How to apply APQP APQP is comprised of one pre-planning stage and five concurrent phases. Once begun, the process never ends and is often illustrated in the Plan Do Study Act (PDSA) cycle. PDSA was made famous by W. Edwards Deming. Each section is aligned with analytical risk discovery tools and techniques. Finding risk in product and process development is more desirable than finding late failure. The APQP Sections are defined below: 01

Section 0: Pre-planning APQP begins with assumptions, concepts and past knowledge. Bookshelf knowledge and standard work practices are listed as well as areas where significant change is expected. This section compiles the inputs into Section 1 – Plan and Define. 02 02

Section 1: Plan & Define Section 1 links customer expectations, wants, needs and desires to requirements. Plan Development will assure the output of this section is satisfactory product quality. Resource planning, process and product assumptions are made. A list of preliminary special characteristics and design / reliability goals are also established. Trainer Notes If you think a problem can’t be solved your right! If you think a problem can be solved your right 03

Section 2: Product Design and Development The focus in Section 2 is on product design and development. Geometry, design features, details, tolerances and refinement of special characteristics are all reviewed in a formal Design Review. Design verification through prototypes and testing are also part of this section. Tools which typically provide great benefit in this section are DFM/A, Design Failure Mode and Effects Analysis (DFMEA) and Design Verification Plan and Report (DVP&R). Trainer Notes If you think a problem can’t be solved your right! If you think a problem can be solved your right 04

Section 3: Process Design & Development Section 3 explores manufacturing techniques and measurement methods that will be used to bring the design engineer’s vision into reality. Process Flow Charts, Process Failure Mode and Effects Analysis (PFMEA) and Control Plan Methodology are examples of tools used in this section. Trainer Notes If you think a problem can’t be solved your right! If you think a problem can be solved your right 05

and Process Validation Section 4: Product and Process Validation Validation of the process quality and volume capabilities is the focus of Section 4. Statistical Process Control (SPC), Measurement Systems Analysis (MSA) and Process Capability Studies are introduced in this section. Product Part Approval Process (PPAP) is ready for submission and production begins upon approval. Section 5: Feedback Assessment and Corrective Action Section 5 explores learnings from the ongoing manufacturing process, RPN reduction, corrective actions (both internal and external), Eight Disciplines of Problem Solving (8D) and the capture of information pertinent for future use. Trainer Notes If you think a problem can’t be solved your right! If you think a problem can be solved your right 06

APQP Inputs & Outputs by Section Each section of APQP depends on risk information that has previously been discovered. The information sharing assures a flow of logical risk discovery and mitigation. The detailed inputs and outputs for each section are described below: Trainer Notes If you think a problem can’t be solved your right! If you think a problem can be solved your right 07

Inputs into Section 1 08 Voice of the Customer Market research Historical issues Team experience Business Plan and Marketing Plan Product and Process Benchmark Product and Process Assumptions Product Reliability Studies Customer Inputs as applicable Trainer Notes If you think a problem can’t be solved your right! If you think a problem can be solved your right 08

Outputs of Section 1 09 Design Goals Reliability and Quality Goals Preliminary Bill of Material (BOM) Preliminary Process Flow Preliminary list of Special Characteristics Product Assurance Plan Gateway approval Trainer Notes If you think a problem can’t be solved your right! If you think a problem can be solved your right 09

Outputs of Section 2 10 Design FMEA (DFMEA) Design for Manufacturing and Assembly (DFM/A) Design Verification Design Review Prototype Control Plan Engineering Drawings CAD the Master Engineering Specifications Material Specifications Change Control for Drawings New Equipment, Tooling and Facilities Requirements Special Product and Process Characteristics Gages / Testing Equipment Requirements Team Feasibility Commitment and Gateway approval Trainer Notes If you think a problem can’t be solved your right! If you think a problem can be solved your right 10

Outputs of Section 3 11 Packaging Standards and Specifications Quality System Review Process Flow Chart Floor Plan Layout Characteristics Matrix Process FMEA (PFMEA) Pre-Launch Control Plan Process Instructions Measurement Systems Analysis (MSA) Plan Preliminary process capability plan Gateway approval Trainer Notes If you think a problem can’t be solved your right! If you think a problem can be solved your right 11

Outputs of Section 4 12 Significant Production Run MSA Results Process Capability Studies Production Part Approval Process (PPAP) Production Validation Testing Packaging Evaluation Production Control Plan Quality Planning Sign-Off and Gateway approval Trainer Notes If you think a problem can’t be solved your right! If you think a problem can be solved your right 12

Outputs of Section 5 13 Reduced Variation Improved Customer Satisfaction Improved Delivery Performance Effective Use of Lessons Learned Trainer Notes If you think a problem can’t be solved your right! If you think a problem can be solved your right 13

Examples of where to incorporate APQP Develop Requirements from Voice of the Customer (VOC) using Quality Function Deployment (QFD) Develop a Product Quality Plan integrated into Program / Project Timeline Translate percentage of new content into Product and Process Assumptions Product design activities communicating special characteristics or key characteristics to the process design activity, prior to design release This may include new geometry, shape, parts, tighter tolerances and new materials linking the DFMEA to PFMEA Develop test plans (DVP&R) Use of formal Design Review to track progress Plan, acquire and install appropriate process equipment and tooling based on design tolerances provided by the product design source Assembly and Manufacturing personnel communicating suggestions of ways to better assemble a product (DFM/A) Establish adequate Quality Controls for Special Characteristics or Key Characteristics features of a product or parameters of a process, which still risk potential failure Performing Stability and Capability studies on special characteristics to understand the variation present and predict future performance with Statistical Process Control (SPC) and Process Capability (PPK and CPK) Trainer Notes If you think a problem can’t be solved your right! If you think a problem can be solved your right 14

How to Develop a Product Quality Plan The APQP process begins with the creation of a Product Quality Plan (PQP). The PQP may be unique for each individual development. During the planning section, a core group of personnel will review the concept design, process and product assumptions, overall goals of the project and past failures. After collecting this information, the core team selects tools from each section, based on the value they may bring when failure prevention is discussed. The PQP is linked to the project timing plan to aid in program / project management efficiency. The tools and techniques are selected based on what risk may be present, created by the intentional and incidental change. Discovering unknown risk is desirable. Each risk is quantified and mitigation actions are developed and implemented increasing the probability of project success. Trainer Notes If you think a problem can’t be solved your right! If you think a problem can be solved your right 15

Example of Product Quality Plan The Quality-One approach depicted in the following PQP example is a matrix with calculated ratios of qualitative tools verses quantitative evidence. Since qualitative tools can be used earlier in the product development process, Quality-One expects a 3:1 qualitative to quantitative ratio. The opportunity to discuss potential issues based on change with qualitative tools should be three times greater than the actual data collected. Observed data collection happens late in Product Development (PD) and reaction to failure may be required. Discussion of the change, using a tool and a Cross Functional Team (CFT), often results in discovering and preventing a failure early in PD. APQP is focused on predicting and preventing failure (80%) and less on detecting it (20%). Trainer Notes If you think a problem can’t be solved your right! If you think a problem can be solved your right 16

APQP Cross Functional Team (CFT) (1) The Cross Functional Team (CFT) in APQP evolves and changes as the process progresses. Preliminary details required to begin Product Quality Planning are collected by a CFT prior to project kick-off. This process is typically short and does not involve any product or process design effort. Aspects of Pre-Planning include: Scope of the project Product and Process Assumptions Past Failure Team size, structure and experience Methods for issue resolution Space and resources required Timing of the project Trainer Notes If you think a problem can’t be solved your right! If you think a problem can be solved your right 17

APQP Cross Functional Team (CFT) (2) The CFT adds members as certain disciplines are required. Two examples of team evolution are: purchasing engagement when “make / buy” decisions are required and engagement of tool design resources when prototype and production tooling is required. APQP is performed using Collaborative Product (Process) Development (CPD). Each CFT discipline communicates with their counterparts on items which can impact quality, cost or delivery, either positively or negatively. Special Characteristics are also communicated between each CFT discipline. The earlier a product or process problem can be found, the less expensive and work intensive it will be to fix it. Working concurrently per the project timeline, the team completes the Plan and Design activity: Product Engineering (PDE) addresses Product Design and Development Process and / or Manufacturing Engineering (ME) addresses the Process Design and Development Each section has inputs, outputs and management gateway reviews. Gateways are timed to coincide with key decisions impacting project Quality, Cost or Delivery. Trainer Notes If you think a problem can’t be solved your right! If you think a problem can be solved your right 18

How is APQP related to PPAP? (1) Product Part Approval Process (PPAP) highlights the proof or evidence collected through APQP. Validated results from the first trial run supports the assertion that quality of delivery is expected. The trial run must represent the production environment, with correct tools, machines, processes, personnel and conditions that may affect part quality. PPAP and APQP cannot be separated, as PPAP documents are the result of APQP. PPAP provides evidence that APQP has been successfully performed. Poor performance in a PPAP or a rejected sample can be attributed to poor APQP. Part Deliverables in PPAP are extensions of APQP Planning. The PPAP elements are listed below, note that many are the same as APQP tools or are the output results of APQP tools: Trainer Notes If you think a problem can’t be solved your right! If you think a problem can be solved your right 19

How is APQP related to PPAP? (2) Submission Warrant (PSW) Design Records Engineering Change Documents Customer Engineering Approval Design FMEA (DFMEA) Process Flow Process FMEA (PFMEA) Dimensional Results Performance and material test results Initial Process Capability Study Measurement Systems Analysis (MSA) Qualified Laboratory Documentation Bulk Material Requirements (if required) Control Plan Cosmetic or Visual Signoff Sample Product Master Sample Checking Aids Records of Compliance with customer specific requirements Trainer Notes If you think a problem can’t be solved your right! If you think a problem can be solved your right 20

How are APQP, NPI and DFSS Related? APQP, New Product Introduction (NPI), Design for Six Sigma (DFSS) and other Product Development Processes share goals and development tools. Examples of these tools can be found in our Core Competencies. APQP is often the Product Development Process that is used as a default process to support supplier engagement. DFSS is a highly focused effort reserved for high value requirements or specifications. APQP is broader in scope than DFSS and scalable to perceived risk each supplier, design or process poses on program success. Trainer Notes If you think a problem can’t be solved your right! If you think a problem can be solved your right 21

Example of APQP, NPI and DFSS Relationship An Original Equipment Manufacturer (OEM) is preparing a new end user product. The product will follow the OEM NPI. Several of the subsystems and components require supplier engagement to assure that their expertise is included in product design. APQP will be used to collaborate with the suppliers. DFSS will focus on key features that are highly valuable and quite different than past products. A Six Sigma Black Belt is assigned to follow these features across all communications channels and groups. The tools used in each of these endeavours are the same. The tools may be used at differing utilization levels at the Black Belt’s discretion. Trainer Notes If you think a problem can’t be solved your right! If you think a problem can be solved your right 21