Compliance4All, Online Event
2016-11-09
Overview: The risk of omission, or what we don't do right, is usually far more dangerous than the risk of what we do wrong (poor quality). Poor quality generally announces its presence during inspections and tests (internal failure) or, in the worst case, when customers complain about it (external failure).
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. As but one example, Kodak once made some of the world's best photographic film, but this product was rendered obsolete by the digital photography that Kodak itself helped invent.
Areas Covered in the Session: Know that the requirement for "actions to address risks and opportunities," i.e. risk based thinking, is among the biggest changes to the ISO 9001 standard. Know that the risk of omission (not doing the right thing) is usually far more dangerous than risks associated with poor quality. Use the word "asymptomatic" to describe waste or muda that often hides in plain view in organizations and their supply chains. Know how to quantify all wastes in terms of the time of things (cycle time), time of people (waste motion), materials, and energy. Learn where risks of supply chain disruption, and wasteful supply chain activities, can hide in the supply chain. Recognize sources of external risks such as new technology and new distribution channels.
Who Will Benefit: Design Engineer Manufacturing Engineer R&D Personnel R&D Project Managers Regulatory Affairs Specialist R&D Manager Quality Engineer Quality Auditor Quality Manager Reliability Engineer
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