SECTION 4 DESIGN CONTROL
GENERAL POLICY
The design process is planned. Design activities are identified, responsibilities for carrying them out are assigned, and organizational interfaces are defined and controlled. The design input is formally documented and reviewed. The design is verified and, when applicable, validated to ascertain that it meets the design input requirements. The design output is documented and checked before it is released for production. Design changes are controlled.
PROCEDURAL POLICIES
1. General
1.1 Bold Technologies, Inc. designs its own standard catalog products as well as customer-specified products and modifications. The Design and Engineering departments are responsible for design. The quality assurance system for design is defined in General Process Specification G9004, Design Control.
2. Design Input
2.1 The design input may be provided to Design and Engineering in two ways. Design input for the company's standard products comes from Marketing in the form of a product brief. Custom products are specified by customers and the Sales department using a User Specification. Establishment of product briefs and design orders is governed by General Process Specification G9004.
3. Design Planning
3.1 The Design Engineering Manager is responsible for the planning of design projects, including assignment of design activities and control of organizational and technical interfaces.
4. Design Verification and Validation
4.1 As a minimum, every design is verified by holding and recording Design Reviews and undertaking qualification tests. Other activities may include performing Failure Mode Effects and Analysis (FMEA), software verification and validation, testing material compatibilities, performing calculations, verifying capacities, creating drawings and performing demonstrations. Design verification activities are described in General Process Specification G9004, Design Control.
5. Design Output
5.1 Design output is documented on two levels: Primary output consists of documents defining the designed product, while the secondary output supports the design with calculations, analysis, etc. Design output documents are checked and approved before they are released for production. Establishment, verification, and release of design output is governed by General Process Specification G9004, Design Control.
6. Design Changes
6.1 Design changes are initiated using Change Request/Order (CRO) forms. CROs may be initiated by Sales & Marketing, Servicing, Production, Quality Assurance, or Engineering itself. The CRO provides design input for making a design change. Planning, design, and design verification activities follow the same rules as apply to original designs, as documented in General Process Specification G9004, Design Control.
6.2 During the design phase, Change Orders are used whenever a customer's specification requires a deviation and the customer has approved the change. For certain minor deviations, the designer decides whether or not a change warrants the customer's approval.
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