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    PR Checklist Stage5 Final

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    Ahmed Samir
    This document outlines the key considerations for establishing an efficient and repeatable manufacturing process (Stage 5). It discusses establishing a quality system, infrastructure with dedicated space for inventory, assembly, testing and shipping, supply chain management, production control, inventory management, testing, and order fulfillment. Setting up these elements of a manufacturing process requires significant investment but is necessary to manufacture products in quantity while maintaining quality standards.

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    © All Rights Reserved
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    PR Checklist Stage5 Final

    Uploaded by

    Ahmed Samir
    8 views6 pages
    This document outlines the key considerations for establishing an efficient and repeatable manufacturing process (Stage 5). It discusses establishing a quality system, infrastructure with dedicated space for inventory, assembly, testing and shipping, supply chain management, production control, inventory management, testing, and order fulfillment. Setting up these elements of a manufacturing process requires significant investment but is necessary to manufacture products in quantity while maintaining quality standards.

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    This document outlines the key considerations for establishing an efficient and repeatable manufacturing process (Stage 5). It discusses establishing a quality system, infrastructure with dedicated space for inventory, assembly, testing and shipping, supply chain management, production control, inventory management, testing, and order fulfillment. Setting up these elements of a manufacturing process requires significant investment but is necessary to manufacture products in quantity while maintaining quality standards.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    8 views6 pages

    PR Checklist Stage5 Final

    Uploaded by

    Ahmed Samir
    This document outlines the key considerations for establishing an efficient and repeatable manufacturing process (Stage 5). It discusses establishing a quality system, infrastructure with dedicated space for inventory, assembly, testing and shipping, supply chain management, production control, inventory management, testing, and order fulfillment. Setting up these elements of a manufacturing process requires significant investment but is necessary to manufacture products in quantity while maintaining quality standards.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 6

    Product Development & Manufacturing

    PROCESS CHECKLISTS

    STAGE 5
    Manufacturing
    An Efficient and Repeatable
    Manufacturing Process
    Product Development & Manufacturing

    PROCESS CHECKLISTS

    • STAGE 1 – Planning
    • STAGE 2 – Design
    STAGE 5 • STAGE 3 – Prototype
    Manufacturing • STAGE 4 – Design for Manufacturing
    • STAGE 5 – Manufacturing
    • STAGE 6 – Post-Manufacturing

    About these Process Checklists


    Launching a new product is a major commitment. No matter what size your business, creating
    a product from scratch requires a significant allocation of time, money and resources.

    A successful new product development project also calls for a process – along with a full
    understanding and acceptance of that process by everyone involved.

    We have broken down the product development and manufacturing process into six stages – from
    requirements and prototype to manufacturing and distribution.

    We developed this series of Process Checklists to help you and your team plan, execute and
    monitor these six stages. We invite you to use these checklists as you plan your own product
    development and manufacturing project.

    About Product Resources


    Product Resources is a product design, engineering and manufacturing company with 35+ years of
    experience developing complex, technically advanced products and instruments for the medical
    device, biotech/life sciences and pharmaceutical industries.

    We provide a full-service approach to product development meaning we handle all aspects of the
    product development process.

    Project Name / Number: STAGE 5 – Manufacturing 1


    STAGE 5 – Manufacturing
    Manufacturing a product requires a significant investment in space, equipment, and personnel to
    build product repeatably and reliably. It is easy to imagine getting started in manufacturing – a
    few benches and some hand tools, a couple of technicians and some drawings, parts arriving at the
    door and voila, a product. That can even work for a time with a simple product and a few customers.
    There are a few things that you should consider when deciding how to build your product.

    Quality System
    A quality system is a fundamental part of the manufacturing plan. Ideally based on recognized
    standards, it covers the details of the manufacturing process (and all other business and
    engineering processes). Product Resources’ quality system is compliant with multiple quality
    systems (ISO9001, ISO13485, EN80079-34), suitable for the products we manufacture and quite
    likely your products as well.

    Quoting/Vendor Selection
     A re there any custom part vendors that need to be used for a specific reason?
     Are the vendors ISO 9001: 2008 certified?

    Infrastructure
    To manufacture a product in significant quantities while maintaining the product quality at
    acceptable levels requires a well thought out system for manufacturing. It will include:

     Dedicated floorspace for Inventory, Inspection (and quarantine), Assembly (and storage for
    fixtures and tools), Test (and test equipment), Utility Equipment, Shipping and Receiving.
    A larger break room, etc.

     Utilities, including proper lighting, electrical power, water, sewer, possibly compressed air,
    HVAC, specialty items like liquid nitrogen, DI water, etc. This will vary depending on the
    requirements of course.

     Equipment, for example workbenches, chairs, anti-static workstations, flow benches,


    engineering machine shop, etc.

     Information Technology – no longer an option for manufacturing, an ERP system covering


    material planning, operations planning, inventory management, cost tracking, device
    master record management, purchasing, document control, change control, CARs, PARs,
    maintenance of calibration, etc., is a fundamental tool.

    Project Name / Number: STAGE 5 – Manufacturing 2


    STAGE 5 – Manufacturing

    Tools
      Hand Tools – complete sets of hand tools (lock them in toolboxes – trust me), soldering
    workstations, calibrated crimp tools (all of them, at $300-$800 each), precision dispensing
    equipment.
      Test and Measurement Equipment – Digital Voltmeters, Oscilloscopes, Network
    Analyzers, Laser Power Meters, Temperature Instruments, Pressure Instruments, Flow
    Instruments, Power Supplies, etc.
     P otting Equipment, Vacuum Oven, Temperature Chambers, etc.

    Supplies
     S upplies – adhesives, thread-locker, sealants, potting compounds, etc.
     H ardware and the million other details needed to keep a manufacturing plant running.

    Supply Chain Management


    Managing the supply chain is one of the keys to success in manufacturing. Starting and maintaining
    the flow of material, synchronized to your manufacturing cycle requires visibility into your
    customer’s requirements and your supplier’s capabilities. A streamlined process for identifying
    suppliers, ordering material, monitoring performance and mitigating risk is imperative.

    Inspection and QA
    Inspection covers incoming inspection, in-process inspections, and outgoing inspection processes.

    Production Control
    Production Control can be a bit of an art depending on the visibility into customer requirements.
    There needs to be solid communications between sales and production so that inventory levels can
    be minimized while still being able to hit on-time delivery performance. Consider:

     Is there a forecast for unit to be delivered?


    W ill units be built to the forecast or order?

    W  hat is the lead time to start production from zero?

    W  hat are the lead times required to adjust the schedule (i.e. how fast can you respond
    to late changes)?

    Project Name / Number: STAGE 5 – Manufacturing 3


    STAGE 5 – Manufacturing

    Inventory Management
    The goal, of course, is to minimize inventory while also minimizing the risk of running out of
    material. This will require coordination with purchasing to identify supply risks while keeping an
    eye on shipping requirements.
    If safety stock is required, depending on how fast production needs to respond safety stock can be
    for raw materials or for finished goods. Raw material safety stock is less expensive to maintain than
    finished goods. The ERP system is an indispensable tool for managing inventory, but like production
    control, there is a bit of art involved.

    Test Department
    Depending on how you have organized the product build (e.g. cells or batch builds, or a
    combination of both), you may require a separate area for the test department to perform
    functional tests, calibration, stress screening, safety tests (UL / CE), etc.

    Order fulfillment and shipping


    With finished goods manufactured, tested and packaged, you must now consider how to ship the
    product to the customer while maintaining product traceability. Product Resources is set up to
    handle bulk shipments to a company warehouse, or drop shipment of product to the end customer.

    STAGE 5 – F
     inal Deliverable should be a finished product and a consistent, repeatable
    manufacturing process

    What we will cover in


    STAGE 6 – Post-Manufacturing: Installation, Service and Support
     IQ/OQ/PQ Services
     Installation/Preventative Maintenance/Field Service
     Depot Repair Service
     Spare Parts Supply
     Training Services

    Project Name / Number: STAGE 5 – Manufacturing 4


    www.prodres.com • 978-524-8500 • NEWBURYPORT, MA

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