Scribd
Upload
68 views3 pages

Internal Audit Check List MR

The document outlines the design and development process for a company. It details the planning, inputs, outputs, review, verification and validation steps. Key responsibilities are assigned to the Design Engineer and Chief Process Engineer. The process aims to ensure designs meet requirements and are thoroughly reviewed before release and implementation.

Uploaded by

ganrash
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
68 views3 pages

Internal Audit Check List MR

The document outlines the design and development process for a company. It details the planning, inputs, outputs, review, verification and validation steps. Key responsibilities are assigned to the Design Engineer and Chief Process Engineer. The process aims to ensure designs meet requirements and are thoroughly reviewed before release and implementation.

Uploaded by

ganrash
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 3

Sec. No.

: QM/MR/Sec 16
QUALITY MANUAL Rev No. : 00
Rev. Date: 01/09/2010
Title : Design & Development
Page No : Page 1 of 3

7.3 Design and development

Design and development planning

Design Engineer determines the design stages & the responsibilities / authorities & the
interface between different groups involved for design and prepares the design plan.

Design Engineer shall update the design plan, as appropriate, as the Design progresses.

Design Engineer ensures that the design documentation includes the methods,
Assumptions, formulas, and calculations.

Design and development inputs

Design Engineer determines the inputs related to product requirement and records the same.
Design Engineer ensures that the design input includes:
a) Functional, performance requirements.
b) Where applicable, information derived from previous provisions similar design,
c) Customer specified requirements, and
d) Other requirements essential for designs

Design Engineer reviews the design inputs for adequacy, and ensures that these
requirements are complete & unambiguous

Design and development outputs

Design Engineer ensures that the design output is documented and expressed in terms that
can be verified against design inputs requirements. The design and development output
documents are approved prior to release.

Prepared by: ( MR) Master Copy Stamp Controlled Copy Stamp Approved by:(Chairman/MD)
Date : 01/09/2010 Date : 01/09/2010

Signature: Signature:
Sec. No. : QM/MR/Sec 16
QUALITY MANUAL Rev No. : 00
Rev. Date: 01/09/2010
Title : Design & Development
Page No : 2 of 3

Design Engineer ensures that the design output shall


a) Meet the input requirement for design.
b) Provide appropriate information for purchasing, production and for service provision.
c) Contain or reference product acceptance criteria, and
d) Specify the characteristics of the products that are essential for its safe and proper
use.

Design and development review

Design Engineer conducts systematic review of design at suitable stages in accordance with
the design and development plan. This is done

a) To evaluate the ability of the result of design to meet requirement, and


b) To identify any problems and propose necessary actions.

He further ensures that participants in reviews include representative of functions concerned


with the design stages being reviewed.

Design Engineer keeps the records of the results of the reviews and any necessary action .

CPE shall ensure that final review & approval is conducted by individual(s) other than
the person or persons who developed the design.

Design and development verification

CPE ensures that the design verification is performed in accordance with planned
arrangements to ensure that the design & development output have met the input
requirements and records of the results of the verification and necessary actions shall be
maintained.

Design verification activities may include one or more of the following:

a) Confirming the accuracy of design results through the performance of alternative


calculation.
b) Review of design output documents independent of activities of design review.

Design and development validation

CPE Validates the designs to ensure that resulting product is capable of meeting the
requirements for specified application or intended use where known.

Prepared by: ( MR) Master Copy Stamp Controlled Copy Stamp Approved by:(Chairman/MD)
Date : 01/09/2010 Date : 01/09/2010

Signature: Signature:
Sec. No. : QM/MR/Sec 16
QUALITY MANUAL Rev No. : 00
Rev. Date: 01/09/2010
Title : Design & Development
Page No : 3 of 3

CPE ensures the design validation is complete prior to the delivery or installation of the
product, wherever practicable.

Design validation may include one or more of the following:

a) Functional and / or operational test of production products.


b) Tests specified by industry standards and / or regulatory requirements.
c) Field performance tests and reviews

Records of the results of validation and any necessary actions shall be maintained

Design and development changes

Design changes are reviewed, verified, validated and approved before implementation.

CPE shall ensure that the methodology of carrying out the design changes includes
evaluation of the effect of the change on constituent parts and products already delivered.

Records of the results of the reviews of changes and necessary actions shall be
maintained.

CPE shall ensure design changes, including changes to design documents, shall require
the same control such as approval, as the original design.

Document reference:

Drawing Turtle Diagram: QP/MR/07


Drawing Flow Chart: PM/MR/02
Design: PM/MR/13

External Standard List: LT/DES/01

6. CROSS REFERENCE :

As per Codes and Standards or Design Guidelines from the Customer.

Prepared by: ( MR) Master Copy Stamp Controlled Copy Stamp Approved by:(Chairman/MD)
Date : 01/09/2010 Date : 01/09/2010

Signature: Signature:

You might also like