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Risk Based Thinking in and Beyond ISO 9001:2015 (MFG662A)

Presented by: William A. Levinson, P.E.
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Pre Recorded Webinar
60 minutes
Event Description
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Going Beyond ISO 9001:2015 to Discover Supply Chain and External Risks

ISO 9001:2015's provision for "actions to address risks and opportunities" is one of the most significant changes to the standard. The standard requires risk-based thinking with regard to (1) context of the organization and (2) needs and expectations of interested parties, but it is vital to go beyond the mandatory aspects of the standard to consider other risks and opportunities. It is of little comfort to get the ISO 9001:2015 certificate only to fail to realize an opportunity, or lose a market segment to a competitor, because we overlooked a risk or opportunity that is not auditable under the standard.

In this session, our expert speaker William A. Levinson will therefore focus primarily on what the traditional audit does not cover, noting that the stated requirements of the standard already tell us what we have to audit. It will also introduce the Army's Risk Management process as a free off the shelf resource that can be adapted to industrial applications.

Session Highlights:

  • ISO 9001 originated to address the quality risks that arise from complex systems rather than poor individual craftsmanship. (This issue was actually recognized in 1959 as shown by MIL-Q-9858A, "Military Specification: Quality Program Requirement," which evolved into ISO 9001:1987.)
  • The provision for "actions to address risks and opportunities" is among the biggest changes to ISO 9001. These actions are mandatory with regard to the context of the organization, and needs and expectations of interested parties. It is important, however, to consider other risks and opportunities as well.
  • Understand risk as a function of the chance of an undesirable occurrence along with its consequences (severity in failure mode effects analysis). Go beyond the FMEA occurrence rating, however, by recognizing that risk is a function of not just the individual chance of occurrence but also the number of opportunities for failure.
  • Know how the Army's Risk Management process, a free off the shelf public domain resource, can be generalized to cover civilian industrial applications.
  • Know where to look for supply chain and external risks that ISO 9001:2015 does not address explicitly. In other words, know what even the most detailed quality audit will not discover.

Learning Objectives

  • Complex business systems and interacting processes, especially handoffs between processes, create quality risks that would have been unfamiliar to individual craft workers (or professionals such as doctors) who had complete control of a task. While "audit" often has a negative connotation, remember that the audit is not of the people but rather of the system in which they work.
  • Organizations that meet the requirements of ISO 9001:2008 reacts to risks as disclosed by nonconformances and defects, and pursue to tackle risks proactively through FMEA and other design and process assessment techniques. ISO 9001:2008 calls for more comprehensive actions to address opportunities and risks.
  • "Risk = np, not just p." FMEA assigns an occurrence rating on a 1 to 10 scale, with 1 being the best, based on the individual chance of failure (the p in the binomial distribution). The Army's Risk Management process recognizes, however, that the risk is actually the number of opportunities for failure (the n of the binomial distribution) as well as p. The practical implication is that engineering controls that make the failure impossible (p=0) are the only way to avoid exposure in mass production.
  • The Army's RM process, as documented in the public domain (publication of the U.S. Government) document Army Techniques Publication (ATP) 5-19, is easily adapted for civilian purposes and includes many elements familiar to quality professionals. It includes a risk assessment process that is much simpler than that of traditional FMEA, and can be used when, for example, the chance of occurrence is known only qualitatively rather than quantitatively. Diligent application of this process should, in fact, encompass the principles and guidelines of ISO 31000:2009.
  • ISO 9001:2015 requires actions to address risks and opportunities with regard to the context of the organization, and needs and expectations of interested parties. It says nothing about supply chain risks (other than those covered by clauses related to purchased goods and services) or external risks and opportunities due to new technologies or distribution channels. Remember that a quality audit cannot issue a finding for a situation that does not contravene the standard, which suggests that internal audits should go beyond the standard's requirements to address missed opportunities and otherwise unforeseen risks.

Who should attend?

  • Quality professionals
    • Auditors,
    • Manufacturing And Service Managers
    • Executives
About Our Speaker(s)

William A. Levinson | Quality and Productivity Management SpeakerWilliam A. Levinson P.E.
William A. Levinson, P.E., is the principal of Levinson Productivity Systems, P.C. He is an ASQ Fellow, Certified Quality Engineer, Quality Auditor, Quality Manager, Reliability Engineer, and Six Sigma Black Belt. He is also the author of several books on quality, productivity, and management, of which the most recent ... More info

Disclaimer: The content herein do not represent any association between ISO and AudioSolutionz. ISO neither endorses any product of AudioSolutionz nor warrants accuracy of the content hereto.
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    Event Title: Risk Based Thinking in and Beyond ISO 9001:2015
    Presenter(s): William A. Levinson, P.E.

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