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终极设计评审清单

设计审查清单

Do not close any Design Phase without this. This extensive 设计审查 checklist is to be used at the end of the design phase of any product, to avoid potentially basic or stupid mistakes that may later be very costly or defeat the complete project, be dangerous or be devastating to the company’s image.

笔记: 6 tips on how to perform a good design review are included at the end of this post.

It is strongly recommended (and mandatory in some industries) to have a formal 设计审查 at the end of the Design Phase. Refer to our 相位门 article for details on this project model.

This review is ideally performed with experts of all concerned fields, but we also strongly suggest including engineers and designers who were NOT included in the design, to bring their fresh views.

Do challenge what seems obvious or “we always did like that before”

… condition, manufacturing, legal, or usage may have changed since your last review!

Many of the following items in the Design Review Checklist may be in your Specifications, to be later checked by your 验证验证 (V&V) process … but maybe not. This list is trying to be as exhaustive as possible, but obviously not applicable and not complete for all domains and products.

 

UPDATE: for a more systematic and complete process, we now propose our original tool: the free Design Review Tree™ (“DRT”):

We are including versioning of the list so that you can update your files or process whenever this list is updated.

设计审查清单

version 1.08

监管
监管

监管

Yes it’s a must, but complex and continuously evolving

Does the product meet all applicable regulations?

Do you have the latest version of the standard?

Of all forecasted countries? not only the head-office

Also the standards in draft mode currently?

Do you have a process in place to alert on evolving standards?

Does the product have all the required labels?

(in this design review checklist so as in the legal definition, “label” includes all markings, on the product, packaging, in any accompanying document)

Legal labeling of the product, including

  • materials marking in the molds/part,
  • on the packaging
  • instruction for the IFU … is it needed & has it started? (we recommend starting a draft of the IFU at the same time the design is made)

… with all local marking or translation or approvals for all the intended marketS (and images and pictograms may save you a lot of translations here)

Check our 塑料设计技巧集锦 article for plastic parts markings

Robustness
Robustness

Environmental, Robustness, and Ageing

Frequently a tradeoff between quality, weight, and price …

Advice: be very careful if averaging the use condition to some mean or average, aka “product is on average at 25°C”, or “product is used on average 2h a day” … some users may be continuously at one side of the scale while some others will be continuously at the other extremity, thus making you a correct average calculation, but all these products WILL fail prematurely.

What is its IP code (Ingress Protection Code or Index)?

check IP code link for the IPXX table

can the product be rotated upside voluntarily and then required a higher IP rate? and accidentally?

Will it stand weather corrosion conditions?

96h or 100h (frequent values) salt mist test is frequently not enough for a product that can be close to the seaside (not even mentioning boat conditions)

Is there any dissimilar pair of metals or alloys having different electrode potentials? Including frequently basic overlooked parts (screws, washers, springs …)

Were cleaning chemical agents taken into account? Do you recommend some particular ones?

Ex.: polycarbonates (PC), even at big thicknesses, in fact even faster at big thicknesses, if there is a local constraint, can crack within minutes if some solvent (MEK) is applied on its surface.

Does it withstand the cold?

Indicating minimal temp in the IFU may not be enough. Mind involuntary misuses.

Batteries (based on chemistry, the cold always slows down its reactions) Have you done specific aging and cycle tests?

Lubricants and sealings becoming harder and losing their performance and even blocking the moving mechanism (piston type) or lowering the flow/pressure (regulator)

Many materials become brittle. Tested?

Does it withstand the heat?

A phone under the windshield of a car in the summertime will be exposed to much more heat than in Death Valley …

Also, mind some concentrating/magnifier effect. Ex.: the mirrored windows of some elegant modern New York building with a concave shape was concentrating the sun on the nearby street ;)

Does it withstand UV and sun?

Related but not necessarily the same as temperature. Tested?

Does it withstand aging?

Related but not necessarily the same as temperature and UV

Extremely tricky with some plastic and rubber material (Nitrile, EPDM …): it may come back literally to dust in 10-15 years even if well stored, with no constrain, and not exposed to sun or temperature. Or fail in 2-3 years if constraints or tight properties are needed.

Does your product include some gluing?

Have done some accelerated Ageing? Accelerating aging simulations, if not backup with normal aging, with too high temperature, or not appropriate Aging Factor (Q10) is valid only with history or reference.

Plastic additives (color, UV resistance, filler …) can change properties a lot compared to a know reference.

Mind dust or even more sand. Fine not perfectly sealed mechanisms will not survive 5 minutes on the beach.

Does it withstand a drop?

Even if no regulation, a quality product or costly product should withstand typical user misuse.

Ex: for a displaceable good, dropping from the height of a table could be expected to be “normal”. While a breakage could be understood by the user for a cristal Champaign glass,  maybe less and less for a slippery glass-coated thin phone.

Has MTBF (or another lifetime unit) been defined and evaluated?

See Mean Time Between Failures theory.

Or is this product in a High Availability class?

知识产权(IP)

Once the product is out, or if 营销 has communicated, it’s too late… so this should be included in any Design Review Checklist also if not already too late because of any external communication.

Is any 专利 already existing (that your product would infringe)?

Can be made knowingly (careful!) … especially if another patent is close to expiring. (for the original owner is the cost of attorney > gain on the remaining period ?)

In all distributed countries?

As your product some aspects that can...

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相关阅读与方法

  • Heuristic Evaluation: Using established usability principles to systematically evaluate a design for potential usability issues.
  • A/B Testing: Comparing two versions of a design to determine which performs better in terms of user engagement or other metrics.
  • Wireframing: Developing wireframes to outline the structure and key elements of a design, facilitating early-stage review and iteration.
  • Stakeholder Interviews: Engaging with stakeholders to understand their perspectives, requirements, and feedback on the design.
  • Cognitive Walkthroughs: Simulating a user’s thought process to identify usability issues and areas for improvement in the design.
  • Design Thinking Workshops: Collaborative sessions focused on creative problem-solving and iterative design improvements.
  • Usability Testing: Observing real users as they interact with the design to identify pain points and areas for enhancement.
  • Accessibility Audits: Reviewing the design to ensure it meets accessibility standards and is usable by individuals with disabilities.

Glossary of Terms Used

Design for Six Sigma (DfSS): 一种系统方法,旨在设计产品或流程以满足客户要求并通过在设计阶段利用六西格玛原则的工具和技术最大限度地减少缺陷和变异来实现高质量。

Failure Mode and Effects Analysis (FMEA): 一种系统方法,用于评估系统、流程或产品中的潜在故障模式,评估其对性能的影响,并确定风险的优先顺序,以通过纠正措施提高可靠性和安全性。

instruction For Use (IFU): 提供有关医疗器械或产品的正确使用、处理和维护的详细信息的文件,以确保用户的安全和有效性。

Mean Time Between Failures (MTBF): 系统或组件在运行过程中连续发生故障之间的平均时间,通常以小时为单位。它被用作评估设备性能和维护需求的可靠性指标。

Metal Active Gas (welding) (MAG): 一种焊接工艺,使用连续供给的消耗性电极和保护气体混合物(通常含有二氧化碳),在黑色金属和有色金属连接过程中保护焊接熔池免受大气污染。

Metal Inert Gas (welding) (MIG): 一种焊接工艺,使用通过焊枪送入的连续实心焊丝,在焊丝和工件之间产生电弧,将两者熔化形成焊接熔池,通常由惰性气体保护以防止污染。

Non-Disclosure Agreement (NDA): 一种法律合同,用于在双方之间建立保密关系,禁止向第三方披露特定信息。它通常用于保护在商业谈判或合作期间共享的敏感信息。

Product Data Management (PDM): 用于管理整个产品生命周期内与产品相关的数据和流程的系统,促进利益相关者之间的协作、版本控制和数据检索,以提高效率并减少产品开发和制造中的错误。

Verification and Validation (V&V): 确保系统符合规范并实现其预期目的的过程,涉及两个不同的活动:验证检查产品是否符合设计规范,而确认评估其是否满足用户需求和要求。

Work in Progress (WIP): 生产过程中部分完成的物品,包括原材料、人工以及达到一定程度的间接成本。这些资产尚未成为成品,对于跟踪生产效率和库存管理至关重要。

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    Historical Context

    (if date is unknown or not relevant, e.g. "fluid mechanics", a rounded estimation of its notable emergence is provided)

    涵盖的主题: Design Review, Checklist, Design Phase, Verification and Validation, Applicable Regulations, Legal Labeling, Ingress Protection Code, Robustness, Environmental Testing, Aging, User Misuse, Standards Compliance, Versioning, Design Review Tree, Product Specifications, Manufacturing Conditions, and Safety Standards..

    1. bessie gerhold

      emphase the importance of involving cross-disciplinary feedback early in the design phase, not just at the end

    2. Colby Jakubowski

      real-world usage insights can uncover issues that may not be apparent in theoretical reviews

    3. Eve Frami

      will use it!

    4. Jensen Ahmed

      Is the checklists effectiveness compromised if regulations change significantly? What about IP considerations in different jurisdictions?

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