Roadmap User Guide

VIABILITY

1. Do you need to consider implementing a new Quality Management System (QMS)? What is a Quality Management System (QMS)? Quality can be defined in many ways, including fitness for use, zero defects, and conformance to requirements. Despite the range of definitions, the goals underlying the pursuit of quality are the same: achieving conformity, reducing variation, eliminating waste and rework, eliminating non-value-adding activity, preventing human error, preventing defects, improving productivity, and increasing efficiency and effectiveness (Okes & Westcott 2003). According to the ASQ glossary, a quality management system (or quality system) can be considered a mechanism for managing and continuously improving core processes to “achieve maximum customer satisfaction at the lowest overall cost to the organization”. It applies and synthesizes standards, methodologies and tools to achieve quality-related goals. A quality system thus represents a specific implementation of quality concepts, standards, methodologies and tools, and is unique to an organization. A quality system is typically enacted to provide a basis for auditability of operations and data-driven continuous improvement. It can be used as the basis for documenting operational processes, procedures and interaction. It requires an understanding of how an organization's processes contribute to its continues operation, growth and viability, and supports the following goals: Achieving conformity Reducing variation Eliminating non-value-adding activity Reducing waste and rework Preventing human error Preventing defects, improving accuracy, improving integrity Improving productivity Increasing efficiency & effectiveness Driving innovation Before starting the process of instituting a Quality Management System (QMS), your organization should determine whether this structure will deliver the benefits you expect. Are your customers requiring that you meet and maintain quality standards (e.g. ISO 9001) to do business with them? Do you need to cut costs or become more efficient in carrying out your mission? Do you have error-prone processes that must be improved? Do you need to improve your competitive position by becoming more innovative? If you answered yes to any of the above questions, then you should consider implementing a QMS. This QMS Roadmap can help you identify the key points of establishing a new quality system. The Roadmap Structure has four components: 1.0 Organizational Evaluation (an assessment of your strategy and readiness for implementation), 2.0 Quality Systems (to help you understand existing frameworks for quality systems), 3.0 Quality Methodologies (to help you choose appropriate approaches for problem solving) and 4.0 Quality Tools (to help you identify data analysis tools and approaches to achieve your quality goals in the context of your operational processes). A QMS should be deployed using a process that respects the importance of community and executive-level involvement, and provides for training at all levels of the organization to realize the promise of the quality system through audits and continuous improvement. The QMS Phase Plan presents a five-phase approach to systematic deployment.

STRATEGY & PROCESS IDENTIFICATION Use Section 1.0 (Organization Evaluation) of the Roadmap to answer these questions.

2. Is your organization ready? Does executive management support achieving maximum customer satisfaction at the lowest overall cost to the organization? Do they want this to happen? Are they willing to provide the resources to make this happen? Are they willing to make this a continuing priority within the organization? Will they staunchly advocate the mission of the quality system within the organization and to senior managers and line managers? If NO, abandon the development of a quality system. Quality must be a value within all levels of the organization, and if it is not (or if it is not sustainable), the process of establishing and maintaining a quality system for continuous improvement will not be value-adding. Is your organization pursuing development of a quality system in order to achieve certification, for example, to be qualified as a supplier? If YES, the required elements of the quality standard that you are required to conform to will dictate the process of establishing your quality system. You may or may not wish to use a model for Process Identification. 3. Are your operational processes identified and documented? If YES, then you are ahead of the game - congratulations! Get your flowcharts out; they will be an important part of your QMS. If NO, then use QMS 1.2 Quality Evaluation, and the APQC Process Classification Framework and/or QMS 1.2.1 Process ID Form to outline your operational processes. It is important to understand which of these processes is Critical to Safety (CTS) or Critical to Quality (CTQ) since these processes will form the core of your quality system. Once your processes are identified, use flow charts, images, diagrams and use cases to describe what occurs. A picture is worth a thousand words.

LINK PROCESS TO QUALITY GOALS AND READINESS

Follow each of the decision paths within Section 2.0 (Quality Systems) of the Roadmap to help answer these questions. At this point, you should have a solid grasp of your organization's strategy, you should be confident of your executive sponsorship and know that your organization is culturally ready to construct and use a QMS, and you should have your processes identified and documented. 4. Which philosophies and approaches are relevant to each process? For the system as a whole, each process, and each key interrelationship, a new path will be navigated through the Quality System Development Roadmap. Start with 2.0 Quality Systems to identify the key philosophies and approaches that can be used. As the quality system is being developed, FMEA can be applied to ensure that the proper paths are traversed. Once quality goals are identified for each global process, operational process, and key interrelationship, it will become appropriate to evaluate pertinent methodologies for problem solving and tools to be used to facilitate that problem solving.

SELECT METHODOLOGIES/TOOLS FOR EACH PROCESS

Use Sections 3.0 (Quality Systems) and 4.0 (Quality Tools) of the Roadmap to answer these questions, in conjunction with the Quality Toolbox (Naghe 2001). 5. How do we identify appropriate methodologies and tools for each process to be continuously improved? According to Naghe (2001), each process can be evaluated with three questions: which stage of the quality improvement discipline are you in (e.g. starting a new quality system vs. continuous improvement stage), what you want to do with the tool (e.g. idea creation, cause analysis) and whether you wish to expand or focus your thinking at the current time with respect to the process. Naghe's Quality Toolbox classifies tools according to six purposes. We note that three are specific to a process and three are not necessarily specific to a process (ie. can be applied to several different types of processes unilaterally, as in the case of problem solving tools). They are: Specific to a process: Process analysis tools Data collection and analysis tools Cause analysis tools Not specific to a process: Project planning and implementation tools Idea creation tools Evaluation and decision making tools For each process identified, start with 3.0 Quality Methodologies and step through the remainder of the decision charts in the roadmap in sections 3 and 4 to evaluate which methodologies and tools are pertinent.