April 2015 Quality & Productivity Solutions, Inc

Transcription

1 April 2015 Quality & Productivity Solutions, Inc Experts in Lean Six Sigma, Management Systems, Supply Chain, Project Management & Professional Development President s Welcome Moving Forward in the New Economy Jay P. Patel As the economy improves, the demand for a skilled workforce increases. Organizations are not only looking to get the job done, but they also look to deliver above and beyond set expectations. The development of skills With over 100 courses, QPS is sure to have a training solution for your organization. Whether it be improvement in product, service, cost performance or In this Issue President s Welcome Page 1 Risk-based Thinking in ISO 9001: 2015 Page 2 Training Grants Available through the Workforce Training Fund Page 6 Organizations are not only looking to get the job done, but they also look to deliver above and beyond set expectations. QPS New Jersey News Page 7 Upcoming Courses Page 8 necessary to achieve this objective can only be achieved through rigorous training. QPS proudly offers training solutions that focus on the needs of each organization. We have a proven track record of success in the implementation of Lean Six Sigma, Project Management, and other initiatives. As we move forward in the new economy, QPS is your partner. systems, bottom-line results are our business. We partner with our customers to understand and assess their needs; developing effective strategies and solutions that enhance the total organization. Our success is based on the commitment and promise to help our clients succeed. Let s succeed together in this new economy! Training Locations Page 10 A customer is the most important visitor on our premises. He is not dependent on us. We are dependent on him. He is not an interruption in our work. He is the purpose of it. He is not an outsider in our business. He is part of it. We are not doing him a favor by serving him. He is doing us a favor by giving us an opportunity to do so. Mahatma Gandhi Page 1 of 10

2 Risk-based Thinking in ISO 9001: 2015 By Jack Reardon ISO 9001:2015 has taken a different approach to the way in which its requirements are stated, when compared to the ISO 9001:2008. To make it really a generic and applicable to all types of organization producing any type of product or services, ISO 9001:2015 aims to: Harmonize Management System Standards Such as QMS, EMS, En-MS, ISMS, FSMS, ITMS and OHMS Eliminate Unnecessary Documented Procedures Requirement Introduce Risk Based Thinking Introduce Common Text, Common Structure and Common Terms What is Risk? Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmaceutical, pharmaco vigilance, and by agencies regulating these industries. Risk is defined as the combination of the probability of occurrence of harm and the severity of that harm. However, achieving a shared understanding of the application of risk management among diverse stakeholders is difficult because each stakeholder might perceive different potential harms, place a different probability on each harm occurring and attribute different severities to each harm. ALL RISKS Internal RISKS External RISKS Mgt. Risks Technology Risks Commercial Risks Regulatory Risks International Organization for Standardization (ISO) standards requires organizations to identify and assess threats, along with their associated risks. Risk Classification There are 2 types of risks: Business risks: A risk of a gain or loss e.g. a product can either gain or lose money Pure (Insurable) risk: Only a risk of loss Example: Fire, theft, which Can be transferred to another party by Contracting, Warranty or Insurance. Page 2 of 10

3 Two primary principles of quality risk management are: 1. The evaluation of the risk to quality should be based on scientific knowledge 2. The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk. Risk Management Planning Risk Management planning is the process of deciding how to approach and plan the risk management activities for a project. It is important to plan for risk management, determine right level, type and visibility of risk, Identify and validate stakeholders risk thresholds and generate the risk management plan. Initiating a Quality Risk Management Process Quality risk management should include systematic processes designed to coordinate, facilitate and improve sciencebased decision making with respect to risk. Possible steps used to initiate and plan a quality risk management process might include the following: Define the problem and/or risk question, including pertinent assumptions identifying the potential for risk Assemble background information and/or data on the potential hazard, harm or human health impact relevant to the risk assessment Identify a leader and critical resources Specify a timeline, deliverables, and appropriate level of decision making for the risk management process Continues on next page Page 3 of 10

4 Overview of a Typical Quality Risk Management Process Initiate Quality Risk Management Process Risk Identification Risk Communication Risk Analysis Risk Evaluation Risk Reduction Risk Acceptance Unacceptable Risk Management Tools Risk Process Output Review Events Risk Identification Risk identification is the process of determining which risks might affect the project and documenting their characteristics such as: Locate risks Display internal and external risk sources Disclose causes and effects of risks Risk Control Involve experts, stakeholders etc. Risk response planning develops the options and actions to enhance opportunities and reduce threats to project objectives and Includes identification and assignment of individuals to take responsibility for each agreed upon risk response. It uses 4 major response strategies Avoidance Transference Mitigation Acceptance Output is a risk response plan Continues on next page Page 4 of 10

5 Risk Review Risk management should be an ongoing part of the quality management process. The output/results of the risk management process should be reviewed to take into account new knowledge and experience. Risk monitoring and control keeps track of the identified risks, monitors residual risks, identifies new risks, ensures execution of risk plans and evaluates effectiveness. It is advisable to Conducts risk reviews periodically and Identify new risks that might results from changes and Implement risk response plans if risks occur. While accepting risk How much is too much needs to be specified for each risk. Example: More than 2 working days delay in installation of X not acceptable. Therefore threshold here is < 2 working days Benefits of Risk Management Followings are the salient advantage of having risk management strategy in place: Protects project objectives Maximizes results of positive events Minimizes consequences of adverse events Minimizes unpleasant surprises Focus on building right the first time Proactive not reactive Author: Jay P. Patel is an ASQ Fellow, Master BB, Lean Expert, PMP, Risk Management Professional with 10 ASQ Certifications, and many other certifications, for more info or questions, contact jayp@qpsinc.com Page 5 of 10

6 Training Grants are Available through the Workforce Training Fund! Benefits Improve quality, on-time delivery, and productivity! Improve business processes! Reduce cost and waste! Meet new challenges coming from demanding customer requirements! Experience company growth! Increase market share! Remain competitive Make breakthrough improvements and be more competitive in the market place by developing robust processes, reducing waste, improving quality and developing innovative products! Have you ever wanted your company to experience a Lean Six Sigma or ISO initiative but were overwhelmed by the costs? If so, this training grant is for you! The Massachusetts Workforce Training Fund awards up to $250,000 for training per applicant! QPS provides free consultation on training need assessment and grant writing service at NO CHARGE! Now is the time to implement Lean, Six Sigma ISO Related Supply Chain Excellence Project Management Performance Excellence FDA Related, ASQ & APICS Certifications Management Development Team Based Initiatives, Strategic Planning Creativity & Innovation at your company! Workforce Training Fund The workforce training fund is a state fund financed entirely by Massachusetts employers. The purpose of the fund is to provide applicants with funds to train current and newly hired employees. The fund has been appropriated a minimum of $18 million each state fiscal year. For further details, contact info@qpsinc.com or call toll-free Page 6 of 10

7 QPS New Jersey News From left to right: Edwin May, Patricia Smith, Jay Patel at ASQ North Jersey section 304 Spring Quality Conference QPS New Jersey representatives Edwin May and Patricia Smith attended the ASQ North Jersey section 304 Spring Quality Conference 2015 along with QPS President Jay Patel. Edwin, Patricia, and Jay were excited to discuss the services QPS has to offer with attendees of the conference. New Jersey residents also have access to many of the courses QPS offers at its corporate headquarters. Courses include: Lean Six Sigma Green Belt Project Management Professional PMP Certification Preparation Risk Management Professional RMP Certification Preparation Medical Device Regulations For more information, please contact New Jersey Director Edwin May at or Page 7 of 10

8 Upcoming Courses: ISO 9001:2015 Quality & Productivity Solutions, Inc. will begin to offer training in ISO 9001:2015 throughout the Northeast. Please check our website for the latest information on courses and dates. ISO 9001: 2015 Quality Management System Today s organization must exceed industry expectations to succeed in global markets. Businesses need to comply to increasing regulations and expectations to compete, requiring more focus on making it right the first time and cutting costs while doing it. ISO 9001 is a quality standard geared to providing product and services companies that provides the foundation from which to build that success. The Strategy The ISO 9001 standard is designed to help businesses standardize their quality by providing a balanced set of core processes that maintain a foundation for management to operate, employees to perform, and products to be made properly in an efficient and effective manner to achieve customer satisfaction. This system allows for widespread visibility of problems and offers the ability to manage those issues at their root, changing processes to continue improved outcomes. ISO is exactly what is says it is a standard for doing business. When we plan, we grow, when we learn, we develop the opportunity to improve, and work smarter. ISO standards set the foundation for good business and safe business practices. It is a process-based management system and requires a fair amount of effort by all to implement properly and achieve the desired results. What ISO 9001 Can Do For You ISO 9001 has the ability to bring out the best in people, process and performance if designed, documented and deployed properly. The QPS program provides all the tools needed to design and implement a system that belongs to you, generating ownership, building an empowered workforce and produce forward-looking focus. Whether it is a new or established system, we can walk you through creating or updating a system that improves your business and brings bottom-line success. Using proven techniques, QPS provides the consulting and training that clients need to understand what is required to implement the quality system appropriate for your business, acquire registration, and realize the potential to improve the workplace. Our services give providers the knowledge they need using a comprehensive method that teaches teams in every function how an ISO 9001 system can make gains for everyone. Continues on next page Page 8 of 10

9 We provide specific support in: Gap Assessment Implementation Plan Development Process Based Documentation Quality Manual & Procedures Developing Internal auditors and Certifying them Preparing your Managers & QMS personnel Organizational Support for Registration Auditors for Ongoing Audit Support Our program starts at the beginning, doing a gap analysis to determine how and if the current system in use can be used or developed, into what is required for registration. QPS will be glad to do all documentation also. We create a plan with you to meet your needs, keeping resources and staffing in mind. We provide training to all levels of staff from management to the production line employee, providing customized materials to the requirements of your business. The QPS Advantage Whether it be improvement in product, service, cost performance or systems, bottom-line results are our business. We partner with our customers to understand and assess their needs; developing effective strategies and solutions that enhance the total organization. We help manage culture change, build confidence in the system and support management to make your system a success. We have proven knowledge and expertise in all Management Systems as well as customized master plans to achieve and maintain the system registration for your needs, at your pace and at a reasonable cost to you. QPS has Exemplar and ASQ certified professionals and they have successfully completed documentation, trained workforces and helped clients achieve first time ISO 9001 registration in less than six months! We guarantee customer satisfaction, including registration at first attempt. Contact us today to create the program that works best for your business. Our consultants will deploy the entire project for you working with your personnel. Where there are multiple sites or global business units involved, we maintain the schedule and integrity of the project to meet the target dates and keep costs at a minimum. We have spent 30 years creating systems to better manage businesses and prepare them to succeed. Contact us to find out how QPS can help you! Page 9 of 10

10 Massachusetts Headquarters 28 Lord Road Suite 205 Marlborough MA Training locations *MASSACHUSETTS* 28 Lord Road, Suite 205, Marlborough, MA *NEW JERSEY* 581 Main Street, Suite 640, Woodbridge, NJ *CONNECTICUT* 1224 Mill Street - Building B East Berlin, CT *RHODE ISLAND* 249 Roosevelt Avenue, Suite 203 Pawtucket, RI Page 10 of 10