7.3.1 Design and Development Planning

Purpose

Unless the organisation has claimed an exemption to this clause, it is required to plan and control the design and development of product.

During the design and development planning, the organisation shall determine;

• the stages of design and development
• the necessary and appropriate review, verification and validation processes for each stage
• the responsibilities and authorities for design and development and the manner in which the organisation manages the relationships between the internal and external parties involved to achieve clear communications and assignment of authority.

All documentation associated with the planning function shall be constantly updated throughout the design and development stages.

Procedure

Exemption

[enter-your-company-name-here] does not contribute to concept or finished design of products; this element is therefore excluded from the Quality Management System.

OR

[enter-your-company-name-here] intends to control design and design management for the purposes of;

• preparing design and construction estimates and tenders in response to written requests or invitations to tender and,
• designing new products and developing them for the market.
• Re-engineering existing products.

Design Management

[enter-your-company-name-here] shall be responsible for design management.  An appointed Design Project Manager will control the design project.

Design management may include, but is not limited to:

• Establishing the stages of design and development
• Developing a program that defines inputs, outputs and roles, both internal and external
• Defining the role of the Design Consultant
• Creating a project file
• Coordinating information, meetings and project team members
• Advising on conceptual design, suitability for construction and practical issues
• Review of drawings
• Review of the design with respect to the client or market brief
• Review of any prototypes
• Review, approval and sign-off of critical work or stages
• With respect to drawing and specification control;
• Ensure that all drawings and specifications are current, are on site and in Job File
• Hand over new drawings and instructions to site personnel and suppliers
• Remove obsolete documents from the Job File and site locations
• Sign, date and mark old documents “superseded”
• Record names of drawing recipients on the Daily Report.

Outsourcing

Where appropriate, a specifically selected, out-sourced design consultant shall be commissioned to carry out, and to be responsible for, design, compliance and finished drawings.

The selection process is based on the consultant having appropriate qualifications, experience with the  product to be designed, and appropriate levels of engineering resources.