AND QUALITY FUNCTION: control, sorting, calculations and qualification RESPONSIBLE FOR QUALITY: quality inspection

PRIMARY GOAL: control WAY OF REACHING QUALITY: → THE AIM OF THE ACTIVITIES: homogenous products with less control METHODS: statistical tools and techniques TASKS OF QUALITY PROFESSIONALS AND QUALITY FUNCTION: trouble shooting, applying statistical methods RESPONSIBLE FOR QUALITY: production and other engineering departments

PRIMARY GOAL: harmonization, prevention WAY OF REACHING QUALITY: → THE AIM OF THE ACTIVITIES: focusing preventing defects and on the other production process in a wider sense METHODS: quality projects and systems TASKS OF QUALITY PROFESSIONALS AND QUALITY FUNCTION: quality planning, quality programs, valuation of quality system RESPONSIBLE FOR QUALITY: all departments

PRIMARY GOAL: strategic pressure WAY OF REACHING QUALITY: assuring stable competitive positions THE AIM OF THE ACTIVITIES: meet market and customer needs and expectations METHODS: strategic planning, setting goals, mobilization of the total system TASKS OF QUALITY PROFESSIONALS AND QUALITY FUNCTION: education, trainings, supporting other departments, planning quality projects, setting quality goals and objectives RESPONSIBLE FOR QUALITY: every employee who contributes and total commitment of management

SPREAD: multitudinous (very different elements), bottom-up strategy (piecing together a system to give rise to a more complex system) BEARING GROUP: quality circles SPECIAL FEATURES: totality, simple tools and techniques KEY ELEMENT: quality circles: formed by employees working together in an operation and meet at intervals to discuss quality problems and how to come up with solutions and improvements

SPREAD: top-down strategy (breaking down of a system to gain insight on its components and sub-systems), snowball principle (rapid increase and growth) BEARING GROUP: top management (managers responsible for controlling and overseeing the entire organization) SPECIAL FEATURES: management environment (the general way management operates in the US) KEY ELEMENT: management climate ???? TQM

SPREAD: production and technology management (goal is to cover the whole system and processes with systematic exploration of defects and corrective actions) BEARING GROUP: middle management (level of management that heads specific departments within a company) SPECIAL FEATURES: standardization (implementing technical standards), regulation (making sure all rules/standards are being followed) KEY ELEMENT: documented shadowing

MAIN GOALS: • Production and testing practice that helps ensure a quality product. FEATURES: • Many countries require that medical and pharmaceutical companies follow GMP procedures • Basic concepts are similar to the ultimate goals of maintaining the health of patients and producing good quality medicine, devices, etc. • GMP guidelines are a series of general principles that must be observed during manufacturing

MAIN GOALS: • systematic preventive approach to food safety and allergenic, chemical, and biological hazards in production processes that can cause the finished product to be unsafe.

FEATURES: • more of a prevention of hazards rather than a finished production inspection. • Focused on the health safety issues of a product, and not the quality of the product

7 PRINCIPLES: • conduct a hazard analysis: a food safety hazard is any biological, chemical, or physical property that may cause food to be unsafe for human consumption. • Identify critical control points: CCP is a point in a food manufacturing process at which control can be applied, and where a food safety hazard can be altered. • Establish critical limits for each critical control point: critical limit is the max or min value to which a physical, biological, or chemical hazard must be controlled at • Establish critical control point monitoring requirements: necessary to ensure the process is under control at each CCP. • Establish corrective actions: actions to be taken when monitoring shows that there has been a deviation from an established critical limit. • Establish procedures for ensuring the HACCP system is working as intended: validation ensures that the plants are successful in ensuring the production of a safe product. Verification ensures that the HACCP plan is adequate, that is, working as intended. • Establish record keeping procedures: all plants must maintain certain documents under HACCP regulations

PRINCIPLES: • conduct a hazard analysis • Identify critical control points and limits for each • Establish corrective actions • Establish monitoring and verification procedures to ensure the system is working as intended • Establish record keeping procedures

QS 9000: quality system requirements of the automotive industry developed by Ford, GM, Chrysler, and other major truck manufacturers. • Section 1: common requirements • Section 2: additional requirements • Section 3: customer specific sections: requirements unique to either Ford, GM, or Chrysler VDA 6.1: German quality management system standard initiated by the automobile industry. Includes all elements of QS 9000 (above) with an additional 4 requirements REQUIREMENTS: • Recognition of product risk • Employee satisfaction • Quotation structure • Quality history **ISO TS 16949: ISO technical specification aiming to the development of a QMS that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain.

QS 9000: quality system requirements of the automotive industry 3 sections • common requirements • additional requirements • customer specific sections

VDA 6.1: Quality management system of automotive industry that includes all elements of QS 9000 (above) with additional 4 requirements • Recognition of product risk • Employee satisfaction • Quotation structure • Quality history

ISO TS 16949: ISO technical specification aiming to the development of a QMS that provides for -continual improvement -defect prevention -reduction of variation and waste in the supply chain.

• The standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer requirements, and that quality is constantly improved. 1. ISO 9000) Quality management systems - Fundamentals and vocabulary 2. ISO 9001) Quality management systems - Requirements 3. ISO 9004) Quality management systems - Guidelines for performance improvements 4. ISO 19011) Guidelines for quality and/or environmental management systems auditing

ISO 9000) Quality management systems - Fundamentals and vocabulary: • Provides an understanding of the basic elements of quality management system • defines core language of ISO 9000 standard series

ISO 9001) Quality management systems - Requirements: •defines requirements for an organization to meet customer expectations through consistent products/services

ISO 9004) Quality management systems - Guidelines for performance improvements: • Recommended to extend the benefits of ISO 9001 to all parties who want to further the improvement of their organization's overall performance • Gives guidance on managing for the long term success of an organization

ISO 19011) Guidelines for quality and/or environmental management systems auditing: • Covers the area of auditing quality management systems • Provides guidance on the audit programs, and the conduct of internal or external audits

• Used when seeking to establish a quality management system that provides confidence in your organizations' ability to provide products that fulfill customer needs and expectations • The following 5 sections of the ISO 9001 define what an organization should do to consistently provide product that meets customer needs/expectations: o Requirements for QMS and documentation o management responsibility, planning, objectives, etc. o Resource management o Product realization and process management o Measurement, monitoring, analysis and improvement.

-by using the ISO 9001 guidelines in an organization... -most new users will obtain measurable payback early in process

• CUSTOMER FOCUS: organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements, and strive to exceed customer expectations • LEADERSHIP: leaders establish unity of purpose ad direction of the organization. • INVOLVEMENT OF PEOPLE: people at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's benefit • PROCESS APPROACH: desired result is achieved more efficiently when activities and related resources are managed as a process • SYSTEM APPROACH TO MANAGEMENT: identifying, understanding, and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its objectives • CONTINUAL IMPROVEMENT: cont. improvement of the organization's performance should be a permanent objective • FACTUAL APPROACH TO DECISION MAKING: effective decisions are based of the analysis of data and info • MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPS: organization and its supplier are interdependent and a mutually beneficial relationship enhances the ability of both to create value

1. engage in top management 2. identify key processes needed to meet objectives 3. implement QMS 4. build ISO 9001 based QMS 5. train staff and verify effective operation of the processes 6. manage QMS 7. if necessary, seek third party certification of QMS

Establish, document, implement, and maintain a quality management system. Continually improve its effectiveness in accordance with ISO 9001 requirements. Implement the system to: • Determine processes needed for the quality management system (and their application throughout the organization) • Determine process sequence and interaction • Determine criteria and methods for process operation and control • Ensure resources and supporting information are available • Monitor, measure where applicable, and analyze these processes • Implement actions to achieve planned results and continual process improvement Manage these processes in accordance with ISO 9001 requirements. Define the type and extent of control applied to any outsourced processes that affect product conformity to requirements.

-Establish, document, implement, and maintain a quality management system -Continually improve its effectiveness using ISO 9001 requirements.

• MANAGEMENT COMMITMENT: provide evidence of this commitment by basically being a good manager • CUSTOMER FOCUS: ensure customer requirements are determined and met in order to improve customer satisfaction • QUALITY POLICY: ensure policy is appropriate and fitted to the organization • PLANNING: have quality objectives established, and ensure planning is meeting needs/integrity policies of company o quality objectives o quality management system planning • RESPONSIBILITY, AUTHORITY, COMMUNICATION: ensure responsibilities and authorities are defined and communicated within the organization o management representatives o internal communication • MANAGEMENT REVIEW: o general: review quality management system at planned intervals o review input o review output

-management commitment -customer focus -quality policy -planning -responsibility, authority, communication -management review -management commitment to the company and its mission -customer focus to ensure requirements are being met, -quality policy implemented -planning the objectives that meet standards -make sure responsibilities are being communicated to the org. -management review of the QMS at intervals

• PROVISION OF RESOURCES: determine and provide resources necessary to maintain and improve the quality management system and enhance customer requirements • HUMAN RESOURCES: o general: ensure people performing work are competent based on skills, edu, etc. o competence, training and awareness: determine competence needs, provide training, inform employees on their skills, etc.??? • INFRASTRUCTURE: determine, provide and maintain necessary infrastructure to achieve product conformity • WORK ENVIRONMENT: determine and manage the work environment needed to achieve product conformity

-provision of resources -human resources -infrastructure -work environment NEED TO: -provide resources necessary to improve QMS and enhance customer requirements, -have human resources to ensure/enhance competence of workers -have the infrastructure/work environment that enables product conformity

definition: term used to describe the work that the organization goes through to develop, manufacture, and deliver the finished goods or services. • PLANNING OF PRODUCT REALIZATION: Plan and develop the processes needed for product realization • CUSTOMER RELATED PROCESSES: o Determine requirements related to product o Review of requirements related to product: before committing to supply the product to the customer o Customer communication: determine effective ways to communicate with customers on the products • DESIGN AND DEVELOP: o Design and development planning: plan and control product design and development o Design and development inputs: determine product requirement inputs and maintain records o Design and development outputs: document outputs of design and development process in a way that it can be compared to the inputs o Design and development review: perform systematic reviews of design and development at suitable stages in accordance with planned arrangements o Design and development verification: do this to ensure output meets design and development input requirements o Design and development validation: to confirm resulting product is capable of meeting the requirements of intended use o Control of Design and development changes: review, verify, and validate the changes and approve them before implementation • PURCHASING o Purchasing process: ensure that purchased product conforms to its specified purchasing requirements. Evaluate suppliers based on their ability to supply product o Purchasing information: ensure the info contains description of the product and the requirements o Verification of purchased product: establish the necessary activities for ensuring the purchasing product meets specified purchasing requirements • PRODUCTION AND SERVICE PROVISION o Control of production and service provision: plan and carry out production and service provision under controlled conditions o Validation of processes for production and service provision: validate any production or service provision where the subsequent monitoring or measurement cannot verify the output. o Identification and traceability: identify the product status with respect to monitoring and measurement requirements throughout product realization. o Customer property: identify customer property provided for use. Record any lost, damaged, or unsuitable property to the customer o Preservation of product: preserve product during internal processing and delivery to intended destination • CONTROL AND MEASURING OF MONITORING EQUIPMENT: Determine the monitoring and measurements to be made, and the required equipment, to provide evidence of product conformity

definition: term used to describe the work that the organization goes through to develop, manufacture, and deliver the finished goods or services. -planning processes -customer related processes -design and develop -purchase -control of measuring and monitoring equipment -plan the process needed for product realization -determine the customer/other requirements related to product -go through the many steps of designing and developing the product in order for it to be fully ready -make sure product contains proper info and meets requirements for purchasing -control the production and supply of the service - determine ways of monitoring/measurement to provide evidence of product conformity

• GENERAL: plan and implement monitoring, measurement, analysis, and improvement processes -monitor necessary information to make sure organization is meeting requirements on all levels -control all non-conforming products from further advancement -analyze data to help better understand the current standing of the QMS system and make improvements from this information -monitoring and measurement -control of nonconforming product -analysis of data -improvement

• CUSTOMER FOCUS: -needs and expectations of the customer must be met every time if the organization as a whole is going to meet the needs of the external customer. -concept requires a collection and analysis of customer requirements that must be understood and met. • PROCESS IMPROVEMENT: -work is a series of interrelated steps that result in an output. -Continuous attention to each of these steps in the work process is necessary to reduce variability. -Reduce variability of the output to improve the reliability of the output • TOTAL INVOLVEMENT: -need active leadership of senior management and the efforts of all employees in an organization to gain a competitive advantage in the marketplace. -Employees at all levels are capable of improving their outputs by coming together

CUSTOMER FOCUS: • LEADERSHIP: role of senior managers as advocates, teachers, and leaders • EDUCATION AND TRAINING: quality is based on the skills of every employee and his or her understanding of what is required PROCESS IMPROVEMENT: • SUPPORTIVE STRUCTURE: senior managers may require support to bring about the change necessary to implement a quality strategy • REWARD AND RECOGNITION: teams and individuals who successfully apply the quality process must be recognized and possibly rewarded TOTAL INVOLVEMENT: • COMMUNICATIONS: communications in a quality environment may need to be addressed differently in order to communicate to all employees a sincere commitment to change. • MEASUREMENT: the use of data becomes paramount in installing a quality management process.

• WORK PROCESS: integration of people, materials, methods and machines to product value-added outputs for customers. A process converts measurable inputs into measurable outputs through an organized sequence of steps. • PARTICIPANTS: o customers o work group o supplier o owner FLOWS OF INFORMATION (see image): 1. Flow of customer requirements to define characteristics of required output 2. Work group integrates materials, equipment, methods, and people to produce these outputs 3. Customer satisfaction forms feedback loop that drives corrective action to improve performance 4. Same thing for suppliers, work group gives feedback to improve performance

• PROCESS MEASURES: define activities, variables, and operations of the work process itself o help to predict the characteristics of the outputs before they delivered to customers. • OUTPUT MEASURES: define specific features, values, characteristics, and attributes of each product or service. o Voice of the customer and voice of the process • OUTCOME MEASURES: define the ultimate impact of the process in the cusomer and dependent on what the customer does with the product or service.

-Outcome: customer satisfaction -Output: characteristics desired by customers, characteristics delivered by process -Process: performance

• LEVEL 1: BASE EXPECTATIONS: minimum performance levels that are always assumed to be present. If missing, customer will be dissatisfied. • LEVEL 2: SPECIFICATIONS/REQUIREMENTS: visible characteristics to the customer that are actively involved in their selection process. Options and trade-offs available for selection by the customer. • LEVEL 3: DELIGHT: value-added features and characteristics that customers did not expect but are delighted to receive (described as delivering all the explicit requirements as well as the latent ones).

• LEVEL 1 (low): REACTIVE MODE: only reveals a minimal understanding of customers' expectations. Approach: gather complaints. Issue: customers fail to complain for a number of reasons, not giving proper feedback. o EXAMPLES: unsolicited, complaints • LEVEL 2 (middle): APPROACH: approaches that communicate with customers by listening to their expectations as their secondary objective (primary being answering questions and selling products). Issue: ability to capture customers' views is compromised b/c the mechanisms are designed mainly to satisfy their primary objective o EXAMPLES: service desk, networks, hotline, sales data analysis, unstructured surveys, customer reps • LEVEL 3 (highest): PROACTIVE: full understanding of customers' expectations can be attained through the use of mechanisms specifically designed to extract information. o EXAMPLES: personal interviews, focus groups, designed surveys.

level 1: -minimal understanding of customers' expectations -gathering complaints -i.e. unsolicited complaints level 2: -higher level of understanding by initiating active approaches to listen to customers -answering customers' questions or selling more/new products -i.e. service desk, hotline, network, unstructured surveys level 3: -fully understanding customers' expectations -use mechanisms specifically designed to extract info -i.e. personal interviews, designed surveys, focus groups, benchmarks, mystery shopper