Apqp REV01

APQPCP
to the
Training Seminar
on
APQPCP
Nathan & Nathan Consultants Pvt. Ltd. NNCPL/PPT/001
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APQPCP
INTRODUCTION
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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APQPCP
INTRODUCTION
The 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 .
Nathan & Nathan Consultants Pvt. Ltd.
NNCPL/PPT/001
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APQPCP
THE APQP MODEL
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 customers requirements.
The commitment from the Top Management is an essential requirement for the success of this process.
NNCPL/PPT/001
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APQPCP
THE APQP MODEL
THE OBJECTIVENESS OF APQP 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
NNCPL/PPT/001
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APQPCP
THE APQP MODEL
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.
NNCPL/PPT/001
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APQPCP
THE APQP PHASES
Plan and Define Product Design and Development
PHASES
Process Design and Development
Product and Process Validation
Feedback, Assessment and Corrective Action
NNCPL/PPT/001
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APQPCP
RESPONSIBILITY MATRIX
THE PRODUCT QUALITY PLANNING RESPONSIBILITY MATRIX
Design Respons ible Manufactu ring Only Service Supplier Heat Treat, Warehousing, Transportation etc., X
Define the Scope Plan and Define Section 1.0 Product Design and Development Section 2.0 Feasibility Section 2.13 Process Design and Development 3.0 Product and Process Validation Section 4.0 Feedback, Assessment and Corrective Action-Section 5.0 Control Plan Methodology Section 6.0
X X X X X X X X
X X X X X
X X X X X
NNCPL/PPT/001
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APQPCP
PRODUCT QUALITY TIMING PLAN
The product quality planning teams 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.
NNCPL/PPT/001
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APQPCP
PLAN AND DEFINE PROGRAM
OBJECTIVES 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 strategy Product/process benchmark data Product/process assumptions Product reliability Customer inputs
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APQPCP
PLAN AND DEFINE PROGRAM
OUTPUTS Design goals Reliability and quality goals Preliminary bill of material Preliminary process flow chart Preliminary listing of special characteristics Product assurance plan Management support
product
and
process
NNCPL/PPT/001
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APQPCP
PRODUCT DESIGN & DEVELOPMENT
OBJECTIVES
Develop design features and characteristic Critically review engineering requirements Assess 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 Customer requirement ( special ch., identification, traceability,etc) Use of information Targets for product quality, life, reliability, durability, maintainability, timing and cost ) Management support
NNCPL/PPT/001
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APQPCP
OUTPUTS BY DESIGN RESPONSIBLE ACTIVITY
Design failure mode and effects analysis(DFMEA) Design for manufacturing and assembly Design verification Design reviews Prototype build control plan Engineering drawings (including math data) Engineering specifications Material specification Drawing and specification changes Product special characteristics Product error proofing as appropriate Product definition Diagnostic guidelines where applicable
NNCPL/PPT/001
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APQPCP
OUTPUTS BY PRODUCT QUALITY PLANNING TEAM New equipment tooling and facilities requirements Special product and process characteristics Gages/testing equipment requirement Team feasibility commitment and management support
NNCPL/PPT/001
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APQPCP
PROCESS DESIGN & DEVELOPMENT
OBJECTIVES
Develop a comprehensive and effective manufacturing system Ensure that the manufacturing systems meets customer requirements.
NNCPL/PPT/001
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APQPCP
INPUTS
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
NNCPL/PPT/001
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APQPCP
OUTPUTS
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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APQPCP
PRODUCT & PROCESS VALIDATION
OBJECTIVES
Validate the manufacturing process & the product Ensure that customers expectations will be met Identify additional concerns
NNCPL/PPT/001
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APQPCP
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 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
NNCPL/PPT/001
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APQPCP
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
NNCPL/PPT/001
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APQPCP
FEEDBACK, ASSESSMENT & CA
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 INPUTS 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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APQPCP
FEEDBACK, ASSESSMENT & CA
OUTPUTS Reduced variation Customer satisfaction Delivery and service
NNCPL/PPT/001
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APQPCP
PROGRAM MANAGEMENT
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
NNCPL/PPT/001
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APQPCP
PROGRAM MANAGEMENT
APQP TEAMS Team Composition Team 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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APQPCP
PROGRAM MANAGEMENT
Team 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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APQPCP
PLAN & DEFINE PROGRAM
OBJECTIVES
Determine customer needs Plan a quality programme
NNCPL/PPT/001
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APQPCP
INPUTS VOICE OF THE CUSTOMER Market Research Obtain market research data to reflect the needs expectations of the customer through Customer interviews Customer questionnaires and surveys New Product quality and reliability studies Competitive product quality studies Things Gone Right (TGR) reports Focus Group discussions
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APQPCP
Historical Warranty and Quality Information Asses customer and wants and the potential for their recurrence Things Gone Wrong (TGW) reports Warranty reports Capability indicators Supplier plant internal quality reports Problem resolution reports Customer plant returns and rejection Field return product analysis Product Sampling & Audit Reports
NNCPL/PPT/001
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APQPCP
Team Experience
Various reports of the organizations personnel Formal feedback from the customers visits tot the plant Past track records similar products performance consolidated during the various reviews meetings Collective experience of the team
NNCPL/PPT/001
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APQPCP
BUSINESS 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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APQPCP
PRODUCT / PROCESS BENCHMARK DATA Benchmarking helps to establish performance targets Identify appropriate benchmarks Identify comparative companies to collaborate for benchmarking Collect data and summarize Identify the gap between current status and the benchmark, and take one of the following actions: - Close the gap - Match the benchmark - Exceed the benchmark
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APQPCP
PRODUCT AND PROCESS ASSUMPTIONS Product and process assumptions presume the product has certain features, design or process concepts. Technical innovations Advanced materials Reliability assessments New technology
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APQPCP
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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APQPCP
CUSTOMER INPUTS OUTPUTS DESIGN GOALS Design goals are tentative and are measurable objectives based on : Product assumptions Functional performance Dimensions Weight Materials Aesthetic
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APQPCP
RELIABILITY AND QUALITY CONTROL Reliability and quality goals must include the following targets: Things Gone Wrong (TGW) targets Things Gone Right (TGR) targets Useful Life Reliability targets Warranty targets Incoming Quality targets Process Quality Targets Note: The above targets must address systems, sub-systems, Components & parts level
NNCPL/PPT/001
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APQPCP
PRELIMINARY BILL OF MATERIAL The team should establish a Preliminary bill of material based on Product process assumptions Include an early subcontractor list Select appropriate design and manufacturing process A 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 material Product/Process assumptions
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APQPCP
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 expectations Identification of reliability goals / requirements Identification of special process characteristics from manufacturing process Similar part FMEAs Earlier experience
EXERCISE 3 :
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APQPCP
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
NNCPL/PPT/001
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APQPCP
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.
NNCPL/PPT/001
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APQPCP
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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APQPCP
- 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
NNCPL/PPT/001
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APQPCP
FOR RISK ASSESSMENT CHECKLIST
CLICK HERE
NNCPL/PPT/001
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APQPCP
APQP STATUS REPORTING PROCESS
The Status reporting should cover the following hierarchy:
COMPONENT
SUBSYSTEM
SYSTEM
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APQPCP
APQP STATUS REPORTING PROCESS
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.
NNCPL/PPT/001
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APQPCP
OBJECTIVES Develop design features and characteristics Critically review engineering requirements Assess potential manufacturing problems INPUTS Design goals Reliability and quality goals Preliminary bill of material Preliminary process flow chart Preliminary listing of special characteristics Product assurance plan Management support
product
and
process
NNCPL/PPT/001
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APQPCP
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 :
NNCPL/PPT/001
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APQPCP
- 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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APQPCP
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.
NNCPL/PPT/001
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APQPCP
PROGRAM 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.
NNCPL/PPT/001
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APQPCP
DESIGN FOR MANUFACTURABILITY AND ASSEMBLY
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.
NNCPL/PPT/001
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APQPCP
DESIGN VERIFICATION
DESIGN VERIFICATION
OBJECTIVE
To ensure that the Design Output meets the Design Input requirements To develop a Design Verification Plan
DESIGN VERIFICATION PLAN

The Design Verification Plan is a single document containing both the Test Plan 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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APQPCP
DESIGN VERIFICATION
USES 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
NNCPL/PPT/001
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APQPCP
DESIGN VERIFICATION
PROGRAM 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.
NNCPL/PPT/001
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APQPCP
DESIGN REVIEW
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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APQPCP
DESIGN REVIEW
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
NNCPL/PPT/001
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APQPCP
PROTO-TYPE CPONTROL PLAN
PROTOTYPE 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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APQPCP
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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APQPCP
- 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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APQPCP
SPECIFICATIONS AND CHANGES
ENGINEERING DRAWINGS SPECIFICATIONS MATERIAL SPECIFICATIONS 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 teams responsibility to review engineering drawings
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APQPCP
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 customers system
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APQPCP
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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APQPCP
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 suppliers or subcontractors material has been approved.
NNCPL/PPT/001
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APQPCP
NEW EQUIPMENT, TOOLING, GAUGES/TESTING FACILITIES
OUTPUTS BY PRODUCT QUALITY PLANNING TEAM NEW EQUIPMENT TOOLING. 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.
GAGES/TESTING
AND
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APQPCP
NEW EQUIPMENT, TOOLING, GAUGES/TESTING FACILITIES
PROGRAM MANAGEMENT RESPONSIBILITY 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 builders 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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APQPCP
SPECIAL PRODUCT & PROCESS CHARACTERISTIC
OBJECTIVES
To identify the Special Product & Process Characteristics To ensure that they are adequately reviewed through FMEA and addressed in Control Plans Their Designation is consistent with the suppliers system and Customers Expectations
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 suppliers system There is an assessment of potential risks with these characteristics and corrective actions are initiated in advance through Statistical Studies, Mistake proofing, etc.
NNCPL/PPT/001
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APQPCP
TEAM FEASIBILITY COMMITMENT & MANAGEMENT SUPPORT
OBJECTIVES
The Advanced Product Quality Planning Team must assess the feasibility of manufacturing the proposed design. Customer design ownership does not preclude the suppliers 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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APQPCP
TEAM FEASIBILITY COMMITMENT & MANAGEMENT SUPPORT
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
NNCPL/PPT/001
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APQPCP
OBJECTIVES
Develop design features and characteristic Critically review engineering requirements Assess 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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APQPCP
PACKAGING STANDARDS
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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APQPCP
PACKAGING STANDARDS
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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APQPCP
PROCESS FLOW CHART
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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APQPCP
PROCESS FLOW CHART
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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PROCESS FLOW CHART
FOR PROCESS FLOWCHART CHECKLIST
CLICK HERE
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APQPCP
FLOOR PLAN LAYOUT
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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APQPCP
CHARACTERISTIC MATRIX
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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APQPCP
CHARACTERISTIC MATRIX
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
* C L A T M Indicates a characteristic is cut or changed Indicates a characteristic is used for clamping Indicates a characteristic is used for location in a subsequent Operation Affects a subsequent operation or other characteristic Indicates relationships within an operation, such as common tools or tool head Characteristic is automatically monitored
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APQPCP
PFMEA
PROCESS FAILURE MODE AND EFFECTS ANALYSIS (PFMEA) OBJECTIVES
The 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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APQPCP
PFMEA
Note : Output from the PFMEA is used as a basis for : Control Plan development Preliminary Process Capability Study Plan development Finalisation of special product and process characteristics Development of Process and monitoring instructions
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APQPCP
PFMEA
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 Manual Characteristics Matrix Warranty information Customer Complaints and Returns Data Corrective or Preventive Actions Process Flow Chart System and / or Design FMEA PFMEA for similar products or processes Internal Quality Reports
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APQPCP
PFMEA
The Team Leader and APQP team should manage the construction of the process FMEA and assess the finished document to ensure that the following expectations are 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
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PFMEA
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 levels
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PFMEA
FOR PROCESS FMEA CHECKLIST
CLICK HERE
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APQPCP
PRE-LAUNCH CONTROL PLAN
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 crossfunctional 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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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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APQPCP
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 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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APQPCP
PROCESS INSTRUCTIONS
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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APQPCP
PROCESS INSTRUCTIONS
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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APQPCP
MEASUREMENT SYSTEM EVALUATION PLAN
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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PRELIMINARY PROCESS CAPABILITY STUDY PLAN
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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APQPCP
PACKAGING EVALUATION
OBJECTIVES
To ensure that individual product packaging (including interior partitions) is designed and developed.

Manage and assess packaging design and evaluation to ensure meeting the Following 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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APQPCP
OBJECTIVES
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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APQPCP
PRODUCTION TRIAL RUN
OBJECTIVES
To ensure the effectiveness of the manufacturing process, using production Tooling, equipment, environment (including production operators), facilities and cycle times.

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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PRODUCTION TRIAL RUN
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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APQPCP
MEASUREMENT SYSTEM EVALUATION
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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APQPCP
PRELIMINARY PROCESS CAPABILITY STUDY
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 customers requirements.
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APQPCP
PRELIMINARY PROCESS CAPABILITY STUDY
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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APQPCP
PRODUCTION PART APPROVAL PROCESS
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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APQPCP
PRODUCTION VALIDATION TESTING
OBJECTIVES 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.
101.
APQPCP
PACKAGING EVALUATION
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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APQPCP
PRODUCTION CONTROL PLAN
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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APQPCP
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 crossfunctional during their meetings. Advanced Product Quality Planning and Control Plan AIAG Reference Manual Customer Prints In-process Prints Customer and Internal Specifications 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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APQPCP
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 used
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APQPCP
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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APQPCP
QUALITY PLANNING SIGN-OFF & MANAGEMENT SUPPORT
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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CONTINUOUS IMPROVEMENT
FEEDBACK, ASSESSMENT & CORRECTIVE ACTIONS 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 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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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 customers prerogative.
110.
APQPCP
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 customers 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 suppliers 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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APPENDIX
PROCESS FMEA
FAILURE MODE AND EFFECT ANALYSIS (FMEA) ORIGIN
US SPACE PROGRAM & DEFENCE SAFETY SYSTEM IN 1960S.
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COMMON DEFINITIONS
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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COMMON DEFINITIONS
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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COMMON DEFINITIONS
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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COMMON DEFINITIONS
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 ASSLY OPN.,
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COMMON DEFINITIONS
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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COMMON DEFINITIONS
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 RPNs for respective potential cause of failure, priortise preventive action directed fist at highest ranked RPNs and severity rank.
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COMMON DEFINITIONS
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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COMMON DEFINITIONS
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 OCCUR, BUT MAY NOT NECESSARY OCCUR. COULD
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COMMON DEFINITIONS
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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COMMON DEFINITIONS
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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COMMON DEFINITIONS
THREE TYPES CONSIDER: OF PROCESS CONTROL /FEATURES TO
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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COMMON DEFINITIONS
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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COMMON DEFINITIONS
RECOMMENDED ACTIONS (S)
ACTIONS ON
1. 2. HIGHEST RANK RPN/SEVERITY WHICH COULD BE HAZARDOUS TO MFG/ASSLY PERSONNEL
- PERMANENT CORRECTIVE ACTION IS REQUIRED - EMPHASIS MUST BE ON PREVENTING DEFECTS
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COMMON DEFINITIONS
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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COMMON DEFINITIONS
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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COMMON DEFINITIONS
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 failure
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COMMON DEFINITIONS
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 RPN
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COMMON DEFINITIONS
PROCESS FMEA FLOW CHART /RISK ASSESSMENT EXAMPLE (Application of Wax to Inside of Door) Process Step
1. Get wax applicator wand from holder 2. Open vehicle Door
Risk Assessment
Low Low
3. Insert wand and pull trigger for 12 secs.

While making three passes 4. Release trigger wait 3 secs. 5. Remove Wand
High
Medium Medium
6. Close vehicle door

7. Replace applicator wand in holder * FMEA required ( high risk )
Low
Low
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COMMON DEFINITIONS
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.
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COMMON DEFINITIONS
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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COMMON DEFINITIONS
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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COMMON DEFINITIONS
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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COMMON DEFINITIONS
MATERIAL PROCESS : MATERIAL OR COMPONENT DOMINANT
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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APQPCP
COMMON DEFINITIONS
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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COMMON DEFINITIONS
METHODS: PROCESS: PREVENTIVE MAINTANANCE DOMINANT
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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COMMON DEFINITIONS
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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COMMON DEFINITIONS
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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GLOSSARY
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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GLOSSARY
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 Programs Chief Engineer and Team Leader. ELEMENT - Specific documents, tasks and disciplines which must be Completed to support the customers 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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GLOSSARY
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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GLOSSARY
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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GLOSSARY
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 _ A statistical relationship between product characteristics and key process characteristics found, using tools such as scatter plots and design of experiments.
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APQPCP
GLOSSARY
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.
NNCPL/PPT/001
146.
APQPCP
GLOSSARY
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
147.
APQPCP
GLOSSARY
SUBSYSTEM characteristics components. SUPPLIER parts. - A major part of a system which itself has the of a system, usually consisting of several A provider of production materials, parts or service
SYSTEM - A set of interdependent subsystems or parts linked to perform a specific function THINGS GONE RIGHT (TGR) Product attributes 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. or
NNCPL/PPT/001
148.
APQPCP
GLOSSARY
YELLOW - Element may not be completed by program need date or may not meet quality expectations. Recovery plan is in place.
NNCPL/PPT/001
149.
APQPCP
ACRONYMS
AIAG CFT DCP DFMEA DOE DVP&R FMA FMEA FTC GR&R PFMEA Automotive Industry Action group. Cross functional Team. Dynamic Control Plan( Dimensional Control Plan. Design Failure Mode and Effect Analysis Design of Experiments. Design Verification Plan and Report. Failure Mode Analysis. Failure mode and effect Analysis. First time capability. Gage Repeatability and Reproducibility Process failure mode and effect analysis.
NNCPL/PPT/001
150.
APQPCP
ACRONYMS
PQP PQPT QFD QSR SFMEA Product Quality Planning. Product Quality Planning Team. Quality Function Deployment. Quality System Requirements. System Failure Mode and Effects Analysis.
TGR
TGW VE/VA
Things gone right.

Things gone wrong. Value Engineering / Value Analysis.
NNCPL/PPT/001
151.
APQPCP
NNCPL/PPT/001
152.

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APQPCP

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An element of Continuous Improvement is built into the company.

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Process Design and Development

Product and Process Validation

Feedback, Assessment and Corrective Action

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Determine customer needs Plan a quality programme

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Feature of the Status Report

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DESIGN FAILURE MODE AND EFFECTS ANALYSIS (DFMEA)

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DESIGN VERIFICATION PLAN

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PROGRAM MANAGEMENT RESPONSIBILITY