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Dr. Joseph A. De Feo, President & CEO 4 Steps Drive Proces s Innovati on To

4 Steps to Drive Process Innovation

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Dr. Joseph A. De Feo, President & CEO

4StepsDriveProcessInnovationTo

A Bit of History

Learning ObjectivesUnderstand the four factors to means to systematically create process innovations.Understand how a systematic design method can enhance innovation.Assure process capability of key operational processesbefore delivery of new designs.

Your team faces an important decision before finalizing your product design. The team must ask, Should the existing operational processes be redesigned, or should we design them from scratch as if we were starting with a clean sheet of paper? In order for you to answer the question above, you first need to clarify some terms.

Process redesign: incremental changes to the existing process.Process design: radical changes to the existing process, creating an entirely new design.Experience has shown that when goals remain the same, all or parts of existing processes may be carried over from previous designs to support the new product design. However, if these current processes prove incapable of meeting these same product goals, they will need to be improved. It is this improvement which can form the basis for the redesign of the process.As your team considers its options, it may decide to keep current processes at the higher levels. However, many lower-level processes may require some improvement or redesign, or an entirely new design. Conversely, you may discover that most of the lower- or micro-level processes function well but that they are organized into the larger overall process in ways which are inefficient or ineffective.Process design (and sometimes redesign) demands that you evaluate the current and alternative anatomies to make a choice. The choice of process anatomy can strongly influence process performance.

3Develop New Processes or Redesign Existing Processes

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A process must be:Effective: Meeting the CTQ product/service goalsEfficient: Cost, resource consumption, zero wasteTimely: Takt time, cycle times, lead times, response timesGoal orientedSimple and systematic Capable and repeatable

Are Your Processes Capable of Meeting CTQs?

You already have learned the tools for creating efficient processes using high capacity and short lead times with the Lean tool set.In this chapter you will learn some additional ways to assure effectiveness of meeting CTQs beyond those you learned using the DMAIC methodology.

To be effective, a process must be:Goal oriented: have specific measurable outcomesSystematic: have a sequence of activities and tasks fully and clearly defined, with all inputs and outputs fully specifiedCapable: is able to meet product quality goals under operating conditionsLegitimate: have clear authority and accountability for its operation

Final processes should be not only effective, but also efficient and meet established time requirements.Process Development

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What is a Business Process?

Supplier(s)Customer(s)The Business Process

A process is a systematic series of actions directed to the achievement of a goal.

Any cross-functional process managed with a permanent infrastructure, that produces a product or service of critical importance, is a business process. The term macro process is sometimes used.For a process to be effective and efficient, it must be owned and managed. What must be owned and managed are those interrelated, value-adding activities that produce the output of the process. Within the boundaries of the process box shown in the slide is the territory that must be identified, assigned ownership, and then managed by the owner and business process team.

Business Process

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Functional GoalsFunction vs. ProcessWhat are the functional objectives?What are the priorities?

Information and communications move with the process flow. The traditional vertical structure conflicts with the actual horizontal flow. Often no one is accountable for, or owns, this horizontal process flow. Since most of the organization is driven by functional goals, resources and goals are not allocated to cross-functional processes. As a result of these functional sub-optimizations, business processes are often not effective or efficient. The process management system is ignored.For example, Froedtert has identified the flow of emergency patients as a key business process. In many emergency departments, the turnaround of labs or medication orders slows the patients progression through the emergency process. The ED, lab, and pharmacy are usually all managed by different leaders, frequently reporting up different chains of command. Agreement upon the organizations key business processes, and management of the key process by multi-functional, matrixed teams can facilitate improvement of the patients experience as it cuts across functional areas of the organization. Function vs. Process Management

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Process PerformanceProcess PerformanceProcess Performance

Process Goals

Our real priorities

Process PerformanceFunctional GoalsFunction vs. Process

Information and communications move with the process flow. The traditional vertical structure conflicts with the actual horizontal flow. Often no one is accountable for, or owns, this horizontal process flow. Since most of the organization is driven by functional goals, resources and goals are not allocated to cross-functional processes. As a result of these functional sub-optimizations, business processes are often not effective or efficient. The process management system is ignored.For example, Froedtert has identified the flow of emergency patients as a key business process. In many emergency departments, the turnaround of labs or medication orders slows the patients progression through the emergency process. The ED, lab, and pharmacy are usually all managed by different leaders, frequently reporting up different chains of command. Agreement upon the organizations key business processes, and management of the key process by multi-functional, matrixed teams can facilitate improvement of the patients experience as it cuts across functional areas of the organization. Function vs. Process Management

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Strategic positioning within organization and new product designImprovement project drivenFinancial/Business targets (revenue, profit, market share, etc.)Unmet customer needsReduce complexity and costNew technologyWhy Innovate Processes?

Basis for Decision to Launch New Product

The decision to launch a new product is a strategic decision. It requires:Clarity on the customer segments and classes of needs to be servedPositioning within the enterprise strategy and product strategyThe target markets and market segmentsThe financial and other business outcomes requiredThe basis for launching this product, such as . . .Unmet needs of existing or prospective customersGaps in the market place specific function-price configurationsMeeting or beating the competitionThe leadership decision to launch the new product effort should be accompanied by clear directions and understanding with respect to:Any potential barriers to success, along with countermeasures to pursueExternal factors that may either promote the need for the product or inhibit itInvestment and resources required

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Process innovation is the implementation of a new or significantly improved production, delivery or business process method. This includes significant changes in technology, techniques, methods, equipment, software and talented people.

What is Process Innovation?

Basis for Decision to Launch New Product

The decision to launch a new product is a strategic decision. It requires:Clarity on the customer segments and classes of needs to be servedPositioning within the enterprise strategy and product strategyThe target markets and market segmentsThe financial and other business outcomes requiredThe basis for launching this product, such as . . .Unmet needs of existing or prospective customersGaps in the market place specific function-price configurationsMeeting or beating the competitionThe leadership decision to launch the new product effort should be accompanied by clear directions and understanding with respect to:Any potential barriers to success, along with countermeasures to pursueExternal factors that may either promote the need for the product or inhibit itInvestment and resources required

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Methods to Design Business Processes

Initiate Business Process Management

Select processesIdentify owners and teams

Process controlPeriodic process review and assessmentRCCA

Process definitionCustomer needs and process flowProcess measurementProcess analysisProcess design or redesignAction plan for implementationPlan deployment

Phase OnePlanningPhase TwoTransferPhase ThreeOperationalManagement

This roadmap outlines, at a high level, the work of a business process team over time. One of the goals of this retreat is to complete the initiation phase and to start on some of the deliverables for the planning phase. This work will be explained in greater detail during the second retreat.Defining the Roadmap

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Quality by Design MethodEvaluate Current Process CapabilityDetermine to Design or Redesign ProcessesDevelop high-level process features and goalsDevelop detailed process features and goalsOptimize ProcessesDevelop Process CapabilityPublish final process designDeliverResultsDesignProductDefineOpportunityDiscoverCustomer Needs DevelopProcess

DefineOpportunityDiscoverCustomer NeedsDesignProductDevelopProcess & ControlsDeliverResultsDefine the opportunityCreate a project charter and launch teamCreate a project planIdentify all customersCreate a process map to follow the customersPlan collection of customer needsCollect customer needs in their language of benefitPrioritize customer needsTranslate needs into CTQsSelect high-level product features and goals (functional design)Develop detailed product features and goalsOptimize product features and goalsSet and publish final product designDevelop ProcessCollect known baselinesSelect general process designIdentify high-level process features and goalsIdentify detailed process features and goalsOptimize process features and goalsEstablish process capabilitySet and publish process final process designDevelop ControlsIdentify control subjectsDevelop feedback loopsDevelop control plansEstablish auditDemonstrate process capability and controllabilityPlan for transfer to operationsImplement planValidate transfer11Change to Chapter NameAll Rights Reserved, Juran Institute, Inc.Insert Code and Date Here

Process Design Begins with Product DesignCustomersEffectNeeds(CTQs)GoalsProcess ControlFeaturesEffectControlFeaturesGoalsNeeds(CTQs)EffectProductFunctionsGoalsProductFunctionsEffectProductFeaturesGoalsProductFeaturesEffectProcessFeaturesGoalsPrioritized

The QbD Backbone of Interlocking Spreadsheets

A method of fine-tuning your overall process design is to determine which sub-processes can be carried over. The same steps the team applied previously for deciding which product features can be carried over can also be used for selecting existing sub-processes to be carried over into the process plan. When you were designing the product, the evaluation of carry-over options was conducted after the product features and goals were selected as part of the optimizing phase. In process design, carry-over analysis is conducted before defining the process features and goals. This sequence is recommended because sub-processes can and should be evaluated first and foremost for their ability to support product goals. This is a more effective use of your teams time since you are able to evaluate or test carry-over process options before identifying the specific resources and detailed designs required to run each sub-process.12Change to Chapter NameAll Rights Reserved, Juran Institute, Inc.Insert Code and Date Here

Develop Process and Process Control FeaturesProcessFeaturesEffectControlFeaturesGoalsProductFunctionsEffectProductFeaturesGoalsProductFeaturesEffectProcessFeaturesGoals

Develop innovative process features

At this point in your project, you will identify sub-processes (and possibly major activities) that will be designed in more detail later. Each of these sub-processes must be clearly defined in terms of:the inputs required and where they come from. These can include raw materials, parts, subassemblies, etc.the process for converting the inputs into outputs. The process includes the activities, tasks, and/or procedures for running the process. These will be defined in more detail for each sub-process in the next booklet.knowing the output(s) generated and where they go. Frequently, outputs of sub-processes serve as inputs to other processes. Each sub-process output must represent value added to other processes to which it provides input.At this phase of your design, the team should only identify sub-processes or other larger elements of the process. While detailed design of sub-processes is not required at this stage, knowing where the key inputs come from and where the outputs go for each process will prove extremely valuable when the team creates a flow diagram of the proposed process later on.

13Develop Process and Process Control Features

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Quality by Design StepsEvaluate Current Process CapabilityDetermine to Design or Redesign ProcessesDevelop high-level process features and goalsDevelop detailed process features and goalsOptimize ProcessesDevelop Process CapabilityPublish final process designDeliverResultsDesignProductDefineOpportunityDiscoverCustomer Needs DevelopProcess

DefineOpportunityDiscoverCustomer NeedsDesignProductDevelopProcess & ControlsDeliverResultsDefine the opportunityCreate a project charter and launch teamCreate a project planIdentify all customersCreate a process map to follow the customersPlan collection of customer needsCollect customer needs in their language of benefitPrioritize customer needsTranslate needs into CTQsSelect high-level product features and goals (functional design)Develop detailed product features and goalsOptimize product features and goalsSet and publish final product designDevelop ProcessCollect known baselinesSelect general process designIdentify high-level process features and goalsIdentify detailed process features and goalsOptimize process features and goalsEstablish process capabilitySet and publish process final process designDevelop ControlsIdentify control subjectsDevelop feedback loopsDevelop control plansEstablish auditDemonstrate process capability and controllabilityPlan for transfer to operationsImplement planValidate transfer14Change to Chapter NameAll Rights Reserved, Juran Institute, Inc.Insert Code and Date Here

Step 1: Collect Known BaselinesConfirm all product features and goalsIdentify operating conditionsOutside organizationWithin organizationPhysical and humanHistory of effectiveness and efficiency of:Existing processesExisting sourced processesSimilar processesCompetitive or other production processesBenchmarked processesCustomer experienceProfessional literatureSimulation and estimationAdd innovative ideas for new processes

The first step in developing the new process is to confirm features and goals generated in the Design phase. Next, collect information to better understand the operating conditions under which the process will function, including environments both outside and inside the organization.The physical environment, such as temperature, noise, or light, can have impacts on process performance. For example, a team designing the process for handling customer inquiries should consider how environmental stress might influence the performance of customer service representatives.The design must account for the demands on the people working in the system, their skill, concentration, speed, endurance, analytical capability and so on. Multiple sources should be investigated to assist in the formulation of general process designs, supplemented by novel ideas.It is unlikely that you will use all the methods here, but consider them all, and use the ones that will give you the best basis for estimating and improving the capability of the process you will be building.Step 1: Collect Known Baselines

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RegulatorsPayersMediaPublicProcessorsDistributorsConsumersUsersExternal CustomersStep 1a: Define the Target CustomersInternal CustomersShippingManagementAccountingLegalGovernanceDownstream departmentsPotentialPurchasingSalesOperationsCustomers are a Cast of Characters

The term customer often is used loosely. This means that it is not always clear whether the reference is made about an organization, individual unit, or person. As you will discover, there are many types of customers, some obvious, others hidden. The examples above illustrate how a particular service company can have many different kinds of customers and how each one can have very different needs. The list is only a partial one. Many direct and potential customers were excluded, such as the management staffs of the respective companies, because there was not enough space to include them all. When your team creates its own customer list, be sure to include the full array of customers affected by your project. You should also be aware that when you start to identify your external customers, you often begin to uncover your internal customers as well. Fight the urge to work on both lists at the same time. When internal customers do appear, place them on a separate list as you may add to it at a later date.

Types of External Customers

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Example: Relocation Service CustomersSteps in the ProcessInternal Customers (Relocation Company)External Customers ObviousExternal Customers Less ObviousAgreementSales force who negotiate service contractClient contract administrationSenior Management client companySelectionRelationship manager who services client and client contact. Also resolves differences that may arise either within own organization or with clientClient contact person identifies relocating transferee.Also resolves differences that may arise either within own organization or with relocation companyIntakeIntake clerks who prepare "file" of new transferee entering systemTransferee and his or her family membersTransferee new managerRelocationService personnel, in branch locations, who work with transferee until property is sold or taken into inventory to be marketed at a later dateCurrent manager of transfereeAppraisers, title company, banks, inspectors, real estate brokers, government agencies, etc.Individuals who close the file after property has been sold to outside buyerReal estate attorneys: Buyer and sellerResale department which maintains and sells inventoried propertiesGardeners, painters, home repair contractorsClosingAncillary departments (e.g., transportation and home finding) that provide additional services to transfereeNew manager of transfereeMovers, real estate agents, banks, school systemsAccounts Receivable, Accounts PayableAccounts Payable, Internal departments which support the transferee and interface with him/herTransferee tax preparer

Example: Relocation Service CustomersSteps in the ProcessInternal Customers (Relocation Company)External Customers ObviousExternal Customers Less ObviousAgreementSales force who negotiate service contractClient contract administrationSenior Management client companySelectionRelationship manager who services client and client contactAlso resolves differences that may arise either within own organization or with clientClient contact person identifies relocating transfereeAlso resolves differences that may arise either within own organization or with relocation companyIntakeIntake clerks who prepare "file" of new transferee entering systemTransferee and his or her family membersTransferee new managerRelocationService personnel, in branch locations, who work with transferee until property is sold or taken into inventory to be marketed at a later dateCurrent manager of transfereeAppraisers, title company, banks, inspectors, real estate brokers, government agenciesIndividuals who close the file after property has been sold to outside buyerReal estate attorneys, both buyer and sellerResale department which maintains and sells inventoried propertiesGardeners, painters, home repair contractorsClosingAncillary departments (e.g., transportation and home finding) that provide additional services to transfereeNew manager of transfereeMovers, real estate agents, banks, school systemsAccounts Payable, Accounts ReceivableAccounts Payable, departments that support the transferee and interface with him/herTransferee tax preparer

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Step 1b: Define the Boundaries

START BoundarySTOP BoundaryProcess

What must suppliers provide?The final product or service

A helpful starting point is to begin the bounding activity with solid team consensus on the external customer(s) and the output(s) they receive from the process. When bounding the process, it is necessary to bound from two directions. Vertical bounding deals with the work scope of the process within a specific, single department. Horizontal bounding deals with the functional and/or cross-functional scope: functional activities within the process that are to be included or excluded.The main bounding considerations are:Name process, define start and stop pointsIdentify major process activities in the process, in orderIdentify the final customers from the last activitySpecify the outputs to those customersIdentify supplier and inputs to first activityComplete intermediate suppliers, inputs, outputs, customersValidate

Define the Boundaries

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Examples of Processes and BoundariesProcess NameStarting PointEnding PointMortgage OriginationObtain the ApplicationFinalize and CloseTraining DevelopmentDefine the Learning ObjectivesComplete Participant ManualBilling/PaymentSend Product or Provide ServiceReceive PaymentEmployee HiringApproval to HireNew Employee StartsNew Facility DesignCapital Budget ApprovedSend Design to ContractorProduct DesignReceive Design RequirementsSend Detailed Design to Design Review TeamDeal ApprovalRequests Quote (Customer)Approved Deal

How might different boundaries on the process affect the project?

How might you change some of these boundaries, and how would that affect the project?

Question for Thought

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Step 1c: Set Performance Goals and TargetsGoals for a design project are much more complicated and extensive than for DMAICThey must still be SMARTCustomer and QualitySatisfaction, LoyaltyNo defectsFinancial RevenueCostMargin

QbD Goals

Most QbD initiatives must meet multiple goals, unlike the much more focused DMAIC goals.All goals must beSpecificMeasurableAgreedRealisticTime-phased namely, completed by when?While the project goals need to be specific as to the customer and the general customer needs and benefits to be addressed, one should avoid excessive constraints that might lead to a suboptimal solution.The most common over-constraint is to specify the technological solution before the customers needs are understood and alternative ways of meeting those needs are fully explored. Companies that lead with technological innovation will naturally want to exploit their strength. They will be most successful when that strength is applied to developing options for clear needs rather than as the starting point.

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Step 2: Select General Process DesignIdentify general anatomySingle unitAssembly tree ProcessionIdentifyVendors/Suppliers/PartnersIn-house sourcingSelection of alternative plants, service centers, offices, etc.Draw high-level first and then detailed process flowsSIPOCDetailed Levels 1, 2, etc.

Do not assume that you will just repeat what you are accustomed to. Open your mind to possible different ways of organizing the work. Think creatively at the highest level.

In developing a general process design, it is useful to consider some basic process anatomies that have specific characteristics of which planners should be aware. A process anatomy is a coherent structure that binds or holds the process together, supporting creation of the goods or the delivery of the service. Examples are illustrated and discussed further on the next page.

With a general anatomy in mind, process mapping can begin, starting with a high-level SIPOC and progressively building detail through multiple levels of process flow diagramming depending the level of complexity. The detailed-level process map shows the complex sequence of steps needed to accomplish each task on the high-level process map. Through this hierarchy of high-level and detailed-level process maps, a team can build a complete, accurate pictorial description of the process. Suppliers and process participants initially are identified at this stage.

Step 2: Select General Process Design

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MultipleInputs

Single Unit

VendorsIn HouseSubassemblyFinal Assembly

Assembly TreeProcession

Step 2: Select General Process Design

Traditional process anatomies include:Single unit: All inputs flow into a single, autonomous department or process that produces a finished good or service.Assembly tree: Vendor and in-house suppliers provide components that are combined into subassemblies that are then incorporated into the final product.Example: An all-inclusive resort vacation will be assembled from subassemblies such as transport, lodging, dining, entertainment, and recreation. The transportation subassembly will be built from the flight, airport greeting, limo to resort, and on-grounds transport to villa.Procession: Work flows as a series of sequential steps to produce a finished good or service. There is no parallel processing or independent work on components.

For discussion, list examples of each traditional Process Anatomy and note what recommends each example.Process Anatomies

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Step 3: Identify High-Level Features & GoalsInclude in your design all departments and all suppliers with any inputs for the product/serviceRemember customer inputsCreate a Value Stream Map of the desired stateForecast demand Takt timeMaximize yieldIdentify constraintsBalanced flowMinimize lead timeMinimize inventoriesMinimize eight deadly wastesMaximize yield of the process by minimizing the defects produced

The Lean tool set will help you with the Value Stream Map and the efficiency, capacity, and timeliness performance of your process.

This section will focus on more tools to help improve the effectiveness: yield and quality of the output.Step 3: Identify High-Level Process Features and Goals

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Process Maps to define the steps needed to achieve the outcomeStep 3: Construct High-level Flow

Detailed Process

Measures

PSIOC

SuppliersInputsProcessOutputsCustomers or Internal CustomerCTQsCTQsMeasures

Process mapping is the graphic display of steps, events and operations that constitute a process.Benefits of Process Mapping Include:A structure for thinking through a complex process in a simplified, visible mannerAn ability to see the entire process as a teamAn ability to see that changes are not made in a vacuum and will carry through, affecting the entire process down the lineThe magnification of non-value added areas or stepsThe ability to identify cycle times for each step in the processSupplier: A person or organization that provides the inputs to your process.Input: Materials, resources and data required to execute your process.Process: A collection of activities that takes one or more kinds of input and creates an output that is of value to the customer.Output: The tangible products or services that result from the process-equivalent to a customer need.Customer or Internal Customer: A person or organization that receives the outputs of your processinternal or external.CTQs: A specific characteristic of the output that will determine the extent to which customer satisfaction is achieved.Boundary: The limits of a particular process, usually identified by the inputs and outputs, identifies what is outside the processwhere it starts and stops.

Process Mapping

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SIPOC Example

Example: SIPOC

This SIPOC is for a customer complaint process. Note that some steps may have multiple entries for suppliers, inputs, outputs or customers. Also note the Triple Role in effect. For example, Operations is a Customer for step 2, an processor for step 3 and a supplier for step 4.

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Concepts for High-Level Design

OptimumAlternativeFunctionsProcess Concept

CapabilityAnalysis

Concept#1

Concept#2

Concept#3Generate &Evaluate

Concept#4

Develop Your Own Roadmap for Design

You have learned in Discover Customer Needs how customers needs can be classified and sorted into a hierarchy: primary, secondary, tertiary, etc. Similarly, there can be a hierarchy of product features which respond to customers needs. For product design purposes, this hierarchy must be subdivided or broken down to the very lowest level of detail. Every feature, however tiny, requires its own design. The terminology used to designate the successive levels in the product hierarchy differs from industry to industry. In the case of business processes, the terms often used are: system; subsystem; process; activity; operation; task. In the case of physical goods, the usual terms are: system; subsystem; component; module; assembly; piece; part.The process for going from the system design level down to more detailed features of the product hierarchy is called product subdivision, product breakdown, etc. For large systems, the constituent elements can run into huge numbersthousands, and even hundreds of thousands. For such numbers, the need for structure becomes absolute since your spreadsheets become numerous and crammed with high-density information.To design new features first think about how to best define the functions for your product. You need to identify several different concepts or options for how you will deliver those functions. Many organizations have product development gates to move a product from concept to reality. Have your Design Engineers assist you in this step.In some cases, the functions are sufficiently independent of each other so that the different concepts may be had at the function level. In other cases, the design concept will relate to the entire collection of functions. After defining each of the concepts, you will evaluate the capability of each to meet the CTQs and project goals. You will select the optimal alternative concept and define it fully in your high-level design.

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Step 4: Identify Detailed Features & GoalsFacilities, equipment, staffing, training, maintenanceStandard Operating ProceduresStandard Work and Visual Factory, including 6SOptimizeSet targets and spec limits for inputsConduct tests:Individual stepsIndividual transactionsSub processesFull pilot/prototype runCreate Process Spreadsheet with detailed features and goals

In Step 3, high level process features and goals were identified. In Step 4, these are drilled down into further detail.

On the next page, you will see how the process features are aligned to product features.

Step 4: Identify Detailed Features and Goals

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The Design Spreadsheets

Output FeaturesProcess FeaturesDeal with contradictions up front.

Filling out the process design spreadsheet is an ongoing process throughout process development. The spreadsheet should have been continually updated to reflect design revisions from such activities as reviewing alternative options, designing for critical factors and human error, optimizing, testing process capability, etc. When you first selected these features and goals, you also entered the appropriate symbol onto the spread-sheet to reflect the degree of importance of these to meeting customers needs. As more detail was added to your design, new process features and process feature goals may have been added to the spreadsheet. Optimizing and measuring process capability may have resulted in the deletion of a number of features and goals because they were not suitable or necessary to the design. In addition, your investigations may have uncovered new customers which prompted you to re-examine the strength of the relationship between the product features and customer needs. Some process features and goals then became more important to customers while others became less important. Any change in this importance of the feature and goal should have also been noted on the process design spreadsheet by converting to the appropriate symbol to reflect the new relationship. The setting of final features and goals concludes with the final optimization of your design.

28The Design Spreadsheets

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Process Design Spreadsheet

.

Load database engineLoad database structureBurn in databaseRun setup queryMold TemperatureMold SpeedMold PressureScore*Detailed Product FeaturesWeight6.52.1 Meg query0.3059919284.1Mega Hard database engine0.193993.0500 Meg data storage0.14199181.7Carbon composite case0.081939211.7Auto web access option0.07801.40.3 mm pitch connectors0.06401.2AHP Validation Rules 0.05901.2ICD10 & CPT coding 0.05900.4Quarterly code update0.02004.54.01.62.70.70.20.7Unit of MeasureMIPSMbitMIPSSecoCrpmBarTarget14537140.1118012090USL0.1318512592LSL13.546713.517511588Maximum allowable defect rate (ppm)4441,0005,0005,0005,000* Raw score from Detailed Design analysis. Weight normalizes sum to 100.GoalDetailed Product Features to Process FeaturesWhat impact does each process feature have on each detailed product feature?TotalRelationshipTotal Ranking

This is a small part of a process spreadsheet.Begin at a high-level and add details.

29Process Spreadsheet

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Managing Development of Process FeaturesApproaches to consider:Divide work by clusters of needsDivide work by functionsWork as a team on each divisionAssign sub-teams to each major divisionConsult subject matter expertsAssure integration before proceedingDo the parts work well together?Does the net final result . . .Meet customer needs?Beat the competition?Meet business goals?

As your team decides which approach or combination of approaches to use for the selection of product features, you must also consider a number of other important issues regarding what type of product feature will be the best response to customers needs. When selecting product features, you need to consider whether to: Develop an entirely new functionality. Functionality is defined as the ability of a product or product feature to meet customer needs. A new functionality looks at satisfying the need in an entirely new and innovative way. For example, customers can call a telephone number to verify a service call. They can call anytime because of a new computerized phone system that allows customers to check the schedules using a cell phone. Replace old features with entirely new ones. This concept takes the form of satisfying an existing need in an entirely new way. For example, car radios traditionally have the controls on the unit themselves. A design of a new product feature would be to have the controls on the steering wheel. This addresses the need for safety by allowing the driver to change stations without taking his or her eyes off the road. You may discover in your analysis that there are redundancies or duplications of certain product features or that certain features are no longer required. An example is a medical supply manufacturing company which processes 700 special orders annually, with an average delivery time of three months. Investigation showed that only a few part numbers accounted for 95 percent of the special orders. The remedy was to convert these frequent specials into standard products. The delivery time dropped dramatically85 percent of the orders were now delivered within two days. The number of special orders dropped from 700 to 200 per year.

30Managing Development of Functional Features

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Step 5: Optimize Features & GoalsEffectiveness:DPU and FTYTolerancesCOPQReview and adapt:Criticality analysisFMEAFault tree analysisValue analysisTimeliness:Minimum lead timeOptimal service levelsEfficiency:Optimal process loadOptimal line balanceMinimize change overMinimum inventoriesMinimum staffing

As a trained Lean Six Sigma belt, you already know many tools to optimize your process design.From DMAIC you know how to diagnose root causes of defects from your process to reduce the defects per unit and increase the first time yield. You can use process capability to assess conformance with tolerances, and reduce costs of poor quality.You have also learned some new tools to help you proactively design higher effectiveness: criticality analysis, FMEA, fault tree analysis, and value analysis.The Lean tool set can help you improve the timeliness and efficiency of your new process. A value stream map, load charts, and value-added analysis can be applied to your new process design proactively and then be used to measure actual performance during test and early production.Study your new design to look for bottlenecks, delays from changeover, and impacts from equipment non-availability. Apply Lean tools to optimize the process before you go live.Assure that your designs are realized with standard work, visual controls, behavioral-based safety, SWIP, and 6S.Step 5: Optimize Features and Goals

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Design ConsiderationsConstraints include:Capital costAvailable spaceSafety concernsEnvironmental impact and projected effluents and emissionsWaste productionOperating and maintenance costs

Designs have objectives and constraints, and even a simple process requires a trade-off among such factors

Step 6: Establish Process CapabilityPause and complete Development of Controls before Design Verification Test Complete Design Verification Test

While Process Controls are discussed in detail in the next module, development of controls begins during the design of the process. When the design team begins testing the process to verify capability, controls are also being tested and verified. Simultaneous development of process and controls will result in a more efficient and robust process, whereas controls can then be designed into the process.

Before a process begins operation, it must be demonstrated to be capable of meeting its quality goals. Although the concept of process capability analysis emerged from manufacturing industries, measurement of process variation applies as well to the spectrum of processes in service industries.

Process Controls and Capability

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Step 7: Set & Publish Final Process DesignComplete Process Design Review based on Design Verification Test Complete and publish all documentationPlan for transfer to operations

Upon completion of the several iterations that occur during the DVT and pilot runs, the design is solidified and the results of the testing are summarized. A design review meeting marks the conclusion of the Develop Process phase when the results of the DVT are reviewed. The design scorecard is updated based upon the DVT results.Following the DVT, plans are made for ramp-up to full-scale processing. Additional pilot runs and process analysis may occur during the transfer to operations. These analyses may include capability analysis and measurement systems analysis.Process controls are verified and adjustments are made to the appropriate standard operating procedures, test procedures, work instructions, and other process documents. These formal documents are handed off to downstream process owners. These documents come under the stewardship of the organizations internal quality systems. One of the considerations of the design team is to ensure that the project documentation will conform to the internal requirements of the quality system.Complete DVT

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4 Steps for Successful Design InnovationBe systematic record information on spreadsheets.- Apply new and proven tools.- Include cross-functional staff in design review.Focus on the user or the customer.- Discover hidden customers and hidden needs.Confront contradictions or challenges directly.- Do not take no or cant for an answer.Design WORKFLOWS to deliver benefits that meet customer and business needs.

Developing product features allows you to dream about a whole range of possibilities without being hampered by any restrictions or preconceived notions. After you have selected a number of promising alternatives, you will have the opportunity to go back and weigh each one against any previous experiences, policies, regulations, standards, and certain quality planning tools which will ultimately determine which product features you will choose for your final product.Innovation is the process of creating something new. New, functional, and useful while meeting customer needs. Innovation does not just happen haphazardly. It happens through collaboration and systematic review of needs and the means to meet those needs.

35Successful Design Innovation

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