Training by Compliance4all on Go Beyond ISO 9001:2015's Requirements when Dealin
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| Description: | Overview: ISO 9001:2015 requires "actions to address risks and opportunities" with regard to "context of the organization" and "needs and expectations of interested parties." These actions are necessary but not always sufficient to achieve organizational success or even survival because many risks and opportunities are outside the standard's explicit scope. ISO 9001 originated because quality practitioners recognized that quality depends on a complex system rather than individual tasks and activities. The newer versions of the standard require consideration of interactions between the systems' processes. It is also, however, necessary to look beyond the scope of the organization's own processes to its supply chain and environment for additional risks and opportunities, some of which it can control only partially (e.g. the supply chain) if at all. We must often go beyond the explicit scope of ISO 9001 to recognize and address the risks and opportunities in question. Why should you Attend: ISO 9001:2015 Clause 6.1 requires "actions to address risks and opportunities" with regard to the "context of the organization" and "needs and expectations of interested parties." The standard also cites the SIPOC (Supplier, Input, Process, Output, and Customer) model, but the scope of "actions to address risks and opportunities" is still not sufficiently wide to cover many existential risks and opportunities. The true scope of organizational risks includes: Poor quality, which is already covered extensively by ISO 9001 as well as traditional quality management Friction, as defined by Major General Carl von Clausewitz's On War (1831). Friction does not necessarily manifest itself as poor quality, but it can easily degrade organizational performance. It includes inefficiencies that are built into jobs but go unnoticed because the jobs do not produce defects or scrap. Variation in transportation and processing times is another form of friction, as depicted in Goldratt's and Cox's The Goal. ISO 9001:2015 does not address this issue explicitly, although it does encourage the general consideration of risks and opportunities. Supply chain risks. ISO 9001:2015 covers only quality-related aspects explicitly. New distribution channels and technological change, which appear to be outside the standard's scope. Areas Covered in the Session: Know that ISO 9001 originated to address deficiencies in complex manufacturing and service systems rather than individual activities. Know that the scope of risk includes (a) internal risks such as poor quality and also friction, waste, or muda, (b) supply chain risks, and (c) external risks such as technological change and new distribution channels. Understand the basic concept of risk, and also the concept of friction. Go beyond the occurrence rating (1-10 scale) of an FMEA to understand that we must also account for the frequency of exposure to the risk. This, in turn, makes it necessary to error-proof critical to quality operations that are performed frequently. Know that Army Techniques Publication (ATP) 5-19, Risk Management, is a public domain off the shelf resource. Recognize common supply chain risks, along with risks of technological change. Recognize how a company can expose itself to risks, as Mylan appears to have done by hiking the price of the EpiPen in the absence of real barriers to market entry. ISO 9001:2015 does not explicitly require consideration of this risk, except with regard to the reaction of customers as interested parties. Who Will Benefit: Manufacturing and service companies in transition to ISO 9001:2015 Lean manufacturing professionals executives, and business risk professionals Speaker Profile William Levinson 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 holds degrees in chemistry and chemical engineering from Penn State and Cornell Universities, and night school degrees in business administration and applied statistics from Union College, and he has given presentations at the ASQ World Conference, TOC World 2004, and other national conferences on productivity and quality. |
| URL: | http://www.compliance4all.com/control/w_product/~product_id=501037LIVE |
| Status: | Deleted |
| Date: | Monday, December 5, 2016 |
| Time: | 3:00pm-4:00pm UTC |
| Duration: | 1 hour |
| Access: | Public |
| Category: | Education*, Webinar*, Marketing*, Health*, Food and Beverage* |
| Created by: | compliance4all |
| Updated: | Thursday, October 27, 2016 11:38am UTC |
| : | One Dial-in One Attendee Price: $150.00 |
| : | 18004479407 |
| : | support@compliance4All.com |
| : | Event Manager |
| : | 18004479407 |
| Comments: | None |