Single Minute Exchange of Die - SMED

Changeover Time is the amount of time it takes to change over equipment/programs/ files/people from the end of the previous step to the beginning of the current step. Changeover time includes set up, warm up, trial run, adjustment, first item/work inspection, etc.

Examples include: Creating a new file for a new customer; Reviewing an existing file before seeing a client; Changing computer programs; and Searching your desk for the correct form.
External setup involves tasks that can be performed to prepare for changeover while the machine is still running.Internal setup involves tasks that can only be performed while the machine is turned off. Lean philosophy recommends that internal setup be facilitated by the use of tools and equipment that make the changeover processes fast and smooth.

Briefly, this methodology includes:

MEASURE the current changeover times and record them in order to monitor improvement.

SEPARATE EXTERNAL AND INTERNAL ACTIVITIES “External” activities are simply the jobs/work that can be carried out while the step or process is continuing (e.g. getting ready for the next customer while the service packet for the last customer is copying, etc.). “Internal” activities are those jobs which cannot be carried out while the step/process is going on (e.g. interviewing the customer while completing a service request packet on the prior customer). By identifying and separating internal and external activities, the intention is to do as much as possible while the step/process is continuing.

CONVERT INTERNAL TO EXTERNAL ACTIVITIES The next step is to try and convert some of the internal tasks into external tasks.

REDUCE THE TIME TO CARRY OUT INTERNAL TASKS Of the remaining internal tasks that cannot be converted to external tasks, efforts should be made to reduce the time taken to carry out them out -- to eliminate, modify, or streamline the changeover tasks. This can include re-design of the forms, protocols, and requirements. Consider tackling no- or low-cost reductions first, but keep in mind that you must not lose your focus on implementing the other reductions.

Techniques to reduce changeover time
You can use several techniques to reduce changeover time:
1- staged tooling and fixtures – this involves preparing parts or tools in advance so that while one part or tool is in the machine, the second can be set up in the fixture.
2- operations conducted in parallel – this technique involves having more than one operator perform a changeover so that the operators can perform their tasks simultaneously.
3- standardization – this involves having one set of tools that can be used to perform changeovers on all the machines, rather than a different set of tools for each machine.
4- quick attachments – this involves using parts and tools that have quick attachments to make changeovers more efficient.
5- assisted tool movement – this involves using simple tools to move machinery, rather than moving heavy equipment with forklifts or cranes.


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Quality Function Deployment (QFD)

QFD stands for Quality Function Deployment. Quality Function Deployment is a structured method in which customer requirements are translated into appropriate technical requirements for each stage of product development and production. The QFD process is often referred to as listening to the voice of the customer and is considered a tool of concurrent engineering.

Basically, QFD relates the customer requirements (product specifications) to the product design parameters in a mathematical manner. The result of this is a product design driven by math.
The advantages that would be realized through the use of QFD include a reduction in the time required for product design as well as a reduction is those costs associated with the process. This is possible because the design alternatives are realized much earlier in the process thus reducing the number of corrections and design errors. Also, a higher level of clarity for decision making is gained through the use of this tool.

The Process:
There is a structure to the use of QFD. Certain steps need to be followed in order to assure the proper outcome. A brief summary of each of the steps will aid in gaining a better understanding.
Since the customer’s input is the driving force here, Identify the customer’s requirements, listen to the “Voice of The Customer.” Be sure that the product design decisions are based on the customer and not on what is perceived as the customer’s needs. Refine the customer’s requirements to more specific points and determine how they can be accomplished. A chart may be helpful at this stage.

Once these decisions and relationships have been determined, a planning matrix can be constructed. The planning matrix determines how factors relate. The relations between the factors are analyzed to determine any design changes If, in general, there are more negative than positive effects, the process or product should be reconsidered. If too many changes need to be made, the customer’s requirements should be analyzed for accuracy.

The relationships between the “Whats” and the “Hows” are formed by assigning weights of 0-9, 9 being the strongest. The column sums give importance ratings. The result should be a few clearly important design features and a few that clearly are not.

The customer’s importance rating is compared to the calculated importance rating. Also, the competitors’ products are rated and ranked. Analysis of these factors will determine strengths and weaknesses among the consumers and compared to the competition. At this point, any technical deficiencies will surface as well.

A number of tools are used to determine the need for any changes. A new set of target values is developed from the previous analysis. A degree of difficulty is determined for the product and a cost versus quality assessment is made. Quality has a cost and a cost/benefit trade-off needs to be made. The decisions do not need to be follow the chart directly, however changes should not deviate too significantly.

For each control characteristic selected, a deployment matrix is developed. The deployment matrix is used to do design work, test the results, and compare them to the target values

This process is long and complex and will require a fairly-large amount of time. However, the end product will be much more competitive and cost far less than not using this method of concurrent engineering. Most likely, the product will also make it to market much faster.

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What is TS -16949: Technical Specification

This standard if for Automotive suppliers.ISO/TS 16949 harmonizes the supplier quality requirements of the U.S. Big Three (QS-9000, Third Edition) and French, German and Italian automakers.The goal was to create a single document and a single third-party registration that the European automakers and the U.S. Big Three would accept.


Framework QS9000 to TS 16949
4.1--Management responsibility: A number of additions to this element are clearly intended to focus suppliers' attention on continuous quality improvement. Suppliers must establish goals, objectives and measurements to develop their quality policies. Continuous improvement in quality, service, cost and technology must be covered in the quality policy. Quality-responsible personnel's authority to stop production is no longer a "note" or suggestion, as in QS-9000, but a requirement. All production shifts must be staffed with personnel responsible for quality. The management review requirement is expanded to include the "performance (of the QMS) over time as an essential part of the continuous improvement process." Evaluation of the cost of poor quality was a parenthetical note in QS-9000, but is a specific requirement of ISO/TS 16949. Suppliers must develop a process for motivating employees to achieve quality objectives and providing employees at all levels with "quality awareness." Customer experience with the supplier's product must be communicated in a timely manner. Finally, the "due care for product safety" requirement from QS-9000 has been expanded to minimize risks to employees, customers and the environment.

4.2--Quality system:
The term "product realization" is introduced to cover the entire process of designing, planning and delivering products that meet customer requirements. A requirement for a project manager and a project team is introduced. The modifying phrase "If a project management approach is used" suggests that this approach is preferred, if not actually required. Continuing to expand the project management concept, ISO/TS 16949 requires that a method be established for measuring the product-realization process against appropriate mileposts, with appropriate analysis and management review. The factors to be measured include quality, risks, costs and lead times. Process capability studies must be conducted on all new processes. Results for the capability studies must be used to establish requirements for production equipment where applicable. Inclusion of all special characteristics on control plans, although always implicit, is now explicitly required. ISO/TS 16949 also has a requirement for procedures on developing and verifying the product-realization process--perhaps one of the murkier requirements of the document. Detailed procedural requirements for process design inputs and outputs have been added, including a verification of the inputs vs. the outputs. The use of the "customer-recognized product approval process" (e.g., production part approval process [PPAP]) is mandated rather than recommended as in QS-9000, although General Motors has had a customer-specific requirement for subsupplier PPAP for some time. Additionally, when the customer so requires, special verification methods for new products must be implemented.

4.3--Contract review:
Suppliers must have a formal process for identifying cost elements and employ this process in the preparation of price quotations for new products.

4.4--Design control:
The requirement for skill qualifications of the supplier's design team is now a "shall" rather than a "should." Suppliers must have access to research and development to support product innovation. Analysis of competitive products is identified as one alternative source of input for the design process. For design changes, the impact on the customer's assembly operations is added to the factors that the supplier must consider for each change.

4.5--Document and data control:
There are no significant changes in this section.

4.6--Purchasing:
Suppliers must encourage their subsuppliers to comply with ISO/TS 16949. However, there's no target date for compliance, nor is there an expectation of third-party registration for subsuppliers.

4.7--Control of customer-supplied products:
There are no significant changes in this section.

4.8--Product identification and traceability:
There are no significant changes in this section.

4.9--Process control:
The term "process monitoring and operator instructions" has been replaced with the simpler "job instructions," which "shall" rather than "should" be accessible at the job station without disruption. These job instructions shall be derived from "appropriate sources," including the control plan and the entire product-realization process. Significant process events shall be noted on control charts.

4.10--Inspection and testing:
Perhaps surprisingly, the incoming material requirements now allow the customer to waive the required control methods. Following the precedent of the Third Edition of QS-9000, requirements for internal laboratories are further strengthened. These laboratories, which include precision metrology and calibration as well as traditional laboratory functions, must now comply with ISO/IEC 17025, although third-party accreditation to that document is not required.

4.11--Control of inspection, measuring and test equipment:
Methods and criteria for measurement system analysis shall conform to customer reference manuals (e.g., the Big Three Measurement Systems Analysis manual).

4.12--Inspection and test status:
There are no significant changes in this section.

4.13--Control of nonconforming product:
Progress on corrective action plans shall be regularly reviewed. A requirement has been added for customer notification when nonconforming material has been shipped.

4.14--Corrective and preventive action:
There are no significant changes in this section.

4.15--Handling, storage, packaging, preservation and delivery:
The controls implemented for nonconforming product must also be used for obsolete product. If delivery will not happen according to schedule, the supplier must notify the carrier as well as the customer of the anticipated delivery problem.

4.16--Control of quality records:
The requirements for scheduling the supplier's production process have been defined in greater detail. There must be a scheduling process based on meeting the customers' requirements, such as just-in-time. The information technology must support access to production data at key production checkpoints.

4.17--Internal quality auditing:
Internal audits must be performed on all shifts and must include all activities affected by ISO/TS 16949 and all relevant customer requirements. Specifically, the internal audit must include an evaluation of the effectiveness of the product-realization and production process. A product audit has been included in 4.17 that includes the "final product" audit required in QS-9000 and expands it to include all specified requirements at appropriate points in the production and delivery process. Internal auditors must meet customer-established criteria.

4.18--Training:
Additions include requirements for on-the-job training for new or modified jobs affecting quality and for training on customer-specific requirements.

4.19--Servicing:
If the supplier provides post-sale servicing, the effectiveness of service centers, special equipment and personnel training must be re-evaluated.

4.20--Statistical techniques:
Appropriate statistical methods shall be determined during the planning process, and these methods shall be understood throughout the organization.

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EFQM Model

EFQM (European Foundation for Quality Management ) is a not for profit membership foundation founded in 1988. It is the primary source in Europe for organizations of all sizes and sectors, both private and public, looking to excel in their field and in their business. It works closely with similar organizations in the USA, Japan and other countries around the world. It is now the most widely used organizational framework in Europe and it has become the basis for the majority of national and regional quality awards.


strong>EFQM self-assessment process?
1- It is a comprehensive, systematic and regular review by an organization of its activities and results referenced against a model of excellence.
2- It allows an organization to discern clearly its strengths and areas in which improvements can be made and culminates in planned improvement actions that are monitored for progress.

Model
The EFQM Excellence Model is a non-prescriptive framework based on 9 criteria. Five of these are 'Enablers' and four are 'Results'. The 'Enabler' criteria cover what an organisation does. The 'Results' criteria cover what an organisation achieves. 'Results' are caused by 'Enablers' and 'Enablers' are improved using feedback from 'Results'.


Leadership (10%)
1- Leaders develop the mission, vision and values and are role models of a culture of excellence
2- Leaders are personnally involved in ensuring the organisation’s management system is developed, implemented and continuously improved
3- Leaders are involved with customers, partners and representatives of society
4- Leaders motivate, support and recognise the organisations people

Policy and strategy (8%)
1- Policy and strategy are based on the present and future needs and expctations of stakeholders
2- Policy and strategy are based on information from performance measurement, research, learning ande creativity realated activities
3- Policy and strategy are developed, reviewed and updated
4- Policy and strategy are developed through a framework of key processes
5- Policy and strategy are communicated and implemented

People (9%)
1- People resources are palnned, managed and improved
2- People’s knowledge and competencies are identified, developed and sustained
3- People are involved and empowered
4- People and the organisation have a dialogue
5- People are rewarded, recognised ande cared for

Partnership and resources (9 %)
1- External partnerships are managed
2- Finances are managed
3- Buildings, equipment and materials are managed
4- Technology is managed
5- Information and knowledge are managed

Processes (14%)
1- Processes are systematically designed and managed
2- Processes are improved, as needed, using innovation in order to fully satisfy and generate increasing value for customers and other stakeholders
3- Products and services are designed and developed based on customer needs and expectations
4- Products and services are produced, delivered and serviced
5- Customer relationships are managed and enchanced

Customer results (20%)
1- Perception measures
2- Performance indicators

People results (9 %)
1- Perception measures
2- Performance indicators

Society results (6%)
1- Perception measures
2- Performance indicators

Key performance results (15%)
1- Key performance outcomes
2- Key performance indicators


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TAGUCHI METHODS

In lean manufacturing there are many techniques but now we will talk about taguchi methods (equation).In 1989, the Japanese engineer, Dr. Genichi Taguchi was awarded the prestigious Purple Ribbon by the emperor of Japan for his contribution to the development of industrial standards.

Taguchi, unlike other leading quality gurus, focuses more on the engineering aspects of quality rather than on management philosophy or statistics. He emphasises the importance of designing quality into products and processes rather than depending on inspection after manufacture. A distinctive feature of Taguchi's approach to quality lies in the application of statistical methods, not to quality control where they have already found wide application, but on improving products and processes (Naylor, 1996). He applied statistical methods in novel ways to:

1- Make products less sensitive to variations in their components and in the environment in which they are made.
2- Improve reliability.
3- Improve testing procedures.
Taguchi methods employ statistical techniques to evaluate the combined effects of environmental variations and manufacturing tolerances on the performance of the product. Dr. Taguchi is widely recognised for adding greatly to our understanding of the importance of properly designed engineering experiments in quality improvement and is therefore often considered the most important contributor to quality engineering concepts and methods.

Quality Loss Function
Traditional definitions of quality usually refer to the conformance of the product or service to requirements. Dr. Taguchi, however, defines quality as: “…..the loss a product causes to society after being shipped, other than any losses caused by its intrinsic functions.” Taguchi attempts to quantify this loss imparted to society by means of his Quality Loss Function (QLF). The QLF is a mathematical function used to calculate the loss to society in financial terms. Investigation of the QLF reveals that any deviation of the quality characteristic from its optimal value results in increased loss to society, whether or not the tolerance limit has been exceeded.
Taguchi proposed the Quality Loss Function to underline the need to aim close to the target (Naylor,1996). It estimates the total cost in the long run of poor quality resulting from a product moving away from exactly matching the target value. The cost covers all losses from the time the product is delivered, including those incurred during use and the consequent effects of failure.



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Malcolm Baldrige National Quality Award

The Malcolm Baldrige National Quality Award is given by the United States National Institute of Standards and Technology.his is the only quality award that is actually awarded by the President of the United States. Awards are given in manufacturing, service, small business, education, health care, and nonprofits. In conjunction with the private sector, the National Institute of Standards and Technology designed and manages the award and the Baldrige National Quality Program.

The award winners are required to share (non-proprietary) information on successful performance strategies and actions, and benefits derived. Eligibility allows for two awards in each of three categories:

1- Manufacturing companies
2- Service companies
3- Small businesses
4- Education
5- Health Care

Hundreds of U.S. firms have experienced improved quality and business performance by using the Baldrige criteria as a model and performing self-assessments. Companies use either internal or external evaluators to review a report, which for all practical purposes is an application that follows the Baldrige guidelines/criteria.
The key to successful quality improvement implementation is that appropriate action is taken on all category/items that are highlighted as areas needing improvement.

The common practice in industry and government self-assessments is to do a Phase I evaluation, followed by a site visit. The following could be labeled the elements of the Baldrige Advanced Quality/Management System.

Award Criteria
As you can see, the criteria go across all segments of an enterprise - from Leadership to Business Results. In scoring the items the evaluator/examiner assesses the enterprises application (description of the quality/management system) based on three evaluation dimensions:

1- Approach
2- Deployment
3- Results
The guidelines indicate which category/items are evaluated for approach-deployment, and those evaluated for results.

1999 CATEGORIES/ITEMS POINT VALUES
1.0 Leadership 125
1.1 Organizational Leadership 85
1.2 Public Responsibility and Citizenship 40

2.0 Strategic Planning 85
2.1 Strategy Development 40
2.2 Strategy Deployment 45

3.0 Customer and Market Focus 85
3.1 Customer and Market Knowledge 40
3.2 Customer Satisfaction and Relationships 45

4.0 Information and Analysis 85
4.1 Measurement of Organizational Performance 40
4.2 Analysis of Organizational Performance 45

5.0 Human Resource Focus 85
5.1 Work Systems 35
5.2 Employee Education, Training, and Development 25
5.3 Employee Well Being and Satisfaction 25

6.0 Process Management 85
6.1 Product and Service Processes 55
6.2 Support Processes 15
6.3 Supplier and Partnering Processes 15

7.0 Business Results 450
7.1 Customer Focused Results 115
7.2 Financial and Market Results 115
7.3 Human Resource Results 80
7.4 Supplier and Partner Results 25
7.5 Organizational Effectiveness Results 115

TOTAL POINTS 1000



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Lean Thinking In Healthcare

Definition Of Lean

Lean originated in manufacturing plants in Japan, but has soon spread around the globe and is relevant not just to private healthcare organisations, but increasingly to healthcare as well.

There are many differing definitions as to what lean actually is, but in essence, lean is about completely eliminating waste within an organisation or business and using less resources to actually do more.

Lean works by analysing any process and then determining its value by breaking the process up into ‘value added steps’ and ‘non-value added steps’. This is then further analysed, with each step that is a non-value added step being completely eradicated from the process. This leaves a process that is made up purely from value added steps, so the process itself is completely efficient.

In terms of lean this brings about a value stream, where everything is simply about value, but not necessarily value in monetary values, it can be about value to the end user.

Why Is Lean Relevant To Healthcare?

Although lean started off being used in the Japanese car industry, the principles of lean are actually very relevant to the healthcare sector. As patients of any healthcare system we all want a service that meets or exceeds our needs and for those that control it, runs at an appropriate cost, but there is often a good deal of waste within large organisations, whether private healthcare providers or in the public sector.

Saving money is very important to both private providers and the government run healthcare organizations. In the private sector, reduced costs means less costly procedures for patients and increased financial security, whereas within the government funded organizations such as the UK’s NHS resources have been subjected to being frozen or only raised by a small amount for year upon year, so saving money is seen as not just desirable, but essential.

A Wholesale Strategy

One of the very interesting aspects of lean thinking is that it has to be something that is applied throughout the whole of an organisation, or to use management ‘speak’ it has to be a roots and branch review.

Everyone who works for that organisation has to be committed to the process and they have to have an input to make it effective. This means that from senior management to cleaning staff, everyone, but everyone has to start thinking along ‘lean lines’. Within any healthcare organisation this is a challenge and can take time, but the strategy has to be wholly embraced for it to be effective.

Lean In Action

There are various ways that lean can actually transform a healthcare organisation. It can ensure that patient waiting times are reduced, through eliminating the reasons why patients have to wait, making sure that all necessary equipment is in place, ensuring that nursing staff have instant access to dressings and supplies that they need, through reducing the time that they have to spend looking for supplies etc. It is also very effective in ensuring that resources are spent appropriately through its integral emphasis on eliminating waste.

Due to the fact that it does need to be comprehensive throughout an organisation, it is not a quick fix solution and it can even take time to make the culture of a healthcare organisation receptive to the concept of lean.

But where lean has been used within a healthcare organisation the results have been quite dramatic and there is no reason why, with time, lean cannot radically transform patients’ experiences of using the healthcare services that are offered by both the private and government funded healthcare providers.


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