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    Research and Development: Reporter: Angelica A. Magdaraog

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    Angelica Magdaraog
    This document discusses research and development (R&D) and the R&D process. It describes the types of R&D as basic research, applied research, and development. It outlines factors to consider when making R&D decisions and provides steps for an effective R&D process including assessing customer needs and creating a team. The document focuses on ISO 9001 design control, which regulates R&D management through 9 subitems that control different phases of the R&D process from planning to design changes.

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    Research and Development: Reporter: Angelica A. Magdaraog

    Uploaded by

    Angelica Magdaraog
    97 views17 pages
    This document discusses research and development (R&D) and the R&D process. It describes the types of R&D as basic research, applied research, and development. It outlines factors to consider when making R&D decisions and provides steps for an effective R&D process including assessing customer needs and creating a team. The document focuses on ISO 9001 design control, which regulates R&D management through 9 subitems that control different phases of the R&D process from planning to design changes.

    Original Title

    R&D report

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    This document discusses research and development (R&D) and the R&D process. It describes the types of R&D as basic research, applied research, and development. It outlines factors to consider when making R&D decisions and provides steps for an effective R&D process including assessing customer needs and creating a team. The document focuses on ISO 9001 design control, which regulates R&D management through 9 subitems that control different phases of the R&D process from planning to design changes.

    Copyright:

    © All Rights Reserved
    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    97 views17 pages

    Research and Development: Reporter: Angelica A. Magdaraog

    Uploaded by

    Angelica Magdaraog
    This document discusses research and development (R&D) and the R&D process. It describes the types of R&D as basic research, applied research, and development. It outlines factors to consider when making R&D decisions and provides steps for an effective R&D process including assessing customer needs and creating a team. The document focuses on ISO 9001 design control, which regulates R&D management through 9 subitems that control different phases of the R&D process from planning to design changes.

    Copyright:

    © All Rights Reserved
    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    of 17

    Research and

    Development
    Reporter:
    Angelica A. Magdaraog

    Research and Development


    Investigative activities that a business chooses to
    conduct with the intention of making a discovery
    that can either lead to the development of new
    products or procedures, or to improvement of
    existing products or procedures.

    Types of Research and


    Development
    Basic Research
    Applied Research
    Development

    Making the R&D Decision


    Proprietariness
    Timing
    Risk
    Cost

    Basic R&D Process

    Creating An Effective R&D


    Process

    Assess Customer Needs


    Identify Objectives
    Define and Design Processes
    Create a Team
    Outsource

    ISO 9001 Design Control


    In the ISO 9001 guidelines, only item "4.4

    design control" regulates research and


    development management. Nine subitems are
    further categorized to respectively control
    different phases of the entire R&D process.

    ISO 9001 Design Control


    General:

    Establish and maintain documented


    procedures to control and verify the design of
    the product in order to ensure that the
    specified requirements are met.

    ISO 9001 Design Control

    Design and Development Planning :


    (1). Prepare strategies for each design and
    development activities, and define responsibility
    for their implementation.
    (2). The design and development activities shall
    be assigned to qualified personnel equipped with
    adequate resources.
    (3). The plans shall be updated as the design
    evolves.

    ISO 9001 Design Control


    Organizational and Technical Interfaces :
    (1). Organizational and technical interfaces
    between different groups which input into the
    design process shall be defined.
    (2). The necessary information shall be
    documented, transmitted and regularly
    reviewed.

    ISO 9001 Design Control


    Design Input :

    (1). Design input requirements relating to the product


    including applicable statutory and regulatory
    requirements shall be identified and documented.
    (2). Selection of input requirements shall be reviewed
    for adequacy.
    (3). Incomplete, ambiguous or conflicting
    requirements shall be resolved with those
    responsible for imposing such requirements. Design
    input shall consider the results of any contract review
    activities.

    ISO 9001 Design Control

    Design Review :
    (1). At appropriate stages of design, formal
    documented reviews of the design results shall be
    planned and conducted.
    (2). Participants at each design review shall
    include representatives of all functions concerned
    with the design stage being reviewed as well as
    other specialist personnel, as required.
    (3). Records of such reviews shall be maintained.

    ISO 9001 Design Control


    Design Output :

    (1). Design output shall be documented and


    expressed in terms that can be verified and
    validated against design input requirements.
    (2). Design output shall contain or make
    reference to acceptance criteria.
    (3). Design output shall adhere to design input
    requirements.
    (4). Design output shall identify those
    characteristics of the design that are crucial to
    the safe and proper functioning of the product.

    ISO 9001 Design Control

    Design Verification :
    (1). At appropriate stages of design, design verification
    shall be performed to ensure that the design stage
    output fulfills design stage input requirements.
    (2). The design verification measures shall be identified
    and include activities such as

    performing alternative calculations.

    undertaking tests and demonstrations.

    comparing the new design with a similar proven design, if


    available.
    reviewing the design stage documents before release.

    (3). The design verification measures shall be recorded.

    ISO 9001 Design Control


    Design Validation :

    (1). Design validation shall be performed to


    ensure that the product conforms to defined
    user needs and/or requirements.
    (2). Validation is normally performed on the
    final product under defined operating
    conditions.
    (3). Multiple validations may be performed if
    there are different intended uses.

    ISO 9001 Design Control


    Design Changes :

    (1). All design changes and modifications shall be


    identified and documented.
    (2). Design changes shall be reviewed and
    approved by authorized personnel before their
    implementation.

    Thank you!

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