Product Design and Development steps

A. Concept Design
1. 2-D drawing /3D drawing/conventional model/ Rapid Prototyping/
VRML (virtual reality) model
2. Form/ Function
3.Targeted customer.
B. Prototype to sales department.
(Alfa-Prototypes, 5-10 in nos.(form and function....Just shape and Function)
1. To get feed back from customer /client.
2. Market survey.
3. Feed back from Critical customers.
4. Market trend/demand analysis.
5. Comparison with existing similar product (Cost and features)
C. Prototype to production department
(Beta-Prototype, 20-25 in no’s (form, fuction, fit...Near to shape, function)
1.Form /function evaluation
2.Ergonimcs considerations.
3.Manufacturing /Production process selection.
4.Process for Mass/batch production.
5.Team feasibility (In house production).
6.Vendor development (Out sourcing /suppliers availability)
d. Design department.
1.Design a product with considering all data or feedbacks.
2. Design for Easy manufacturing.
3. Design for mass production.
4. Design for Easy assembly.
5. Design for Easy maintenance.
6. Designs for Durability. Functional (static & dynamic)\ /Structural
&Thermal optimization /FEA Methods/simulation)
7. Redesign, Review, Re-evaluation.
 8. Product optimization.
9.Production part approval.
E. Production part approval process (PPAP)
Introduction
Production parts are manufactured at the production site using the production
tooling, gauging process, materials, operators, and environment and process settings.
E.g. feed /speed/ cycle times/pressures/temperatures. Parts for production part
approval must be taken from a significant production run. This run would typically be
from one hour to one shift’s production, with the specific production. Quantity to total
300 parts minimum unless otherwise specified. Parts from each position of a multiple
cavity die, mold tool or patterns are to be measured and reprehensive parts tested.

Production part review and approval

Its required for each part prior to the first quantity shipment of product When,
1 .new part or product (i.e., a specific part, material, or color not
previously supplied to the specific customer)
2.correction of a discrepancy on a previously submitted part.
3.Product modified by an engineer change to design record,
specifications or materials.
4.when supplier notify the customer and submit for part prior to the first
production shipment.
5.Use of another optional construction or material than was used in the
previously approved part.
6.Production from new or modified tools, dies, molds and patterns.
7.Production following refurbishment or rearrangement of existing tooling
or equipment.
8.Production following any change in process or method of
manufacturing.
9.Production from tooling and equipments transferred to a different plant
location or from an additional plant location.
10.change of the source for subcontracted parts, material or services.
 11.Product re-released after the tooling has been inactive for volume
production for twelve months or more.
12.Following a customer request to suspend shipment due to a supplier
quality concern.
Purpose
This is to determine if the entire customer engineering design record and the
supplier properly understands specifications and that the process has potential to
produce product and meeting these requirements during an actual production run at the
quoted production rate. And identify changes that might affect the direct customer or
ultimate purchaser of the component.
And primary supplier is responsible for subcontracted material and services.
Requirements for part approval process steps
1. Production part submission warrants.
2. Appearance approval report for parts with color, grain, or surface
requirements.
3. 3.two sample parts or as agreed to in the control plan. Master samples to be
retained by the supplier.
4. 4.All customer and supplier design records (e.g. CAD/CAM math data, part
drawing, specifications) included detail drawing.
5. 5.any authorized engineering change documents not yet incorporated in the
design record but incorporated in the part.
6. Dimensional results referenced to the part drawing requirements or a checked
print where the results are legibly written on a part drawing (including cross section,
tracings, or sketches are applicable)
7. Checking aids (fixtures, models, templates, Mylars etc), specific to the part
being submitted, used in inspecting or testing.
8. Material, performance and durability test results as specified on the design
record.
9. Process flow diagrams.
10. Process failure mode and effects analysis (Process FMEA)
11. If the supplier is responsible for design, Design FMEA is also required.
 12. Control plans, which include all product and process, related significant or key
characteristics. Control plans for families of similar parts are acceptable if the new parts
have been reviewed for commonalty
13. Process capability results showing conformance to customer requirements for
key, significant, safety, critical and compliance related characteristics, with supporting
data such as control charts.
14. Measurement system variation studies for all equipments used for the
statistical studies for new or modified gages, measurement and test equipments.
15. Engineering approval when so required on the customer's part drawing or
specification.

Process requirements.
1.Auxillary drawing and sketches
The Part number, change level, drawing and supplier's name shall be
shown all on all the auxiliary documents i.e., supplementary layouts results
sheets, sketches, tracing, cross section, CMM inspection point results,
geometric dimensioning and tolerance sheets or other auxiliary drawings
used in conjunction with the part drawing). Copies of these auxiliary materials
are to accompany the dimensional results according to the retention
/submission requirements table .A tracing shall be included when an optical
comparator is necessary for inspection.
2.Part specific inspection or test device
If a product, whole or in part, requires that a part specific inspection or test device
be used, the supplier is required to provide it with submission when so requested. The
supplier is required to certify that all aspects of the gage, etc. Agree with part
dimensional requirements. The supplier must have documentation showing that all
released engineering design changes, up to the level being submitted, have been
incorporated in the gage. Suppliers are responsible for maintenance of such gauges for
the life of the part.
Measurement system variation studies (gage R&R, accuracy, linearity,
and stability studies) per customer requirements must be conducted.
 3.Customer Identified Special Characteristics
Customer may use unique symbols to identify important characteristics, such as
those that affect the customer safety, compliance with regulations, function, fit, or
appearance. These characteristics are variously termed as "Critical”, key”,” safety" or
"significant".
4. Preliminary Process Capability Studies
An acceptable of preliminary process capability must be determined prior to
submission for all characteristics designated by the customer or supplier as safety, key,
critical, or significant, that can be evaluated using variables data. The purposes of these
requirements are to determine, if the production process is likely to produce product that
will meet customer's requirement. The conventional procedure for estimating process
capability is described below.
Preliminary process studies are short-term and will not predict the effects of time
and variation in people, materials, methods, equipments, measurement systems, and
environment. Even for these short-term studies, it is important to collect and analyze the
data in the order they are produced using control charts.
It is necessary to perform a measurement system analysis (Gage R&R,
accuracy, linearity and stability studies) to understand how measurement error is
affecting the study measurements.

4. Appearance approval requirements

A separate appearance approval report must be completed for each parts for
which a submission is required if the part has been designated by the customer as an
"appearance Item"
Upon satisfactory completion of all required criteria, the supplier is to record the
required information on the appearance approval report (AAR0.
5.Dimensional Evaluation
Dimensional inspection must be performed on all parts and product materials
with dimensional requirements to determine conformance with all relevant design record
specification.
 When third party inspection services are used, the results must be submitted on
their letterhead or normal report format. The name of the inspection service that
measured those part(s) must be indicated.
All dimensions, characterstics, and specifications as noted on the design record
and control plan are to be listed on convenient format with actual results recorded.

6.Material Tests
Material tests must be performed for all parts and product materials when
chemical/physical/metallurgical requirements are specified. The supplier must perform
the tests by the material specifications and control plan.
If the supplier cannot perform the required tests services must be procured from
a qualified source or, upon special arrangement, form customer’s laboratories. When
third party laboratory services are used the results must be submitted on their letterhead
or normal report format. The name of the laboratory that performs the tests must be
indicated.
7. Performance Tests:
Performance tests must be performed for all parts and product materials when
performance requirements are specified. The supplier must perform the test required by
the performance specification and control plan.
If the supplier cannot perform the required tests services must be procured from
a qualified source or, upon special arrangement, form customer’s laboratories. When
third party laboratory services are used the results must be submitted on their letterhead
or normal report format. The name of the laboratory that performs the tests must be
indicated.
It is the suppliers’ responsibilities to meet all applicable specifications are cause
for the supplier not to submit the parts and/or documentation. Every effort must be
made to correct process so that all design record requirements are met.
8. Part submission warrant
Upon satisfactory completion of all required measurements and tests, the
supplier must enter required information on the warrant. A separate warrant must be
completed for each part numbers unless otherwise agreed to by the customer. Since
the warrant has been developed as an industry-wide form, certain customers will not
require entries in al spaces.

9.Engineering Changes
For submissions due to engineering changes, the inspection and testing
requirements are determined by the extent of change. For example, if certain
dimensions are changed, the dimensional evaluation may be limited to those areas
affected by the change. For guidance on specific changes, contact your responsible part
approval activity.
10. Multiple Cavity molds, Tools, Dies, and Patterns
If production parts will be produced from more than one cavity, mold, tool, die, or
pattern, a complete dimensional evaluation is required on one part from each cavity,
mold, etc., The supplier must identify the specific cavities, Molds, etc., for which parts
are being submitted on the "explanation/comments” line of the warrant or in an
attachment.

Record & Master Sample Retention

The customer shall retain a complete record of findings and the master samples
for each submission including SPC results and, when applicable, apprarance approval.
This record should show conformance to all dimensional, chemical, metallurgical,
physical, and other test specification.
Documentation includes
a. Inspection results referenced to and accompanied by the costumer’s
engineering –approved design record for all dimensional requirements.
b. Laboratory test reports covering all chemical, mechanical, physical, and
performance tests specified for the material and part.
c. Preliminary process capability results for all critical and significant
characteristics.
d. Measuring systems analysis (gage R and R, accuracy, linearity, stability
studies) results, process flow diagrams, Process (and, when applicable,
design) FMEA’s, control plans, preliminary process performance
 evaluation, sub contracted supplier warrants and supporting
documentations, appearance approval and master samples.
All suppliers are required to complete and retain copies of all of the
documentation.

Part Submission Status

The Customer as to disposition of the submission will notify suppliers. After
sample approval, suppliers are responsible for assuring that future production continues
to meet all customer requirements.

F. Advanced product quality planning & Quality Control

(APQP & QC)
Some of the expected benefits in using guidelines are:
1. A reduction in complexity of product quality planning for customers and
suppliers.
2. A means for suppliers to easily communicate product quality planning
requirements to subcontractors.
Introduction
Product quality planning is structured method of defining and
establishing the steps necessary to assure that the product satisfies the
customer .The goal of product quality planning is to facilitate communication with
every one involved to assure that all required steps are completed on time.
Effective product quality planning depends on company’s top management
commitment to the effort required in achieving customer satisfaction.
Some of the advantages of product Planning are
1. To direct resources to satisfy customer.
2. To promote early identification of required changes.
3. To provide a quality product on time at the lowest cost.
 Organizing the team
The supplier’s first step in Product quality planning is to assign responsibility to a
cross functional team. Effective productive quality planning requires the
involvement of more than just quality department .The initial team should include
representatives from engineering, manufacturing, material control, purchasing,
quality, sales, field service, subcontractors and customers as appropriate.
Define the scope
It is important for the Product quality Planning team in the earliest stage of
product program to identify customer needs, expectations and requirements. At a
minimum the team must meet to:
1.Select a project team leader responsible for overseeing the planning process.
2.Define the roles and responsibilities of each area represent.
3.Identify the customer internal and external.
4.Define customer requirements.
5.Select the disciplines, individuals, and/or subcontractors that must be added to
the team, and those not required.
6.Understand customer expectations i.e., design, number of tests.
7.Assess the feasibility of proposed design, performance requirements and
manufacturing process.
8.Identify costs, timing, and constraints that must be considered.
9.Determine assistance required from the customer.
10.Identify documentation process or method.
Team to team
The product quality planning team must establish lines of communication with
other customer and supplier terms. This may include regular meetings with other
teams .the extent of team to team contact is dependent upon number of issues requiring
resolution
Training
The success of a PQP is dependent upon an effective training program that
communicates all the requirements and development skills to fulfill the customer needs
and expectation
 Customer and supplier involvement
The Primary customer may initiate the quality planning process with a supplier.
However, the supplier has an obligation to establish a cross functional team to manage
the product quality planning process. Suppliers must expect the same performance from
the subordinates.
Simultaneous engineering
Simultaneous engineering is a process where cross-functional teams strive for a
common goal or goals.
Control Plans
Control plans are written description of system for controlling parts and process.
Separate control plans cover three distinct phases:
Prototype: A description of dimensional measurements and material and
performance tests that will occur during prototype build.
Prelaunch: A description of dimensional measurements and material and
performance tests that will occur after the prototype and before full production
Production: A comprehensive documentation of product/process characterstics,
process controls tests and measurements systems that will occur during mass
production.
Concern resolution
During the planning Process, the team will encounter product design and
processing concerns. These concerns should be documented with responsibility
assigned and timing. Disciplined problem solving methods also has to be used in
difficult situations.
Product quality timing plan
The product quality planning team’s first order of business following
organizational activities should be the development of a timing plan. The type of
product, complexity and customer expectations should be considered in selecting the
timing elements that must be planned and charted .All team members should agree with
each event, action, and timing .A well organized timing chart should list tasks,
assignments, and /or other events. Also the chart provides the planning team with a
consistent format for tracking progress and setting meetings agendas .To facilitate
status reporting, each event must have a “start” and a “completion” date with the actual
point of progress recorded. Effective status reporting supports program monitoring with
a focus on identifying items that require special attention.

Steps of APQP
1.Plan and Define a Program
This section determines customer needs and expectations in order to plan and
define a quality program. All work must be done with customer in mind, providing better
products and define a quality program. All work must be done with customer in mind,
providing better products and services than competition. The early stage of the product
quality planning process is designed to assure that customer needs and expectations
are clearly understood.

Inputs
Voice of customer
Market Research
Historical warranty and quality Information
Team experience
Business Plan/Marketing Strategy
Product/Process Benchmark data
Product/Process assumption
Product reliability studies
Customer Inputs
 Fig: Product quality Planning Timing Chart

Outputs
Design goals
Reliability and quality goals
Preliminary Process Flow chart
Preliminary Listing of special product and process characteristics
Product assurance plan
Management Support

2.Product Design and Development

This section discusses the elements of planning process during which
design feature and characteristics are developed into near final form. The product
quality Planning team should consider the entire design factor in planning process even
if customer owns design or shared. The step includes prototype build to verify that the
product or service meets the objectives of the voice of customer. A feasible design must
permit meeting production volumes and schedules and be consistent with the ability to
meet engineering requirements, along with quality, reliability, and investment cost, unit
cost and timing objectives.

Inputs
• Design Goals (Derived from the output of Planning)
• Reliability and quality goals
• Preliminary Bill of material
• Preliminary Process flow chart
• Preliminary listing of special Product and Process characteristics.
• Product Assurance Plan
• Management Support

Fig: Product quality Planning Timing Chart

Outputs By Design Responsible activity
• Design Failure mode and effective Analysis
• Design for manufacturability and assembly
• Design verification
 • Design Reviews
• Prototype Build-Control Plan
• Engineering Drawing
• Engineering Specification
• Material Specification
• Drawing and specification Changes

3. Process Design and development

This section discusses the major features of developing and manufacturing
system and its related control plans to achieve quality products. The tasks to be
accomplished at this step of product quality planning process depend upon successful
completion of prior stages contained in the first two sections.

Inputs (Derived from the output of Product Design and Development)

• Design Failure Mode and effective Analysis
• Design for manufacturability
• Design Verification
• Design reviews
• Prototype Build- control plan
• Engineering Drawings (Including math Data)
• Engineering specifications
• Drawing and specification changes
• New equipment, Tooling and facilities requirements
• Special product and process characteristics
• Gages/Testing Equipment requirements
• Teams Feasibility Commitment and management support
 Fig: Product quality Planning Timing Chart

Outputs (Become Input for section Product and process validation)

• Packing Standards/Product/Process Quality system review
• Process Flow chart
• Floor Plan layout
• Characteristics Matrix
• Process failure mode and effective analysis
• Process Instructions

4. Product and process Validation

This section discusses the major features of validating the manufacturing
process through an evaluation of a production trail run. During a production trial run, the
product quality planning team should validate that control plan and process flow charts
are being followed and products meet customer requirements.
Inputs (Process and design developments)
• Packing Standards
 • Product/Process Quality system Review
• Process Flow chart
• Floor Plan layout
• Characteristics Matrix
• Process Failure Mode and effects and analysis
• Pre-Launch Control Plan
• Process Instructions
• Measurement systems Analysis Plan
• Preliminary Process Capability Study plan
• Packaging Specification
• Management Support

Outputs
• Production Trail run
• Measurement system evaluation
• Preliminary Process capability study
• Production Part approval
• Production Validation testing
• Packaging Evaluation
• Production control Plan
• Quality Planning Sign-off and management support
 Fig: Product quality Planning Timing Chart

5. Feedback, Assessment and Corrective Action

Quality Planning does not end with process validation and installation. It is
component-manufacturing stage where output can be evaluated when all special and
common causes of variation are present. This is also the time to evaluate the
effectiveness of product quality planning effort. The production control plan is the basis
for evaluating product or service at this stage. Variable and attribute data must be
evaluated.
The inputs and outputs applicable to the process step in this section are as
follows

Inputs (Derived from Product and process validation)

• Production trail run
• Measurement system evaluation
• Preliminary Process capability study
 • Production Part approval
• Production validation testing
• Packaging evaluation
• Production Control plan
• Quality planning sign-off and management Support

Fig: Product quality Planning Timing Chart

Output
• Reduced Variation
• Customer Satisfaction
• Delivery and service

6.Control Plan
The purpose of this control plan methodology is to aid in manufacture of
quality products according to customer Requirements. It does this by providing
structured approach for design selection and implementation of value added control
methods for the total system. Control plans provide a written summary description of
systems used in minimizing process and product variation. The intent of control plan
form displayed in this section is to provide an example of how this information can be
documented.
An important phase of process for quality planning is the development of a
control plan. a control plan written description of the system for controlling parts and
processes. A single control plan may apply to group or family of products that are
produced by same process at same source. Sketches, as necessary, may be attached
to control plan for illustration process.
In effect the control plan describes the action that is required at each
phase of process including receiving, in process, out going, and periodic requirements
to assure that all process outputs will be in a state of control. During regular production
runs, the control plan provides the process monitoring and control methods that will be
used to control characteristics. Since process are expected to be continually updated
and improved, control plan reflects a strategy that is responsive to these changing
process conditions.
Control plans should be maintained and used through out the product life cycle.
Early in the product life cycle its primary purpose is to document and communicate the
initial plan for process control and subsequently, it guides manufacturing, in how to
control the process and ensure product quality. Ultimately, the control plan remains a
living document reflecting the current methods of control and measuring systems used
and it should be updated as measurement systems and control methods are evaluated
and improved.
Control plan development
For process control and improvement to be effective, a basic understanding of
the process must be obtained. A multi –disciplined team is established to develop the
control plan by utilizing all the available information to gain a better understanding of the
process.
Such as
• Process flow diagram
• Systems /design /Process failure mode and effective analysis.
• Special characteristics
 • Lessons learned from similar parts
• Team’s knowledge of the process
• Design reviews.
• Optimizations methods

The benefits of developing and implementing a control plan

Quality: the control plan methodology reduces waste and improves the quality of
products during design, manufacturing and assembly. This structured discipline
provides a through evaluation of the product and process. Control plans identify process
characteristics and help to identify their sources of variation ( input variables) ,which
cause variation I product characteristics (output variables)
Customer satisfaction: Control plans focus resources on processes and
products related to characteristics that are important to the customer .the proper
allocations of resources on these major items helps to reduce costs without sacrificing
quality.
Communications: as a living document the control plan identifies and
communicates changes in the product /process characteristics, control method and
characteristic measurement.

G. Design failure mode and Effect analysis

(DFMEA)
DFMEA should be conducted through out the design cycle, beginning in the
concept stage to revised in the preliminary design stage and revised in prototype stage
and finalized in the final design stage. It should be conducted at every design changes.
Various steps
1. Review the design uses the blue print or schematic of design/product identify
each component and interface.
 2. Brain storm potential failure modes reviewing existing documentation and data
for clues.
3. List the potential effects of failure there may be more than one failure.
4. Assign severity ratings based on severity of consequences of failure.
5. Assign occurrences ratings based on how frequently the failure is likely to
occur.
6. Assign detection ratings based on chances of failure will be detected prior to
the customer finding it
7. Calculate the RPN, Severity occurrence detection
8. Develop the action that will do what by when
9. Take action :Implement the improvements identified by your DFMEA team.
10. Calculate the resulting RPN & re-evaluate each of potential failures once the
improvements have been made and determine their impact on RPN.
(RPN =Risk priority number)

Some tips how to customize each one of scales.

Severity
Provide description of what ramification of the failure could be often ramification focus
on safety issues especially in higher ratings.

Occurrence
If possible use objective and measurable description for each rating.

Detection
Use the definition of type 1,2,3 detection control to help distinguish between stronger
and weaker detection ratings.

Type 1 or prevention controls are strongest type of design control. Prevention

control includes technique such as mistake proofing, predictive design, validation and
reliability studies.
Type 2 or Detection of Failure mode mechanisms are not strong as the type 1
Controls. They include system that self-alarm, if a failure mechanism is triggered.
Type 3 or Detection of failure and the weakest form of design controls. They only
detect the failure after it has occurred

On basis of RPN (risk priority no) action to reduce or to mitigate the effect, and should
be based on priority.