Advanced Product Quality Planning and Control Plan eek? ad Second EditionADVANCED PRODUCT QUALITY PLANNING (APQP) AND CONTROL PLAN Reference Manual Second Edition taued Jina 1804, Sanne Poning Fetruaey 1998 (new ever ony: Beene lon, ay 2008 right © 1994, © 1995, © 2008 hoor Gororation, Fees Motor Company, an anor Motors Corporation ISBN: 970-1-60534-137FOREWORD Second Edition Effective November 1, 2008, APQP and Control Plan Second Edition replaces APQP and Control Plan First Edition unless otherwise specified by your customer. APQP and Control Plan Second Edition includes: ‘© incorporation of the customer focused process approach + updated terminology and concepts consistent with ISO/TS 16949 and other Chrysler, Ford and General Motors core tool manuals ‘© appropriate references to customer specifics provided without the full text ‘This manual continues to provide general guidelines for ensuring that Advanced Product Quality Planning is implemented in accordance with the requirements of the customer. It does not give specitic instructions on how to arrive at each APQP or Control Plan entry, a task best left to each organization. While these guidelines are intended to cover most situations normally occurring either in the early planning, design phase, or process analysis, there will be questions that arise. These questions should be directed to your authorized customer representative. ‘The Supplier Quality Requirements Task Force gratefully acknowledges the contributions of the following individuals and their respective companies that participated in the revision process. Bryan Book, Chrysler LLC, Chait Russ Hopkins, Ford Motor Company William Fick, General Motors Corporation Robert Minkler, Delphi Corporation Craig Williams, Eaton Corporation This document is copyrighted by Chrysler LLC, Ford and General Motors, all rights reserved, 200 Additional copies can be ordered from AIAG at ww. Orgenizations purchasing APQP Second Edition have permission to copy any forms and/or checklists contained herein. July 2008 iiiTABLE OF CONTENTS FOREWORD. oroccssessiososennnn iti i ni TABLE OF CONTE! INTRODUCTION... FUNDAMENTALS OF PRODUCT QUALITY PLANNING. Organize the Tea... Define the Scope. : Team-to-Team: : : ‘ . _ Training. Customer and Organization Involvement Simultaneous Engineoring. Control Pans Concern Resolution. Product Quatity Timing Plan. Plans Relative to the Timing Chart. CHAPTER I PLAN AND DEFINE PROGRAM. InTRopUCTION. . 1.1 Voice of the Customer. i 1.2 Business Plan and Marketing Strategy. 13 ProductiProcess Benchmark Data u 1-4 Product/Process Assumptions R 1.5 Product Reliability Studies. R 1.6 Cusiomer Inpuuis 2 17 Design Goals... : 2D 18 Reltabitty and Quan Goats 2 1.9 Preliminary Bill of Material. .0.c.0o0 2 1.10 Preliminary Process Flow Chart. B LL Prelininary Identification Of Spel Product and Pres Ch Characteristics. 7 mld 112 Product Assurance Plats 1.13 Management Support CHAPTER 2 PRODUCT DESIGN AND DEVELOPMENT ... INrmanucTION: 2.1 Design Failure Mode and Elects Analysis (DF MEA). 2.2 Design for Manufacturability and Assembly. 2.3 Design Verification 244 Design Reviews 2.5 Prototype Build ~ Control Plan 2.6 Engineering Drawings (Including Math Dats). 2.7 Engineering Specifications... 2.8 Material Specifications 2.9 Drawing and Specification Changes. 2.10 New Equipment, Tooling and Facilities Requirements. 2.11 Special Product and Process Characteristics. 2.12 Gages/Testing Equipment Requirements 2.13 Team Feesibiliyy Commioment and Management Support 22 CHAPTER 3 PROCESS DESIGN AND DEVELOPMENT. INTRODUCTION. 3.1 Packaging Standards and Specifications3.2 Product/Process Quatity System Review. 3.3 Process Flow Chart. 34 Floor Plan Layout . 3.5 Charaeterisies Matrix... 356 Process Feilure Mode and Effects analysis (PPMEA) 3.7 Pre-Launch Control Pla . 3.8 Process Instruc oe . 3.9 Measurement Srsiems Analisis Plan. 3.10 Preliminary Process Capability Study Plan. 3.11 Management Support CHAPTER 4 PRODUCT AND PROCESS VALIDATION.. DSTRODUCTION. cone 4.1 Significant Production Rus. 4.2 Measurement Systems Analsis 43 Preliminary Process Capability Study 44 Production Part Approval. .c.0.0 4.5 Production Validation Testing 4 Packaging Evaluation 4.7 Prohuction Control Plan. 48 Qualicy Planning Sign-Offand Management Support CHAPTER 5 FEEDBACK, ASSESSMENT AND CORRECTIVE ACTION IyTRoDUCTION. o 5.1 Reduced Variation. 5.2 Improved Customer Satisfaction 5.3 Improved Delivery and Service.. 3.4 Effective Use of Lessons Learned Best Practices. CHAPTER 6 CONTROL PLAN METHODOLOGY ... IntRoDuCTION, 6.1 Conrol Plan Column Descriptions. 6.2 Process Analysis. APPENDIX A PRODUCT QUALITY PLANNING CHECKLISTS... APPENDIX B_ ANALYTICAL TECHNIQUES. Assembly Build Varlation Analysis... Benchmarking : Cause and Effect Diagram. Characteristies Matrix Critical Path Method. Design of Experiments (DOE)... Design for Manufacturabiliy and Assembly’. Design Verification Plan and Report (DVP&R) Mistake Proofing/Error- Proofing ou... ms Quality Funetion Deployment (OFD) - APPENDIX C_ REFERENCE MATERIAL senso APPENDIX D TEAM FEASIBILITY COMMITMENT. - APPENDIX E PRODUCT QUALITY PLANNING SUMMARY AND APPROVALS.. APPENDIX F GLOSSARY. APPENDIX G INDEX. viPRODUCT QUALITY PLANNING CYCLE Feedback Assessment and Corrective Action Plan and Define Product and Process Validation Product Design and Development Process Design and Development viiiIntroduction Introduction The purpose of this manual is to communicate to organizations (internal and extemal) and suppliers, common Product Quality Planning and Control Plan guidelines developed jointly by Chrysler, Ford and General Motors. This manual provides guidelines designed to produce a product Quality plan, which will support the development of a product or service that will satisfy the customer (see Section 1.6). ‘The following terms, used in this edition are used to describe the supply chain. The term “organization” refers to the unit to which these guidelines apply. The term "supplier" replaces the term subcontractor that was used in the First Edition. Some of the expected benefits in using these guidelines are: A reduction in the complexity of product quality planning for the customers and organizations. A means for organizations to easily communicate product quality planning requirements to suppliers. This reference manual contains guidelines that support the requirements as described in ISO/TS 16949 and spplicable customer-specific requirements. All forms in this manual are provided as examples only. The purpose is to assist the organization’s product quality planning team in developing the appropriate communication forms to support meeting customer requirements, needs, and expectations. The Product Quality Planning Cycle shown on the facing page is a graphic depiction of a typical program. The various phases are sequenced to represent planned timing to execute the functions described. The purpose of the Product Quality Planning Cycle is to emphasize: Up-front planning. The first three quarters of the cycle are devoted to up-front product quality planning through product/process validation, ‘The act of implementation. The fourth quarter is the stage where the importance of evaluating the output serves two functions: to determine if customers are satisfied, and to support the pursuit of continual improvement, Depicting product quality planning as a cycle illustrates the never-ending, pursuit of continual improvement that can only be achieved by taking the experience in one program and applying that acquired knowledge to the next program.Introduction PRODUCT QUALITY PLANNING RESPONSIBILITY MATRIX The matrix shown below depicts the Product Quality Manning Functions for three typos of organizations. I¢ ix to assist organizations in defining the scope of their planning responsibilitios. Refer to Fundamentals of Product Quality Planning oa the next page, The matrix does not depiet 1 the diferent types of product quality planning relationships that could exist among organizations, suppliers, and customers, *Serviee Organization le. Mont Trent, “Design “Manufacturing Warehousing, Responsible Only ‘Transportation, ete. Define the Scope x x x Plan and Define Chapter 1.0 x Product Design and Development x Chapter 2.0 Feasibility Section 2.13 x x x Process Design and Development x x x Chapter 3.0 Product and Process Validation x x Chapter 4.0 Feedback, Assesment and Corrective x x x Action Chaptor 5.0 Control Plan Methodology Chapter 6,0 x x x * Refer to Section | “Scope” of ISO/TS 16949,Introduction Fundamentals of Product Quality Planning Organize the Team Define the Scope Product Quality Planning is @ structured method of defining and establishing the steps necessary 10 assure that a product satisfies the customer, The goal of product quality planning is to focilt communication with everyone involved to assure that all required steps are completed on time, Effective product quality planning depends on x company’s top management commitment to the effort required in achieving customer salistuction, Some of the benefits of product quality planning are: sources to xatisty the custome ‘To promote early identification of required changes. To avoid late changes. ‘To provide a quality product on time at the lowest cost, The work practices, tools, and analytical wechniques dexeribed in this manual are listed in a logical sequence }o make it easy to follow, Bach Product Quality Plan is unique, The actual timing and sequence of execution is dependent on customer needs and expectations and/or other practical matters. The earlir a work practice, tool, and/or analytical technique can be implemented in the Product Quality Planning Cycle, the better. ‘The organization's first step in product quality planning is to nssign a process owner for the APOP project. In addition, a cross functional team should be established to assure effective product quality planning. The team should inchide representatives from multiple functions such as engineering, manufacturing, material control, purchasing, quality, human resources, sales, field service, suppliers, and customers, as appropriate. It is important for the organization's product quality planning earn in the carliost sage of the product program to klentity customer needs, expectations, and requirements, At minimum, the team must meet to: Select # project team lead ng, the planning process, (In some cases it may be advantageous to rotate the team leader during the planning cycle.) Define the roles and responsibilities of each area represented, entity the customers - internal and exiernal, Define customer requirements, (Use QFD if applicable, as referenced in Appendix 8.) jeleet the disciplines, individuals, and/or suppliers that must be added to the team, and those not required,Introduction Understand customer expectations, i¢, design, number of tests, | Asscws the feasibility of the proposed design, performance requirements and manufacturing pracess, = Idoniity costs, timing, and constraints that must be considered, + Determine assistance required from the customer. ‘= Identify documentation process or method, Team-to-Team The organization's product quality planning team must establish lines of communication with other customer and organization teams. This may include regular meotings with other teams, The extent of team-to-team coninet is dependent upon the number of issues requiring resolution, Training ‘The suecess of w Product Quality Plan is dependent upon an effective taining program that communicates all the requirements and development skills to fulfill cusiomer noeds and expectations, Customer and Organization Involvement “The primary customer may initiate the quality planning process with an ofgenization. However, the organization has an obligation to establish « crous functional eam to manage the product quality planning, press Organizations must expect the same performance from thelr suppliers Simultaneous Engineering Simultaneous Engineering is a process where cfoss functional teams strive for a common goal, It replaces the sequential series of phases where results are tansmitied to the next area for execution, The purpose is to expedite the introduction of quality products sooner, The organization's product quality planning team assures that other frens/teams plan and execute activities that support the common goal or goals. Control Plans Contiol plans ate written doseriptions of the systems for controlling parts and processes, Separate control plans cover three distinet phases: = Prototype - A deseription of the dimensional measurements and material and petformance tests (hat will ogeur during Prototype buildConcern Resolution Introduction Pre-launch = A description of the dimensional measuremenié and ‘material and performance tests that will occur afer Prototype before full Production, Production - A comprehensive docu characteristics, process controls, teats will ovcur during, masy production f product/process systems that During the planning. process, the team will encounter product desiga and/or processing concerns. These concems should be documented on a matrix with assigned responsibility and timing. Disciplined proble solving methods are recommended in difficult situations. Analytical techniques described in Appendix B should be used a¥ appropriate, Product Quality Timing Plan “The organization's product quality planning team's first onder of business following organizational aetivities should be the development of a Timing Plan, ‘The type of product, complexity and customer expectations should be considered in selecting the timing elements that ‘mnust be planned and charted. All team members should are with euch event, action, and timing, A well-organized timing chart should list tusks, assignments, and/or other events. (‘The Critical Path Method may be appropriate; relerence Appendix B.) Also, the chart provides the planning team with a consistent format for tricking, progress and setting necting agendas. ‘To facilitate siatus reporting, each event must have a ‘surt" ond a “completion” date with the aetal point of progress reconed, Effective status reporting supports program monitoring, with a focus on identifying items that require special attention, Plans Relative to the Timing Chart ‘The success of any program depends on meeting customer needs and expectations in a timely manner at & cost that represents value, ‘The Product Quality Planning ‘Timing Chart below and the Product Quality Planning Cycle described previously require a planning team to concentrate its efforts on problem prevention, Problem prevention ix driven by Simultaneous Engineering performed by product and manufacturing engineering activities working concurrently, Planning teams must be prepared to modify product quality plans to meet customer expectations, ‘The organization's product quality planning team ix responsible for assuring that timing meets or exceeds the customer timing plan.concept Inkiatlon/approval Introduction PRODUCT QUALITY PLANNING TIMING CHART Program J Prototype Product Process Design and Ds Danigs ard Dov Javelopment iter Launch Plorining [ere ‘and Process Validation Proeuetion ——$ Fesdback Aszosament and Gorrectlve Action pRoDUCT Process PLAN AND DESIGN AND ——_DESION AND. RooucT FREDDACK periNe DeveLOPMENT DEVELOPMENT ANDPROCNss. ASSESSMENT AND PROGRAM —— VERIFICATION VERIFICATION VALIDATION CORRECTIVE ACTIONChapter 4 Plan and Define Chapter | Plan and Define ProgramChapter 1 Plan and Define PRODUCT QUALITY PLANNING TIMING CHART Initiation Approval Pro Approval Prototype Pitot Launch <> | Plansing | Product Design and Gov Prodvel and Process Validation Se Procustion | Poedback Assessment and Corrective Action sp OUTPUTS: = Design Goals + Reliability and Quality Goals + Proliminary Bill of Material * Preliminary Process Flow Chart = Proliminary Listing of Special Product and Procoss Characteristics * Product Assurance Plan . Management SupportChapter 1 Introduction 1.1 Voice of the Customer Plan and Define This chaptor describes how customer needs and expectations ary linked to planning and defining a quality peogram. ‘The goal of any produet program is meeting customer needs while providing competitive value, “The initial step of the product quality planning process is to ensure that customer necels sand expectations are eleaily understood, The inputs and outputs applicable to the planning process may vary avcotding t the product development process, and customer needs and expectations, Some recommendations discussed in this chapter are as follows: INPUTS. + Voice of the Customer ‘© Market Research (including OEM Vehicle Build Timing and OEM Volume Expectations) © Historical Warranty and Quality Information © Team Experience © Business PlaryMarketing Sirategy = Product/Process Benchmark Date ‘+ ProduevProcess Assumptions = Product Ketabutty studies Customer Inputs OUTPUTS (Become inputs for Chapter 2) # Design Goals © Reliability and Quality Gouls * Preliminary Bill of Material = Preliminary Process Flow Chart Preliminary Listing of Special Product and Process Characteristics © Product Assurance Plan = Management Support (including program timing and planning for rewoureos ind staffing. to support required capactry) ‘The "Voice of the Customer" encompasses complaints, reommendations, Jia and information oblained from infernal and/or extemal customers Some metho for gathering this information appear in the following paragraphs,Chapter 1 Plan and Define 41.1.1 Market Research ‘The organization's product quality planning team may need to obiain market research data and information reflecting the Voice of the Customer, The following sources can assist in identilying customer concerns and wants and anslating thors concems into product and process characieristios * Customer interviews + Customer questionnaires and surveys + Market test and positioning reports New procluct quality and reliability studios © Competitive product quality studies + Best Practices = Lessons Learned 1.1.2 Historical Warranty and Quality Information A list of historical customer concems and wants should be prepared to fssers the potential for roeurrence during the design manufeture, installation and uso of the product, These should be considered as an extension of the other design requirements and inehided in the analysis of customer needs, Many of the following. items ean assist the tear in identifying customer concerns and wants and prioritizing appropriate resolutions, = Best Pr 8 + Lessons Lenned = Warranty reports ‘+ Capability indicators ‘© Supplior plant internal quality reports = Problem revolution reports + Customer plant retuens and rejeetions ‘+ Field retum product analysis 4.1.3 Team Experience Tho foam may use any source of any information as appropriate, inching, the following ‘+ Input from highcr system level or past Quality Function Deployment (QED) projects + Media commentary and analysis: magazine and newspaper reports, ete 10Chapter 1 Pian and Define © Customer leters and suggestions + Best Practices = Lessons Learned + Dealer comments © Flect Operator's comments = Field service reports = Internal evaluations using surrogate customers = Road trips + Management comments of direction = Problems and issues reported from intemal customers ‘+ Government requirements and reyuutations = Contract review 1.2 Business Plan and Marketing Strategy a The customer business plan and marketing strategy will wet the framework for the product quality plan, ‘The business plan may place constraints (6.x. timing, cost, investment, product positioning, researeh and development (R&D) resources) on the team that affect the direction taken, The, inarketing stiategy wil slofine the target customer, the key sales points, and. key competitors 1.3 Product/Process Benchmark Data ‘The use of benchmarking (referenced in Appendix 1) will provide input to estublishing producvprocess performance targets, Revoarch and development may also provide benchmarks and concept ideas. One method to successfinl benchmarking. is ‘4 Identify the appropriate benchmarks, # Undersiand the reason for the gap between yo benchmark, current status und the + Develop a plan to close the gap, match the benchmark, oF exceed the bonctunack,Chapter 1 Pian and Define 1.4 Product/Proce: Assumptions Thore will be assumptions that the product hax certaln features, design, or process concepts, These Include technical innovations, advanced materials, teliability assessments, and new technology. All should be utilized ax inputs. 4,5 Product Reliability Studies This type of data considers thequene componenis within designated periods of tt rolinbility/durabitity texts, of repair of replacement of yo and the results of long-term 1.6 Customer Inputs ‘The next users of the product ean provide valuable information relating to their needs and expeciations, In addition, the nest product usore may have already conducted some of all of the aforementioned reviews and studies. hese inputs should be used by the customer and/or organization to develop agreed upon measures of customer satisfaction 1.7 Design Goals _ Design goals are a translation of the Voice of the Customer inte measurable design objectives. ‘The proper selection of design goals awsures that the Voige of the Customer is not lost in subsequent design activity, ‘The Voice of the Customer also includes regulatory requirements such as materials composition reporting and polymeric part making 1.8 Reliability and Quality Goals Reliability goals ate established based on customer wants and expectations, program objectives, and reliability benchmarks. An example of customer wants and expectations could include no safety failures. Some reliability benchmarks could be competitor product reliability, warranty data, or frequency of repair over a set time period, Quality goals should be based ‘on melrigs sueh as parts per million, problem levels, or scrap reduction, 4.9 Preliminary Bill of Material The team should establish w profiminary bill of material based on product/process axsumptions and include a potential supplier lst. In onder to identify the preliminary special product/process characteristicn it is necessary to have soleeted the appropriate design and -manifactasing process,Chapter 1 Plan and Define 1.10 Preliminary Process Flow Chart The anticipated manuficturing process should be described using. process flow chart developed ftom the preliminary bill of miterial and produc/process assumptions, 1.11 Preliminary Identification of Special Product and Process Characteristics _ Special product and process characteristics are identified by the customer in addition t those selected by the organization through knowledge of the product and process Esamples of input to identification of special ‘characteristics include: + Product assumptions based on the analysis of customer needs nd expectations. + Identification of reliability goals and requirements, + [dentifiention of special process charucteristics from the anti manuthoturing process = Similar part FMEAS, 1.12 Product Assurance Plan The Product Assurance Plan (ranslites design goals into design requirements and ig based on customer needs and expectations. This manual docs not require a specific method for prepuring a Product Assurance Plan, The Product Assurance Plan can be developed in any format understood by the organization and should include: + uilining of program req rents, tion of reliability, durability, and apportion mentallocation goals and/or requirements, + Assesment of new technology. complexity, materials, application, environment, packaging, service, nnd manufacturing requirements, oF any other factor that may plaee the progam at risk, ‘+ Use of Failure Mode and Effects Analysis (FMEA), Development of preliminary engineering requirements,Chapter 1 Plan and Define 1.13 Management Support Ons of the keys to the success of Advanced Product Quality Plarining is the interest, commitment and support of upper management. Pasticipation by ‘management in product quality planning meetings is vital to ensuring the sueeess of the program. Management should be vipdated at the conclusion of every product quality planning phase to reisforse their commitment and support. Updates and/or requests for assistance can occur more frequently as required. A primary goa! of Advanced Product Quality Planning is to ‘maintain management support by demonstrating that all planning Fequlfements have been met and/or concerns documented und scheduled for resolution, including program timing and planning for resources and staffing to support requited capacityChapter 2 Product Design and Development Chapter 2 Product Design and DevelopmentChapter 2 Product Design and Development Initiatlon/Approval Pr PRODUCT QUALITY PLANNING TIMING CHART oo cry si a | [ered hn ara Passes Design are Coaeprvent JProwet and Process Validation: : Production: —EE < Foodback Assasemont and Corrective Action - | DESIGN OUTPUTS Design Failure Mode and Effects Analysis (FMEA) Design For Manufacturability and Assembly Design Verification Design Reviews Prototype Bulld = Control Plan Engineering Drawings (Including Math Data) Engineering Specifications Material Specifications Drawing and Spocification Changes. APQP OUTPUTS New Equipment, Tooling and Facilitios Requirements Special Product and Process Characteristics Gages/Testing Equipment Requirements Team Feasibility Commitment & Management SupportChapter 2 Introduction Product Design and Development rer discusses the elements of the planning process during which and characteristics are developed into a near final form, AV) dosign fhetors should be considered by the organization in the Advanced Product Quality Planning process even if the design is owned by the customer of shared, ‘The steps include prototype build to verify that the product or service meets the objectives of the Voice of the Customer, A feasible design must permit meeting production volumes and schedules. and bbe consistent with the ability (o moet engincering requirements. along with quality, reliability, investment cost, weight, unit cost anx! timing objectives. Although feasibility studies and ‘contol plane are primarily based on engineering drawings and specifieation requirements, valuable information ccan be dotived from the analytical tools described in this chapter to furthsr deine and pronize the eharactriice chat may nest speci product and process controls In this chapter, the Product Quality Planning Process is designed to assure a ‘comprehensive and critien! review of engineering wquiremventis and other elated technics! information, At this stage of the process, a preliminary easibility analysis will be made to assexs the potential problems that could occur during manufacturing. “The inputs andl outputs applicable to this chapter are as follow INPUTS (Derived from the outputs of Chapter 1) # Design Goals + Reliability and Quality Cioals + Preliminary Bill of Material ‘+ Preliminary Process Flow Char, ‘+ Preliminary Listing of Spocin! Product and Process Charaeteristies + Product Assurames Plan # Management Support DESIGN OUTPUTS (Become Inputs for Chapter 3) wl Effects Anulysis (DFMEA) + Design for Manutucturability and Assembly, * Design Failure Mode + Design Verification © Design Reviews + Prototype Build ~ Control Plan + Enginesring Drnwings (neluding Math Data) + Enginecring Specifications * Material Specifications + Drwwingg and Specification Changes 7Chapter 2 Product Design and Development APQP OUTPUTS (Becomes Inputs for Now Equipment, Tooting and Facilities Requirements hapter 3) Special Produet and Procoss Characteriatics Gages/Testing Equipment Requirements ‘Team Feasibility Commitment and Management Support 2.4 Design Failure Mode and Effects Analysis (DFMEA) 2.2 Design for Manufacturability and The DEMEA is @ disciplined analytical technique that assesses the probability of failure as well as the effect of such failure, A DEMEA is a living document continvlly updated as eustomer nets aid) expectations roquire, The DFMEA is an important input to the APQP process thet may’ shuske previously selected product and process characteristics, | The Chrysler, Ford and Gungeal Motors Potential Failure Mode and Effects ‘Analysis (FMEA) reference manual provides guidance for the preparation ofa DEMEA, The Design FMEA Checklist in Appendix A-1 should also be reviewed fo assure that the appropriate design characteristics have been considered, Design for Manufiacturability and Asembly is a Simultaneous Engineering process designed 10 optimize the relationship between design funtion, Imanuficturability, and ease of assembly, The scope of customer needs an Capectations defined in Chapter | will determine the extent of the organization's proxhict quality planning team involvement in this activity. This manual does not include of Fefer to a formal method of preparing a Design for Manufncturability and Assembly Plan, Ata minis, the ben fisted here should be considered by the organization's product quality planning team: neti Design, eoneep and sensitivity fo manullcturing variation Manuitheturing andior usembly process. Dimensional tolerance Performance requirements Number of components Process adjusinents Materia fandlirgChapter 2 Product Design and Development ‘The above list may be augmented based on the organization's product duality planning team's knowledge, experience, the prodd/process, suovornment exulations, and servioe requirements, 2.3 Design Verification Design verification verifies that the product design meets the customer requirements derived from the activities described in Chapter 1 2.4 Design Reviews Design reviews are regularly scheduled meetings led by the organization's design engineering activity and must include otber affected areas, The design review is an effective method to prevent problems und misunderstandings: it also. provides a mechanism 1 moniter progress, Feport to management, and obtain customer approval as required, Design reviews are a series of verification activities that are more than an incering inspection. At u minimum, design reviews should include evaluation of; * Design/Functional requirement(s) considerations + Formal reliability and confidence goals * Componeni/subsystern/system duty eyeles ‘+ Computer simulation and bench test results + DIMEAG) + Review of the Devign for Manufacturability ond Assembly effort + Design of Experiments (DOE) and assembly build variation results (Refer to Appendix B.) © Test failures + Design verification progress A major function of design reviews is the tacking of design verification progress, The otgonization should trick design verification progress through the wwe of « plan and report format, referred to. as Design Verification Plan and Report (DVP&R) by some customers. The plan and roport is a formal method 10 assure: + Design v Product and process validation of components and assemblies through the pplication of a comprehensive test plan and report, ‘The organization's product quality planning team is not limited f0 the items listed, The team should consider and use as appropriate, the analytical techniques listed in Appendix B, icationChapter 2 Product Design and Development 2.5 Prototype Build - Control Plan Prototype control plang are 4 sleseription of the dimensional measurements find material and functional texts that will accur during prototype build, The Organization's product quality planning team should ensure that a prototype Control plan ix prepared. Control plan methodology is deseribed in Chapter 6A Control Plan Checklist is provided in both Section 6 ane Appendix: A-R to assist in the preparation of the prototype control plan ‘The manufaeture of prototype parts provides an excellent opportu the eam and the customer to evalunte how well the product or service meets the Voice of the Customer objectives, It is the organization's product quality planning, team’s responsibility to review prototypes for the following: Assure that the product of service meets specification and report data as required, nsute that particular attention has beon given to special prosiuet and process charneteristion. Lise dita and experience to establish preliminary process parameters ancl puckaginy requirements Communicate any concerns, deviations, and/or cost impact 16 the customer: 2.6 Engineering Drawings (Including Math Data) _ Cust mer designs do not preclude the organization's product quality ‘s responsibility to review enginecring drawings in the fallowing manner. Engineering drawings may include | special (governmental regulatory and safety) charneteriatics that rust be shown on the control plan, When customer engineering drawings ate nonexistent, the controlling drawings should be reviewed by the team to determine which characteristics affect fit, fimetion, durability and/or governmental regulatory safety requirements. Drawings should be revicwed to determine if there is sufficient information jonal layout of the individual parts. Contol or datum surfaces/Iocatore should be clearly identified so that appropriate functional panes und equipment can be designed for ongoing controls. Dimensions Should be evaluated to assure feasibility and compauibility with industry nanufvcturing and measwring standards, I appropriate, the team shoul fugue that math data {s compatible with the customer's system for effective two-way communieations. 20