TOTAL QUALITY MANAGEMENT Answers for question bank

2 MARKS 1. Give the seven basic steps to get an organization towards TPM? Management learns the new philosophy Management promotes the new philosophy Training is funded and developed for everyone in the organisation Areas of needed improvement are identified Performance goals are formulated An implementation plan is developed Autonomous work groups are established

2. What are the Goals of TPM? Maintaining and improving equipment capacity Maintaining equipment for life Using support from all areas of the operation Encouraging input from all employees Using teams for continuous improvement

3. What are the Major loss area in TPM? Planned Unplanned downtime Idling and minor stoppages Slow down Process nonconformities

4. What are the phases of QFD?

5. Define TPM? TOTAL PRODUCTIVE MAINTENANCE-A manufacturing method that increase production and reduces Waste through continuos attention to the condition of machines and processes 6. Give the iso 9000 series of standards? ISO 9000 Fundamentals and Vocabulary: this introduces the user to the concepts behind the management systems and specifies the terminology used. ISO 9001 Requirements: this sets out the criteria you will need to meet if you wish to operate in accordance with the standard and gain certification. ISO 9004 Guidelines for performance improvement: based upon the eight quality management principles, these are designed to be used by senior management as a framework to guide their organizations towards improved performance by considering the needs of all interested parties, not just customers. 7. What is the need for iso 9000? Purchasers require their supplier to hold ISO certification Several stakeholders benefits Financial benefits for organisation

8. Give the objectives of internal audits? Internal audit is an independent appraisal function established by the management of an organization for the review of the internal control system as a service to the

organization. It objectively examines, evaluates and reports on the adequacy of internal control as a contribution to the proper, economic and effective use of resources. 9. What are the requirements of ISO 14000? a. b. c. d. e. Review Requirements Checking Requirements Operational Requirements Systemic Requirements Policy Requirements

10. What are the benefits of ISO 14000 in global and organizational level? The benefits of acquiring ISO certification go beyond the satisfaction of doing a good deed. Adhering to the standard may result in better conformance to environmental regulations, greater marketability, better use of resources, higher quality goods and services, increased levels of safety, improved image and increased profits.

8 MARKS 1. Why is ISO 9000 important? The importance of ISO 9000 is the importance of quality. Many companies offer products and services, but it is those companies who put out the best products and services efficiently that succeed. With ISO 9000, an organization can identify the root of the problem, and therefore find a solution. By improving efficiency, profit can be maximized. As a broad range of companies implement the ISO 9000 standards, a supply chain with integrity is created. Each company that participates in the process of developing, manufacturing, and marketing a product knows that it is part of an internationally known, reliable system. Not only do businesses recognize the importance of the ISO 9000, but also the customer realizes the importance of quality. And because the consumer is most important to a company, ISO 9000 makes the customer its focus. A good foundation builds a good business, and ISO 9000 is a good foundation for small businesses that want to expand their market. By introducing a quality management system like ISO 9000 to a small business, the quality of processes will increase and costs due to inefficiency will decrease. In addition, a small business will be able to advertise their use of the internationally recognized ISO 9000. This may create business

opportunities that were not available before an objectively verified quality management system was in place. Having management systems in place, such as ISO 9000, will also help when selling a business. The integrity and value of a small business will be apparent with welldocumented processes and proof of quality. ISO 9000 will ensure the reputation of your business in any situation.

2. Explain the steps that are necessary to implement the quality management systems? 1. Clarify Vision, Mission and Values Employees need to know how what they do is tied to organizational strategy and objectives which makes it important that all employees understand where the organization is headed (its vision), what it hopes to accomplish (mission) and the operational principles (values) that will steer its priorities and decision making. Having a process to educate employees during new employee orientation and a communication process to help ensure that the mission, vision and values is always in front of the people is a major first step. 2. Identify Critical Success Factors (CSF) Critical success factors help an organization focus on those things that help it meet objectives and move a little closer to achieving its mission. These performance based measures provide a gauge for determining how well the organization is meeting objectives. 3. Develop Measures and Metrics to Track CSF Data Once critical success factors are identified, there needs to be measurements put in place to monitor and track progress. This can be done through a reporting process that is used to collect specified data and share information with senior leaders. For example, if a goal is to increasecustomer satisfaction survey scores, there should be a goal and a measure to demonstrate achievement of the goal.

4. Identify Key Customer Group Every organization has customers and understanding who the key customer groups are is important so that products and services can be developed based on customer requirements. The mistake a lot of organizations make is not acknowledging employees as a key customer group. 5. Solicit Customer Feedback The only way for an organization to know how well they are meeting customer requirements is by simply asking the question. There should be a structured process to solicit feedback from each customer group in an effort to identify what is important to them. Organizations often make the mistake of thinking they know what is important to customers and ask the wrong survey questions. This this type of feedback is obtained through customer focus groups. 6. Develop Survey Tool Next develop a customer satisfaction survey tool that is based on finding out what is important to customers. For example, customers might care more about quality than cost but if you are developing a product and trying to keep the cost down and skimping on the quality, you are creating a product that might not meet the needs of the customer. 7. Survey Each Customer Group Each customer group should have a survey customized to their particular requirements and they should be surveyed to establish baseline data on the customers perception of current practice. This provides a starting point for improvements and demonstrates progress as improvement plans are implemented. 8. Develop Improvement Plan Once the baseline is established you should develop an improvement plan based on customer feedback from each group. Improvement plans should be written in SMART goals format with assignments to specific staff for follow through. 9. Resurvey After a period of time (12-18 months), resurvey key customers to see if scores have improved. Customer needs and expectations change over time so being in-tune to changing needs and expectations is critical to long-term success.

10. Monitor CSF It is important to monitor CSF monthly to ensure there is consistent progress toward goals. This also allows for course correction should priorities and objectives change during the review period. 11. Incorporate Satisfaction Data into Marketing Plans Once youve achieved some positive results with your satisfaction data, use it as a marketing tool! A lot of successful organizations miss the boat by not letting others know what they do well. Customers want to know how an organizations internal processes work especially if those process help to deliver an outstanding product or service! 12. Technology Make sure technology is user-friendly and supports targeted improvements. For example, a website should be easy to navigate as well as easy to find (SEO) the the content should be easy to understand.

3. Explain house of quality in QFD? House of Quality is a diagram, resembling a house used for defining the relationship between customer desires and the firm/product capabilities. It is a part of the Quality Function Deployment (QFD) and it utilizes a planning matrix to relate what the customer wants to how a firm (that produces the products) is going to meet those wants. It looks like a House with a "correlation matrix" as its roof, customer wants versus product features as the main part, competitor evaluation as the porch etc. It is based on "the belief that products should be designed to reflect customers' desires and tastes". It also is reported to increase cross functional integration within organizations using it, especially between marketing, engineering and manufacturing. The basic structure is a table with "Whats" as the labels on the left and "Hows" across the top. The roof is a diagonal matrix of "Hows vs. Hows" and the body of the house is a matrix of "Whats vs. Hows". Both of these matrices are filled with indicators of whether the interaction of the specific item is a strong positive, a strong negative, or somewhere in between. Additional annexes on the right side and bottom hold the "Whys" (market

research, etc.) and the "How Muches". Rankings based on the Whys and the correlations can be used to calculate priorities for the Hows. House of Quality analysis can also be cascaded, with "Hows" from one level becoming the "Whats" of a lower level; as this progress the decisions get closer to the engineering/manufacturing details.

4. Explain quality auditing? Quality audit is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team. It is an important part of organization's quality management system and is a key element in the ISO quality system standard, ISO 9001. Quality audits are typically performed at predefined time intervals and ensure that the institution has clearly defined internal system monitoring procedures linked to effective action. This can help determine if the organization complies with the defined quality system processes and can involve procedural or results-based assessment criteria. With the upgrade of the ISO9000 series of standards from the 1994 to 2008 series, the focus of the audits has shifted from purely procedural adherence towards measurement of the actual effectiveness of the Quality Management System (QMS) and the results that have been achieved through the implementation of a QMS. Audits are an essential management tool to be used for verifying objective evidence of processes, to assess how successfully processes have been implemented, for judging the effectiveness of achieving any defined target levels, to provide evidence concerning reduction and elimination of problem areas. For the benefit of the organization, quality auditing should not only report non-conformances and corrective actions, but also highlight areas of good practice. In this way other departments may share information and amend their working practices as a result, also contributing to continual improvement. Quality audits can be an integral part of compliance or regulatory requirements. One example is the US Food and Drug Administration, which requires quality auditing to be performed as part of its Quality System Regulation (QSR) for medical devices (Title 21 of the US Code of Federal Regulations part 820).

16 MARKS 1. Explain the seven elements for the implementations & operations of ISO 14001? Get the quality manager in place. He will:-co-ordinate the implementation program which will comprise arange of projects managed by the individual sections within the organisation; -cajole and persuade middle managers to set realistic timescales for completing their bits of the QMS, and badger them until they have met the requirements of the QMS; -ensure, through a team of internal auditors, that each component of the QMS meets the required standards; -report progress, costs and issues to top management. His personal objective should be to work himself out of a job as quickly as possible. Once the QMS is running, however imperfectly, responsibility should be reflected in the personal objectives of management at all levels. Plan the implementation The organisation will be looking for quick gains i.e. where the procedures are already in place, and either there is already some monitoring of non-conformance or it will be easy to introduce.Ordnance Survey chose the Map Printing section, and was able to quickly develop a comprehensive QMS for that section with little additional work. This gave OS confidence in the process. For each area, work through what is required scope; promotion; training; participation; documentation; review and revision. Analyse the existing processes: Top down: senior management will outline the main business processes production; supply; distribution; marketing. Bottom up: team leaders and production units will identify their processes and relate them to the top down analysis. Define the main processes what comes in, what do we do, what Identify improvement sources Get staff to identify where they think processes can be improved, particularly for when things go wrong. Involve existing quality control staff where appropriate. Congratulations, you are holding your first quality improvement circle. Record the findings, find out how the improvements can be done (may effect other areas) and initiate changes. They may take some time, so in the meantime record what happens now. This can be a checklist for recording the activity, and a template for recording non-conformance, actions taken to remove non-conformance, and actions taken to prevent non-conformance. Manage the QMS itself

A QMS tends to create its own documentation industry. This is bad for moral, and the QMS will quickly lose credibility. The analysis will not be perfect, some documentation will be unnecessary and other items will quickly become out-of-date. Remove these quickly review documents periodically, starting with the assumption it is not required. If its existence is justified, review the scope, content and clarity. If its taking too long to review and revise, its probably implying the process its describing can be improved. If documents are too prescriptive, change the philosophy, emphasising competence and empowerment rather than detailed routines. Ensure those who have to use the procedure are involved in its definition and review that they own it. If staff are completing templates because the QMS says so, change it (the recent problems at the Sellafield nuclear reprocessing plant are an example of this symptom of poor management).

11 Documentation Document control is typically the most challenging aspect of ISO 9000 compliance. Starting with a simple, versatile structure provides the best opportunity to organize documentation and effectively orient the workforce. ISO 9000 contains rules and methods that an operating quality management system should consider. The standard defines what has to be done. It is part of the organisations role, to prove how specific requirements are fulfilled. Choose a process-mapping approach The description of the processes can follow a top-down approach from the top management. In a top-down approach, the main processes are first identified, and then broken down in sub-processes and finally procedures describing the activities of the daily work. Alternatively, a bottom-up approach can be used. This approach starts with a floorsurvey among all categories of employees, asking them in interviews about their daily work. All activities taking 5-40 % in time are recorded and quantified. Activities taking more than 40 % should be sub-divided. The activities are then connected to workflows, and combined into procedures and processes. The top-down approach must be based on the top managements view of the business and its processes. This view is not always a true description, and for large organisations such as NMAs almost certainly not a complete view. The advantage of the bottom-up approach are all on-going work of any significance will be detected; - employees can be asked how much time they put into each activity and thereby distribute manpower costs to those; - they can also be asked to estimate time loss due to muddle and thereby locate candidate procedures for improvements; As the top managements view of the companys business must anyway characterise the final process map, a combined approach is ideal. The recorded activities

from the floor-survey are combined and positioned in the overview process map coming from the management.

2. Explain the steps necessary to implement the Quality Management system? Step 1: Commitment from Top Management The top management of an organisation should be determined and committed to implement aquality management system. No quality initiative within an organisation can succeed without commitment from top management. Top management can demonstrate to their clients that the organisation is committed to quality through the certification and registration of the ISO 9000 standard. Top management should thus come to the realization that overall business efficiency would be improved by means of a quality management system. Step 2: Establishing an Implementation Team People are responsible for the implementation of ISO 9000. An implementation team, headed by a Service Provider and a Management Representative (MR), is to be established. The Service Provider and MR is the coordinator and is responsible for planning and overseeing the implementation of the quality management system. He is thus the link between top management and the ISO 9000 registrar. All departments within the organisation should be represented on the implementation team. Step 3: Conducting ISO 9000 Awareness Programs Conducting ISO 9000 awareness programs will inform all employees about the aim of a quality management system. These include the advantages offered to customers and employees, their respective responsibilities and roles within the system, and how the quality management system operates. The benefits that an organisation hopes to realize through aquality management system implementation should be emphasized through ISO 9000awareness programs. Step 4: Providing Training All personnel and all areas in an organisation are affected by a quality management system. Training regarding the quality management system should thus be provided for all employees. The quality management system implementation plan should make provision for this training. All basic concepts of quality management systems and its impact on the organisation should be covered.

Step 5: Conducting an Initial Status Survey A quality management system conforming to the ISO 9000 standard should be created. However, this does not preclude incorporating, adapting, or adding onto quality programs that already exists. Thus, this step basically involves comparing an organizations existing quality management system (if there is one) with the requirements of ISO 9001:2008. Step 6: Creating a Documented Implementation Plan Once an organizations quality management system has been compared with the ISO 9001:2008 standard, a documented implementation plan is used to address any nonconformances. The documented implementation plan identifies and describes processes in order to make the organizations current quality management system in full compliance with the ISO 9000 standard. Step 7: Developing a Quality Management System Documentation Documentation is an area where non-conformance regarding quality management systemsare very common. In order to avoid these non-conformities, documentation of a quality management system should include the following:

Documented statements of a quality policy and quality objectives; A quality manual; Documented procedures and records required by the standard of ISO 9001:2008; and Documents needed to ensure effective planning, operation and control of its processes.

Step 8: Control of Documents In order to control quality management system documentation, a documented system should be created. The creation, approval, distribution, revision, storage, and disposal of various types of documentation are thus managed. Document control systems should be as easy and simple to operate as possible. However, it should still be sufficient enough to meet the requirements of ISO 9001:2008. Step 9: Implementation In large organizations, it is best to implement the quality management system being documented as the documentation is developed. This is in stark contrast to smaller organizations, where the quality management system is implemented throughout the

organisation all at once. During phased implementation, however, an evaluation can take place regarding the effectiveness of the system in different areas. Through management review and an internal quality audit, the implementation progress is monitored to ensure that the quality management system is effective and thus conforms to the IS0 9000 standard Step 10: Internal Quality Audit The effectiveness of the installed system should be checked regularly by means of an internal quality audit. Below are some reasons for conducting an internal quality audit into a quality management system:

To ensure that the quality management system conforms to the quality management system requirements established by your organization, as well as to the requirements of the ISO 9001:2008 standard; and To ensure that the quality management system is implemented and maintained in an effective manner

Step 11: Reviewing by Management A management review should be conducted three to six months after quality management system implementation took place. The reasons for conducting management reviews are to ensure continuous effectiveness, adequacy, and suitability of the quality management system. Step 12: Pre-assessment Audit Before applying for certification, a pre-assessment audit usually takes place. Certification bodies provide a qualified but independent auditor to conduct this service. Some degree of confidence is gained before application for certification if the pre-assessment audit goes well Step 13: Certification and Registration A formal application for certification is made at a certification body as soon as the quality management system has been operating for a few months and has stabilized. An audit of the documents (known as an adequacy audit) is first carried out, and if it conforms to the requirements of the quality standard, it is followed by an on-site audit. A certificate is only awarded to the organisation if the certification body is satisfied with the workings of the system. However, the certificate is valid for a period of three years only, after which the certification body will carry out periodic surveillance audits.

Step 14: Continual Improvement Although an organisation gained certification, it is important to note that it has to try and improve the suitability and effectiveness of the quality management system on a continuous basis.

3. Explain the implementation and documentation of quality systems? Implementation of Quality System The work involved in establishing and implementing a Quality System e.g. ISO 9001 or 9002 should not be underestimated. It is a very demanding project both in terms of manhours and of resources. Proper planning including well defined project organisation and very often with assistance from outside consultants is a necessity for a successful result. Further, full commitment and motivation as well as intensive training of all employees are indispensable requirements. Figure 5.5 illustrate the various activities involved as well as a time schedule for a smaller company. To initiate the project and as responsible for its completion, a Quality Management Group will normally be formed. For food industries this Group may comprise the following persons: Managing Director, Technical Director, R & D Manager, Sales Manager and Head of Laboratory. The key functions of the Group can be summarized as follows:

Definition of quality policy and objectives. Definition of responsibilities. Decision on time schedule for the project from start to certification. Allocation of resources required. Information and motivation of all staff members. Training of all employees. Follow-up on time schedules. Resolving differences of opinions, argumenting etc.

The various phases and activities following the formation of the Quality Management Group are shown in Table 5.21 and Figure 5.5 which almost speak for themselves. The time required i.e. about 12 years or more, for the implementation and certification of the system in a medium size company, should be noticed.

Phases of a quality system approach.

1. 2. 3. 4.

Formation of a quality management group Hazard Analysis Audit of present system elements Estimation of resources and total period of time required for the project including certification 5. Formation of project organisation 6. Preparation of Quality Manual (level 1) 7. Training of all staff members 8. Definition of procedures and instructions (levels 2 and 3) to be included in departmental manuals i.e. table of contents 9. Decision on time schedule for preparation of departmental manuals 10. Establishment of working groups for the preparation of the individual procedures and instructions 11. Commenting, reviewing, approving and issuing procedures and instructions 12. Implementation of procedures and instructions 13. First approach to certifying body 14. Internal auditing 15. Corrections, adjustments etc. 16. Further training of staff 17. Certification

Time schedule for establishing and implementing a quality system in a small size food processing plant.

Documentation is a vital part of the system, and so is Document Control. This control shall ensure that all necessary documents are available where needed and obsolete documents promptly removed from all locations. It is a key point of ISO 9000 that Purchasing only takes place from approved suppliers which have been selected on the basis of previous performance and an effective control system as well as their ability to meet the specified requirements. When applying the HACCP concept for the Salmonella in farmed frozen shrimp, it means that feed for the farm should only be purchased from feed mills producing feeds which do not contain Salmonella according to the specifications agreed upon. The standard reaches even further in demanding mutual cooperation and a contractual understanding with the feed mill; the mill shall be assessed to be included in the list of approved suppliers established according to ISO 9000 requirements. The feed mill shall be audited just like all other suppliers on the list, and purchased products shall be inspected on receipt, and feed-back on performance at all points shall be ensured. The very obvious reasons for these detailed requirements for purchasing obviously will be the inevitable effect of raw materials, machines, cleaning agents, services, etc. on the quality of the final product. The documented quality system Level 1 is described in the Quality Manual. It is normally a short easy-to-read manual briefly stating the company's quality objectives and policies. All requirements of the appropriate ISO Standard will be addressed. The Quality Manual need not contain confidential information, and it is intended to be handed out to potential customers and others, to inspire confidence in the company being able to satisfy customers' expectations.

Figure5.4. Typical structure of the Quality System.

4. Explain the Requirements for ISO 14000? The ISO 14000 is a family of standards the International Organization for Standardization (ISO) designed for environmental management systems (EMS). ISO 14001 is the management tool to help organizations control the environmental impacts of their activities, implement a system of developing environmental objects and manage continuous improvement towards those objectives. ISO 14004 gives organizations guidelines on key elements of an EMS. Following is a summary of the basic requirements for ISO 14000. Systemic Requirements The organization must establish an EMS which is compliant with the ISO 14001 2004 standard. The EMS must be implemented, maintained, continuously improved and fully documented. Policy Requirements The organization must define and document, implement, maintain and communicate its environmental policy. It must put procedures in place to identify and explain legal requirements applicable to the EMS. The organization must also have environmental goals, documenting how its policies and procedures are reaching and maintaining those goals. Operational Requirements Organizations need to allocate resources towards establishing the EMS, then implementing, maintaining and improving the EMS. It must assign at least one management representative to the EMS. The organization must define, document and communicate roles of all management involved with the EMS, along with their authorities and responsibilities. Training and awareness programs must be in place to ensure competency in any role that could have a significant impact on the environment. The organization must document its environmental policy, objectives, and targets, as well as the structure and scope of its EMS. The organization must have active, documented procedures in place to communicate EMS policies within the organization and externally, as well as a way to control communication documents. The organization must identify operations, goods and services that are environmentally significant and have procedures to manage and control them. A tested emergency management process must identify potential accidents and emergency situations, determine how to best prevent them and direct how to respond to them should they occur to reduce any environmental consequences. Checking Requirements

The organization must have procedures to monitor and measure operations that may have significant environmental consequences. It must maintain and document monitoring and measuring equipment. It also must document compliance with legal requirements and have procedures to evaluate, implement and maintain these requirements. The organization must perform internal environmental management audits, with documented procedures for policy non-conformance. Review Requirements The organization must review EMS for its effectiveness, including its policies and objectives. They then must document these reviews and assessments for improvement.

5. Explain QFD process? Quality function deployment (QFD) is a method to transform user demands into design quality, to deploy the functions forming quality, and to deploy methods for achieving the design quality into subsystems and component parts, and ultimately to specific elements of the manufacturing process. as described by Dr. Yoji Akao, who originally developed QFD in Japan in 1966, when the author combined his work in quality assurance and quality control points with function deployment used in value engineering. QFD is designed to help planners focus on characteristics of a new or existing product or service from the viewpoints of market segments, company, or technology-development needs. The technique yields charts and matrices. Areas of application

QFD is applied in a wide variety of services, consumer products, military needs (such as the F-35 Joint Strike Fighter), and emerging technologyproducts. The technique is also used to identify and document competitive marketing strategies and tactics QFD is considered a key practice of Design for Six Sigma (DFSS - as seen in the referenced roadmap).It is also included in the new ISO 9000:2000 standard which focuses on customer satisfaction. Results of QFD have been applied in Japan and elsewhere into deploying the high-impact controllable factors in Strategic planning and Strategic management (also known as Hoshin Kanri, Hoshin Planning). Acquiring market needs by listening to the Voice of Customer (VOC), sorting the needs, and numerically prioritizing them (using techniques such as the Analytic Hierarchy Process) are the early tasks in QFD. Traditionally, going to the Gemba (the "real place" where value is created for the customer) is where these customer needs are evidenced and compiled. While many books and articles on "how to do QFD" are available, there is a relative paucity of example matrices available. QFD matrices become highly proprietary due to the high density of product or service information found therein. House of Quality House of Quality appeared in 1972 in the design of an oil tanker by Mitsubishi Heavy Industries. Akao has reiterated numerous times that aHouse of Quality is not QFD, it is just an example of one tool. A Flash tutorial exists showing the build process of the traditional QFD "House of Quality" (HOQ). (Although this example may violate QFD principles, the basic sequence of HOQ building are illustrative.) There are also free QFD templates available that walk users through the process of creating a House of Quality. Other tools extend the analysis beyond quality to cost, technology, reliability, function, parts, technology, manufacturing, and service deployments. In addition, the same technique can extend the method into the constituent product subsystems, configuration items, assemblies, and parts. From these detail level components, fabrication and assembly process QFD charts can be developed to support statistical process control techniques. Pugh concept selection Pugh Concept Selection can be used in coordination with QFD to select a promising product or service configuration from among listed alternatives. Modular Function Deployment Modular Function Deployment uses QFD to establish customer requirements and to identify important design requirements with a special emphasis on modularity. There are three main differences to QFD as applied in Modular Function Deployment compared to

House of Quality:

The benchmarking data is mostly gone. The checkboxes and crosses have been replaced with circles. The triangular roof is missing.

There are also other minor differences between the application of QFD in Modular Function Deployment as compared to House of Quality, for example the term "Customer Attribute" is replaced by "Customer Value", and the term "Engineering Characteristics" is replaced by "Product Properties". But the terms have similar meanings in the two applications. Relationship to other techniques The QFD-associated Hoshin Kanri process somewhat resembles Management by objectives (MBO), but adds a significant element in the goal setting process, called "catchball". Use of these Hoshin techniques by U.S. companies such as Hewlett Packard have been successful in focusing and aligning company resources to follow stated strategic goals throughout an organizational hierarchy. Since the early introduction of QFD, the technique has been developed to shorten the time span and reduce the required group efforts.

6. Explain the elements of ISO 9000:2000? With the ISO 9000:2000 draft review process moving into its last phase, there has been a sudden increase of interest in the scope and interpretation of the new requirements. Registrars, auditors, consultants and course providers are all under pressure to develop their positions on specific, technical issues. Companies using ISO 9000 quality systems are also growing impatient as they wait to find out what they'll need to do to upgrade their systems. The most visible changes are in the structure of the ISO 9000 family of standards and in the sectional organization of the ISO 9001 standard. New requirements are predominantly in the areas of customer-related processes and continual improvement. There are also miscellaneous new requirements pertaining to process control, measuring and monitoring devices, training and awareness, internal communication, work environment, and legal and regulatory requirements. Structure The ISO 9000 series now consists of three standards:

ISO 9000:2000 Quality Management Systems -- Fundamentals and Vocabulary ISO 9001:2000 Quality Management Systems -- Requirements ISO 9004:2000 Quality Management Systems -- Guidance for Performance Improvement ISO 9000 discusses the underlying concepts, approaches and roles of key elements and provides definitions for the new vocabulary. ISO 9000 is not intended to be used as a specification; however, it is named in ISO 9001 as a normative reference and thus can be used by auditors to support their interpretations of ISO 9001 requirements. ISO 9001 is the actual specification for the quality management system. Its requirements define the criteria for the quality system audit. The role of this standard in the series has not changed, but its content and sectional organization are completely revised. Quality system requirements are now organized into four sections: Section 5 -- Management Responsibility; Section 6 -- Resource Management; Section 7 -- Product and/or Service Realization; and Section 8 -- Measurement, Analysis and Improvement. This new organization makes ISO 9001 more compatible with the ISO 14001 (environmental) standard, and is consistent with ISO 9004's Plan-Do-Check-Act improvement cycle. It also corrects the undue emphasis on the manufacturing industries that characterized previous editions. ISO 9002 and ISO 9003 will be discontinued. Instead of choosing a standard with the appropriate scope, all companies will now use ISO 9001, but they're allowed to reduce the scope of the standard to exclude requirements that don't apply. The reduction of scope may only be applied to Section 7 -- Product and/or Service Realization, and exclusions may not affect the organization's ability to meet requirements. Reduction of scope must be clearly identified in the quality manual. The role of ISO 9004 in the series is unchanged. As in previous editions, it's a guide for developing quality management systems. However, it has been completely rewritten to align it with the new ISO 9001. ISO 9004 is not named in ISO 9001 as a normative reference, and thus it can't be used to define audit criteria for the ISO 9001 certification audit. Overview of new requirements The most important new requirements in ISO 9001:2000 concern customer- related processes and continual improvement. With regard to customer processes, the new requirements call for identifying customer requirements, needs and expectations; determining customer satisfaction; establishing procedures for customer communication;

and making employees aware of the importance of meeting customer requirements. In the area of continual improvement, the new requirements concern the quality policy, quality objectives, quality planning, quality performance data and management reviews. There are also miscellaneous new requirements for process control, measuring and monitoring devices, training and awareness, internal communication, work environment, and legal and regulatory requirements. Rather than being grouped in specific, additional clauses, the new requirements are spread throughout the standard and are often restated and expanded under several sections. For example, requirements pertaining to process control are first introduced in Section 5, are developed in two separate clauses of Section 7, and then are restated in Section 8. This approach follows the logic of the standard's new organization, but it also makes it difficult to identify and interpret the requirements. Often the intent of the standard can be interpreted only after related requirements are culled from different sections and analyzed together. Customer-related processes ISO 9001:1994 had two clauses directly relevant to customer-related processes: Clause 4.3 -- Contract Review and Clause 4.7 -- Customer-Supplied Product. In the new revision, both clauses have been renamed and edited, but the underlying requirements are basically unchanged. The corresponding clauses in ISO 9000:2000 are 7.2.2 -- Review of Customer Requirements and 7.5.3 -- Customer Property. Together, these clauses seem to demonstrate that the standard now requires organizations to include in the quality system all departments and functions that deal with and represent customers. Typically, these would include marketing, sales, customer service, billing and servicing. Once this intent is understood and accepted, interpretation and implementation of all underlying requirements will follow naturally. Like everyone else in the system, these functions must develop effective methods and processes, document them in procedures, and maintain records of their activities. To be sure, there will be a lot of resistance to such a sweeping interpretation in many companies. Marketing and sales people genuinely care about the quality of the product or service they sell, but they don't necessarily see their own work as being directly relevant to quality. Many engineers had this kind of adverse reaction when ISO 9000 asked them to define their methods and write procedures for the design and development process. The effort necessary to implement the new requirements will depend on the complexity of marketing, sales and customer service operations, and on how much documentation already exists. Typically, implementation will consist of the following actions:

Revising existing contract review procedures and/or developing new procedures to document the processes for identification of customer requirements Developing a new procedure for measuring customer satisfaction and dissatisfaction, which may incorporate or reference the existing procedure for customer complaints Developing procedures and work instructions defining arrangements for communication with customers in matters pertaining to product information, order handling, customer complaints and customer feedback Establishing programs for creating awareness of customer requirements and the importance of meeting these requirements Developing measures to ensure that customer needs and expectations are determined and converted into specific requirements. A written procedure is not explicitly required, but there must be a means of demonstrating conformance. Continual improvement ISO 9001:2000 doesn't actually have a clause named "Continual Improvement," which is curious because references to that concept are everywhere. Many of the elements supporting the continual improvement cycle were already required in previous editions of the standard. But now there is a new, stronger linkage between these elements, and there are several completely new requirements. Identifying the requirements that pertain to continual improvement is not a precise science. The following requirements are all new; whether they're discussed here or under another heading doesn't really matter: This basic structure for continual improvement is supported by many other elements of the quality system. Some of these elements have already been required in previous editions of the standard, but others (such as activities for collecting quality performance data, internal audits and measurement of customer satisfaction) are new. Indeed, it can be argued that each and every element of the quality system has a role in the continual improvement cycle. Implementation of these requirements will include: Revision of the quality policy to include commitments to meeting requirements and to continual improvement Establishment of quality objectives consistent with the quality policy and the commitment to continual improvement Establishment of plans to achieve quality objectives

Development of a new procedure for collecting and analyzing quality performance data Development of a new procedure for using relevant information and data to facilitate continual improvement Revision of the existing management review procedure to address new requirements concerning the scope and output of the review Training, awareness and communication Training requirements in ISO 9001 :2000 are considerably broader. Most of Section 6 -Resource Management is dedicated to training and related issues. In addition to the old requirements for identifying training needs, providing training, assigning qualified personnel and maintaining records, the standard now also requires organizations to evaluate the effectiveness of training and establish employee awareness programs. There are also new requirements for internal communication in Section 5 -- Management Responsibility. Although these requirements are not specifically linked to training, it will be natural to integrate training and employee awareness programs with the communication system. Implementation of these requirements will include: Revision of the training procedure to define how training effectiveness is evaluated Establishment of employee awareness programs (documented in procedures) Development of new procedures for internal communication The clause states that "The organization shall determine how each process affects the ability to meet product and/or service requirements and shall determine and implement criteria and methods to control processes, to the extent necessary, to achieve product and/or service conformity with the customer requirements." If this means that process control measures must be sufficient to eliminate the occurrence of nonconformity, it's the same as requiring implementation of the best-known process control system for each process. But this could not be the intent of the standard. If such a requirement were to be enforced, it would cost billions of dollars. On the other hand, if this clause means that process control measures are sufficient as long as the shipped product conforms to requirements, one could comply by inspecting and segregating nonconforming product without any process control measures at all. Again, this could not be the intent of the standard. The criteria for selecting and implementing appropriate process control systems must be somewhere in between, but the standard fails to specify where.

The requirement is to apply suitable methods for measurement and monitoring of processes necessary to meet customer requirements and to demonstrate the process's continuing ability to satisfy its intended purpose." Here, again, the language is indefinite. It could imply formal process capability and process performance studies, but could also mean a simple inspection of output. It will be a challenge for auditors to find a nonconformance based on this clause. Because the new standard fails to provide any meaningful criteria for selecting and implementing process control measures, one can argue that nothing has changed from the previous editions. Organizations can still decide on their own how they want (or don't want) to control their processes. Auditors can only require that each process be reviewed for relevant process control measures, and that the implemented process control systems are properly operated and maintained. Lack of clarity aside, it's obvious that the new standard has moved significantly toward requiring implementation of formal process control systems for all relevant processes. Process control is no longer an optional activity expected only in special industries such as automotive or aerospace. With this new standard, auditors will expect every organization, regardless of the nature of its product or service, to have the knowledge of process control techniques and systematically evaluate all processes to determine which should be controlled and how. The effort needed to implement these requirements will depend on the current state of process control programs in the company. In many smaller companies, especially those lacking experience with formal process control, it will be substantial. First of all, they will need to acquire the relevant knowledge, and then apply it to a systematic review of all key processes to identify those that need to be controlled. The next step will be to select suitable process control measures for these processes. Finally, they will need to establish the actual control procedures and instructions and train process operators in their use. Additional requirements All together, there are more than 30 new actionable and auditable requirements in ISO 9000:2000. About three-quarters of them fall into the four major categories discussed above. The remaining requirements can't be neatly grouped into such major categories; they're spread throughout the standard and pertain to diverse elements of the quality system. Most of them are minor and easy to understand and implement. Of the remaining requirements, the following four are probably the most important. Overall, ISO 9001:2000 is a much better standard than its predecessors. It represents a more modern approach to quality management and is closer to current management system thinking. The most important improvements are the reorganization of the standard

to follow the Plan-Do-Check-Act loop, the introduction of systems and activities to facilitate continual improvement, greater emphasis on employee awareness and involvement, and the incorporation of functions representing the voice of the customer into the quality system. On the negative side, the standard introduces these new ideas and concepts with some hesitation and a lack of conviction.

7. Explain total productive maintenance? TPM is a management process developed for improving productivity by making processes more reliable and less wasteful.TPM is an extension of TQM(Total Quality Management). The objective of TPM is to maintain the plant or equipment in good condition without interfering with the daily process. To achieve this objective, preventive and predictive maintenance is required. By following the philosophy of TPM we can minimize the unexpected failure of the equipment. To implement TPM the production unit and maintenance unit should work jointly. Original goal of total productive management: Continuously improve all operational conditions, within a production system; by stimulating the daily awareness of all employees TPM focuses primarily on manufacturing (although its benefits are applicable to virtually any "process") and is the first methodology Toyota used to improve its global position (1950s). After TPM, the focus was stretched, and also suppliers and customers were involved (Supply Chain), this next methodology was called lean manufacturing. This sheet gives an overview of TPM in its original form. An accurate and practical implementation of TPM, will increase productivity within the total organization, where: (1) A clear business culture is designed to continuously improve the efficiency of the total production system (2) A standardized and systematic approach is used, where all losses are prevented and/or known. (3) All departments, influencing productivity, will be involved to move from a reactive- to a predictive mindset. (4) A transparent multidisciplinary organization in reaching zero losses. (5) Steps are taken as a journey, not as a quick menu.

Finally TPM will provide practical and transparent ingredients to reach operational excellence.

TPM is an evolving process, starting from a Japanese idea that can be traced back to 1952 , when preventive maintenance was introduced into Japan from the USA (Deming). Nippondenso, part of Toyota, was the first company in Japan to introduce plant wide preventive maintenance in 1960. In preventive maintenance, operators produced goods using machines and the maintenance group was dedicated to the work of maintaining those machines. However, with the high level of automation of Nippondenso, maintenance became a problem as so many more maintenance personnel were now required. So the management decided that much of the routine maintenance of equipment would now be carried out by the operators themselves. Autonomous Maintenance, one of the features of TPM, is more cost-effective as the operator (compared to a highly skilled engineer) is on a lower pay rate. This is not to reduce costs however; the operator has a better understanding of the how the equipment works daily, can tell if an issue is appearing, can tell if quality is decreasing, and, through constant learning, is allowed to follow a career path to a better job. The maintenance group then focused only on more complex problems and project work for long term upgrades. The maintenance group performed equipment modification that would improve its reliability. These modifications were then made or incorporated into new equipment. The work of the maintenance group, with the support and input from operators and production engineers, is then to make changes that lead to maintenance prevention and increased quality through fewer defects and a reduction in scrap levels. Thus preventive maintenance along with maintenance prevention and maintainability improvement were grouped as productive maintenance. The aim of productive maintenance was to maximize plant and equipment effectiveness to achieve the optimum life cycle cost of production equipment. Nippondenso already had quality circles which involved the employees in changes. Therefore, now, all employees took part in implementing Productive maintenance. Based on these developments Nippondenso was awarded the distinguished plant prize for developing and implementing TPM, by the Japanese Institute of Plant Engineers (JIPE). Thus Nippondenso of the Toyota group became the first company to obtain the TPM certifications. Implementation TPM has basically 3 goals - Zero Product Defects, Zero Equipment Unplanned Failures and Zero Accidents. It sets out to achieve these goals by Gap Analysis of previous historical records of Product Defects, Equipment Failures and Accidents. Then through a clear understanding of this Gap Analysis (Fishbone Cause-Effect Analysis, Why-Why Cause-Effect Analysis, and P-M Analysis) plan a physical investigation to discover new

latent fuguai (slight deterioration) during the first step in TPM Autonomous Maintenance called "Initial Cleaning". Many companies struggle to implement TPM due to 2 main reasons. First is having insufficient knowledge and skills especially in understanding the linkages between the 8 Pillar-Activities in TPM.[1] It does not help in that most TPM books are long on the theories but scanty on the implementation details. The second reason is that TPM requires more time, resources and efforts than most of these companies believe they can afford. A typical TPM implementation requires company-wide participation and full results can only be seen after 3 years and sometimes 5 years. The main reason for this long duration is due to the basic involvement and training required for Autonomous Maintenance participation where operators participate in the restoring the equipment to its original capability and condition and then improving the equipment. An effective Fast-Track TPM Implementation Approach has been successful in a Paper Mill and Electronics Industries and documented. It circumvented this problem by assigning Project Teams to do Autonomous Maintenance for the AM Steps of 1) Initial Cleaning and 2) Eliminating Sources of Contamination and Improving Equipment Accessibility. Production Operators take over the Autonomous Maintenance after the AM Step 3 (Initial Maintenance Standards) has been established. This has been proven to reduce TPM implementation time by about 50%. TPM identifies the 7 losses (types of waste) (muda), namely set-up and initial adjustment time, equipment breakdown time, idling and minor losses, speed (cycle time) losses, start-up quality losses, and in process quality losses, and then works systematically to eliminate them by making improvements (kaizen). TPM has 8 pillars of activity,[2] each being set to achieve a zero target. These 8 pillars are the following: focussed improvement (Kobetsu Kaizen); autonomous maintenance (Jishu Hozen); planned maintenance; training and education; early-phase management; quality maintenance (Hinshitsu Hozen); office TPM; and safety, health, and environment. Few organisation also add Pillars according to their Work Place like: Tools Management; Information Technology & more. The Base for the TPM Activity is 5S; Seiri (Sorting out the required or not required items); Seition (Systematic Arrangement of the required items); Seiso (Cleaniness); Seiketsu (Standardisation); Shitsuke (Self Discipline). The Pillars & their details a) Efficient Equipment Utilisation b) Efficient Worker Utilisation c) Efficient Material & Energy Utilisation 1. Focused improvement (Kobetsu Kaizen) - Continuously even small steps of improvement.

2. Planned Maintenance - It focusses on Increasing Availability of Equipments & reducing Breakdown of Machines. 3. Initial Control - To establish the system to launch the production of new product & new equipment in a minimum run up time. 4. Education & Training - Formation of Autonomous workers who have skill & technique for autonomous maintenance. 5. Autonomous Maintenance (Jishu Hozen) - It means "Maintaining one's equipment by oneself". There are 7 Steps in & Activities of Jishu Hozen. 6. Quality Maintenance (Hinshitsu Hozen) - Quality Maintenance is establishment of machine conditions that will not allow the occurrence of defects & control of such conditions is required to sustain Zero Defect. 7. Office TPM - To make an efficient working office that eliminate losses. 8. Safety, Hygiene & Environment - The main role of SHE (Safety, Hygiene & Environment) is to create Safe & healthy work place where accidents do not occur, uncover & improve hazardous areas & do activities that preserve environment. Other Pillars Like: Tools Management - To increase the availability of Equipment by reducing Tool Resetting Time, To reduce Tool Consumption Cost & to increase the tool life. TPM success measurement - A set of performance metrics which is considered to fit well in a lean manufacturing/TPM environment is overall equipment effectiveness, or OEE. For advanced TPM world class practitioners, the OEE cannot be converted to costs using Target Costing Management (TCM) OEE measurements are used as a guide to the potential improvement that can be made to an equipment. and by identifying which of the 6 losses is the greater, then the techniques applicable to that type of loss. Consistent application of the applicable improvement techniques to the sources of major losses will positively impact the performance of that equipment. Using a criticality analysis across the factory should identify which equipments should be improved first, also to gain the quickest overall factory performance. The use of Cost Deployment is quite rare, but can be very useful in identifying the priority for selective TPM deployment. Steps to start TPM are Identifying the key people

Management should learn the philosophy. Management must promote the philosophy. Training for all the employees. Identify the areas where improvement are needed. Make an implementation plan. Form an autonomous group.

8. Explain taguchi quality loss function? You will most likely encounter Taguchi methods in a manufacturing context. They are statistical methods developed by Genichi Taguchi to improve the quality of products. Where as statisticians before him focused on improving the mean outcome of a process, Taguchi recognized that in an industrial process it is vital to produce a product on target , and that the variation around the mean caused poor manufactured quality. For example, car windshields that have the target average mean are useless if they each vary significantly from the target specifications. Taguchi's key argument was that the cost of poor quality goes beyond direct costs to the manufacturer such as reworking or waste costs. Traditionally manufacturers have considered only the costs of quality up to the point of shipping out the product. Taguchi aims to quantify costs over the lifetime of the product. Long term costs to the manufacturer would include brand reputation and loss of customer satisfaction leading to declining market share. Other costs to the consumer would include costs from low durability, difficulty interfacing with other parts, or the need to build in safety margins. Think for a moment about how the costs of quality would vary with the products deviation on either side of the mean. Now if you were to plot the costs versus the diameter of a nut, for example, you would have a quadratic function, with a minimum of zero at the target diameter. We expect therefore that the loss (L) will be a quadratic function of the variance (, or standard deviation) from the target (m). The squared-error loss function has been in use since the 1930's, but Taguchi modified the function to represent total losses. Next we will walk though the derivation of the Taguchi Loss Function. Loss function for one piece of product:

Where: L = Loss in Dollars y = Quality Characteristic (diameter, concentration, etc) m = Target Value for y k = Constant (defined below) The cost of the counter measure, or action taken by the customer to account for a defective product at either end of the specification range, Ao, is found by substituting y = m + 0 into the loss function:

Now we can solve for the constant k,

Since we are not usually concerned with only one piece of product, the loss function for multiple units is

The process capability index (Cp) is used to forecast the quality level of non-defective products that will be shipped out. The Cp has been used in traditional quality control and is defined rather abstractly as:

where

represents the tolerance of the product.

Substituting k into the loss function and then rearranging in terms of Cp, Taguchi Loss Function:

The Taguchi quality loss function is a way to assess economic loss from a deviation in quality without having to develop the unique function for each quality characteristic. As a function of the traditionally used process capability index, it also puts this unitless value into monetary units. Quality Loss Function for Various Quality Characteristics There are three characteristics used to define the quality loss function: 1. Nominalthe-Best Characteristic 2. Smaller-the-Better Characteristic 3. Larger-the-Better Characteristic Each of these characteristic types is defined by a different set of equations, which is different from the general form of the loss function equation. NominalDefined upper and lower boundries For a nominal characteristic, there is a defined target value for the product which has to be achieved. There is a specified upper and lower limit, with the target specification being the middle point. Quality is in this case is defined in terms of deviation from the target value. An example of this characteristic is the thickness of a windshield in a car. The equation used to describe the loss function of one unit of product:

Where: L = Loss in Dollars y = Output Value m = Target Value of Output k = Proportionality Constant The proportionality constant (k) for nominal-the-best characteristics can be defined as:

Where: A0 = Consumer Loss (in Dollars) 0 = Maximum Deviation from Target Allowed by Consumer When there is more than one piece of product the following form of the loss function is used:

= Mean Squared Deviation A graphical representation of the Nominal Characteristic is shown below. As the output value (y) deviates from the target value (m) increasing the mean squared deviation, the loss (L) increases. There is no loss when the output value is equal to the target value (y = m).

Smaller-the- Better In the case of Smaller-the-Better characteristic, the ideal target value is defined as zero. An example of this characteristic is minimization of heat losses in a heat exchanger. Minimizing this characteristic as much as possible would produce a more desirable product. The equation used to describe the loss function of one unit of product:

Where: k = Proportionality Constant y = Output Value The proportionality constant (k) for the Smaller-the-Better characteristic can be determined as follows:

A0 = Consumer Loss (in Dollars) y0 = Maximum Consumer Tolerated Output Value A graphical representation of the Smaller-the-Better characteristic is below. The loss is minimized as the output value is minimized.

Larger-the-Better The Largerthe-Better characteristic is just the opposite of the Smaller-the-Better characteristc. For this characteristic type, it is preferred to maximize the result, and the ideal target value is infinity. An example of this characteristic is maximizing the product yield from a process.

The equation used to describe the loss function of one unit of product:

Where: k = Proportionality Constant y0 = Minimum Consumer Tolerated Output Value The proportionality constant (k) for the Larger-the-Better characteristic can be calculated by using the equation given for the Smaller-the-Better proportionality constant. The only difference between the two is the deffinition of y0. A graphical representation of the Larger-the-Better characteristic is shown below. This characteristic is the opposite of the Smaller-the-Better characteristic, as the loss is minimized as the output value is maximized.

Specifying Tolerances for a Process A manufacturer is responsible for only shipping products that meet certain specifications. Products that do not meet these determined specifications are defective and cannot be shipped for sale, resulting in a loss to the company. In aiming to meet these specifications, manufacturers have a determined level of tolerance for deviation from the desired target specification. The problem that often occurs is products that barely meet specifications are shipped and fail after customer purchase. This causes negative feedback from customers, which results in losses to the manufacturer and ultimately society. The standard to fix this problem is to tighten up the tolerances. More stringent tolerances would result in fewer products failing on customers, reducing losses in the market, but they would also result in increased costs to manufacturers. Before Taguchi, there was no set method for determining optimal tolerances for a given process.

Since it is very difficult to quantify the loss to society for a defective product after customer purchase, Taguchi predicts the quality level. The quality loss function is the basis for determining tolerances for a process. In quality engineering, tolerance is defined as the deviation from the target, not the deviation between products. Taguchi's method determines tolerances that aim for a balance between losses to the manufacturer and the customer. To do determine these tolerances, the quality loss function can be used to determine how much it costs the manufacturer to fix the defective product before shippment, and compare that value to the cost that the defective product would have on the customer (society).