Procedure for designing and developing product
Procedure for designing and developing product
1. PURPOSE:
The purpose of this procedure is to ensure that the products of the company are designed and developed correctly as requested by the customers.
2. SCOPE:
This procedure applies to the design and development of the product.
3. DEFINITION:
3.1. The terms used in this procedure are suitable with standard ISO 9001:2008.
3.2. Abbreviation:
Document Maintenance procedure: DMP
4. CONTENT:
4.1. Procedure for designing:
4.2. PROCEDURE NARRATIVE
a> Make the product design and development plan.
According to the customer’s request (or company’s), the Technical Division is responsible for make the design and development plan for each type of product (by requested or ordered). This plan must include:
• Describe the specific process to design and develop the product in accordance with the order/order No.
• Stages to examine and identify the value in use for each period.
• Responsibility and right of each employee participating in designing.
Related divisions such as Plan, Sales, Materials and Product Quality Examination are responsible to provide information as requested by the Technical division to complete the plan.
During the process of plan making, if there is any change requested by the company or customer, the technical division must update this change in the process.
The technical Division is responsible for identifying the input fully and adequately, which includes: functional and operational requirements, information from previous similar design and so on. The related documents in the process must be kept for record.
The output of this process must meet the following requirements:
• Meet the beginning design and development requirements.
• Provide appropriate information to the sales, manufacturing and supply of service.
• Identify the primary characteristics of safety and correct use of the products.
b> Check the development and design of the product:
During the plan making and executing, the process must be checked for the following purpose:
• Evaluate the ability to satisfy the design and development requirements.
• Discover any problem and take necessary actions.
The division and individuals who take part in the Checking must have repetitive of units relating to the design and development process along with in order to:
• Check the conformance and accuracy of the plan.
• Check the result of each stage (if have).
• Check the final Product.
c> Trial-manufacture:
• After collecting all the necessities for the designing, the technical division will perform Trial-manufacturing as plan. The trial producing period must be suitable with the deadline required by the customer (or the sales division).
• Each stage of the design and development process must be checked and confirmed the accordance with plan. The checker confirms independently with the producer, designer and developer.
• The records relating to the checking must be carefully kept as mentioned in the DMP.
d> Confirm the value in use of the product design and development:
• After finishing the design and development process, the head of technical division is responsible to make a Quality checking report as requested to the product.
• To fault or unsatisfactory product, do as mentioned in the procedure for maintaining unsatisfactory products.
• Technical and related divisions (which are transferred the checking report of value in use to) are responsible for keep these documents carefully as mentioned in the DMP.
e> Manage change in design and development request:
• The technical division has responsibility to manage the record of change in the design and development process.
• The changes must be approved by the head of Technical division before being applied.
• The changes need considering, evaluating and confirming the value in use appropriately. The consideration of change in design and development must include the evaluation of their impact on the product components and the transferred product.
f> Trial-manufacture, Quantity-manufacture:
• The manufacturing sector will work with technical division to produce trial-product in certain quantity and examine the sample if it meets the design and development requirements or not.
• When discover any fault, the manufacturing sector must inform the technical division to solve. If they cannot solve either, then notice the customer or the sales division.
• If the sample meets the requirement, then carry out Quantity-manufacturing as planned.
5. REFERENCE DOCUMENT:
• Quality handbook
6. APPENDIX:
• None
Related ISO documents:
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