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.”

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.

Graphic of a front line worker confused and looking at different systems

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.
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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.

Graphic of a worker looking at different types of documents

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
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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.

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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
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