Engineering Technical Solutions


A STRATEGIC APPROACH TO PRODUCT DESIGN


Modern technology is having a profound effect (hoàn toàn hiệu quả) not only on the materials that can be employed but also on the scale of production and the locations in which manufacturing can now take place. To an extent, this relies (nhờ vào) on designers being able to control both the design and the means of production. The information is, for each process (quá trình; quy trình), broken down under the following subjects: Volumes (khối lượng) of production – Unit prices vs capital investment (vốn đầu tư) – Speed – Surface – Types and complexity of shape – Scale (tỷ lệ) – Tolerances (kích cỡ, khối lượng...của một bộ phận có thể dao động mà không gây tác hại) – Relevant (thích đáng) Materials – Typical (tiêu biểu, điển hình) applications – Similar methods. As with any specialist field, the world of manufacturing has its own unique vocabulary with a huge list of descriptions specific to particular areas of manufacturing.

A strategic approach to product development to design in quality. The basic approach to product design and development to meet customer needs, quality expectations, competitive price, reduction of product design cycle time, and minimizing disruptive design changes can be effectively produced with a well-planned process.

Achieving Design to Cost Objective: Target costing for a new product comes from decisions made during the design phase as the designers are drafting blueprints for engineers to evaluate. This approach will map out what the product will be like, how it will work, what features it will have, and how it will be manufactured. Suppliers are also well-integrated into the development process to ensure that you're producing the best product for the lowest price possible. Material is the first and most important element of cost. In most manufacturing organizations, materials form the single largest component of cost.

Building Quality Into Product Design: If quality is not assured by the initial design, then expensive change orders will have to be carried out, wasting valuable engineering resources and possibly including further quality problems in the process. Optimize tolerances for a robust design using GD&T to ensure high quality by design. This is a systematic way to optimize tolerances to achieve high quality at a low cost. The procedure can identify critical dimensions that need tight tolerances and precision parts, which can then be toleranced methodically. This approach can minimize cost while assuring the high quality by identifying low-demand dimensions that can have looser tolerances and cheaper parts. Simplify the design for the fewest parts, interfaces, process steps, and uncomplicated manufacturing with automated processing resulting in inherently hight quality products. By setting the right specifications and the careful evaluation of potential suppliers, product quality can be achieved during the design stage.


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Design for Manufacturing and Assembly (DFMA). An engineering methodology that focuses on reducing time-to-market and total production costs by prioritizing both the ease of manufacture for the product's parts and the simplified assembly of those parts into the final product. It was developed by Hitachi’s Assembly Evaluation Method (AEM) which used a point-loss standard to rate the ease of automatic assembly for a particular product. The Hitachi Assembly Evaluation Method facilitates design improvements by means of adopting the following approach (Miyakawa, S and Ohashi, T; 1986) by identifying weaknesses in the design at the earliest stage in the design process by using an assembly-ability evaluation score (E) and an assembly cost ratio (K).

Design for Assembly's (DFA) goal is similar to DFM but concerned only with reducing product assembly costs. Design for easier manual or automatic handling in assembly, and to reduce the labor and time involved in the assembly. DFA leads to improved design and reduces the product assembly cost by minimizing the part count, and the number of assembly operations needed to produce the part and by making these assembly operations as easy and fail-proof as possible. The aim is to make the manufacturing process easier, faster, and more consistent, therefore more productive. When designing for assembly, remember the simpler the design the easier it is to assemble. If the product is sold as a kit and assembled in the field by a technician, it is different than if it will be assembled on an assembly line or in a work cell.

The Design for Manufacturing (DFM) goal is similar to DFA but concerned only with reducing overall part production cost is the method of design for ease of manufacturing of the collection of parts that will form the product after assembly "Optimization of the manufacturing process..." DFM is concerned with reducing overall part production costs by minimizing the complexity of manufacturing operations with common datum features and primary axes. DFM operates on key principles that are critically considered during the design phase of any project.

Design for Reliability (DFR). Design against failure is to understand the failure (why, where, how long, application, etc.). Reliability, and reducing the stress that causes failure can be achieved by material selecting, packaging geometry, and dimensioning modification.

Dependability. Collecting data and recording results. Verification and validation techniques are used to discover and remove faults in a design and before a prototype is built.

Time-to-Market. Use of modular design approaches. Sufficient resources to undertake development processes underway. Continuous surveillance of the marketplace and understanding of customer needs. Well-defined development processes based on tightly integrated design automation tools. Well-planned and managed programs with clear definitions and acceptance of responsibilities. Process equipment to handle a wide range of work envelopes; FMS; quick set-up and changeover.

Innovativeness. Using measuring and diagnostic equipment; make calculations and estimates and report on findings.

Technology: A technology plan and roadmap based on the business and product strategy and plan. Effective technology management. The process to review new technologies developed outside for applicability internally. Effective process to deploy new technology to development programs. State-of-the-art design and analysis tools to support requirements of new technology. Policies to invest in training and development of personnel to master new technology. Culture is open to new ideas and taking risks. Investment in new process technology.


PRODUCT DEVELOPMENT & THE APPROACHING PROCESS


Phase I: The Objectives.
This is where the idea for the new product is generated (preliminary design, conceptual design, or functional design) and documented. In this objective phase, the inventor shares their original idea as designers collect and learn as much as possible about the conceptual idea. If a 3D model is required, the designer will sign a non-disclosure agreement with the inventor to keep the conceptual design discussed confidentially. At this early stage, the designer would deliver a proposal with a firm quote to build the 3D model to help the project engineer decide whether the design will include an electrical, mechanical, or software solution that can be incorporated into the design and whether the product will be designed from the ground up or synthesized from off-the-shelf components.

Phase II: Design Strategy.
Design modeling is where hired designer creates the 3D model based on the conceptual idea and the specifications agreed upon in phase I. The work is summarized and presented to the client so the inventor can make changes to the product with the confidence that the design will work before proceeding to detailing the parts and creating engineering drawings and documents. Included within this phase are assembly verification, component design, and electro/mechanical design, it should be very clear to all engineers/designers what the final product will look like and what its features will be. If, after the review, the project engineer believes parts of the design need to be improved or decides they want modification or new features added, this will be incorporated into the next phase. An updated proposal with a new quote for the next phase is submitted to the client before proceeding.

Phase III: Product Development.
Detail drafting is where designer modifies the presented 3D model for detailing and creating manufacturing drawings and documents of the approved design presented in phase II. Any changes or modifications to the design requested by the engineer at Phase II Review are also incorporated before manufacturing drawings are made. Once drawings and necessary documents are completed, We will send them out to local sub-contractors or manufacturers specified/preferred by the project manager for a quote so that we all have an estimated price for the building of the product. A written report is summarized and detailing everything done in phase III with the approved changes in phase II. At the end of this phase, the costs for a prototype build are submitted before proceeding.

Phase IV: Prototype Build.
Approved by the project manager, all the parts/hardware to build the prototype are ordered, and received and the product is assembled. Any faults in the assembly process are checked out and inspected. Also, the initial manufacturing procedures are recorded and necessary manufacturing documentation and BOM are created, then a fully built prototype would be delivered to the customer. Special assembly tools or larger volume assemblies may also require custom design tools to do fine tunes, alignments, or just speed up the assembly process. This would also be addressed here with an updated proposal with the cost for special tool design and build before proceeding.

Phase V: Production Launch.
In this stage, the process listed above is repeated to eliminate product issues discovered in testing. Also, this is where DFM (Design for Manufacturing), DFA (Design for Assembly), and DFW (Design for Warranty with Cost Reduction) can be achieved at the highest level as several prototypes are being built and tested to get the final imperfections out of the design as production is ready for the initial product launch. Biotech PackagingThe goal of this release phase is to create a short run of prototypes that are as close to the prototype release as possible and get them into the hands of key quality engineers, selected customers to do their final testing, and ensure that the subsystems function together as a system at production launch. The production launch phase is usually just to get the final imperfections out of the design as production is ramped up for the initial product launch.


ENGINEERING DESIGN RESOURCES


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ENGINEERING & MANUFACTURING KEY TERMS & DEFINITIONS


Activity-based Costing (ABC) assigns indirect or manufacturing overhead costs to products and services based on the products that are actually demanding the activities. ABC process allows for a more accurate reflection of indirect costs by recognizing certain products or services that require more time than others. It's also help the company decide which products or customers to cut or keep.

CAD Validation. CAD model validation is a powerful way to identify unrealistic, bad geometry that impedes re-use of models in analysis and manufacturing process. The validation process involves:

  • The fundamental tests which are simple enough in terms of geometry and problem formulation. These tests are used to verify basic physical laws and algorithmic correcness.
  • Demonstrate how well a particular function of a product or physical model is working (e.g. conjugate heat transfer, vibration, cativation, condensation, etc.).
  • Apply industrial problems and benchmarks. Software validations for a specific equipment with complex geometry are considered (engines, pumps, blowerss, heat exchangers, etc.)
  • Integrate validation tests and benchmark from a select industry (HVAC, process, electronics, marines, aerospace & defense, etc.) as a prerequisite for certification or accreditation.

Corrective and Preventive Actions (CAPA) is the action performed to eliminate the root cause(s) of an existing nonconformity, defect, or other undesirable situation to prevent recurrence. Preventative Action is the process of investigating, identifying and addressing issues or problems. This method looks at the manufacturing process, customer complaints and internal audits to identify areas where non-conformities or undesirable outcomes occur and seeks to prevent those same issues in the future. CAPA is used to improve manufacturing and end products by eliminating all potential for errors and non-conformities. Ultimately the goal of CAPA is to address the heart of the issue so that no other similar issue will occur.

‹•› CAPA decision addresses —›

  1. Address the requirements of the OS regulation been defined and documented —›
  2. Existing problems: Were quality data sources identified? | Corrective actions (tác dụng hiệu chỉnh). Have data from these sources been analyzed to identify existing product and quality problems that require rorrective action? —›
  3. Potential problems: Were sources of product and quality informationthat may show unfavorable trends identify by the firm? | Preventive actions (tác dụng ngăn ngừa). Have data from these sources been analyzed to identify potential product and quality problems that may require preventive action? —›
  4. Are the data received by the CAPA system complete, accurate and timely? —›
  5. Are appropriate stastical analysis methods used? | Are results of analyses compared across different data sources to identify and develop the extent of product and quality problems? —›
  6. Investigating cause: Are failure investigation procedures followed? | Is the failure investigation commensurate with the significance and risk of the nonconformity? | Are failure analyses conducted to the root cause, where possible? | Is there control to prevent the distribution of nonconforming product? —›
  7. Has appropriate corrective action been taken for significant product and quality problems identified from data sources? —›
  8. Were corrective and preventive actions effective; verified and validated prior to implementaion? —›
  9. Were corrective and preventive actions for product and quality problems implemented and documented? —›
  10. Has information regarding nonconforming product, quality problems and corrective and preventive actions been properly disseminated? | Is information disseminated (được phổ biến) for management review? —›
  11. Evaluate subsystem for adequacy based on findings —› Continue inspection of Other Subsystems.

Corrective Action Request (CAR) is a formal notification from a Supplier Quality Management (SQM) source requesting a supplier or manufacturer to open an investigation into the occurrence of nonconformity or a defect of a specific product, process or service be eliminated, with the objective of preventing recurrence.

Contract Manufacturer (CM) is a firm/business hired by a company to handle all the manufacturing services or assembly of all or part of the final product. A contract manufacturer (CM) is a third-party manufacturer of components or products for a company. This is a form of outsourcing. A company generally approaches a CM with a design or product and ask for pricing to manfacture based upon variables like processes, labor, tooling, and material costs.

Contract Electronics Manufacturer (CEM) is company that make products under contract for other manufacurers. The CEM typically take on the manufacturing responsibility for OEMs in sectors like industrial, defence, energy, test and measurement, computing, instrumentation, and communications. More and more OEM products are manufactured by CEMs, which are then usually branded with the OEM's name and then sold out by the OEM to its customer base.


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Continuous-Flow Manufacturing (CFM), or repetitive-flow manufacturing, is an approach to discrete manufacturing (the manufacturing of finished products that are distinct items capable of being easily counted, touched or seen) that contrasts with batch production. CFM, also referred to as Process Manufacturing, is a production line which operates 24/7 to produce a flow production to manufacture, produce, or process materials (gases, liquids, powders, or slurries) uninterrupted.

The cycle time refers to the time required to complete a full cycle of production in manufacturing. It is the time from the start of production to the delivery of the final product. It includes processing, queue, inspection and all wait times. It is used to measure manufacturing process efficiency.

Compliance means an organization must be followed established guidelines, laws, standards, regulations or specifications to ensure the quality and safety of products for the consumer, and that customers are treated fairly and with respect. The FDA oversees consumer safety, one of the largest regulatory mandates.

Compliance mark is a physical mark placed on the product or packaging stating that a product has met the regulatory standards and specific requirements. Most notably, the CE mark is placed on products that meet the specification for products sold in the European Economic Area. Similar to the CE, in the United States the Federal Communications Commission grants the FCC mark to electronic devices that meet its regulatory standards and is often seen worldwide. These marks indicate that they may be sold in the respective economic areas regardless of the country of origin.

Document Change Request (DCR) is a type of change request used in manufacturing to detail a proposed change to documents (e.g., standard operations, procedures, specifications, instructions or SOPs).

Design History File (DHF) is a collection of records documenting all stages of the design phase of a product tested and met quality standard. The chronological format document shows the development process through the collection of drafts, detailing decision making, meeting notes, test data and reports that lead to the production and manufacturing of the final product. A DHF may be required for a certification mark, as the DHF will show the product has been inspected thoroughly and repeatedly tested to meet quality control standards.

Electronics Manufacturing Services (EMS) are companies that design, manufacture, test, distribute, and provide return/repair services for electronic components and assemblies for original equipment manufacturers (OEMs). Electronics Manufacturing Services companies specialise in manufacturing high volume, low complexity products and, as a result, demand multimillion-dollar spend levels, which is why most of the world's consumer electronics end up shipping from their factories.

Enterprise Resource Planning (ERP) is a business strategy used to track activities like purchasing, inventory and orders. ERP is the ability to deliver an integrated suite of business applications to effectively model and analyze data across departments including finance, HR, distribution, manufacturing and the supply chain. ERP software can be used in any industry to help a business become more efficient. It provides an effective communication tool that can manage information between internal and external departments, assist with daily activities to manage projects, track adherence to guidelines, and handle day-to-day intricacies that come with running a business.

Form, Fit and Function (FFF) is used in manufacturing to describe the identifying characteristics of a part/component that goes into the final build/assembly of a product. Form is the physical characteristics of the product. It includes things like shape, weight, color, material, etc. | The relationship or orientation of a part to another. Fit may also meant whether the physical dimensions of a part fit into the product it was designed to go into. | Function is what the product actually does. A part’s function follows the purpose of its design to a final role or action, such as holding other components together or shielding them from wear and tear.See GD&T.

A Field Failure Request (FFR) is a type of change request which details a problem or non-conformity with the product as observed in the use of the product by the end-user known as the “field.” Products can fail for many reasons and are often not noticed in manufacturing and testing, by documenting field failure requests, manufactures can implement changes into the design or manufacturing process to avoid similar issues from occurring. A field failure of a component or a subsystem in a repairable system for the first time is markedly different from a once repair/replaced component/subsystem failure. Field replaced parts are assembled after a field diagnosis, removed and replaced by field service personnel in varying field settings. Field environment is markedly different from the assembly line. It may not provide the comfort of the assembly line for the service personnel and the accessibility is often a challenge. Since the lowest part reliability determines the overall system reliability, field replaced parts can bring down the overall system reliability.

ISO 9000: The International Standards Organization 9000 is an international quality-process auditing program. ISO 9000 is defined as a set of international standards on quality management and quality assurance developed to help companies effectively document the quality system elements needed to maintain an efficient quality system. The goal of ISO 9000 is to embed a quality management system within an organization, increasing productivity, reducing unnecessary costs, and ensuring quality of processes and products. There are three standards: ISO 9000:2005 - Fundamentals and vocabulary. ISO 9001:2015 - Requirements. ISO 9004:2000 - Guidelines for performance improvement.

ISO 13485: Medical devices | Quality management systems | Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical. Any company involved in the supply chain of medical devices needs ISO 13485 certification. It was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

ISO 14000: Environmental Management Standards developed and published by the International Organization for Standardization ( ISO ) for companies and organizations of any type that require practical tools to manage their environmental responsibilities.

Lean manufacturing is a production method aimed primarily at reducing times within the production system as well as response times from suppliers and to customers. Lean manufacturing is built off the idea that the reduction of waste can be more profitable than an increase in sales. So what is waste? Waste can be an overburden or inequality in workloads, wasted materials and unnecessary movement (production activities in a typical manufacturing operation add no value at all for the customer) through the production process. By reducing cycle time and waste from the system manufacturing plants, company will able to improve quality, efficiency and profitability.

Material Requirements Planning (MRP) is a production planning, scheduling, and inventory control system used to manage manufacturing processes. ERP systems help to plan and automate a variety of business functions including accounting, manufacturing, supply chain, customer management, quality, processes and planning. MRP systems focus on materials management. The main benefits of materials requirement planning are: Better inventory control – Improved scheduling – MRP gives a clear indication of when production operations need to be carried out. The three basic steps of MRP are Identifying requirements for items to be included in an MRP run. | Running the MRP and creating suggestions for action. | Firming the suggestions to release manufacturing orders and purchase orders.

New Product Development (NPD) is the process of conceptualizing, designing, planning and commercializing a new product to be brought to market. NPD is referred to as product development. Although it differs by industry, new product development is the transformation of a market opportunity into a sellable product. NPD covers ideation, research, planning, prototyping, sourcing, costing, and commercialization.

New Product Introduction (NPI) is a multi-step plan that takes a product from initial idea to working prototype to a thoroughly refined and reproducible final product. The New Product Introduction plan can deliver an array of benefits, including: Enhanced risk management plan | Lower overall development cost | Improved manufacturability | Improved product quality and durability.

Overall Equipment Effectiveness (OEE) is a manufacturing practice for measuring productivity in a plant. Measuring the utilization of raw materials, time and machinery, OEE offers a percentage score, where 100% indicates firms are manufacturing products as efficiently as possible with no defects and no lag time. By measuring OEE, managers can assess the overall performance of the cycle and insights can be generated on how to best improve workflow. The OEE formula is calculated by multiplying availability, performance and quality and is represented by a percentage. Finding the OEE of an asset starts with measuring availability, which is calculated by dividing the total run time of an asset by the total planned production time of an asset. OEE = Availability x Performance x Quality.


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Original Equipment Manufacturers (OEM) offers components or sub-systems that are re-sold by another company as part of their end product. OEM company business models typically focus on product innovation and development. OEMs design most of the products themselves and own the rights to them, i.e. the intellectual property (IP). However, for OEMs that design and sell low to medium volume, often complex products, in sectors away from consumer electronics, Tier 1 suppliers may not be the most appropriate fit. Instead, OEMs are encouraged to take an alternative view of the EMS horizon, to find the most appropriate supplier for their business model and product range.

Original Design Manufacturer (ODM) is similar to a contract electronics manufacturer, but they typically own interlecture property for the product itself, while regular CEM use their customers' designs and IP. In addition, CEMs often produce a vast array of different products, across multiple markets, whereas ODMs typically specialise in a small number of specific product types.

Project. A project is a process for attaining a specified goal or objective. Simply put, a project is a series of tasks that must be completed to achieve a specific outcome. A project can also be defined as a set of inputs and outputs required to achieve a particular goal. Projects manage a product lifecycle and keep a record of events and decisions. Projects are often described and delegated by a manager or executive. They go over their expectations and goals, and it's up to the team to manage logistics and execute the project on time.

Redline. To mark or highlight edited text, as with a red line, to distinguish it from unedited portions of a document or drawing. In order to capture these changes the project drawings are redlined. Redlining the drawings is when you draw on a drawing (sometimes in red) to reflect what is actually installed (areas for review/correction or deleting).

Revision: The definition of a revision is the process of changing, correcting or improving something. A new version of a drawing or a document such as a procedure or an instruction that has been corrected or changed.

Restriction of Hazardous Substances (RoHS). EU rules restricting the use of hazardous substances in electrical and electronic equipment to protect the environment and public health. The RoHS Directive restricts the use of ten substances: lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE), bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP).

Return Material Authorization (RMA) A return merchandise authorization, return authorization or return goods authorization is a part of the process of returning a product to receive a refund, replacement, or repair during the product's warranty period. The seller of a good or product agrees to have a customer or client ship that item back to them in exchange for a refund, replacement, repair or credit.

Supplier Corrective Action Request (SCAR) is a formal change request that describes an issue with a part, process, or component of a product from a manufacturer that asks for a resolution. CAR’s are normally determined during quality assurance activities. There are 4 levels of CARs and it should clearly state that the request should be treated by the supplier as a customer complaint.

Six Sigma is a data-driven approach and quality measure for eliminating product defects in manufacturing. It is one method of preparing and controlling the compliance of processes and products with quality standards. A six sigma process guarantees that production is defect-free 99.999966% of the time. At Motorola in the 1980s, Mikel Harry and Bill Smith developed Six Sigma to make improvements on the manufacturing floor. The six steps of Six Sigma is Define, Measure, Analyse Improve, Control, Improve.

Standard Operating Procedure (SOP) is a set of step-by-step instructions compiled by a manufacturer to help workers carry out routine operations. SOPs aim to achieve efficiency, quality output and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations. By following these standards, managers can ensure manufacturing regulations are met while increasing performance and quality assurance.

Total Effective Equipment Performance (TEEP) is a performance metric that provides insights as to the true capacity of your manufacturing operation. It takes account both Equipment Losses (as measured by OEE) and Schedule Losses (as measured by Utilization). Total Effective Equipment Performance (TEEP) considers maximum time to be All Available Time – that is 24 hours, 365 days a year. Therefore, TEEP = Performance x Quality x Availability (where Availability = Actual Production Time / All Time).


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