SOP FRAMEWORK For

Product / process Development & Maturation

( Conceptualization to Supply till customer end )

Date: 16.01.24
Major outline provided by ISO 9001:2015

ISO 9001 GUIDELINES

8.3 Design and development of products and services .............................................................................................. 11
8.3.1 General
................................................................................................................................................................................... 11
8.3.2 Design and development planning 11
................................................................................................................

8.3.3 Design and development inputs ...................................................................................................................... 11

8.3.4 Design and development controls 12
.................................................................................................................

8.3.5 Design and development outputs ..................................................................................................................12

8.3.6 Design and development changes ..................................................................................................................12
General requirement
8.3 Design and Development of products and services.

ISO 9001 GUIDELINES

8.3.1 General

The organization shall establish, implement and maintain a design and

development process that is appropriate to ensure the subsequent provision
of products and services.
Design and Development Planning
Section 8.3.2 of the ISO 9001/AS9100D Standard
•The nature, duration & complexity of the design & development processes.
•The requirements that specify particular process stages, including applicable
design and development reviews.
•The required design and development verification and validation activities.

ISO 9001 GUIDELINES

•The responsibilities and authorities involved in the design and development
process.
•The internal & external resource needs for the design & development of the
products and services.
•The need to control interfaces between individuals and parties involved in the
design and development process.
•The need for involvement of customer and user groups in the design and
development process.
•The requirement for subsequent provision of products and services.
•The level of control expected for the design and development process by customers
and other relevant interested parties.
•The necessary documented information to confirm that design and development
requirements have been met.
Design and Development Inputs
8.3.3 Design and development inputs
The organization shall determine the requirements essential for the specific
types of products and services to be designed and developed. The
organization shall consider:

ISO 9001 GUIDELINES

• functional and performance requirements
• information derived from previous similar design and development activities
• statutory and regulatory requirements
• standards or codes of practice that the organization has committed to
implement
• potential consequences of failure due to the nature of the products and services

Inputs are required to adequate, complete and unambiguous for the design and
development process undertaken and any conflicting inputs must be resolved.

Documented information on design and development inputs is required to be

retained.
Design and Development Controls
8.3.4 Design and development controls
The organization shall apply controls to the design and development process to
ensure that:

ISO 9001 GUIDELINES

• the results to be achieved are defined
• reviews are conducted to evaluate the ability of the results of design and
development to meet requirements
• verification activities are conducted to ensure that the design and development
outputs meet the input requirements
• validation activities are conducted to ensure that the resulting products and
services meet the requirements for the specified application or intended use
• any necessary actions are taken on problems determined during the reviews,
or verification and validation activities
• documented information of these activities is retained
Note: Design and development reviews, verification, and validation each have
distinct purposes. That they can be conducted separately or in any combination,
as appropriate to the specific products and services of the organization.
Design and Development Outputs
Clause 8.3.5 Design and development outputs.
The organization shall ensure that design and development outputs:
• meet the input requirements

ISO 9001 GUIDELINES

• are adequate for the subsequent processes for the provision of products and
services
• include or reference monitoring and measuring requirements, as
appropriate, and acceptance criteria
• specify the characteristics of the products and services that are essential for
their intended purpose and their safe and proper provision.

The organization shall retain documented information on design and

development outputs.
Design and Development changes
8.3.6 Design and development changes
The organization shall identify, review and control changes made during, or
subsequent to, the design and development of products and services, to the

ISO 9001 GUIDELINES

extent necessary to ensure that there is no adverse impact on conformity to
requirements.
The organization shall retain documented information on:
• design and development changes
• the results of reviews
• the authorization of the changes
• the actions taken to prevent adverse impacts
Existing ISO Documents in Design and
Development at FUJI Silvertech

ISO 9001 EXISTING PROCESS IN DESIGN DEPARTMENT

• Design SOP Hydraulic
• Design SOP Structural
• Data Enquiry Forms (For Design | For Quantity)
• Design Request
• Structural Design Plan Vs Actual
• Hydraulic Design Plan Vs Actual
• Quantity Plan Vs Actual
KEY DESIGN SOP POINTS
Design and Development Planning
Nature of design and development activities
1
Examples:
a) New product (e.g. Segmental retaining wall)
b) New segment (e.g. Sewage Treatment Plant, Building)
c) Modification of existing product (e.g. different size of Box Culvert)
d) New Technology (Coupler jointing, fiber concrete)
e) New service (Post tensioning, Installation)

Duration
2
Typical Standard Design Process 4- 8 Weeks
Pricing 2 Weeks
Segmental retaining wall

•Segmental block retaining walls have a facing and

lateral tieback system. The facing system most often
includes modular concrete blocks. These blocks
interlock with one another and the lateral restraining
members. Lateral tiebacks are geogrids, a type of
reinforcement, that are buried in the backfill.
Advantages of Segmental
retaining wall
•Segmental retaining walls offer many advantages:

• rapid construction
• horizontal and vertical curvatures
• easy grade changes
• a wide variety of colors, sizes and textures
• no need for a concrete footing
•Some segmental systems use steel or fiberglass pins, clips or
integral lips to create a continuous facing system. Some blocks are
hollow, some are solid. Just about all block systems permit backfill
drainage through the face joints.
Disadvantages of •Segmental block retaining walls can be quite labor-
Segmental retaining intensive. For a wall to be done correctly and be as sturdy
as possible, the contractor needs to possess the proper
wall skills.

•These types of walls are not ideal for every situation.

They’re versatile in design by not necessary in certain
situations.
Precast Sewage Treatment
Plant concrete elements for ecological wastewater
Precast
treatment
• Precast concrete elements
as economic alternative

• Reduced installation
time and non odorous
operation
 PRECAST Building
Precast is fast adopting itself into the construction
sector, as skilled labor availability is diminishing
day by day in India, and the construction demand
is on the rise in the country. Builders and
Developers are looking at ways of adopting the
precast into the construction and achieve speeds
and quality.
Precast Advantages
• Factory condition production, all weather working, better quality,
finish and accuracy.
• Less labor requirement, less wastage and less cost based on
repeatability of items.
• Faster cycle time, scalability and repeatability.
• Offsite working and parallel working, standardization of design,
engineering and execution.
Types Of Precast Systems

Depending on the load-bearing structure, precast systems can be divided

into the following categories:

• Large-panel systems,
• frame systems,
• slab-column systems with walls and mixed systems.
Large-Panel Systems

• The designation large-panel system refers to multistorey

structures composed of large wall and floor concrete panels
• Connected in the vertical and horizontal directions
• The wall panels enclose appropriate spaces for the rooms
within a building.
• These panels form a box-like structure.
Precast Frames

• Precast frames can be constructed using either linear

elements or spatial beam column sub-assemblages.
• Precast beam-column sub-assemblages have the advantage
that the connecting faces between the sub-assemblages can
be placed away from the critical frame regions.
Slab-Column Systems With Shear Walls

• These systems rely on shear walls to sustain lateral load

effects, whereas the slab-column structure resists mainly
gravity loads.

• There are two main systems in this category:

• Lift-slab system with walls

• Prestressed slab-column system
Modification of existing product (e.g. different size of Box Culvert)
New Technology Coupler jointing
• Rebar couplers are used in precast construction for facilitating strong
and efficient connections between precast concrete elements.
• Their significance lies in expediting construction timelines by
enabling rapid and precise assembly, reducing labor costs, and
ensuring structural integrity.
New Technology fiber concrete

Synthetic fiber concrete reinforcement is premixed with the

concrete and delivered straight to the precast mould, eliminating
the steel installation process.

• 50% Increase in Production Speeds

• Eliminate the need for storage and installation of
standard steel reinforcement in precast elements.
• Project experience has shown that synthetic fiber
concrete reinforcement can increase precast
production speeds by nearly 50%.
Lower Your Costs
• macro synthetic fiber concrete reinforcement
delivers more than just increased production
speeds.
• Labor costs reduced
• Material costs reduced
• Transportation Costs Reduced
• Storage costs reduced
• Element Breakage is reduced

eliminating concrete cover requirements. In many

cases this will allow for a reduction in element
thickness and a reduction in weight.
Rust Free – Long Lasting Concrete
• Macro synthetic fiber concrete reinforcement will
never rust and will continue to perform for the full
life of the concrete.
• Many precast items are exposed to the elements
and corrosive environments, none of which will
affect the long-term performance of fibers.
• Durable, long lasting, low maintenance concrete.
Suitable for Nearly any Precast Application
• Precast tunnel segments
• Invert segments
• Road barriers
• Water and wastewater tanks
• Manholes
• Water troughs
• Architectural elements
• Electrical cabinets
• Walls and barriers
• Ballast pads
• Burial vaults
• Seating
• Structural elements
• And many more
New service Post tensioning Design and Installation.

What is Post-Tensioning?

Post-tensioned concrete means that the concrete is poured and then the tension is applied to
the high strength Steel, but it is still stressed before the loads are applied so it is still
prestressed.
 Advantages & Applications of Post-Tensioning

* It reduces or eliminates shrinkage cracking-therefore no joints, or fewer joints, are needed.

* Cracks that do form are held tightly together.
* It allows slabs and other structural members to be thinner.
* It allows us to build slabs on expansive or soft soils.
* It lets us design longer spans in elevated members, like floors or beam.
Post-Tension Type
• Bonded Post-Tensioning
It is used for large structural elements such as beams and transfer girders,
design advantages include increased span lengths and load carrying
capacity and reduced deflection.
Post-Tension Type

• Unbonded Post-Tensioning
It is typically used in new construction for elevated slabs, slabs-on-grade, beams, and
transfer girders, joists, shear walls, and mat foundations. Light and flexible, the
unbonded mono strand can be easily and rapidly installed – providing an economical
solution.
Thickness or Depth of Section

<Thickness-span correlation by each slab system>

 Design and Development Planning
Complexity
3 Tools may be available
Emerging concept.
Advanced tools and
testing is required
Example
Total precast building
Precast Floating Jetty
Timebound and totally
new.
Advanced tools and
testing may not be
available
Example
Futran Project
Expert help is required
Testing may be required
Example
Segmental retaining wall
Noise barrier
Drain with fencing
Box Culvert where soil
stabilization may be required
Standards, methods,
tools, knowhow are
available
Example
L Shape retaining wall or
Simple box culvert on
good SBC Ground
Simple Project:
Standards, methods, tools, knowhow are available

Precast elements are already designed, and execution completed, so

its in and out is known and task for the same is very easy to
complete.
Complicated Project:
Expert help is required, Tools may be available, Testing may be required

Some design complication like precast member typical size not fitting in the
project, any special load may come than usual load design, support system
differ than usual like, low sbc or soil stabilization required.

Some shape complication than usual shape may lead to have expert help.
 complex Project:
Emerging concept. Advanced tools and testing is required

Full building designed as per all codal guideline need to be full filled for
EQ, Wind, Gravity and all loads.
Chaotic Project:
Timebound and totally new. Advanced tools and testing may not be available

Special structures like PRECAST floating Jetty, etc.…

Design and Design and
Development Inputs Development Outputs
Functionality Performance

Safety Regulations

Maintainability Traceability
 Design and Development Inputs
Functionality

Functional analysis is a systematic process in industrial design

that involves breaking down a product's intended functions to
understand their interactions and dependencies. In the context of
kitchen cabinet design, functional analysis entails
deconstructing the cabinet's purposes, such as storage,
organization, and accessibility. By examining how each
function contributes to the overall design, I ensure that the
cabinet is optimized to meet user needs effectively
Design and Development Inputs
Performance

Performance refers to a product's primary operating characteristics. For

a Precast Concrete, performance would include traits like load caring
capacity, deflection, moment capacity, etc... Because this dimension of
quality involves measurable attributes, brands can usually be ranked
objectively on individual aspects of performance. Overall performance
rankings, however, are more difficult to develop, especially when they
involve benefits that not every customer needs.
Design and Development Inputs
Safety

How do you ensure product safety during R&D?

• Know the regulations

To ensure product safety during R&D is to know the relevant regulations and standards that apply to your product
and your market.

• Test early and often

To ensure product safety during R&D is to test your product early and often, using various methods and
tools.

• Design for safety

A third important step to ensure product safety during R&D is to design your product with safety in mind,
from the beginning to the end

• Document everything
To ensure product safety during R&D is to document everything you do, from the planning to the execution.

• Follow the ethics

To ensure product safety during R&D is to follow the ethics of your profession and your industry.
Design and Development Inputs
Regulation
 Design and Development Controls
Review

Review depends on
Check Progress of Review timeline or customer requirement,
Assess Results Check Progress of Cost
design activities milestone risk involved, size,
complexity

Verification

Design compliance Design compliance Design compliance Constructability and

Design Compliance to Design economy and
with client with standards, guides with local and maintainability review
inputs value for money
requirement and codes statutory requirement complete

Validation

Specific user Responding to Managing changes to

Design is suitable for
requirements have information request by design and Site inspection Shop drawing review
intended use
been met customer specifications
Design and Development Changes
Document Design Changes

Evaluate impact of change (process, resource, product character, budget, schedule etc.)

Change authorization

Action for change

Design and Development
Responsibility and Authority
Design Manager • Design and Development Planning

• Ensure Design Team carries out

Design Manager key activities

Design Manager • Design changes record

Designer • Design activity and Logs

Designer • Review

Peer, expert, third • Verification

party

Design Manager • Verification of outputs/compliance

Consultant/Client • Design Validation

Representative
NEW PRODUCT DEVELOPMENT
Example Goals of a large size D&D / R&D
Center
• Develop new products, processes and technologies in line with current and futuristic customer requirements
• Provide world-class, innovative scientific & technical support to our operations and marketing teams
• Facilitate the extension of the life of our natural resources (environment conscious)
• Remain proactive, track global developments
• Create a pool of super specialists for a company
• Generate new knowledge and manage the company's Intellectual Property (IP) rights and patents
• Maintain high level of engagement with academia and other research organizations, nationally and
internationally
• Ensure to remain one of the top global precast concrete R&D organizations
• Rely on our competent team of world class scientists and engineers
• ISO 9001 for D&D / R&D | NABL Laboratory | Eco friendly materials and initiatives

Reference: Ultratech R&D Center

 Objective

Introduction

Key Components of Product Development

New New Product Development Strategy

produc New Product Development Process

Managing New Product Development

t Product Life cycle Strategies

develo Additional Product and Service Considerations

pment Quality Function Deployment

Product Failure Mode Analysis and Risk Assessment

Advanced Product Quality Planning (APQP)

Production Part Approval Process (PPAP)

Reference: CII NPD Course
• TO BE CONTINUED……
 Thank you

Ahmedabad | Aurangabad | Bagodara | Mumbai | Vadodara

Ahmedabad | Aurangabad | Bagodara | Mumbai | Vadodara
Purpose
• To define and document a procedure for new product development.
Scope
• This procedure applies to precast concrete products:
a) New product development (e.g. Segmental retaining wall)
b) New segment development (e.g. Sewage Treatment Plant, Building)
c) Modification of existing product (e.g. Different size of Box Culvert)
d) New Technology development (Coupler jointing, fiber concrete)
e) New service development (Post tensioning, Installation)
Project Committee
The Managing Director applies for initiation of the project.
New Product Technical Committee is responsible for designing and documenting inputs and outputs of design
and development activities.
NPTC comprises of:
1. One Executive Director (Technical)
2. Head / General Manager (Operations)
3. Head / GM (Procurement)
4. Manager (Quality Control)
5. Head / GM (Design , Method Development & Validation)
6. Head / Senior Manager (Production)
7. Head / Senior Manager (Regulatory Affairs/Communication + Documentation)
8. Head / Manager (Product Development)
Initiation of Ideas
New Product ideas / requirements

The new product ideas / requirements are forwarded to

1. Managing Director (MD)

2. New Product Technical Committee (NPTC)

Method of communication: Email to npd@fujisilvertech.com

Source of New Product Ideas / Requirements

3. Internal Sources: R&D & Employees

4. External Sources: Customers | Competitors | Distributors | Suppliers | Outsourcing firms | Design Firms | Product Consultancies | Online Collaborative Communities | Online Opinions

Derivation of New Product Ideas

New product ideas are derived from either one or more of the following groups:

• Suggestions to New Product Technical committee

• Brainstorming sessions arranged by MD

• Market survey and literature

• Competitor’s product samples

• Customer requirements

• In-house designing efforts (from original research Products)

Idea Screening
Idea Screening
These ideas and requirements are reviewed by the ED (Technical) and VP (Marketing), recorded on Project Initiation Form approved by the
MD and is forwarded to EDT for further working.
Preliminary Elimination:
1. Promising Ideas
2. Marginal Ideas
3. Rejected Ideas
Screening:
Basis of screening
4. Estimate of market size
5. Product Price
6. Development Time and Costs
7. Manufacturing Costs
8. Rate of Return
Concept Development and Testing
Ideas selected after screening go for Concept Development

Design & Development Planning: Executive Director Technical [EDT] prepares Design and Development Plan for the project indicating the
design phases, departmental interfaces during the design process, tentative planned duration of each design phase, etc. The tentative durations
are only minimum projected durations and may vary depending on the availability of resources and personnel. The plan is forwarded to
Manager Product Development along with the Project Initiation Form for execution.

Product Concept Proposal

1. Product User / Target Customer

2. Product Application / Main and consolidated uses

3. Primary Benefit of the Product / USP

4. Time of consumption

5. Testing / Check with group of customer for Appeal

Marketing Strategy Development
Overall:

1. Target Market

2. Planned Value Proposition

3. Product Positioning

4. Sales

5. Market share

6. Profit Goals

Short Term Outline:

7. Planned price

8. Distribution

9. Marketing Budget

Long Term Plan:

10. Planned Long run sales and Profit Goals

11. Marketing Mix Strategy

Literature survey and innovator/
competitive product development analysis
Literature Survey

Literature survey of available methods, similar applications, similar products, related testing, etc. with references if prepared by Manager
Product Development and submitted to EDT.

Manager Product Development checks innovator / competitor’s product or technology and submits report to EDT.

EDT provides suggestions / recommendations and returns the report.

Design Inputs and Specification Plan

Product Development Team (PD Team) under the supervision of Head/Manager - Product Development starts working on the tentative design
of the intended product with 3D Concept/Visuals and required inputs for Design and Development.

These inputs may include:

1. Material properties

2. Loading criteria

3. Environmental criteria

4. Other functionality related criteria (e.g. Fire safety)

5. Handling criteria – Product weight limitations and TEP availability

6. Loading and Transportation criteria – For product size

7. Formwork criteria

8. Other operations criteria

NPTC approves design inputs from Product Development Team and supports in necessary data capturing.
Design and Development
Product Development Team (PD Team) shall consider the following and prepare a design report:

1. the nature of design and development activities,

2. duration required,

3. nature of complexity,

4. required process stages including reviews,

5. verification and validation activities,

6. responsibilities and authorities in design and development process,

7. internal and external sources required,

8. need for involvement of customers,

9. design controls,

10. control interfaces among other departments,

11. requirements for future provisions of products and services,

12. level of control expected from design department

13. level of control expected from other departments, customers and other interested parties
 Advanced Production and Quality Planning
Once the product design is reviewed, verified and validated, the NPTC takes decision on order of formwork and proceeds for the Advanced
Production and Quality Planning (APQP Process).
Once the formwork is ordered, the item code is opened in SAP.

Design FMEA (Failure

Customer order Customer specifications Ability Appearance mode and effect Design review Design verification plan
analysis)

Prototype item
Inspection method, Inspection/Control Plan Design – Drawing and Confirmation of
Quality Planning production and
equipment and tools for prototype specification manufacturing feasibility
inspection

Logistic Concept
Process flow chart and Inspection equipment Preproduction/ Pre
Process FMEA Process instructions including packaging
mass production layout capability release control Plan
material

Mass production Initial process capability Technical test on Initial sampling

Production first trial run
inspection plan study Production items inspection
APQP Timing chart and Phases
Design and Development Output
Documented outputs:

1. Design

2. Specifications

3. Raw material

4. Quality Assurance and Testing Procedure

5. Packaging and Promotional Materials

Production Part Approval Process (PPAP)
Stability study
1. GM (Operations) prepares a stability protocol for first 3 samples of products. An SOP may be developed.

2. Stability study may be carried out and reported every 6 months. Any deviations/failures may be recorded and the results maybe intimidated to EDT.

3. EDT holds a Design Review Meeting with Team where probable causes of deviation / failures are discussed and modification in the product are proposed and
approved.

4. The decisions / modifications in the intended product are implemented through Process revision Form.
Design and Development Reviews
Minimum 3 reviews:

1. Design review on completion of Design by NPTC

2. QA Review on completion of first trial/mock

3. Third review after completion of stability studies by NPTC

SOP FRAMEWORK FOR
NEW PRODUCT DEVELOPMENT
Date: 16.01.24
 Initiation and Screening of NPD Ideas MANAGEMENT + MARKETING + BUSINESS DEVELOPMENT
Approval
Concept Development: Solution narrowed to product DESIGN & DEV TEAM
Approval
Raw Design of Product DESIGN & DEV TEAM
Joint Review – DD / Manuf & Dispatch / S&M / Installation /Management

Core Design of Product Formwork Development Accessories Development

DESIGN AND DEVELOPMENT TEAM

Dimensional Connecting parts

Functional Lifting parts

Mix Other handling parts

Smart Component (optional) Special Tech – Manuf. / Install

(INDIA + JAPAN)
Technology (optional) Chemicals
Reinforcement Anchors/ Pre or post tensioning

Embedded parts including Packing Materials

couplers, flanges, inserts

Simulation: Method Statement with 3D Visuals DD TEAM + MANUFACTURING TEAM

Joint Review – DD / Manuf & Dispatch/ S&M / Installation /Management
 DESIGN REVISIONS IF ANY

DESIGN AND DEVELOPMENT

Communication
CORRESPONDING APPLICABLE REVISIONS

TEAM (INDIA + JAPAN)

Communication
FINAL DESIGN
Joint Review – DD / Manuf & Dispatch / S&M / Installation /Management

Product Design Formwork Design Accessories Development

Special Tech – Manuf. / Install

TRIAL PRODUCT MANUFACTURING MANUFACTURING TEAM

MOCK WITH APPLICABLE TESTING, VALIDATION MANUF. TEAM + DISPATCH TEAM + QUALITY TEAM + DD TEAM
Joint Review – DD / Manuf & Dispatch/ Installation SOP, ITP etc.

SPECIFICATIONS DRAFTING COMPLETE DOCUMENTATION SET MANAGEMENT + MARKETING + BD + DD

STABILITY STUDY – 3 MONTH MONITORING LED BY MANAGEMENT FAILURE MODE EFFECT ANALYSIS (FMEA) (IF APPLICABLE) DD TEAM
Joint Reviews – DD / Manuf & Dispatch/ S&M / Installation /Management

TOTAL HANDOVER TO OPERATIONS WITH PART DOCUMENTATION

 Timeline for SOP
Date
01 February 2024 First draft submission by AS (In process DR inputs will be taken)
07 February 2024 Inputs expected from DR, PT, KD & BS
Incorporation of comments
14th February 2024 Team Development and Training Discussion
14th February 2024 RRA Discussion / New recruit / New talent development requirement All parties involved
21st February 2024 Deadline for any changes in SOP to be provided
28th February 2024 Final SOP for circulation and trial implementation
March / April 2024 Implementation date as decided by BS