In a recent forum discussion, a quality manager shared that their customer failed an audit, claiming that all calibrations should include a Gage R&R to ensure repeatability. The customer's auditor did not reference any specific standard, leading to confusion. Several experienced contributors clarified that Gage R&R is not a requirement under ISO 9001 for … [Read more...] about Are Gage R&Rs required for Calibration?
Quality-Skills
Practical Techniques to Adapt Training to Learner’s Needs
Personalized learning is a crucial approach to training that adapts content to meet the individual needs of learners, enhancing their engagement and overall learning experience. A one-size-fits-all approach led to disengagement in a hotel training session because the content didn't cater to the participants' diverse knowledge levels and roles. Personalized learning, defined as … [Read more...] about Practical Techniques to Adapt Training to Learner’s Needs
Assessing changes in reliability methods over time: An unsupervised text mining approach
The study by Charles K. Brown and Bruce G. Cameron analyzes how reliability engineering methods have evolved by performing a systematic literature review on 30,543 reliability engineering papers. Using topic modeling, they identified 279 topics, which were reduced to eight top-level method topics (prognostics, statistics, maintenance, quality control, management, physics of … [Read more...] about Assessing changes in reliability methods over time: An unsupervised text mining approach
Workflow Documentation: How to Increase Efficiency, Reduce Error, & Focus On Impactful Tasks
Workflow documentation is more accessible than ever. Rather than having organizations drown in stacks of paper, workflow management software helps companies edit, locate, and store crucial workflow documents. Various workflow management software programs can help automate time-consuming data entry, leaving employees more time to focus on critical business tasks. Further, an … [Read more...] about Workflow Documentation: How to Increase Efficiency, Reduce Error, & Focus On Impactful Tasks
A 3-Step Method for Writing LPA Questions
To reduce defects, complaints from customers, and eliminate cost, manufacturers use easy and cost-effective LPAs, or layered process audits. However, to achieve and support plant floor inspections on a regular basis, plants have to overcome their trouble creating LPA questions. What results from a lack of quality LPA questions is people zooming through paperwork with the goal … [Read more...] about A 3-Step Method for Writing LPA Questions
Why EV Suppliers and Startups Should Implement Layered Process Audits
While the electric vehicle (EV) industry makes momentous gains in wealth, and is expected to quadruple in revenue by 2030, their suppliers typically come from an entrepreneurship or design background.This is where the problem stems from—the best technology does not imply it can be introduced to customers with the best quality. To succeed in the world’s competitive market, there … [Read more...] about Why EV Suppliers and Startups Should Implement Layered Process Audits
How to Conduct Remote Supplier Quality Audits in a QMS
Since the Covid pandemic, regulators and notified bodies have been doing more remote audits to conduct routine inspections. In fact, it helped the FDA exceed domestic inspections in FY2021 by more than double the number projected. As a result, the FDA and EMA have released guidance on what to expect during a remote audit.However, remote audits can … [Read more...] about How to Conduct Remote Supplier Quality Audits in a QMS
Determination of external and internal issues – The PESTEL Method (Part 2)
In this post, the second part of this title, I am going to describe a method, called PESTEL, which can be very useful for organizations to identify, analyze, prioritize and determine the relevant external issues, in accordance with Sub-clause 4.1 of the different management system standards.In the first part I commented on the need for the management system standards, in … [Read more...] about Determination of external and internal issues – The PESTEL Method (Part 2)
Internal Auditing and Risk Determination
I've read through a few posts about this clause but I still don't think I quite get it.Currently we are ISO 9001 and transitioning over to IATF 16949 and I'm trying to make a 3 year audit calendar to spread out a few of our audits over this three year period.I believe that some processes can be audited every 2 or 3 years due to strong documentation and previous audits showing … [Read more...] about Internal Auditing and Risk Determination
How Smart Leaders Spot Ideas No-One Else Does
Most disruptive ideas arise outside an industry. Leaders need a more open mindset to see early signals of change and respond to disruption.Today’s post is by Kurt Matzler, co-author of Open Strategy: Mastering Disruption from Outside the C-Suite (CLICK HERE to get your copy).In 1938, MIT student Claude Shannon solved one of the most complex problems of … [Read more...] about How Smart Leaders Spot Ideas No-One Else Does
Remove Error From Your Business Operations Using a Pareto Chart (How to Create a Pareto Chart in 10 Steps)
The Pareto Chart is a powerful tool that maintains the quality of services and products. Decision making is steered in the right direction, meaning efforts are streamlined to maximize output quality.When implemented properly, Pareto analysis – via the Pareto chart – will identify major pitfalls in any business process in order to improve quality. This analysis uses the Pareto … [Read more...] about Remove Error From Your Business Operations Using a Pareto Chart (How to Create a Pareto Chart in 10 Steps)