Design Procedure
1.0 Objective
This procedure defines the method of creating a design for the product of PPF which can lead towards the production and verification of the product.
2.0 Scope
This procedure applies to the entire product produced in PPF under QMS.
3.0 Procedure
3.1 Design and Development Planning
3.1.1 PPF is basically converting the customer’s requirements into specification by following the recommendation of QMS and other recommended customer needs..
3.1.2 Production and Design Section are responsible to create a comprehensive design package.
3.1.3 Production department ensure that all the activities of design are included and considered while design plan is prepared.
3.1.4 Production department is responsible to prepare the design plan for every customer order. Design plan is prepared to develop a product specification format for each order. Following activities are covered in design plan.
• Design input,
• design reviews
• design out put
• Design verification and
• Design validation.
3.1.5 Production manager approves the design plan. The responsibilities, and target dates are also defined in Design Plan.
3.2 Design and Development Input
3.2.1 Basic design inputs are taken from the customer requirements.
3.2.2 The customer requirements are received, reviewed and documented by Design Section. Customer’s requirements are considered as design input. Marketing department send these requirements to Design Section who uses this information for developing the product specification format. The design input includes where applicable;
• Functional and performance requirements
• Applicable statutory and regulatory requirements.
• Information derived from similar previous design
• Any other requirements.
3.3 Design and Development Out Put
3.3.1 Design input documents are generated through a comprehensive study of design in-put requirements.
3.3.2 Design out put facilitate the design verification and validation activities.
3.3.3 The Product specification format is taken as design out put document which is established from the requirements of design input.
3.3.4 The Product specification format is derived form customer requirements, other applicable national/international standard.
3.3.5 Production manager ensure that design out put;
• Meets the design input requirements.
• Provide appropriate information for purchasing, production.
• Specify acceptance criterion.
• Specify the product characteristics.
3.4 Design Reviews
3.4.1 Design review is carried out to ensure that design activities are carried out according to design in-put requirements.
3.4.2 Design review is carried out during the design cycle.
3.4.3 Design review is performed by factory manager who has no role in developing the design of the product.
3.4.4 Product specification format is reviewed by General Manager which is considered as design review activity.
3.4.5 Production Manager also sign the product specification format as an evidence of design review.
3.5 Design Verification
3.5.1 Design verification is carried out to ensure that design out put meets the design input requirements.
3.5.2 PM perform the comprehensive inspection and testing on every first pipe of every order to ensure that design out put meet the design input requirements.
3.5.3 The whole lot of production in put on HOLD in case of any problem in first pipe of the order.
3.5.4 PM is responsible to take necessary corrective action to validate the conformance of the produced pipes.
3.5.5 The approval of first Design from the GM indicates that design is verified.
3.5.6 Inspection/ test report is kept by Production Department as an evidence of design verification.
3.6 Design Validation
3.6.1 Design validation is carried out to ensure that product specification is valid for operating condition.
3.6.2 In PPF, the inspection/testing of customer or his representative is considered as design validation.
3.6.3 The report submitted by customer or his representative is considered as design validation.
3.7 Design and Development Changes
3.7.1 In case of any suggested change in design whole cycle of design will be repeated and it will be again reviewed, verified and validated.
3.7.2 Design change includes change in Spec or change in customer technical specification.
3.7.3 During the design change production department personnel will also evaluate the impact of design changes on all the products which are already delivered to customer.
3.7.4 In case of any significant impact customer is intimated via GM / marketing department.
3.7.5 All the records of design change, including amended product specification format is kept by planning department.
4.0 Related Documents
Design and Development Plan
Product Specification sheet
Inspection/ Test reports
Customer Reports.
Design change records.