Engineering Change Order (thủ tục thay đổi kỹ thuật) designed to control engineering changes incorporated into the company product lines. ECO is a document that specifies either new product design details or proposed changes (mục đích thay đổi) to existing products. ECO controls item revisions and bill of material changes.
The Eco: The Engineering Change Order process provides for review of proposed changes requiring engineering decision and ensures orderly incorporation of approval design changes. The process begins with the need for change —» Development of the change —» Planning of how the change is to be implemented —» Official approval for the entire change package. The change process applies to all products are in Pre-production and Production release.
The ECO is an approval and implementation (thi hành, bổ sung) process. An ECO can be triggered by one of the following causes in the manufacturing operation or other reasons:
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A modified BOM is typically used to either schedule future engineering changes or to keep track of past ones. Therefore, a BOM plays a big part in the engineering change order process, it provides us a mechanism to evaluate the positive (đánh giá điều có thực) or negative effects the engineering change has made. It is visual and gives a design engineer, quality control manager, or process engineer the baseline to make sound business decisions. The person assigned responsibility for planning change must:
Department Each department shall be responsible for creating new document and drafting proposed changes to documents required for operations specific to its functions.
The Change Control Board (CCB): Or the Change Committee decides whether a Change Request will be implemented or not. Sometimes this task is performed by the project manager as well.
Change Control Board Responsibilities: The Change Control Board must approve all maintenance and revisions to the company policy, using the ECO process.
CCB Administration Controls:
CCB Member Responsibilities:
Change Consolidation: Document revision and engineering changes should be combined in the following method.
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Effectivity Principles: When effectivity (hiệu quả) is specified as a date, it’s the date when the change will be incorporated on the highest-level assemblies, kits or parts, indicated within the body of the ECO. Lower-level changes or activities to support the ECO such ordering, stocking of parts or reworking subassemblies may have earlier effectivity dates determined by Inventory Production Control Planning. Effectivity should reference a System Number where the change goes into effect. System Number is mandatory for reliability, retrofit, and rework ECOs.
The following factors determine effectivity: Pending ECOs - Drafting Backlog - Scrap Cost - Test Fixture – Material availability – Labor Availability – Procedures – Priority Modification.
Originator Responsibility: Originator can recommend effectivity based upon an assessment of the basic for change and its expected effect upon Manufacturing. Field Engineering, Materials, Spares, etc. Materials sets the effectivity date at CCB, and follows up with the first System Number affected, at least 5 days before effectivity date. Document Control will redistribute ECO cover sheet when starting System Number is added.
ECO change categories define the nature of the problem and identify the basic reasons for recommending a change. They are the only categories for change considered acceptable. If an ECO has two categories, the higher indicated approval class prevails (chiếm ưu thế). The ECO Form shows these categories.
Pre-Production ECO: Unreleased piece parts for production use. All new parts are structured to Engineering Project numbers. The numbering system is to be determined. The system parts into the Engineering Project number. Materials will procure (thu được, hiện hành, thông dụng) all new prerelease parts, and buy the released part conservatively. The Master Scheduler will ensure demand is added to PLM System to drive the appropriate requirement. This does not allow shipment; an ECO is required for Production Release.
Reliability: Changes required to overcome a failure to meet minimum requirements of the product design specification, or failing to meet accepted industry standards.
BOM Change: Change or add item numbers, reference designators or quantity on the BOM only, doesn’t affect drawing other than revision change.
New Product: Release of new products and options.
Product Improvement: Changes to improve product life, performance, maintainability, or capabilities which exceed the requirements of the existing product design specification.
Procurement: Changes required to overcome inventory shortages, supplier problems, or part availability.
Producibility: Changes required to overcome manufacturing difficulties BOM errors, etc.
Safety: Changes required to correct actual or potential personnel safety problems, damage to equipment or environment.
Defect: Changes required when a manufacturing defect occurs when something in the manufacturing process caused the product not to be made according to the design.
Rework: Changes required when a manufacturing rework to correcting defective, failed, or non-conforming items after inspection. This process includes responsibilities like disassembly, repair, replacement, reassembly, and more.
Excessive Scrap: Changes required to overcome the scrap count exceeds the amount allotted when the job was set up.
Obsolete Components: Changes required to overcome the need to outsource a different component based on the lack of availability of resources from outside vendor(s).
Compliance Violation: Changes required when any newly enacted laws affecting how the product performs in the market place, and whether those create a violation.
ECO processing can be viewed as three basic steps: creation, approval, and implementation.
CREATION: Identifies a problem or issue and determines that it may require a change —» Originator —» Complete ECO form —» Update Revision Level —» Verify that ECO is correct and complete —» Obtain any necessary approvals from Engineer, Manufacturing, Quality, Scheduler, Marketing, Retrofit —» Document all procedures affected within ECO —» Completed ECO form —» Distribute ECO package to affected CCB members —» Create CCB meeting agenda —» Notify CCB members of meeting date and time —» Attend CCB meeting —» Review any changes or issues with CCB members —» Marked up ECO —» Approved ECO changes —»
APPROVAL: The ECO is circulated for review and discussion among key stakeholders and is modified as needed —» Document Control —» Enter ECO data into MRP system —» Update revision level, ECO number and Date of Release as required —» Maintain Master document and Master digital files and Backup as required —» Distribute ECO package to Distribution List —» Management approved ECO as requested includes R&D Engineer + Manufacturing Engineer + Purchasing + Material Planner + Planning Engineer + Electrical Engineer + Software Engineer + Quality Control + CCB Members —»
IMPLEMENTATION: Those responsible for implementation use the information in the ECO and ECN to make the requested change —» Engineering Release —» Pre-production —» ECO must go through CCB review + Engineering review + Manufacturing review + Quality review + —» Inactivating Part (bộ phận vô hiệu hóa, không hoạt động) or Obsoleting (bộ phận quá hạn, đã lỗi thời) Part.
Abandoned: The Abandoned status is an inactive status which indicates that a Design stage Item is no longer being worked on and should not be considered for new designs.
BOM: A comprehensive list of parts, items, assemblies and other materials required to create a product, as well as instructions required for gathering and using the required materials. The Bill of Materials (BOM) is the basic building block for manufacturing a part. A Bill of Materials can be comprised of three items: Components, Sub-assemblies, and Phantom BOM’s.
Change Order (CO): A generic term for all type of change orders.
Change Request (CR): Used to plan or execute design, process, supplier and/or supplier process changes.
Change Request Management: The change request management process in systems engineering is the process of requesting, determining attainability, planning, implementing, and evaluating of changes to a system. Its main goals are to support the processing and traceability of changes to an interconnected set of factors.
Complete: Moving a Change to the Completed phase signifies that all work and implementation activities are finished.
Component: Raw materials used to manufacture a product; typically items that are purchased from an outside vendor.
Deprecated: An Item in the Deprecated phase of the Item lifecycle is not recommended for use in new designs. A deprecated Item is typically on its way to obsolescence, but is not yet considered obsolete because it is still being produced and used. A common practive is to mark an Item as Depredacted for a limited time before obsoleting it, to discourage use in future design.
Design History File (DHF): The compilation of records that describes the design history of a finished device.
Design Master Record (DMR): A compilation of records containing the procedures and specifications for a finished device. DMRs shall include or reference the location of —›
‹•› Device specifications including appropriate drawings, composition, formulation, component specifications, and software speicifications.
‹•› Production process specifications including appropriate equipment specifications, production methods, production procedures, and production environment specifications.
‹•› Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used.
‹•› Packaging and labeling specifications including methods and processes used.
‹•› Maintenance servicing procedures and methods.
Document Change Order (DCO): A change order detailing modifications to documents, specifications, or SOPs.
Engineering Change Management (ECM): Engineering Change Management is a systematic approach to the documentation of changes from the identification of the required change, through the planning and implementation of the change, and culminating with the closure of the issue.
Engineering Change Notice (ECN): A document to authorizing and recording design changes throughout the prototyping and life-cycle phases of a product. Once the ECO has been approved, an engineering change notification/notice (ECN) is sent to affected individuals to let them know that the ECO has been approved and the change should now be implemented.
Effectivity Revision: The most recent released revision of an item.
Engineering Change Order (ECO): A change order that is used to track changes to items in the production level revision (alpha revision) within Change Management.
Engineering Change Request (ECR): A correction to address or fix the problem, what items would have to change to fix it, and signoffs to say the suggestions are approved and to move forward with the ECO process.
Engineering Design Specification (EDS): A specification often refers to a set of documented requirements to be satisfied by a material, design, product, or service. A specification is often a type of technical standard. It is a common early part of engineering design and product development processes in many fields.
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Engineering Purchase Specification (EPS): The characteristics that are associated with an item or product to be purchased. It can include weight, size and dimensions, quality, safety requirements and the products performance parameters.
Engineering Reference Specification (ERS): A specification that calls out a material, product or method based on the requirements of testing standards written by organizations such as ASTM, ANSI, UL, OSHA, etc.
Engineering Requirement Specification (ERS): An Engineering Requirements Document specifies how a product will be built in order to fulfill the PRD's multitude of wishes.
Engineering Specification (ES) or (ENSP) are the records which provide detailed documentation of the construction, wiring, arrangement and related engineering details of the information processing equipment.
Engineering Specification Waiver (ESW): A correction to a performance or safety deficiency for systems in the field. It is provided to the customer at no cost.
Engineering Units: A unit of measurement is a definite amount of a physical quantity defined and adopted by convention and or law, that is used as a standard for measurement of the same physical quantity of any amount. Examples of engineering units are seconds, degrees Celsius, Kilograms, Newtons etc. For example, the metric of braking distance may be measured in units of meters.
Manufacturing Change Order (MCO): A change order describing modifications to the manufacturing process or equipment. It is used to track modifications to the manufacturing process, equipment or sourcing (e.g. updating supplier information from a potential source relationship to an approved source relationship) without change to the form, fit or function of the item. This change does not affect the revision of the item.
Manufacturing Change Request (MCR): A change request specifying proposed modifications to the manufacturing process or equipment.
Part Lists, also known as (BOM): Bill of Materials is an Engineering document containing a list of parts that make up an assembly and contribute to the cost of that assembly. Part Lists can have layers of hierachy that build up to the complexity of a completed product. Additionaly, part lists can include non-material parts such as labor or testing.
Phantom BOM’s: Another production BOM used in conjunction with other BOM components or sub-assemblies.
Obsolete: An Item in the obsolete stage of the Item lifecycle may not be used in any new designs. An obsolete Item may be re-activated using Re-Activated Item function or via a Change, depending on whether or not Change Management is required in the workspace.
Pending Revision: A lock-down revision that is scheduled to become the next effective revision at a future date upon effectivity of a change.
Phase is a period within a stage of an object's lifecycle. Items, Requests and Changes have predefined lifecycle stages and phases, but Account Administrators can customize the Item lifecycle by creating their own phases. Project phases are defined by the creator of a Project.
Procurement Process: The process of purchasing goods or services and is usually in reference to business spending. Business procurement requires preparation, solicitation, and payment processing, which usually involves several areas of a company.
Product Engineering Specification (PES): The product engineering specification (or product design/requirements specification, often “spec”) is a critical document in the creation of every product. Specifications are quantitative, measurable criteria that the product is designed to satisfy. PES must contain a metric, target value and engineering units for the target value.
Product Improvement Kit (PIK): Equipment needed to enhance the system, purchased by customer for a system in the field. Require field services can be provided or self-installed.
Quality Function Deployment (QFD): Quality Function Deploymentis a model for product development and production popularized in Japan in the 1960's. The model aids in translating customer needs and expectations into technical requirements by listening to the voice of customer. QFD is a systemmatic way of obtaining information and presenting it. The benefits of QFD is fewer engineering changes and shorter product development cycle.
Retrofit: A correction to a performance or safety deficiency for systems in the field. It is provided to the customer at no cost.
Submitter: Person submitting th Change Order. This can be different from the Initiator.
Target Value: Target values is the range of the metric that is acceptable, Examples of target values include “less than 6 seconds”, “greater than 7 pounds” or “between 20 and 50 Kilograms”. For the braking distance example, the range of acceptable values might be less than 30 meters.
Unique Device Identifier (UID): An identifier that adequately idnetifies a device through its distribution and use by meeting the requirements 830 FDA Unique Device Identification System. A unique device identifier is composed of —›
‹•› A device identifier: A mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device; and
‹•› A production identifier: A conditional, variable portion of a UDI that identifies on or more of the following when included on the label of the device —›
Work Instruction (WI): A document containing low level procedure details that specify how a task is to be performed, in order to implement and support policies/SOPs. Formal document change control is required for all WIs.
Working Revision: The ditable revision of an item, where users make changes. There is only one working revision at a time.
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