apqp REV01
Transcript of apqp REV01
Nathan & Nathan Consultants Pvt. Ltd. NNCPL/PPT/001 1.
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Training Seminar on
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This program is designed to provide a working knowledge of the Advance Product Quality Planning Process as per the requirements Of QS 9000. This topics should be understood in the broader perspective of a New Product Development rather than as a technique.
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. 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 organisation. 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.
Some of the techniques like FMEA are discussed in greater detail whereas other techniques like Design of Experiments, Value
Engineering, etc. are discussed as a outline only.
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APQPCPAPQPCPThe participants are advised to read other text books for these techniques to acquaint themselves with its working knowledge. Several exercises are planned as a part of this program to enable the participants to appreciate the application. Participants are encouraged to participate fully to obtain the maximum benefit from this program.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 ”.IN
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THE ADVANCED PRODUCT QUALITY PLANNING (APQP) MODEL
WHAT IS APQP?
Advance Product Quality Planning is a structured & systematic method of defining and establishing the steps necessary to assure that a product satisfies the customer’s requirements.
The commitment from the Top Management is an essential requirement for the success of this process.
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The goals of Quality Planning are :
Effective communication with everyone involved.
On-time completion of all required steps
Minimal or no quality problems
Minimal product launch quality risks
Minimal cycle time to launch the product
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THE BENEFITS OF APQP
• Resources are directed toward customer satisfaction
• Required changes are identified early
• Changes close to or after product launch are avoided
• A quality product is provided on time at the lowest cost.
• An element of Continuous Improvement is built into the company.
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Plan and Define
Product Design and Development
Process Design and Development
Product and Process Validation
Feedback, Assessment and Corrective Action
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IX THE PRODUCT QUALITY PLANNING RESPONSIBILITY MATRIX
DesignRespons
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Manufacturing Only
ServiceSupplier Heat
Treat,Warehousing,Transportation
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Define the Scope X X X
Plan and Define Section 1.0X
Product Design andDevelopment Section 2.0 X
Feasibility Section 2.13X X X
Process Design andDevelopment 3.0 X X X
Product and Process ValidationSection 4.0 X X X
Feedback, Assessment andCorrective Action-Section 5.0 X X X
Control Plan MethodologySection 6.0
X X X
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The product quality planning team’s first effort should be the development of a timing plan. This timing plan should list all tasks with responsibility and target dates. It is a good practice to follow the project management techniques like Gantt Chart, Critical Path Method, PERT etc. This plan can be regularly reviewed and updated as the planning evolves.
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• Determine customer needs
• Plan a quality program (which includes Scope, Time, Budget, etc.)
INPUTS
Voice of the customer-market research-historical warranty and quality information-team experience
Business plan/marketing strategyProduct/process benchmark dataProduct/process assumptionsProduct reliabilityCustomer inputs
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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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OBJECTIVESDevelop design features and characteristicCritically review engineering requirementsAssess potential manufacturing problems
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Design goals Reliability and quality goals Preliminary process flow chart Preliminary listing of special product and process characteristics Product assurance plan Customer requirement ( special ch., identification, traceability,etc) Use of information Targets for product quality, life, reliability, durability, maintainability,
timing and cost ) Management support
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OUTPUTS BY DESIGN RESPONSIBLE ACTIVITY
Design failure mode and effects analysis(DFMEA)Design for manufacturing and assemblyDesign verificationDesign reviewsPrototype build – control planEngineering drawings (including math data)Engineering specificationsMaterial specificationDrawing and specification changesProduct special characteristicsProduct error proofing as appropriateProduct definitionDiagnostic guidelines where applicable
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OUTPUTS BY PRODUCT QUALITY PLANNING TEAM
New equipment tooling and facilities requirementsSpecial product and process characteristicsGages/testing equipment requirementTeam feasibility commitment and management support
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OBJECTIVES
Develop a comprehensive and effective manufacturing system
Ensure that the manufacturing systems meets customer requirements.
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Design Output data Targets for productivity, process capability and cost Customer requirements if any Experience from previous developments Design failure mode and effect analysis (DFMEA) Design for manufacturibility and assembly Design verification Design reviews Prototype build-control plan Engineering drawings (including math data) Engineering specifications Material specifications 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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Packaging standards specifications and drawings Product process quality system review Process flow chart Floor plan layout Process approval acceptance criteria Data for quality, reliability, maintainability and measurability Results of error proofing activities Methods of rapid detection and feedback of product/manufacturing
process non conformities Characteristics matrix Process failure mode and effects analysis (PFMEA) Pre-launch control plan Process instruction Measurement systems analysis plan Preliminary process capability study plan Packaging specification Management support
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OBJECTIVES
Validate the manufacturing process & the product Ensure that customer’s expectations will be met Identify additional concerns
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Packaging standards Product process quality system review Process flow chart Floor plan layout Characteristics matrix Process Failure Mode and Effects Analysis (PFMEA) Pre-launch control plan Process instruction Measurement Systems Analysis Plan Preliminary process capability study plan Packaging specification Process approval acceptance criteria Data for Quality, reliability, maintainability and measurability Results of error proofing activities, as appropriate Methods of rapid detection and feedback of product/manufacturing process
nonconformities. Management support
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OUTPUTS
Production trial 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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Obtain objective feedback for future planningTo plan the next phase of product development or modificationTo improve the system of planning (from lessons learnt)To identify opportunities for Improvement
INPUTS
Production trial runMeasurement systems evaluationPreliminary process capability studyProduction part approvalProduction validation testingPackaging evaluationProduction control planQuality planning sign-off and management support
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OUTPUTS
Reduced variationCustomer satisfactionDelivery and service
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TEAM LEADER
Each program has a team leader, but a team leader may manage one or more programs. The team leader:
-is typically a senior Production or Quality Manager-interfaces with the customer-ensures that the Program Need Dates (PND) are met-is responsible for resources and organisation-is responsible until product launch-forms and manages one or more APQP Teams
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Team CompositionTeam should be cross-functional; it is not composed of only people from the Quality Department. Typical members might come from:
-Engineering-Manufacturing-Material Control-Purchasing-Sales-Field Service-Subcontractors-Quality-Industrial Engineering-Maintenance-Customers(as appropriate)-Finance
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APQPCPAPQPCPTeam Responsibilities
Success of the Product Quality Planning Team is dependent upon the interest, commitment, support and direction of upper management. The APQP team:
- is the Product launch Steering Committee responsible for quality planning
- works with the programme manager establish PNDs- determines the extent of require APQP activities- determines initial risk assessments and feasibility requirements- demonstrates that all planning requirements have been met- ensures that concerns have been documented and scheduled for
resolution
• Overall, through this process, the team initiates the building of a Culture of Simultaneous Engineering in the Organisation.
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OBJECTIVES
Determine customer needsPlan a quality programme
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INPUTS
VOICE OF THE CUSTOMER
Market Research
Obtain market research data to reflect the needs expectations of the customer through
Customer interviewsCustomer questionnaires and surveysNew Product quality and reliability studiesCompetitive product quality studiesThings Gone Right (TGR) reportsFocus Group discussions
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Historical Warranty and Quality Information
Asses customer and wants and the potential for their recurrence
Things Gone Wrong (TGW) reportsWarranty reportsCapability indicatorsSupplier plant internal quality reportsProblem resolution reportsCustomer plant returns and rejectionField return product analysisProduct Sampling & Audit Reports
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Team Experience
Various reports of the organization’s personnel Formal feedback from the customer’s visits tot the plant Past track records similar product’s performance
consolidated during the various reviews meetings Collective experience of the team
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APQPCPAPQPCPBUSINESS PLAN / MARKETING STRATERGY
The Business Plan Marketing Strategy are the basis of the Product Quality plan
The Business Plan may define the direction the team will take regard to:
-Timing-Cost-Investment-Product positioning-Research and development (R&D)-Target objectives for obsolescence
The Marketing Strategy will define:-Target customer-Key sales points-Key competitors
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PRODUCT / PROCESS BENCHMARK DATA
Benchmarking helps to establish performance targets
Identify appropriate benchmarksIdentify comparative companies to collaborate for benchmarkingCollect data and summarizeIdentify 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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PRODUCT AND PROCESS ASSUMPTIONS
Product and process assumptions presume the product has certain features, design or process concepts.
Technical innovationsAdvanced materialsReliability assessmentsNew technology
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PRODUCT RELIABILITY
Product Reliability studies compare frequency of repair/replacement of components and the results of long-term reliability /durability tests.
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CUSTOMER INPUTS
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DESIGN GOALS
Design goals are tentative and are measurable objectives based on :
Product assumptionsFunctional performanceDimensionsWeightMaterialsAesthetic
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RELIABILITY AND QUALITY CONTROL
Reliability and quality goals must include the following targets:
Things Gone Wrong (TGW) targetsThings Gone Right (TGR) targetsUseful Life Reliability targetsWarranty targetsIncoming Quality targetsProcess Quality Targets
Note: The above targets must address systems, sub-systems, Components & parts levelP
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PRELIMINARY BILL OF MATERIAL
The team should establish a Preliminary bill of material based onProduct process assumptions
Include an early subcontractor listSelect appropriate design and manufacturing processA preliminary make Vs buy analysis
PRELIMINARY PROCESS FLOW CHART
The manufacturing process should be described using a Preliminary Process Flow Chart, developed from :
Preliminary bill of materialProduct/Process assumptions
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PRELIMINARY LISTING OF SPECIAL PRODUCT AND PROCESS CHARCTERISTICS
A Preliminary List of Special Product and Process Characteristics should be developed based on analysis of inputs including but not limited to :
Product assumptions based on customer needs and expectationsIdentification of reliability goals / requirementsIdentification of special process characteristics from manufacturing processSimilar part FMEAsEarlier experience
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PRODUCT ASSURANCE PLAN
The Product Assurance Plan translates design goals into design requirements.
Outlining of program requirements Identification of reliability, durability, and apportionment/
allocation goals and/or requirements Assessment of new technology, complexity, skill, materials,
application, environment, packaging, service, and manufacturing requirements, or any other factor that my place the program at risk.
Development of Failure Mode Analysis (FMA) Development of preliminary engineering standards
requirements
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MANAGEMENTS SUPPORT
The understanding, acceptance, and commitment of the Top Management formally provided to the team. This includes the assessment of funds, manpower and their deployment at the appropriate time.
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RISK ASSESSMENT
APQP Requirements
- APQP Scope
If program is considered low risk or only minor changes are required, supplier may skip some elements, such as:
- Existing control plans may be used - Packaging evaluations may not required
Team must conduct a risk assessment as soon as possible to determine if all elements in the APQP process must be completed.
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- Customer Inputs
Customer may require all APQP elements to be completed
Customer must agree to all deviations from the APQP process
If it is agreed that an element is not required, supplier should formally record this status
- Subcontractor APQP Status
The supplier performs risk assessment of potential subcontractors as initial step in evaluating subcontractor APQP status
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FOR RISK ASSESSMENT CHECKLIST
CLICK HERE
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The Status reporting should cover the following hierarchy:
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Vehicle Review
Feature of the Status Report
Give an overview of plan vs achievement Identify critical success factors Identify potential threats to fulfillment of objectives Determine any resources to be provided to expedite the progress Facilitates communication to all concerned Facilitates the next process to be ready for their side of the activity Provides a reference for tracking for future use Provide assurance that all activities are considered in advance Provide a basis for approving change to the timing, content, scope, etc.
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OBJECTIVES
Develop design features and characteristicsCritically review engineering requirementsAssess potential manufacturing problems
INPUTS
Design goalsReliability and quality goalsPreliminary bill of materialPreliminary process flow chartPreliminary listing of special product and process characteristicsProduct assurance planManagement support
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OUTPUTS BY DESIGN RESPONSIBLE ACTIVITY
DESIGN FAILURE MODE AND EFFECTS ANALYSIS (DFMEA)
OBJECTIVES
A Design FMEA is an 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 of failures by :
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- Aiding in design requirements and design alternatives- Aiding in initial design for manufacturing and assembly
requirements- Ensuring that potential failure modes and their effects have been
considered in the design/development process- Exposing design deficiencies- Providing additional information which will be useful in planning thorough and efficient design test and development processes- Ensuring Design controls are effective in highlighting potential
threats- Detecting potential failure modes, and listing and ranking them according to their effect on customer- Providing an open issue format for recommending and tracking
risk actions- Providing future reference for analysing concerns, evaluating
design changes, and developing advanced designs.
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• The Design FMEA should not relay on the process controls to overcome the potential design weaknesses but should take into account the limitations of the manufacturing process.
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APQPCPAPQPCPPROGRAM MANAGEMENT RESPONSIBILY
Program Management Responsibility is to ensure that :- A design responsible cross-functional team develops the DFMEA- The DFMEA is prepared using a customer approved manual- Campaigns, recalls, user plant concerns, similar part DFMEAs, things gone wrong,
and warranty data are addressed during DFMEA development- Every component design function is included in the DFMEA- Failure modes are described in physical, technical and measurable terms- Effects of failure address the effect on each part, next higher assembly system,
vehicle, customer wants, and government regulations- Corrective actions, responsibilities, and completion dates are addressing high
severity numbers and high risk priority numbers.- Risk priority numbers are revised to quantify the impact of corrective actions.- Potential special product characteristics are considered in the FMEA- Potential causes of failure are identified for all failure modes.
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Design for Manufacturibility and Assembly is a simultaneous engineering Process design to optimise the relationship between design function,manufacturibility and ease of assembly.
Customer needs and expectations will determine the extent of the APQP. Team involvement in this activity.
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DESIGN VERIFICATION
OBJECTIVETo ensure that the Design Output meets the Design Input requirementsTo develop a Design Verification Plan
DESIGN VERIFICATION PLANThe Design Verification Plan is a single document containing both the TestPlan and the Test report
The Test Plan itemizes all tests necessary to assure that functional and reliability criteria and target requirements are met and specifies :
- Test responsibility- Test quantities- Timing requirement- Acceptance Criteria
The Test Report provides test results and progress made toward design targets specified by the Test Plan
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The Design Verification Plan is a working document to aid engineering Personnel in :
Development of thoroughly planned tests needed to assure that the Component or system meets all engineering requirements
Ensuring that product reliability meets customer-driven objectives
Indicating situations where customer timing requires an accelerated test Plan
Summarizing functional, durability, and reliability testing requirements in one document
Providing easily prepared test status and progress reports for Design Reviews
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APQPCPAPQPCPPROGRAM MANAGEMENT RESPONSIBILITY
Program Management Responsibility is to ensure that : A cross-functional team is formed for the completion of the design verification
plan. Specified tests, methods, equipment, acceptance criteria, samples sizes, design
level, and timing are clearly documented in the design verification plan Tests include variation within tolerance on product characteristics selected by the
team The design verification plan includes testing environmental aging, dimensional
wear and material fatigue The plan includes testing the useful life of the product The plan includes testing the effects of the external environment (climate road
surface conditions, etc.,) The plan includes testing the effects of the internal environment created
neighboring subsystems The plan includes testing of the physical interfaces between components or
systems The plan includes testing that detect a failure using variables data. Note: A failure is significant – partial, degraded, intermittent, or total product failure. The team agrees on the definitions of failure and success The plan includes documentation and reaction processes when product failure
distribution design and reliability goals are not met.
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DESIGN REVIEWS
OBJECTIVES
Design Reviews are regularly scheduled meetings led by engineering and are intended to prevent problems and misunderstandings and to monitor the progress of design activities and report to management.Design Reviews are more than engineering inspection; they are evaluations of :
Design/functional requirement considerations Formal reliability and confidence goals Component / subsystem / system duty cycles Computer simulation and bench test results DFMEAs Review for the Design for Manufacturibility and Assembly effort Design of Experiments (DOE) and assembly build variation results Test failures Design Verification progress Safety Concerns
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PROGRAM MANAGEMENT RESPONSIBILITY
Program Management Responsibility is to ensure that :
Design feasibility concerns are resolved in time Issues brought up in the Design Verification Plan and Sign off
Report are addressed Issues brought up in the APQP Status Report are addressed Issues regarding reliability, quality, cost, Safety and timing are
Identified
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APQPCPAPQPCPPROTOTYPE BUILD – CONTROL PLAN
OBJECTIVES
Prototype Control Plan describes the controls to be ensured during the Prototype build stage. These could include the dimensional measurements, materials and functional tests that will occur during prototype build
The Prototype Control Plan evolves into the Production Control Plan It is used to measure the preliminary capability of “potential” special
characteristics identified during the Design FMEA process It supplies information to the manufacturing / assembly about the type of
controls expected Specific requirements and supporting data such as P.I.P.C.% (Percent
indicates that are process capable) and P.I.S.T (percent of inspection points that satisfy tolerance) may be required to support prototype vehicle evaluations.
Prototypes should be manufactured using production equipment when possible.
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PROGRAM MANAGEMENT RESPONSIBILITY
Program Management Responsibility is to ensure that :
- A cross – functional team is used to complete the Prototype-Build Control Plan
- The team reviews all product characteristics, identifies prototype requirements, and obtains Design Engineering approval
- Potential special characteristics are clearly identified on the Control Plan
- Inspection plans are developed for all material and engineering specifications
- Gages and test equipment used for the prototype are identified on the Prototype Control Plan
- Gages and test equipment must be accurate, discriminate, repeatable and reproducible
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- The control plan includes documented measurement procedures, techniques and datums-
- The customer has the opportunity to approve Prototype Control Plan
- Prototype processes that are different from production are identified on the Prototype Control Plan
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ENGINEERING DRAWINGS SPECIFICATIONS MATERIALSPECIFICATIONS AND DRAWINGS & SPECIFICATION
CHANGES
OBJECTIVES
Drawings and specifications cover all engineering drawings, CAD Data, Material specifications, and engineering specifications
Customer designs do not preclude the planning team’s responsibility to review engineering drawings
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- Engineering drawings may include drawings special (governmental regulatory and safety) characteristics that must be shown on the control plan
- When customer engineering drawings are nonexistent, supplier drawings should be reviewed by the planning team to determine which characteristics affect fit, function, durability and / or governmental regulatory safety requirements.
- Drawings should be reviewed to determine if there is sufficient information for a dimensional layout of the individual parts
- Control or datum surfaces / locators should be clearly identified so that appropriate functional gages and equipment can be designed for ongoing
controls.- Dimensions should be evaluated to assure feasibility and compatibility with
industry manufacturing and measuring standards.- Team should assure that math data is compatible with customer’s system
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SPECIAL PRODUCT AND PROCESS CHARACTERISTICS
The Product Quality Planning Team should review the preliminary
special product and process characteristics list and reach a consensus during development and design.
The consensus should be documented on the Control Plan- The supplier can use any form that accomplishments
the same documentation requirements The customer may have unique approval requirements
Note : Refer to Chrysler, Ford and General Motors Quality System Requirements Section II
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PROGRAM MANAGEMENT RESPONSIBILITY
Program Management Responsibility ensures that :
The customer has been given Program Need Dates Drawings and specifications include engineering specifications
tests and Product Validation Test requirements, and are documented in time for the Pre-Launch Control Plan development
Major feasibility are resolved prior to the Production Trial Run The supplier’s or subcontractor’s material has been approved.
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OUTPUTS BY PRODUCT QUALITY PLANNING TEAM
NEW EQUIPMENT TOOLING. GAGES/TESTING AND FACILITIES REQUIREMENTS
OBECTIVES
To ensure the facilities, tools and gages requirements are identified, procured, and proven-out in time to meet program need dates. The DFMEA activity considerations and / or Design Reviews may identify new equipment and facilities requirements.
Product APQP should add these items to the Timing Chart Team should ensure that the new equipment, gages and
tooling is capable and can be delivered on time. Facilities progress should be monitored to assure completion
before Planned production tryout.
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Program Management Responsibility is to ensure that :
The product quality timing plan includes facilities, permits, planning,approval, drawing and utilities.
Funding approval is complete Tooling, equipment, and gages have been sourced with
statistical requirements. Acceptance criteria has been agreed upon Tooling and equipment comply with TE-9000 requirements (as
appropriate) There is a trial run at the machine builder’s location to qualify
equipment, Tooling and gages. Corrective Actions for all gages and tooling that do not meet
customer Requirements must be completed prior to the production trial run.
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To identify the Special Product & Process CharacteristicsTo ensure that they are adequately reviewed through FMEA and addressed in Control PlansTheir Designation is consistent with the supplier’s system and Customer’sExpectations
PROGRAM MANAGEMENT RESPONSIBILITY
The product Quality planning team ensures the timely identification & review of these characteristics
The relevant documents where they have to be identified are reviewed Their designation symbols are consistent with the supplier’s system There is an assessment of potential risks with these characteristics and
corrective actions are initiated in advance through Statistical Studies, Mistake proofing, etc.
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The Advanced Product Quality Planning Team must assess the feasibility of manufacturing the proposed design.
Customer design ownership does not preclude the supplier’s obligation to assess design feasibility
The team must be satisfied that proposed design is fir for its intended use and meets customer expectations, including:
- Time schedules- Testing requirements- Packaging requirements- Delivery requirements- Cost objectives- Quality Objectives
Suppliers must also assess risk and determine which of their subcontractor must do a feasibility assessment. Suppliers that affect special characteristics must do a feasibility assessment.
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PROGRAM MANAGEMENT RESPONSIBILITY
Program Management Responsibility ensures that :
The team agrees that the proposed design is suitable for its intended use and can be manufactured, assembled, tested, packaged, and delivered in sufficient quantity and acceptable cost and quality on schedule
Suppliers have completed risk assessment and determined which suppliers will do a feasibility assessment
The team provides a feasibility document to the customer
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AN
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OBJECTIVESDevelop design features and characteristicCritically review engineering requirementsAssess potential manufacturing problems
INPUTS
Design goals Reliability and quality goals Preliminary process flow chart Preliminary listing of special product and process characteristics Product assurance plan Management support Customer requirement ( special ch., identification, traceability,etc) Use of information targets for product quality, life, reliability, durability, maintainability,
timing and cost )
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OUTPUTS
PACKAGING STANDARDS
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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AC
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OBJECTIVES
To ensure that the existing Quality System can meet the requirements of the new product
To identify the system modification, additions to be done for meeting the Quality Assurance requirements
PROGRAM MANAGEMENT RESPONSIBILITY
To ensure that the team activity considers this element and it is timed The responsibility for review of the system is defined The review considers all aspects of the Quality System (Ref: ISO
9000/QS 9000) The identification of new/modified documents, resources, training, etc.
are completed on time and action initiated for their completion
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FL
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CH
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OBJECTIVES
To ensure that all operations of a manufacturing flow have been graphically shown to show the direct and alternate paths of production
Customer requirements, in the form of product characteristics, are mapped to the affected operations.
Sources of variation and process characteristics are considered at each operation
A comprehensive Process Flow Chart provides the foundation for the development of an effective Process FMEA and Control Plan.
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SOURCES
Customer Prints In-Process Prints Plant Layout Problems reports and Logs System and / or Design FMEA Process FMEA from a similar product or process
Note: The Process flowchart and the appropriate updates to the Floor Plan shall be completed at this level. Other documents that will be partially or fully completed at the same time as the Process Flowchart include the following :
Floor Plan Characteristics Matrix (optional) List of Special Product and Process Characteristics Process flow In-process prints
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FOR PROCESS FLOWCHART CHECKLIST
CLICK HERE
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OBJECTIVES
The Floor plan should be developed and reviewed to determine the acceptability of inspection points, control chart location, applicability of visual aids, interim repair stations and storage areas to contain defective material.
It can be also used for evaluating the ergonomics factors, requirements for Reduced material travel, etc
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HA
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IC M
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RIX Characteristics Matrix :
Displays the relationship between product/process characteristics and the operations of the process
Identified the impacts operations have on characteristics Identifies the impacts that characteristics have on each other Provides criteria for assessing importance levels of
characteristics Indicates where common tooling is used.
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THE BASIC STEPS IN CONSTRUCTING THE CHARACTEISTICS MATRIX
List all the characteristics in order on the top row of the matrix List all the operations in order by OP# on the left column of the matrix Place a relationship symbols in interior cells in the Matrix RELATIONSHIP
SYMBOLS
Using the following symbols indicates the relationships between operations and characteristics
* Indicates a characteristic is cut or changedC Indicates a characteristic is used for clampingL Indicates a characteristic is used for location in a subsequent OperationA Affects a subsequent operation or other characteristicT Indicates relationships within an operation, such as common tools or tool headM Characteristic is automatically monitored
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PROCESS FAILURE MODE AND EFFECTS ANALYSIS (PFMEA)
OBJECTIVESThe primary objective of the Process Failure Mode Effects Analysis (PFMEA) is to reduce manufacturing risk by :
Aiding in the analysis of new manufacturing and assembly processes Assuring that potential manufacturing and / or assembly process failure modes
and effects are considered. Identifying process deficiencies and provide for the development of controls to
resolve the problems by : - Eliminating or reducing the frequency of unacceptable products - Increasing the detection of unacceptable products
Identifying critical characteristics and significant characteristics contributing to the development of a complete manufacturing control plan
Establishing priorities for process improvement activities Providing automatic process design documentation to guide the development
of future manufacturing and assembly processes.
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Note : Output from the PFMEA is used as a basis for :
Control Plan developmentPreliminary Process Capability Study Plan developmentFinalisation of special product and process characteristicsDevelopment of Process and monitoring instructionsP
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SOURCES
The data or reference documents that should be utilised by the cross-functional team to help develop the PFMEA include :
Process FMEA AIAG Reference ManualCharacteristics MatrixWarranty informationCustomer Complaints and Returns DataCorrective or Preventive ActionsProcess Flow ChartSystem and / or Design FMEAPFMEA for similar products or processesInternal Quality Reports
PF
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PROGRAM MANAGEMENT RESPONSIBILITY
The Team Leader and APQP team should manage the construction of the processFMEA and assess the finished document to ensure that the following expectationsare met :
The PFMA is developed on or before the Program Need Date A cross functional team has been formed to assist in the development of the
PFMEA Appropriate data have been identified that shall be used by the team to develop
the PFMA. Some forms of data for a similar product or process might include:- Warranty information- TGW data- Corrective or preventive actions- A list of current error proofing techniques used for similar processes- Higher assembly of component processes- FMEAs from similar product- Other data that would help assist the group better understand and assess the process
PF
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The appropriate PFMEA is chosen Failure modes are quantifiable The effects on all customers are considered Causes are identified that point to process deficiencies Risk has been assessed and reduced to acceptable levelsP
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FOR PROCESS FMEA CHECKLIST
CLICK HERE
PF
ME
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OBJECTIVES
To ensure that a written plan for controlling all parts and process after prototype and before full production is documented.
The plan should include :
- All operations listed on the Process Flow Chart.- The machine jig or tooling- Product and process characteristics- Designation of special characteristics- Specifications or tolerances- Gaging or evaluation techniques- Sample sizes and frequency- Control methods- Reaction instruction at each stage of production
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The Pre-launch Control Plan will be similar to the Production Control Plan but should include greater sampling for certain characteristics to reflect the initial capability studies (Ppk) and audits to validate that the process is robust.
A full layout inspection will normally be performed at this stage and then yearly or as specified by the customer.
Note : The Pre-Launch Control Plan is used as input for finalizing:- Measurement System Analysis Plans- Operator Process and Monitoring Instructions- Reaction Plan- Preliminary Process Capability Study Plan
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SOURCES
The data or inputs that will be used to develop the Pre-launch Control Plan may include some or all of the following. This data will be reviewed By the cross-functional team during their meetings.
Advance Product Quality Planning and Control Plan AIAG Reference Manual Customer Prints Inspection Plans and Sampling Frequency Work Instructions for similar parts or processes List of special characteristics List of Machines, tools, Jigs or Fixtures List of Gaging with data showing calibration, discrimination, accuracy,
repeatability and reproducibility Performance Testing Requirements Design Reviews Optimisation Data (e.g., QFD, DOE, etc.,) Process Flow Chart System and / or Design FMEA Process FMEA
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APQPCPAPQPCPPROGRAM MANAGEMENT RESPONSIBILITY
The Team Leader and APQP Team should manage the construction of the Production Control Plan and assess the finished document to ensure that the following expectations are met :
A cross-functional team to assist in the development of the Control Plan
All operations and special characteristics are included on the Control Plan
Recommended actions from the PFMEA are incorporated in the Control Plan
Sampling plans are included as defined by customer requirements Sampling Plans for Ppk studies for Special Characteristics are
included on the Control Plan Work Instructions for setup, operation, testing, inspection, SPC and
reaction are indicated on the Control Plan The Production Control Plan identifies all qualified measurement and
test equipment
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Control Plan Instructions are defined for all material and engineering specifications Only rational sampling plans are used. Control methods are defined to produce only acceptable product output Control methods should focus on :
- meeting all customer requirements- process control rather than product control- prevention rather than detection- targeting nominal rather than specification limits- error proofing rather than inspection- managing the control method
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Process data have been used to confirm cause and effect relationships between product and process characteristics. The PFMEA should be a primary tool for exposing process deficiencies and potential product/ process relationships.
The Production Control Plan and PFMEA are consistent in defining current process controls
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IN
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OBJECTIVES
To ensure that documented instructions are available at all operations where the absence of such instructions could adversely affect quality. Instructions shall include specific information that describes in a step-by-step fashion ‘how to’ perform an activity.
Instructions provide all the required information to perform a job and shall be referenced by an operator for a number of different circumstances required on-the-job Work Instructions shall be referenced by the Control Plan.
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OPERATING INSTRUCTIONS
• After ensuring setup, follow Quality Check Sheet Instructions• Follow Process Parameter Log Instructions• Change tool as indicated on Control Plan• Follow SPC Instruction as noted on control plan and quality check sheet• Master Gages per frequency indicated on control plan
REACTION INSTRUCTIONS
If Non-Conforming material is detected.
• Stop Process• Isolate Non-conforming Material. Place in proper Quarantine Area• Correct Problem• Inform Supervisor if problem persists
Note all out of control conditions on control chart (only for charted Characteristics)
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OBJECTIVES
A plan must exist for the evaluation of measurement devices and methods specified in the Control Plan to ensure gage linearity, accuracy, repeatability, reproducibility, and correlation (for duplicate gages)
FOR MEASURE MENT SYSTEM EVALUATION PLAN
CLICK HERE
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LIM
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PR
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S
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PA
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OBJECTIVES
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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AC
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To ensure that individual product packaging (including interior partitions) is designed and developed.
PROGRAM MANAGEMENT RESPONSIBILITY
Manage and assess packaging design and evaluation to ensure meeting theFollowing expectations:
Packaging requirements will be agreed upon by the supplier and the customer
The packaging design must assure that the product performance and characteristics will remain unchanged during packing, shipping and unpacking
Packaging evaluations must test the packaging under the expected conditions of transport and material handling. (Customer-specified packaging does not preclude Advance Product Quality Planning Team involvement in evaluating the packaging method.)
FOR CONTROL PLAN CHECKLIST
CLICK HERE
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RO
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& P
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VA
LID
AT
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Validate the manufacturing process Ensure that customer expectations will be met Identify additional concerns
INPUTS Packaging standards Product process quality system review Process flow chart Floor plan layout Characteristics matrix Process Failure Mode and Effects Analysis (PFMEA) Pre-launch control plan Process instruction Measurement Systems Analysis Plan Preliminary process capability study plan Packaging specification Management support
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RO
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OBJECTIVES
To ensure the effectiveness of the manufacturing process, using production Tooling, equipment, environment (including production operators), facilities and cycle times.
PROGRAM MANAGEMENT RESPONSIBILITY
Manage and assess the production trial run to ensure meeting the following expectations :
The pre-launch control plan is followed during the production trial run.
The trial run must be used to confirm or add linkages between product and process characteristics.Note : Linkages should be captured in the PFMEA.
Corrective design and process actions must be established for concerns
identified during the trial run.
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OUTPUT
Production Part Approval Preliminary Process capability Study Measurement Systems Evaluation Final Feasibility Process Review (feedback to process flow and Process
FMEA, input to Production Control Plan) Production Validation Testing Packaging Evaluation First Time Capability (FTC) Quality Planning sign-off
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The study should be done as per the Plan defined in Process Design & Development. This study should address all the Measurement Systems listed in the Control plan and the measurement systems used for SPC.
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RE
LIM
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PR
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S
CA
PA
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OBJECTIVES
To ensure the determination of an acceptable level of process capability for all characteristics designated by the customer or supplier as Special Characteristics, prior to part submission.
To provide a statistical assessment of the readiness of the process for production prior to program launch to determine if the production process is likely to produce product that will meet the customer’s requirements.
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PROGRAM MANAGEMENT RESPONSIBILITY
Manage and assess the Preliminary Process Capability Study to ensure meeting the following expectations :
All special characteristics must be studied and have Pp and Ppk >1.67.
Statistical and analytical techniques used to determine capability must be acceptable to the customer.
Preliminary capability studies must be performed as documented in the pre-launch control plan
Preliminary capability studies must be completed and the customer given the opportunity for review prior to Production Part Approval.
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PRODUCTION PART APPROVAL PROCESS (PPAP)
OBJECTIVES
To ensure there is documented verification that all customer the supplier meets engineering design requirements and the process has the potential to produce to these requirements during an actual production run.
To validate that the products made from the production tools and processes meet the engineering requirements.
To ensure that all the requirements mentioned in PPAP manual are adhered to.
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RO
DU
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ION
VA
LID
AT
ION
T
ES
TIN
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To ensure that products made from production tools and processes meet engineering standards
PROGRAM MANAGEMENT RESPONSIBILITY
Manage and assess production validation testing to ensure meeting the following expectations:
Parts for testing must be selected from the production trial run per the sample sizes and frequencies outlined in the pre-launch control plan
All customer specified dimensional, material, functional and reliability tests must be completed prior to production part approval
For tests not completed prior to production part approval, appropriate action plans and customer approvals are required.
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OBJECTIVES
To ensure that the packaging material meets both the specification requirements and the performance requirements.
The packaging material in full packaged condition is tested in conditions that resemble the conditions of use and / or tested in actual user conditions.
The program should allow appropriate timing for completion of this activity.
Feedback received from this stage should be used for modifying the packaging specifications.
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RO
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ION
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OBJECTIVES
To ensure that a comprehensive plan for controlling all parts and processes before full production is documented.
The plan includes all operations listed on the Process Flow Chart, including :
- The machine jig or tooling- Special product and process characteristics- Designation of special characteristics- Specification or tolerances- Gaging or evaluation techniques- Sample sizes and frequency- Control method and reaction instructions at each stage of
production.
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APQPCPAPQPCPSOURCES
The data or inputs that will be used to develop the Pre-launch Control Plan may include some or all of the following. This data will be reviewed by the cross-functional during their meetings.Advanced Product Quality Planning and Control Plan AIAG Reference ManualCustomer PrintsIn-process PrintsCustomer and Internal SpecificationsInspection Plans and Sampling FrequencyWork Instructions for similar parts or processesList of Special CharacteristicsList of Machines, tools, Jigs or FixturesList of Gaging with data showing calibration, discrimination, accuracy, repeatability and reproducibilityPerformance Testing RequirementsDesign ReviewsOptimisation Data (e.g, QFD, DOE etc.,)Process Flow ChartSystem and / or Design FMEAProcess FMEAP
RO
DU
CT
ION
CO
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PROGRAM MANAGEMENT RESPONSIBILITY
The Team Leader and APQP Team should manage the construction of the Production Control Plan and assess the finished document to ensure that the following expectations are met :
A cross-functional team to assist in the development of the Control Plan All operations and special characteristics are included on the Control Plan Recommended actions from the PFMEA are incorporated in the Control Plan Sampling plans are included as defined by customer requirements Sampling Plans for Ppk studies for Special Characteristics are included on the
Control Plan Work Instructions for setup, operation, testing, inspection, SPC and Reaction are
indicated in the Control Plan The Production Control Plan identifies all qualified measurement and test
equipment The customer is given the opportunity to approve the Control Plan Tests and measurements for PPAP approval are included on the Control Plan Instructions are defined for all material and engineering specifications Only rational sampling plans are usedP
RO
DU
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ION
CO
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Control methods are defined to produce only acceptable product output Control methods should focus on :
- meeting all customer requirements- process control rather than product control- prevention rather than detection- targeting nominal rather than specification limits- error proofing rather than inspection- managing the control method
Process data have been used to confirm cause and effect relationships between product and process characteristics. The PFMEA should be a primary tool for exposing deficiencies and potential product/ process relationships.
The Production Control Plan and PFMEA are consistent in defining current process controls
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OD
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TIO
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ON
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UA
LIT
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LA
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MA
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SU
PP
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OBJECTIVES
The APQP team should review all the activities have been successfully completed and make a formal sign-off. Management support is necessary prior to the quality planning sign-off. The format given below is an example of the documentation required to do this sign-off.
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OBJECTIVES
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
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INPUTS
Production trial runMeasurement systems evaluationPreliminary process capability studyProduction part approvalProduction validation testingPackaging evaluationProduction control planQuality planning sign-off and management support
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OUTPUTS
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 required 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. Often the reduction or elimination of a common cause results in lower costs. Suppliers should not be reluctant to prepare proposals based on value analysis, reduction of variation, etc., The decision to implement, negotiate, or progress to the next product design level is the customer’s prerogative.CO
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CUSTOMER SATISFACTION
Detailed planning activities and demonstrated process capability of a product or service do not always guarantee customer satisfaction. The product or service must perform in the customer environment. The product usage stage required supplier participation. It is in this stage where the most can be learned by both the supplier and customer. The effectiveness of the Product Quality Planning efforts can be evaluated in this stage. The supplier and customer must be partners in making the changes necessary to correct deficiencies to achieve customer satisfaction.
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DELIVERY AND SERVICE
The delivery and service stage of quality planning continues the supplier/customer partnership in solving problems and continual improvement. The customer’s replacement and service operations always merit the same consideration in quality, cost and delivery. Failure to correct a problem the first time always damages the supplier’s reputation and customer partnership. It is important that both and supplier and customer listen to the Voice of the Customer. The experience gained in this provides the customer and supplier with the necessary knowledge to recommend price reductions achieved by reducing process, inventory, and quality costs to provide the right component or system for the next product.
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DIX PROCESS FMEA
FAILURE MODE AND EFFECT ANALYSIS (FMEA)
ORIGIN
US – SPACE PROGRAM & DEFENCE SAFETY SYSTEM IN 1960’S.
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FAILURE:
A ‘Failure’ is that a component, assembly or system which does not meet the requirements or function in accordance with design intent. Ex: Not meeting the specification
FAILURE MODE:
A ‘Failure Mode’ is the manner in which a component, assembly or system failure occurs. ex: How the component could not meet the specifications.
WHAT IS FMEA ?
FMEA IS A SYSTEMISED GROUP OF ACTIVITIES TO :• Recognize & evaluate the potential failure of a product/process and its effects.• Identify actions which could eliminate or reduce the chance of potential failure
occurring.• Document the process
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WHY FMEA?
• For a company policy where continuous improvement is emphasized for its product, process.
• FMEA is a living document.
WHO SHOULD DO FMEA?
• Cross functional team effort – with a leader.• Team of knowledgeable individuals Ex : Expertise in mfg., Assly., Quality,
etc.,
WHEN FMEA SHOULD MBE DONE?
• Essence is timeliness.• Pro-active rather than reactive.• Before process failure mode occurs.
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ADVANTAGES OF FMEA:
• Avoids late change crisis• Reduces or eliminates chance of implementing corrective change• Excellent technique for preventive action• Interactive process which is never ending
TYPES OF FMEA
• Design FMEA• Process FMEA• System FMEA
POTENTIAL – PROCESS FMEA
Potential means ‘anticipated’. It is an analytical technique to assure that potential failure mode and their
associated causes have been considered and addressed Collection of teams thought as a process is developed.
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AIMS OF POTENTIAL PROCESS FMEA
• Identifying potential product related process failure mode.• Assessing the potential customer effects of the failures• Identifying the potential mfg., or assembly process causes
& process variables on which to focus controls for occurrence reduction or detection of the failure conditions.
• Developing a ranked list of potential failure modes.• Documenting the results of the mfg. Or assembly process
CUSTOMER MEANS – NORMALLY ‘END USER’
BUT CAN ALSO BE A SUBSEQUENT OR DOWN STREAM MFG. OR ASS’LY OPN.,
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WHEN SHOULD POTENTIAL PROCESS FMEA DONE (AS PER QS 9000 REQUIREMENT
- For all new parts/processes- Changed parts/processes- Carryover parts / processes in new application or
environment- Before or at feasibility stage- Prior to tooling for production
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HOW TO DEVELOP & COMPLETE POTENTIAL PROCESS FMEA ?
ASSUMPTION – 1 :
PROCESS FMEA ASSUMES THE PRODUCT AS DESIGNED WILL MEET THE DESIGN INTENT.
STEPS :• Assemble a team (cross functional)• Assign responsibilities• Develop flowchart for risk assessment• Collect data/information• Arrive at RPN for each potential causes of failure• Based on pareto rankings of RPN’s for respective potential cause of
failure, priortise preventive action directed fist at highest ranked RPN’s and severity rank.
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• Formulate the recommended/preventive action for each potential failure Cause after examining the inadequacy of the present/current design & process control
• Implement actions & record results• Estimate & record the new resulting severity., occurrence &
detection ranking & calculate RPN
COLLECT DATA / INFORMATION Develop FMEA form Process function requirement- description of the process (ex : Gear cutting, broaching, hobbing,
et.,)& purpose in brief
Potential failure mode :- is defined as the manner in which the process could potentially fail
to meet the process requirements and/or design intent.- is a description of non-conformance a that specific operation.
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ASSUMPTION - 2 :
ALL INCOMING PARTS/MATERIALS ARE CORRECT.
• List each potential failure mode for the particular operation.
ASSUMPTION – 3 :
ASSUMPTION IS MADE THAT THE FAILURE COULD OCCUR, BUT MAY NOT NECESSARY OCCUR.
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TIPS ON THOUGHTS : FOR CFT
How can the process/part fail to meet the specifications Regardless of engineering, Spec., what would a customer
consider objectionable Comparison of similar processes/customer claims
TYPICAL FAILURE MODES :
Bent, Binding, Burred, Handling Damage, Cracked, Deformed, Dirty, Improper setup, Grounded, Tool Worm, etc.,
Only specific errors or malfunctions should be listed. Ex. Improper Heat Treat – Time, Temperature Improper
Torque – Over, Under Ambiguous phrase should not be used Ex : Operator Error,
Machine Malfunction
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OCCURRENCE (O) :
DEFINITION :
Occurrence is how frequently the specification failure cause / mechanism is projected to occur only occurrences resulting in the failure mode should be Considered for ranking. Estimate the likelihood of the occurrence a ‘1’ to ‘10’ scale.
CURRENT PROCESS CONTROLS :
DEFINITION :
Current control are descriptions of the control that either prevent to the extent possible.
The failure mode from occurring or detecting. The failure mode should it occur.
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THREE TYPES OF PROCESS CONTROL /FEATURES TO CONSIDER:
• Prevent the cause/mechanism or failure mode effect from occurring or Reduce their rate
• Detect the cause/mechanism & lead to corrective action.• Detect the failure mode DETECION (D):
DEFINITION :
Is an assessment of the probability that the current process controls will detect a potential cause/mechanism or subsequent failure mode.
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ASSUMPTION – 4 :Assume the failure has occurred and then assess the capabilities of all ‘current process controls’ to prevent shipment of the part having the failure mode or defect.A ‘1 ‘ TO ‘10’ SCALE IS USED.
RISK PRIORITY NUMBER : (RPN)
RPN IS THE PRODUCT OF SEVERITY (S), OCCURRENCE (O)& DETECTION (D) RANKINGS
i.e., RPN = (S) x (O) x (D)
RPN WILL BE BETWEEN “1” & “1000”
THIS VALUE SHOULD BE USED TO TANK THE CONCERN IN THE PROCESS IN THE “PARETO FASHION”
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RECOMMENDED ACTIONS (S)
ACTIONS ON
1. HIGHEST RANK RPN/SEVERITY
2. WHICH COULD BE HAZARDOUS TO MFG/ASS’LY PERSONNEL
- PERMANENT CORRECTIVE ACTION IS REQUIRED- EMPHASIS MUST BE ON PREVENTING DEFECTS
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DESIGN FMEA
• Fmea number• System, sub system or component name and
number• Design responsibility• Prepared by• Mode year (s) / vehicle(s)• Key date• Fmea date• Core team• Item / function• Potential failure mode• Effect(s) of failure• Severity• Classification
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DESIGN FMEA
• Potential cause(s) / mechanism (s) or failure• Occurrence(o)• Current design controls• Detection(d)• Risk priority number (rpn)• Recommended action(s)• Responsibility (for the recommended action)• Action taken• Resulting rpn
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PROCESS FMEA
• Fmea number• Item• Process responsibility• Prepared by• Mode year(s) / vehicle(s)• Key date• Fmea date• Core team• Process function/requirements• Potential failure mode• Potential effect(s) of failureC
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PROCESS FMEA
• Severity (s)• Classification• Potential cause (s) / mechanism (s) or failure• Occurrence(O)• Current design controls• Detection (d)• Risk priority number (RPN)• Recommended action (s)• Responsibility and target completion date• Action taken• Resulting RPNC
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PROCESS FMEA FLOW CHART /RISK ASSESSMENT EXAMPLE
(Application of Wax to Inside of Door)
Process Step Risk Assessment
1. Get wax applicator wand from holder Low
2. Open vehicle Door Low
3. Insert wand and pull trigger for 12 secs. High
While making three passes
4. Release trigger wait 3 secs. Medium
5. Remove Wand Medium
6. Close vehicle door Low
7. Replace applicator wand in holder Low
* FMEA required ( high risk )
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EQUIPMENT : TOOLING DOMINANT PROCESS :
Tool life and design characteristics are the variables affecting the process output.
A sheet metal stamping die is used to form a steel bracket that has several angles and a pierced hole. The pierced hole diameter will not vary significantly, therefore it is not marked as a Special Characteristic. The presence of the hole is critical to the part. The angles on the part are critical and two angles are marked as Special Characteristics. Historically, broken hole punches are a problem with this type of tooling. Further, moving parts in the tool can vary when forming the angles in the bracket.C
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The process characteristic is the tooling. Tools can have details that break or moving parts that intermittently/permanently fail to move. Tools can also be repaired incorrectly. The product characteristics are affected by these tooling problems.
Types of controls for tooling dominant processes are mainly seen in the Product. First piece check can verify that a tool has been properly repaired. When in operation a tool failure may go unnoticed except in the part, therefore, lot control is appropriate. Error proofing techniques that check for holes or a dimension are also needed.
Product characteristic are a very important measure of proper tool life performance.
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EQUIPMENT : TOOLING DOMINANT PROCESS:
Tool life and design characteristics are the variables affecting the process output.
A broach is used to form the internal spline teeth on a steel propshaft yoke. The pitch diameter of internal spline is the Special Product Characteristic
The sharpened tool is checked on a visual comparator for correct pitch diameter and relief angle prior to being approved for production.
First piece of a production run is checked for sharpness of cut and correct pitch diameter.
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PEOPLE: OPERATOR DOMOINANT PROCESS:
The system is sensitive /dependent upon operator knowledge and control.
Headlamp aim is one of the final operations during car and truck assembly. An aiming device, which contains two bubble levels, attaches to the headlamp. The operator adjusts the headlamps by turning aiming Screws until bubbles center the level. Proper headlamp aim is an FMVSS requirement and therefore a Special Product Characteristic. The Special Process Characteristic is operator knowledge and control, ensuring the two bubble levels center during aiming. The Special Product Characteristic is measured by shining the headlamps on a headlamp aim board that measures beam pattern.
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MATERIAL : MATERIAL OR COMPONENT DOMINANT PROCESS
Characteristics of materials/components are the variables affecting the Process output.
An automobile hood is made of SMC. SMC is a molding compound that is temperature sensitive, has a specific shelf life, and for which mixing is critical. The parts produced from this material can become brittle when the material is improperly mixed, handled or rotated. A force specification on one end of the bracket is a Special Product Characteristic. The Special Process Characteristics are the proper formulation, storage, and use of material date control. The customer requires a laboratory report on each lot of compound and the lots of material are dated for proper rotation.
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The materials or components are the process characteristics for this process. The variation found in the materials or components will affect the output of the process.
Types of controls for the process characteristics include the various ways of testing and controlling the specification on the material or component being used (i.e, control charts, lab reports, error proofing)
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METHODS: PREVENTIVE MAINTANANCE DOMINANT PROCESS:
Equipment maintenance is the main variable that effects the process output.
A painting operation for a decorative parts requires clean equipment and dirt-free work area. Dirt-free paint a Special Product Characteristic. Periodic cleaning of the paint equipment and paint room prevents the problem of dirt in the paint. The process characteristic is a scheduled routine cleaning, repair and replacement.
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Periodic maintenance is the process characteristic. Where input variables exist, replacing worn out parts, cleaning, calibration, tool adjustments, and other maintenance activities have an effect on the product characteristics, and must be controlled.
Types of controls for these process characteristics include scheduled maintenance programs and warning devices for monitoring.
Product characteristics are checked after each maintenance to verify the Process is properly performed.
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ENVIRONMENT : CLIMATE DOMINANT PROCESS :
Climate variables such as temperature, humidity, noise, vibrations, have major impact on the process outputs.Humidity adversely affects the function of plastic molding machines. Plastic material absorbs dampness from the air, causing defects in the molded part. Material dryers are installed on the molding machines to eliminate the problem.
The proper functioning of the dryer is the process characteristic in having the process perform properly
Type of control for this process characteristic is a planned, periodic check to make sure the dryer is turned on and performing properly.
Product characteristics are checked by visual examination during first piece check and by subsequent periodic checks.
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Y COMPONENT – The individual parts that are linked or integrated into a subsystem, system, or vehicle
CRITICAL CHARACTERISTICS - Product requirements (dimensions, performance tests) or process parameters that can compliance with government regulations of safe vehicle / product function and which require specific supplier, assembly, shipping or monitoring.
CUSTOMER - The next operation, department, person or company WHETHER internal or external, that receives or purchases product or services.
DYNAMIC CONTROL PLANNING (DCP) - A methodology to ensure customer expectations in the form of product design requirements are understood, deployed and controlled in the manufacturing and assembly processes. A team approach is used for the step-wise understanding and control of manufacturing process and products.
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DESIGN FREEZE – A point in time determined by the Program Management when the design must be completed to support a prototype Test program. Subsequent changes to the frozen design are not accepted without agreement from the Program’s Chief Engineer and Team Leader.
ELEMENT - Specific documents, tasks and disciplines which must be Completed to support the customer’s program.
FAILURE MODE ANALYSIS (FMA) – A disciplines systematic approach to quantify the failure modes, failure rates and root causes of known failures. FMAs are based on historical information including warranty data, field data, service data, and / or process data.
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FAULT MODE ANALYSIS (FMA) - A disciplines systematic approach to quantify the failure modes, failure rates and root causes of known failures. FMAs are based on historical information including warranty data, field data, Service data, and / or process data.
FAULT TREE ANALYSIS - A deductive analytical technique that uses a Graphical tree to show cause and effect relationships between a single undesired event (failure) and the various contributing causes.
FUNCTIONAL CHECK REPORT - Certifies that a physically representative part installed in a vehicle performs in a accordance with the design intent. Element will be completed by program need date and will meet quality expectations.
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LESSON LEARNED - Problems, mistakes, things gone wrong / right (TGR, TGW) learned from reviewing similar part data. Information from in-plant manufacturing data, 8Ds, ES test data, user plant data, warranty data, Field data, service data, campaigns, recalls or other sources of information.
MISTAKE PROOFING - Techniques that use simple and inexpensive devices to prevent errors about to occur or detect errors and defects that have occurred.
PERCENT INDICES WHICH ARE PROCESS CAPABLE (PIPC) - The minimum number of points continually monitored to ensure control of the special characteristics or each operation of the manufacturing process. These points may be developed from surrogate parts if required.
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PERCENT INSPECTION POINTS WHICH SATISFY TOLERANCE (PIST)
PIST is the number of conforming inspection checks divided by the total number of checks made, times 100.
PRODUCT ASSURANCE PLAN - A prevention oriented management tool that addresses product and process design. It emphasizes FMA and process simulation. This plan is part of the overall Product Quality Plan.
PRODUCT TO PROCESS CHARACTERISTIC LINKAGES _ Astatistical relationship between product characteristics and key process characteristics found, using tools such as scatter plots and design of experiments.
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PRODUCT QUALITY TIMING PLAN - A supplier imitated plan that supports all elements of the APQP process. This plan includes supplier tasks, assignments, events, and timing required to ensure the system, subsystem or component meets customer expectations.
PROGRAM METRICS TRACKING AND TRENDS - A supplier led team that defines and monitors the status of key metrics used throughout the APQP process. Metrics may include cost, weight, quality targets, mean time to failure, reliability growth curves, 8D status, CR/ CR status and functional performance.
PROGRAM NEED DATA _ The last possible date the elements can be completed and not adversely affect quality or timing of program.
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PROTOTYPE - An initial or original model from subsequent copies are Made or improved models are developed.
QUALITY OPERATING SYSTEM (QOS) - A systematic disciplines approach that uses standardized tools and practices to manage the business and achieve ever increasing levels of customer satisfaction.
RED - Element will not be completed by program need date or will not Meet quality expectations. Program is at risk.
SYSTEM DESIGN SPECIFICATION (SDS) - A compilation of performance metrics for a system or subsystem. Performance metrics are measurable characteristics derived from customer expectations.
SUBCONTRACTOR - Provides of materials, parts, or services to a supplier
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SUBSYSTEM - A major part of a system which itself has the characteristics of a system, usually consisting of several components.
SUPPLIER - A provider of production materials, parts or service parts.
SYSTEM - A set of interdependent subsystems or parts linked to perform a specific function
THINGS GONE RIGHT (TGR) - Product attributes or characteristics that produce a positive reaction from customers.
THINGS GONE WRONG (TGW) - Product attributes or characteristics that produce a negative reaction from customers. TGW includes both components and correct component functions that do not meet customer expectations.
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YELLOW - Element may not be completed by program need date or may not meet quality expectations. Recovery plan is in place.
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S AIAG Automotive Industry Action group.
CFT Cross functional Team.
DCP Dynamic Control Plan( Dimensional Control Plan.
DFMEA Design Failure Mode and Effect Analysis
DOE Design of Experiments.
DVP&R Design Verification Plan and Report.
FMA Failure Mode Analysis.
FMEA Failure mode and effect Analysis.
FTC First time capability.
GR&R Gage Repeatability and Reproducibility
PFMEA Process failure mode and effect analysis.
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PQP Product Quality Planning.
PQPT Product Quality Planning Team.
QFD Quality Function Deployment.
QSR Quality System Requirements.
SFMEA System Failure Mode and Effects Analysis.
TGR Things gone right.
TGW Things gone wrong.
VE/VA Value Engineering / Value Analysis.
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