The Health First Pharmaceutical Company is implementing a project to improve its quality document management system. The current system is inadequate due to growth and increased regulations. The project will assess current practices, recommend a new system or changes, and implement the solution. The project budget is $125,000. Key deliverables will be a feasibility study, requirements analysis, and implementation plan. The solution must meet ISO standards and integrate with other systems. Regular updates will be provided via an internal blog/wiki to communicate with stakeholders. The quality goal is to define problems, assess options, and present a viable solution to the project board.
This document compares and contrasts the Project Management Professional (PMP) certification and the PRINCE2 certification. The PMP certification, administered by the Project Management Institute, is recognized globally and focuses on generally accepted project management practices. The PRINCE2 certification, administered in the UK by AXELOS, provides a standardized project management methodology. Both certifications can increase salaries, with average PMP salaries being higher in the US and PRINCE2 salaries higher in Europe and the UK. The PMP exam is 4 hours with 200 multiple choice questions, while the PRINCE2 exam is shorter at 1-2.5 hours with fewer multiple choice or scenario-based questions.
The document compares the Project Management Professional (PMP) and PRINCE2 project management certifications. PMP is administered by PMI and focuses on general project management knowledge and techniques. It is recognized globally but especially in the US, Canada, Africa and Australia. PRINCE2 is administered in the UK and focuses on standardized processes and project structure. It is recognized in the UK, Europe, and Australia. Both certifications improve career prospects, but salaries tend to be higher for PMP certified individuals, especially in the US. Maintaining certification requires ongoing training or exams. While the certifications differ in approach, obtaining both can provide complementary skills and knowledge for project managers.
IT Projects are typically complex undertakings where requirements, and their gathering from often multiple stakeholders, can often be difficult. The practice of Quality Management during the course of IT Projects should, in theory, lead to better governance and overall outcomes. This paper explores four individual IT Projects and details the methods of qualification gathering, stakeholder engagement and overall Quality Management employed. Following this is a review of the common themes found in each project and a discussion on their application from a Quality Management perspective.
The document discusses different outsourcing models for software testing. It recommends a blended model that uses a combination of offshore, onshore, and onsite testing resources to minimize risks while maintaining effectiveness and cost savings. This approach improves communication, knowledge transfer, and project management while reducing costs compared to solely using offshore resources. The document provides considerations for selecting outsourcing partners and implementing outsourcing arrangements.
Technology assessment case study implementation and adoption of a statistical...D-Wise
This document discusses d-Wise Technologies' work with a pharmaceutical client to implement a Statistical Computing Environment (SCE). The SCE is a clinical data repository and analytics platform using SAS Drug Development software. D-Wise helped develop a strategic implementation plan in phases, prioritizing quick wins. They facilitated meetings to define the project scope and priorities. The resulting plan took an iterative approach to rolling out the SCE and addressing change management challenges. A pilot implementation of the SCE core technology was also recommended.
This document discusses project management and managing people on software projects. It covers topics like risk management, motivating team members, and dealing with different personality types. It provides an example of an individual motivation issue where a team member has lost interest in the project work and is no longer developing the skills they want. The project manager talks to the team member to understand the problem and find a way to re-engage them by addressing their skill development needs.
This document summarizes the results of an online survey about factors influencing the adoption of agile practices. The survey received 103 responses. Based on the results, the authors hypothesized that: 1) Extreme Programming is the most popular adopted agile methodology. 2) Agile methodologies are chosen more by small teams. 3) Direct interaction with stakeholders is the most effective way to gather requirements. 4) User stories and diagrams are commonly used to capture requirements in agile. 5) Agile gives higher access to stakeholders to resolve problems quickly. 6) Adopting agile increases customer satisfaction and productivity. The survey results provide preliminary support for these hypotheses.
IT PROJECT SHOWSTOPPER FRAMEWORK: THE VIEW OF PRACTITIONERSijseajournal
This document summarizes a study that investigated factors affecting requirements adherence to business processes in agile projects. The study conducted a cross-case analysis of seven companies, collecting data through interviews, observations, and document analysis. The analysis identified that customer business knowledge by the development team and customer availability during requirements elicitation and validation are essential for requirements to align with business needs in agile projects. This allows developed systems to better meet the needs of an organization's business processes.
This document compares and contrasts the Project Management Professional (PMP) certification and the PRINCE2 certification. The PMP certification, administered by the Project Management Institute, is recognized globally and focuses on generally accepted project management practices. The PRINCE2 certification, administered in the UK by AXELOS, provides a standardized project management methodology. Both certifications can increase salaries, with average PMP salaries being higher in the US and PRINCE2 salaries higher in Europe and the UK. The PMP exam is 4 hours with 200 multiple choice questions, while the PRINCE2 exam is shorter at 1-2.5 hours with fewer multiple choice or scenario-based questions.
The document compares the Project Management Professional (PMP) and PRINCE2 project management certifications. PMP is administered by PMI and focuses on general project management knowledge and techniques. It is recognized globally but especially in the US, Canada, Africa and Australia. PRINCE2 is administered in the UK and focuses on standardized processes and project structure. It is recognized in the UK, Europe, and Australia. Both certifications improve career prospects, but salaries tend to be higher for PMP certified individuals, especially in the US. Maintaining certification requires ongoing training or exams. While the certifications differ in approach, obtaining both can provide complementary skills and knowledge for project managers.
IT Projects are typically complex undertakings where requirements, and their gathering from often multiple stakeholders, can often be difficult. The practice of Quality Management during the course of IT Projects should, in theory, lead to better governance and overall outcomes. This paper explores four individual IT Projects and details the methods of qualification gathering, stakeholder engagement and overall Quality Management employed. Following this is a review of the common themes found in each project and a discussion on their application from a Quality Management perspective.
The document discusses different outsourcing models for software testing. It recommends a blended model that uses a combination of offshore, onshore, and onsite testing resources to minimize risks while maintaining effectiveness and cost savings. This approach improves communication, knowledge transfer, and project management while reducing costs compared to solely using offshore resources. The document provides considerations for selecting outsourcing partners and implementing outsourcing arrangements.
Technology assessment case study implementation and adoption of a statistical...D-Wise
This document discusses d-Wise Technologies' work with a pharmaceutical client to implement a Statistical Computing Environment (SCE). The SCE is a clinical data repository and analytics platform using SAS Drug Development software. D-Wise helped develop a strategic implementation plan in phases, prioritizing quick wins. They facilitated meetings to define the project scope and priorities. The resulting plan took an iterative approach to rolling out the SCE and addressing change management challenges. A pilot implementation of the SCE core technology was also recommended.
This document discusses project management and managing people on software projects. It covers topics like risk management, motivating team members, and dealing with different personality types. It provides an example of an individual motivation issue where a team member has lost interest in the project work and is no longer developing the skills they want. The project manager talks to the team member to understand the problem and find a way to re-engage them by addressing their skill development needs.
This document summarizes the results of an online survey about factors influencing the adoption of agile practices. The survey received 103 responses. Based on the results, the authors hypothesized that: 1) Extreme Programming is the most popular adopted agile methodology. 2) Agile methodologies are chosen more by small teams. 3) Direct interaction with stakeholders is the most effective way to gather requirements. 4) User stories and diagrams are commonly used to capture requirements in agile. 5) Agile gives higher access to stakeholders to resolve problems quickly. 6) Adopting agile increases customer satisfaction and productivity. The survey results provide preliminary support for these hypotheses.
IT PROJECT SHOWSTOPPER FRAMEWORK: THE VIEW OF PRACTITIONERSijseajournal
This document summarizes a study that investigated factors affecting requirements adherence to business processes in agile projects. The study conducted a cross-case analysis of seven companies, collecting data through interviews, observations, and document analysis. The analysis identified that customer business knowledge by the development team and customer availability during requirements elicitation and validation are essential for requirements to align with business needs in agile projects. This allows developed systems to better meet the needs of an organization's business processes.
This document provides an overview of project quality management. It discusses key concepts like quality vs grade, precision vs accuracy, and continuous improvement models. Quality management involves planning quality, performing quality assurance, and controlling quality. The goal is to meet requirements and prevent issues rather than inspecting for them. Management is responsible for providing resources to support quality initiatives. Continuous improvement approaches like OPM3, Malcolm Baldrige, and CMMI can be used to improve both project management and deliverables.
Presentation on DR testing featuring quotes by Robert Nardella in an intervie...Robert Nardella
This document provides an overview and guidance for developing an effective disaster recovery (DR) test plan. It discusses the benefits of DR testing such as reducing downtime and improving organizational preparedness. Regular DR testing ensures an organization's DR plan stays up-to-date as IT infrastructure changes and validates the effectiveness of recovery procedures. The document outlines a 4-phase process for creating a DR test plan and provides tools and templates to help with planning, execution, and incorporating lessons learned from tests. It also offers options for guided or onsite assistance to help organizations develop and implement their DR test plan.
This document provides an overview of key aspects of medical device product development including planning, design controls, design history files, design inputs and outputs, design reviews, verification and validation testing, design changes, and design transfer. It analyzes the processes used by Company A for their stalled medical device project, finding that while they had documented processes, planning was not fully executed, technical risks were not identified, and formal verification and validation testing had not commenced. This likely contributed to the project not making progress towards its goals.
Process Improvement for better Software Technical Quality under Global Crisis...Optimyth Software
Software development failure rates are higher than any other mankind activity. Lack of quality is frequently the most relevant underlying reason. Agile methodologies offer a framework that try to support change, covering scope and time/budget, and keeping quality at an adequate level at the same time. But the gap between current software complexity and the Software Quality Assurance (SQA) knowledge, techniques and tools has grown bigger, even for organizations with high maturity level correctly using Agile methodologies.
Experience tells us that simply adopting Agile was not sufficient for producing software with quality above average. The most efficient techniques and trends from the SQA arsenal, adapted to Agile methodologies, will be discussed. Their cost/benefit ratios will be analyzed, and a process improvement roadmap will be presented, as a practical way to made software deliverables both more agile and with higher technical quality, under the constraints dictated by the Global Economic Crisis.
The presentation ends with a case study in process improvement for quality in a TSP + Agile scenario, and final recommendations that any organization using Agile methodologies could implement for short-term benefits.
This document discusses project quality management. It defines quality as meeting requirements and customer satisfaction. Quality management aims to ensure quality standards are defined and followed. It addresses quality of both the project processes and final product or service. Key aspects of quality management are quality planning, assurance, and control. Quality managers are responsible for defining and monitoring quality measures. Quality is unique to each project and judged based on meeting requirements, schedule, and budget as well as technical and business criteria.
This document provides guidance on selecting a disaster recovery (DR) solution. It discusses conducting a requirements gathering process and evaluating different DR solutions, including in-house or co-location sites, managed services, and cloud-based options. The key phases outlined are: 1) Conduct requirements gathering; 2) Evaluate potential DR solutions; and 3) Design a best-fit DR strategy. Different deployment models and levels of control with various solutions are also reviewed to help determine an appropriate solution.
This document provides an overview of IT project management. It discusses that project management follows the PMBOK guide and involves planning, organizing, and controlling resources to meet objectives for scope, time, cost and quality. IT projects have a poor success rate, completing only 16% on time and on budget, demonstrating the need for formal project management practices. Project management involves knowledge in areas like integration, scope, time, cost, quality, risk, and procurement management.
This document describes the Evolve methodology for implementing CRM solutions. The methodology aims to adapt best practices to diverse IT organizations. It outlines key principles such as iterative development, requirements management, and quality verification. The methodology consists of inception, evolution, and retrospection phases. During inception, the project is scoped and designed. The evolution phase involves iterative analysis, design, construction, and deployment. Retrospection provides project closure. The Evolve Plan documents how the project process will be tuned based on client participation, delivery iterations, and artifact requirements.
This document discusses tools and techniques for managing projects that encounter problems and become "red" or off-track. It provides two case studies of implementing Oracle ERP projects and discusses lessons learned. The objectives are to familiarize audiences with readily available tools to get projects back on schedule, such as enhanced communication, examining the "triple constraints," breaking projects into smaller phases, and reanalyzing and mitigating risks. Keywords include risk identification/mitigation and early warning signs of project issues.
This document contains a professional summary and work experience for Vikram Singh K, an IT professional with 12 years of experience seeking assignments in ITES, operations management, project management, or client relationship management. It summarizes his expertise in areas like project management, resource management, training, incident management, and more. It then details his work history managing projects and operations teams for clients like Bharti Airtel, Cairn India, Horizon Health Care, Walgreens, and Woolworths.
According to a number of studies; up to 80% of businesses deem their ERP initiatives as failing to meet objectives... What must business management consider prior to taking the leap. How do mitigate the risk of being one of that 80%. If you represent a business an have questions please use the contact form on the changespecialist.org site and I will respond.
Global Pharma Networks provides services to help new pharmaceutical startups and facilities, including site selection, project management, facility and design reviews, quality system development, regulatory compliance, supply chain operations, and operational improvement. They take a three-pronged approach of using their expertise to resolve issues, develop new processes and ideas, and teach clients to be self-sufficient. Their team of subject matter experts have extensive experience across various areas of the pharmaceutical industry.
EuroSPI O'Donnell Richardson Agile Methods in a Very Small CompanyMichael O'Donnell
This document discusses a case study of implementing agile methods at a small Irish software company called Sporting Software Ltd. The company tried implementing Extreme Programming (XP), an agile method, but ultimately declared it a failure. Some of the key problems encountered were lack of management support for agile methods and pre-existing employment contracts that did not align with agile values. The case study highlights that implementing agile methods can be challenging for small, remotely located companies.
This document provides an overview of project integration management, which involves developing the project charter and project management plan. It discusses the inputs, tools and techniques, and outputs for developing the project charter and project management plan. The project charter formally authorizes the project and provides authority to apply resources, while the project management plan documents actions to define, prepare, integrate and coordinate all subsidiary plans and baselines. Expert judgment and facilitation techniques are used as tools. The key outputs are the project charter and fully developed project management plan.
Kiruthika S. Anbarasu received an overall performance rating of "Effective" in her 2007 year-end assessment. Her manager, Joseph L. McCollough, praised her technical competence and growth. While noting she is a valuable team member, he encouraged her to resolve issues more timely and become a leader by coaching others. Kiruthika met most of her goals, including identifying process improvements and completing training assignments. To improve, her manager suggested taking on leadership roles and sharing her experience with junior team members.
Prateek chauhan cv senior business analyst_cscPrateek Chauhan
- Prateek Chauhan is a senior business analyst with over 8 years of experience in the IT industry. He has worked on various projects for clients like Aviva, Swiss Re, and CSC.
- Some of his responsibilities include requirement gathering and analysis, performing GAP analysis, mapping requirements to applications, and addressing production issues.
- He is seeking a challenging position that offers growth opportunities.
Bishnu has over 12 years of experience in the ITES industry working on mainframe technology and delivery management. He currently serves as a Senior Consultant and Deliver Manager at Capgemini, where he oversees mainframe development and support projects for The Coca-Cola Company. Prior to this role, he successfully led the data center migration of mainframe applications and servers. Bishnu has extensive experience in requirements gathering, analysis, design, development, testing and project management. He has led teams of up to 17 resources on various projects for clients such as Coca-Cola, Abercrombie & Fitch and Winn Dixie Store.
Carlos Sousa has over 25 years of experience leading technology projects and ensuring alignment between business objectives and technology investments. He has a track record of successfully delivering projects on time and on budget across different industries. Sousa is passionate about strategy, governance, and results and has managed multi-million dollar budgets and teams of over 60 professionals.
Using CMMI Process Management Practices to Build and Maintain a QMSPECB
This webinar discussed some of the management tools which help in developing and maintaining the QMS. Moreover, the session provided insights about the importance that the designing and building of the QMS has for the future of the company.
Main points covered:
• How CMMI practices in the OPF and OPD process areas can benefit from the QMS development and maintenance
• The process as a product – the importance of designing your QMS
• Building a QMS for now and for the future
Presenter:
Michael West has spent 25 years in process and performance improvement. As a principal and founder of Natural Systems Process Improvement, Inc. he has helped many client organizations in numerous industry sectors achieve their process and performance goals. Mr. West is a CMMI Institute-Certified Lead Appraiser and an AS9100 Auditor.
Link to the recorded YouTube video: https://youtu.be/VkEEmYZlgr4
Sanjeevi has over 4 years of experience as a Test Engineer and Scrum Master in the healthcare IT industry. He has extensive experience implementing HL7 interfaces and testing Electronic Health Record systems like Centricity EMR, Allscripts Pro PM&EHR, and hospital transition care programs. Some of his key skills include Agile methodologies, SQL, testing tools like ALM, and healthcare standards like HIPAA, LOINC, and ICD-9/10.
This hotel in Gurgaon offers 21 air conditioned rooms with modern amenities like mini bars, tea/coffee makers, and WiFi. It has a multi cuisine restaurant, fully equipped conference hall, 100% power backup, a lift, doctor on call, an in-house travel agency, and safe parking.
This document provides an overview of project quality management. It discusses key concepts like quality vs grade, precision vs accuracy, and continuous improvement models. Quality management involves planning quality, performing quality assurance, and controlling quality. The goal is to meet requirements and prevent issues rather than inspecting for them. Management is responsible for providing resources to support quality initiatives. Continuous improvement approaches like OPM3, Malcolm Baldrige, and CMMI can be used to improve both project management and deliverables.
Presentation on DR testing featuring quotes by Robert Nardella in an intervie...Robert Nardella
This document provides an overview and guidance for developing an effective disaster recovery (DR) test plan. It discusses the benefits of DR testing such as reducing downtime and improving organizational preparedness. Regular DR testing ensures an organization's DR plan stays up-to-date as IT infrastructure changes and validates the effectiveness of recovery procedures. The document outlines a 4-phase process for creating a DR test plan and provides tools and templates to help with planning, execution, and incorporating lessons learned from tests. It also offers options for guided or onsite assistance to help organizations develop and implement their DR test plan.
This document provides an overview of key aspects of medical device product development including planning, design controls, design history files, design inputs and outputs, design reviews, verification and validation testing, design changes, and design transfer. It analyzes the processes used by Company A for their stalled medical device project, finding that while they had documented processes, planning was not fully executed, technical risks were not identified, and formal verification and validation testing had not commenced. This likely contributed to the project not making progress towards its goals.
Process Improvement for better Software Technical Quality under Global Crisis...Optimyth Software
Software development failure rates are higher than any other mankind activity. Lack of quality is frequently the most relevant underlying reason. Agile methodologies offer a framework that try to support change, covering scope and time/budget, and keeping quality at an adequate level at the same time. But the gap between current software complexity and the Software Quality Assurance (SQA) knowledge, techniques and tools has grown bigger, even for organizations with high maturity level correctly using Agile methodologies.
Experience tells us that simply adopting Agile was not sufficient for producing software with quality above average. The most efficient techniques and trends from the SQA arsenal, adapted to Agile methodologies, will be discussed. Their cost/benefit ratios will be analyzed, and a process improvement roadmap will be presented, as a practical way to made software deliverables both more agile and with higher technical quality, under the constraints dictated by the Global Economic Crisis.
The presentation ends with a case study in process improvement for quality in a TSP + Agile scenario, and final recommendations that any organization using Agile methodologies could implement for short-term benefits.
This document discusses project quality management. It defines quality as meeting requirements and customer satisfaction. Quality management aims to ensure quality standards are defined and followed. It addresses quality of both the project processes and final product or service. Key aspects of quality management are quality planning, assurance, and control. Quality managers are responsible for defining and monitoring quality measures. Quality is unique to each project and judged based on meeting requirements, schedule, and budget as well as technical and business criteria.
This document provides guidance on selecting a disaster recovery (DR) solution. It discusses conducting a requirements gathering process and evaluating different DR solutions, including in-house or co-location sites, managed services, and cloud-based options. The key phases outlined are: 1) Conduct requirements gathering; 2) Evaluate potential DR solutions; and 3) Design a best-fit DR strategy. Different deployment models and levels of control with various solutions are also reviewed to help determine an appropriate solution.
This document provides an overview of IT project management. It discusses that project management follows the PMBOK guide and involves planning, organizing, and controlling resources to meet objectives for scope, time, cost and quality. IT projects have a poor success rate, completing only 16% on time and on budget, demonstrating the need for formal project management practices. Project management involves knowledge in areas like integration, scope, time, cost, quality, risk, and procurement management.
This document describes the Evolve methodology for implementing CRM solutions. The methodology aims to adapt best practices to diverse IT organizations. It outlines key principles such as iterative development, requirements management, and quality verification. The methodology consists of inception, evolution, and retrospection phases. During inception, the project is scoped and designed. The evolution phase involves iterative analysis, design, construction, and deployment. Retrospection provides project closure. The Evolve Plan documents how the project process will be tuned based on client participation, delivery iterations, and artifact requirements.
This document discusses tools and techniques for managing projects that encounter problems and become "red" or off-track. It provides two case studies of implementing Oracle ERP projects and discusses lessons learned. The objectives are to familiarize audiences with readily available tools to get projects back on schedule, such as enhanced communication, examining the "triple constraints," breaking projects into smaller phases, and reanalyzing and mitigating risks. Keywords include risk identification/mitigation and early warning signs of project issues.
This document contains a professional summary and work experience for Vikram Singh K, an IT professional with 12 years of experience seeking assignments in ITES, operations management, project management, or client relationship management. It summarizes his expertise in areas like project management, resource management, training, incident management, and more. It then details his work history managing projects and operations teams for clients like Bharti Airtel, Cairn India, Horizon Health Care, Walgreens, and Woolworths.
According to a number of studies; up to 80% of businesses deem their ERP initiatives as failing to meet objectives... What must business management consider prior to taking the leap. How do mitigate the risk of being one of that 80%. If you represent a business an have questions please use the contact form on the changespecialist.org site and I will respond.
Global Pharma Networks provides services to help new pharmaceutical startups and facilities, including site selection, project management, facility and design reviews, quality system development, regulatory compliance, supply chain operations, and operational improvement. They take a three-pronged approach of using their expertise to resolve issues, develop new processes and ideas, and teach clients to be self-sufficient. Their team of subject matter experts have extensive experience across various areas of the pharmaceutical industry.
EuroSPI O'Donnell Richardson Agile Methods in a Very Small CompanyMichael O'Donnell
This document discusses a case study of implementing agile methods at a small Irish software company called Sporting Software Ltd. The company tried implementing Extreme Programming (XP), an agile method, but ultimately declared it a failure. Some of the key problems encountered were lack of management support for agile methods and pre-existing employment contracts that did not align with agile values. The case study highlights that implementing agile methods can be challenging for small, remotely located companies.
This document provides an overview of project integration management, which involves developing the project charter and project management plan. It discusses the inputs, tools and techniques, and outputs for developing the project charter and project management plan. The project charter formally authorizes the project and provides authority to apply resources, while the project management plan documents actions to define, prepare, integrate and coordinate all subsidiary plans and baselines. Expert judgment and facilitation techniques are used as tools. The key outputs are the project charter and fully developed project management plan.
Kiruthika S. Anbarasu received an overall performance rating of "Effective" in her 2007 year-end assessment. Her manager, Joseph L. McCollough, praised her technical competence and growth. While noting she is a valuable team member, he encouraged her to resolve issues more timely and become a leader by coaching others. Kiruthika met most of her goals, including identifying process improvements and completing training assignments. To improve, her manager suggested taking on leadership roles and sharing her experience with junior team members.
Prateek chauhan cv senior business analyst_cscPrateek Chauhan
- Prateek Chauhan is a senior business analyst with over 8 years of experience in the IT industry. He has worked on various projects for clients like Aviva, Swiss Re, and CSC.
- Some of his responsibilities include requirement gathering and analysis, performing GAP analysis, mapping requirements to applications, and addressing production issues.
- He is seeking a challenging position that offers growth opportunities.
Bishnu has over 12 years of experience in the ITES industry working on mainframe technology and delivery management. He currently serves as a Senior Consultant and Deliver Manager at Capgemini, where he oversees mainframe development and support projects for The Coca-Cola Company. Prior to this role, he successfully led the data center migration of mainframe applications and servers. Bishnu has extensive experience in requirements gathering, analysis, design, development, testing and project management. He has led teams of up to 17 resources on various projects for clients such as Coca-Cola, Abercrombie & Fitch and Winn Dixie Store.
Carlos Sousa has over 25 years of experience leading technology projects and ensuring alignment between business objectives and technology investments. He has a track record of successfully delivering projects on time and on budget across different industries. Sousa is passionate about strategy, governance, and results and has managed multi-million dollar budgets and teams of over 60 professionals.
Using CMMI Process Management Practices to Build and Maintain a QMSPECB
This webinar discussed some of the management tools which help in developing and maintaining the QMS. Moreover, the session provided insights about the importance that the designing and building of the QMS has for the future of the company.
Main points covered:
• How CMMI practices in the OPF and OPD process areas can benefit from the QMS development and maintenance
• The process as a product – the importance of designing your QMS
• Building a QMS for now and for the future
Presenter:
Michael West has spent 25 years in process and performance improvement. As a principal and founder of Natural Systems Process Improvement, Inc. he has helped many client organizations in numerous industry sectors achieve their process and performance goals. Mr. West is a CMMI Institute-Certified Lead Appraiser and an AS9100 Auditor.
Link to the recorded YouTube video: https://youtu.be/VkEEmYZlgr4
Sanjeevi has over 4 years of experience as a Test Engineer and Scrum Master in the healthcare IT industry. He has extensive experience implementing HL7 interfaces and testing Electronic Health Record systems like Centricity EMR, Allscripts Pro PM&EHR, and hospital transition care programs. Some of his key skills include Agile methodologies, SQL, testing tools like ALM, and healthcare standards like HIPAA, LOINC, and ICD-9/10.
This hotel in Gurgaon offers 21 air conditioned rooms with modern amenities like mini bars, tea/coffee makers, and WiFi. It has a multi cuisine restaurant, fully equipped conference hall, 100% power backup, a lift, doctor on call, an in-house travel agency, and safe parking.
Universitas Muhammadiyah Malang adalah perguruan tinggi swasta yang telah terakreditasi A dan bertempat di Kota Malang, Jawa Timur. Universitas ini memiliki 9 fakultas dan 25 jurusan program sarjana serta 2 program pascasarjana dan 1 akademi keperawatan. Universitas ini juga telah menjalin kerjasama dengan berbagai instansi baik di dalam negeri maupun luar negeri seperti Arab Saudi, Mesir, Amerika Serikat, dan Australia.
El lupus eritematoso sistémico es una enfermedad autoinmune, inflamatoria y sistémica de etiología desconocida que causa destrucción de células y tejidos mediante autoanticuerpos e inmunocomplejos. Se manifiesta clínicamente en distintos órganos como la piel, riñones, articulaciones y pulmones. El diagnóstico se realiza mediante once criterios y el tratamiento incluye antiinflamatorios, antimaláricos, corticoides e inmunosupresores para controlar
Este documento describe las manifestaciones cutáneas del VIH, incluyendo erupciones, infecciones e inflamaciones que ocurren a diferentes etapas de la infección y niveles de recuento de células CD4. Explica que el VIH infecta células inmunes como los linfocitos T CD4+, lo que conduce a la inmunosupresión y enfermedades oportunistas. También cubre las vías de transmisión, grupos de riesgo, diagnóstico, tratamiento y complicaciones como el síndrome de reconstitución in
La enfermedad de Parkinson es una enfermedad neurológica progresiva causada por la degeneración de las neuronas dopaminérgicas en la sustancia negra del cerebro. Sus principales síntomas son temblor en reposo, rigidez, bradicinesia y alteraciones de la postura. El diagnóstico se realiza clínicamente y el tratamiento se enfoca en reemplazar la dopamina faltante, principalmente con levodopa.
El documento describe el cáncer broncogénico, incluyendo su clasificación, etiología, manifestaciones clínicas, diagnóstico y tratamiento. El cáncer broncogénico es una de las neoplasias más mortales a nivel mundial y en México. Se clasifica en cáncer de células pequeñas y cáncer de células no pequeñas, siendo el factor de riesgo más importante el tabaquismo. Los síntomas pueden incluir tos, expectoración y disnea, aunque inicialmente puede ser asintomático. El diagnó
This document discusses best practices for managing global projects. It identifies several key challenges in global project management including developing a consistent approach, resource allocation, and managing too many projects. It then outlines several best practices for global project management methodology and structure. This includes developing a standardized methodology, establishing executive sponsorship and global/regional project management offices for support, and using web-based knowledge management of best practices. The document also discusses the importance of project portfolio management, multi-cultural training, developing individual and organizational global competencies, and using maturity models to benchmark project management capabilities.
The document provides an executive summary of a feasibility study conducted by DR & CM Consulting International to evaluate options for improving Health First Manufacturing Division's (HFMD) quality document management system. The current system is at risk of failing an ISO audit due to obsolete documents. The study analyzed options ranging from no changes to implementing an integrated document content management system with intranet capabilities. The preferred option is a combination of streamlining workflows and using an IDCM system integrated with the company intranet to track, maintain, and ensure current quality documentation for HFMD. The next step is to conduct a user requirements specification to identify the best IDCM system to fit HFMD's needs.
Asma resume strategy business solutions finalasmajaleel
This document provides a curriculum vitae for Syeda Asma Fatima, who is seeking a position as Head Projects. It outlines her employment history including roles at Khawarizmi International College, Global Meditech & HSMCC, and Saudi German Hospitals Group. It also lists her education including multiple PhDs and MBAs from institutions in India. Finally, it provides details of her experience and responsibilities in areas like strategic planning, information systems, accreditation, and project management.
Software Engineering Practices and Issues.pptxNikilesh8
The document discusses planning for a software project. It emphasizes the importance of careful planning to clarify goals, needs and constraints. This helps avoid issues like schedule slippage and cost overruns. The planning process involves defining the problem, developing solution strategies, and planning the development process. Goals and requirements are also important to establish. Goals can be qualitative or quantitative, and apply to both the development process and final product. Requirements specify necessary system capabilities and can be functional, for performance or interfaces. High-level goals and requirements are often expressed in terms of quality attributes like reliability, efficiency and usability.
Increasing Project Success through Project Management Maturity Based on ISO 2...PECB
The webinar presented has introduced the main project management methodology which project managers use nowadays. The methodology is based on best ISO 21500 practices. In addition, the presenter has provided useful information to the audience, in regards of survey findings and facts which PMs can use in their daily activities.
Main points covered:
• Short introduction of the project management methodology ISO 21500
• PM maturity, PM organizations
• Results of project survey including fact and findings
Presenter:
The webinar was presented by John Roos is project –en program manager on consultancy bases. He has an extended experience in many fields a.o. Business Improvement, ISO 27001/ISO 21500 and Total Quality Management (TQM).
Link of the webinar published on YouTube: https://youtu.be/ziqybFGtJDo
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This document provides an overview of software project management. It discusses key topics like the project life cycle, stakeholders, tools and techniques, and challenges of software projects. Several studies found that 31-53% of IT projects were cancelled or over budget. Effective project managers balance scope, time and costs, use proven techniques, and have both technical and soft skills. Projects require defining goals, planning, execution, closure and evaluation to deliver value.
GSTi India’s mission is to provide end-to-end IT solutions for clients across the globe by aligning, creating, developing and providing efficient and cost effective services.
The document outlines the requirements and development plan for a CRM application project. It discusses the objectives of providing effective customer relationship management and measuring benefits over traditional systems. It will be developed by a team of four individuals using HTML, CSS, JS, SQL and PHP. The project will go through various stages of development, testing, deployment and effectiveness analysis to incorporate the application into the company's operations and eliminate bottlenecks. Some challenges around integration, communication and unknown factors are also highlighted. Gap analysis will be used during planning and analysis to identify differences between requirements and capabilities.
“Selecting and implementing a new asset finance system? In the second of three articles, we go back to basics to take a look at what you need to consider at the start of your project to give yourself the best chance of success.”
This has necessarily been a brief look at Project Initiation. We welcome comments and would be happy to help you get your project off to a good start.
Asset finance system project initiation 101. “Selecting and implementing a new asset finance system? In the second of three articles, we go back to basics to take a look at what you need to consider at the start of your project to give yourself the best chance of success.” This has necessarily been a brief look at Project Initiation. We welcome comments and would be happy to help you get your project off to a good start.
Customerlogo hereProject Name Project CharterCompanyOllieShoresna
Customer
logo here
Project Name: Project Charter
Company
logo here
Project Name:
Value Driven Project and Portfolio Management in the Pharmaceutical Industry
Project Charter
Project:
Value Driven Project and Portfolio Management in the Pharmaceutical Industry
Title:
Project Charter
Document number:
Version
0.1
Document status:
Final
Author:
Chellyn Jones
Responsible:
Date created:
14/08/2021
Protection class:
"For internal use only"
Document history
Version
Date
Author
Comment/Change
0.1
10/08/2021
Draft
14/08/2021
Final
Page
1Background/Project purpose or justification4
2Goals5
2.1Goals
2.2Scheduling goals/milestones
3Project product description6
4Delivery units7
4.1Delivery units/services
5Project success criteria8
6High-level risks9
7Key stakeholders10
8Assumptions, restrictions and external dependencies11
9Responsibility of the customer12
9.1Tasks
9.2Resources and staffing
10Project category13
11Project budget (overview)14
12Project startup15
13Project end16
13.1Signatures for release
Annex17
A.Glossary and abbreviations17
B.References, accompanying documents
1.
Background/Project Purpose or Justification
Pharmaceuticals' perspective has shifted as a result of the rising healthcare expenses that are currently affecting everyone, and pharmaceuticals are focusing on the generation of value in research and development. Value-driven portfolio management is a term that has long been associated with the financial sector but has recently gained popularity in the pharmaceutical industry. The notion of value-driven portfolio management focuses on connecting a company's strategic goals and objectives with resource allocation. A corporation can raise the value of pharmaceuticals while also lowering healthcare expenses by focusing on studying the risks and effects.
The project's purpose is to create a value-driven project for the pharmaceutical company by following a set of decision-making stages. The steps will include developing a targeted product profile, defining a timeframe, developing a budget that is consistent with the goal product profile, and ultimately developing a stage gate decision-making system.
2. Goals
This section addresses the goals of the project which indicate what the project intends to achieve and the milestones related to the goals established.
a. Goals
Goal
Description
Efficiency
Efficiency in the drug development process will mean that pharmaceuticals develop drugs through maximum utilization of the resources and ensuring that the waste products from the process are as minimal as possible.
Strategic alignment
The goal is to come up with projects that are aligned with financial and strategic goals of pharmaceuticals.
b. Scheduling Goals/Milestones
Schedule
Description
Phase 1
· Defining the scope and the budgets for the projects
· Developing the goals of the project.
· Evaluation of the potential risks
Phase 2
· Coming up with the key performance indicators
· Tracking per ...
VoIP Implementation WBSTask NameDurationStart DateEnd DatePredeces.docxjessiehampson
VoIP Implementation WBSTask NameDurationStart DateEnd DatePredecessors% CompleteStatusAssigned ToCommentsStartFinishCritical1. Intiation14d10/02/1910/15/1999%CompleteJevin 1.1 Recommendation & evaluation3d10/02/1910/04/19100%CompletedJenny 1.2 Project chart Deveelopment2d10/05/1910/06/19100%CompletedJenny 1.3 Outline of deliverable2d10/07/1910/08/19100%CompletedMark 1.4 Stakeholders analysis3d10/09/1910/11/194100%CompletedJoe 1.5 Charter signed by Authority4d10/12/1910/15/1995%In ProgressJoe2. Planning22d10/16/1911/07/19 2.1 Make a scope management2d10/16/1910/17/190%Not StartedJudy 2.2 Design the project team4d10/18/1910/21/090%Not StartedMolly 2.3 Intial meeting to boost the project3d10/22/1910/24/190%Not StartedMolly 2.4 Development of project plan2d10/25/1910/26/19130%Not StartedJudy 2.4.1 Create the schedules2d10/27/1910/28/190%Not StartedAlex 2.4.2 Analysis the critical path3d10/29/1911/01/190%Not StartedAlex 2.5 Submission of Project plan4d11/02/1911/05/190%Not StartedTim 2.6 Approval for project Plan2d11/06/1911/07/19120%Not StartedTiana3. Designing20d11/08/1911/27/19 3.1 Meeting to boost the team2d11/08/1911/09/190%Not StartedMandy 3.2 Verify the user requirements3d11/10/1911/12/190%Not StartedMandy 3.3 Designing of system4d11/13/0911/16/190%Not StartedKathy 3.4 procurement of software and hardware3d11/17/1911/19/190%Not StartedKathy 3.5 Installation of development system2d11/20/1911/21/190%Not StartedTim 3.6 Initiate testing3d11/22/1911/24/190%Not StartedHarry 3.7 Installation of live system2d11/25/1911/26/19200%Not StartedHarry 3.8 Training of users1d11/27/1911/27/190%Not StartedTiana4. Control20d11/28/1912/18/19 4.1 Management of Project4d11/28/1912/01/190%Not StartedMolly 4.2 Meetings to track the status of the meeting4d12/02/1912/05/190%Not StartedMolly 4.3 Risk management8d12/06/1912/13/190%Not StartedManoj 4.4 Updation of project management plan5d12/14/1912/18/190%Not StartedMandy5. Closing11d12/19/1912/29/19 5.1 Audit procurement4d12/19/1912/22/190%Not StartedAlisha 5.2 Updating and revision of documents2d12/23/1912/24/19300%Not StartedPrem 5.3 Update records and files2d12/25/1912/26/190%Not StartedHari 5.4 Receive the acceptance formally1d12/27/1912/27/190%Not StartedJames 5.5. Archieve Documents and files2d12/28/1912/29/190%Not StartedJames
Comments
Running Head: PROJECT PLAN-BUSINESS REQUIRMENT DOCUMENT 1
PROJECT PLAN-BUSINESS REQUIRMENT DOCUMENT 21
Project Plan-Business Requirement Document
CIS 599 Graduate Info Systems Capstone
Abstract
After finishing project plan inception with introduction Docume ...
The document provides an overview of the Standard Customer Relationship Management Processes (SCRMP) project for HLR Inc. The project aims to consolidate HLR's incompatible customer relationship management systems into a single, standardized and secure database. The project charter outlines the background, goals, objectives, timeline, budget and approach. It also identifies the project team members and criteria for measuring success. A stakeholder analysis identifies the project sponsor, stakeholders and key customers, and discusses their roles, interests and influence levels. Potential barriers to success are also addressed. The project must be completed within 18 months for $500,000.
Lisa Cesnick has over 10 years of experience as a project manager leading implementations of SharePoint, .NET, and other technologies. She is currently the Director of Customer Success at BrightStarr, where she manages a team of 12 people overseeing IT projects. Previously, she led projects such as a SharePoint 2013 implementation for Xylem and an intranet solution for Michael Kors. She has strong skills in project management, software development processes, and building high-performing teams.
The document outlines a quality management integration plan for a project to design a SharePoint 2010 data document library website for the 4th Brigade, 3rd Infantry Division. It discusses selecting the Capability Maturity Model Integration as the quality system, analyzing quality dimensions using David Garvin's eight dimensions of quality, and using a combination of Lean Six Sigma and Design for Six Sigma as the quality process improvement tools and techniques. Weekly progress reports and testing will be used to monitor quality.
CRJS466 – Psychopathology and CriminalityUnit 5 Individual Proje.docxfaithxdunce63732
CRJS466 – Psychopathology and Criminality
Unit 5 Individual Project Grading Criteria
(125 points)
Content (75 points):
Question 1 (20 points)
Question 2 (20 points)
Question 3 (15 points)
Question 4 (20 points)
Organization (25 points):
Clarity and conciseness of thought, minimum page length
APA Formatting (12.5 points):
Title page with Running head, page numbers, 12-pt. Times New Roman or
Arial font, 1” margins, spacing, in-text citations, and References (minimum of
three peer-reviewed, scholarly sources)
Mechanics (12.5 points):
Grammar, spelling/word usage, punctuation
______________________________________________________________________
For the Unit 5 IP, below are the specific questions and my expectations:
In a 3–5 page position paper, respond to the following:
(1) Articulate the mental disorder being considered by the court in the case that you selected, and why this disorder would make the defendant unfit for trial.
**Based on information and knowledge gathered from the DSM-IV-TR or DSM-5, course text, Live Chats, Learning Materials, and other peer-reviewed/scholarly sources, determine ONE possible mental disorder being considered. Discuss your rationale as to why you selected the diagnosis for this particular case. Before choosing a disorder, think about the defendant's mental status, including appearance, attitude, behavior, mood and affect, speech, thought process, thought content, perception, cognition, insight, and judgment.
(2) Explain the relationship between the actions and behavior that would cause the court to remand the defendant for a mental evaluation.
**Address the association between the actions or offenses of the defendant and the mental disorder associated with the offense.
(3) Evaluate the outcome of the case you selected in terms of the defendant, the victim, and the community.
**Identify the impact of the trial’s outcome on the community, the victim, and the defendant.
(4) Critique and assess the court’s decision in the case you selected. Choose ONE of the following:
(a) Support the court’s correct decision.
**Discuss why you support (agree with) the court's decision. Explain your rationale.
(b) Challenge the court’s decision with your supported reasons.
**Discuss why you challenge (disagree with) the court's decision. Explain your rationale.
SWE440-1402A-01
Software Project Management
Project Plan
27 April 2014
Content
Page
1)Project Description and Methodology
3-6
2)Project Plan Outline
7-8
3)ISO & IEEE Standard
9-11
4)Configuration Management
12-16
5)Defect Tracking
17
6)Risk Management
19-22
7) Final Project Report
23
8)References
24
Project Description and Methodology
The IT ecosystem of financial services institutions faces many challenges in aligning business needs with IT solutions which generally.
This document discusses the project integration management knowledge area and its processes, including developing the project charter to formally authorize a project, developing the project management plan by defining subsidiary plans and integrating them into a comprehensive plan, directing and managing project work, monitoring and controlling project work, performing integrated change control, and closing the project or phase. It provides details on the inputs, tools and techniques, and outputs of developing the project charter and project management plan.
Nancy Johnson is a highly experienced IT Project Manager with over 10 years of experience managing medium to large scale projects. She has proven abilities in project planning, budget management, resource allocation, and achieving deliverables. She is adept at developing collaborative relationships and acting as a liaison between business and technical teams. Johnson has hands-on experience leading projects across various technologies and methodologies. She has a track record of successfully delivering projects on time and within budget while meeting business needs.
Similar to Project Initiation Document Linda Doll (20)
The document discusses implementation options for a new document management system at Health First Manufacturing Division (HFMD). Four options are considered: 1) Direct cutover after migrating data/documents with progressive backfile conversion; 2) Direct cutover with full backfile conversion; 3) Parallel operations with progressive migration; 4) Agile methodology with staged releases. Option 1 or a combination of Options 1 and 4 is recommended, as it addresses immediate needs while allowing flexibility for future improvements.
User Requirements Specification Linda DollLinda Doll
This document outlines user requirements for a document management system for Health First Pharmaceutical Company's Manufacturing Division. It defines requirements for document submission, review, approval, metadata migration from current systems, and record retention. The system must support ISO and cGMP compliance. Key user types are identified along with their access levels and needs. Document library structure and metadata requirements are also specified.
3. Project Initiation Document
Purpose
The purpose of the Project Initiation Document is to define the project, the objectives and scope
of the project, and to establish parameters for assessment of its success.
Background
Health First Pharmaceutical Company, a company dedicated to putting its patients first, is a
global company, headquartered in Kent, Ohio, USA, with offices in multiple geographic
locations, including a significant component of its manufacturing division in Sydney, Australia.
The Quality Manager at HFMD has raised the risk that the division may fail a quality audit based
on the current inadequacies in managing quality documents.
o He has identified gaps in HFMD’s current practices and systems,
o He has discovered obsolete documents still in use.
o There are internal risks: e.g., an accident involving chemicals and/or other occupational
health risks and safety issues and
o There are also external risks, such as incorrect dosages applied to the pharmaceutical
products and sold to the community.
The Quality Manager has implemented manual methods to support compliance requirements,
and organized for regular audits. He has instituted procedures to try and rectify instances of
obsolete documents. These measures have failed to adequately address the underlying
1
4. inadequacies that have been exposed due to the unparalleled growth in market share and the
necessity of compliance with increased regulations and the additional paperwork such an
increase generates. The system that was once deemed adequate is increasingly inadequate. For
further details, please reference the terms of requirement.
The Quality Manager has been appointed Project Owner by HFMD; he will represent the Project
Sponsor in the operational aspects of the project. The Project Sponsor will ultimately be
responsible for the project outcome. The Quality Manager will be responsible for assembling the
Project Board, and for identifying stakeholders in the project.
HFMD has contracted with DR & CM International Consulting to plan and implement a
solution. Linda Doll wiill be Principal Consultant, with the assistance of two staff members of
DR & CM. Other personnel may be added as deemed necessary by the Project Owner and the
Principal Consultant, with the concurrence of the Project Board. All disputes will be settled by
the Project Board, with a simple majority vote of a quorum of stakeholder members present.
Project Definition
Project Objectives
The primary objective is to effectively manage quality documents within the Health First
Manufacturing Division (HFMD) in Sydney, Australia.
o Deliver an effective solution for managing quality documents within HFMD to support
ISO document control requirements.
o Provide an improved process for managing new and amended quality documents and
tracking review and approval processes.
2
5. o Provide search for and retrieval capabilities that allow HFMD users to quickly access
correct versions of quality documents.
o Specify and assess the capability of the technology solution to determine its flexibility,
scalability and extensibility for deployment with HFP for other document management
requirements.
o Transfer existing metadata and documents to the new technology system for managing
quality documents.
Project Scope
The scope of the project will be to assess the current document management system, and to
recommend procedures and products that will amend the current shortcomings of the system, or
to identify a new system, if it is deemed needful and necessary.
Scope Inclusions
o Plan, specify, acquire and implement a solution for managing quality documents that
includes all staff in HFMD’ 70 work centers.
o Assess software packages to determine their flexibility and scalability to be deployed for
other document types and/or across HFP.
o Test the DMS solution to ensure it satidfies user requirements and is inter-operable with
current HFMD networks and systems.
o Assess options for migrating quality data from the Document Control System and existing
quality documents from file systems and databases.
o Devise an implementation strategy that features an approach satisfactory to HFMD and
includes staff training and feedback.
o Evaluate the success of the solution in terms of performance, staff feedback, and quality
audits.
3
6. Scope Exclusions
o Engineering drawings will be excluded from the scope of this project, due to the
specialized nature of their storage printing and reproductions needs.
o Headquarters in Kent, Ohio has requested incorporating the requirement for managing
corporate policy documents. This requirement falls outside the scope of this project.
Every effort will be made to select a solution that will be scalable for future expansion
possibilities, or to become part of an Enterprise Content Management System. At this
time, this project lacks the scope or funds to pursue this option further.
Project Approach
Project Deliverables and/or Outcomes
The project deliverables will consist of: a feasibility study, a user requirement study, and an
implementation strategy for the solution.
Outcomes will be deemed successful after identification of the underlying causes of the failure of
the current system, and composition of an appropriate solution that works on operational,
technical and financial levels.
Constraints
The budget for the project shall be $125,000.00; $50,000.00 for DR & CM International
Consulting for personnel for the projected 6 months required to complete the project.
$50,000.00 is to be devoted to hardware and software assessment and purchase. The re
remaining funds are to be dedicated to incidentals, such as flying, room reconfiguration for the
installation of equipment or licensing fees not included in the hardware/software allotment.
4
7. The project should be ISO 9001 compliant, to insure the International Standards Organization
accreditation.
The project should be compatible with Dublin Core metadata standards.
Security of HFMD proprietary information will be maintained at all times. DR & CM
International Consulting personnel are required as a condition of their employment to respect and
uphold the security of HFMD’s information.
Interfaces
The project should interface with the Computer Assisted Drafting (CAD) tool employed by
Engineering.
The project should also be compatible with the Health First Intranet.
Assumptions
It is assumed that Health First Manufacturing Division (HFMD) will supply suitable workspace,
adjacent to the Quality Manager’s office and Information Systems (IS), and reasonably close to
the main floor of the facility.
HFMD will also furnish the workspace, and supply computers, scanners, printers, phones and fax
machines, and all other equipment deemed necessary in the pursuance of the project objectives.
HFMD will supply staff, appointed by the Quality Manager, to assist DM & CR International
Consulting Staff, pursuant to the completion of the project.
Any unforeseen costs will be the responsibility of HFMD. Every effort will be made by DR &
CM to see that this does not happen.
5
8. Initial Business Case
The intangible benefits of implementing the project include proactively addressing the gaps and
shortcomings insures ISO compliance. This will maintain credibility, which is the basis of our
business viability.
Tangible benefits will also accrue due to increased efficiency which will directly translate to
productivity. Systems that are easier to deal with improve company morale, which may
favorably impact employee turnover.
Cost savings will result from improved efficiencies.
Securing the firm from legal liability may be the ultimate intangible benefit. Intangible as it may
be, peace of mind and the securing of the firm’s reputation and good will is not to be
underestimated.
Communication Plan
To keep stakeholders and other employees informed of the project, its progress and future
milestones, the Project Manager and Quality Manager will institute an internal blog/wiki
combination. Information will be posted on the wiki; questions and/or concerns will be
answered by either the Project Manager or the Quality Manager, or both, as deemed appropriate.
The questions on the blog will be submitted anonymously, and all questions posted will be
answered. This should keep interest in the project high, and keep rumors and misinformation to
a minimum. After the successful project completion, the wiki/blog may continue to be part of
the HFMD communication landscape.
Project Quality Plan
The quality expectations of the project are that the deliverables, taken together, will define the
problems with the current system, assess potential solutions, and present them to the Project
6
9. Owner and the Project Board for consideration, along with professional assessments as to the
advantages and disadvantages of each potential solution. Through this method, the perceived
shortcomings of the current system should be amended, or replaced, and ISO 9001 accreditation
should be assured.
Initial Project Plan
The project is to start within four weeks of the signing of the contract. The intervening time
should be used to arrange for adequate office space and equipment and materials for the use of
the DR & CM staff, upon their arrival. The initial 6 weeks should be used in assessment,
through observation in the main facility, interviews with stakeholders, and construction of a
flowchart detailing the current system, with any additions or exceptional cases accounted for.
The second six weeks will be utilized in investigating the feasibility of correcting the current
system of document management, or the possible replacement of the current system. This period
should end with the production and presentation of the Feasibility Study. Formal presentation
will be to the Project Owner and the Project Board, with any other stakeholders also invited. The
third 6 week period will be devoted to assessment of possible solutions, and the development of
the User Requirement Specification, to be presented to the Project Owner and the Project Board
and other stakeholders at the end of that time. The final 6 week period will see the
Implementation Strategy unfold, and at the end of that timeframe, the assessment of the project
by the Project Owner, the Project Manager and the Project Board.
Initial Risk Log
The project may be unnecessarily enlarged by ambitious parties; all scope changes must be
presented to the board, along with an assessment of the time and money constraints that this will
impose on the project.
The project may suffer from bad timing, and be too late to stop the failing of a quality audit by
ISO; every effort will be made on the part of DM & CR to complete the project before the next
7
10. slated quality audit. HFMD will do its part by keeping DM & CR informed of the dates of the
next quality audit, and by cooperating fully and in a timely manner with the requests for
information and the interview process.
Any unforeseen risk will be met by the Project Owner and the Project Manager in concert, with
the guidance and assistance of the Project Board.
Project Controls
The steering of the project will be the responsibility of the Project Manager, with input from the
Project Owner, and with guidance from the Project Board, which will be comprised of
stakeholders appointed by the Project Owner. The stakeholders will make themselves available
to DR & CM International Consulting staff, as needed in a timely manner. The Project Owner
will arraign for the duties of the stakeholders to be adjusted and compensated for to reflect their
new status and responsibilities.
Exception Process
If a basic parameter of the project falls outside the margin of plus-or-minus 10%, the Project
Board will convene, to consider if the project is still viable.
Contingency Plans
If a basic parameter of the project falls inside the margin of plus-or-minus 10%, the project will
go forward, with the substitution of alternate products or suppliers that fall within the budget
constraints. This will be at the discretion of the Project Owner, in consultation with the Project
Board.
8
11. Project Filing Structures
DR & CM International Consulting staff will maintain all raw data collected for the HFMD
project, while the project is current until completion.
HFMD staff, as appointed by the Project Owner, will be responsible for the maintenance of all
data collected after the completion of the project. Any additional training necessary for the
completion of this clause will be the responsibility of HFMD, and handled through the
Professional Development Department.
Evaluation
The deliverables and projected outcomes will be assessed at the end of six months. At that time,
the Project Owner, the Project Manager and the Project Board will convene to consider the
information and assessments, and to evaluate the success of the project as presented by the
Project Manager.
Conclusion
DR & CM International Consulting looks forward to working with Health First Manufacturing
Division to resolve their quality document control issues. We feel that by working together, we
can find a solution to this problem that will work on operational, technical and financial levels.
9