Define Systems of Record to Boost Performance

Quality depends on data because effective decision making depends on data. As a result, successful business and process outcomes will depend on building a culture of quality around data. This includes creating and following management processes to make data accessible, available, and accurate.

One strategy for improving process quality through data is to identify master data and decide which system of record will hold each type of master data. This is similar to knowing who the experts are in your company, knowing how to find them when you need them, and getting assurance that they will provide you with accurate, up-to-date information. For example, your Environment, Health, Safety & Quality (EHSQ) system may be your system of record for emissions, incidents, exposure data, and quality events, providing a single source of truth for these processes.

Master Data

Master data is some of the most important data your organization has – … Read more...

Next Generation Quality: It’s All About the Data

As early as 2015, McKinsey’s “Digital America” report projected that adoption of Industry 4.0 technologies in manufacturing alone was expected to increase domestic GDP by over $2 Trillion by 2025. This estimate, developed from expectations surrounding productivity enhancements, waste reduction using methods from lean manufacturing, and new business models enabled by technologies like 3D printing and practices such as remanufacturing, is on track to not only be met — but exceeded.

Manufacturing is Being Revitalized

All of these sea changes are happening because of data – and the software used to collect, manipulate, and understand it. While traditional manufacturing jobs have relied on physical and mechanical skills, new manufacturing jobs require additional cognitive skills. As a result, manufacturers are scrambling to identify and roll out technology training for workers that will best support these emerging needs. At the same time, organizations recognize that institutional memory remains critical. Job shadowing … Read more...

Statistical Process Control Turns Potential Problems into Valuable Opportunities

Imagine how nice it would be if you could predict the future, if you could make decisions with the confidence that you knew exactly what their consequences would be.

Unfortunately, we can’t predict the future. But we can get greater insight into the hidden patterns in processes and information that exist right now, and that can give us a much better idea of how to respond to potential problems before they become a reality. When we put what we learn from these insights to good use with an integrated EHSQ (environment, health, safety, and quality) management system, we can also unlock the potential for incredibly valuable financial opportunities.

Statistical process control (SPC) is a method traditionally associated with manufacturing. However, it can provide deep and valuable insight into any business or production process. SPC is a mathematical technique developed in the 1920s to monitor random processes and provide alerts when … Read more...

Close the Loop on CAPAs with Verification of Effectiveness

In addition to meeting compliance requirements for many ISO defined management systems, corrective and preventive actions (CAPAs) serve another critical role: to be the backbone for your organization’s continuous improvement efforts. CAPAs help you keep track of problems that are observed, problem solving processes used to investigate them, and resolutions. Additionally, the CAPA process provides a way to trace exactly how a quality management system evolves and matures through business processes.

In ISO 9001:2015, the emphasis has shifted exclusively to corrective actions (CARs), since a risk-based approach (which includes continuous risk assessment, and regular dispatch of actions to mitigate or otherwise manage risks) should theoretically accomplish the same goals as preventive actions did in the past.

Despite the value that can be driven by a robust CAPA process, it can also quickly become overwhelming and unmanageable. Not every quality event has to be immortalized in a CAPA — some don’t … Read more...

How EHSQ 4.0 Is Set to Supercharge Your Organization

When people think of Industry 4.0, they might think of connected factories and smart manufacturing. Yet the methods and tools of Industry 4.0 extend far beyond manufacturing. Soon, every organization will be able to benefit from Industry 4.0 methods and practices as they adopt more flexible and connected networks of people, data, and machines to improve efficiency of assets, quality of products and services, and process flow.

The approach of Industry 4.0 is poised to supercharge the world of EHSQ. For several years, the EHSQ community has been using integrated management systems to consolidate ISO 9001, ISO 14001, and ISO 45001 systems, an approach that ISO has recently made easier with the introduction of the High-Level Structure (HLS). As EHSQ assimilates the tools of Industry 4.0 to become EHSQ 4.0, it will move from being a way to record incidents and track quality events to one of bridging multiple disciplines … Read more...

Root Cause Analysis and the Tools You Need to Drive Continuous Improvement

Root Cause Analysis is part of an ecosystem of tools and techniques you can implement to help your organization harness the value from their EHSQ integrated management systems. Improving your organization’s processes requires identifying a methodology and approach that can spur innovation through evidence-based analysis.  

Root Cause Analysis (RCA) is one of several methodologies in your toolkit – including Failure Mode Effects Analysis (FMEA), Control Plans and Corrective Actions (CAR or CAPA) – that can be used to uncover the reasons for safety incidents or near misses, occupational health issues, environmental issues like repeated violations and quality events like recalls and nonconformances. Implementing a framework that incorporates multiple analysis tools to achieve a desired outcome can result in measurable results.  

Top Five Tools for Continuous Improvement

These tools can be extremely valuable for performance when used proactively — and in conjunction with one another. Here’s how they might be used together:   

  1. Identify potential failure modes through a Process Failure Mode Effects
Read more...

What Can We Learn from the Organizational Cultures of Different Industries?

Many industries have no clear boundary between safety and quality culture. In fact, they are often very closely integrated. Quality failures and nonconformances that require rework have been correlated with increased accidents and recordable injury rates in manufacturing organizations. These injuries are frequently the result of fatigue, workplace pressure, and the pressure from extra work due to quality failures.

Among the important collective of people, processes, and tools, people are the primary point of failure in increasingly automated systems. Unlike machines, we are subject to fatigue, information overload, and stress that can have a serious impact on our ability to work safely and efficiently. However, people are also the place where dynamic sensemaking, decision-making, and situational awareness reside, which are vital ingredients in complex and high-reliability organizations (HRO).

Culture is therefore an integral element of every organization. In the new Intelex Insight Report Integrating Quality and Safety in Organizational Culture: Read more...

10 Tips for Effective FMEAs

The Failure Mode and Effects Analysis (FMEA) can reduce or eliminate failure costs and protect against errors by illuminating issues before they arise. The technique can be used to design products or services, the production processes that deliver them, or to improve prototypes or existing processes.

What practices should you adopt to promote a robust FMEA process? Here are some to start with:

  1. Decide on a scope for the FMEA exercise before you begin. Will it pertain to one process, subprocess, part or product? Will it be unique to one site or facility, or can it be applied to many? Defining a scope can make the deliberation process easier.
  2. Start the FMEA process as early as possible. Don’t wait to explore risks and risk management approaches until designs are fixed, and the assets to support a production process and procured and installed. It’s easier to make error-preventing changes
Read more...

Culture Of Quality: Achieving Transformational Success

Technology can solve many problems. As business and consumer technology becomes cheaper and more powerful, it’s easy to think that simply purchasing a new platform or application is all we need to do to ensure revolutionary increases to our productivity. With software-as-a-service (SaaS) becoming the standard approach to implementing software, it’s also easier to use and distribute technology across the organization than ever before.

Yet technology is not a magic wand we can wave around to achieve innovation or transformational success. Organizations are more than just collections of tools for measuring production methods, and simply collecting process data doesn’t guarantee that you’ll be able to compete effectively in the marketplace. It’s only when tools come together with processes and people to produce a true culture of quality that organizations will be able to implement a quality management system that will drive operational excellence.

For a culture of quality to flourish, … Read more...

What is Data Governance and Why Do You Need It?

Improving product and process quality requires that organizations make data-driven decisions about when, how much, and how often to adjust aspects of operations.

This means the data has to be available and accurate! Unfortunately, information often is siloed, living in Word docs and Excel files, and although that data might be on a publicly accessible network, finding it and knowing whether it will meet your needs can be impossible.

Busting silos and encouraging collaboration facilitates systems integration and leads to better decisions — ones that save time, money and effort while capturing valuable opportunities for growth and improvement. A solid plan for data governance — strategic, high-level planning and control for data management tasks.

A data governance framework essentially is a quality management system for data. Setting one up is an essential part of planning for Quality 4.0 for large enterprises or other organizations that are drowning in data.… Read more...