The Process Approach to QMS In ISO 9001 and ISO 9004
Revisions make the two standards more straightforward and applicable to all organizations
by Jeffrey H. Hooper
This article is adapted from chapter two of the new Quality Press ASQ ISO 9000 Handbook edited by Charles A. Cianfrani, Joseph J. Tsiakals and John E. "Jack" West. West is a member of QP's regular panel of "Standards Outlook" columnists. The handbook provides insight on each clause of ISO 9001:2000 by authors from around the world who were involved in the process of writing the new standard. This article deals directly with the use of the process approach. Other chapters in the handbook provide further insight into the use of the process approach in the documentation of a quality management system and in continual improvement.
One of the most important aspects of the year 2000 revisions of ISO 9001 and ISO 9004 was the adoption of the process approach to quality management systems (QMSs). A strong consensus for adopting the process approach formed very early in the revision cycle.
This approach improves on that of the previous standard by providing a much more generic structure readily applicable to all sectors of the economy and sizes of organization. At the same time, it allows the requirements to be stated in language more familiar to line managers and less encumbered by quality jargon.
ISO 9001:2000 focuses on improving the effectiveness of a QMS to enhance customer satisfaction by meeting customer requirements, while ISO 9004:2000 focuses on improving the effectiveness and efficiency of a QMS to enhance interested party satisfaction by meeting interested party requirements. The common structure of the two standards is demonstrated in Figure 1.
Understanding the approach
The process approach is one of the eight quality management principles upon which the entire ISO 9000 series of standards is based. This principle says a desired result is achieved more efficiently when activities and related resources are managed as a process.
The word "process" is defined in ISO 9000:2000 clause 3.4.1 as "a set of interrelated or interacting activities that transforms inputs into outputs." Inputs to a process are generally outputs of other processes. Processes in an organization are generally planned and carried out under controlled conditions to add value.
From the principle and process definition you can see the process approach is a powerful way of organizing and managing how work activities create value. While a more traditional structure organizes and manages work activities vertically by function, with quality problems frequently occurring at the boundaries of the functional departments, the process approach organizes and manages work horizontally the way work activities create customer value.
The process approach directly links process inputs that come from suppliers to the outputs of the process that go to customers. This horizontal linkage between suppliers and customers is an excellent way to manage and continually improve both the effectiveness (the amount of value created for the customers) and the efficiency of the process (the amount of resources consumed). Figure 2 (p. 72) shows these relationships.
Once the processes needed for the QMS and their sequences and interactions have been identified (see Figure 1), it is necessary to establish management responsibilities and accountabilities for the performance of these processes. Many methodologies are available for managing and improving processes, but all share some simple basic elements. A simple process management and improvement methodology organized in a series of steps is described in the following:
Step one: Establish the responsibilities for managing the process. It is critical to have an overall process manager or process owner with end to end responsibility and accountability for all aspects of process performance. The process manager needs to understand the entire process and have the authority to effect changes in any part of it.
The process manager is responsible for the following:
- Forming the process management team, which includes representatives from each major part of the process.
- Ensuring the process operates in a controlled state of predictable performance.
- Establishing process performance measures that adequately characterize the efficiency and effectiveness of the process in meeting the needs of all customers and other interested parties.
- Ensuring all aspects of process management and improvement are performed. This includes creating documentation, tracking performance, and securing and allocating resources.
Step two: Define the process. The process manager and process management team need to carefully define the process so everyone working within the process has a shared understanding of how it operates. How much documentation is required depends on such attributes as the stability and education of the workforce and the complexity and criticality of the process.
All process inputs and outputs are identified, along with the suppliers and customers, who may be internal or external. The team also identifies process steps and flows. Many quality tools, such as block diagrams and flowcharts, are available to support these activities.
Step three: Identify customer requirements. Carefully gather, analyze and document customer needs, including how customers use the outputs of the process. Communicate frequently with customers to understand needs from their viewpoint.
To the extent possible, define measurable customer needs and rank them in order of importance. Directly validate needs and requirements with customers.
Step four: Establish measures of process performance. Translate customer needs and requirements into measures of process performance. This is one of the most important and difficult steps in process management.
Include customer satisfaction, in-process measures and measures of supplier performance in process measures. Relate all important customer needs, such as on time performance, defect or error rates, tolerance intervals, product reusability, and worker health and safety, to performance measures.
The process approach is therefore one of the strongest approaches for integrating management system standards because each process must be managed and improved simultaneously for all process performance measures. Directly linking process performance measures with customer needs is one of the most powerful aspects of process management.
Step five: Compare process performance with customer requirements. Use the process performance measures to ensure your process is operating in a stable and predictable manner.
Compare the process performance measures with the needs and requirements of the customers. Use a variety of statistical tools for analyzing process measurement data to help quantify process performance. Identify critical process improvement opportunities through gaps in process performance.
These first five steps provide a basic methodology for process management. But the responsibilities of the process manager and process management team do not end there. A significant benefit of process management is its natural fit with process improvement. Once process performance has been compared with customer requirements, process improvement is the natural next step.
Step six: Identify process improvement opportunities. Use gaps in process performance vs. customer needs to determine critical process improvement opportunities. Analyze process performance measures for improvement opportunities related to sources of such attributes as errors and defects, process simplification opportunities, process bottlenecks and lack of adequate process controls.
Both process effectiveness and efficiency can improve as a result of process improvement activities. Many tools exist to identify process improvement opportunities.
Once process improvement opportunities are identified, any of the many quality improvement methods can be used to improve process performance. These quality improvement methods fit naturally into step seven of the process management and improvement methodology.
One quality improvement method that can be used at this step is the plan, do, check, act (PDCA) cycle.
Step seven: Improve process performance. Select the process improvement opportunity to pursue. This selection should take into account such attributes as the criticality of certain improvement needs, difficulty of improvement opportunities, and resources and expertise available.
Establish quality improvement teams to pursue specific improvement opportunities. These teams are established by the process manager and process management team. The quality improvement teams report to the process manager or the process management team and are typically disbanded once their improvement project is completed.
The quality improvement teams complete the following activities:
- Clarify the improvement opportunity problem statement, schedule and budget.
- Determine the root causes of problems.
- Develop and implement countermeasures to reduce or eliminate the occurrence of root causes.
- Stabilize the process at the new level of performance.
- Return to step six or seven.
Support for the system approach
The process approach is an important part of the system approach to management. The process approach assumes understanding and managing interrelated processes as a system can contribute to an organization's effectiveness and efficiency in achieving objectives.
Using the process approach, a QMS is comprised of the following four categories of interrelated processes (shown in Figure 1, p. 70):
- Management responsibility.
- Resource management.
- Product realization.
- Measurement, analysis and improvement.
Each process can be managed and improved using process management and improvement methodology, but managing the interrelated processes as a system introduces additional improvement opportunities.
First, processes can be analyzed and improved together as mega-processes, increasing the opportunities for improvement. But you can also directly pursue improvement of the entire QMS using audit and self-assessment (using 9004:2000 or quality award criteria) results and the PDCA cycle.
The multiple levels at which continual improvement occurs
make QMSs based on the process approach a powerful way to manage organizations
toward achieving performance excellence.
Process Quality Management & Improvement Guidelines, Issue 1.1, AT&T Quality Steering Committee, 1988, AT&T.
PQMI: Tips, Experiences & Lessons Learned, AT&T Quality Steering Committee, 1990, AT&T.
JEFFREY H. HOOPER is managing vice president of information services with Lucent Technologies, Warren, NJ. He earned a doctorate in operations research from Cornell University in Ithaca, NY. Hooper was the project leader of the year 2000 revisions of ISO 9001 and ISO 9004 and vice chair of the U.S. Technical Advisory Committee to ISO Technical Committee 176. He is a member of ASQ.
Q. I am looking for a comparison between QS-9000 and AS9100 showing their similarities and differences, plus a bottom-line assessment of which standard is considered "better."
A: It's an "apples and oranges" question.
Comparisons end there. QS-9000 was developed for
volume manufacturing, process capability and control requirements.
On the other hand, AS9100 is more focused on the lower volumes of aerospace, on the complexities of design of the technology of aerospace and on controlling design change implementation. And it is heavy on the civil requirements of civil aviation, military and space organizations.
So a one-to-one comparison is not possible, but you can see both the commonality and differences