DOCUMENTS USED IN DESIGN & DEVELOPMENT

Design & Development of product/service can be termed as process which guides a product/service from beginning to launch in market. 

Requirement to Design and Develop a product or service can be triggered by following:
  • Customer requirement 
  • Market need
  • Obsolescence of old products
  • To enhance features of existing products
  • Performance issues reported in previous products
To guide Design & Development process throughout, a well defined documented approach is very helpful. Following documents at every step of Design & Development will help to monitor the process:


1. Design & Development Procedure:

Design & Development procedure defines the methodology of product/service creation from start to finish. It should contain the details regarding steps involved in Design and Development process, their execution and control method along with allocated resources and defined responsibilities.

2. Product and Component Drawing:

In case of product Design & Development, drawings are 2D or 3D representation of an object for the purpose of communication regarding shape, dimensions, specification, feature and appearance.
Drawings are helpful in determining manufacturing technique and related sub processes.

3. Design & Development Planning Record:

Design Planning Record is basically a design project timeline. It tracks the progress of Design & Development activities. Is should have following details:
  • Design project name and description
  • Name of team members
  • Estimated project costing
  • Estimated annual/monthly requirement
  • Name of customer (If any)
  • Design & Development activities, their sequence, allocated responsibilities and target date of completion. 

4. Design & Development Input Record

Input record is an important document which forms base of Design & Development project. It contains all the necessary information which are needed to start the project. It should include following information:
  • Product/process description and application
  • Customer's requirement/specification
  • Information available from similar kind of design
  • Standards to be used
  • Statutory and regulatory requirements
  • Potential consequences of failure of product/service

5. Design & Development Outputs:

Design & Development outputs are those documents that meet the design input requirement and satisfies the acceptance criteria. Following can be listed as Design & Development Outputs:
  • Drawing and part list
  • Test procedure
  • Test standard
  • Work/Process Instruction

6. Design & Development Verification:

To meet the design input requirements, design outputs are prepared. These output documents are then approved. The approval and release of these output documents indicates that the design meets the required specification of product. To keep a track of these approvals, a form can be prepared having all the outputs listed and their approval status. 

7. Design Review Record:

Design review is conducted throughout the development process to ensure that the design satisfy the requirements. Reviews should be conducted at defined stages of development process in order to provide formal approval to move to next stage; or it can be done when an issue arises with respect to product functionality, quality, performance, appearance etc. A design review record should include following information:
  • Issue discussed
  • Action plan
  • Completion target
  • Responsibility
  • Name of approving authority

8. Design Change Record:

Triggered by design review, one may need to change drawing, work instruction, procedure, specification etc. as suggested. Theses design changes are reviewed and approved and a proper record of design changes are kept for tracking and future reference. Design change record should include following information:
  • Description of change
  • Reason for change
  • Effect of change on other documents/process
  • Name of approving authority
  • Status of change implementation

9. Design Validation Record:

The stage of Inspection and testing related to product function and performance against customer requirement is termed as Design Validation. A design validation record contains information of all the required parameters, their specification along with findings. This record is approved by approving authority from design and development team and from customer.

Comments

Post a Comment

Popular posts from this blog

DOCUMENTS USED IN PRODUCTION DEPARTMENT

Image
Production department within an organization is responsible for manufacturing products. It converts raw materials and other inputs into finished goods using proper resources. With the required inputs, production department plans the production activities and allocate manpower to perform those activities. To be effective in production planning and execution, department needs documented approach to ensure smooth movement.  Some of the commonly used documents in production department are discussed below: 1. Standard Operating Procedure (SOP): Standard Operating Procedure is methodology which describes specific way to carry out a process. This document is on organizational level and links various departments. Standard Operating Process focuses on WHAT to do and by WHOM. It mainly comprises of organization's policy and guide to perform a process with defined departmental roles. E.g. Procedure for deviation management, Procedure for handling non conforming products. 2. Work Instruction:
Read more

TYPICAL DEPARTMENTAL DOCUMENTS FOR QMS (ISO 9001:2015) IN MANUFACTURING ORGANIZATION

Image
For implementation and maintenance and of Quality Management System (ISO 9001:2015) there are several documented information which are mandatory. As required by International standard ISO 9001:2015, these documents are mandatory for compliance of Quality Management System and obtaining ISO 9001:2015 certification. Refer here for details regarding mandatory documented information and non mandatory documented information as per requirements of international standard. While structuring Quality Management System, an organization can be divided into several departments for smooth running of organization's activities. Departmentalizing an organizations brings clarity regarding who's gonna do what. Every department is responsible and accountable for certain tasks.  In doing so, a defined set of documents helps each department to perform and control its tasks in an effective way. These set of documents not only ensure easy going of department's activities but also helps in conform
Read more

REQUIRED DOCUMENTS FOR QMS(ISO 9001:2015)

Image
While implementing QMS(ISO 9001:2015), it is important to understand the required documented information. The documented information can be used for communicating information, knowledge sharing, to demonstrate what was planned and and what has been done and to disperse and preserve organizations know how to conduct its processes. As per the requirement of standard(ISO 9001:2015), following documents are mandatory for compliance and obtaining ISO 9001:2015 certification: Non mandatory documents There are several documented information which are non mandatory but can be used during implementation of ISO 9001:2015. These documents are: Quality Manual Process Mapping, Process Flow Diagrams Organizational Chart Procedure for addressing risks and opportunities Procedure for change management Procedure for training Procedure for control of documented information Procedure for design and development Procedure for handling of non conformity and corrective action Procedure for internal audit Pro
Read more