The consultants provided 27 days of support to quality engineers at a plant to deploy a process certification initiative. Their initial mandate faced challenges including lack of deployment strategy, unidentified project owners, and producers not being ready. They revised their mandate to focus on establishing a deployment strategy, clarifying responsibilities, and defining a critical path. Roadblocks included low availability of procurement staff, lack of process mapping, and no selection of doable projects. They worked with procurement on developing tools to enhance the methodology and initiated producer certification. Their budget was exceeded due to additional time spent addressing issues preventing effective deployment.
This document is an evaluation questionnaire about Advanced Product Quality Planning (APQP). It contains 10 multiple choice questions about APQP. The questions cover topics like the definition of APQP, its phases and important outputs, elements of good planning, and documents linked together in the APQP process. The goal of the questionnaire is to test knowledge of the key aspects and stages of implementing the APQP methodology.
The document provides information on Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP). It discusses the APQP process which consists of four phases - planning, product design, process design, and validation. The goal of APQP is to plan quality in from the beginning to reduce costs and ensure customer satisfaction. PPAP is then described as the process used to get formal approval for a production part by providing evidence that the manufacturing process is capable of meeting requirements. It involves a first article inspection and data submission from a production run.
Industrial engineers work to improve processes, products, and systems. They focus on areas like project management, manufacturing, supply chain management, productivity, quality, and more. Some of their key roles include developing project plans, ensuring manufacturability, managing resources, conducting quality audits, developing strategic plans, and managing change. Industrial engineers use techniques like lean manufacturing, simulation, statistical analysis, and six sigma to solve problems in many different industries.
This document presents a mathematical model for analyzing the Advanced Product Quality Planning (APQP) process used in the automotive industry. It divides the APQP process into 4 stages: plan and define, product design, process design, and product/process validation. For each stage, it defines the activities, time estimates, costs, and relationships between activities. It then uses the Program Evaluation and Review Technique (PERT) to analyze the critical paths and time/costs for each stage. The analysis identified critical activities and allowed for resource reallocation, reducing times for key activities by 10% and improving understanding of the intricate APQP process.
Apqp bumming you out briefing may 30 2013John Cachat
Sales can’t update the customer on launch status. Engineering spends more time updating Gantt charts than they do actually engineering stuff. Quality can’t find the documentation. Purchasing has no idea when the supplier status is. Sound familiar?
What this means is:
• Products are late
• Quality is unacceptable
• Resources are wasted
• Problems are repeated
What we have found is that Project Management is done with the wrong tools and/or people
• Resources are over-scheduled
• Issues are not resolved
• True costs are unknown / inaccurate
What we have found with Project Management Software
• Tools are cumbersome, force detailed information that is unknown
• People resort back to XLS
• Management cannot support the team and resort to firefighting issues
Learn about an approach to APQP and a SaaS technology that allows you to implement APQP the right way and engage your people and suppliers to improve communication, and launch higher quality products faster and on-time and under budget.
The document discusses Advanced Product Quality Planning (APQP). It introduces APQP and describes its key phases and elements. The phases include planning and defining the program, product and process design and development, validation, and feedback. The elements include tools like Design FMEA, control plans, and requirements like special product characteristics. The presentation provides details on each phase's objectives and inputs/outputs to guide effective quality planning.
The document outlines the APQP (Advanced Product Quality Planning) process from design through the end of a product's life cycle. It involves establishing a core functional team of sales, marketing, engineering, quality, production, and logistics personnel. The team holds weekly meetings to update the tooling and APQP processes and address any quality or engineering issues. The process also includes supply agreement reviews, tooling design reviews, PPAP submission, and production part approval upon delivery to the customer.
Episode 24 : Project Quality Management
Include the processes required to ensure that the project will satisfy the needs for which it was undertaken
Include all activities of the overall management function that determine the quality policy, objectives and responsibilities and implements them by means such as quality planning, quality assurance, quality control, and quality improvement, within the quality system
This document is an evaluation questionnaire about Advanced Product Quality Planning (APQP). It contains 10 multiple choice questions about APQP. The questions cover topics like the definition of APQP, its phases and important outputs, elements of good planning, and documents linked together in the APQP process. The goal of the questionnaire is to test knowledge of the key aspects and stages of implementing the APQP methodology.
The document provides information on Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP). It discusses the APQP process which consists of four phases - planning, product design, process design, and validation. The goal of APQP is to plan quality in from the beginning to reduce costs and ensure customer satisfaction. PPAP is then described as the process used to get formal approval for a production part by providing evidence that the manufacturing process is capable of meeting requirements. It involves a first article inspection and data submission from a production run.
Industrial engineers work to improve processes, products, and systems. They focus on areas like project management, manufacturing, supply chain management, productivity, quality, and more. Some of their key roles include developing project plans, ensuring manufacturability, managing resources, conducting quality audits, developing strategic plans, and managing change. Industrial engineers use techniques like lean manufacturing, simulation, statistical analysis, and six sigma to solve problems in many different industries.
This document presents a mathematical model for analyzing the Advanced Product Quality Planning (APQP) process used in the automotive industry. It divides the APQP process into 4 stages: plan and define, product design, process design, and product/process validation. For each stage, it defines the activities, time estimates, costs, and relationships between activities. It then uses the Program Evaluation and Review Technique (PERT) to analyze the critical paths and time/costs for each stage. The analysis identified critical activities and allowed for resource reallocation, reducing times for key activities by 10% and improving understanding of the intricate APQP process.
Apqp bumming you out briefing may 30 2013John Cachat
Sales can’t update the customer on launch status. Engineering spends more time updating Gantt charts than they do actually engineering stuff. Quality can’t find the documentation. Purchasing has no idea when the supplier status is. Sound familiar?
What this means is:
• Products are late
• Quality is unacceptable
• Resources are wasted
• Problems are repeated
What we have found is that Project Management is done with the wrong tools and/or people
• Resources are over-scheduled
• Issues are not resolved
• True costs are unknown / inaccurate
What we have found with Project Management Software
• Tools are cumbersome, force detailed information that is unknown
• People resort back to XLS
• Management cannot support the team and resort to firefighting issues
Learn about an approach to APQP and a SaaS technology that allows you to implement APQP the right way and engage your people and suppliers to improve communication, and launch higher quality products faster and on-time and under budget.
The document discusses Advanced Product Quality Planning (APQP). It introduces APQP and describes its key phases and elements. The phases include planning and defining the program, product and process design and development, validation, and feedback. The elements include tools like Design FMEA, control plans, and requirements like special product characteristics. The presentation provides details on each phase's objectives and inputs/outputs to guide effective quality planning.
The document outlines the APQP (Advanced Product Quality Planning) process from design through the end of a product's life cycle. It involves establishing a core functional team of sales, marketing, engineering, quality, production, and logistics personnel. The team holds weekly meetings to update the tooling and APQP processes and address any quality or engineering issues. The process also includes supply agreement reviews, tooling design reviews, PPAP submission, and production part approval upon delivery to the customer.
Episode 24 : Project Quality Management
Include the processes required to ensure that the project will satisfy the needs for which it was undertaken
Include all activities of the overall management function that determine the quality policy, objectives and responsibilities and implements them by means such as quality planning, quality assurance, quality control, and quality improvement, within the quality system
The document outlines the Advanced Product Quality Planning (APQP) process flow, which consists of 5 main steps: 1) Plan and Define the Program, 2) Product Design and Development, 3) Process Design and Development, 4) Product and Process Validation, and 5) Feedback, Assessment and Corrective Action. The process flow shows the inputs, outputs, and activities involved at each step to ensure a new product or process is fully developed and validated prior to production.
Software quality assurance aims to develop a quality culture within a team by ensuring the required level of quality is achieved through improvements to the development process. It should be independent of project management and directly affects process quality and indirectly affects product quality. SQA incorporates all development processes from requirements to release with the goal of ensuring quality. It establishes checkpoints to evaluate project performance and manages change impact while maintaining good team relations.
The document provides an overview of an APQP (Advanced Product Quality Planning) training programme held on July 30th, 2009. It discusses the key phases and objectives of APQP, including plan and define, product design and development, process design and development, product and process validation, and feedback, assessment and corrective action. It also covers APQP formats, programme management, the role of target working group and benchmarking exercises, and concludes with an expression of thanks.
The document outlines the Advanced Product Quality Planning (APQP) process, which consists of several phases: Prepare for APQP, Plan and Define Program, Product Design and Development, Process Design and Development, Product and Process Validation, and Feedback, Assessment and Corrective Action. It provides inputs and outputs for each phase to ensure new products and processes meet quality objectives and customer requirements. The goal of APQP is to reduce variation and improve customer satisfaction through cross-functional teamwork and planning across the entire product development lifecycle.
Advanced Product Quality Planning (APQP) is a structured approach to product and process development that aims to ensure suppliers understand customer requirements and are able to meet them. It involves 5 phases - planning and defining the program, product design and development, process design and development, product and process validation, and feedback and assessment. The key goals of APQP are up-front quality planning, satisfying the customer, and supporting continual improvement. Common roadblocks to effective APQP implementation include a lack of management commitment, unclear responsibilities, and insufficient resources or knowledge.
The document provides guidance on using an ASAP implementation methodology template. It includes sections for project identification, revision history, review and approval, and a quality management plan. The quality management plan outlines a process for quality planning, assurance, and control. It provides details on acceptance criteria, reviews, and quality measurements that will be used to manage quality.
Tech Mahindra's Advanced Product Quality Planning For New Product Introduction built on Pega Application Platform. Know more at http://tec.hm/Pega-Resource
The document discusses the Production Part Approval Process (PPAP), including when PPAP submissions are required, the different submission levels, and the forms and documents required for each submission level. A PPAP submission is needed for new parts, design or process changes, changes in suppliers, inactive tooling, and more. The default submission level is level 3, which requires samples, supporting data, a design record, a process flow diagram, and more. Level 1 requires only a warranty, while level 2 adds limited data and samples.
The document discusses Project Quality Management (PQM) and its importance in project management. It describes PQM as ensuring a project satisfies its intended needs through quality planning, assurance, and control. These include identifying quality standards, evaluating project performance, and monitoring results. The document also outlines tools for PQM like benefit-cost analysis, checklists, and audits. Its target audience is project officers and it recommends teaching PQM through lectures, discussions, and interactive exercises.
The document discusses quality management processes from Chapter 8 of the PMBOK Guide 5th Edition. It provides details on the three main quality management processes: plan quality management, perform quality assurance, and control quality. For plan quality management, the key inputs, tools and techniques, and outputs are described. This includes developing a quality management plan, quality metrics, and checklists. Perform quality assurance focuses on auditing quality requirements and results from quality control. Control quality involves measuring and recording quality against requirements.
The document provides information on Advanced Product Quality Planning (APQP) and its 5 phases: 1) Plan and Define Program, 2) Product Design and Development, 3) Process Design and Development, 4) Product and Process Validation, and 5) Feedback, Assessment and Corrective Action. It describes the objectives and key activities that should be completed in each phase of the APQP process.
This document outlines the quality plan for the construction of a technical records center in Qatar. It details the organizational structure and responsibilities for quality assurance. Key roles include the executive manager overseeing all project aspects, a project manager responsible for site activities and quality implementation, and a quality control engineer administering the quality program and inspections. It also lists reference documents, management responsibilities, and procedures for quality control, audits, non-conformances, document control, and record keeping to ensure the project meets specifications.
The document provides information about quality management strategy examples including common forms, tools, and strategies used. It discusses the contents of a quality management strategy document, including introducing the purpose and objectives, describing quality management tools and techniques, specifying the timing of quality activities, and defining roles and responsibilities. Specific quality management tools discussed include check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, histograms, and other related quality management topics.
The Production Part Approval Process (PPAP) document provides information about NCR's PPAP requirements for suppliers. It describes what a Production Warrant is and its purpose of documenting part approval. The summary explains that suppliers must submit a Production Warrant and supporting documentation and samples according to the required PPAP submission level before shipping production parts to NCR. The submission level depends on factors like the part's risk level and any engineering changes.
The document provides an overview of APQP (Advanced Product Quality Planning) and PPAP (Production Part Approval Process). It defines APQP as a standardized product development process used by automakers and their suppliers. PPAP defines the requirements and procedures for approving a product or service for production. The purpose of APQP and PPAP is to ensure effective communication, identify potential issues early, and verify the supplier has the ability to meet all requirements before production starts.
The document provides an overview of the Production Part Approval Process (PPAP), including:
- PPAP is a standardized process used to approve new or changed parts and ensure they meet requirements before production.
- It originated in the automotive industry but has spread to many industries. An approved PPAP package is required for new parts or when changes are made.
- A PPAP package contains extensive documentation like design records, process flow diagrams, inspection results and more to fully validate the part and manufacturing process. The goal is to reduce risks for customers and ensure conforming parts are delivered.
Episode 23 : PROJECT TIME MANAGEMENT
Activity Definition – identifying the specific activities that must be performed to produce the various project deliverables
Activity Sequencing – identifying and documenting interactivity dependencies
Activity Duration Estimating – estimating the number of work periods that will be needed to complete individual activities
Schedule Development – analyzing activity sequences, activity durations, and resource requirements to create the project schedule
Schedule Control – controlling changes to the project schedule
SAJJAD KHUDHUR ABBAS
Chemical Engineering , Al-Muthanna University, Iraq
Oil & Gas Safety and Health Professional – OSHACADEMY
Trainer of Trainers (TOT) - Canadian Center of Human
Development
The document discusses Advanced Product Quality Planning (APQP). It describes APQP as involving organizing a team, defining the scope, involving customers and suppliers, and using simultaneous engineering. The benefits of APQP are listed as directing resources to satisfy customers, promoting early identification of required changes, and avoiding late changes to promote a quality product on time at the lowest price. Key stages and inputs of the APQP process are also outlined.
Quality management ensures that an organization, product or service is consistent. Quality management is focused not only on product and service quality, but also on the means to achieve it. Quality management, therefore, uses quality assurance and control of processes as well as products to achieve more consistent quality.
Project Quality Management includes the processes and activities of the performing organization that determines quality policies, objectives, and responsibilities so that the project will satisfy the needs for which it was undertaken
Project Quality Management includes the processes and activities of the performing organization that determines quality policies, objectives, and responsibilities so that the project will satisfy the needs for which it was undertaken
Advanced Product Quality Planning (APQP) is a methodology used to develop products and processes to help ensure they will meet customer requirements. It involves 5 phases - Planning, Product Design and Development, Process Design and Development, Product and Process Validation, and Production. The goal is to plan thoroughly at each stage, address potential issues proactively, and validate designs before production to facilitate communication and customer satisfaction.
The document outlines the Advanced Product Quality Planning (APQP) process flow, which consists of 5 main steps: 1) Plan and Define the Program, 2) Product Design and Development, 3) Process Design and Development, 4) Product and Process Validation, and 5) Feedback, Assessment and Corrective Action. The process flow shows the inputs, outputs, and activities involved at each step to ensure a new product or process is fully developed and validated prior to production.
Software quality assurance aims to develop a quality culture within a team by ensuring the required level of quality is achieved through improvements to the development process. It should be independent of project management and directly affects process quality and indirectly affects product quality. SQA incorporates all development processes from requirements to release with the goal of ensuring quality. It establishes checkpoints to evaluate project performance and manages change impact while maintaining good team relations.
The document provides an overview of an APQP (Advanced Product Quality Planning) training programme held on July 30th, 2009. It discusses the key phases and objectives of APQP, including plan and define, product design and development, process design and development, product and process validation, and feedback, assessment and corrective action. It also covers APQP formats, programme management, the role of target working group and benchmarking exercises, and concludes with an expression of thanks.
The document outlines the Advanced Product Quality Planning (APQP) process, which consists of several phases: Prepare for APQP, Plan and Define Program, Product Design and Development, Process Design and Development, Product and Process Validation, and Feedback, Assessment and Corrective Action. It provides inputs and outputs for each phase to ensure new products and processes meet quality objectives and customer requirements. The goal of APQP is to reduce variation and improve customer satisfaction through cross-functional teamwork and planning across the entire product development lifecycle.
Advanced Product Quality Planning (APQP) is a structured approach to product and process development that aims to ensure suppliers understand customer requirements and are able to meet them. It involves 5 phases - planning and defining the program, product design and development, process design and development, product and process validation, and feedback and assessment. The key goals of APQP are up-front quality planning, satisfying the customer, and supporting continual improvement. Common roadblocks to effective APQP implementation include a lack of management commitment, unclear responsibilities, and insufficient resources or knowledge.
The document provides guidance on using an ASAP implementation methodology template. It includes sections for project identification, revision history, review and approval, and a quality management plan. The quality management plan outlines a process for quality planning, assurance, and control. It provides details on acceptance criteria, reviews, and quality measurements that will be used to manage quality.
Tech Mahindra's Advanced Product Quality Planning For New Product Introduction built on Pega Application Platform. Know more at http://tec.hm/Pega-Resource
The document discusses the Production Part Approval Process (PPAP), including when PPAP submissions are required, the different submission levels, and the forms and documents required for each submission level. A PPAP submission is needed for new parts, design or process changes, changes in suppliers, inactive tooling, and more. The default submission level is level 3, which requires samples, supporting data, a design record, a process flow diagram, and more. Level 1 requires only a warranty, while level 2 adds limited data and samples.
The document discusses Project Quality Management (PQM) and its importance in project management. It describes PQM as ensuring a project satisfies its intended needs through quality planning, assurance, and control. These include identifying quality standards, evaluating project performance, and monitoring results. The document also outlines tools for PQM like benefit-cost analysis, checklists, and audits. Its target audience is project officers and it recommends teaching PQM through lectures, discussions, and interactive exercises.
The document discusses quality management processes from Chapter 8 of the PMBOK Guide 5th Edition. It provides details on the three main quality management processes: plan quality management, perform quality assurance, and control quality. For plan quality management, the key inputs, tools and techniques, and outputs are described. This includes developing a quality management plan, quality metrics, and checklists. Perform quality assurance focuses on auditing quality requirements and results from quality control. Control quality involves measuring and recording quality against requirements.
The document provides information on Advanced Product Quality Planning (APQP) and its 5 phases: 1) Plan and Define Program, 2) Product Design and Development, 3) Process Design and Development, 4) Product and Process Validation, and 5) Feedback, Assessment and Corrective Action. It describes the objectives and key activities that should be completed in each phase of the APQP process.
This document outlines the quality plan for the construction of a technical records center in Qatar. It details the organizational structure and responsibilities for quality assurance. Key roles include the executive manager overseeing all project aspects, a project manager responsible for site activities and quality implementation, and a quality control engineer administering the quality program and inspections. It also lists reference documents, management responsibilities, and procedures for quality control, audits, non-conformances, document control, and record keeping to ensure the project meets specifications.
The document provides information about quality management strategy examples including common forms, tools, and strategies used. It discusses the contents of a quality management strategy document, including introducing the purpose and objectives, describing quality management tools and techniques, specifying the timing of quality activities, and defining roles and responsibilities. Specific quality management tools discussed include check sheets, control charts, Pareto charts, scatter plots, Ishikawa diagrams, histograms, and other related quality management topics.
The Production Part Approval Process (PPAP) document provides information about NCR's PPAP requirements for suppliers. It describes what a Production Warrant is and its purpose of documenting part approval. The summary explains that suppliers must submit a Production Warrant and supporting documentation and samples according to the required PPAP submission level before shipping production parts to NCR. The submission level depends on factors like the part's risk level and any engineering changes.
The document provides an overview of APQP (Advanced Product Quality Planning) and PPAP (Production Part Approval Process). It defines APQP as a standardized product development process used by automakers and their suppliers. PPAP defines the requirements and procedures for approving a product or service for production. The purpose of APQP and PPAP is to ensure effective communication, identify potential issues early, and verify the supplier has the ability to meet all requirements before production starts.
The document provides an overview of the Production Part Approval Process (PPAP), including:
- PPAP is a standardized process used to approve new or changed parts and ensure they meet requirements before production.
- It originated in the automotive industry but has spread to many industries. An approved PPAP package is required for new parts or when changes are made.
- A PPAP package contains extensive documentation like design records, process flow diagrams, inspection results and more to fully validate the part and manufacturing process. The goal is to reduce risks for customers and ensure conforming parts are delivered.
Episode 23 : PROJECT TIME MANAGEMENT
Activity Definition – identifying the specific activities that must be performed to produce the various project deliverables
Activity Sequencing – identifying and documenting interactivity dependencies
Activity Duration Estimating – estimating the number of work periods that will be needed to complete individual activities
Schedule Development – analyzing activity sequences, activity durations, and resource requirements to create the project schedule
Schedule Control – controlling changes to the project schedule
SAJJAD KHUDHUR ABBAS
Chemical Engineering , Al-Muthanna University, Iraq
Oil & Gas Safety and Health Professional – OSHACADEMY
Trainer of Trainers (TOT) - Canadian Center of Human
Development
The document discusses Advanced Product Quality Planning (APQP). It describes APQP as involving organizing a team, defining the scope, involving customers and suppliers, and using simultaneous engineering. The benefits of APQP are listed as directing resources to satisfy customers, promoting early identification of required changes, and avoiding late changes to promote a quality product on time at the lowest price. Key stages and inputs of the APQP process are also outlined.
Quality management ensures that an organization, product or service is consistent. Quality management is focused not only on product and service quality, but also on the means to achieve it. Quality management, therefore, uses quality assurance and control of processes as well as products to achieve more consistent quality.
Project Quality Management includes the processes and activities of the performing organization that determines quality policies, objectives, and responsibilities so that the project will satisfy the needs for which it was undertaken
Project Quality Management includes the processes and activities of the performing organization that determines quality policies, objectives, and responsibilities so that the project will satisfy the needs for which it was undertaken
Advanced Product Quality Planning (APQP) is a methodology used to develop products and processes to help ensure they will meet customer requirements. It involves 5 phases - Planning, Product Design and Development, Process Design and Development, Product and Process Validation, and Production. The goal is to plan thoroughly at each stage, address potential issues proactively, and validate designs before production to facilitate communication and customer satisfaction.
This document provides an overview of Advanced Product Quality Planning (APQP) for a training program. It discusses the objectives of APQP as developing robust products in a short time through teamwork. The document outlines the APQP model and phases, including plan and define, product design and development, process design and development, validation, and feedback. It emphasizes the importance of management support and cross-functional teams in effective product quality planning.
This document discusses project quality management. It defines quality as the degree to which a project fulfills requirements. Quality management includes creating and following policies and procedures to ensure a project meets customer needs. Completing a project with no deviations from requirements is the goal. The document discusses quality planning, assurance, and control processes. It also discusses quality concepts, tools like control charts and benchmarking, and influential quality management thinkers like Deming, Crosby, and Juran.
ASPICE VER. 3.0 is a domain specific version of ISO/IEC 15504 for evaluating the efficiency of development processes in the automotive industry. It assesses processes in three categories - primary, organizational, and supporting. Capability levels range from 0 to 5 based on process attributes. Processes are evaluated using process performance and capability indicators. The document outlines various engineering and management processes like requirements elicitation, project management, configuration management etc. categorized under different process groups.
ASPICE – Automotive Software Process improvement and capability determination
This is a domain specific version of ISO / IEC 15504
Purpose: To evaluate the efficiency of development processes of ECU suppliers in the automotive industry.
This document provides an overview of process validation according to FDA guidance. It defines process validation as collecting data from process design through commercial production to establish that a process is capable of consistently delivering quality products. The guidance outlines a lifecycle approach with three stages: process design, process qualification, and continued process verification. Process design defines the commercial process based on development knowledge. Process qualification evaluates the design and determines if the process is reproducible. Continued process verification ensures the process remains controlled during routine production. Critical quality attributes and critical process parameters are identified, and control strategies are established.
The document discusses project quality management. It describes the three main processes as plan quality, perform quality assurance, and perform quality control. Plan quality involves identifying quality requirements. Perform quality assurance involves auditing quality requirements and ensuring standards are followed. Perform quality control involves monitoring results, assessing performance, and recommending changes. It provides details on key activities, tools, and outputs for each of the three processes.
SQA (Software Quality Assurance) involves planned and systematic activities to ensure quality of software products and processes. This includes establishing standards and procedures for development, continuous monitoring of products and processes, and conducting audits. Key SQA activities include product evaluation to ensure adherence to standards, process monitoring to ensure procedures are followed correctly, and product audits to thoroughly review products and processes. The SQA plan documents the quality assurance approach and controls quality throughout the project.
A brief description about second eddition of C&Q Volume 5.
"V" module of validation system obsoluted and risk based aproach described as per cGMP requiremnet.
APQP or Advanced Product Quality Planning is a structured 5-phase method for ensuring a product satisfies the customer. The 5 phases are: 1) Plan and Define, 2) Design and Development, 3) Process Design and Development, 4) Product and Process Validation, and 5) Feedback, Assessment and Corrective Action. Key activities include understanding customer needs, design reviews, failure analysis, verification and validation, and proactive feedback. The benefits are early planning, directing resources to the customer, identifying required changes early, providing quality on time and at lowest cost.
Lilly Risk-Based CQ_ ISPE-CCPIE China Conference 2010_9-19-10Scott Hamm
This document outlines Eli Lilly's risk-based commissioning and qualification program. It discusses integrating commissioning and automation testing to avoid redundant testing. The program focuses qualification on critical systems and uses risk assessments to determine appropriate testing strategies. Commissioning aims to verify design meets requirements and support subsequent qualification activities.
The topic was delivered by Mr. S. Shanmugasundaram, General Manager – Engineering Quality, Renault-Nissan Technology & Business Centre India Pvt. Ltd., Chennai.
The document provides an overview of Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP). It describes:
1) APQP as a cross-functional planning process with 5 phases to ensure a product meets customer expectations. It involves tools like DFMEA, PFMEA, control plans.
2) PPAP is required when a product or process changes and validates that production meets requirements. There are 5 submission levels with varying documentation required.
3) Both APQP and PPAP aim to launch defect-free products and improve quality, customer satisfaction and cost savings through thorough upfront planning and validation of designs and manufacturing processes.
The document discusses project quality management. It describes the seven basic quality tools used in project quality management which include cause-and-effect diagrams, flowcharts, checksheets, Pareto diagrams, histograms, control charts, and scatter diagrams. It then explains the process of performing quality assurance which includes determining quality policies and objectives. Key techniques discussed are quality audits and process analysis to identify improvements. The outputs of quality assurance are change requests, updated project plans and documents, and organizational process asset updates.
This document provides an overview of Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP). It describes the APQP process which consists of planning, product design, process design, validation, and feedback phases. The goals of APQP include planning activities, preventing issues, and validating processes before production. PPAP is required when new parts or processes are introduced to validate that customer requirements can be consistently met. It involves submitting documentation and product samples from a production run. The benefits are reducing risks and non-conformances to improve quality and customer satisfaction.
The document describes the verification process for SSC Pacific. The process involves 7 tasks: 1) selecting work products for verification, 2) defining the verification strategy and acceptance criteria, 3) establishing the verification environment, 4) documenting plans and procedures, 5) conducting verification, 6) analyzing results, and 7) communicating results. The purpose is to ensure work products meet requirements through methods like peer review, inspection, and testing.
The Validation Master Plan (VMP) outlines the company's approach to validation. It defines responsibilities, schedules, and documentation requirements for qualification of facilities, equipment, and processes. The VMP ensures management understands validation needs and the validation team understands their tasks. Key elements include qualification protocols for equipment operational performance and process validation protocols to demonstrate processes consistently meet requirements. The VMP is a living document that is updated with changes to facilities, equipment, or processes.
The Validation Master Plan (VMP) outlines the company's approach to validation. It defines responsibilities, schedules, and documentation requirements for qualification of facilities, equipment, and processes. The VMP ensures management understands validation needs and the validation team understands their tasks. Key elements include qualification of equipment and facilities, process validation, cleaning validation, change control procedures, and periodic revalidation. Qualification includes design, installation, operational, and performance qualification to confirm equipment and facilities operate as intended. Process validation demonstrates manufacturing processes consistently produce products meeting specifications. The VMP helps regulatory inspectors evaluate the company's validation program.
Introduction to software quality assurance by QuontraSolutionsQUONTRASOLUTIONS
Quontra Solutions provides QA training by Real time Industry experts. QA is having good demand in the market. Our QA online training Instructors are very much experienced and highly qualified and dedicated.
Our QA online training program is job oriented. After completion of QA training with us you should be able to work on any kind of project. After completion of QA online training our dedicated team will be supporting you.
Industrial Tech SW: Category Renewal and CreationChristian Dahlen
Every industrial revolution has created a new set of categories and a new set of players.
Multiple new technologies have emerged, but Samsara and C3.ai are only two companies which have gone public so far.
Manufacturing startups constitute the largest pipeline share of unicorns and IPO candidates in the SF Bay Area, and software startups dominate in Germany.
At Techbox Square, in Singapore, we're not just creative web designers and developers, we're the driving force behind your brand identity. Contact us today.
3 Simple Steps To Buy Verified Payoneer Account In 2024SEOSMMEARTH
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Anny Serafina Love - Letter of Recommendation by Kellen Harkins, MS.AnnySerafinaLove
This letter, written by Kellen Harkins, Course Director at Full Sail University, commends Anny Love's exemplary performance in the Video Sharing Platforms class. It highlights her dedication, willingness to challenge herself, and exceptional skills in production, editing, and marketing across various video platforms like YouTube, TikTok, and Instagram.
Unveiling the Dynamic Personalities, Key Dates, and Horoscope Insights: Gemin...my Pandit
Explore the fascinating world of the Gemini Zodiac Sign. Discover the unique personality traits, key dates, and horoscope insights of Gemini individuals. Learn how their sociable, communicative nature and boundless curiosity make them the dynamic explorers of the zodiac. Dive into the duality of the Gemini sign and understand their intellectual and adventurous spirit.
Event Report - SAP Sapphire 2024 Orlando - lots of innovation and old challengesHolger Mueller
Holger Mueller of Constellation Research shares his key takeaways from SAP's Sapphire confernece, held in Orlando, June 3rd till 5th 2024, in the Orange Convention Center.
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3. Initial Mandate
●
Client Objective:
●
●
Our mandate:
●
●
●
Accelerate the deployment of the ‘Process Certification
initiative’ that is based on statistical tools for decision-making
Provide 57 days of support in the implementation and
deployment of the assembly & test certification process at the
Mississauga plant
Provide 27 days of support to quality engineers and some key
Producers in the deployment of certification process
Conditions :
●
●
●
●
Deployment Strategy Established
Aligned Organization
Trained People
Producers ready to initiate
5. Revised Mandate (Charter)
●
Objectives
●
●
●
●
●
●
Focus the intervention to maximize our contribution
given the unexpected conditions
Highlight Risks
Communicate Critical Success Factors
Define and agree on a common action plan
Clarify responsibilities and expectations for all
participants
Establish and communicate the critical path, with key
deliverables, responsibilities & due dates
6. Roadblocks to Progression
●
Procurement:
●
●
●
●
●
●
●
●
●
●
Reduced availability (< 10%)
Additional organisational changes, vacations, etc.
Analysts not identified and/or changed several times
No priority & no context for Process Certification
Evolution of mindset required, still anchored in RCCA
Fundamental understanding and mindset
Resistance, sense of urgency, priorities
Knowledge and Skills
Producers not available, committed or ready to initiate
Competition with various dept’s and other analysts for
access
7. Roadblocks to Progression
●
Plant Assy’ and Test:
●
●
●
●
●
●
●
Owner of deployment process not visible
Leaders not formally identified, no planning, no
budget, no resources
Staff educated but not trained (or experienced)
No processes mapped
Lacking means of selecting projects at a do-able level
Measurements hit & miss, data not validated
Constant variation in product configurations
- little opportunity to characterise behaviour
statistically
8. Budget Status
●
84 Days Budget :
●
●
●
Procurement : 57 days
Plant & Assembly : 27 days
69 Days Spent :
●
●
Procurement : 30 days
Plant & Assembly : 39 days
10. Objectives
Validate & enrich the Process Certification
methodology as appropriate
Increase the key practical & applied knowledge of
Process Certification methodology & Tools for
Producer Certification
Improve support to producers in achieving
certification
11. Summary of Work
Accomplished
●
Process Certification Deployment
●
●
●
Identified issues to deployment and developed
solutions/recommendations
Developed tools to enhance efficiency and
effectiveness of deployment
Producer certification
●
Initiated first steps of Producer Certification with 3
producers
13. Approach
●
Focusing on specific engine models, assess :
●
Approach to deployment
–
–
●
Apparent strategy and tactics
Analysts’ roles & responsibilities
Methodology and tools:
–
–
–
–
–
Specifics of Process Certification
Use of Process Robustness Index (PRI) for Producer
evaluation
Procedure/Cookbook for Process Certification interventions
Corporate Procedure
Any other available material
14. Issue
Approach to deployment
●
Internal coordination
●
●
Strategy & Planning not visible
Coordination & assignments not optimal
–
Analysts’ assignment by part number/family. Therefore, analysts from
different departments have parts at the same Producer:
●
●
●
●
–
Communication flow between departments not properly established
●
●
Overloads Producers
Unsuited to a Process-centered philosophy and methodology
Missed opportunities to share expertise
Significantly impedes deployment of Process Certification
Multiple audit questionnaires. Each department has its own.
Approach to producer interventions
●
Analysts and auditors drive the certification by
producer or part numbers – May need months or
years to implement producer-wide
15. Issue
Approach to deployment
●
Suitability and Application of tools
●
●
●
Not well integrated, less effective
Confusion of terminology
Misunderstandings in role and application of Process
Certification methodology
–
●
Connection not made between Process Certification training
and day to day work
Staff readiness
●
●
●
●
Resistance of staff
Misconceptions of the method and of statistics
Misunderstanding of KPC, what is “Key”
Lack of data analysis expertise
16. Resolution/Recommendation
Approach to deployment
●
Revise and formalise the overall deployment strategy
●
Create and stabilise a multidisciplinary Process Certification
team
–
●
●
●
●
●
●
Made up of analysts, procurement experts, engineers (Black Belt level)
Agree on realistic certification objectives and pace
Create a visible deployment “dashboard” metric
Create a Producer-part-process criticality matrix
Develop a standard communication plan for Producers that will
manage their perception “before, during and after” the
deployment
Develop and communicate a high level action plan including
responsible and target dates
Align People, Tools & Approach with Producers (next slide)
17. Resolution/Recommendation
Approach to deployment
●
Align People
●
●
●
●
●
Align tools (next slides)
●
●
●
●
Analyse analysts’ resistance and develop strategy to overcome
Assign one coordinator/leader of Process Certification efforts at a given
Producer
Communicate and train personnel in the strategy and tools
Provide availability for the project
Align System audits and PRI content and application
Formalise and Implement the Process Certification Worksheet tool
Replace “cookbook” with ISO procedure that references training manual
Align Approach with Producers
●
●
●
Get availability commitment
Develop and share a detailed action plan with each Producer
Efforts and action plans must be driven by specific processes
–
●
●
Ex.: Instead of shop-wide gauge try-out program throughout, perform gage R&R
or MSA only on measurement systems of CRITICAL processes.
In order to leverage efforts, identify processes common to several parts
Develop mechanism for quickly and assuredly transferring KPCs to
producers.
18. Resolution/Recommendation
Integration and Utility of various tools
Implement deployment process :
Legacy Producer
System Audit
UTCQR-09.1
par 4.1.1
Certifiable Producer
Functioning Support
Infrastructure
Apply ProCert Method
UTCQR-09.1
par 4.2 & 4.3
Selection of Priority Targets
parts and processes
Readiness Progress Tracking
Critical Processes Identified
and previously Certified?
NPI / Re-sourcing
requirement
Certifiable
Producer?
(per system audit)
Identification of
Target Parts &
Processes:
Inputs from
Engineering, Assy &
Test, Procurement, etc.
Certify Selected
Process(es)
by UTCQR-09.1
par 4.4 using Process
Certification Worksheet
NO
YES
Producer submits
Readiness Plan:
Model supplied by P&WC
Plan validated and/or
modified by P&WC
Confirm Certification
on New / Changed
Parts
19. Issue
Integration and Utility of various tools
●
●
Terminology not consistent between parent & subsidiary
PRI is not suited to Process Certification or
producer certification:
●
●
●
●
●
●
Producer scores are weak in areas within Process
Certification’s domain
Without criteria or standards of comparison – fails in
fundamental manner as auditing tool
Shotgun approach – check everything, no focus on
what is Critical or Key to a part or process
Deals with manufacturing hardware issues where
Producer ought to be more knowledgeable than
analysts
Is not a roadmap to certify Producer processes
Appropriate only to New Part Introduction /
Engineering Changes – should be truncated.
20. Resolution/Recommendation
P/N:
family:
engine program: PW 307 & PW 308
ProCert Elements to be addressed
Step 1
Activities foreseen / Comments
Benefits/Financial Impact
N/A - process not yet selected
Was a Benefit-Effort analysis used to select the process?
N/A - process not yet selected
Has the financial impact been determined?
Is Management support evident? What drives need & desire for improvement?
Step 2
5
Team composition
Is there a process cell team or supporting organisation?
Step 3
Ressorces are there
4
Need to identify a Procert team
Process/Problem/Opportunity Definition
They have a high level list of operations and a process review system
1
A Process map that includes all in-scope areas or process steps / sub-processes
2
A clear definition of the key product characteristic (KPCd or Y) and measurement procedure
(there is agreement on definitions of KPCs)
3
Key input, process and output indicators (KPCMs - Xs & small Ys) are identified and linked to the
process map.
4
4
A Control Plan covering key input, process, and output indicators.
4
5
Measurement System Analysis showing that measurement error is not more than 20% of either the
process or the tolerance spread, whichever is the lesser.
4
6
The producer is organised to collect data and sufficient data has been collected to evaluate the
process performance
4
Make a process map
First KPCs received during our visit, at Smith's request.
Pratt needs to identify and communicate to Smiths What part number is most critical and key characteristics for those parts
Validate the received KPCs with Pratt and new ones as they become available
MOS shows process outputs to be controlled
Identify KPC-Ms , Highlight them on MOS and on process map
Good MOS, that contains certain elements of a control plan, Will have to be adapted to include SPC features and reaction plan
Step 4
Smiths has an established process for verification between the lab's CMM and shop floor gauges
Evidence that measurement error is kept below 20 % of tolerance spread is required
Data is measured and recorded per B.P. requirements
5
Review & Assess Process & Metrics
They have the data, data acquisition structure and data analysis personnel
1
Process stability and special cause variation determined by Control Charts.
2
With Process Capability determined, are there stated improvement goals (shift mean, reduce
variation or both)? (if Cpk >1.33, are measures in place to sustain ? And, is there fundamental
understanding of what factors influence KPCs?)
3
Process Inputs, parameters & outputs (Xs or KPCMs) influencing the key output indicators (Ys for
capacity and quality) are prioritised for improvement.
4
Relationships between key influences (significant Xs) and KPCs (Ys) statistically determined
by hypothesis testing, regression, ANOVA, Design of Experiments (DOEs) or other such tool
Start using SPC to assess process stability
3
Previous step is a prerequisite
TBD : Evaluate QN SSON & Escapes for potential improvement targets
As data is collected and analysed, target at least one area (machine or process) for improvement
3
They have the personnel that makes them able to do it if required
4
Organisational capability is in place, application is T.B.D.
estimated date of
completion
Applicability - P/Ns,
part families, engine
programs:
Specific Process Targeted for Improvement
Unique description
Plant and location within facilities
P&W level of effort req'd
Process - description,
location:
Smiths Orillia
ne No
ed t a
s h dd
igh res
s
n lev ed
Me eed el d
ets s d eve
re eve lop
q
l
m
Co uire opm en
mp me en t
let nts t
e& a
Su t pre
sta se
ina nt
ble
Producer:
producer level of effort req'd
Low-Medium-High
Process Certification Worksheet
21. Resolution/Recommendation
Process Certification Worksheet
●
●
●
●
●
●
●
Provides structure for gap and progress analysis
– audit criteria grounded in Process Certification
training materials
Highlights shortcomings and roadblocks
Encourages process-specific scoping of efforts
Consistent with PRI and Process Certification
terminology - provides familiar ground
Step by step roadmap to Process Certification analyst knows what to do and Producer knows
what to expect
Provides tasks, timeline & participation of parties
Measures and tracks progress quantitatively
22. Issue
Process Certification Cookbook
●
●
●
Need for ISO procedure to apply Process
Certification & tools
Cookbook attempts to repeat Process
Certification training content
Lack of document control :
●
●
Various versions of PRI in use
No evidence of control and approval of key
documents
25. Work Accomplished
●
●
●
●
Selected 3 Producers as test cases
Gathered relevant information
Attempted identification of relevant part numbers
Attempted to acquire associated KPC-Ms
(difficult to obtain, various opinions, not complete)
●
●
Performed site visits for Readiness Assessment
Performed first draft Gap Analysis (Process
Certification Worksheet)
●
Determined short term action plan for each
(Process Certification Worksheet)
26. Casting Supplier – Highlights
●
●
Analyst’s skills & mindset hinder Process Certification
deployment
Readiness
●
●
●
Weakest area is Step 4 “Review & Assess Process Metrics”
Haley, sandcasting ProCert status
Only inputs controlled using SPC
(% complete)
Output metric is yield
100%
–
–
●
Finished casting dimensions not measured
Use of targeting fixture is go/no-go
- no info on trends or variability
Completed Milestones
●
●
●
Evaluation of Certifiability
Gap analysis
Gained ability to gather data
on part dimensional variation:
decision to fix datum pts. in targeting fixture
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
27. Casting Supplier – Highlights (Cont’d)
●
Next Steps & Recommendations
●
●
●
Suppier to revise QFD and C & E prioritisation matrix
and re-define areas of improvement
Establish meaningful Process OUTPUT metrics
Statistically identify and confirm which process
parameters, inputs and outputs are key (KPC-Ms)
–
●
●
Inputs already controlled by SPC must be part of that
confirmation study
Greater and more effective use of Designed
Experiments for fundamental understanding of
process capability drivers
Review the Process Certification worksheet and
create a detailed action plan
28. Supplier Orillia – Highlights
●
Readiness
●
●
●
●
●
●
●
●
Ready for Process Certification
Weakness due only to lack of
targeted parts & related processes
Good Management support
Resources to form Process
Certification teams seem available
Good overall practice, confirmed by
initial Process Certification
evaluation
Processes mapped & documented
System for data collection
Completed Milestones
●
●
●
Understanding of situation
Gap analysis
Customer permission to select
parts & processes subject to
certification.
Smiths Orillia, system ProCert status
(% complete)
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
29. Supplier Orillia – Highlights (Cont’d)
●
Next steps & Recommendations
●
●
●
Engineering to supply key characteristics for subject
parts
Review the Process Certification worksheet and
create a detailed action plan
Monitor part quality and update/revise improvement
targets and KPCs as appropriate
30. Supplier Montreal – Highlights
●
●
Analyst’s beliefs and approach hinder Process
Certification deployment
Readiness
●
●
●
●
●
Management replacement & re-organisation in process
No culture, no procedures, no tools, no measurements
History of continual quality escapes
High scrap and inventory levels
Completed key Milestones
●
●
Understanding of situation
Gap analysis
31. Supplier Montreal - Highlights (Cont’d)
Next steps & Recommendations
1)
2)
Choose among 2 options:
Disqualify
Massive effort, supported by Customer, to identify
and certify critical processes:
Contingent on proof of Supplier’s commitment
Use subject processes as models to replicate onto next
priorities
Expand from initial certification successes