Designing for quality
is a structured method of defining and establishing the steps necessary to
ensure that a product satisfies the customer. Designing for quality involves 75% up front planning and 25%
implementation through production, to determine customer satisfaction and
continuous improvement.
It focuses on
1. Up-front quality
planning
2. Determining if
customers are satisfied by evaluating the output and supporting continual
improvement
APQP (Advanced product
quality planning) is one of advance technique used for Design for quality
It
consists of five phases
1. Plan and Define
Program
2. Product Design and
Development Verification
3. Process Design and
Development Verification
4. Product and Process
Validation
5. Launch, Feedback,
Assessment & Corrective Action
It consists of five major activities
1. Planning
2. Product Design and
Development
3. Process Design and
Development
4. Product and Process
Validation
5. Production
It consists seven major elements
1. Understanding the
needs of the customer
2. Proactive feedback
and corrective action
3. Designing within the
process capabilities
4. Analyzing and
mitigating failure modes
5. Verification and
validation
6. Design reviews
7. Control special / critical characteristics.
Phase 1 -Plan and define the
program
Form a cross functional
team. The first step in planning the program is to define who will make up the
cross functional team. Cross functional team does not mean one(1) person doing
everything. Typical members of a cross functional team may include:
Engineering, Production, Quality, Sales, Costing, Manufacturing, Marketing,
Purchasing etc.
While planning
following activates should be carried out.
1. Personnel
within the design activity should be qualified in the following/or other
skills, as appropriate
1. Geometric Dimension
and Tolerance (GD&T)
2. Quality Function
Deployment (QFD)
3. Design for
Manufacture/Assembly (DFM/DFA)
4. Value Engineering
(VE)
5. Design of
Experiments (Taguchi & Classical)
6. Failure Mode and
Effects Analysis - Design and Process
7. Finite Element
Methods (FEM)
8. Solid Modeling
(CAD/CAE)
9. Simulation
techniques etc..
2. Determine
customer requirements
Customer requirements
are typically determined by any or all of the following:
1. Market research
2. Quality Function
Deployment
3. Warranty history
from similar products
4. Supplier Quality Reports
5. Team Experience
3.
Business plan
The Business plan is a
strategic document which may place some constraints on the development of the proposed
product. Examples of Constraints: Project timing, cost of investment in
technology, machinery and human resources, quality requirements, manufacturing
capabilities, government regulations
4. Benchmark
data
At this stage of the
program Benchmark data should be obtained for the process and product as appropriate.
Benchmark data may be used to establish the “GAP” between your current product
or process and that of the “World Best”. Corrective action plans should be
developed to close the “GAP” with the focus on becoming “World Best”.
5. Product
and Process assumptions
List all of the current
product and process assumptions.
Examples may be:
1. Material
Characteristics and Performance
2. Reliability
assessments
3. Machine capabilities
4. Management Structure
6. At the
completion of this stage the following
aspects
should be defined;
1. Design goals
2. Reliability goals
3. Quality targets
4. Preliminary Bill of
Material (BOM)
5. Preliminary process
flow chart
6. Preliminary listing
of special characteristics
7. Any governmental,
environmental or safety regulations
Phase 2-Product Design and Development
The Product Design and
Development phase begins with the generation of a design FMEA (Design Failure
Mode and Effects Analysis)
1. Design
output shall be the result of a process that includes the following.
Efforts to simplify,
optimize, innovate and reduce waste with methods such as: Critical to Quality
(CTQs), Design for Manufacture/Assembly (DFM/DFA), Design of Experiment, Tolerance
studies (GD&T),Analysis of costs/performance/risks trade offs, Use of
feedback from testing production and the field, Use of Design FMEA’s
2. Plan and
Conduct Design verification at appropriate
The purpose of the
design verification is to ensure that the design output is meeting the planned
design input as defined in phase 1, Plan and Define the program.
Example:
Phase 1: Design Input -
Hole locations +/- 1.0 mm
Phase 2: Design Output
- Engineering Drawings stipulating the Hole locations at the tolerance of +/-
1.0 mm
3. Plan and
Conduct Design reviews (formal documented review)
Design reviews are
conducted to monitor the progress of the project relative to customer
requirements. The reviews are conducted by a cross functional team and the
results of each review must be documented. Typically, the Design reviews might
cover; Design FMEA, Design verification progress, reliability tests and
studies, computer simulation results, benchmark data and overall progress
relative to time constraints
4.
Finalization of:
The following thing
should be finalize
1. Engineering drawings
including CAD data
2. Engineering
specifications
3. Material
specifications
At this stage the cross
functional team should have reviewed and approved all drawings, engineering specifications
and material specifications.
4. New equipment,
tooling and facilities
During the design
review the cross functional team may determine that new equipment, tooling and
facilities will be required. These details must be addressed and included in
the overall timing plan. Emphasis must be placed on ensuring that new
equipment, tooling and facilities are completed on time.
5.
Finalization of any new inspection, measuring and test equipment device
Any new inspection,
measuring and test equipment is required. If the equipment is required, this
should be recorded into the overall timing plan and progress towards the acquisition
be monitored.
6. Team
Feasibility statement
At this time the cross
functional team must be satisfied that the proposed design can be manufactured
to the customer’s requirements. Once satisfied, the cross functional team members
must sign off the Team Feasibility Statement.
Phase 3 Process Design & Development
The Process Design and
Development phase requires the following
aspects to be defined
and/or documented;
1. Customer
packaging and labelling standards
Generally, the customer
will provide documented packaging and labelling guidelines. These documents
should be followed. When no guidelines are available, the cross functional team
is responsible for developing guidelines to ensure integrity of the packaged
product.
2. Review of
the current Quality Management System to ensure its suitability for the
prospective product and associated processes
The cross functional
team should review the manufacturing sites Quality Manual to ensure the current
Quality Management System addresses all of the requirements to design and manufacture
the product under consideration. Any additional controls and/or procedural
changes should be used to improve the Quality Management System in operation
3.
Finalization of the process flow chart
The finalized process
flow chart is a schematic representation of the process flow. This chart is
used to detect any potential bottlenecks, such as, material flow problems and
manpower. This chart also serves as a starting point when conducting the Process
Failure Mode and Effects Analysis.
4. Floor plan
layout with an emphasis on minimising material travel
The floor plan should
be developed to determine the acceptability of inspection points, control chart
locations, visual aid locations, rework area(s) and storage areas. When
developing the process and subsequent floor plan an emphasis must be placed on
utilising floor space for value added activities.
5. Completion
of the Process Failure Mode and Effects Analysis (FMEA)
The Process FMEA should
be conducted prior to production commencing. The process FMEA is a structured
and detailed study performed by a cross functional team on a process to
determine how potential external and internal factors could impact a process.
Once potential problems are established, preventive actions are developed to
control all such problems.
6. Completion
of the Pre-launch Control Plan
The Pre-Launch control
plan provides a description of the dimensional measurements and functional test
that occur after prototype and prior to full production. The pre-launch control
plan typically includes additional product/process controls until the
production process is validated.
7.
Measurement systems analysis plan to encompass all of the inspection measuring
and test equipment designated on the control plan
All inspection,
measuring and test equipment utilized to measure product or process
characteristics as defined in the Control plan must under go a Measurement Systems
Analysis. The analysis should not be just restricted to Gauge Repeatability and
Reproducibility but should also include studies on, linearity, and accuracy, as
appropriate.
8. Process
Monitoring and Operator Instructions
These shall typically
include or reference as follows: 1.Operation Name and number keyed to process
flow chart,2.Part Name and Number, 3.Current Engineering level/date, Required
tools,4.gages and other equipment, 5.Material identification and disposition
instructions, 6.Customer and supplier designated special characteristics, 7.SPC
requirements,8.Relevant Engineering and manufacturing standards,9. Inspection
and test instructions, 10.Corrective action instructions, 11.Revision date and
approvals, 12.Visual aids,13.Tool change intervals and set up instructions
9.
Preventative maintenance
The cross functional
should identify key process equipment and develop an preventative maintenance
system. At a minimum the system must include;1.A procedure that describes
planned maintenance activities, 2.Scheduled maintenance activities, 3.Predictive
maintenance methods,4.Review of Manufacturers recommendations,5.Tool wear,6.Fluid
Analysis,7.Vibration Analysis,8.Availability of replacement parts for key,9.manufacturing
equipment
Phase
4- Product and Process Validation
The Product and Process
validation phase requires the following aspects to be defined and/or
documented;
1. Production
trial run as stipulated in the Control
Plan - typically the
results from this trial production run are used for; 1.Preliminary process
capability studies, 2.Measurement systems analysis (Gauge R&R),3.– Process
review, 4.Product validation testing (Functional fit), 5.Production Part
Approval, 6.Packing evaluation, 7.Quality Planning signoff, 8.Finalization of
Production Control Plan
2. Production
Part Approval
Production Part
Approval is required to validate that the product manufactured meets all
customer requirements.
3. Production
Validation Testing
Production Validation
testing refers to Engineering tests that validate the production process as
meeting all of the customer requirements, particularly, Engineering requirements.
4. Packaging
Evaluation
Validating the
packaging to ensure product is protected to the point of delivery is an
integral phase of Product and Process Validation. In addition the cross
functional team representatives should ensure that the type of packaging will
allow the end user to handle the product in a safe and efficient manner.
5. Production
Control Plan
The production control
plan describes the systems for controlling the entire process. The production
control plan is a living document that must reflect the current flow of production.
Any addition or deletions of process, inspection activities etc. Must be
reflected in the control plan.
6. Quality
Planning Sign-off
The Quality planning
sign off is typically is typically conducted by the cross functional team once
the control plan accurately reflects the entire process, process instructions
are satisfactory, FMEAs are complete and Measurement System Studies have been
completed. The form which is typically used for sign off is referred to as the
Product Quality Planning Summary and Sign Off Report.
Phase 5- Feedback, Assessment and Corrective
Action
Based on the output of
phase 4, more specifically the: 1.Production trial run 2.Measurement Systems
Analysis, 3.Preliminary process capability study, 4.Production part approval,
5.Production validation testing, 6.Packaging Evaluation, 7.Customer concerns.
The results(feedback)
are assessed and corrective action is instigated with a focus on; CONTINUOUS
IMPROVEMENT. Additionally, the following
three aspects need to be continually assessed;
1. Variation
Control charts or other
statistical techniques should be utilized to identify process variation. This
should be assessed and corrective action taken if required
2. Customer
Satisfaction
The supplier in
conjunction with the customer must continually assess the performance of the
end product in its operating environment. This may be done by product audits,
warranty analysis, customer complaints, benchmark details etc…This information
should be assessed and if required corrective action taken.
3. Delivery
and Service
Delivery and service is an integral part of
quality. The delivery performance of suppliers must be focused on achieving
100% delivery on time. The supplier must assess its delivery performance and
service and if appropriate take the required corrective action.
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