Engineering Processes and Project Management
- 1. Definition Plan Implementation Audit Core Processes Define Objectives - VOC - Concept Plan Design Develop Verify Prepare Validate Produce Data & Customer Feedback • New Products Development • Product Improvement • Portfolio Management • Project Management • Process Controls • Problems Solving • Technology Transfer Process Details • Risk Analysis Scaled and Tailored to Organization’s Needs
- 2. Definition Plan Implementation Audit New Product Development Define Objectives - VOC - Concept Plan Design Develop Verify Prepare Validate Produce Data & Customer Feedback • Periodic Project Portfolio Review Process Guide and Procedures • Define Priorities Phase IV Purpose: Pre-Production Product Development Process Guide Finalize the product design and validate that the product meets customer needs. • Focus on Fast Track Projects Prepare product(s) for full ongoing production and market place commercialization. Product Development Process Guide Description: The product design is refined to its final form. The final product design is documented and validated to meet Product Design Specification requirements and customer needs. Phase III Prototype The final phase of Manufacturing and Procurement Plans are conducted. Process design/development are conducted. Process Purpose: Design and document the preliminary product design, and verifyvendor sample evaluation are conducted in preparation for studies and that it Pre-Production Run. meets the Product Design Specification. Proceed with Manufacturing, Marketing, Support and Test Plans. Conduct a Pre-Production run. Samples will be used to validate both Description: The Product Development Team designs, documents and validatesmanufacturing processes. the design and the product(s) using existing systems. Product Development Process and product designs are refined after Pre-Production Run in Process Guide A rigorous cross-functional design review process is used throughout Ongoing Production. preparation for Full this phase. Implement the final phase of Support and Marketing Plans in • Focused Leader Delivers Project Goals Manufacturing, Marketing, Support and Test Plans proceed on a product commercialization. preparation for Phase II Feasibility parallel path. A rigorous cross-functional Design, Process and Program Phase Purpose: Deliverables: Select, define and commit to a product concept; define and initiate Reviews are conducted. plans for non-product design functions. • Prototypes • Preliminary Test Results; R & D Deliverables: and or Verification Testing Definition: The Project Team transforms the broad requirements Design Documentation: Drawings, Programs, • (what’s) of the • Final Design Doc.: Drawings, Test Specifications, Use Manuals!. Initial Product Specification into product design concept. • Release of Long Lead Parts • Final Risk Management Review: Risk Analysis, FMEA ! • Capex • Design & Process Reviews Product Development • Risk Management Review: Risk Analysis, FMEA • Process Studies Innovative concept alternatives that satisfy the Initial Product ! Process Guide Specification are explored. The most promising product concept is • FMEA • Product Validation & Test Results selected and documented during this phase (only one Design Review Results • concept for each • Manufacturing, Marketing, Support Plan Review system or sub-system). Concept development shouldProcess Review Results • be limited to • Pre-production Review, Product Team Sign-Off & ECN Release clarifying concept definitions and reducing risks to acceptable levels. Marketing, Support Plan Review • Manufacturing, Phase I Concept (note: concept development and design takes place in the next phase) • Project Plan (Tasks, Budget, Schedule) Phase Review and Approval are required prior to substantially moving to next Program phase. Some overlapping of phase activities is expected. Purpose: Identify, rigorously define and launch promising new product committed product concept is rigorously defined in a Product The Program Phase Review and Approval are required prior to substantially moving to next opportunities. This phase is arguably the most important Specification. Once approved, concept changes must be approved. part of the project. It defines our goals / targets. Shoot at the wrong target and phase. Some overlapping of phase activities is expected. • Consistent Processes Tailored to Needs even the most expert marksman gets no reward. Focusing our efforts Marketing, Support and Test Plans are defined. Parallel Manufacture, on the right target is essential. paths for each are initiated. Revision B Page: 10 Product Development Description: The Project Manager/Leader leads a cross-function team. Deliverables: Process Guide Engineering, Marketing and other department representatives are Specification (design specification) • Product members of the team or provide support. • Manufacturing, Marketing, Support and Test Plans • Risk Management Review: Risk Analysis, FMEA ! During this phase, customer/market needs, competitive analysis, • Project Plan (Tasks, Budget, Schedule) PRODUCT DEVLOPMENT PROCESS business needs and technological opportunities are synthesized by the • Review Long Lead Items team to define new product opportunities. These products opportunities are defined in the Initial Product Specification. • Design Review Purpose: To Deliver Profitable New Product to Our Customers. • DHF Review Ownership: Enterprise The Voice of the Customer is brought into the process through various methods: market research, customer interviews, questionnaires, etc. Approval are required prior to substantially moving to next Program Phase Review and Roles: Project Team Technological opportunities are compiledphase. Some overlapping of phase activities is expected. through various methods Revision B Page: 9 R&D, competitive analysis, design concepts and technology searches. Each Project or New Product Idea is entrusted to a Project Team. The Initial Product Specification is reviewed and approved by a cross- Highly Effective Teams: functional Management Team. Approved projects are prioritized and • Deliver the Project Plan overcoming the inevitable unforeseen launched when resources are available. obstacles. • Are a group of result-oriented professionals working together in a Initial Product Specifications contains: high trust environment to get the project done right. • Product Specification (market driven, broad high level requirements, • Are committed to the customer, the project objectives and delivering what needs to be accomplished, not solutions) their project plan, from the start. • Target Cost and Price; Projected Sales Volumes • Emphasize frequent and effective team communication to • Business case (development and product cost, return, etc.) support/speed decision making and action. • Fit With Product Line Strategy • Proceed with a sense of urgency, ownership and empowerment. • Competitive Analysis Revision B Page: 8 • Make the project decisions. • Development Risks • Complete tasks as early as possible. • Resource Requirements • Complete tasks in a parallel or overlapping manner were possible to • Development Budget And Schedule Constraints compress cycle time. • Have a "Can Do" attitude. Deliverables: • Initial Product Proposal The Project Team owns the success of the project! Program Phase Review and Approval are required prior to substantially moving to next Management Team phase. Some overlapping of phase activities is expected. The Management Team's role: • Launching projects & supporting implementation. Empowering Team to run their project. • Ensure management understanding, consensus and buy-in Revision B Page: 6 • Allocating resources (Human, Financial & Physical) • Project oversight • set objectives (approve changes when necessary) • budget/schedule approval • cancel projects when necessary • address barriers that impede progress • Support and coach the Project Team Revision B Page: 3
- 3. Definition Plan Implementation Audit Process Cycle Time Reduction Define Objectives - VOC - Concept Plan Design Develop Verify Prepare Validate Produce Data & Customer Feedback Company News Letter • New Product Development Process Improvements • New Technology Transition • 10% sales growth that grew to double sales within a two years
- 4. Definition Plan Implementation Audit Product Improvement Engineering Define Objectives - VOC - Concept Plan Design Develop Verify Prepare Validate Produce Data & Customer Feedback Focused On 1. Quality 2. Delivery 3. Cost Savings 4. Product Line Extension Product Improvements * Not Part of NPD Team Action Oriented Manage Work Manage Resources – Priorities & Availability Resources • Define Objectives and Plans • Cross-Functional • Review Progress Against Results • Dedicated, Focused, Separate From NPD • Collaborate with NPI Problem Solving Short Term – Max Gain in Shortest Time with Limited Risk Measure Progress and Results Long Term – Root Cause Solution - No Question of Adequacy
- 5. Definition Plan Implementation Audit Product Line Planning Define Objectives - VOC - Concept Plan Design Develop Verify Prepare Validate Produce Data & Customer Feedback
- 6. Definition Plan Implementation Audit Fast Experimentation Define Objectives - VOC - Concept Plan Design Develop Verify Prepare Validate Produce Data & Customer Feedback Kaizen Event - Several Days - Cross-functional 1. Visit Customers, Observe 3. Mockup Ideas and Define Needs 2. Team Meets & Brainstorms 4. Evaluate – Refine 5. Reconnect with Customers
- 7. Definition Plan Implementation Audit Project Management Define Objectives - VOC - Concept Plan Design Develop Verify Prepare Validate Produce Data & Customer Feedback Qtr 2, 2002 Qtr 3, 2002 Qtr 4, 2002 Qtr 1, 2003 Qtr 2, 2003 Product Development Process Guide Name Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May 103 Obsolescence/Service Parts Howard Loewenthal;Dale Nash;Wes;Dave A. 104 Electronics Design and Build 105 106 Initial Design Drawings Tom Neroda Drafting Major Innovations, Platform & Significant Derivations, Project Checklist 107 Initial Prototype Tom Neroda 108 Testing & Evaluation Tom Neroda;Dave Mahilo Phase I Phase II Phase III Phase IV Phase V Phase IV 109 Design Iteration Tom Neroda Concept Feasibility Prototype Pre-Production Production Audit & Continuous Improv’t 110 Prototype Iteration Tom Neroda • Gantt Charts and Checklists 111 Testing & Evaluation Tom Neroda;Dave Mahilo 112 Drawing Revision Drafting Product Proposal ! Define Concepts Alternatives ! Preliminary Design (Prototype) ! Refine & Finalize Design ! Full Production ! Customer Satisfaction Audit ! Project Objectives 113 Develop Pendant Design Tom Neroda;Ann Fleming;Gary H. ! Select Concept & Freeze ! DFMA/VA ! Detail Design/Draw’s/Spec … ! Define Product Cost ! Top Level Product 114 Develop Test Plan Tom Neroda Requirements (Whats) ! Concept Review ! Preliminary FMEA ! User Documents ! Finalize Process Design 115 LA27 Tooling Gary H ! Market Analysis ! Concept DFMA/VA ! Prototypes ! Final FMEA ! Schedule Targets 116 Supplier Audit Gary H.;Gerry Finley ! Product Design Specification ! Prototype Tests ! Refine Product Cost Est. ! Product Cost Targets 117 CapEx Hi-Lo & Pendant Tooling Tom Neroda;Gary H.;Dave R. ! Project Costs (Estimate) ! Preliminary Product Cost Est. ! Field Evaluation ! Pre-Production Test & Validate 118 Release Hi-Lo & Pendant Tooling Tom Neroda;Gary H. ! Resource Requirements ! Risk Analysis ! Quality Returns Assessment ! Design Verification ! Finalize Product Sepc. 119 Run Production Parts Gary H. ! Competitive Analysis ! Regulatory Req’ts Assessment ! Refine Product Cost Est. ! Transfer DHF 120 BOM Update Tom Neroda ! Concept Alternative ! Patent Search ! Test Plan Review & Approval ! Pre-production Run 121 Obsolescence/Service Parts Dale Nash;Tom Neroda;Gary H ! Manufacture Assessment 122 Risk Analysis / Bed End Initial Andrew Spriegel;Dave Mahilo;Ron Cline;Howard Loewenthal;Gerry Finley;Linda G;Steven Snyder ! Capacity Study 123 Risk Analysis / Bed End Final Andrew Spriegel;Dave Mahilo;Ron Cline;Howard Loewenthal;Gerry Finley;Linda G;Steven Snyder ! Capex ! Finalize Process Design 124 Risk Analysis / Bed End Peer Review Andrew Spriegel;Dave Mahilo;Ron Cline;Howard Loewenthal;Gerry Finley;Linda G;Steven Snyder ! Explore Process Alternative ! Explore Process Alternative ! PPAP; Purch. Part Qualificati’n 125 Risk Analysis / Electronics Initial Tom Neroda;Dave Mahilo;Ron Cline;Howard Loewenthal;Gerry Finley;Linda G;Steven Snyder ! Peer Review ! Finalize Control Plan 126 Risk Analysis / Electronics Final Tom Neroda;Dave Mahilo;Ron Cline;Howard Loewenthal;Gerry Finley;Linda G;Steven Snyder ! Risk & Hazard Assessment ! Risk & Hazard Assessment ! Risk & Hazard Assessment 127 Risk Analysis / Electronics Peer Review Tom Neroda;Dave Mahilo;Ron Cline;Howard Loewenthal;Gerry Finley;Linda G;Steven Snyder ! Review Business Case ! Review Business Case ! Review Business Case 128 Field Evaluation Dale Nash ! Project Schedule/Management ! Project Schedule/Management ! Project Schedule/Management 129 Quality and Process Control Plan Gerry Finley Define: Cross-functional Review: Cross-functional Review: Cross-functional Review: Review of Results: 130 Savings from Maint Free Bed End Dale Nash;Andrew Spriegel;Howard Loewenthal ! Design ! Design ! Design ! Customer Satisfaction 131 Marketing Plan Dale Nash ! Process & MFG Plan ! Process & MFG Plan ! Process & MFG Plan ! Process & MFG Plan ! Design 132 Photo Shoot Dale Nash ! Marketing Plan ! Marketing Plan ! Marketing Plan ! Marketing Plan ! Cost ! Support Plan ! Support Plan ! Support Plan ! Support Plan ! Sales 133 Initial Financial Rollup Dave Rades ! Test Plan (including R&M) ! Test Plan ! Test Plan ! Test Plan ! Cost Down 134 Initial Financial Rollup Dave Rades ! Requirements Quality Index ! Requirements Quality Index ! Product Release - ECNl 135 Prototype Program Review HCNGB Team ! Program Review & Approval ! Program Review & Approval ! Program Review & Approval ! Program Review & Approval ! Program Review & Approval 136 Product Documentation ! Launch Cross-functional Team ! Open Project File ! Release Long Lead Items ! Finalize Design ! ECN - Production Release Untitled - page4 ! Project Team Commitment Revision B Page: 13 % Complete Item / Status Action Item / Next Step Owner 2 5 7 1 When (Accountable) 5 0 5 0 0 Training General, Products, Doc and Testing Russ P 2/10 • Project Tracking Leader in US Russ P 3/1 to 3/21 Subject: Global Engineering Initiative To: George Status As Of: November 10, 2003 From: R. Pizzuto 2. Celebrate!! Date: November 10, 2003 CC: M. : Resent Successes, Milestones Completed 1. 4. Office and Lab Plan Summary Trip To China November 1 through November 8 % Complete (Major Milestones, Tasks) Item / Status Action Item / Next Step Owner 2 5 7 1 When (Accountable) 5 0 5 0 Goal: Gather Information Necessary to Select City & Locate Engineering Center 0 Oct Nov Dec Jan Feb Mar Apr May Jun Select City Define Requirements Russ P Determine Cost to Setup Office Not located at Intco Dave M Open Train Start Major Select Location Hire Leader Leader Const. Eng. In Assign Train Leader in US Assess Talent Base – Key Point Suzhou Visit Shanghai Russ P 11/1 to 11/7 Milestones Select Office Starts Office Center China ments Assess Transportation ! Modern, good facilities - Setup visit w/ real Estate Agent Russ P 11/1 to 11/7 11/4 – 11/7 Gather Info & Contacts for Startup Process ! Limited design engineering - Define cost and benefit Russ P 11/1 to 11/7 Trip China: Phone/Video - Leader & Holiday Eng. and Leader Train in US ! Between Shanghai & Intco Visit Suzhou Russ P 11/1 to 11/7 st ! Shanghai/Suzhou Interview Tech Starts Drftr. Start Real Estate Search 1 Wk Nov. - Setup visit w/ real Estate Agent Russ P 11/1 to 11/7 ! SGS Lab - Sign Lease ! Greg Flolid and Dave Mahilo ! 2 Real Estate Agents – shanghai - Define cost and benefit Russ P 11/1 to 11/7 ! Define Talent Base Trip to China Trip China ! Shanghai ! 1Real Estate Agent Select City Russ P 11/14 ! Def. Office Cost - Interview Tech - Construct Lab, - Train CAD and Leader Office & comp. & Doc.; o 2 Real Estate Agents Move Into Office Visit China to Select Office Site Russ P 12/9 to 12/13 11/14 - Make Offers - Hire Secretary IVC Prod. Sign Lease Russ P 1/10 Select City o 1 Recruiter Complete renovation & move In Eng Man 1/10 to 2/10 Tasks - ID Properties - Temp Office And of Interest o SGS Labs Install Computers Tom H 1/10 to 2/10 Events - Interview ! Suzhou Install Software and Database Tom H 2/15 Start Search Engineer Lab Setup st 1 Double Drum Dave M 11/1 for Others Drafters o IDEX Plant Define Lab requirements Dave M China o 1 Recruiter Establish SGS Relationship Define Goal & Negotiated Agreement Dave M Install & test o 1 Real Estate Softw. & Comp. ! Nanjing Invamex o Medical Products Show Sanford " 11/10 1. Status of Tasks: Black On Plan, Gay Complete, Blue Change, Yellow At Risk or Incomplete Plan, RED High Risk or Negative Impact , Global Tracker China Move 03-11-06.doc Yellow Important & Concerned Not Out of Bounds; Red High Risk Important & Out of Bounds At Pg. 4 Global Tracker China Move 03-11-06.doc Yellow Important & Concerned Not Out of Bounds; Red High Risk Important & Out of Bounds At Pg. 1 Global Tracker China Move 03-11-06.doc Yellow Important & Concerned Not Out of Bounds; Red High Risk Important & Out of Bounds At Pg. 2 Invacare Corp. Confidential 11/29/11 Invacare Corp. Confidential 11/29/11 PROJECT SUMMARY PROJECT: CHAIR Revised: 6-Sep-10 SUMMARY Original Business Goals PROJECT STATUS PERCENTAGE OF COMPLETION DATES AOP PROJECT Project Increm. Margin US$ 200,000 RED - Yellow - Green PLAN / ACTUAL Launch Date Objective Aug,2010 25% 50% 75% 100% INPUT 2/3/10 • Project Book S1 2/3/10 INPUT GOALS Target Annual Volume Year 2 S2 4/16/10 Product/Product Line ASP Unit Cost Intro Yr Year 2 Year 3 Inc. Margin PROCESS EU (H273) $317 $120 $0 $0 $0 $0 S3 90% 10/31/10 S4 11/15/10 EU (H263) $219 $1,100 $0 $0 $0 $0 S5 2010-12-15 (Launch) 0 $0 $0 $0 $0 $0 $0 0 $0 $0 $0 $0 $0 $0 PROJECT OVERVIEW TOTAL 0 0 0 $0 Chair Models: utilizes 23” rear wheels with hand rim and 18 !” seat utilizes 5” casters all around with 18 ! “ seat S1 - TARGET FINANCIAL SUMMARY Target Annual Volume Year 2 Product/Product Line ASP Unit Cost Intro Yr Year 2 Year 3 Inc. Margin The products have good selling and good margin in US market, as well as high customer satisfaction (almost no US complaints). Marketing 6895-EU (H273) $317 $170 3,000 7,000 7,700 $180,000 study shows the proposed products will also have good business results in European market. Redefined verification tests in ATL will be 6891-EU (H263) $219 $154 1,200 2,800 3,200 $15,000 performed before product lauch. There might also be slight changes to the proposed products if necessary. Product 3 $0 $0 0 0 0 $0 Product 4 $0 $0 0 0 0 $0 TOTAL 4,200 9,800 10,900 $195,000 S2- PLAN FINANCIAL SUMMARY PLAN Annual Volume Year 2 PROJECT TEAM Product/Product Line ASP Unit Cost Intro Yr Year 2 Year 3 Inc. Margin Business results Mngr Jim Engineering Lead Roger 6895-EU (H273) $317 $170 3,000.0 7,000.0 7,700.0 $180,000.0 Implementation Mngr Ken Engineering Support Li 6891-EU (H263) $219 $154 1,200.0 2,800.0 3,200.0 $15,000.0 Test Harold Product 3 $0 $0 0.0 0.0 0.0 $0.0 Category Product Mngr George Product 4 $0 $0 0.0 0.0 0.0 $0.0 Operation Lead N/A TOTAL 4,200.0 9,800.0 10,900.0 $195,000.0 Regulatory /Quality Dirk Sourcing Tim Andres Romann Finance Frank S3 - DEVELOP TEST & DESIGN FINANCIAL SUMMARY PLAN Annual Volume Year 2 Product/Product Line ASP Unit Cost Intro Yr Year 2 Year 3 Inc. Margin 6895-EU (H273) $0 To be defined $0 $0 $0 $0 CURRENT STEP 6891-EU (H263) $0 $0 $0 $0 $0 $0 Product 3 $0 $0 $0 $0 $0 $0 Currently in S3 - Develop, Verify and Detailed Design Product 4 $0 $0 $0 $0 $0 $0 TOTAL $0 $0 $0 $0 All the verification tests completed and passed except for BIO test for Back upholstery. BIO test failed on existing Back upholstery sample. Sourcing has found two new suppliers for better UPH. S4 - PREPRODUCTION FINANCIAL SUMMARY PLAN Annual Volume Year 2 Product/Product Line ASP Unit Cost Intro Yr Year 2 Year 3 Inc. Margin Product 1 $0 $0 0 0 0 $0 Product 2 $0 $0 0 0 0 $0 Product 3 $0 $0 0 0 0 $0 Product 4 $0 $0 0 0 0 $0 TOTAL 0 0 0 $0 NEXT STEP Get new samples of UPH and have BIO test and retest on CAL117, RoHS test. S5 - ACTUAL FINANCIAL SUMMARY PLAN Annual Volume Year 2 Update cost information. Product/Product Line ASP Unit Cost Intro Yr Year 2 Year 3 Inc. Margin Product 1 $0 $0 0 0 0 $0 Product 2 $0 $0 0 0 0 $0 Product 3 $0 $0 0 0 0 $0 Product 4 $0 $0 0 0 0 $0 TOTAL 0 0 0 $0 Invacare Corp., Elyria Ohio Page 3 of 3 Invacare Corp., Elyria Ohio Page 1 of 3 o Gate Review Record S2 CONCEPT & PROJECT PLAN S2 CONCEPT & PROJECT PLAN PROJECT: CHAIR Revised: 28-Apr-10 PROJECT: CHAIR GENERAL STATUS OF S2 Marketing specification finished. Market data acquired from the various EU markets. Business case is finished. Project plan is made. Product Manager: George Plan Sales Launch Date: 30-Aug-10 Business Results Manager: MatthiGeorgeas Schmidt Bonath Chinese Projoect Leader Roger Implementation Manager: Ken Support GENERAL DESCRIPTION OF PROJECT Finance: Support Certification of the Chair to EU standrads to launch the product on the EU markets in 2010. Ops/Sourcing: Wilson Support KEY CHARACTERISTICS - That Define/Differential the Target Product/Product Line The folding mechanism represents a un-common but well appreciated feature in most markets, as storage in institution is made easy. ACTIVITIES/ APPROVAL GATES The aluminum frame provides corrosion protection without adding the weight (and price) of stainless steel. The standard padded seat S2 CONCEPT & PROJECT PLAN Project Plan - Team Approval CONCEPT & PROJECT PLANcost S2 Schedule, can be attached in four different orientations providing space for the personal hygiene of the patient. This feature is un-common and unique on EU markets. The chairs comes completely assembled and can be use out-of-the-box. PROJECT: CHAIR Revised: 28-Apr-10 Freeze product Spec PROJECT: CHAIR Meet Regulatory & Standards Requirements The robust and simple frame design is ideal day long use in hospitals and all accessories GENERAL STATUS OF S2 heel loops) (safety belt, soft seat, insert, PROJECT PLAN BUSINESS CASE Business case approval come standard. The soft backrest add comfortspecification finished. Market data acquired from the various EU markets. Business case is finished. Marketing for the user. Test Plan Approved Project plan is made. Product Manager: George Plan Sales Launch Date: 30-Aug-10 Business Results Manager: MatthiGeorgeas Schmidt Bonath Chinese Projoect Leader Roger PLAN FINANCIAL SUMMARY PLAN Annual Volume Year 2 Marketing plan finalized Implementation Manager: Ken Support Product/Product Line ASP Unit Cost Intro YrGENERAL DESCRIPTION OF 3 Year 2 Year PROJECT Margin Inc. Finance: Support EU (H273) Certification of the Chair to EU standrads to3,000 the product on the EU markets in 2010. $317 $170 launch 7,000 7,700 180,000 S2 Key Action Plans Ops/Sourcing: Wilson Support KEY CHARACTERISTICS - That Define/Differential the Target Product/Product Line EU (H263) $219 $154 1,200 2,800 3,200 15,000 Target Date Rev. Date % Done Status The folding mechanism represents a un-common but well appreciated feature in most markets, as storage in institution is made easy. Product 3 - Marketing Plan & Freeze Prod ACTIVITIES/ APPROVAL GATES Spec. 1/29/10 Closed The aluminum frame provides corrosion protection without adding the weight (and price) of stainless steel. The standard padded seat Product 4 - Product Concept Selection 1/30/10 Project Plan - Team Approval N/A Schedule, cost can be attached in four different orientations providing space for the personal hygiene of the patient. This feature is un-common and TOTAL 4,200 9,800 10,900 $195,000 - Business Case 1/31/10 Freeze product Spec Closed Meet Regulatory & Standards Requirements unique on EU markets. The chairs comes completely assembled and can be use out-of-the-box. INTENDED USE OF THE PRODUCTS and EXPECTED LIFE Product cost 2/1/10 Closed The robust and simple frame design is ideal day long use in hospitals and all accessories (safety belt, soft seat, insert, heel loops) PROJECT PLAN BUSINESS CASE Business case approval To provide aid for showering and toiletingstandard. The soft backrest add is at a level the user. come to individuals whose disability comfort for that prevent them from performing these PLAN BY REGION Incremental margin 2/2/10 Closed/ Test Plan Approved activities without the assistance of this product. North A Europe Australasia Revenue 2/3/10 Closed/ User should be trained by a medical professional. Product/Product Line PLAN FINANCIAL SUMMARY Volume Sales US$ S2 CONCEPT & PROJECT PLAN US$Volume Volume Sales US$ Volume PLAN Annual Sales Year 2 - Project Plan 4/10/10 Marketing plan finalized Closed S2 CONCEPT & PROJECT PLAN The chair is used in institution (60%) and homecare (40%) environment for transit between the bedroom area and the shower. EU (H273) 1,650 Product/Product Line690,000 ASP 7,000 2,200,000 Unit Cost Intro Yr Year 2 Year 3 Inc. Margin- Qualification Plan (Test, TUV!) 4/2/10 Closed Additional use as a toliet commode. EU (H263) EU (H273) 200,000 500 PROJECT: CHAIR$170 2,800 $317 615,000 3,000 7,000 7,700 180,000 Revised: 28-Apr-10 S2 Key Action Plans PROJECT: CHAIR GENERAL STATUS OF S2 The product will be used 365 days per year by a single (homecare) or multiple (up to eight per day in instituinal use) user(s). Product 3 EU (H263) $219 $154 1,200 2,800 3,200 MARKETING PLAN 15,000 Target Date Rev. Date % Done Status Marketing specification finished. Market data acquired from the various EU markets. Business case is finished. The SP version is used for people with a higher level of independance or with disabilities limited to the lower limbs. Project plan is made. Product 4 Product 3 Product Manager: George Plan Salesproduct will be positioned as 30-Aug-10 The Launch Date: an - Marketingshower commode, the Aquatec Ocean will represent the upperClosed the range. Both entry level Plan & Freeze Prod Spec. 1/29/10 Business Results Manager: end of MatthiGeorgeas Schmidt Bonath Chinese Projoect Leader Roger TOTAL Product 4 $890,000 2,150 9,800 $2,815,000 0 $0 versions of the Mariner will be sold at the same price in Selection a quick switch from 1/30/10 products. USPs in EU will be the - Product Concept EU to allow the old N/A Implementation Manager: Ken Support TOTAL 4,200 GENERAL DESCRIPTION OF PROJECT 9,800 10,900 $195,000 seat positions, Aluminum frame and foldable design. The products will mainly focus on France, Portugal, Spain with possible different - Business Case Finance: 1/31/10 Closed Support upsides in Germany, Sweden and UK. The product name will be changed to "Lima" in the EU to avoid issues with the bathboard INTENDED USE OF THE PRODUCTS and EXPECTED LIFE EFFECTS ON EXISTING PRODUCTS Certification of the Chair to EU standrads to launch the product on the EU markets in 2010. Product cost Ops/Sourcing: 2/1/10 Closed Wilson Support "Marina". To provide aid for showering and toileting to individuals whose disability is at a level that prevent them fromProduct/Product Line KEY CHARACTERISTICS - That Define/Differential the Target performing these Depending on tender and contract PLAN BY REGION situations the following products will be discontinued six to twevel months after the launch of the Incremental margin 2/2/10 Closed/ activities without the assistance of this product. The folding mechanism represents a un-common but well appreciated feature in most markets, as storage in institution is made easy. Mariner: North A Europe Australasia Revenue ACTIVITIES/ APPROVAL GATES Closed/ 2/3/10 User should be trained by a medical professional. QUALIFICATION CRITERIA - REGULATORY & STANDARDS CONSIDERATIONS The aluminum frame provides corrosion protection without adding the weight (and price) of stainless steel. The standard padded seat - H243 Cascade, H253 Cascade, Lagon Product/Product Line 5", Lagon 22" Volume Sales US$ Volume Sales US$ Volume Sales PRODUCT CONCEPT STATUS US$ - Project Plan 4/10/10 Closed ISO 7176 (for 6895 only) adjusted to product is used in institution (60%) andcan be attached in environment for transit between the space for the personal hygiene of the patient. This feature is un-common and The chair segment homecare (40%) four different orientations providing bedroom area and the shower. Sales volume is estimated to be transferred to EU (H273) Mariner sales by 95% 1,650 690,000 7,000 2,200,000 Based on the adjusted specification from Matthias, Plan (Test, TUV!) made for NA can 4/2/10 - EU needs. No Closed change is - Qualification the current product Projectsatisfy Team Approvaldesign Plan Schedule, cost Freeze product Spec MDD, Directive 93/42/EWG Meet Regulatory & Standards Requirements Additional use as a toliet commode. unique on EU markets. The chairs comes completely assembled and can be use out-of-the-box. EU (H263) 500 200,000 2,800 615,000 foreseen. MD, Directive 06/42/EG The product will be used 365 days per year by a single (homecare) or multiple ideal day long use in in instituinal use) accessories (safety belt, soft seat, insert, heel loops) The robust and simple frame design is (up to eight per day hospitals and all user(s). RESOURCE REQUIREMENTS Product 3 TOOLING COSTS - US$ PROJECT PLAN BUSINESS CASE MARKETING PLAN Business case approval ISO 10535 The SP version is used for people with a come standard. independance or with disabilities limited to the lower limbs. higher level of The soft backrest add comfort for the user. Eng 1.2 person*month Product 4 N/A The product will be positioned as an entry levelTest Plan Approved the Aquatec Ocean will represent the upper end of theISO 12182 shower commode, range. Both ATL 0.4 person*month TOTAL 2,150 $890,000 PLAN FINANCIAL SUMMARY 9,800 $2,815,000 0 $0 PLAN Annual Volume versions of the Mariner will be sold at the sameMarketing plan allow a quick switch from the old products. USPs in EU willISO the price in EU to finalized be 60601 Year 2 different seat positions, Aluminum frame and foldable design. The products will mainly focus on France, Portugal, Spain with possible Separate testing specification is identified in the test plan Product/Product Line ASP Unit Cost Intro Yr Year 2 Year 3 Inc. Margin EFFECTS ON EXISTING PRODUCTS upsides in Germany, Sweden and UK. The product name will be changed to "Lima" in the EU to avoid issues with the bathboard EU (H273) $317 $170 3,000 7,000 7,700 180,000 S2 Key Action Plans Depending on tender and contract situations the following products will be discontinued six to twevel months after the launch of the "Marina". Mariner: EU (H263) S2 CONCEPT & PROJECT PLAN* S2 GATE REVIEW APPROVALS $219 $154 1,200 2,800 3,200 15,000 S2 CONCEPTRev.PROJECT PLAN Target Date & Date % Done Status RISKS, CHALLENGES & FEASIBILITY Product 3 - Marketing Plan & Freeze Prod Spec. 1/29/10 Closed QUALIFICATION CRITERIA - REGULATORY & STANDARDS CONSIDERATIONS REGIONAL CONSIDERATIONS Risks: Design of the Mariner (especially toliet pan & H253 Cascade, Lagon 5", Lagon 22" - H243 Cascade, holder) are un-common in EU. Possibly longer time for market penetration CHAIR Signature PRODUCT CONCEPT STATUS Date Comments Product 4 PROJECT: or Revised: - Product Concept Selection 28-Apr-10 PROJECT: CHAIR 1/30/10 N/ARegion user manual and typelable ISO 7176 (for 6895 only) adjusted to product segment have to be used. GENERAL STATUS OF S2 acceptance problems. Sales volume is estimated to be transferred to Mariner sales by 95% John Based on the adjusted specification from Matthias, the current product made for NA can satisfy EU needs. No design change is John Approved TOTAL 4,200 9,800 10,900 $195,0004/27/10 - Business Case 1/31/10 Closed Common transport package with NA region can be 93/42/EWG MDD, Directive used. If that acceptance causes major issues, the design of the pan holder has to be changed to accomodate an EU style pan. VP of Product Category foreseen. INTENDED USE OF THE PRODUCTS and EXPECTED from the various EU markets. Business case is finished. Marketing specification finished. Market data acquired LIFE Product cost 2/1/10 Closed MD, Directive 06/42/EG Project plan is made. RESOURCE REQUIREMENTS Product Manager: - US$ TOOLING COSTS George Jim Plan Sales Launch Date: Jim approved30-Aug-10 Business Results Manager: MatthiGeorgeas Schmidt Bonath ISO Projoect Leader Chinese 10535 Roger To provide aid for showering and toileting to individuals whose disability is at a level that prevent them from performing these PLAN BY REGION 4/23/10 Incremental margin 2/2/10 Closed/ Eng 1.2 person*month N/A VP/Director of Quality Implementation Manager: Ken Support 12182 activities without the assistance of this product. North A Europe Australasia Revenue 2/3/10 Closed/ ISO GENERAL DESCRIPTION OF PROJECT Tim approved Finance: Support 60601 User should be trained by a medical professional. ATL 0.4 person*month Product/Product Line Volume Sales US$ Volume Sales US$ Tim Volume Sales US$ 4/23/10 - Project Plan 4/10/10 Closed ISO Certification of the Chair to EU standrads to launch the product on the Engineering in 2010. VP/Director of EU markets The chair is used in institution (60%) and homecare (40%) environment for transit between the bedroom area and the shower. EU (H273) 1,650 690,000 7,000 2,200,000 - Qualification Plan (Test, TUV!) Ops/Sourcing:4/2/10 Wilson Closed Support Separate testing specification is identified in the test plan Frank approved Additional use as a toliet commode. KEY CHARACTERISTICS - That Define/Differential the Target Product/Product Line EU (H263) 500 200,000 2,800 615,000 Frank 4/22/10 ACTIVITIES/ APPROVAL GATES The product will be used 365 days per The folding mechanism represents a un-common but per day in instituinal use) user(s). year by a single (homecare) or multiple (up to eight well appreciated feature in most markets, as storage in institution is made easy. Product 3 Finance Representative MARKETING PLAN The aluminum frame provides corrosion protection without adding the weight (and price) of stainless steel. The standard padded seat * S2 GATE REVIEW APPROVALS The SP version is used for people with a higher level of independance or with disabilities limited to the lower limbs. RISKS, CHALLENGES & FEASIBILITY Product 4 Ronald Ronald approved Project Plan - Team Approval Schedule, cost The product will be positioned as an entry level shower commode, the Aquatec Ocean will represent the upper end of the range. Both can be attached in four different orientations providing space for the personal hygiene of the patient. This feature is un-common and 4/26/10 REGIONAL CONSIDERATIONS Risks: Design of the Mariner (especially toliet pan & holder) are un-common in EU. Possibly longer$890,000market penetration or $2,815,000 time for Director, Sourcing Signature Date Comments versions of the Mariner will be sold at the same price product Spec a quick switch from the old products. USPs in EU will be themanual and typelable have to be used. Freeze in EU to allow Meet Region user& Standards Requirements Regulatory unique on EU markets. The chairs comes completely assembled and can be use out-of-the-box. TOTAL 2,150 9,800 0 $0 The robust and simple frame design is ideal day long use in hospitals and all accessories (safety belt, soft seat, insert, heel loops) John different seat positions, Approved frame and Business case approval John Aluminum foldable design. The products will mainly focus on France, Portugal, Spain with transport package with NA region can be used. acceptance problems. PROJECT PLAN BUSINESS CASE 4/27/10 Common possible come standard. The soft backrest add comfort for the user. If that acceptance causes major issues, EFFECTS ON EXISTING PRODUCTSchanged to accomodate an EU style pan. the design of the pan holder has to be Optional VP of Product Category upsides in Germany, Sweden and UK. The product name will be changed to "Lima" in the EU to avoid issues with the bathboard Jim approved Test Plan Approved Depending on tender and contract situations the following products will be discontinued six to twevel months after the launch of the Jim "Marina". 4/23/10 PLAN FINANCIAL SUMMARY PLAN Annual Volume of Quality VP/Director Year 2 Marketing plan finalized Mariner: Product/Product Line ASP Unit Cost Intro Yr Year 2 Tim Year 3 Inc. Margin Tim approved QUALIFICATION CRITERIA - REGULATORY & STANDARDS CONSIDERATIONS - H243 Cascade, H253 Cascade, Lagon 5", Lagon 22" PRODUCT CONCEPT STATUS 4/23/10 Page 4 of 4 ISO 7176 (for 6895 only) adjusted to product segment S2 EU (H273) $317 $170 3,000 7,000 7,700 Page 2 180,000 VP/Director of Engineering of 4 Based on the adjusted specification from Key Action Plans product made for NA can satisfy EU needs. No design change is S2 Matthias, the current S2 Page 1 ofSales volume is estimated to be transferred to Mariner(H263)by 95% 4 EU S2 sales $219 $154 1,200 2,800 Frank 3,200 15,000 Target Date Rev. Date % Done Status MDD, Directive 93/42/EWG foreseen. Frank approved Product 3 4/22/10 - Marketing Plan & Freeze Prod Spec. 1/29/10 Closed MD, Directive 06/42/EG RESOURCE REQUIREMENTS TOOLING COSTS - US$ Finance Representative Product 4 - Product Concept Selection 1/30/10 N/A ISO 10535 Eng 1.2 person*month N/A Ronald Ronald approved 4/26/10 ISO 12182 in One Document TOTAL 4,200 9,800 10,900 Director, Sourcing $195,000 - Business Case 1/31/10 Closed ATL 0.4 person*month ISO 60601 INTENDED USE OF THE PRODUCTS and EXPECTED LIFE Product cost 2/1/10 Closed PLAN BY REGION Incremental margin 2/2/10 Closed/ Separate testing specification is identified provide aidplanshowering and toileting to individuals whose disability is at a level that prevent them from performing these To in the test for Optional activities without the assistance of this product. North A Europe Australasia Revenue 2/3/10 Closed/ User should be trained by a medical professional. Product/Product Line Volume Sales US$ Volume Sales US$ Volume Sales US$ - Project Plan 4/10/10 Closed RISKS, CHALLENGES & FEASIBILITY * S2 GATE REVIEW APPROVALS The chair is used in institution (60%) and homecare (40%) environment for transit between the bedroom area and the shower. EU (H273) 1,650 690,000 7,000 2,200,000 - Qualification Plan (Test, TUV!) 4/2/10 Closed REGIONAL CONSIDERATIONS Risks: Design of the Mariner (especially toliet pan & holder) are un-common in EU. Possibly longer time for market penetration or 615,000 Signature Date Comments Additional use as a toliet commode. EU (H263) 500 200,000 2,800 Page 2 of 4 S2 Region user manual Pagetypelable have to be used. and 4 of 4 S2 acceptance problems. Page 1 of 4 S2 John John Approved The product will be used 365 days per year by a single (homecare) or multiple (up to eight per day in instituinal use) user(s). Product 3 4/27/10 MARKETING PLAN Common transport package with NA region can be used. If that acceptance causes major issues, the design of the pan holder has to be changed to accomodate an EU style pan. VP of Product Category The SP version is used for people with a higher level of independance or with disabilities limited to the lower limbs. Product 4 The product will be positioned as an entry level shower commode, the Aquatec Ocean will represent the upper end of the range. Both Jim approved Jim TOTAL 2,150 $890,000 9,800 $2,815,000 0 $0 VP/Director of Quality versions4/23/10Mariner will be sold at the same price in EU to allow a quick switch from the old products. USPs in EU will be the of the different seat positions, Aluminum frame and foldable design. The products will mainly focus on France, Portugal, Spain with possible Tim Tim approved EFFECTS ON EXISTING PRODUCTS upsides 4/23/10 in Germany, Sweden and UK. The product name will be changed to "Lima" in the EU to avoid issues with the bathboard VP/Director of Engineering "Marina". Depending on tender and contract situations the following products will be discontinued six to twevel months after the launch of the Frank approved Mariner: Frank 4/22/10 Finance Representative QUALIFICATION CRITERIA - REGULATORY & STANDARDS CONSIDERATIONS - H243 Cascade, H253 Cascade, Lagon 5", Lagon 22" PRODUCT CONCEPT STATUS Ronald Ronald approved ISO 7176 (for 6895 only) adjusted to product segment Sales volume is estimated to be transferred to Mariner sales by 95% Based on the adjusted specification from Matthias, the current product made for NA can satisfy EU needs. No design change is 4/26/10 Director, Sourcing MDD, Directive 93/42/EWG foreseen. MD, Directive 06/42/EG RESOURCE REQUIREMENTS TOOLING COSTS - US$ Optional ISO 10535 Eng 1.2 person*month N/A ISO 12182 ATL 0.4 person*month ISO 60601 Separate testing specification is identified in the test plan Page 2 of 4 S2 Page 4 of 4 S2 Page 1 of 4 S2 RISKS, CHALLENGES & FEASIBILITY * S2 GATE REVIEW APPROVALS REGIONAL CONSIDERATIONS Risks: Design of the Mariner (especially toliet pan & holder) are un-common in EU. Possibly longer time for market penetration or Signature Date Comments Region user manual and typelable have to be used. acceptance problems. John John Approved 4/27/10 Common transport package with NA region can be used. If that acceptance causes major issues, the design of the pan holder has to be changed to accomodate an EU style pan. VP of Product Category Jim Jim approved 4/23/10 VP/Director of Quality Tim Tim approved 4/23/10 VP/Director of Engineering Frank Frank approved 4/22/10 Finance Representative Ronald Ronald approved 4/26/10 Director, Sourcing Optional Page 2 of 4 S2 Page 4 of 4 S2 Page 1 of 4 S2 • Management Summary
- 8. Definition Plan Implementation Audit Transfer Process Phases Define Objectives - VOC - Concept Plan Design Develop Verify Prepare Validate Produce Data & Customer Feedback Phase I - Plan, Identify & Define Phase II - Launch, Knowledge Transfer, Proof of Project Cost Strategic Planning & Concept Management Project Identification Led By Sending Team Model Q Jan-07 Target cost China Cost US Cost 1 Shipping cost based on shipping from Shanghai to GA 2 Cost is without parts from Apex. 3 Two brackets Cost reflects MSA pricing. 11/28/06: Added 10% increase to the Apex Actuator Project Definition Launch 4 VOH.11/28/06: New VOH was added. 5 Estmate Feasibility/Approve Model Q w/o Apex parts 2 $ 124.00 $ 101.00 $ 160.9800 M Launch Project Total Materials $ 124.00 $ 101.00 $ 160.98 & Preparation Labor and Overhead 5 N/A $ 26.62 $ 122.4253 Manufacturing Cost N/A $ 127.62 $ 283.41 Phase III –Process Development & Production Select Implementation 8% Transfer Margin N/A $ 10.21 N/A Total Cost Before VAT N/A $ 137.83 $ 283.41 Select Source Led By Receiving Team Cost With 4% VAT N/A $ 5.74 N/A M Transfer Total Cost before Shipping $ 124.00 $ 143.57 $ 283.41 Transportation Cost 1 $ 48.98 $ 48.16 $ 8.98 Total Cost to Invacare $ 172.98 $ 181.52 $ 292.39 Knowledge Transfer Total Price to Marketing $ 172.98 $ 191.73 $ 292.39 Gap Analysis & Plan Saving Invacare (w/o Apex) $ 119.41 $ 110.86 $ 0.00 T Confirm Notes: Cost of Apex Parts 3 $213.46 $204.82 $213.46 Confirm New Shipping Cost from Act. 4 $ 5.45 Total cost of Apex Parts $ 218.91 $ 204.82 $ 213.46 Concepts / Prototype Transfer Margin N/A $ 16.39 N/A Develop/Verify VAT on Transfer Margin $ 0.68 Total Cost to IVC $ 391.89 $ 387.03 $ 505.85 Total Price to Marketing $ 391.89 $ 413.62 $ 505.85 Process Development $ 496.87 Pilot Run & Design Change Verification T Preproduction M Preproduction Process Validation T Management Review Team Review M Sending Team Checklist Sending Team Project Preparation Required Who % Complete Target Date Revised Date Cost Saving Analysis Product Specification Countries Sold In Customer Issues Phase Out / Phase In VA Issues Models Being Tranfered & Rationalization Annual Volume Global Product Opportunities Market Launch ** In Distribution Center Ready To Sell Date: Service Parts Interfaces with products & components Cost (Use most significant or typical models.) Drawings BOM's Freight to APR MAY JUN JUL AUG SEP OCT NOV DEC Marketing Forecast NA NA 5,000 5,000 5,000 5,000 5,000 5,000 5,000 Process Instructions Product Material Labor Fix. OH Var. OH Tax Customer Total Material Content Mix CN & NY CN & NY CN & NY CN & NY CN CN CN CN CN Define Critical Print Features & Requirments CN Production 35 China 0 20 200 1,000 2,000 3,000 3,000 5,000 Measure Parts Against Drawings (Units) Pilot Run Product 1 Current 0 Landed in N.A. Check Material Against Purchaing Records 0 1/0/00 0 20 200 1,000 2,000 3,000 3,000 (Units) Work Instruction Against Actual Process Target 0 NY Production 100% 100% NY (Units) Current Models Current Models 5,000 4,980 4,800 4,000 3,000 2,000 2,000 Floor Space Used TOTAL IN N.A. 0 0 5,000 5,000 5,000 5,000 5,000 5,000 5,000 Processes Used (UNITS) Product 2 Current 0 Tooling Requirements & Equipment Model 101 8" Caster Drawings of Tooling Target 0 Model 102 Fork Stem H Blocks Fork Stems Seat Screws 1110069 & 1018225 Spring Drawings of Inspection Fixturing Uph Parts Hardware (NEW MODEL) Upholstery Buttons China Orders for Wheellock Spring Buttons 20225x000 Lock 1074462 & tbd tbd tbd tbd Video Tape Of Manufacturing Processes NY Components HT Bearing Fork Stems Nut Cancelled Capital 0 H Blocks Seat Screws China is working 1088472 Define Regulatory Requirements to qualify 100% Balance of (80K) Identify risks, gaps and existing problems Hardware Upholstery local China parts. Seat Screws Spring Buttons Qualification Requirements & Test Plan Savings Annual Volume Month Needed Jun-06 Jun / Jul-06 Jul / Aug-06 Aug-06 Aug-06 Nov-06 Dec-06 Jan-07 Feb-07 Risk Analysis Average Annual Saving/Unit Risk Management Buffer Components at NY NA NA 0 20 100 500 1,000 750 0 Process Control Characteristics Average Annual Savings 0 % of Risk Cover 100% 100% 50% 50% 50% 25% 0% 1. Identify which parts/components will be controlled 2. Define Functionality and determine a way to quantify Simple Return ** Capital Cost/Average Annual Savings #DIV/0! 3. Define a characteristic that can be measured accurately 4. Sample minimum 10 parts/components for defined PCC and determine Cp/Cpk Approval/Launch: Date: