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A. Purpose:
The Objective of this procedure is to define the process applied to the design and development of Titan Industries
Devices as well as the design of the associated manufacturing processes and to control the design through review,
verify, and validate any design change before implementation
B. SCOPE
This procedure is applied on all the concerned departments in any stage of the design/change of product/process.
C. Responsibility
Design development is responsible for planning and controlling the design and development of products
committee including the evaluation and approval of any new design
consist of
 General Manager
 Sales / Export Manager
 Plant Manager
 Quality Manager
General Manager Is sponsors for any new projects /design change.
Sales / Export Manager Responsible for data providing from the market
Plant Manager Execute and verify required new designs / changes and development
Quality Manager Establish and monitoring the needed controls and validation as well as to provide feedback
to development committee
D. Abbreviations & Definitions

E. Forms and Enclosures

-
F. Process/ method:
- Product design and development process is a cycle of continuous improvement over time with iterative
feedback and recurring inputs from development team members, executives, sales and marketing
departments and production teams
- The process of product design and development together, mainly includes following phases:
 Analyzing market and customers’ needs
 Product concept generation
 Product design specifications
 Design for manufacturing
 Development of concept and prototype
 Detailed design
 Design evaluation and review
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 Product launch

Design Planning
 Program / Project management
 Customer inclusion
 Complete definition of the process to be used for a specific design
 Including stages, approvals, testing, resources, RISKS, etc
Design Inputs
 Documented procedure.
 Market study for competitive products.
 Customer Complaint.
 Production and Quality feedback
 Customer requirement (Market needs).
 Statutory &regulatory requirements.

Design Controls
 Design Verification – was the article built right? (insp / test)
 Design Validation – was the right article built? (qualification)
 Configuration Management (iterative process of design)
 Test / Acceptance conditions
 Design Reviews

Design Outputs
 Engineering drawing /technical specs for each part /product.
 Intermediate / Product BOM.
 Records of design review.
 Records of design verification.
 Records of design validation.
 Test /Inspection acceptance criteria.
 Process parameters updates.
- Specify the characteristics of the products that are essential for its safe and proper use.
- Design team receives the new design / change in product /process and development inputs and explain
the requirements including the priorities and the resources in form QF-008-001
- Design team reviews the design and development requirements.
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- Systematic Review at suitable stages in accordance with planned alignments and evaluates the results to
meet the requirements and identify any problems and to be recorded in QF-008-002
- During this review considering, opportunities for design and developments process, and Evaluation of
potential hazards or fault models in products.
- Records of the results of review and any necessary action are mentioned in. QF-008-003
- Control of design and development changes are identified through complete Revision, Verification, and
Validation as appropriate and approved before implementation.
- Review of design control and development changes shall include evaluation of The effect Of these
changes on the constituent parts and the delivered products.

Design and Development’ Process model is displayed on Fig. 1.

‘Design and Development’ Process Model Flows

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1) Development request
2) Decisions on opportunities for improvement
3) Decisions on the needs for change, including resources
4) Functional requirements and indicators
5) Statutory and regulatory requirements
6) Standards and regulations, the requirements of which the Organization complies to
7) Proposals to improve the product (improve service provision methodology)
8) The data acquired from the design and development work completed earlier
9) Potential consequences of failure due to the characteristics of products and Services
10) Characteristics of services, that are essential for their purpose and their safe and proper use
11) Monitoring and measuring requirements
12) Acceptance criteria
13) Information about new developments
14) QP-008 ‘Design and Development’
15) - Technical director and project managers
- Personal computers
- Company server, software

A. References.

B. Change History.
Issue/modification date Issue/modification No. Description of modificaton
DD/MM/YY (1/0) First issue

C. Approvals
Name Position Signature / date
Prepared by
Reviewed by
Approved by