Documentation- The Key to Manufacturing Success:
Many new start-up companies have little understanding of how crucial the documentation process is to their product's manufacturing success. In a very real sense, EDA's deliverable to you is the document package defining your product. If it is incomplete or "fuzzy", your product will surely experience costly mistakes and delays when it is quoted and manufactured. Electronic products typically are very parts intensive - a materials list for a moderate sized PWA can be hundreds of lines long. EDA views preparation of the document package as a serious matter. We subscribe and adhere to FDA's Good Manufacturing practices for both medical and industrial products.This page summarizes our approach to product documentation. Before a product design ever begins, there is normally a trail of conceptual work done before a working specification can be written. This group of documents form the:
Design History File (DHF): Good manufacturing processes may include a design history file. A DHF is now required by USA's FDA. You should expect a series of design memo's and reports to be added to your company's IP as the product concept matures to a working design specification
The following documents are listed from top-level to low-level. The product's User Requirements or specification and preliminary risk/ hazard analysis is presumed to already exist. To compliment this process, EDA has a well-defined part manufacturing number system and configuration control procedure for your use, if needed.
Product Manufacturing Documents: -- any data which defines and communicates the construction and/or specifications of a part or software. It could be in the form of a paper drawing, a computer data file, an artwork, etc.
Product Bible: The entire set of product documents defining a product is organized into a digital folder and organized file. This "bible" may contain drawings, procedures, code listings and so forth. There may be a separate bible for each Phase of a product's development - e.g.: Pilot Production Bible, Production Prototype Bible...
Device Master Record (DMR): This is typically a one or two page document. As a spread-sheet document, it is organized as a table of all custom assemblies comprising your product. Each Assembly has its defining documents listed by its current revision number or letter. The "rev." number of the DMR = the Product's rev.#.
Overview Drawing (-DV): This is ordinarily a single page which sketches a sub-assembly from a perspective view. It is designed to rapidly communicate a look and "feel" for the sub-assembly. The drawing tools may be anyone of a number of CAD drawing tools but it is delivered as both source file and a PDF.
Doc. Record & Parts List (-LP): This "List, Parts" is a combined parts list (often called a Bill of Materials or "BOM") for an assembly and a list of documents which exist to support its manufacture. EDA normally defines each custom part with its seven-digit number system, which in turn refers to either custom documents or a purchase specification.
Doc. Schematic (-DE): Each electronic circuit sub-assembly will have its own schematic diagrams. These are typically CAD drawings. EDA's schematic procedure demands that this diagram not only communicates wiring, but also signal flow, basic test information and other data, important to understanding the function and engineering design intent, in a concise manner. EDA's CAD support software is primarily Autodesk's "Eagle" which has a freeware reader for your use.
PWB Specification Package (-SP): Each electronic printed wiring board has a document package of its own, which typically consists of a Purchase Spec., a Mechanical/Drill drawing and many artwork layers. These circuit wiring and masking layers are typically specified and recorded as Gerber plotter files on computer disks. The CAD source files are also provided.
Mechanical Drawing (-DM): Mechanical parts, such as brackets, box parts and so forth, are specified on drawings using TurboCAD, AutoCAD Inventor or similar CAD software.
Artwork, Graphic (-AG): Panel markings, labels and so forth are defined as CAD art computer files and usually will be reformatted as PDF or JPG files for your easy viewing.
Procedure, Guideline for Assembly (-PG): This informal written procedure outlines the assembly process as envisioned by the design engineering team. This engineering "view- point" is vital for communication with any future manufacturing team and is especially effective for complex sub-assemblies.
Procedure, Test (-PT): This procedure defines a recommended test process for a sub-assembly. EDA expands its scope to include a basic test specification, as well as, a preliminary test procedure. This reduces your development costs for new products.
Software Listing (-LS): Each embedded computing or programmable device will have its own firmware listing, which includes source code and compiled code. The source listing is typically provided as ASCII readable files. EDA's source code is prefaced with a "technical memo", which provides nearly complete background on the "why", "what" and "how" of the design. This substantially reduces your future maintenance costs.
EDA : Electronic Design Associates Tampa/ St. Petersburg, FL; email@example.com 727.440.6635