Fouryes TQM Consultants

Training on APQP
Advanced Product Quality Planning

AG-3, Second Floor, Shanthi Colony, Anna Nagar, Chennai-600040, India

Ph.: +91-44 42127102, 98414 31336 Email: [email protected], Web: www.fouryestqm.in
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 Purpose of Session

§  To provide Basic understanding of APQP Process

§  To explain APQP methodology in detail

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 Survival and Growth

§  Products & Services must be preferable to Customers

over Competitors

§  Organization must continually meet Needs &

Expectations of Customers

i.e. Voice of Customers also called QUALITY

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 KANO Model

Customers do know what they want but may not be proficient

at describing their needs. By understanding the three types of
customer needs and how to reveal them, you’ll be well on
your way to knowing customers’ needs as well as, or perhaps
better than, they do.

Level of customer need

§  Expected quality - I assume

§  Normal quality – Spoken
§  Normal quality - Unspoken I'll know it when I see it!
§  Exciting quality- Wow!!

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 Voice of Customer: How to meet?

-  Must understand voice of customer

- Must deploy it in
- Voice of Design and
- Voice of Process

APQP is a platform to satisfy the above needs

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 What is Quality Planning?

Customer
Quality Planning Product
Requirements

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 What is Quality Planning?

Systematic approach

-  to understand the customer requirements and

- to ensure that all the requirements are met

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 What is APQP

•  APQP stands for Advanced Product Quality Planning

•  This is to serve as a guideline for consistent approach
to all users.
•  Big three has published a manual on APQP

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 What is APQP

•  A structured & systematic method of defining and

establishing the steps necessary to assure that a
product satisfies the customer.

•  The commitment from the Top Management is an

essential requirement for the success of this process.

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 What is APQP

•  The two main requirements of a good Product

Development are developing a robust product and
developing it in a short time.

•  All the methods discussed in this program are oriented

towards these objectives.

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 What is APQP

The philosophy of APQP can be summed up as :

“IT IS BETTER TO SPEND A LITTLE EXTRA TIME

DURING THE UPSTREAM PROCESS SO THAT THE
DOWNSTREAM PROCESSES ARE FREE FROM ERRORS ”.

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 Goal of APQP

•  Effective communication with everyone involved.

•  On-time completion of all required steps

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 APQP Model

Advanced Product Quality Planning (APQP) was designed

to help deliver benefits to the entire supply chain

- Promote early identification of required changes

- Avoid late changes
- Provide quality product on time at lowest cost
- Designed to be a ‘before-the-event’ action, not an ‘after-
the-fact’ exercise”

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 1-10-100 Rule

The 1-10-100 rule states that as a product or service

moves through the production system, the cost of
correcting An error multiplies by 10.

Activity Cost
Order entered correctly $ 1
Error detected in billing $ 10
Error detected by customer $ 100

Dissatisfied customer shares the experience with others

the costs is
$1000

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 Five Phases of APQP

Plan and Define Program

Product Design and Development

PHASES

Process Design and Development

Product and Process Validation

Feedback, Assessment and Corrective Action

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 APQP Phases

The four stages of the planning cycle are Plan, Do,

Check (Study) and Act.

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 APQP Phases

•  Out of Five Phases, first three

stages(phases) are devoted to the up-
front development and planning
process through product and process
validation.

•  Lastly, Act is the implementation

phase - focusing on customer
satisfaction andcontinual
improvement.

•  Now Adopts a process approach

•  In reality, these phases overlap and

many tasks are done in parallel to
streamline and maximize resource
utilization.
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 Benefit

•  A common approach throughout supply chain

•  Better Customer - Organization communication
•  Reduced non-value added time and costs of processes
•  Effective Risk Management; say by FMEAs’
•  Faster access to product & project data
•  Re d u c t i o n o f c o m p l e x i t y i n c o n v e r t i n g c u s t o m e r
requirements / needs to a finished product or service.
•  Avoidance of design and product quality problems in the
earliest possible time.
•  Increased success on meeting target quality in all areas of
the product life cycle.

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 APQP Success – Key Factor

•  Factor for successfully executing

APQP is the commitment of
Executive Management

i.e. Management's recognition of the

need for APQP and the understanding
of their needs to educate others in all
aspects of the system

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 APQP Failure – Key Factors

•  Without the need being successfully

defined and without the value recognized,
APQP is just another quality acronym.

•  Some very good APQP systems at

companies fail because of a lack of
understanding and commitment by top
management

•  Deprived of endorsement and support,

APQP becomes just a paper system with
no chance of success
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 So, We know APQP

•  The APQP system is a cross-functional system that

stresses customer requirements throughout the phases.

•  If you need information, go, get or generate it.

•  Make decisions based on facts and sound data

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 When is APQP Appropriate

- For development of “New Products”

- Incorporating major changes in “Existing Products”

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 Team Work

One of the essential requirements for the success of this

approach is the ability to work in teams.

Team working is a culture which has to be developed and

practiced in the organization. If we do not adhere to this
principle of team working, we may end up without the
benefits expected from this process of product
development.

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 Team Approach

•  The first step in Product Quality Planning is to assign a

process owner for the APQP Project.
•  Team should be cross-functional; it is not composed of only
people from One Department. Typical members might come
from:
-  Engineering
-  Manufacturing
-  Material Control
-  Purchasing
-  Sales
-  Field Service
-  Quality
-  Industrial Engineering
-  Maintenance
-  Customer / Supplier (as appropriate)
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 Team Scope

Team must meet to decide

- Project Team Leader

- Their Roles and Responsibilities,
- Customers (Internal / External),
- Customer Requirements,
- Additional Members, when required
- Feasibility Assessment,
- Cost, Timings, Constraints, etc.
- Customer Assistance, when required
- Documentation process or method

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 Team Leader

Each program has a team leader. A team leader may

manage one or more programs.

The team leader:

•  is typically a senior Manager

•  interfaces with the customer
•  ensures that the Program Need Dates (PND) are
met
•  is responsible for resource organization
•  is responsible until product launch
•  forms and manages one or more APQP Teams

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 Training

The success of Product Quality Plan is dependent upon

an effective training program that communicates all the
requirements and development skills to fulfill customer
needs and expectations.

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Customer & Organization Involvement

•  The primary customer may

initiate the quality planning
process with an organization.

•  However, the organization

has an obligation to establish
a cross functional team to
manage the process.

•  Organization must expect the

same performance from their
suppliers
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 Simultaneous Engineering

•  It is a process where CFT strives for a common goal.

•  It replaces the sequential series of phases where

results are transmitted to the next area for execution

•  Saves time

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 Concern Resolution

§  During the planning process, the team will encounter

product design and/or processing concerns.

§  These concerns should be documented on a matrix

with assigned responsibility and timing.

§  Disciplined problem solving methods such as Cause

and Effect diagram, Characteristics Matrix, CPM, DOE,
Error Proof etc. should be used

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 Timing Plan

§  Team’s first effort should be the development of a timing plan.

§  The type of product, complexity and customer expectation

should be considered in selecting the timing elements.

§  It should list all tasks with responsibility and target dates.

§  All team members should agree with each event, action &
timing.

§  It is a good practice to follow the techniques like CPM, etc.

§  The timing plan should provide the provision for tracking
progress. Each event must have “Start” & “Completion” Date

§  Regularly reviewed and updated as the planning evolves.

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 Timing Plan

Elements of Good Planning

•  Commitment
•  Training
•  Teamwork
•  Logical methodology
•  Sound techniques
•  Documentation
•  Communication
•  Feedback

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 Tracking Sheet

Remarks
GYR Program Resp.
Sl. Timing Closed or
Elements Status Need Member
No. Date Date Assistance
 Date Initials
Required

 GYR G – Green Colour – Element will meet the program need date and an quality expectations.
Status Y - Yellow Colour - Element may not meet program need date or quality expectations; needs
management attention
R - Red Colour - Element will not meet program need date or quality expectations;
Program is at risk and needs
Immediate management attention.

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 Management Support

n  Participation by management in product quality

planning meetings is vital to ensuring the success of
the program.

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 Five Phases of APQP

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 Responsibility Matrix

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Plan and Define Program
Phase-I

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 Plan and Define Program

OBJECTIVES
•  Determine customer needs & expectation
•  Plan a quality program (includes Scope, Time,
Budget, etc.)
•  To establish design intent

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 Plan and Define Program

INPUTS

•  Voice of the customer

- Market research
- Historical warranty and quality information
- Team experience
•  Business plan/marketing strategy
•  Product/process benchmark data
•  Product/process assumptions
•  Product reliability studies
•  Customer inputs

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 Plan and Define Program

OUTPUTS

•  Design goals
•  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

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 Plan and Define Program

Plan and Define: Key questions (Inputs)

•  Customer requirements: How to know?

•  Who are the competitors?

•  Where we are as compared to competitors?

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 Plan and Define Program

VOICE OF THE CUSTOMER

It encompasses complaints, recommendations, data and
information obtained from internal / external customers.

Market Research:
Obtain market research data including OEM vehicle build
timing and Volume Expectations through following methods:
•  Customer interviews
•  Customer questionnaires and surveys
•  Market test and positioning reports
•  New Product quality and reliability studies
•  Competitive product quality studies
•  Best Practices
•  Lesson Learned

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 Plan and Define Program

Historical Warranty and Quality Information:

List of historical customer concerns / wants to assess

the potential for recurrence during design, manufacture,
installation and use.
The following item can be used:
•  Best Practices
•  Lessons learned
•  Warranty reports
•  Capability indicators
•  Internal quality reports
•  Problem resolution reports
•  Customer plant returns and rejection
•  Field return product analysis

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 Plan and Define Program

Team Experience

The team may use other source of information such as:

- Media commentary and analysis: magazine and newspaper reports
- Customer letters and suggestions
- TGR / TGW reports
-  Dealer comments
-  Field service reports
- Road trips
- Management comments or direction
- Problems and issues reported from internal customers
- Government requirements and regulations
- Contract review  

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 Plan and Define Program

BUSINESS PLAN / MARKETING STRATERGY

§  The Business Plan Marketing Strategy are the basis of

the Product Quality plan

•  The Business Plan may define the issues

•  Timing
•  Cost
•  Investment
•  Research and development (R&D)
•  Resources

•  The Marketing Strategy will define:

•  Target customer
•  Key sales points
•  Key competitors
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 Plan and Define Program

PRODUCT / PROCESS BENCHMARK DATA

Benchmarking helps to establish performance targets

•  Identify appropriate benchmarks

•  Collect data and summarize

•  Identify the gap between current status and the

benchmark, and take one of the following actions:
- Close the gap
- Match the benchmark
- Exceed the benchmark

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 Plan and Define Program

PRODUCT AND PROCESS ASSUMPTIONS

§  Product and process assumptions presume the

product has certain features, design or process
concepts.

•  Technical innovations

•  Advanced materials

•  New technology

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 Plan and Define Program

PRODUCT RELIABILITY STUDIES

§  Product Reliability studies compare frequency of

repair/replacement of components and the results of
long-term reliability /durability tests.

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 Plan and Define Program

CUSTOMER INPUTS

User of product provides valuable information

relating to the needs and expectations of
customers. Additionally, user may have conducted
various studies and reviews on the product. Should
be used to develop agreed upon measures of
customer satisfaction

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 Plan and Define Program

OUTPUTS
DESIGN GOALS
§  Design goals are translation of the voice of the
customer (including regulatory requirements) into
measurable design objectives.

•  Functional performance
•  Dimensions
•  Weight
•  Materials
•  Aesthetic

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 Plan and Define Program

RELIABILITY AND QUALITY GOAL

•  Reliability goals are established based on customer

wants and expectations (eg. no safety failure),
program objectives and reliability benchmarks.

•  Reliability benchmark could be

•  Competitor product reliability
•  Warranty data
•  Frequency of repair
•  Quality goals should be based on metrics such as
PPM, scrap reduction etc
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 Plan and Define Program

PRELIMINARY BILL OF MATERIAL

•  The team should establish a Preliminary bill of

material based on Product / process assumptions

•  Include a potential supplier list

PRELIMINARY PROCESS FLOW CHART

The anticipated manufacturing process should be
described using a Process Flow Chart developed from:

•  Preliminary bill of material

•  Product/Process assumptions
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 Plan and Define Program

PRELIMINARY LISTING OF SPECIAL PRODUCT &

PROCESS CHARACTERISTICS

§  Customer and team identify based on knowledge of

product and process. List could be developed from

- Product assumptions based on the analysis of

customer needs and expectations
- Identification of reliability goals / requirements
- Identification of special process characteristics from
the anticipated manufacturing process
- Similar part FMEAs

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 Plan and Define Program

MANAGEMENTS SUPPORT

§  One of the keys to success of APQP is the interest,

commitment and support of top management

§  Participation by the management in APQP meting is

vital to ensuring the success of the program

§  A primary goal of APQP is to maintain management

support by demonstrating that all planning
requirements have been met and/or concerns
documented and scheduled for resolution, including
program timing and planning for resources and
staffing to support required capacity
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Product Design & Development
Phase-II

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 Product Design & Development

OBJECTIVES
•  Develop design features and characteristic into a
near final form
•  Critically review engineering requirements
•  Assess the potential problems that could occur
during manufacturing

INPUTS
•  Design goals
•  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
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 IATF 16949 – Product Design Inputs

8.3.3.1 Product Design Inputs

a)  Product specifications including but not limited to special

characteristics;
b)  Boundary and interface requirements;
c)  Identification, traceability, and packaging;
d)  Consideration of design alternatives;
e)  Assessment of risks with the input requirements and the
organization’s ability to mitigate/manage the risks, including
from the feasibility analysis;

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 IATF 16949 – Product Design Inputs

8.3.3.1 Product Design Inputs

a)  Targets for conformity to products requirements including

preservation, reliability, durability, serviceability, health, safety,
environmental, development timing and cost;
b)  Applicable statutory and regulatory requirements of the
customer-identified country of destination, if provided;
c)  Embedded software requirements.

The organization shall have a process to deploy information

gained from previous design projects, competitive product
analysis (benchmarking), supplier feedback, internal input, field
data, and other relevant sources for current and future projects of
a similar nature.

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 Product Design & Development

DESIGN OUTPUTS

•  Design failure mode and effects analysis(DFMEA)

•  Design for manufacturing and assembly
•  Design verification
•  Design reviews
•  Prototype build – control plan
•  Engineering drawings
•  Engineering specifications
•  Material specification
•  Drawing and specification changes

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 Product Design & Development

APQP OUTPUTS

•  New equipment, tooling and facilities requirements

•  Special product and process characteristics
•  Gages/testing equipment requirement
•  Team feasibility commitment and management support

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 Product Design & Development

DESIGN FAILURE MODE AND EFFECTS ANALYSIS

(DFMEA)

•  A Design FMEA is a disciplined analytical technique

utilized by a Design Responsible Engineer/Team to
ensure that potential failure modes and associated
causes/mechanisms have been considered and
addressed. The Design FMEA supports the design
process in reducing risk

•  Use FMEA reference manual

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 Product Design & Development

DESIGN FOR MANUFACTURABILITY AND

ASSEMBLY
•  Design for Manufacturability and Assembly is a
simultaneous engineering Process design to optimize the
relationship between design function, manufacturability and
ease of assembly.
•  Customer needs and expectations will determine the extent
of the APQP.
•  The following items may be considered
- Design, Concept, Function and Sensitivity to Manufacturing
Variations
- Manufacturing and/or Assembly Process
- Dimensional Tolerances
- Performance Requirements
- Number of Components
-  Material Handling
-  Process Adjustment
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 Product Design & Development

DESIGN VERIFICATION

To ensure that the Product Design meets the

customer requirements

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 Product Design & Development

DESIGN REVIEW

- Regularly scheduled meeting led by design engineering

activities and must include other affected area

-  A n e f f e c t i v e m e t h o d t o p r e v e n t p r o b l e m s ,
misunderstandings and provide mechanism to monitor
progress

- Design reviews are a series of verification activities

that are more than an engineering inspection

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 Product Design & Development

DESIGN REVIEW (Contd.)

Shall evaluate

- Design / Functional requirement(s) considerations

- Formal reliability and confidence goals
- Component / subsystem / system duty cycles
- Computer simulation and bench test results
- DFMEA(s)
- Review of the Design for Manufacturability and
Assembly effort
- Design of Experiments (DOE)
- Test failures
- Design Verification progress

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 Product Design & Development

PROTOTYPE BUILD – CONTROL PLAN

•  Prototype Control Plan describes the controls to be ensured

during the Prototype build stage.
•  The manufacture of Prototype parts provides an excellent
opportunity for the team and the customer to evaluate how
well the product and service meets the VOC objectives.
•  Prototype should be reviewed to
- Assure that product or service meets specifications and report data
- Ensure that particular attention has been given to special product and
process characteristics
- Use data and experience to establish preliminary process parameters
and packaging requirements
- Communicate any concerns, deviations and/or cost impact to the
customer

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 Product Design & Development

ENGINEERING DRAWINGS

•  Customer design do not preclude the responsibility to review

the following in the engineering drawings
-  Special characteristics (Governmental Regulatory and
Safety) that must be shown on the control plan

-  In case customer drawings do not exist, review which

characteristic affect fit function durability and/or
governmental, regulatory and safety requirements
- Drawing should be reviewed to determine
- adequacy of information for dimensional layout of the
individual part
-  Control / locators clearly identified
-  Dimensional evaluation to assure feasibility and
compatibility with manufacturing and measuring standards

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 Product Design & Development

ENGINEERING SPECIFICATIONS

•  Specification review helps to identify functional durability and

appearance requirements
•  Sample size frequency and acceptance criteria generally
identified in the specifications otherwise establish in the
control plan
•  Determine which characteristics affect or control the results
that fulfill functional durability and appearance requirements

MATERIAL SPECIFICATIONS

•  Material specifications should be reviewed for special

characteristics relating to physical properties, performance,
environmental, handling and storage requirements
•  These characteristics should be included in control plan

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 Product Design & Development

DRAWINGS & SPECIFICATIONS CHANGES

Where changes are required, the team must ensure that

the changes are promptly communicated and properly
documented to all affected areas.

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 Product Design & Development

NEW EQUIPMENT, TOOLING AND FACILITIES

REQUIREMENTS

-  DFMEA, product assurance plan, design reviews may

identify new equipment and facilities requirements

-  Should address the items in the timing chart

-  Ensure new equipment, tooling is capable and

delivered on time

- Facilities progress should be monitored to assure

completion prior to planned production tryout

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 Product Design & Development

SPECIAL PRODUCT AND PROCESS

CHARACTERISTICS

-  Preliminary special characteristics identified through

voice of customer

-  Team should build on this listing and reach

consensus during the review and development

-  Special characteristics must be documented in the

control plan

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 Product Design & Development

GAUGE / TESTING EQUIPMENT REQUIREMENTS

-  Gauge / Testing equipment requirements is also

identified and added in the timing chart

- Monitor progress to assure the meeting of required

timings

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 Product Design & Development

TEAM FEASIBILITY COMMITMENT (TFC) &

MANAGEMENT SUPPORT

•  The Product Quality Planning Team must assess the

feasibility of proposed design.

•  The team must be satisfied that the proposed design can

be manufactured, assembled, tested, packaged, and
delivered in sufficient quantity on schedule at an
acceptable cost to the customer.

•  Feasibility document with all open issues should be

submitted to management for their support
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 Product Design & Development

CONSIDERATION YES NO
Is product adequately defined (application requirements, etc to enable feasibility evaluation?
Can Engineering Performance Specifications be met as written?
Can Product be manufactured to tolerances specified on drawing?
Can Product be manufactured with Cpk’s that meet requirements?
Is there adequate capacity to produce product?
Does the design allow the use of efficient material handling techniques?
Can the product be manufactured within normal cost parameters? Abnormal cost

T E A M
considerations may include:
• Costs for capital equipment?

FEASIBILITY
• Costs for tooling?
• Alternative manufacturing methods?

COMMITMENT
Is statistical process control required on product?
Is statistical process control presently used on similar products?

(TFC) Where statistical process control is used on similar products:

• Are the Processes in control and stable?
• Does Cpk’s meet customer requirements?
Conclusion

Feasible Product can be produced as specified with no revisions

Feasible Changes recommended (see attached)
Not Feasible Design revision required to produce product within the specified
requirements.
Sign-Off

Team Member / Title / Date Team Member / Title /

Date

Team Member / Title / Date Team Member / Title /

Date

Team Member / Title / Date Team Member / Title /

Date

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 IATF 16949 –Product Design Outputs

8.3.5.1 Design and Development Outputs – Supplemental

a)  Design risk analysis(FMEA)

b)  Reliability study results;
c)  Product special characteristics;
d)  Results of product design error proofing, such as DFSS,
DFMA, and FTA;
e)  Product definition including 3D models, technical data
packages, product manufacturing information, and geometric
dimensioning & tolerancing (GD & T);

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 IATF 16949 –Product Design Outputs

8.3.5.1 Design and Development Outputs – Supplemental

f) 2D drawings, product manufacturing information, and

geometric dimensioning & tolerancing (GD & T);
g) Product design review results;
h) Service diagnostic guidelines and repair and serviceability
instructions;
i) Service part requirements;
j) Packaging and labelling requirements for shipping;

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Process Design & Development
Phase-III

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 Process Design & Development

OBJECTIVES

•  D e v e l o p a c o m p r e h e n s i v e a n d e f f e c t i v e
manufacturing system

•  Ensure that the manufacturing systems meets

customer requirements.

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 Process Design & Development

INPUTS

•  Design failure mode and effects analysis(DFMEA)

•  Design for manufacturing and assembly
•  Design verification
•  Design reviews
•  Prototype build – control plan
•  Engineering drawings
•  Engineering specifications
•  Material specification
•  Drawing and specification changes
•  New equipment tooling and facilities requirements
•  Special product and process characteristics
•  Gages/testing equipment requirement
•  Team feasibility commitment and management support

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 IATF 16949 – Mfg. Process Design Inputs

8.3.3.2 Manufacturing Process Design Inputs

a)  Product design output data including special characteristics;
b)  Targets for productivity, process capability, timing and costs;
c)  Manufacturing technology alternatives;
d)  Customer requirements, if any;
e)  Experience from previous developments;
f)  New material;
g)  Product handling and ergonomic requirements; and
h)  Design for manufacturing and design for assembly.

The manufacturing process design shall include the use of error-proofing

methods to a degree appropriate to the magnitude of the problem(s) and
commensurate with the risks encountered.

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 Process Design & Development

OUTPUTS

•  Packaging standards & specification

•  Product / process quality system review
•  Process flow chart
•  Floor plan chart
•  Characteristics matrix
•  Process failure mode and effects analysis (PFMEA)
•  Pre-launch control plan (Including Error proofing)
•  Process instruction
•  Measurement systems analysis plan
•  Preliminary process capability study plan
•  Management support

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 Process Design & Development

PACKAGING STANDARDS AND SPECIFICATIONS

•  This is applicable if the customer has any packaging

standards to be incorporated.

•  If not, the design of packaging should ensure product

integrity at the point of use.

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 Process Design & Development

PRODUCT / PROCESS QUALITY SYSTEM REVIEW

•  Team should review the Quality Management System

•  To ensure that the existing Quality System can meet

the requirements of the new product

•  To identify the system modification and additional

controls and to be included in Control Plan

•  Team to improve the existing quality system based on

customer inputs, team expertise and previous
experience

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 Process Design & Development

PROCESS FLOW DIAGRAM

•  Process flow chart is a schematic representation of

current / proposed process flow

•  Used to analyze sources of variation of machines,

materials, methods and manpower from the beginning to
end

•  Used to emphasize impact of sources of variation on the

processes

•  Help to analyze the total process rather than individual

steps

•  Assist to focus on process when conducting PFMEA and

designing control plan.
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 Process Design & Development

FLOOR PLAN LAYOUT

•  It should be developed and reviewed to determine the

acceptability of important control items, such as
inspection points, control chart location, applicability of
visual aids, interim repair stations, and storage areas to
contain non conforming materials
•  All material flow should be keyed to process flow chart
and control plan
•  It should be developed in such a manner to optimize the
material travel, handling and value-added use of floor
space.
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 Process Design & Development

CHARACTEISTICS MATRIX

It is a recommended analytical technique for displaying

the relationship between process parameters and
manufacturing stations

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Process Design & Development

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 Process Design & Development

PROCESS FAILURE MODE AND EFFECTS ANALYSIS

(PFMEA)

•  Should be conducted during product quality planning

and before beginning production. A disciplined review
and analysis of a new / revised process and conducted
to anticipate, resolve, or monitor potential process
problems. Is a living document and needs to be
reviewed and updated as new failure modes are
discovered

•  Use FMEA Reference Manual

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 Process Design & Development

PRE-LAUNCH CONTROL PLAN

•  A description of the dimensional measurements, material and
functional tests that will occur after prototype and before full
production. Should include additional product / process
controls to be implemented until the production process is
validated.

Examples
- More frequent inspection
- More in-process and final check points
-  Robust statistical evaluations
-  Increased audits
-  Identification of error-proofing devices

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 Process Design & Development

PROCESS INSTRUCTIONS

•  Ensure that understandable process instructions, provide

sufficient detail for all operating personnel who have direct
responsibility for the operation of the processes.

•  These should be developed from the following sources:

- FMEAs
- Control plan(s)
- Engineering drawings, performance specifications,
material specifications, visual standards and industry
standards
- Process flow chart
- Floor plan layout
-  Characteristics matrix
-  Packaging standards

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 Process Design & Development

PROCESS INSTRUCTIONS (Contd.)

- Process parameters
- Producer expertise and knowledge of the processes
and products
- Handling requirements
-  Operators of the Process

•  Should include set-up parameters such as: machine

speeds, feeds, cycle times, etc., and should be accessible
to the operators and supervisors.

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 Process Design & Development

MSA PLAN

A plan must exist for the evaluation of measurement

devices and methods specified in the Control Plan to
ensure gage linearity, accuracy, repeatability and
reproducibility

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 Process Design & Development

PRELIMINARY PROCESS CAPABILITY STUDY PLAN

•  To ensure that there is a plan for conducting the Process

Capability Study for characteristics identified as Special
Characteristics. This plan should include the methodology
to be adopted, the responsibility, the timing etc.

•  Appropriate training needs have to be identified and the

measurement systems to be used are covered under
Measurement Systems Analysis plan.

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 IATF 16949-Mfg. Process Design
Output
8.3.5.2 Manufacturing Process Design Output
a)  Specification and drawings;
b)  Special characteristics for product and manufacturing process;
c)  Identification of process input variables that impact
characteristics;
d)  Tooling and equipment for production and control, including
capability studies of equipment and process(es);
e) Manufacturing process flow charts/layout, including linkage of
products, process, and tooling;
f) Capability analysis;
g) Manufacturing process FMEA;

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 IATF 16949-Mfg. Process Design
Output
8.3.5.2 Manufacturing Process Design Output
h) Maintenance plans and instructions;
i) Control plan;
j) Standard work and work instructions;
k) Process approval acceptance criteria;
l) Data for quality, reliability, maintainability, and measurability;
m) Results for error-proofing identification and verification, as
appropriate;
n) Methods of rapid detection, feedback and correction of product/
manufacturing process nonconformities.

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 Process Design & Development

MANAGEMENT SUPPORT

Schedule for the review

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Product and Process Validation
Phase-IV

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 Product and Process Validation

OBJECTIVES

•  Validate the manufacturing process & the

product through an evaluation of a significant
production run

•  Validate the control plan and process flow chart

are being followed and products meet customer
requirements

•  Identify additional concerns

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 Product and Process Validation

INTPUTS

•  Packaging standards & specification

•  Product / process quality system review
•  Process flow chart
•  Floor plan chart
•  Characteristics matrix
•  Process failure mode and effects analysis (PFMEA)
•  Pre-launch control plan (Including Error proofing)
•  Process instruction
•  Measurement systems analysis plan
•  Preliminary process capability study plan
•  Management support

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 Product and Process Validation

OUTPUTS

•  Significant Production Run

•  Measurement systems evaluation
•  Preliminary process capability study
•  Production part approval
•  Production validation testing
•  Packaging evaluation
•  Production control plan
•  Quality planning sign-off and management support

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 Product and Process Validation

SIGNIFICANT PRODUCTION RUN

•  The validation of the effectiveness of the manufacturing

process begins with the production trial run. The minimum
quantity for a production trial run is usually set by the
customer but can be exceeded by the Product Quality
Planning Team.

•  Output of the production trial run (product) is used for:

- Preliminary process capability study
- Measurement system evaluation
- Final feasibility
- Process review
- Production validation testing
-  Product Approval Process
-  Packaging evaluation
-  Quality Planning Summary sign-off

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 Product and Process Validation

SIGNIFICANT PRODUCTION RUN (Contd.)

•  Conduct Trial Run by using

- Production Tooling
- Equipment
- Environment
- Operators
- Facilities
- Cycle Time

•  Follow PPAP Manual or Customer specified PAP

procedures

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 Product and Process Validation

MSA EVALUATION

•  The study should be done during or prior to the

significant production run.

•  This study should address all the Measurement

Systems listed in the Control plan.

•  Refer MSA Manual

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 Product and Process Validation

PRELIMINARY PROCESS CAPABILITY STUDY

•  Perform preliminary process capability studies on

the characteristics specified in the control plan
(Preliminary process capability study plan). This
assessment help to evaluate process readiness for
production

•  Follow SPC Reference Manual

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 Product and Process Validation

PRODUCTION PART APPROVAL PROCESS (PPAP)

•  To provide the evidence that all customer

engineering design record and engineering
specification requirements are properly understood
and the manufacturing process has the potential to
produce product consistently meeting these
requirements during an actual production run at the
quoted production rate.

•  Refer PPAP Manual

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 Product and Process Validation

REQUIREMENTS FOR PPAP

1. Design Records of Saleable Product

– for proprietary components / details
– for all other components / details
2. Engineering Change Documents, if any
3. Customer Engineering Approval, if required
4. Design FMEA
5. Process Flow Diagrams
6. Process FMEA
7. Dimensional Results
8. Material / Performance Test Results
9. Initial Process Study
10. Measurement System Analysis Studies
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 Product and Process Validation

REQUIREMENTS FOR PPAP (Contd.)

11. Qualified Laboratory Documentation

12. Control Plan
13. Part Submission Warrant (PSW)
14. Appearance Approval Report (AAR), if applicable
15. Bulk Material Requirements Checklist (for bulk material)
16. Sample Product
17. Master Sample
18. Checking Aids
19. Records of Compliance with Customer Specific requirements

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 Product and Process Validation

PPAP SUBMISSION LEVEL

•  There are 5 Levels

•  Level 3 is the Default level (Level 5 for Bulk Material)
•  Levels are agreed and documented in the form of QSR

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 Product and Process Validation

PRODUCTION VALIDATION TESTING

•  To ensure that products made from production

tools and processes meet engineering standards
including appearance requirements

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 Product and Process Validation

PACKAGING EVALUATION

•  All test shipments (when required) and test

methods must asses the protection of the product
from normal transportation damage and adverse
environmental factors.

•  Feedback received from this stage should be used

for modifying the packaging specifications.

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 Product and Process Validation

PRODUCTION CONTROL PLAN

•  A written description of the systems for controlling parts

and processes.

•  A living document and should be updated to reflect the

addition / deletion of controls based on experience
gained by producing parts (Approval of the procuring
organization(s) may be required).

•  Logical extension of the pre-launch control plan.

•  Mass production provides the producer the opportunity

to evaluate output, review the control plan and make
appropriate changes.

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Product and Process Validation

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 Product and Process Validation

QUALITY PLANNING SIGN-OFF & MANAGEMENT

SUPPORT

•  Ensure that all control plans and process flow charts are
being followed.

•  It is suggested that the Product Quality Planning Team

performs its review at the manufacturing location(s) and
coordinates a formal sign-off.

•  A review of the following items prior to first production

shipment is required:

- Process Flow Chart is being followed

-  Control Plans. Exist and be available at all times for all
affected operation
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 Product and Process Validation

QUALITY PLANNING SIGN-OFF & MANAGEMENT

SUPPORT

- Process Instructions. Verify that these documents contain all the

Special Characteristics specified in the control plan and that all
PFMEA recommendations have been addressed. Compare the
process instructions and process flow chart to the control plan

- Gage and Test Equipment. Where special gages, fixtures, or test

equipment are required per the control plan, verify gage
repeatability and reproducibility (GR&R) and proper usage

•  Management support is necessary prior to the quality

planning sign-off.
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 Product and Process Validation
PRODUCT QUALITY PLANNING SUMMARY AND SIGN-OFF
DATE: ________
PRODUCT NAME : _________________________________ PART NUMBER :
_______________________
CUSTOMER : _____________________________________ MANUFACTURING
PLANT : ____________

1. PRELIMINARY PROCESS CAPABILITY STUDY QUANTITY

REQUIRED ACCEPTABLE
PENDING*
Ppk - SPECIAL CHARACTERISTICS

2. CONTROL PLAN APPROVAL (If Required) APPROVED : YES/NO* DATE

APPROVED __________

3. INITIAL PRODUCTION SAMPLES QUANTITY

CHARACTERISTIC CATEGORY
SAMPLES CHARACTERISTICS ACCEPTABLE
PENDING*
PER SAMPLE
DIMENSIONAL
VISUAL
LABORATORY
PERFORMANCE

4. GAGE AND TEST EQUIPMENT QUANTITY

MEASUREMENT SYSTEM ANALYSIS
REQUIRED ACCEPTABLE
PENDING*
SPECIAL CHARACTERISTICS

5. PROCESS MONITORING QUANTITY

REQUIRED ACCEPTABLE
PENDING*
PROCESS MONITORING INSTRUCTIONS
PROCESS SHEETS
VISUAL AIDS

6. PACKAING/SHIPPING QUANTITY

REQUIRED ACCEPTABLE
PENDING*
PACKAGING APPROVAL
SHIPPING TRIALS

7. SIGN-OFF

_________________________________________________
___________________________________________
TEAM MEMBERS / TITLE / DATE TEAM MEMBER / TITLE / DATE

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Feedback, Assessment and
Corrective Action – Phase-V

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 Feedback, Assessment and
Corrective Action

OBJECTIVES

•  To review the effectiveness of total quality planning

system outputs
•  Obtain objective feedback for future planning
•  To plan the next phase of product development or
modification
•  To improve the system of planning (from lessons
learnt)
•  To identify opportunities for Improvement

© Copyright 2016. Fouryes TQM Consultants. All rights reserved

 Feedback, Assessment and
Corrective Action

INTPUTS

•  Significant Production Run

•  Measurement systems evaluation
•  Preliminary process capability study
•  Production part approval
•  Production validation testing
•  Packaging evaluation
•  Production control plan
•  Quality planning sign-off and management support

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 Feedback, Assessment and
Corrective Action

OUTPUTS

•  Reduced variation
•  Improved Customer satisfaction
•  Improved Delivery and service
•  Effective use of Lessons learned / Best practices

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 Feedback, Assessment and
Corrective Action

REDUCED VARIATION

•  Control charts and other statistical techniques should be

used as tools to identify process variation. Analysis and
corrective actions should be used to reduce variation.

•  Continual improvement requires attention not only to the

special causes of variation but understanding common
causes and seeking ways to reduce these sources of
variation.

•  Proposals should be developed including costs, timing, and

anticipated improvement for customer review.

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 Feedback, Assessment and
Corrective Action
IMPROVED CUSTOMER SATISFACTION

•  Detailed planning activities and demonstrated process capability of

a product or service are important components to customer
satisfaction.
•  The product or service must perform in the customer environment.
•  The product usage stage requires organization participation. In this
stage much can be learned by the organization and customer.
•  The effectiveness of the Product Quality Planning efforts can be
evaluated in this stage.
•  The organization and customer must be partners in making the
changes necessary to correct any deficiencies and to improve
customer satisfaction.

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 Feedback, Assessment and
Corrective Action

IMPROVED DELIVERY AND SERVICE

•  The delivery and service stage of quality planning

continues the organization / customer partnership in
solving problems and continual improvement.

•  Failure to correct a problem the first time always damages

the supplier’s reputation and customer partnership. It is
important that both organization and customer listen to
the Voice of the Customer and satisfy end-user customer.

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 Feedback, Assessment and
Corrective Action
EFFECTIVE USE OF LESSONS LEARNED /BEST
PRACTICES

§  A lessons Learned or Best Practices portfolio is beneficial for

capturing, retaining and applying knowledge.

§  Input to Lessons Learned and Best Practices can be

obtained through a variety of methods including:

§  Review of Things Gone Rights/Things Gone Wrong

(TGR/TGW)
§  Data from warranty and other performance metrics
§  Corrective action plans
§  DFMEA and PFMEA studies

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© Copyright 2016. Fouryes TQM Consultants. All rights reserved