Pak Elektron Limited

Division: Power Department: Design Document No.: PD/DND/SP/01

Supersedes: 17-10-2016 Effective:28-10-2020 Rev.#: 02
Procedure for Design and Development Control

Name & Designation Signatures

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Ahmad Nawaz
Sr. Engineer Design Transformers

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Ahsan Waseem
Asst. Manager ITR
Prepared By:
Hafiz Shahzad Ahmad
Engineer Design EMP

Mehtab AhmadED
Asst.Manager Design SG
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Ali Mahmood
Team lead QHSE
Reviewed By:
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Muhammad Shahbaz Nazar

Engineer QHSE
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Muhammad Shoaib
Head Design Transformers
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Approved By: Mehmood Ahmad

Head Design EMP

Jalil-ul-Rehman
General Manager Mfg (SG)

Controlled By: QHSE Department

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 Pak Elektron Limited
Division: Power Department: Design Document No.: PD/DND/SP/01
Supersedes: 17-10-2016 Effective:28-10-2020 Rev.#: 02
Procedure for Design and Development Control

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Amendment History

S# Rev. # Page Section Description of Changes DCR #

Head EMP replaced by head design EMP in all

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1 01 - -
energy meter section(s) 359
2 01 - - Existing design is deleted in all EMP section
3 02 - - Procedure has been amended by adding new
department “Instrument Transformer (ITR)”. 578

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LL
RO
NT
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 Pak Elektron Limited
Division: Power Department: Design Document No.: PD/DND/SP/01
Supersedes: 17-10-2016 Effective:28-10-2020 Rev.#: 02
Procedure for Design and Development Control

1. PURPOSE

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The purpose of this procedure is to provide a consistent and disciplined approach to all
design and development work.

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2. SCOPE

This procedure applies to all design and development work leading a new deliverable
product and for the modification of an existing design for Distribution Transformer, Power
Transformer, Switchgear Department, Energy Meter Plant & Instrument Transformer.

3. RESPONSIBILITIES:

3.1 Design/Product Development Department

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3.1.1 To document a design plan prior to commencing design activities.
3.1.2 To manage interface between different groups/departments involved in design
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and development.
3.1.3 To get WAPDA prototype re-approval before expiry.
3.1.4 To issue Fabrication Number against new development and WAPDA prototype.
3.1.5 To review Design inputs for adequacy.
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3.1.6 To ensure for the documentation of design outputs.

3.1.7 To decide and conduct Design review meeting prior to issuance of Design out
puts in case of Distribution and Power Transformers.
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3.1.8 To ensure that review at suitable stages of design and development is performed
and conducted in accordance with planned arrangements.
3.1.9 To ensure that participants of all concerned functions take part in all design and
development stages being reviewed.
3.1.10 To perform design verification and validation at different stages of design and
development.
3.1.11 To investigate about the root cause(s) of failure in any routine/type test for new
development/prototype transformers in coordination with Production and QC
departments.
3.1.12 To ensure that all design & development changes are identified and
documented.
3.1.13 To maintain all relevant records pertaining to Design and Development activities.

3.2 Marketing Department

3.2.1 To provide Customer approved technical / commercial specifications, sale advice

/ purchase order to Design department.

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Division: Power Department: Design Document No.: PD/DND/SP/01
Supersedes: 17-10-2016 Effective:28-10-2020 Rev.#: 02
Procedure for Design and Development Control

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3.3 Concerned Department

3.3.1 To suggest or request for any new development/prototype to concerned Design

department.

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3.3.2 To provide updated rate lists of raw materials/components on monthly basis or
when required by Head of Design/ Product Development department.

4. PROCEDURE

4.1 Design and Development Planning

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4.1.1 Distribution and Power Transformers

Head of Design /Product Development department is responsible for documenting a design

plan prior to commencing design activities as per Form (PD/TDD/FM/01)/(PD/PDD/FM/01).
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The design plan shall include.

a. A project schedule in the form of table / matrix or similar scheduling technique.

The plan breaks the design process into phases and schedules the design activities
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including design reviews, verifications and validations. The expected dates of

subsequent operations in Plan form will be flexible until the Target date of completion.
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b. Identification of persons responsible for the design and development activities.

c. Identification of design team and members from other appropriate functions with
intimation to departmental heads to ensure effective interface and coordination
where applicable.

d. Design tools, programs and other resources required.

e. The review, verification and validation that are appropriate to each design stage.

f. Nomination of Project Owner in case of new development/Prototype as defined under

clause 4.2.1.1. The nominated Project owner will be responsible for overall monitoring
of new product/prototype design & development.

Project Owner shall manage interface between different groups/departments involved in

design and development to ensure effective communication and that clear responsibilities
are assigned for effective execution of design and development activities. The planning
outputs shall be updated, as appropriate, as the design and development progress and shall
be distributed to the departmental heads and / or section in charges.

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Division: Power Department: Design Document No.: PD/DND/SP/01
Supersedes: 17-10-2016 Effective:28-10-2020 Rev.#: 02
Procedure for Design and Development Control

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4.1.2 Switchgears

The Head of Manufacturing Switchgear (Mfg SG) is responsible for documenting a design
plan prior to commencing design activities as per Form PD/SDD/FM/01. The design plan

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shall include:

a. A project schedule in the form of table or similar scheduling technique. The plan
breaks the design process into phases and schedules the design activities including
design reviewsand validations.

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b. Identification of persons responsible for the design and development activities.

c. Identification of the design team and members from other appropriate functions
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with intimation to departmental heads to ensure effective interface and
coordination, when applicable.

d. The review, verification and validation that are appropriate to each design stage.
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The head of Mfg SG shall manage interface between different groups/ departments
involved in design and development to ensure effective communication and that clear
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responsibilities are assigned for effective execution of design and development activities.
The planning outputs shall be updated, as appropriate, as the design and development work
progresses and shall be distributed to the departmental heads and / or section in charges.
It is a responsibility of concerned design personnel to revise and update the design plan if
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planned dates are not achieved.

4.1.3 Energy Meters

Head of design EMP is responsible for planning and documenting all design & development
activities. Prior to commencing any design & development activity, concerned Design
personnel shall fill in the Form, PD/EDD/FM/02, for the new design. The overall design &
development planning shall address

a. Customer information and other relevant data of Purchase Order/Tender

b. Design & Development stages

c. Review, verification, and validation of each stage, and

d. Assigned responsibilities/authorities in each stage

Head of design EMPshall be responsible for effective communication, assignment of clear

responsibilities, and the approval of each stage. As the Design & Development progresses,

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 Pak Elektron Limited
Division: Power Department: Design Document No.: PD/DND/SP/01
Supersedes: 17-10-2016 Effective:28-10-2020 Rev.#: 02
Procedure for Design and Development Control

planning output shall be updated and upon completion shall be distributed to all concerned

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including Production and Process & Development.

4.1.4 Instrument Transformers

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Head of ITR Department is responsible for documenting a Design & Development Plan prior
to commencing New Development/Prototype as per Form (PD/IDD/FM/01). The design plan
shall include;

a. A project schedule that breaks the design process into phases and schedules the

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design activities including design reviews, verifications and validations. The expected
dates of subsequent operations in Plan form will be flexible until the Target date of
completion.
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b. Assigned responsibilities/authorities in each stage to the concerned.

c. Intimation to departmental heads to ensure effective interface and coordination

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where applicable.

d. The review, verification and validation that are appropriate to each design stage.
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e. Nomination of Project Owner. The nominated Project owner will be responsible for
overall monitoring of new product/prototype design & development.
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Head of ITR shall be responsible for effective communication, assignment of clear

responsibilities, and the approval of each stage. As the Design & Development progresses,
planning output shall be updated and upon completion shall be distributed to all concerned
including Production, I & QC & Procurement.

4.2 Design and Development Inputs

4.2.1 Distribution and Power Transformers

4.2.1.1 New Development Transformers:

Anyone from senior management or marketing personnel can generate a suggestion or
request for any new development/prototype to Head of Design/Product Development
Department using portion “A” of Prototype/new development Initialization Request
PD/DND/FM/01. The new development other than WAPDA Prototype will be defined as a
Complete Transformer Package without any sale advice received.

Head of Design/Product Development Department will assign concerned Design personnel

to work out and give feedback in form of filled up portion “B” of Prototype/new product
Initialization Request while addressing the technical parameter as defined in 4.2.1.1a to
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 Pak Elektron Limited
Division: Power Department: Design Document No.: PD/DND/SP/01
Supersedes: 17-10-2016 Effective:28-10-2020 Rev.#: 02
Procedure for Design and Development Control

4.2.1.1d. Head of Design/ Product Development Department will evaluate the working and

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the budgetary development cost before approval and get it approved by Functional Head.

Following parameters are considered before approval of new development using

Prototype/new development Initialization Request PD/DND/FM/01:

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a) Need of the prototype manufacturing: This defines the basic purpose of introducing
new prototype. This could be initiated by any one from the Senior Management or
Marketing personnel.

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b) Time Frame required for prototype/new product approval: This defines the
targeted time period within which the prototype/new product should be
satisfactorily approved.
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c) Required Quality parameters/standards of the prototype/new product to be
established, different tests to be performed, testing criteria to be met etc.
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d) Financial feasibility for the manufacturing of the prototype/new product would be

prepared.

After approval, fabrication number is issued by Head of Design/ Product Development

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Department and a copy of Form PD/DND/FM/01is sent to Functional Head Finance,

concerned Head Manufacturing and MPS Department for information.

Design activities shall be initiatedafter opening a development fabrication number in case

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of prototype after approval. For the purpose of WAPDA prototype approval, two
transformers for any rating will be manufactured but this quantity can be different based
upon the Management Decision.

Head of Design/ Product Development department will be responsible for WAPDA

prototype re-approval before expiry.

4.2.1.2 Routine Design Transformers

The Marketing department shall provide a Commercial/Technical specifications and
requirement to Head of Design/ Product Development Department who define the design
requirements of the product. Design input include customer approved Technical data,
Customer specification (if available), Sale Advice / P.O. Design activities shall initiates after
opening a fabrication number upon receiving of the sales advice along with other approved
design inputs. Head of Design/ Product Development Department shall interpret the
commercial specification and customer requirements and is responsible for ensuring all
design requirements are clearly documented and communicated to the concerned design
team members and records maintained. These requirements should describe the product in
terms of functional and performance characteristics requirements, applicable standards and
regulations, physical dimensions, and any other requirements which may be imposed by a
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 Pak Elektron Limited
Division: Power Department: Design Document No.: PD/DND/SP/01
Supersedes: 17-10-2016 Effective:28-10-2020 Rev.#: 02
Procedure for Design and Development Control

contract or which is necessary to achieve end use performance and customer satisfaction or

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information derived from similar design. Design inputs are reviewed by Head of Design/
Product Development department for adequacy. The Head of Design/ Product Development
department is responsible for resolving any incomplete, ambiguous or conflicting
requirements before proceeding with the Design and Development activities.

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Head of Local and Foreign Procurement Departments will provide updated rate lists of raw
materials/components on monthly basis or when required by Head of Design/ Product
Development Department for the preparation of new and / or updated material costs.
In case of internal customer, design inputs will be provided to design department either

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from the concerned customer department or from the Marketing department, which will
also be reviewed by Head of Design/ Product Development Department and the procedure
defined above will be followed.
Records of the design inputs and any necessary actions shall be maintained in accordance
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with the Documentation and Record Management Procedure.

4.2.2 Switchgears
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The Marketing department shall provide the design input which may be in the form of
Customer approved technical / commercial specifications, sale advice / purchase order to
Head of Mfg SG who defines the design requirement of the product. Head of Mfg SG shall
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interpret the commercial/technical specifications, customer requirement and is responsible

for ensuring that all design requirements are clearly documented and communicated to the
concerned design team members and records maintained. These requirements should
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describe the product in terms of functional and performance characteristics, applicable

standards and regulations, physical dimensions and any other requirements which may be
imposed by a contract or which is necessary to achieve end use performance and customer
satisfaction or information derived from a similar design. Design inputs are reviewed by
Head of Mfg SG for adequacy. Head of Mfg SG is responsible for resolving any incomplete,
ambiguous or conflicting requirements before proceeding with the design and development
activities. Head of Local and Foreign Procurement will provide updated rate lists of raw
material/components when required by the Head of Mfg SG for the preparation of new and
updated material costs. In case of internal customer, design inputs will be provided to
Design department either from the concerned customer department or from the Marketing
Department which will also be reviewed by Head of Mfg SG and will follow the same
procedure as above. Head of Mfg SG will be responsible for Wapda prototype approval
before expiry if order of that particular equipment is in hand. Records of the design inputs
and any necessary actions shall be maintained in accordance with the Documentation and
Record Management Procedure.

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 Pak Elektron Limited
Division: Power Department: Design Document No.: PD/DND/SP/01
Supersedes: 17-10-2016 Effective:28-10-2020 Rev.#: 02
Procedure for Design and Development Control

4.2.3 Energy Meters

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Head of design EMP shall ensure to interpret all the provided information into product
design & development requirements. Moreover, documenting these requirements shall also
be included in the responsibilities of concerned design personnel.

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Marketing department shall provide Commercial/Technical specifications along with Tender
and/or Purchase Order to Head of design EMPwho sends a copy to concerned Design
personnel. Other inputs may include information derived from previous similar designs
(functional and/or performance requirements) and/or other required essentials for
improvements.
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Any individual/supervisor/executive concerning Energy Meter Plant or the Marketing
department could request for design change by filling in ‘Design Input Form
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(PD/EDD/FM/03). Head of Production EMP and concerned Design personnel shall review
these inputs for adequacy. If the change is accepted, the form shall be forwarded to Head of
EMP for approval. If requested change is not accepted, the form shall be filed in Design
records with a reason of disapproval and copy shall be sent to the initiator by the Design
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department. The records shall be maintained in accordance with ‘Documentation and

Record Management Procedure’.
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4.2.4 Instrument Transformers

4.2.4.1 New Development / Prototype Re-approval:

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Head of Design Switchgears, Senior management or marketing personnel can generate a

suggestion or request for any New Development to Head of ITR Department using portion
“A” of Prototype/New Development Initialization Request PD/DND/FM/1. For the new
development, No sale advice shall be required.
Head of ITR Department will assign concerned Design Engineer to work out and give
feedback in form of filled up portion “B” of Prototype/new product Initialization Request
while addressing the technical parameter as defined in 4.2.4.1a to 4.2.4.1d. Head of Design/
Product Development Department will evaluate the working and the budgetary
development cost before approval and get it approved by Functional Head.

Following parameters are considered before approval of new development using

Prototype/new development Initialization Request PD/DND/FM/01:

a. Need of the prototype manufacturing: This defines the basic purpose of introducing
new prototype. This could be initiated by any one from the Senior Management or
Marketing personnel.

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 Pak Elektron Limited
Division: Power Department: Design Document No.: PD/DND/SP/01
Supersedes: 17-10-2016 Effective:28-10-2020 Rev.#: 02
Procedure for Design and Development Control

b. Time Frame required for prototype/new product approval: This defines the

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targeted time period within which the prototype/new product should be
satisfactorily approved.

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c. Required Quality parameters/standards of the prototype/new product to be
established, different tests to be performed, testing criteria to be met etc.

d. Financial feasibility for the manufacturing of the prototype/new product would be

prepared.

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After approval, fabrication number is issued by Head of ITR Department and a copy of Form
PD/DND/FM/01 is sent to Functional Head Finance, concerned Head Manufacturing and
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MPS Department for information.

Design activities shall be initiated after opening a development fabrication number in case
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of prototype after approval. For the purpose of WAPDA prototype approval, For Instrument
transformers for any rating will be manufactured but this quantity can be different based
upon the Management Decision.
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Head of ITR Department will be responsible for WAPDA prototype re-approval before
expiry.
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4.2.4.2 Routine Designs:

Head of Design Switchgear, Head of Design Distribution and Power Transformer &
Marketing department shall provide a Commercial/Technical specifications and requirement
to Head of ITR Department who define the design requirements of the product. Design input
include customer approved Technical Data, Customer Specification (if available), Sale Advice
/ P.O if in Case form Marketing Department and an email/Plan in case of internal
Department Requirement. Design activities shall initiate after opening a fabrication number
upon receiving of the sales advice / Email along with other approved Design inputs. Head of
ITR Department is responsible for ensuring all design requirements are clearly documented
and communicated to the concerned design team members and records maintained. These
requirements should describe the product in terms of functional and performance
characteristics requirements, applicable standards and regulations, physical dimensions, and
any other requirements which may be imposed by a contract or which is necessary to
achieve end use performance and customer satisfaction or information derived from similar
design. The Head of ITR Department is responsible for resolving any incomplete, ambiguous
or conflicting requirements before proceeding with the Design and Development activities.

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Supersedes: 17-10-2016 Effective:28-10-2020 Rev.#: 02
Procedure for Design and Development Control

Head of Procurement Departments will provide updated rate lists of raw

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materials/components on monthly basis or when required by Head of ITR Department for
the preparation of new and/or updated material costs.

Records of the design inputs and any necessary actions shall be maintained in accordance

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with the Documentation and Record Management Procedure.

4.3 Design and Development output

4.3.1 Distribution and Power Transformers

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Head of Design/ Product Development Department is responsible for the documentation of
design output. Design output shall be documented and expressed in terms of Winding Data
Sheet, Dimensional Drawings, BOQ and Work order that can be verified prior to release
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against design and development input requirements and shall be approved prior to release.
Design output shall:
a) Meet the input requirements for design and development.
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b) Provide appropriate information for Production, Local Procurement, Foreign

procurement (if necessary) and Quality Control Department. Information can be in
the form of winding data sheet, dimensional drawings, BOQ and Work Order. For
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local purchasing and foreign procurement (if necessary), BOQ and dimensional
drawings / specifications will be provided.
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c) Contain or refer to the product acceptance criteria that may be in the form of client
Approved Technical Data Sheet, Dimensional Drawings or specification.

d) Specify the characteristics of the product that are essential for its safe and proper
use.

Quantity of products mentioned in work order matches with that on the sale advice but
advice may be taken from production department in case of WAPDA.

4.3.2 Switchgears

Head of Mfg SG is responsible for the documentation of the design output. Design output
may be in the form of GA Drawings, BOQs, LOMs, Fabrication Drawings, Work Orders and
Wiring Diagram that can be verified prior to release against design and development input
requirements and shall be approved by Head of Mfg SG / Sr. Design Engineer prior to their
release. In case of their absence, Design Engineer will be responsible for approval. Design
output shall:
a) Meet the input requirements for design and development.

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Division: Power Department: Design Document No.: PD/DND/SP/01
Supersedes: 17-10-2016 Effective:28-10-2020 Rev.#: 02
Procedure for Design and Development Control

b) Provide appropriate information for Production, Local procurement, Foreign

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Procurement (if necessary) and Quality Control Department. Information can be in
the form of GA Drawings, BOQs, LOMs, Fabrication Drawings, Work Orders and
Wiring Diagrams.

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4.3.2.1 Work Orders

The Production requirements are specified by work order (WO). Work orders along with
other manufacturing information; also contain fabrication (FB) Number. Fabrication number

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is assigned to every manufacturing order. A separate work order and fabrication number is
opened for every individual type of Switchgear for every order. The Production Section In
charges that receive the work order is responsible for ensuring that the requirements of the
work order are met. For WAPDA standard design, Head of Mfg SG issues Work Order after
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receiving Sale advice from Marketing Department.
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4.3.3 Energy Meters

Head of design EMP shall be responsible for documenting design & development outputs.
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The outputs shall be in the form of Bill of Quantity (BOQ), which shall be approved and
verifiable. Design & Development output shall be able to verify,

a) Meeting customer input requirements.

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b) Providing appropriate information for process & development and

production.

c) Referring to product acceptance criteria, this can be in the form of

customer’s specifications.

d) Referring/specifying characteristics of the product for its safe and proper use.
This can be in the form of a circuit diagram or product leaflet

4.3.4 Instrument Transformers

Head of ITR Department shall be responsible for documenting design & development
outputs. The outputs shall be in the form of Electrical Design, Dimensional Drawings, List of
Mechanical Design& Work order, which shall be approved and verifiable. Bill of Quantity
(BOQ) or Bill of Material (BOM) shall be uploaded in Oracle System. Design & Development
output shall;

a. Meet all the Customer Requirements.

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Procedure for Design and Development Control

b. Provide appropriate information for process & development, production &

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Procurement.

c. Refer to product acceptance criteria, this can be in the form of customer’s

specifications.

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d. Refer/specify characteristics of the product for its safe and proper use.

4.4 Design and Development Review

4.4.1 Distribution and Power Transformers

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4.4.1.1 Design and Development Review Meeting
For new developments defined in paragraph 4.2.1.1, Head of Design/ Product Development
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department will decide for a review meeting prior to issuance of Design output like winding
data sheet, dimensional drawings, and BOQ and work order. It will be the responsibility of
Project Owner to arrange a Design review meeting and ensure that participants of all
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concerned functions take part in the review meeting. Design Review meeting is conducted
in order to evaluate the ability of meeting the customer requirements & feasibility. Design
review meeting will be mandatory in case of WAPDA prototypes however in case of new
development other than WAPDA prototype; it will be defined as product falling under
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following points for which the review meeting shall be coordinated:

a) Non compliance of any manufacturing process to the Design
Drawing/Data.
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b) Limitation of the testing with respect to agreed specifications.

c) Special accessories needed to be imported if required.

d) If large reduction in manufacturing time is required in existing design.

Participation of Design, Production and I&QC will be mandatory in all cases. Project Owner
will define the requirement of representative of functions which should participate in
Design Review for a particular project other than mandatory participants. All participants
will confirm the parameters of different Design out-puts & other Manufacturing
requirements, if any by printing their initials on Design Review Forms. Once all participants
agree on the design and manufacturing parameters, all Design out-puts will be issued to all
concerned. Records of the reviews and any necessary actions shall be maintained in
accordance with the Documentation and Record Management procedure.
4.4.1.2 Design and Development Review (Manufacturing Stage)

It is the responsibility of Head of Design/ Product Development department to ensure that

review at suitable stages of design and development shall be performed and conducted in
accordance with planned arrangements as per the following review forms
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Procedure for Design and Development Control

(PD/TDD/FM/02)/(PD/PDD/FM/02),(PD/TDD/FM/03)/(PD/PDD/FM/03),(PD/TDD/FM/04)/(P

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D/PDD/FM/04), (PD/TDD/FM/05)/(PD/PDD/FM/05) and PD/TDD/FM/06.

Reviews are conducted to evaluate that the ability of the results of the design and
development to meet requirements. During reviews any problem arising will be identified

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and the necessary actions will be proposed for execution. Head of Design/ Product
Development department will ensure that participants of all concerned functions take part
in all design and development stages being reviewed. Records of the results of the reviews
and any necessary actions shall be maintained in accordance with the Documentation and
Record Management Procedure.

4.4.2 Switchgears
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It is the responsibility of Head of Mfg SG to ensure that review at critical stages of design
and development shall be performed and conducted in accordance with planned
arrangements as per Review forms PD/SDD/FM/02 and PD/SDD/FM/03. Reviews are
conducted to evaluate the ability of the results of the design and development to meet the
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requirements. During reviews any problem arising will be identified and necessary action
will be proposed for execution. Head of Mfg SG will ensure that participants of all concerned
functions take part in all design and development stage(s) being reviewed. Records of the
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results of reviews and any necessary action/s shall be maintained in accordance with
Documentation and Record Management Procedure.

4.4.3 Energy Meters

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For new design & development, detailed reviews shall be carried out at both Electrical and
Mechanical stages. These reviews shall be done utilizing two forms, PD/EDD/FM/04 &
PD/EDD/FM/05 for Electrical & Mechanical stages respectively.

The review forms shall address the activities, participants, result of review, and comments
as per need. All reviews shall be finalized after the approval of Head of design and Head of
production. The review forms shall be able to

a) Evaluate the ability of results of design & development activities in

meeting customer requirements, and

b) Identify any problems and propose necessary actions in case of any

deviation(s) from customer requirements

Record of results of reviews shall be maintained in accordance with Documentation and

Record Management Procedure. Head of design & Production shall ensure that participants
of all concerned functions/individuals take part in all design & development stages that are
being reviewed.

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Procedure for Design and Development Control

4.4.4 Instrument Transformers

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4.4.4.1 Design and Development Review Meeting
For new developments defined in paragraph 4.2.4.1, Head of ITR Department will decide for
a review meeting with all concerned functions prior to issuance of Design output like

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Electrical Data Sheet, Dimensional drawings and Work orders. Design Review meeting is
conducted in order to evaluate the ability of meeting the customer requirements &
feasibility. Design review meeting will be mandatory in case of WAPDA / KE prototypes
however in case of new development other than WAPDA / KE prototype; it will be defined
as product falling under following points for which the review meeting shall be coordinated:
a) Non-compliance
Drawing/Data.
of
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any manufacturing process to the Design
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b) Limitation of the testing with respect to agreed specifications.

c) Special accessories needed to be imported if required.

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d) If large reduction in manufacturing time is required in existing design.

Participation of Design, Production and I&QC will be mandatory in all cases and all
participants will confirm the parameters of different Design out-puts & other Manufacturing
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requirements, if any by printing their initials on Design Review Forms. Once all participants
agree on the design and manufacturing parameters, all Design out-puts will be issued to all
concerned. Records of the reviews and any necessary actions shall be maintained in
accordance with the Documentation and Record Management procedure.
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4.4.4.2 Design and Development Review (Manufacturing Stage)

It is the responsibility of Head of ITR Department to ensure that review at suitable stages of
design and development shall be performed and conducted in accordance with planned
arrangements as per review form PD/IDD/FM/03.

During reviews any problem arising will be identified and the necessary actions will be
proposed for execution. Head of ITR Department will ensure that participants of all
concerned functions take part in all design and development stages being reviewed. Records
of the results of the reviews and any necessary actions shall be maintained in accordance
with the Documentation and Record Management Procedure.

4.5 Design and Development Verification

4.5.1 Distribution and Power Transformers

At different stages of design and development, Design verification shall be performed to

ensure that the design and development output have met the design and development
input requirements. All design documents are reviewed by Head of Design/ Product
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Development department before issuance. Records of the results of the verification and any

PY
necessary action shall be maintained in accordance with the Documentation and Record
Management Procedure.

4.5.2 Switchgears

CO
At different stages of design and development, design verification shall be performed to
Ensure that design and development output have met the design and development input
requirements. Records of the results of the verification and any necessary actions shall be
maintained in accordance with the Documentation and Record Management Procedure. All

ED
the design documents are verified by Head of Mfg SG before issuance.

4.5.3 Energy Meters

LL
At appropriate stages of design & development, verification shall be performed. This is to
ensure that the design & development output has met the input requirements. for new
design, verification shall be carried out during Mechanical as well as Electrical stage.
RO

During the Mechanical Stage, with the participation of Production, Process & Development
shall carry out dimensional and functional verification and shall maintain the record. While,
NT

during the Electrical Stage, Design department shall perform verification of the product and
shall keep the record.

Records of the results of the verification and any necessary action shall be maintained in
CO

accordance with the Documentation and Record Management Procedure.

4.5.4 Instrument Transformers

Verification shall be performed at Different stages of design & development to ensure that
output has met the input requirements. For new design, verification shall be carried out
during Mechanical as well as Electrical stage.

During the Mechanical Stage, with the participation of Production, Process & Development
shall carry out dimensional and functional verification and shall maintain the record. While
during the Electrical Stage, Design department shall perform verification of the product and
shall keep the record.

Records of the results of the verification and any necessary action shall be maintained in
accordance with the Documentation and Record Management Procedure.

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Procedure for Design and Development Control

4.6 Design and Development Validation

PY
4.6.1 Distribution and Power Transformers

Design validation shall be performed in accordance with planned arrangements to ensure

CO
that the resulting product is capable of meeting the requirements for the specified
application or defined user needs, where known. Validation shall be completed prior to
delivery or after onsite installation (where practicable) of the product. Along with the
routine tests, additional tests may be performed if deemed necessary.
Records of the results of the validation and any necessary actions shall be maintained in

ED
accordance with the Documentation and Record Management Procedure.

4.6.1.1 Non-Conforming Material

LL
In case of failure in any routine/type test for new development/prototype transformers,
Design department will investigate about the root cause(s) of failure in coordination with
Production and QC departments and corrective actions will be taken accordingly and record
RO

maintained. Head of Design/ Product Development department will decide about the
repair/replacement of non-conforming product.
NT

4.6.2 Switchgears

Design validation shall be performed in accordance with planned arrangements to ensure

CO

that the resulting product is capable of meeting the requirements for the specified
application or defined user needs, where known. Validation shall be completed prior to
delivery or implementation (where practicable) of the product. Records of the results of the
validation and any necessary actions shall be maintained in accordance with the
Documentation and Record Management Procedure.

4.6.3 Energy Meters

Design & Development validation shall be performed in accordance with design &
development plan to ensure that resulting product conforms to defined user needs and/or
requirements. For new design, Prototype Testing shall be done for design validation as
appropriate. Prototype testing can be done by customer and/or by any independent
laboratory and/or Product Engineering Laboratory of PEL as the case may be. Validation
shall be performed prior to the delivery of the product. Validation shall be done using
validation review form, PD/EDD/FM/06. Records of the results of the validation and any
necessary actions shall be maintained in accordance with the Documentation and Record
Management Procedure.

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 Pak Elektron Limited
Division: Power Department: Design Document No.: PD/DND/SP/01
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Procedure for Design and Development Control

4.6.4 Instrument Transformers

PY
Design validation shall be performed to ensure that the resulting product is capable of
meeting the requirements for the specified application or defined user needs, where
known. Validation shall be completed prior to delivery of the product. Along with the

CO
routine tests, additional tests may be performed if deemed necessary.

Records of the results of the validation and any necessary actions shall be maintained in
accordance with the Documentation and Record Management Procedure.

4.6.4.1 Non Conforming Material

ED
In case of failure in any routine/type test for new development/prototype, Design
LL
department will investigate about the root cause(s) of failure in coordination with
Production and QC departments and corrective actions will be taken accordingly and record
maintained. Head of ITR Department will decide about the repair/replacement of non-
conforming product.
RO

4.7 Control of Design and Development Changes

NT

4.7.1 Distribution and Power Transformers

All design changes are identified, documented, and approved in compliance with
“Modification In Engineering Drawings/Data” procedure, which require impact analysis for
CO

each change i.e. evaluation of the affect on the change on constituent parts and products
already delivered. All changes shall review, verified and validated as appropriate and
approved by Head of Design/ Product Development department before implementation.
Records of the results of the review of changes and any necessary actions shall be
maintained as per the Documentation and Record Management Procedure.

4.7.2 Switchgears

All design changes are identified, documented, and approved in compliance with
“Modifications In Engineering Drawings/Data” procedure, which requires impact analysis for
each change i.e. evaluation of the effect on the changes on constituent parts and products
already delivered. All changes shall be reviewed verified and validated as appropriate and
approved by Head of Mfg SG /Sr. Design Engineer before implementation. In case of their
absence, Design Engineer will be responsible for approval. Records of the results of review
of changes and necessary action(s) shall be maintained as per the Documentation and
Record Management Procedure.

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Procedure for Design and Development Control

4.7.3 Energy Meters

PY
All design & development changes shall be identified and documented. Prior to
implementation, they shall be reviewed, verified, and validated as appropriate. Moreover,
Head of design & Production shall approve the changes before their realization. The records

CO
shall be maintained in accordance with the Documentation and Record Management
Procedure.

4.7.4 Instrument Transformers

ED
All design changes are identified, documented, and approved in compliance with
“Modifications in Engineering Drawings/Data” procedure, which requires impact analysis for
each change i.e. evaluation of the effect on the changes on constituent parts and products
already delivered. All changes shall be reviewed verified and validated as appropriate and
LL
approved by Head of ITR before implementation. In case of their absence, Design Engineer
will be responsible for approval. Records of the results of review of changes and necessary
action(s) shall be maintained as per the Documentation and Record Management
RO

Procedure.
NT
CO

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 Pak Elektron Limited
Division: Power Department: Design Document No.: PD/DND/SP/01
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Procedure for Design and Development Control

PY
5. PROCESS FLOW CHARTS

Design & Development Planning

CO
ED
LL
RO
NT
CO

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Division: Power Department: Design Document No.: PD/DND/SP/01
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Procedure for Design and Development Control

PY
Design & Development Inputs

CO
ED
LL
RO
NT
CO

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 Pak Elektron Limited
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Procedure for Design and Development Control

PY
CO
ED
LL
RO
NT
CO

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 Pak Elektron Limited
Division: Power Department: Design Document No.: PD/DND/SP/01
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Procedure for Design and Development Control

Design & Development Outputs

PY
CO
ED
LL
RO
NT
CO

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 Pak Elektron Limited
Division: Power Department: Design Document No.: PD/DND/SP/01
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Procedure for Design and Development Control

Design & Development Review

PY
CO
ED
LL
RO
NT
CO

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 Pak Elektron Limited
Division: Power Department: Design Document No.: PD/DND/SP/01
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Procedure for Design and Development Control

Design & Development Verification

PY
CO
ED
LL
RO
NT
CO

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 Pak Elektron Limited
Division: Power Department: Design Document No.: PD/DND/SP/01
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Procedure for Design and Development Control

Design & Development Validation

PY
CO
ED
LL
RO
NT
CO

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 Pak Elektron Limited
Division: Power Department: Design Document No.: PD/DND/SP/01
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Procedure for Design and Development Control

Design & Development Changes

PY
CO
ED
LL
RO
NT
CO

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Division: Power Department: Design Document No.: PD/DND/SP/01
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Procedure for Design and Development Control

6. RELATED FORMS:

PY
Sr. Form Title Code Minimum
No. Retention
1 Design and Development Plan (DTR) PD/TDD/FM/01 3 Years

CO
2 Design and Development Plan (PTR) PD/PDD/FM/01 3 Years
3 Winding Shop Review Form (DTR/PTR) (PD/TDD/FM/02) 3 Years
/(PD/PDD/FM/02)
4 Core Shop Review Form (DTR/PTR) (PD/TDD/FM/03) 3 Years
/(PD/PDD/FM/03)
5

6
(DTR/PTR) ED
Mechanical Components Review Form (PD/TDD/FM/04)
/(PD/PDD/FM/04)
Inspection and Testing Review Form (PD/TDD/FM/05)
3 Years

3 Years
LL
(DTR/PTR) /(PD/PDD/FM/05)
7 Prototype / new development Initialization PD/DND/FM/01 3 Years
Request
RO

8 Design and Development Plan (SG) PD/SDD/FM/01 3 Years

9 Panel Welding Shop Review Form PD/SDD/FM/02 3 Years
10 Panel Assembly Shop Review Form PD/SDD/FM/03 3 Years
11 Product Design & Development Plan (For PD/EDD/FM/01 3 Years
NT

Existing Design)
12 Product Design & Development Plan (For New PD/EDD/FM/02 3 Years
Design)
CO

13 Design Input Request Form PD/EDD/FM/03 3 Years

14 Electrical Stage Review Form (For new Design) PD/EDD/FM/04 3 Years
15 Mechanical Stage Review Form (For new PD/EDD/FM/05 3 Years
Design)
16 Validation Stage Review Form (For new PD/EDD/FM/06 3 Years
Design)
17 Design and Development Plan (ITR) PD/IDD/FM/01 3 Years
18 Design Input Request Form (ITR) PD/IDD/FM/02 3 Years
19 Instrument Transformer Review Form PD/IDD/FM/03 3 Years

7. ASSOCIATED PROCEDURES:

Procedure Code Procedure Title

PEL/QHSE/SP/01 Procedure for Documentation and Records
Management.
PD/DND/SP/03 Procedure for Modifications In Engineering
Drawings/Data.

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 Pak Elektron Limited
Division: Power Department: Design Document No.: PD/DND/SP/01
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Procedure for Design and Development Control

8. ASSOCIATED ERP SOFTWARES:

PY
Nil

CO
ED
LL
RO
NT
CO

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