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
Quality and Compliance of Imported Products
To run a successful business, you want to make and distribute products that are at the right quality standard and that comply with the regulations of the countries of sale. I guess nobody will argue with that. But what do “Quality and Compliance” mean, in practice?They are often separated under different functions inside the same company. Why?Let’s look at … [Read more...] about Quality and Compliance of Imported Products
Understanding the context of your process
Context, the first lens of the 6CON process development framework, provides the development team with critical information against which they can readily make informed decisions. Context, by itself, does not eliminate the failure modes we have mentioned, but it is the foundation for the rest of the work to come, reducing the likelihood of the failure modes. The components … [Read more...] about Understanding the context of your process
Risk Management Rarely Gets to the Root Cause
Large corporations typically have internal risk management functions. Many are staffed by individuals with advanced degrees—even Ph.D.s—in areas such as mathematics, statistics, actuarial science, etc. The role of these folks is to identify areas of financial risk and forestall or reduce the threat they pose to their employer’s profitability. Supply chain risk is evaluated and … [Read more...] about Risk Management Rarely Gets to the Root Cause
Are Supply Chains Too Lean?
Supply chains everywhere have become too lean — and not just in auto. This trend was highlighted by pandemic-driven shortages in virtually everything – drugs, medical equipment, construction supplies, even toilet paper. The chip shortage alone is projected to impact global automotive sales by 1.3 million units in 2022.The issues behind these shortages show no signs of abating. … [Read more...] about Are Supply Chains Too Lean?
Cybersecurity Supply Chain Risk Management Practices for Systems and Organizations
This new NIST publication provides guidance to organizations on identifying, assessing, and mitigating cybersecurity risks throughout the supply chain at all levels of their organizations. The publication integrates cybersecurity supply chain risk management (C-SCRM) into risk management activities by applying a multilevel, C-SCRM-specific approach, including guidance on the … [Read more...] about Cybersecurity Supply Chain Risk Management Practices for Systems and Organizations
The Purpose and Importance of Audit Trails
It is a general principle that well-managed audit trails are key indicators of good internal business controls. Over the last few decades, audit trails have transitioned from manual to automated electronic logs that make this historical information more accurate, readily accessible, and usable. This article will define an audit trail, what should be included, the importance … [Read more...] about The Purpose and Importance of Audit Trails
PFMEA: Learn How to Remove Error From a System With This 10 Step Guide
What is PFMEA? Process Failure Mode Effect Analysis explainedProcess Failure Mode Effect Analysis (PFMEA) is a Six Sigma methodology designed to identify risk and rate critical failure modes of a given process.PFMEA is traditionally applied to operating processes within the manufacturing industry and was developed with the notion that such processes are rarely … [Read more...] about PFMEA: Learn How to Remove Error From a System With This 10 Step Guide
ISO Certification and Risk Management Practices
ISO Certification Standard is an essential Certification for all major industry sectors and companies of any size and nature of work. There are numerous business benefits from getting an ISO Certification for an organization.Depending on the area of operation, the organization can choose from a wide variety of ISO Certification Standards for them to transform their business … [Read more...] about ISO Certification and Risk Management Practices
Unleashing the potential of internal audits: a review and research agenda
Research on internal audits of quality management systems is scarce, and no clear study exists that could guide practitioners in improving the auditing practice and help researchers advance existing knowledge. Thus, the aim of this paper is to review empirical research on internal audits of ISO 9001 to synthesise advice for increasing the value of internal audits and to … [Read more...] about Unleashing the potential of internal audits: a review and research agenda
How To Manage Multiple And Diverse Customer Needs?
As a business owner, you will likely face the challenge of resolving conflicting customer requirements. Managing a diverse customer base and their unique needs can be challenging simultaneously.Types of DiversityThere are many types of diversity. Some examples include:• Diversity in gender, race, age, religion, sexual orientation, etc.• Diversity between products and services• … [Read more...] about How To Manage Multiple And Diverse Customer Needs?
Going beyond buzzwords in the Industrial IoT
There is a lot to gain from diving deeper into the Industrial IoT. This huge topic requires some navigation. Avnet provides resources to help engineers find the right solution for their current and future design objectives.The Industrial IoT is one, important, element of Industry 4.0. On a wider scale, Industry 4.0 impacts all vertical markets. It describes new ways of doing … [Read more...] about Going beyond buzzwords in the Industrial IoT
How the Next Industrial Revolution Will Impact Our Future
If there's a common buzzword in almost any industry these days, it's sustainability. Its ubiquity tells us something about its importance — but even as we become more familiar with the term, the concept itself has become largely diluted.Traditionally, our conversations around sustainability have been focused on two concerns: fighting global warming and conserving natural … [Read more...] about How the Next Industrial Revolution Will Impact Our Future
Four fundamental challenges stalling your Industry 4.0 ambitions
From mechanization, it is astonishing to realize how far we have come as a society. The modern-day factories and manufacturing units are nothing less than revolutionary as some of the most advanced systems and equipment operate here – autonomously.Yes, they did so earlier as well but this, they call it Industry 4.0 – where physical and metaphysical realms come together. Humans … [Read more...] about Four fundamental challenges stalling your Industry 4.0 ambitions
Unleashing the potential of internal audits: a review and research agenda
Research on internal audits of quality management systems is scarce, and no clear study exists that could guide practitioners in improving the auditing practice and help researchers advance existing knowledge. Thus, the aim of this paper is to review empirical research on internal audits of ISO 9001 to synthesise advice for increasing the value of internal audits and to … [Read more...] about Unleashing the potential of internal audits: a review and research agenda
The Factors That Make for a Successful Transformation
The goal of many Lean Six Sigma projects revolves around making a successful change in how a business operates that will result in reduced costs or revenue growth. But many companies continue to fall short when it comes to making a successful transformation.That persistent lack of success is part of the latest McKinsey Global Survey that focuses on core issues … [Read more...] about The Factors That Make for a Successful Transformation
The competitive advantage of lean process creation
As the new manager at the site, I was trying to be respectful about what I was seeing. I had learned long before that there was always a reason why things were the way they were. Perhaps not a great reason, but a reason that made sense at the time. Then I walked into the environmentally controlled pump production room. It had been recently installed and was touted as the … [Read more...] about The competitive advantage of lean process creation
Problem-solving: Anatomy of an 8D
Over the last three weeks, I've talked about ways to improve your root cause analyses. But a root cause analysis is just one step — albeit the most important step — in the whole process of problem-solving. Now that we've discussed it in some detail, let's back up to look at the whole cycle from beginning to end.There are several different tools or methods to formalize solving a … [Read more...] about Problem-solving: Anatomy of an 8D
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)
The Principles and Implementation of Lean Improvement
To succeed in today's hyper-competitive environment, organizations must strive to improve continuously. But, because that's easier said than done, forward-thinking business leaders have developed several structured improvement methodologies over the years. One of the most widespread is an approach that grew out of the Japanese automotive industry, Lean manufacturing. … [Read more...] about The Principles and Implementation of Lean Improvement