Content By William A. Levinson

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By: William A. Levinson

ISO 9004:2018—“Quality of an organization—Guidance to achieve sustained success” expands considerably on the former (2009) revision. It introduces the important concept of “quality of an organization” (Clause 4.1), which makes excellent sense. If the organization’s processes are of high quality, we can expect good outputs, or at least rapid corrective and preventive action (CAPA) in response to problems.

William A. Levinson’s picture

By: William A. Levinson

Quality and manufacturing practitioners are most familiar with the effect of variation on product quality, and this is still the focus of the quality management and Six Sigma bodies of knowledge. Other forms of variation are, however, equally important—in terms of their ability to cause what Prussian general Carl von Clausewitz called friction, a form of muda, or waste—in production control and also many service-related activities. This article shows how variation affects the latter as well as the former applications.

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By: William A. Levinson

A job safety analysis (JSA) worksheet is almost identical in organization to a job breakdown sheet and standard work, all of which assess a job (or process) on a step-by-step basis. This suggests combining standard work with job safety analysis to support ISO 45001.

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By: William A. Levinson

Inspection is a mandatory but nonvalue-adding activity, and our objective is to do as little as possible, provided that we continue to fulfill the customer’s requirements. The zero acceptance number (c = 0) sampling plan requires far less inspection than the corresponding ANSI/ASQ Z1.4 (formerly MIL-STD 105) plan, and becomes viable when the supplier is extremely confident in its level of quality.1

William A. Levinson’s picture

By: William A. Levinson

William A. Levinson’s picture

By: William A. Levinson

William A. Levinson’s picture

By: William A. Levinson

Joseph Juran once warned1 that ISO 9001 standardizes mediocrity, and users often discover that it does not deliver outstanding or world-class results. This is not because of any inherent problems with the standard, but rather the manner in which organizations use it. If their goal is solely to “get the certificate” to satisfy their customers, the outcome is similar to that of a student who crams for an exam solely to pass the test and get credit for the course.

William A. Levinson’s picture

By: William A. Levinson

‘We’ve always done it that way” explains why many suboptimal and even obsolete methods are taken for granted. The range chart for statistical process control (SPC) is, for example, somewhat inferior to the sample standard deviation chart, and it is almost certainly a holdover from when all calculations had to be done manually.

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By: William A. Levinson

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.