HG/MR/SOP/CO/03
Hannan Group Standard Operating Procedure Issue 2
Page 1 of 3
(Hannan Fashion’s Ltd./Fancy Fashion Sweaters Ltd./Hannan Knit & Textiles Ltd./Hannan Knitwears Ltd.)
Procedure for Design and Development
Purpose:
The purpose of this procedure is to define the design control process used by Hannan Group
during the design and development of its products and services.
Scope:
This procedure covers all roles, responsibilities, and authorities related to the Design process
at Hannan Group.
Responsibility and Authority:
The Design Manager is responsible for implementation and management of this procedure.
Details of Procedure:
Design Planning:
1. The Design Manager plans the stages and controls for Design and development, by taking
into account:
a. Nature, duration and complexity of design activities
b. Required process stages, including applicable design activities
c. Required verification and validation activities
d. Internal and external resources needed
e. Interfaces between persons involved in Design
Design regulations, standards:
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.
3. The Design Manager must ensure that the Design Team:
a. Implements design control
b. Generates the design plan and schedule
c. Reviews changes to product or service design
d. Defines activities of verification and validation
4. At any stage, the Designers must maintain design control with history of changes as per
Design Change Log.
Design inputs:
Revision
Prepared by: Signature Approved by: Signature Revision Date:
No:
Head of Quality Managing 14.07.2018
01
Department Director
HG/MR/SOP/CO/03
Hannan Group Standard Operating Procedure Issue 2
Page 2 of 3
(Hannan Fashion’s Ltd./Fancy Fashion Sweaters Ltd./Hannan Knit & Textiles Ltd./Hannan Knitwears Ltd.)
5. Design “inputs” are the requirements for the final product or service.
6. 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.
7. The product or service specifications/ requirements are maintained in the Document
Register by the Department Head.
Developing the Design Plan:
8. According to the Design Task, the Design Team creates the Design Plan and defines:
a. The design phases
b. All activities related to phase realization
c. Input elements of each phase
d. Responsibilities of team members for each phase
e. Phase realization deadlines
f. Phase deliverables
g. Resources needed
h. Changes in phases and approval of changes
i. Design phase status (reviewed, validated, verified and completed)
9. The Design Plan will be updated as the design work progresses.
Design Outputs:
10. 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.
11.The Department Head oversees the development of the appropriate design outputs,
including those produced by third party providers.
12.All design outputs must be developed so they properly address the applicable design input
requirements.
Design Controls:
13.Design Reviews and Verification
14.The Designer/ Drafter of the design output shall review the Design.
15.Additional verification shall be performed by peer, expert designers or by a third party.
16.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
Revision
Prepared by: Signature Approved by: Signature Revision Date:
No:
Head of Quality Managing 14.07.2018
01
Department Director
HG/MR/SOP/CO/03
Hannan Group Standard Operating Procedure Issue 2
Page 3 of 3
(Hannan Fashion’s Ltd./Fancy Fashion Sweaters Ltd./Hannan Knit & Textiles Ltd./Hannan Knitwears Ltd.)
maintained as formal approvals. The design process may not proceed until all design
outputs are verified as having addressed the design inputs.
17.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.
18.After phase review, the Department Head approves the start of the new phase by signing
the Design Plan.
Design Validation:
19.Design validation is performed by Consultants/ Client Representatives by comparing the
design documents with the project specifications and the design data.
20.The Design Team conducts validation before release of product or service.
21.The Design Manager will ensure necessary actions are taken on problems/changes
identified during the review or verification and validation activities.
Design Changes:
22.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.
23.The Design Manager shall review the change request and record his approval in the
Change Review Record.
24.The status of all design changes shall be maintained in a Design Change Log.
25.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.
26.Changed designs must go through the same design review, verification and validation as
the original design.
Related Documents:
Documents Name Document Number
Design Change Log HG/STR/F/ACS/01
Design Task HG/STR/F/ACS/02
Design Plan HG/STR/F/ACS/03
Change Review Record
Revision
Prepared by: Signature Approved by: Signature Revision Date:
No:
Head of Quality Managing 14.07.2018
01
Department Director