QUALITY MGT SYSTEM

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1) List the documents, used in QMS? a) Statements of Quality Policy and Quality Objective b) Quality manual-providing consistent information about the organisation¶s QMS c) Quality plans-providing description as to how QMS is applied to specific product, project or contract. d) Specifications²state requirements d) Guidelines²recommendations or suggestions e) Documents needed by the organization, to ensure effective and consistent activities and control of its processes, and f) Records to provide objective evidence of activities performed or results achieved.

2) What is meant by Quality Manual? The Quality manual contains: a) the scope of the QMS, including details of and justification for any exclusions. b) the documented procedures established for the QMS, or reference to them, and c) a description of the interaction between the processes of the QMS

3). Define µaudit¶ It is a systematic, independent and documented process, for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.

4) Write briefly on the two types of audit system. (1) Internal audit: This is also called first-party audit. This is conducted by, or on behalf of, the organization itself for internal purposes and can form the basis for an organisation¶s self-declaration of conformity. (2) External audit: a) This is also called second or third party audit. The second party audits are conducted by parties having an interest in the organization, such as customers, or by other persons on their behalf. b) The third party audits are conducted by external independent organisations, to provide certification or registration of conformity with requirements, such as those of ISO 9001:2000 and ISO 14001:1996

5) What are the benefits of QMS? a) Improvement in internal quality (reduction in scrap, rework and non-conformities in the shop)

Checking and Management review. 11) Define µenvironmental aspect¶. Bureau Veritas Quality International. rework etc) 6) Name some certifying agencies for ISO standards in India? Det Norske Veritas. claims of non-conforming products. It includes land.b) Improvement in external quality (customer satisfaction. space. Bureau of Indian Standards. returned products. QMS EMS 1) Focus on customer 1) Focus on the society 2) Process evaluation 2) Organisation evaluation and product evaluation 9) Define µenvironment¶. KVQA etc ENVIRONMENT MGT SYSTEM: 7) Name the elements in ISO 9001 that are similar to ISO 14001. It is defined as global surroundings where the organisation operates. either wholly or partially affecting the environment. Implementation. percentage down time etc) d) Improvement in Time performance (on-time delivery. warranty claims. water. American Quality Assessors (India). time to market etc) e) Reduction in the cost of poor quality (external non-conformities. 10) Define environmental impact. human being and their interactions.. air. Any change in the organisation activity. TUV Suddeutschland India. . scrap. NQA. Planning. penalty claims etc) c) Improvement in Production reliability (number of break downs. 8) List two differences between the QMS and EMS.

The application of system of processes within the organization. but also to enchant them. b) Leadership: Top management should establish unity of purpose and direction of the organization. understanding and managing inter-related processes as a system. facts. 12) Define µenvironmental objective¶. c) Involvement of people: Their abilities are used for the benefit of organization d) Process approach: The desired result is achieved efficiently when activities and related resources are managed as a process e) System approach to management: Identifying. that any organization desires to achieve. is referred to as µprocess approach¶ 16) Define µa product¶. It is the environmental goal (which is quantified). f) Continual improvement means continual actions g) Factual approach to decision making: Effective decisions are based on the analysis of data. (1) The result of a set of interrelated or interacting activities . 15) Define µprocess approach¶. wherein people become fully involved in achieving the objectives. which is practically possible. the identification and interactions of these processes and their management. They should create and maintain the internal environment. helps in organisation¶s effectiveness and efficiency in realizing its objectives. is a process.The organizational activities. and information h) Mutually beneficial supplier relationship. 13) List the basic principles of quality management and explain briefly on each of these. a) Customer focus: Organisation should understand the current needs and future expectations. 14) Define µprocess¶ An activity (or a set of inter-related or interacting activities) using resources and managed to transform inputs to outputs. This enhances the ability to create value for both. and services interacting with the environment. should meet the customer requirements and strive not only to delight them. products.

. 21) Define µquality objectives¶. lubricant) (3) Product can also mean µservice¶. The part of quality management focused on setting objectives and specifying necessary operational processes and resources to realise the objectives 23) Define µcontinual improvement¶. management reviews etc and generally lead to corrective actions and preventive actions. dictionary) c) hardware (e. It is the recurring activity to increase the ability to fulfill the requirements. This is achieved by continual process through the use of audit findings. Coordinated activities to direct and control an organization. It consists of statement or target aimed and related to quality. It provides a frame work for establishing and reviewing quality objectives. with regard to Quality. There are four generic product categories: a) services (e. It is the manipulation (utilization. in quantitative (measurable) terms. conclusions. including non-utilisation) of the available resources to achieve the desired objectives. analysis of data. It is the customer¶s perception of degree to which one¶s requirements have been fulfilled 18) Define µmanagement¶. tyre. 19) Define µquality management system¶.g. 20) Define µquality policy¶ It consists of overall intentions and directions of an organization related to quality. The objectives need to be consistent with the quality policy and commitment to continual improvement.(2) The result of a process. normally and formally expressed by top management. tube) d) processed material (e. as per ISO 9001:2000 17) Define µcustomer satisfaction¶. 22) Define µquality planning¶.g.g. It is a system to direct and control an organization. transport) b) software (e.g.

a defect means nonfulfillment of a requirement related to an intended or specified use. It is taken before the occurrence and to prevent occurrence. It is taken to prevent recurrence. Rework or re-grade is the example for correction. 25) Differentiate between µeffectiveness¶ and µefficiency¶. Corrective action is an action to eliminate the cause of a detected non-conformity or other undesirable situation. But Correction is an action to eliminate the detected non-conformity. 28) Distinguish between µcorrective action¶ and µpreventive action¶. Non-conformity means non-fulfillment of a requirement. Corrective action is the action taken to eliminate the cause of a detected non-conformity. But efficiency is the ratio of the results achieved (output) to the resources used (input) 26) Distinguish between a non-conformity and a defect.24) Define µan organization¶. whereas. But Preventive action is the action taken to eliminate the cause of a potential non-conformity or other undesirable potential situation. It is taken to prevent recurrence. related to organisation¶s product / service (2) Employees and (3) Owners / Investors? (1) Customer and end user: a) Conformity b) Dependability c) Availability d) Delivery e) Price and life cycle costs f) Product safety g) Product liability h) Environmental impact . It is a group of people and infrastructure facilities with specified authorities. Effectiveness is the extent to which planned activities are realized and planned results are achieved. responsibilities and interrelationships. 29) What are the contents of a µquality manual¶? a) the scope of QMS b) documented procedures established for QMS and c) description of the interaction between the processes of the QMS 30) Name a few needs and expectations of (1) Customer and end user. 27) Distinguish between µcorrective action¶ and µcorrection¶.

because the process involves only copying and adapting. Hence the critical objectives have to be constantly innovated. Innovation or creative e ideas converted into actions and results.(2) Employees: a) Recognition. 31) What are the three Ds referred to in QMS? Declare what are going to Do. 4) Define the µvoice of the customer¶ The needs and the expectations of the customer are called the voice of the customer. helps in assuring the quality of the product/service d) This identifies the strengths and weakness of one¶s product or service with competitors e) It helps the organization to build marketing strategies f) This is time and cost efficient. Do as you have Declared. 5) What is the role of QFD? QFD translates the customer¶s needs and expectations (voice of the customer) into the Technical characteristics and then the Design specifications (voice of the engineer) 6) What is the pre-requisite to QFD? . It is also called µquantum jump¶. 2) What are the limitations of bench marking? a) The target always keeps changing. and Document all actions and results Bench Marking: 1) What are the advantages of bench marking? a) It inspires the organization to compete with others b) It inspires the people to compete and achieve the goals c) Bench marking testing procedures. b) Bench marking will not be effective. if it is focused on processes with no opportunity for improvements. µbreak through¶ performance. b) work satisfaction and c) personal development (3) Owners/Investors: Financial and other results. to overcome technology barriers. 3) Define.

7) Write briefly on the house of quality. reduced market share. relationship matrix between What? and How? at the center (hall) of the house. For the house of quality: the left side indicates the voice of the customer (WHAT). producer¶s loss and also environmental pollution. The loss function is proportional to the square of the deviation of the performance characteristic from the target value. where our products stand.Market Research is the pre-requisite. According to Taguchi. Based on the customer¶s perception. to understand the customer¶s needs and expectations. and matches against how an organization will meet those requirements. meets the specified target values. loss of good-will due to unsatisfactory performance. 9) What is meant by customer competitive assessment? This part of the study is added to the right side of the relationship matrix. 11) Define µsignal¶. This is an effective management tool. and thus accommodates five areas for design. roof of the house indicating the interrelationship between the technical characteristics. ceiling of the house indicates how each desires of the customer can be achieved (HOW). the gap between our product and the competitor¶s product is identified by appropriate ranking. imparted to the society. the quality is the loss. this comparison tells us. caused by . if all the customer requirements are met and to identify the areas for improvement in the design. For each technical characteristic. It is done to check. TAGUCHI LOSS FUNCTION: 10) Define µloss function¶. Prioritised customers voice and Planning matrix on the right exterior side. The three types of noise are: a) External noise. The desired part of the performance is called µthe signal¶ 12) Define µnoise¶ and its types. The undesirable part of the performance is called µthe noise¶. The societal loss includes the failure to meet the customer requirements. which uses the voice of the customer to drive design process. 8) What is meant by technical competitive assessment? This part of study is added beneath the relationship matrix. after the product is transported from the shop. effected by the environment b) Internal or Deterioration noise.

which involves every level and function in the organisation from top management to the shop floor employees. waste.e. involvement of operators. It is a team based productive maintenance. . over burden or strain 3. monitoring and diagnosing the failures before they occur.e.. Predictive or diagnostic maintenance means the usage of sensors. difference between the individual parts that are produced to the same specifications 13) Define µrobust design¶. Another definition is: It is the design of a product. MURI or Muscling. i. 17) Define preventive maintenance. the System design. which involves the cost reduction and performance improvement. TPM combines preventive maintenance. i. It is a planned maintenance and hence does not affect the manufacturing or service of the equipment. MURA or Murkiness. without removing the causes of variation and c) Tertiary. MUDA or Muddling. fatigue. The inspections are carried out and the selected parts are replaced periodically as preventive measure. the Tolerance design. which is insensitive to the disturbances.. which considers the customer¶s requirements.e. 15) Name the three Ms for effective TPM. i. cut or minimize the waste 2. and appropriate training to the operators. and the prototype is developed using technology principles b) Secondary. Taguchi defined design for quality. in three levels as follows: a) Primary.e. which may occur due to controlled or uncontrolled factors. Instability or discrepancy 16) Define predictive maintenance.. This eliminates unplanned maintenance and ensures maximum equipment / plant effectiveness. Avoid 1. which concentrates on eliminating or reducing the variation by controlling the causes. TOTAL RPODUCTIVE MAINTENANCE: 14) Define TPM. i. and also elimination of the damage to the mating parts as a consequential effect. It facilitates identification of bad performing parts and their removal or replacement. the Parametric design.usage or non-usage or storage c) Unit to unit noise.

18) Define breakdown maintenance. incurred by the purchaser. It is also defined as the probability that a machine or equipment. and Rate of quality. will operate satisfactorily. It is the principle and practice of design and installation of the equipment that needs little or no maintenance. Normally the target is 90% for the Overall equipment effectiveness. It is the ratio of the theoretical cycle time to the operating time per unit 23) Define µrate of quality¶. 20) Define µmaintenance prevention¶. 21) Define µavailability¶ in maintenance. Performance efficiency. to avoid sudden failure thereafter. Equipment effectiveness is the product of Availability. It is the ratio of the time a machine is actually available to the total time it should be available for use. at any time. and 80% for the Overall plant effectiveness 26) Define Autonomous work groups. throughout its full life cycle. 24) Define Life cycle cost. the yield. This is sometimes called. For example the electric bulbs are replaced after they fuse. in maintenance . It is the total cost of acquisition and ownership of the product / service. Repair or maintenance is done only after the failure occurs. It is the ratio of the number of parts accepted to the total number of products produced. 22) Define performance efficiency. Maintenance of equipment is done at specified time intervals and the parts are replaced if found necessary. 19) Define periodic maintenance. This is permitted when equipment failure is not significant. 25) Define equipment effectiveness. when used under stated conditions in an actual / ideal environment.

This team is authorised to make decisions to keep the machine fit for production. while in use. and includes the testing of the products to ensure their safety. 30) Define RPN. and also the set-up. This helps one in establishing control or reducing the occurrence and in easy detection. focusing on global system functions. focusing on manufacturing and assembly process. Process FMEA. focusing on software function Another way of classification: Design FMEA and Process FME 28) What is meant by µdesign FMEA¶? The design FMEA. and is viewed as a relative measure of the design risk. It is a measure of priority on the failure modes. focusing on service function. 29) What is meant by µprocess FMEA¶? The process FMEA consists of: Identification of potential failure modes and ranking them according their severity and frequency. focusing on components and sub-systems. trouble shooting of problems.It is a team consisting of operators and maintenance crew. as per the customer requirements. and Software FMEA. keeping these design characteristics out of the system or minimising their resulting effects. 31) What is meant by potential failure mode? . and the difficulty in detection. Probability of occurrence. Its value is obtained as the product of Severity. Service FMEA. consists of: Identification and anticipation of the failure modes. ranking them according to their severity on the product performance. Design FMEA. FAILURE MODE AND EFFECT ANALYSIS 27) List different types of FMEA? One way of classification: System FMEA. These groups are usually trained by skilled maintenance personnel in Minor maintenance works.

It is the probability that one of the specific causes will occur. (can not detect is ranked 10 to almost certain to detect is ranked 1) .A potential failure mode is defined as the mode of failure wherein the component or subsystem or system or process could potentially fail to meet the intent of the design or function 32) What is meant by the potential effect of failure? It is defined as how a customer perceives the failure. is said to be the potential effect of failure. The failure effect may include injury or impairment to the user or degraded environment or damaged equipment or erratic operation or degraded performance or poor appearance. 34) Define µdetection¶. 33) Define µoccurrence¶. It is the difficulty with which the design control or process control can prevent or detect each of the failure modes. The effect of failure. whose mode scores highest RPN.

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