Professional Documents
Culture Documents
Development
preteshbiswas Uncategorized February 8, 2019 4 Minutes
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
4.1 Design verification: Testing aimed at ensuring that all design outputs meet design
conditions imposed at the beginning of the process.
The Design Manager is responsible for implementation and management of this procedure.
6.1.1. The Design Manager plans the stages and controls for Design and development, by
taking into account:
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:
6.1.4. At any stage, the Designers must maintain design control with history of changes as
per Design Change Log.
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.
6.3.1 According to the Design Task , the Design Team creates the Design Plan and defines:
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.
6.5.1.1 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.
6.6.1 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.