Planning the QMS
Quality planning is the paramount element of ISO 9001. The standard makes a clear -distinction between planning the quality management system (QMS) and other, more detailed planning of product realization, monitoring, measurement, and improvement. This month we’ll look at planning the QMS.
ISO 9001, subclause 5.4 -- “Planning” addresses the requirements for determining an organization’s quality objectives and planning the QMS to meet those objectives. Subclause 5.4.2 addresses the requirements to which such system planning must conform to meet the quality objectives and requirements of subclause 4.1 (general requirements for the QMS). Subclause 5.4.2 also requires that as the QMS changes, it maintains its integrity.
In my June 2006 Quality Digest column (“Creating a Solid Quality Foundation”), I pointed out that top managers must complete a number of tasks before considering the organization’s objectives. These relate to clearly establishing the organization’s mission, vision, and values. Once these are clearly understood, the question to ask when establishing quality objectives is, “What are the quality-related activities that support our organizational mission, vision, and overall business objectives, and what is our policy regarding those activities?”
Once established, objectives become major factors in planning the system. It does no good to design a QMS that’s inherently incapable of meeting the organization’s objectives. An incapable QMS means that other, redundant, efforts will be required to achieve the objectives. When this happens, the QMS is often viewed as irrelevant, a situation that’s likely to destroy it.
The details for planning the system are actually found in subclause 4.1, which requires an organization to identify the processes needed for its QMS as well as their sequence and interactions. Criteria and methods must be established for successful operation, monitoring, measurement, and control of processes. All necessary resources must be determined and provided. Plans are needed to both achieve results and improve the processes.
A key activity in process planning is to understand and anticipate process interfaces. It’s at the interfaces that trouble normally lurks.
Process and interface planning must address all key system processes, such as assigning responsibilities, management review, and managing human and other resources. It includes macro-level decisions related to planning for product realization as well as for measurement analysis and improvement. For example, some organizations may need to decide if a single corrective action process should be used for the whole system or if a separate corrective action process for each organizational unit would be more appropriate. Interfaces such as those between corrective action processes and processes for data collection, analysis, and management review must also be worked out.
Once key processes have been identified, it’s necessary to understand how each one contributes to meeting customer requirements, internal objectives, and ISO 9001 requirements. This implies establishing criteria to determine if each process is contributing to the organization’s success in meeting those goals. Each process can then be mapped out to ensure that it’s followed efficiently and hence achieving success.
Change happens all the time, so why is it so difficult to see it occurring until disaster strikes? It’s imperative that organizations plan for change to happen, whether it’s anticipated or comes about due to outside forces. To do this, organizations must implement processes to identify imminent changes and ensure that the integrity of the QMS is maintained. This means that changes to the QMS should be carefully planned and executed. The challenge presented by outsourcing activities of the product-realization cycle to locations on other continents is an obvious example, but much smaller changes can have a big effect.
Planning the QMS might be thought of as a “big picture” activity that answers the question, “How do the processes and associated resources of the QMS work together to ensure that the organization meets customer requirements, internal objectives, and ISO 9001 requirements?” Although this planning may deal with the details of a number of processes, the macro-level understanding of how these processes work together is most important. I don’t want to play down detail planning, but effective, overall system planning is also critical. It drives attention to the right details. A good system with carefully thought-through interactions, robust analyses, and critical management reviews will prevent critical failures, correct problems, and drive improvements.
I’ll review the more detailed planning for product realization, monitoring, measurement, and improvement in future columns.
John E. (Jack) West is a consultant, business advisor, and author with more than 30 years of experience in a wide variety of industries. From 1997 through 2005, he was chair of the U.S. TAG to ISO/TC 176. He remains active in TC 176 and is chair of the ASQ Standards Group.
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