From time to time, someone asks me for advice on how to prepare for a factory audit. Since we have run an auditing service for years, we have a few ideas about this. I collected some of my usual advice in this article*. *(I am assuming … [Read more...]
What Is the APQP? (Advanced Product Quality Planning Process)
The APQP, or Advanced Product Quality Planning, is a proven approach for developing a new product to be made in high volume and under strict quality, timing, and cost requirements. It was developed by the North American automotive … [Read more...]
The Concept of Quality: Little q VS Big Q.
Take a deep dive into the concept of quality. A lot of importers focus narrowly on if the products they're getting from their manufacturers/suppliers are within tolerance (little q). But without a wider view that looks at the entire … [Read more...]
What Manufacturing KPIs Show if a QMS is Performing Effectively?
Many factories are proud of their ISO 9001/ISO 13485 certificate, but a look at their quality management system (QMS) and manufacturing KPIs reveals serious issues. I wrote before about how some companies get certified with a very poorly … [Read more...]
Engineering Change Notification and Approval: a Vital Process
A lot of quality/reliability issues are the result of a poor engineering change notification & approval process or the complete lack of such a process. That's especially common in the context of OEM/ODM manufacturing. Let's uncover … [Read more...]
Manufacturing Organizational Chart: Top 7 Common Mistakes To Avoid
One of the first things we look at, during factory audits, is the supplier’s manufacturing organizational chart. And it often points to serious operational dysfunctions. Here are the top 7 common mistakes that you don’t want to see your … [Read more...]
What is the product return rate and how to reduce it? [Podcast]
In this episode… The Sofeast Group's head of New Product Development, Andrew Amirnovin explores what the product return rate is and provides advice you can take to reduce yours before you even start mass producing your product. If you do … [Read more...]
QMS Implementation Consultant vs. Certifying Body
I realized that many people are confused about the companies that typically get involved when a factory wants to get its quality management system (QMS) certified to ISO 9001 or ISO 13485. Let's break it down into the logical steps to … [Read more...]
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 … [Read more...]
What Are The Long-Term Costs of Poor Quality & Reliability? [Podcast]
In this episode… Renaud is joined this week by two interesting guests who've been on the podcast before: Clive Greenwood a quality consultant at WWMG associates who is a Six Sigma Black Belt and has a special focus on medical devices and … [Read more...]
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