Product Quality Planning is a structured method of defining and establishing the steps necessary to assure that a product satisfies the customer. The goal of product quality planning is to facilitate communication with everyone involved to assure that all required steps are completed on time. Effective product quality planning depends on a company’s top management commitment to the effort required in achieving customer satisfaction. Some of the benefits of product quality planning are:
- To direct resources to satisfy the customer.
- To promote early identification of required changes.
- To avoid late changes.
- To provide a quality product on time at the lowest cost.
The work practices, tools, and analytical techniques described in this manual are listed in a logical sequence to make it easy to follow. Each Product Quality Plan is unique. The actual timing and sequence of execution is dependent on customer needs and expectations and/or other practical matters. The earlier a work practice, tool, and/or analytical technique can be implemented in the Product Quality Planning Cycle, the better.
Organize the Team:The organization’s first step in product quality planning is to assign a process owner for the APQP project. In addition, a cross functional team should be established to assure effective product quality planning. The team should include representatives from multiple functions such as engineering, manufacturing, material control, purchasing, quality, human resources, sales, field service, suppliers, and customers, as appropriate.
Define the Scope: It is important for the organization’s product quality planning team in the earliest stage of the product program to identify customer needs, expectations, and requirements. At a minimum, the team must meet to:
- Select a project team leader responsible for overseeing the planning process. (In some cases it may be advantageous to rotate the team leader during the planning cycle.)
- Define the roles and responsibilities of each area represented.
- Identify the customers – internal and external.
- Define customer requirements. (Use QFD if applicable.)
- Select the disciplines, individuals, and/or suppliers that must be added to the team, and those not required
- Understand customer expectations, i.e., design, number of tests.
- Assess the feasibility of the proposed design, performance requirements and manufacturing process.
- Identify costs, timing, and constraints that must be considered.Determine assistance required from the customer.
- Identify documentation process or method.
Team-to-Team: The organization’s product quality planning team must establish lines of communication with other customer and organization teams. This may include regular meetings with other teams. The extent of team-to-team contact is dependent upon the number of issues requiring resolution.
Training: The success of a Product Quality Plan is dependent upon an effective training program that communicates all the requirements and development skills to fulfill customer needs and expectations.
Customer and Organization Involvement: The primary customer may initiate the quality planning process with an organization. However, the organization has an obligation to establish a cross functional team to manage the product quality planning process. Organizations must expect the same performance from their suppliers.
Simultaneous Engineering: Simultaneous Engineering is a process where cross functional teams strive for a common goal. It replaces the sequential series of phases where results are transmitted to the next area for execution. The purpose is to expedite the introduction of quality products sooner. The organization’s product quality planning team assures that other areas/teams plan and execute activities that support the common goal or goals
Control Plans: Control plans are written descriptions of the systems for controlling parts and processes. Separate control plans cover three distinct phases:
- Prototype – A description of the dimensional measurements and material and performance tests that will occur during Prototype build
- Pre-launch – A description of the dimensional measurements and material and performance tests that will occur after Prototype and before full Production.
- Production – A comprehensive documentation of product/process characteristics, process controls, tests, and measurement systems that will occur during mass production.
Concern Resolution: During the planning process, the team will encounter product design and/or processing concerns. These concerns should be documented on a matrix with assigned responsibility and timing. Disciplined problem- solving methods are recommended in difficult situations. Analytical techniques described in Appendix B should be used as appropriate.
Product Quality Timing Plan: The organization’s product quality planning team’s first order of business following organizational activities should be the development of a Timing Plan. The type of product, complexity and customer expectations should be considered in selecting the timing elements that must be planned and charted. All team members should agree with each event, action, and timing. A well-organized timing chart should list tasks, assignments, and/or other events. (The Critical Path Method may be appropriate;) Also, the chart provides the planning team with a consistent format for tracking progress and setting meeting agendas. To facilitate status reporting, each event must have a “start” and a “completion” date with the actual point of progress recorded. Effective status reporting supports program monitoring with a focus on identifying items that require special attention.
Plans Relative to the Timing Chart: The success of any program depends on meeting customer needs and expectations in a timely manner at a cost that represents value. The Product Quality Planning Timing Chart below and the Product Quality Planning Cycle described previously require a planning team to concentrate its efforts on problem prevention. Problem prevention is driven by Simultaneous Engineering performed by product and manufacturing engineering activities working concurrently. Planning teams must be prepared to modify product quality plans to meet customer expectations. The organization’s product quality planning team is responsible for assuring that timing meets or exceeds the customer timing plan.
1.0 Plan and Define Program
IT describes how customer needs and expectations are linked to planning and defining a quality program. The goal of any product program is meeting customer needs while providing competitive value. The initial step of the product quality planning process is to ensure that customer needs and expectations are clearly understood.The inputs and outputs applicable to the planning process may vary according to the product development process, and customer needs and expectations.
INPUTS
- Voice of the Customer
- Market Research (including OEM Vehicle Build Timing and OEM Volume Expectations)
- Historical Warranty and Quality Information
- Team Experience
- Business Plan/Marketing Strategy
- Product/Process Benchmark Data
- Product/Process Assumptions
- Product Reliability Studies
- Customer Inputs
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 (including program timing and planning for resources and staffing to support required capacity)
1.1 Voice of the Customer
The “Voice of the Customer” encompasses complaints, recommendations, data and information obtained from internal and/or external customers. Some methods for gathering this information are as follows.
1.1.1 Market Research
The organization’s product quality planning team may need to obtain market research data and information reflecting the Voice of the Customer. The following sources can assist in identifying customer concerns and wants and translating those concerns into product and process characteristics:
- Customer interviews
- Customer questionnaires and surveys
- Market test and positioning reports
- New product quality and reliability studies
- Competitive product quality studies
- Best Practices
- Lessons Learned
1.1.2 Historical Warranty and Quality Information
A list of historical customer concerns and wants should be prepared to assess the potential for recurrence during the design, manufacture, installation and use of the product. These should be considered as an extension of the other design requirements and included in the analysis of customer needs. Many of the following items can assist the team in identifying customer concerns and wants and prioritizing appropriate resolutions.
- Best Practices
- Lessons Learned
- Warranty reports
- Capability indicators
- Supplier plant internal quality reports
- Problem resolution reports
- Customer plant returns and rejections
- Field return product analysis
1.1.3 Team Experience
The team may use any source of any information as appropriate, including the following:
- Input from higher system level or past Quality Function Deployment (QFD) projects
- Media commentary and analysis: magazine and newspaper reports, etc
- Customer letters and suggestions
- Best Practices
- Lessons Learned
- Dealer comments
- Fleet Operator’s comments
- Field service reports
- Internal evaluations using surrogate customers
- Road trips
- Management comments or direction
- Problems and issues reported from internal customers
- Government requirements and regulations
- Contract review
1.2 Business Plan and Marketing Strategy
The customer business plan and marketing strategy will set the framework for the product quality plan. The business plan may place constraints (e.g., timing, cost, investment, product positioning, research and development (R&D) resources) on the team that affect the direction taken. The marketing strategy will define the target customer, the key sales points, and key competitors.
1.3 Product/Process Benchmark Data
The use of bench-marking will provide input to establishing product/process performance targets. Research and development may also provide benchmarks and concept ideas. One method to successful bench-marking is:
- Identify the appropriate benchmarks.
- Understand the reason for the gap between your current status and the benchmark.
- Develop a plan to close the gap, match the benchmark, or exceed the benchmark.
1.4 Product/Process Assumptions
There will be assumptions that the product has certain features, design, or process concepts. These include technical innovations, advanced materials, reliability assessments, and new technology. All should be utilized as inputs.
1.5 Product Reliability Studies
This type of data considers frequency of repair or replacement of components within designated periods of time and the results of long-term reliability/durability tests.
1.6 Customer Inputs
The next users of the product can provide valuable information relating to their needs and expectations. In addition, the next product users may have already conducted some or all of the aforementioned reviews and studies. These inputs should be used by the customer and/or organization to develop agreed upon measures of customer satisfaction.
1.7 Design Goals
Design goals are a translation of the Voice of the Customer into measurable design objectives. The proper selection of design goals assures that the Voice of the Customer is not lost in subsequent design activity. The Voice of the Customer also includes regulatory requirements such as materials composition reporting and polymeric part marking.
1.8 Reliability and Quality Goals
Reliability goals are established based on customer wants and expectations, program objectives, and reliability benchmarks. An example of customer wants and expectations could include no safety failures. Some reliability benchmarks could be competitor product reliability, warranty data, or frequency of repair over a set time period. Quality goals should be based on metrics such as parts per million, problem levels, or scrap reduction.
1.9 Preliminary Bill of Material
The team should establish a preliminary bill of material based on product/process assumptions and include a potential supplier list. In order to identify the preliminary special product/process characteristics it is necessary to have selected the appropriate design and manufacturing process.
1.10 Preliminary Process Flow Chart
The anticipated manufacturing process should be described using a process flow chart developed from the preliminary bill of material and product/process assumptions.
1.11 Preliminary Identification of Special Product and Process Characteristics
Special product and process characteristics are identified by the customer in addition to those selected by the organization through knowledge of the product and process. Examples of input to identification of special characteristics include:
- Product assumptions based on the analysis of customer needs and expectations.
- Identification of reliability goals and requirements.
- Identification of special process characteristics from the anticipated manufacturing process.
- Similar part FMEAs.
1.12 Product Assurance Plan
The Product Assurance Plan translates design goals into design requirements and is based on customer needs and expectations. This manual does not require a specific method for preparing a Product Assurance Plan. The Product Assurance Plan can be developed in any format understood by the organization and should include:
- Outlining of program requirements.
- Identification of reliability, durability, and apportionment/allocation goals and/or requirements.
- Assessment of new technology, complexity, materials, application, environment, packaging, service, and manufacturing requirements, or any other factor that may place the program at risk.
- Use of Failure Mode and Effects Analysis (FMEA).
- Development of preliminary engineering requirements.
1.13 Management Support
One of the keys to the success of Advanced Product Quality Planning is the interest, commitment and support of upper management. Participation by management in product quality planning meetings is vital to ensuring the success of the program. Management should be updated at the conclusion of every product quality planning phase to reinforce their commitment and support. Updates and/or requests for assistance can occur more frequently as required. A primary goal of Advanced Product Quality Planning is to maintain management support by demonstrating that all planning requirements have been met and/or concerns documented and scheduled for resolution, including program timing and planning for resources and staffing to support required capacity
2.0 Product Design and Development
It discusses the elements of the planning process during which design features and characteristics are developed into a near final form. All design factors should be considered by the organization in the Advanced Product Quality Planning process even if the design is owned by the customer or shared. The steps include prototype build to verify that the product or service meets the objectives of the Voice of the Customer. A feasible design must permit meeting production volumes and schedules, and be consistent with the ability to meet engineering requirements, along with quality, reliability, investment cost, weight, unit cost and timing objectives. Although feasibility studies and control plans are primarily based on engineering drawings and specification requirements, valuable information can be derived from the analytical tools described in this chapter to further define and prioritize the characteristics that may need special product and process controls.In this chapter, the Product Quality Planning Process is designed to assure a comprehensive and critical review of engineering requirements and other related technical information. At this stage of the process, a preliminary feasibility analysis will be made to assess the potential problems that could occur during manufacturing.
DESIGN INPUTS
- Design Goals
- Reliability and Quality Goals
- Preliminary Bill of Material
- Preliminary Process Flow Chart
- Preliminary Listing of Special Product and Process Characteristics
- Product Assurance Plan
- Management Support
DESIGN OUTPUTS
- Design Failure Mode and Effects Analysis (DFMEA)
- Design for Manufacturability and Assembly
- Design Verification
- Design Reviews
- Prototype Build – Control Plan
- Engineering Drawings (Including Math Data)
- Engineering Specifications
- Material Specifications
- Drawing and Specification Changes
APQP OUTPUTS
- New Equipment, Tooling and Facilities Requirements
- Special Product and Process Characteristics
- Gages/Testing Equipment Requirements
- Team Feasibility Commitment and Management Support
2.1 Design Failure Mode and Effects Analysis (DFMEA)
The DFMEA is a disciplined analytical technique that assesses the probability of failure as well as the effect of such failure. A DFMEA is a living document continually updated as customer needs and expectations require. The DFMEA is an important input to the APQP process that may include previously selected product and process characteristics. The Design FMEA Checklist should also be reviewed to assure that the appropriate design characteristics have been considered.
2.2 Design for Manufacturability and Assembly
Design for Manufacturability and Assembly is a Simultaneous Engineering process designed to optimize the relationship between design function, manufacturability, and ease of assembly. The scope of customer needs and expectations defined will determine the extent of the organization’s product quality planning team involvement in this activity. This manual does not include or refer to a formal method of preparing a Design for Manufacturability and Assembly Plan. At a minimum, the items listed here should be considered by the organization’s product quality planning team:
- Design, concept, function, and sensitivity to manufacturing variation
- Manufacturing and/or assembly process
- Dimensional tolerances
- Performance requirements
- Number of components
- Process adjustments
- Material handling
The above list may be augmented based on the organization’s product quality planning team’s knowledge, experience, the product/process, government regulations, and service requirements.
2.3 Design Verification
Design verification verifies that the product design meets the customer requirements derived from the activities.
2.4 Design Reviews
Design reviews are regularly scheduled meetings led by the organization’s design engineering activity and must include other affected areas. The design review is an effective method to prevent problems and misunderstandings; it also provides a mechanism to monitor progress, report to management, and obtain customer approval as required.Design reviews are a series of verification activities that are more than an engineering inspection. At a minimum, design reviews should include evaluation of:
- Design/Functional requirement(s) considerations
- Formal reliability and confidence goals
- Component/subsystem/system duty cycles
- Computer simulation and bench test results
- DFMEA(s)
- Review of the Design for Manufacturability and Assembly effort
- Design of Experiments (DOE) and assembly build variation results
- Test failures
- Design verification progress
A major function of design reviews is the tracking of design verification progress. The organization should track design verification progress through the use of a plan and report format, referred to as Design Verification Plan and Report (DVP&R) by some customers. The plan and report is a formal method to assure:
- Design verification
- Product and process validation of components and assemblies through the application of a comprehensive test plan and report.
The organization’s product quality planning team is not limited to the items listed. The team should consider and use as appropriate, the analytical techniques.
2.5 Prototype Build – Control Plan
Prototype control plans are a description of the dimensional measurements and material and functional tests that will occur during prototype build. The organization’s product quality planning team should ensure that a prototype control plan is prepared. A Control Plan Checklist is provided to assist in the preparation of the prototype control plan.The manufacture of prototype parts provides an excellent opportunity for the team and the customer to evaluate how well the product or service meets the Voice of the Customer objectives. It is the organization’s product quality planning team’s responsibility to review prototypes for the following:
- Assure that the product or service meets specification and report data as required.
- Ensure that particular attention has been given to special product and process characteristics.
- Use data and experience to establish preliminary process parameters and packaging requirements.
- Communicate any concerns, deviations, and/or cost impact to the customer.
2.6 Engineering Drawings (Including Math Data)
Customer designs do not preclude the organization’s product quality planning team’s responsibility to review engineering drawings in the following manner. Engineering drawings may include special (governmental regulatory and safety) characteristics that must be shown on the control plan. When customer engineering drawings are nonexistent, the controlling drawings should be reviewed by the 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. If appropriate, the team should assure that math data is compatible with the customer’s system for effective two-way communications.
2.7 Engineering Specifications
A detailed review and understanding of the controlling specifications will help the organization’s product quality planning team to identify the functional, durability and appearance requirements of the subject component or assembly. Sample size, frequency, and acceptance criteria of these parameters are generally defined in the in-process test section of the Engineering Specification. Otherwise, the sample size and frequency are to be determined by the organization and listed in the control plan. In either case, the organization should determine which characteristics affect meeting functional, durability, and appearance requirements.
2.8 Material Specifications
In addition to drawings and performance specifications, material specifications should be reviewed for special characteristics relating to physical properties, performance, environmental, handling, and storage requirements. These characteristics should also be included in the control plan.
2.9 Drawing and Specification Changes
Where drawing and specification changes are required, the team must ensure that the changes are promptly communicated and properly documented to all affected areas.
2.10 New Equipment, Tooling and Facilities Requirements
The DFMEA, Product Assurance Plan and/or design reviews may identify new equipment and facilities including meeting capacity requirements. The organization’s product quality planning team should address these requirements by adding the items to the Timing Chart. The team should assure that there is a process to determine that new equipment and tooling is capable and delivered on time. Facilities progress should be monitored to assure completion prior to planned production tryout.
2.11 Special Product and Process Characteristics
In the Plan and Define Program stage, the team identified preliminary special product and process characteristics. The organization’s product quality planning team should build on this listing and reach consensus through the evaluation of the technical information. The organization should refer to the appropriate customer-specific requirements
2.12 Gages/Testing Equipment Requirements
Gages/testing equipment requirements may also be identified at this time. The organization’s product quality planning team should add these requirements to the Timing Chart. Progress should be monitored to assure that required timing is met.
2.13 Team Feasibility Commitment and Management Support
The organization’s product quality planning team must assess the feasibility of the proposed design at this time. Customer design ownership does not preclude the organization’s obligation to assess design feasibility. The team must be satisfied that the proposed design can be manufactured, assembled, tested, packaged, and delivered in sufficient quantity on schedule at an acceptable cost to the customer. The Design Information Checklist allows the team to review its efforts in this section and make an evaluation of effectiveness. This checklist will also serve as a basis for the open issues discussed in the Team Feasibility Commitment. The team consensus that the proposed design is feasible should be documented along with all open issues that require resolution and presented to management for their support.
3.0 Process Design and Development
It discusses the major features of developing a manufacturing system and its related control plans to achieve quality products. The tasks to be accomplished at this step of the product quality planning process depend upon the successful completion of the prior stages contained in the first two sections. This next step is designed to ensure the comprehensive development of an effective manufacturing system. The manufacturing system must assure that customer requirements, needs and expectations are met. The inputs and outputs applicable to the process step in this chapter are as follows:
INPUTS
- Design Failure Mode and Effects Analysis (DFMEA)
- Design for Manufacturability 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 Requirements
- Team Feasibility Commitment and Management Support
OUTPUTS
- Packaging Standards & Specifications
- Product/Process Quality System Review
- Process Flow Chart
- Floor Plan Layout
- Characteristics Matrix
- Process Failure Mode and Effects Analysis (PFMEA)
- Pre-Launch Control Plan (including Error-Proofing Devices)
- Process Instructions
- Measurement Systems Analysis Plan
- Preliminary Process Capability Study Plan
- Management Support (including operator staffing and training plan)
3.1 Packaging Standards and Specifications
The customer will usually have packaging requirements that should be incorporated into any packaging specifications for the product. If none are provided, the packaging design should ensure product integrity at point of use. The organization’s product quality planning team should ensure that individual product packaging (including interior partitions) is designed and developed. Customer packaging standards or generic packaging requirements should be used when appropriate. In all cases the packaging design should assure that the product performance and characteristics will remain unchanged during packing, transit, and unpacking. The packaging should have compatibility with all identified material handling equipment including robots.
3.2 Product/Process Quality System Review
The organization’s product quality planning team should review the manufacturing site(s) Quality Management System. Any additional controls and/or procedural changes required to produce the product should be updated, documented and included in the manufacturing control plan. This is an opportunity for the organization’s product quality planning team to improve the existing quality system based on customer input, team expertise, and previous experience. The Product/Process Quality Checklist can be used by the organization’s product quality planning team to verify completeness.
3.3 Process Flow Chart
The process flow chart is a schematic representation of the current or proposed process flow. It can be used to analyze sources of variations of machines, materials, methods, and manpower from the beginning to end of a manufacturing or assembly process. It is used to emphasize the impact of sources of variation on the process. The flow chart helps to analyze the total process rather than individual steps in the process. The flow chart assists the organization’s product quality planning team to focus on the process when conducting the PFMEA and designing the Control Plan. The Process Flow Chart Checklist can be used by the organization’s product quality planning team to verify completeness.
3.4 Floor Plan Layout
The floor plan should be developed and reviewed to determine the acceptability of important control items, such as inspection points, control chart location, applicability of visual aids, interim repair stations, and storage areas to contain non-conforming material. All material flow should be keyed to the process flow chart and control plan. The Floor Plan Checklist can be used by the organization’s product quality planning team to verify completeness. The floor plan layout should be developed in such a manner to optimize the material travel, handling and value-added use of floor space and should facilitate the synchronous flow of materials through the process.
3.5 Characteristics Matrix
A characteristics matrix is a recommended analytical technique for displaying the relationship between process parameters and manufacturing stations.
3.6 Process Failure Mode and Effects Analysis (PFMEA)
A PFMEA should be conducted during product quality planning and before beginning production. It is a disciplined review and analysis of a new or revised process and is conducted to anticipate, resolve, or monitor potential process problems for a new or revised product program. The Process FMEA Checklist i can be used by the organization’s product quality planning team to verify completeness.
3.7 Pre-Launch Control Plan
Pre-launch control plans are a description of the dimensional measurements and material and functional tests that will occur after prototype and before full production. The pre-launch control plan should include additional product/process controls to be implemented until the production process is validated. The purpose of the pre-launch control plan is to contain potential non-conformities during or prior to initial production runs. Examples of enhancements in the pre-launch control plan are:
- More frequent inspection
- More in-process and final check points
- Robust statistical evaluations
- Enhanced audits
- Identification of error-proofing devices
The Control Plan can be used by the organization’s product quality planning team to verify completeness.
3.8 Process Instructions
The organization’s product quality planning team should ensure that process instructions provide sufficient understanding and detail for all personnel who have direct responsibility for the operation of the processes. These instructions should be developed from the following sources:
- FMEAs
- Control plan(s)
- Engineering drawings, performance specifications, material specifications, visual standards and industry standards
- Process flow chart
- Floor plan layout
- Characteristics matrix
- Packaging Standards and Specifications
- Process parameters
- Organization expertise and knowledge of the processes and products
- Handling requirements
- Operators of the process
The process instructions for standard operating procedures should be posted and should include set-up parameters such as: machine speeds, feeds, cycle times, and tooling, and should be accessible to the operators and supervisors. Additional information for process instruction preparation may be found in appropriate customer-specific requirements.
3.9 Measurement Systems Analysis Plan
The organization’s product quality planning team should ensure that a plan to accomplish the required measurement systems analysis is developed, including checking aids. This plan should include, at a minimum, a laboratory scope appropriate for the required measurements and tests, the responsibility to ensure gage linearity, accuracy, repeatability, reproducibility, and correlation for duplicate gages.
3.10 Preliminary Process Capability Study Plan
The organization’s product quality planning team should ensure the development of a preliminary process capability plan. The characteristics identified in the control plan will serve as the basis for the preliminary process capability study plan. .
3.11 Management Support
The organization’s product quality planning team should schedule a formal review designed to reinforce management commitment at the conclusion of the process design and development phase. This review is critical to keeping upper management informed as well as gaining assistance to assist in resolution of any open issues. Management support includes the confirmation of the planning and providing the resources and staffing to meet the required capacity.
4.0 Product and Process Validation
IT discusses the major features of validating the manufacturing process through an evaluation of a significant production run. During a significant production run, the organization’s product quality planning team should validate that the control plan and process flow chart are being followed and the products meet customer requirements. Additional concerns should be identified for investigation and resolution prior to regular production runs.The inputs and outputs applicable to the process steps in this chapter are as follows:
INPUTS
- Packaging Standards & Specifications
- 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 Instructions
- Measurement Systems Analysis Plan
- Preliminary Process Capability Study Plan
- Management Support
OUTPUTS
- Significant Production Run
- Measurement Systems Evaluation
- Preliminary Process Capability Study
- Production Part Approval
- Production Validation Testing
- Packaging Evaluation
- Production Control Plan
- Quality Planning Sign-Off and Management Support
4.1 Significant Production Run
The significant production run must be conducted using production tooling, production equipment, production environment (including production operators), facility, production gages and production rate. The validation of the effectiveness of the manufacturing process begins with the significant production run . The minimum quantity for a significant production run is usually set by the customer, but can be exceeded by the organization’s product quality planning team. Output of the significant production run (product) is used for:
- Preliminary process capability study
- Measurement systems analysis
- Production rate demonstration
- Process review
- Production validation testing
- Production part approval
- Packaging evaluation
- First time capability (FTC)
- Quality planning sign-off
- Sample production parts
- Master sample (as required)
4.2 Measurement Systems Analysis
The specified monitoring and measuring devices and methods should be used to check the control plan identified characteristics to engineering specification and be subjected to measurement system evaluation during or prior to the significant production run. Refer to the Chrysler, Ford, and General Motors Measurement Systems Analysis (MSA) reference manual.
4.3 Preliminary Process Capability Study
The preliminary process capability study should be performed on characteristics identified in the control plan. The study provides an assessment of the readiness of the process for production. Refer to customer-specific requirements for unique requirements.
4.4 Production Part Approval
PPAP’s purpose is to provide the evidence that all customer engineering design record and specification requirements are properly understood by the organization and that the manufacturing process has the potential to produce product consistently meeting these requirements during an actual production run at the quoted production rate.
4.5 Production Validation Testing
Production validation testing refers to engineering tests that validate that products made from production tools and processes meet customer engineering standards including appearance requirements.
4.6 Packaging Evaluation
All test shipments (when required) and test methods must assess the protection of the product from normal transportation damage and adverse environmental factors. Customer-specified packaging does not preclude the organization’s product quality planning team involvement in evaluating the effectiveness of the packaging.
4.7 Production Control Plan
The production control plan is a written description of the systems for controlling production parts and processes. The production control plan is a living document and should be updated to reflect the addition or deletion of controls based on experience gained by producing parts. (Approval of the authorized customer representative may be required.) The production control plan is a logical extension of the pre-launch control plan. Mass production provides the organization the opportunity to evaluate output, review the control plan and make appropriate changes.
4.8 Quality Planning Sign-Off and Management Support
The organization’s product quality planning team should perform a review at the manufacturing location(s) and coordinate a formal sign-off. The product quality sign-off indicates to management that the appropriate APQP activities have been completed. The sign-off occurs prior to first product shipment and includes a review of the following:
- Process Flow Charts. Verify that process flow charts exist and are being followed.
- Control Plans. Verify that control plans exist, are available and are followed at all times for all affected operations.
- Process Instructions. Verify that these documents contain all the special characteristics specified in the control plan and that all PFMEA recommendations have been addressed. Compare the process instructions, PFMEA and process flow chart to the control plan.
- Monitoring and Measuring Devices. Where special gages, fixtures, test equipment or devices are required per the control plan, verify gage repeatability and reproducibility (GR&R) and proper usage.
- Demonstration of Required Capacity. Using production processes, equipment, and personnel.
Upon completion of the sign-off, a review with management should be scheduled to inform management of the program status and gain their support with any open issues.
5.0 Feedback, Assessment and Corrective Action
Quality planning does not end with process validation and installation. It is the component manufacturing stage where output can be evaluated when all special and common causes of variation are present. This is also the time to evaluate the effectiveness of the product quality planning effort. The production control plan is the basis for evaluating product or service at this stage. Variable and attribute data must be evaluated. Organizations that fully implement an effective APQP process will be in a better position to meet customer requirements including any special characteristics specified by the customer.
INPUTS
- Significant Production Run
- Measurement Systems Evaluation
- Preliminary Process Capability Study
- Production Part Approval
- Production Validation Testing
- Packaging Evaluation
- Production Control Plan
- Quality Planning Sign-Off and Management Support
OUTPUTS
- Reduced Variation
- Improved Customer Satisfaction
- Improved Delivery and Service
- Effective use of Lessons Learned/Best Practices
5.1 Reduced Variation
Control charts and other statistical techniques should be used as tools to identify process variation. Analysis and corrective actions should be used to reduce variation. Continual improvement requires attention not only to the special causes of variation but understanding common causes and seeking ways to reduce these sources of variation. Proposals should be developed including costs, timing, and anticipated improvement for customer review. The reduction or elimination of a common cause may provide the additional benefit of lower costs. Organizations should be using tools such as value analysis and reduction of variation to improve quality and reduce cost.
5.2 Improved Customer Satisfaction
Detailed planning activities and demonstrated process capability of a product or service are important components to customer satisfaction. However, the product or service still has to perform in the customer environment. This product usage stage requires organization participation. In this stage much can be learned by the organization and customer. The effectiveness of the product quality planning efforts can also be evaluated at this stage.The organization and customer become partners in making the changes necessary to correct any deficiencies and to improve customer satisfaction.
5.3 Improved Delivery and Service
The delivery and service stage of quality planning continues the organization and customer partnership in solving problems and continual improvement. The customer’s replacement parts and service operations must also meet requirements for quality, cost, and delivery. The goal is first time quality. However, where problems or deficiencies occur in the field it is essential that the organization and customer form an effective partnership to correct the problem and satisfy the end-user customer.The experience gained in this stage provides the customer and organization with the necessary knowledge to reduce process, inventory, and quality costs and to provide the right component or system for the next product.
5.4 Effective Use of Lessons Learned/Best Practices
A Lessons Learned or Best Practices portfolio is beneficial for capturing, retaining and applying knowledge. Input to Lessons Learned and Best Practices can be obtained through a variety of methods including:
- Review of Things Gone Right/Things Gone Wrong (TGR/TGW)
- Data from warranty and other performance metrics
- Corrective action plans”Read-across” with similar products and processes
- DFMEA and PFMEA studies
PRODUCT QUALITY PLANNING CHECKLISTS
The following checklists are provided to assist the organization’s product quality planning team in order to verify that the APQP process is both complete and accurate. These checklists are not intended to fully define or represent all elements of the APQP process. The use of the checklists is one of the last steps of the process and not intended as a “check the box” activity or exercise to circumvent full application of the APQP process. In reviewing the questions in the checklist, where “No” is identified as the appropriate response, the column “Comment/Action Required” is used to identify the action required to close the gap, including the impact on the APQP process. The follow up action should include identification of an individual responsible and schedule. Use the “Person Responsible” and “Due Date” columns.
ANALYTICAL TECHNIQUES
Assembly Build Variation Analysis: An assembly build variation analysis is an analysis that simulates the buildup of an assembly and examines tolerance accumulation, statistical parameters, sensitivity, and “what if” investigation.
Benchmarking: Benchmarking is a systematic approach to identifying standards for comparison. It provides input to the establishment of measurable performance targets, as well as ideas for product design and process design. It can also provide ideas for improving business processes and work procedures.Product and process benchmarking should include the identification of world class or best-in-class based on customer and internal objective performance measures and research into how this performance was achieved. Benchmarking should provide a stepping stone for developing new designs and processes that exceed the capabilities of the benchmark companies.
Cause and Effect Diagram: The “cause and effect” diagram is an analytical tool to indicate the relationship between an “effect” and all possible “causes” influencing it. This is sometimes referred to as fishbone diagram, Ishikawa diagram, or feather diagram.
Characteristics Matrix
A characteristics matrix is a display of the relationship between process parameters and manufacturing stations. A method of developing the characteristics matrix is to number the dimensions and/or features on the part print and each manufacturing operation. All manufacturing operations and stations appear across the top, and the process parameters are listed down the left-hand column. The more manufacturing relationships there are, the more important the control of a characteristic becomes. Regardless of matrix size, the upstream relationships of characteristics are evident. A typical matrix is shown below
CHARACTERISTICS MATRIX
(EXAMPLE)
| TOLERANCE | OPERATION NOS. | |||||
| DIM. | DESCRIPTION | 05 | 10 | 20 | 30 | |
| NO. | ||||||
| 1 | ID | X | C | X | ||
| 2 | FACE | X | C | C | ||
| 3 | X | L | L | |||
| 4 | X | |||||
| 5 | X | |||||
| 6 | OD | X | ||||
- C = Characteristic at an operation used for clamping
- L = Characteristic at an operation used for locating
- x = Characteristic created or changed by this operation should match the process flow diagram form
Critical Path Method
The critical path method can be a Pert or Gantt Chart that shows the chronological sequence of tasks that require the greatest expected time to accomplish. It can provide valuable information as to:
- Interrelationships
- Early Forecast of Problems
- Identification of Responsibility
- Resource Identification, Allocation and Leveling
Design of Experiments (DOE)
A design experiment is a test or sequence of tests where potential influential process variables are systematically changed according to a prescribed design matrix. The response of interest is evaluated under the various conditions to: (1) identify the influential variables among the ones tested, (2) quantify the effects across the range represented by the levels of the variables, (3) gain a better understanding of the nature of the causal system at work in the process, and (4) compare the effects and interactions. Application early in the product/process development cycle can result in: (1) improved process yields, (2) reduced variability around a nominal or target value, (3) reduced development time, and (4) reduced overall costs.
Design for Manufacturability and Assembly
Design for Manufacturability and Assembly is a Simultaneous Engineering process designed to optimize the relationship between design function, manufacturability, and ease of assembly. The enhancement of designs for assembly and manufacturing is an important step. Plant representatives should be consulted early in the design process to review components or systems and provide input on specific assembly and manufacturing requirements. Specific dimensional tolerances should be determined based on the like process. This will assist in identifying the equipment required and any process changes necessary.
Design Verification Plan and Report (DVP&R)
The Design Verification Plan and Report (DVP&R) is a method to plan and document testing activity through each phase of product/process development from inception to ongoing refinement. An effective DVP&R provides a concise working document that aids engineering personnel in the following areas:
- Facilitates the development of a logical testing sequence by requiring the responsible areas to thoroughly plan the tests needed to assure that the component or system meets all engineering requirements.
- Assures product reliability meets customer-driven objectives.
- Highlights situations where customer timing requires an accelerated test plan.
- Serves as a working tool for responsible area(s) by:
- Summarizing functional, durability, and reliability testing requirements and results in one document for ease of reference.
- Providing the ability to easily prepare test status and progress reports for design reviews.
Mistake Proofing/Error- Proofing
Mistake proofing is a technique to identify errors after they occur. Mistake proofing should be used as a technique to control repetitive tasks or actions and prevent non-conformances from being passed on to the subsequent operation and ultimately the customer. Error-proofing is a technique used to identify potential process errors and either design them out of the product or process, or eliminate the possibility that the error could produce a non- conformance.
Process Flow Charting
Process flow charting is a visual approach to describing and developing sequential or related work activities. It provides both a means of communication and analysis for planning, development activities, and manufacturing processes.Since one goal of quality assurance is to eliminate non-conformities and improve the efficiency of manufacturing and assembly processes, advanced product quality plans should include illustrations of the controls and resources involved. These process flow charts should be used to identify improvements and to locate significant or critical product and process characteristics that will be addressed in control plans to be developed later.
Quality Function Deployment (QFD)
QFD is a systematic procedure for translating customer requirements into technical and operational terms, displaying and documenting the translated information in matrix form. QFD focuses on the most important items and provides the mechanism to target selected areas to enhance competitive advantages.Depending upon the specific product, the technique of QFD may be used as a structure for the quality planning process. In particular, QFD Phase I – Product Planning translates customer requirements into counterpart control characteristics or design requirements. QFD provides a means of converting general customer requirements into specified final product and process control characteristics.
A. ASPECTS OF QFD
The two dimensions of QFD are:
- Quality Deployment: Translation of Customer Requirements into Product Design Requirements.
- Function Deployment: Translation of Design Requirements into appropriate Part, Process and Production Requirements.
B. BENEFITS OF QFD
- Increases the assurance of meeting the customer requirements.
- Reduces number of changes due to increased engineering understanding of customer requirements.
- Identifies potentially conflicting design requirements.
- Focuses various company activities on customer-oriented objectives.
- Reduces product development cycle time.
- Reduces costs of engineering, manufacturing, and service.
- Improves quality of product and services.
TEAM FEASIBILITY COMMITMENT
Customer: Date:
Part Number:
Part Name:
Revision Level
Feasibility Considerations
Our product quality planning team has considered the following questions.
The drawings and/or specifications provided have been used as a basis for analyzing the organizations ability to meet all specified requirements. All “no” answers are supported with attached comments identifying our concerns and/or proposed changes to enable the organization to meet the specified requirements.
| YES | NO | CONSIDERATION |
| Is product adequately defined (application requirements, etc. to enable feasibility evaluation? | ||
| Can Engineering Performance Specifications be met as written? | ||
| Can product be manufactured to tolerances specified on drawing? | ||
| Can product be manufactured with process capability that meet requirements? | ||
| Is there adequate capacity to produce product? | ||
| Does the design allow the use of efficient material handling techniques? | ||
| Can the product be manufactured within normal cost parameters? Abnormal cost considerations may include: | ||
| – Costs for capital equipment? | ||
| – Costs for tooling? | ||
| – Alternative manufacturing methods? | ||
| Is statistical process control required on the product? | ||
| Is statistical process control presently used on similar products? | ||
| Where statistical process control is used on similar products: | ||
| – Are the processes in control and stable? | ||
| – Does process capability meet customer requirements? |
Conclusion
Feasible Product can be produced as specified with no revisions.
Feasible Changes recommended (see attached).
Not Feasible Design revision required to produce product within the specified requirements. Approval
| Team Member/Title/Date | Team Member/Title/Date | Team Member/Title/Date |
| Team Member/Title/Date | Team Member/Title/Date |
- Under “required,” for each item indicate the number of characteristics required. Under “acceptable,” for each item, indicate the quantity that was accepted per customer requirements. Under “pending,” for each item, indicate the quantity not accepted. Attach action plan for each item.
- Indicate if control plan has been approved by the customer (if required) by circling yes or no. If yes, indicate date approved. If no, attach action plan.
- Under “samples,” indicate the quantity of samples inspected for each item. Under “characteristics per sample,” for each item indicate the number of characteristics inspected on each sample for each category.Under “acceptable,” for each item indicate the quantity of characteristics acceptable on all samples.Under “pending,” for each item indicate the quantity of characteristics not accepted. Attach action plan for each item.
- Under “required,” for each item indicate the number of characteristics required. Under “acceptable,” for each item indicate the quantity acceptable per Chrysler, Ford and General Motors Measurement Systems Analysis Reference Manual.Under “pending,” for each item, indicate quantity not accepted. Attach action plan for each item.
- Under “required,” for each item indicate the quantity required. Under “acceptable,” for each item, indicate the quantity accepted. Under “pending,” for each time, indicate quantity not accepted. Attach action plan for each item.
- Under “required,” for each item indicate yes or no to indicate if item is required. Under “acceptable,” for each item indicate yes or no to indicate acceptance. Under “pending,” if answer under “acceptable” is no – attach action plan.
- Each team member should sign form and indicate title and date of signature.
