Procedure for Design and Development

1. SCOPE

This procedure covers all roles, responsibilities, and authorities related to the Design process at XXX

2. PURPOSE

The purpose of this procedure is to define the design control process used by XXX during the design and development of its products and services.

3. REFERENCE DOCUMENTS

3.1 XXX Quality Manual.
3.2 Procedure for Correction and Corrective Action.
3.3 Procedure for Production.
3.4 Procedure for Purchase.
3.5 Procedure for QA.
3.6 Business Development and Marketing Procedure
3.7 Procedure For Review of Customer Requirements

4.TERMS & DEFINITIONS

4.1 Design verification: Testing aimed at ensuring that all design outputs meet design conditions imposed at the beginning of the process.

4.2. Design validation: Testing aimed at ensuring that a product or system fulfills the defined user needs and specified requirements, under specified operating conditions. See also validation.

4.3 Design review: A design review is a milestone within a product development process whereby a design is evaluated against its requirements in order to verify the outcomes of previous activities and identify issues before committing to – and if need to be re-prioritise – further work. The ultimate design review, if successful, therefore triggers the product launch or product release.

5.0 RESPONSIBILITY AND AUTHORITY

The Design Manager is responsible for implementation and management of this procedure.

6.0 DETAILS OF PROCEDURE

6.1. Design Planning

6.1.1. The Design Manager plans the stages and controls for Design and development, by taking into account:

  • Nature, duration and complexity of design activities
  • Required process stages, including applicable design activities
  • Required verification and validation activities
  • Internal and external resources needed
  • Interfaces between persons involved in Design
  •  Design regulations, standards

6.1.2. The design planning documentation shall be recorded electronically and/ or in hard copy form, as appropriate. This will include the Design Team comprising of the assigned design engineers, support staff, subordinate third party providers, and the responsibilities and authorities for each. Where third parties are utilized, this shall define the approved points of contact.
6.1.3. The Design Manager must ensure that the Design Team:

  • Implements design control
  • Generates the design plan and schedule
  • Reviews changes to product or service design
  • Defines activities of verification and validation

3.1.4. At any stage, the Designers must maintain design control with history of changes as per Design Change Log.

6.2. Design inputs

6.2.1 Design “inputs” are the requirements for the final product or service.
6.2.2 According to the preliminary design, the Design Manager decides whether to involve customers with the Design team, and creates the Design Task, which contains the input data that defined the request for product or service.
6.2.3 The product or service specifications/ requirements are maintained in the Document Register by the Department Head.

6.3 Developing the Design Plan

6.3.1 According to the Design Task , the Design Team creates the Design Plan and defines:

  • • The design phases
    • All activities related to phase realization
    • Input elements of each phase
    • Responsibilities of team members for each phase
    • Phase realization deadlines
    • Phase deliverables
    • Resources needed
    • Changes in phases and approval of changes
    • Design phase status (reviewed, validated, verified and completed)

6.3.2 The Design Plan will be updated as the design work progresses.

6.4 Design Outputs

6.4.1 Once design inputs are captured, the production of design outputs may begin. Typically, these are:

  • Drawings
  • Specifications
  • Models
  • Standards and specifications, work instructions, method statements etc.

6.4.2 The Department Head oversees the development of the appropriate design outputs, including those produced by third party providers.
6.4.3 All design outputs must be developed so they properly address the applicable design input requirements.

6.5 Design Controls

6.5.1 Design Reviews and Verification

6.5.1.1 The Designer/ Drafter of the design output shall review the Design.
6.5.1.2 Additional verification shall be performed by peer, expert designers or by a third party.
6.5.1.3 The Design Manager shall then perform design verification, to check that the design inputs have been addressed satisfactorily in the design outputs. Records of design verification are maintained as formal approvals. The design process may not proceed until all design outputs are verified as having addressed the design inputs.
6.5.1.4 Should the design review/ verification phase identify any problems/changes, the Design Team shall suggest actions to resolve them. These actions shall be recorded in the Change Review Record.
6.5.1.5 After phase review, the Department Head approves the start of the new phase by signing the Design Plan.

6.5.2. Design Validation

6.2.1 Design validation is performed by Consultants/ Client Representatives by comparing the design documents with the project specifications and the design data.
6.2.2 The Design Team conducts validation before release of product or service.
6.2.3 The Design Manager will ensure necessary actions are taken on problems/changes identified during the review or verification and validation activities.

6.6. Design Changes

6.6.1 Where changes/ variations are required in the design, the customer shall request these formally, or the customer’s approval obtained prior to commencing any work.
6.6.2 The Design Manager shall review the change request and record his approval in the Change Review Record.
6.6.3 The status of all design changes shall be maintained in a Design Change Log.
6.6.4 Applicable design data or documents will be revised with their revision indicator incremented and updating of Document Register. Obsolete design documents shall be removed from circulation, or identified as such, to prevent their unintended use.
6.6.5 Changed designs must go through the same design review, verification and validation as the original design.

7.0 RETAINED DOCUMENTED INFORMATION

7.1 Change Review Record (D&D / QF/01)
7.2  Design Plan (D&D / QF/02)
7.3 Design Task (D&D / QF/03)
7,4 Design Change Log(D&D / QF/04)


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