Author Archives: Nicole Radziwill

About Nicole Radziwill

Nicole Radziwill is a quality manager and data scientist with more than 20 years leadership experience in software, telecommunications, research infrastructure, and higher education. Prior to joining Intelex, she was an associate professor of data science and production systems at James Madison University, Assistant Director for End to End Operations at the National Radio Astronomy Observatory (NRAO), managed software product development for the Green Bank Observatory (GBO), and managed client engagements for Nortel Networks and Clarify (CRM). She is an ASQ-certified manager of operational excellence (CMQ/OE), an ASQ-certified Six Sigma Black Belt (CSSBB), and contributed to the development of ISO 26000—“Guidance on Social Responsibility.”

Next Generation Quality: It’s All About the Data

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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...

Nonconformance vs. CAPA: Three Key Questions

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Communicating the differences between nonconformances (NCRs) and corrective/preventive actions (CAPAs) to staff can be challenging. It’s extremely important, too, that everyone fully grasps the distinctions — because consistency in using your organization’s quality management system will directly contribute to the accuracy of your metrics. Furthermore, this will impact the quality of the insights that can be generated by studying them.

In ISO 9001:2015, there is a defined progression between nonconformity, correction, and corrective action:

  • A nonconformity occurs when a requirement is not fulfilled. The result of a nonconformity, according to Hoyle (2017), is a failure to meet product requirements, carry out a task as required, or meet customer or stakeholder requirements.
  • A correction is the step taken to remedy that single nonconformity. Removing the nonconformity does not prevent the issue from happening again. The result of a correct is to prevent the nonconformity from advancing further in the process.
  • A
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Close the Loop on CAPAs with Verification of Effectiveness

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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...

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

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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...

The Business Case for Document Control

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Knowledge management is the heart of any business enterprise. Having ready access to accurate and up-to-date information strengthens decision making capabilities, aligns everyone in the organization around learning, and supports a culture of innovation. The ability to effectively manage documents is also a central element of most quality management systems, including ISO 9001:2015, Baldrige, and EFQM.

Documents are “the means… to communicate legitimacy, work requirements, instructions, methods and results.” (Pho & Tanbo, 2014) Because they are so central and elemental, document management systems also unify the people within an organization (and sometimes also across boundaries of the supply chain ecosystem) around shared processes. They are used to manage the internal flow of information, and also to advance sustainability targets by substantially reducing paper usage. Together, they can:

  • Create new documents or edit existing documents
  • Keep track of document versions, and what changes were made in each revision
  • Collaborate with people
… Read more...

Demonstrate Risk-Based Thinking to Auditors

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The auditor is coming, or will be coming, to evaluate your organization. While continuous improvement and compliance helps, there are things that you can do to make the auditing process go much more smoothly (this applies to internal audits as well). Preparation doesn’t start the week before, it starts the minute you implement a quality management system or prepare for ISO 9001 certification. You need a systematic approach to audit reporting that begins with core management principles, training, traceability, and credibility.

Because risk-based thinking is more prominent in ISO 9001:2015 than in previous versions of the standard, many organizations are wondering how to demonstrate how they do it to auditors. Fortunately, most activities in the domain of quality management, if successful, serve to reduce risks. The key is to keep track of how your efforts relate to risk.

Here are five actionable recommendations to demonstrate risk-based thinking to auditors :… Read more...

How and Why to Adopt Risk-Based Thinking

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Why implement risk-based thinking?

Are  you looking for certification? Undergoing an audit? Just trying to achieve compliance? There are many reasons, but put simply organizations adopt risk-based thinking with the objective of making better decisions — especially when they are operating in a challenging, fast-paced or otherwise uncertain environment. Although the return on investment (ROI) for risk-based thinking is difficult to characterize, most organizations have anecdotes about the (sometimes spectacular) failures and inefficiencies that have come from pretending that nothing unexpected will happen – or by not investing the time or resources required to plan for the unanticipated.

According to Willumsen et al. (2017), this improved decision making can yield many benefits, including:

  • Reducing frequency of losses
  • Reducing likelihood of losses
  • Reducing costs of losses
  • Improving response time to unexpected events
  • Reducing stress
  • Improving communication
  • Enhancing organizational learning
  • Capturing new opportunities for growth and improvement

Risk assessment and risk management … Read more...

Risk-Based Thinking: Where to Begin

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What is Risk?

Risk can be defined as “the effect of uncertainty on outcomes” (ISO 31000) or, alternatively, as “anything that can prevent an organization from achieving its objectives” (Kendall, 2017). Managing risk means taking responsibility and exploring uncertainty. Successfully addressing risk means making decisions that further an organization’s mission and goals. This framework is fundamental to ensuring effective quality management.

Hazards and threats are sources of risk. Hazards, which are situations with the potential to result in injuries, damage or harm, can be physical, chemical, biological, ergonomic, psychological, political or social. Hazards can become threats if (and when) they are activated. For example, a virus (computer or biological) may be a hazard, but it only becomes a threat if you might be impacted by it. The likelihood and severity of that impact on a particular person, place or thing determines the risk.

What you can do to effectively manage

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10 Tips for Effective FMEAs

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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...

“Documented Information” in ISO 9001:2015

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In the transition from ISO 9001:2008 to 9001:2015, some key definitions have shifted to support the more holistic philosophy of the revision. In particular, references to “documentation,” the “Quality Manual,” “procedures,” and “records” have been replaced by the more nebulous “documented information.”

What does this mean? Should you get rid of your Quality Manual?

The short answer is no – you shouldn’t stop documenting your processes, and you shouldn’t toss your Quality Manual if it’s facilitating communication in your organization and helping you meet your quality goals! You should, however, feel as if the requirements can be adapted to your organization’s unique situation. The key question to ask, following clause 4.4, is: What information is necessary to support the operation of processes?

Rather than focusing on how the process itself is conducted, look at what information you need to determine whether the process outputs conform to their stated requirements. Additionally, … Read more...