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  • 1.  Design Change versus Engineering Change Order (ECO)

    Posted 04-Nov-2019 10:39
    Hi everyone, 

    What are the differences between engineering change orders (ECOs) and design changes? To me, they are both processes within the QMS to ensure changes or modifications to the devices are approved and documented having done the impact analysis. 

    I'd appreciate any insight. Thanks.

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    Karen Zhou
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  • 2.  RE: Design Change versus Engineering Change Order (ECO)

    Posted 04-Nov-2019 11:32
    Hi Karen,

    ECOs are used to propose a design change by the engineering department. ECOs are assigned to applicable people who need to review the change and is discussed in the Change control board meetings to determine if the design change is ok to proceed and what areas the change will affect. Whether the change needs a regulatory approval, what will happen to the product in field, drawing changes etc.

    Thanks,
    Meenakshi

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    Meenakshi Verma
    Regulatory Affairs Professional - Medical Devices
    Ontario
    Canada
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    Original Message


  • 3.  RE: Design Change versus Engineering Change Order (ECO)

    Posted 05-Nov-2019 03:31
    Karen,

    To some they are the same, as well to others, a design change is much more broad where an engineering change is something specific.  As an example, "design changes" is a specific section in ISO 13485 and FDA QSR describing changes to a design.  This could potentially be any type of change from labeling, indications for use, specifications, components, materials, etc.  Within a quality management system organisations need to determine when a design change is "just a change" versus something where the design control process needs to be followed again.  When considering an Engineering Change Order (ECO) this is typical a specific process in the quality system with a form that is completed, changes approved by SMEs, and implemented according to an implementation schedule.  Typically an ECO is used for many different type of changes, even changes to SOPs, depending on how the company has their documentation system set up.  From my perspective the design changes is an overall process where ECO is a specific process managing those changes.  So there could be multiple ECO generated for a design change depending on the type of product and type of change being made.  This is quite a short and brief explanation, but there is a lot of information around design changes and what could be considered an ECO - but do agree with Meenakshi these are processes within the quality management system.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: Design Change versus Engineering Change Order (ECO)

    Posted 05-Nov-2019 09:11
    Just have to jump in here -

    What specifically an "ECO" is and what specifically a "design change" is vary tremendously by company. Thus, the correct question is "what does it mean in my company?" These terms are not called out in the QSR or any other regulation. Over time, I have worked in systems that had...

    - ECOs were for design changes to products. GCOs were for changes to processes etc and DCOs were for changes to manufacturing, equipment etc etc

    - ECRs were the changes requests and where the assessment was done and the ECO was the final approval for change for all types of documents

    - ECOs were really the "requests" that could be bundled together into larger, final ECRs

    - CRs were used for design change requests and documenting design controls for incremental changes while COs were used for final implementation of any changes (design, manufacturing, QS etc)

    - DCOs were used for product design changes and ECOs were used for everything else

    - somewhere the DHF was a separate document and another place the DHF was a compilation of other controlled documents that were released separately via ECO

    So there really isn't a "right" answer. Depending on the "school" of configuration management you belong to, some might work better than others. But generally, it is better to stay away from what something is called and focus on how this allows the product and documentation to meet the regulatory and quality requirements.

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


  • 5.  RE: Design Change versus Engineering Change Order (ECO)

    Posted 05-Nov-2019 08:21
    From a regulatory perspective Engineering Change Orders do not exist. ECO is a method of implementing the regulatory requirements for a Design Change Process. The ECO should also be in compliance with your Document Control process and be retained in your Design HistoryFile/Medical Device File.

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    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.com
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    Original Message


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