William A. Levinson’s picture

By: William A. Levinson

Chad Kymal1 gave an excellent overview of the ISO 45001 occupational health and safety (OHS) standard that was released in March 2018. I purchased a copy of the standard, and it provides an excellent framework, modeled on Annex SL, which defines the structure of all the new ISO standards, for an OHS management system. “Management system” is important because, although workplace safety has been mandatory for decades, traditional safety departments have the same limitations as traditional quality departments: The activity in question is limited to an organizational silo, as opposed to being part of a comprehensive and integrated management system.

Kymal’s webinar pointed out that ISO 45001 is not prescriptive. It does not include product safety (a separate issue from workplace safety) or even OSHA requirements, although it is emphatically synergistic with OSHA requirements, including those for OSHA’s voluntary protection program (VPP).

Andreas Engelhardt’s picture

By: Andreas Engelhardt

An international standard that specifies requirements for an occupational health and safety (OH&S) management system, ISO 45001:2018—“Occupational health and safety management systems–requirements” replaces OHSAS 18001 as the primary OH&S standard used internationally. It follows other management system approaches, including ISO 14001 and ISO 9001, and can help organizations develop a framework that improves safety, reduces workplace risks, and creates safer working conditions.

The growing globalization and fragmentation of supply chains has increased the levels of OH&S risk for multinational organizations because their business functions, and those of their suppliers and customers, cross multiple geographic boundaries. Without the assurance of a robust OH&S across that supply chain, an organization may be unwittingly exposed to substantial legal, financial, and reputational damage.

Anthony Chirico’s picture

By: Anthony Chirico

In my first article, the merits and cautions of AS9138 c=0 sampling plans were discussed and a simple formula was provided to determine the required sample size to detect nonconforming units. In the second article, the process control properties of MIL-STD-105 c>0 sampling plans were demonstrated, and the connectivity to other process control techniques was discussed. Here, a third alternative will be explored that applies the procedures of MIL-STD-105 to “imaginary limits” which are set proportionally inside the real “engineering specification.” This imaginary limit procedure thereby does not allow nonconforming units in the sample and has superior detection capabilities.

Anthony Chirico’s picture

By: Anthony Chirico

In my previous article, I discussed the merits and cautions of the “acceptance number” equal zero (c=0) sampling plans contained within AS9138. A simple formula was provided to determine appropriate sample size, and it was illustrated that twice the inspection does not provide twice the consumer protection. Although there is an undeniable emotional appeal to implement sampling procedures that have an acceptance number of zero, readers must not jump to the conclusion that c=0 sampling procedures provide better consumer protection at the designed lot tolerance percent defective (LTPD) point.

In this article the merits and limitations of MIL-STD-105 will be illustrated, and its link to process control will be demonstrated. Before discussing the technical merits of MIL-STD-105, its impressive evolution deserves some recognition.

Chad Kymal’s picture

By: Chad Kymal

Omnex began working in the automotive industry by assisting Ford powertrain suppliers in 1986. The U.S. automotive industry’s Big Three used GM’s Targets for Excellence, Ford’s Q 101, and Chrysler’s SQA standards to qualify its supply bases. The automotive industry was making deep reductions in its supply bases based on the results of these assessments and other factors. Though many on the Omnex team at that time came from General Motors, Ford’s Q 101 was the standard that really received our attention. This is the standard that many automotive suppliers used to guide them on their path to improvement.

Anthony Chirico’s picture

By: Anthony Chirico

Aerospace standard AS9138—“Quality management systems statistical product acceptance requirements” was issued this year (2018), a few years after its accompanying guidance materials in section 3.7 of the International Aerospace Quality Group’s (IAQG) Supply Chain Management Handbook. The new aerospace standard supersedes the aerospace recommended practice of ARP9013 and, related to MIL-STD-105 (ANSI/ASQ Z1.4), claims to shift focus from the producer’s risk to the consumer’s risk with sampling plans having an acceptance number of zero (c=0).

Somewhere along this evolutionary path, the sampling procedures of MIL-STD-105 have fallen out of favor, even though the consumer risks of MIL-STD-105 at their designed lot tolerance percent defective (LTPD) point are superior to most plans found within AS9138.

Mike Richman’s picture

By: Mike Richman

IMTS was a blast, but it was great to be back home in lovely Northern California this week. On this episode of QDL, we covered the skills that workers need and the innovations that organizations want. Plus, we brought you a live interview with author Mark Graban, and one on tape from Burt Mason of Hexagon Manufacturing Intelligence captured at IMTS. Let’s take a look:

“Only 20 Percent of Employees Have Skills Needed for Their Current Roles and Future Careers”

Adapting to the coming digital transformation means that organizations must hire, train, and motivate workers in a whole new way. Gartner research indicates that companies can best do this by identifying and developing so-called “connected learners.”

Richard Pazdur’s picture

By: Richard Pazdur

During the past decade, advances in understanding of cancer biology have led to the development of targeted treatments that are more effective than the chemotherapies of the past century. These therapies are demonstrating response rates large in magnitude or response durations prolonged in early trials, or both. Patient demand to enter these trials has increased, and so have calls to expedite the drug development and approval processes, all while maintaining high standards for safety and efficacy.

The U.S. Food and Drug Administration (FDA) never loses sight of its dedication to patients faced with a life-threatening disease, and to making progress in the fight against cancer.

The administration works with industry, researchers, and other stakeholders developing innovative cancer therapies to ensure clear understanding of the FDA’s latest thinking on how clinical trials can be efficiently and effectively designed to demonstrate a cancer therapy’s safety and efficacy.

Last week, the FDA published a draft guidance to help advance effective and innovative clinical trial designs early in drug development to help bring new cancer therapies to patients as quickly as possible. Below is a quick summary of this guidance:

Nicole Radziwill’s picture

By: Nicole Radziwill

ISO 31000 defines risk as “the effect of uncertainty on outcomes.” Identifying risks and determining ways to respond to them help you learn about your processes, your organization, and the environment you’re operating within. It also raises your awareness of how any of these things might change in the future. Perhaps most important, this helps you quickly respond to—and recover from—negative events like natural disasters, supply chain disruptions, and cyberattacks.

Risk management can also help your organization uncover new opportunities, if risks are considered within the context of strengths, capabilities, and threats.

But let’s face it: Risk management can be difficult and time-intensive, and it doesn’t easily reveal returns on investment. Especially when people are busy, and budgets are tight, taking a risk-based approach can feel like a distraction. “Compliance complacency” is not uncommon, and sometimes only the minimal amount of effort goes toward meeting governance or documentation requirements. In 2016, Carmela Cucuzzella, of Concordia University in Canada, mentioned that some product designers even express contempt for risk management, claiming that it can strip them of their creative freedom.

Oscar Combs’s picture

By: Oscar Combs

ISO 9001:2015, clause 6.1 requires an organization to identify its risks and take actions to address identified risks. It is very tempting to start with a huge list of potential risks for the organization, but is the organization focusing on the actual risks that have an effect on its operations? To perform an effective risk assessment, an organization must first identify the uncertainty in its processes.

When uncertainties are identified, mitigation controls can be targeted at the effects of the identified uncertainties. Failing to identify an uncertainty first could lead to flawed risk identification and nonvalue-added controls. The approach defined here will lead to more effective and meaningful risk identification and mitigation.

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