Content by William A. Levinson
Counterfeit Parts and the 1,000 Risk Priority NumberReal-world case studies
Tue, 12/05/2017 - 12:03
The recent revelation that a major steel maker falsified test data,1 and similar scandals at other companies,2 underscores the menace of counterfeit parts, or what a 1987 Senate hearing called COME UPS: COunterfeit MatErials and Unauthorized…
Culture: A Decisive Competitive AdvantageGet ahead of ISO 9004:2018 by turning your company’s culture and identity into a competitive advantage
Tue, 10/03/2017 - 12:03
Some ISO 9001 users complain that the standard does not improve performance or deliver bottom-line results, while others are delighted by the standard as a framework for effective quality management systems. I pointed out previously that ISO 9001:…
ISO 9001:2015 and the Seven WastesWe have an ‘opportunity’ with ISO 9001:2015 to address more than product quality
Wed, 08/09/2017 - 12:03
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…
Replacing the Risk Priority Number A risk assessment should clearly account for the frequency of exposure
Tue, 06/20/2017 - 12:03
‘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…
Use a SIPOC Matrix to Deploy ISO 9001:2015 Clause 4.4There’s no need to rewrite processes to match the new standard
Tue, 04/25/2017 - 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…
Use a Variable-Height Desk to Improve Productivity and HealthFlexible workstations can be created for less than $300
Mon, 02/27/2017 - 12:03
‘Sitting is the new smoking” is a common new adage. James Levin, M.D., of the Mayo Clinic explains, “Too much sitting also seems to increase the risk of death from cardiovascular disease and cancer.” He adds that sitting for four rather than two…
Using a Conformity Matrix to Align Processes to ISO 9001:2015No need to rewrite procedures; simply demonstrate how they meet the standard’s provisions
Mon, 11/21/2016 - 11:27
Sept. 22, 2018, is the deadline for registration to ISO 9001:2015, and this seems to allow organizations plenty of time to make the transition to the new standard. The good news is that, despite the radical changes to the standard’s structure, the…
Mylan’s Self-Created RisksBeginning by bluster
Wed, 09/14/2016 - 16:42
Clause 6.1 of ISO 9001:2015 requires “Actions to address risks and opportunities” first with regard to section 4.1, “Understanding the organization and its context” and second in section 4.2, “Understanding the needs and expectations of interested…
Facebook vs. F.B. PurityWhen one interested party’s value is another’s <em>muda</em>
Thu, 08/25/2016 - 11:50
ISO 9001:2015 clause 4.2—“Understanding the needs and expectations of interested parties” requires the organization to determine the “requirements of these interested parties that are relevant to the quality management system.” The recent two-day…
The Value-Adding TwangA bang beats a twang hands down
Mon, 07/25/2016 - 09:54
Masaaki Imai, author of Gemba Kaizen (McGraw-Hill Education, 1997), introduced the concept of the value-adding “bang,” the exact moment at which a process adds value for the customer. He meant the moment at which an official stamped a document, but…