Today’s manufacturers have plenty of software solution options that are meant to enhance their productivity. You may be familiar with each of these software packages. However, if you are not, it is important to understand what each of these software packages are designed to deliver.

Enterprise resource planning (ERP): ERP systems help you to focus on the business aspects of your manufacturing processes. This includes things like supply and demand, scheduling, actual costs, accounting, and more. In essence, ERP tracks the execution of the business aspects of manufacturing. But while an ERP system offers high-level tracking of many business operations, it may have gaps in specific functionality. These gaps are often filled by additional software like PLM, MES, or QMS.

Production life-cycle management (PLM): The PLM system was developed to help track processes and product innovation. As such, it focuses on design, development, and production planning. In other words, PLM focuses on the innovation of your product line.

As the coronavirus wreaks economic turmoil around the world, our modern supply chains are facing unprecedented stress. For months prior to the Covid-19 crisis, trade tensions had been mounting due to the escalating tariff war between Washington and Beijing. A rise in protectionism, coupled with concrete costs and new financial barriers, has fueled broader challenges and concerns for worldwide logistics networks. Against this backdrop, our modern supply chain infrastructure is well overdue for a rethink.

Today’s globalized supply chain networks have been optimized to identify minimum lead times at the lowest possible costs. However, rapid political developments, extreme climate events, and now a global pandemic have all revealed the hidden costs of single-source dependencies and poor flexibility in adapting to real-time shocks, with fast changes to supply and demand. During the next several years, as we undertake a broader overhaul of our logistics infrastructure, I believe that a new order will emerge based on three key dimensions.

The U.S. House of Representatives has passed the HEROES Act (Health and Economic Recovery Omnibus Emergency Solutions Act)¹ which will, if approved by the Senate and president, require OSHA to develop a standard for workplace protection against Covid-19.

Under section 120302 the legislation says specifically (emphasis is mine):

“(a) EMERGENCY TEMPORARY STANDARD

(1) In general—in consideration of the grave danger presented by COVID-19 and the need to strengthen protections for employees, notwithstanding the provisions of law and the Executive orders listed in paragraph (7), not later than 7 days after the date of enactment of this Act, the Secretary of Labor shall promulgate an emergency temporary standard to protect from occupational exposure to SARS-CoV-2—

(A) employees of health care sector employers;
(B) employees of employers in the paramedic and emergency medical services, including such services provided by firefighters and other emergency responders; and
(C) other employees at occupational risk of such exposure. ...

Given the death, suffering, social disruption and economic devastation caused by Covid-19, there is an urgent need to quickly develop therapies to treat this disease and prevent the spread of the virus.

But the U.S. Food and Drug Administration (FDA), charged with the task of evaluating and deciding whether to approve new drugs and other products, has a problem. The FDA’s standards appear to be dropping at a time when rigorous regulatory review and robust oversight are crucial.

Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall business management. In this article we look at the clauses and subclauses of section 8 of the standard.

Clause 8: Operation

Clause 8 contains the requirements for planning, designing, and bringing to fruition your products or services. The processes within this clause must be robustly implemented to achieve business excellence. They must also be continually scrutinized for foreseeable risk.

8.1 Operational planning and control

8.1 and excellence
The “plan” is a series of interrelated process, each with acceptance criteria, and each with metrics that tie to the organization’s key objectives and key process indicators. Or, at least that has been my interpretation while leading scores of implementations.

Long before coronavirus appeared and shattered our preexisting “normal,” the future of work was a widely discussed and debated topic. We’ve watched automation slowly but surely expand its capabilities and take over more jobs, and we’ve wondered what artificial intelligence will eventually be capable of.

The pandemic swiftly turned the working world on its head, putting millions of people out of a job and forcing millions more to work remotely. But essential questions remain largely unchanged: We still want to make sure we’re not replaced, we want to add value, and we want an equitable society where different types of work are valued fairly.

To address these issues—as well as how the pandemic has impacted them—this week Singularity University held a digital summit on the future of work. Forty-three speakers from multiple backgrounds, countries, and sectors of the economy shared their expertise on everything from work in developing markets to why we shouldn’t want to go back to the old normal.

For many manufacturing quality professionals, the thought of updating their statistical process control (SPC) solution is like getting an extra birthday. Many quality experts know that modernizing the way they collect, analyze, and use data is a critical need for their organizations, now more than ever.

But it may not be easy to convince the rest of the stakeholders in a company to not only approve a new quality intelligence solution but also adopt and use it. Fortunately, InfinityQS understands the challenge. We’ve been helping organizations through this process for three decades, and we’ve learned one fundamental principle for success: Start with a proof of concept.