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William A. Levinson
Published: Tuesday, April 25, 2017 - 12:03 Among other requirements ISO 9001:2015, clause 4.4.1 requires an organization to identify the inputs and outputs of the processes of the quality management system; identify the sequence and interaction of these processes, noting that handoffs between processes often create risks; and identify the resources required by the processes. These provisions are consistent with the supplier, input, process, output, customer (SIPOC) model that treats processes as internal customers and suppliers. This article recommends the SIPOC conformity matrix as a centerpiece of a quality manual that serves as a centralized information source for management and auditors. The fact that ISO 9001:2015 does not require a quality manual does not mean, of course, that a first tier document that describes the entire quality management system (QMS) is not extremely useful. It is a good place to identify the context of the organization (clause 4.1), relevant interested parties (4.2), the scope of the QMS (4.3), the quality policy (5.2), and possibly the performance metrics, inputs, and outputs of the management review (9.3). This tells an auditor or other relevant interested party up front what your organization considers important. The SIPOC conformity matrix meanwhile addresses the QMS and its processes (4.4) with a one-stop resource for information on the flow of resources and information between the processes, and on the deployment of the standard’s requirements by the processes. It can’t be overemphasized that the new clause structure for ISO 9001:2015 is for the purpose of stating requirements, and not for restructuring the QMS. There is no need to rewrite or restructure procedures (except to cover the new requirements), and the conformity matrix can be used to show how the QMS meets the requirements. Figure 1 shows a SIPOC conformity matrix for seven processes, along with “relevant interested party” as a source of inputs and outputs. A real QMS will certainly have more, but only eight is presented here for simplicity. Figure 1: SIPOC conformity matrix The center of the matrix lists the processes of the QMS as suppliers, and the columns on the right show the same processes as customers. The matrix on the left, meanwhile, shows the major sections of ISO 9001:2015. This is not just a checklist because the first question an auditor is likely to ask, for example, is “How does your corrective and preventive action (CAPA) process deploy the Planning clauses of the standard?” The answer is available by clicking on the cell as shown in figure 2. Figure 2: Information content of cells This tells an auditor that the CAPA process can be used to eliminate not just the root causes of nonconformities but also muda (waste). The line for CAPA could, in practice, be hyperlinked to the actual document to allow immediate inspection of the second-tier procedure. A hyperlink was in fact created to another worksheet in the same Excel file; the worksheet contains a sample process for hiyari hatto (“experience of an almost-accident situation,” a stakeholder-initiated report of a safety or quality risk, or an opportunity to remove muda). The additional information can be placed in the cell as shown in figure 3. The intention is not to validate data, however, but simply to display the input message that elaborates on the X that indicates a relationship between the process and the element of the standard. Figure 3: Use the data validation feature to add information to a cell Note also that we could hyperlink the X to detailed information, but it is preferable to keep the quality management tool as simple as possible. Even so, the SIPOC conformity matrix is far more than a checklist, regardless of how we display the additional information. It provides the user or an auditor with everything they need to know about the processes of the QMS, including inputs, outputs, and handoffs between processes. The right side of the matrix shows these interactions and handoffs. Figure 4, for example, shows that any relevant interested party such as an employee, customer, or supplier can initiate a hiyari hatto for any situation that could create a safety or quality risk, or for any opportunity to remove muda. The interested party is the “supplier,” and the hiyari hatto process is the “customer.” Clicking on the cell shows this relationship clearly. Figure 4: Hiyari hatto process as the “customer” for interested parties Figure 5 shows the hiyari hatto process as a supplier to the organizational knowledge process because, even if the process owner can resolve the issue on the shop floor, the solution becomes part of a lessons learned database for future reference. Figure 5: Hiyari hatto as a supplier process If the problem is too complicated for resolution at the shop floor level, then the hiyari hatto process initiates a formal corrective and preventive action (CAPA) process such as team-oriented problem solving, 8 Disciplines. This makes it a supplier to the CAPA process as well. Note also that the organizational knowledge process is a supplier for CAPA and hiyari hatto. Users can perform a keyword search to determine whether somebody encountered a similar problem before. The organizational knowledge database should therefore be identified as a resource in both the CAPA and hiyari hatto processes. The SIPOC portion of the matrix similarly illustrates other relationships. For example, purchasing is a customer of “planning of product realization” because the latter process is the source of the specifications. Planning of product realization is a customer of “relevant interested parties” because the voice of the customer, e.g., through quality function deployment, is an input to the former process. The SIPOC conformity matrix is therefore offered as a new planning and maintenance tool for a QMS whose SIPOC portion displays all the customer-supplier relationships of the processes in a compact format that can nonetheless access detailed information upon demand. The conformity portion can meanwhile show how existing processes deploy the requirements of ISO 9001:2015. This underscores the fact that there is no need to rewrite or restructure the processes to match the structure of the new standard. Quality Digest does not charge readers for its content. We believe that industry news is important for you to do your job, and Quality Digest supports businesses of all types. However, someone has to pay for this content. And that’s where advertising comes in. Most people consider ads a nuisance, but they do serve a useful function besides allowing media companies to stay afloat. They keep you aware of new products and services relevant to your industry. All ads in Quality Digest apply directly to products and services that most of our readers need. You won’t see automobile or health supplement ads. So please consider turning off your ad blocker for our site. Thanks, William A. Levinson, P.E., FASQ, CQE, CMQOE, is the principal of Levinson Productivity Systems P.C. and the author of the book The Expanded and Annotated My Life and Work: Henry Ford’s Universal Code for World-Class Success (Productivity Press, 2013).Use a SIPOC Matrix to Deploy ISO 9001:2015 Clause 4.4
There’s no need to rewrite processes to match the new standard
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William A. Levinson
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