In this post “ISO 9001 Clauses Explained” we dive into Context of the Organization. 4.1 Understanding the organization and its context Context of the organization is one of the newer terms of the ISO 9001:2015 edition of the standard. The concept of context of the organization isn’t at all new. Every good business owner or…
7.5 Documented Information | CONTROL OF DOCUMENTED INFORMATION In this post “ISO 9001 Clauses Explained” we dive into Documented information, arguably at the core of any effective management system. Documented information includes not only our documents, but also our records. There are many types of documents and many types of records, but with a simple…
Quality Coordinator / Management Representative, Quality Manager, what’s the difference? Well, we’re going to tell you in this episode. ISO 9001 really doesn't give much direction other than leadership and top management, but generally accepted is the role of the “Quality Manager”. This means and is important that your Quality Manager has management level authority. …
The Value of well-defined NCR and CAR Introduction to NCR’s “Nonconformance Reports” & CAR’s “Corrective Action Reports” When it comes to operational excellence, fundamentals of QMS “Quality Management System” are critical. I would argue that nonconformities and corrective actions are the foundations of an effective quality management system (QMS). They represent the “boots on the…
One more new thing, UGH! This is a struggle in the workplace, we've all heard it there's “An App for That”. It seems that there is always a new flashy program that’s going to make things easier, better, faster, greatly improve how we do things.
We are excited to share with you some new changes coming to #QualityMatters. Kyle recently launched a poll on LinkedIn to see what you, our listeners thought of the content and would like to hear. Your responses were heard. You all want more about tips and tricks and running a QMS, less about case studies. …
The Dalkon Shield was an IUD developed in the 1960s by OB-GYN Hugh Davis with electrical engineer Irwin Lerner. They brought in a lawyer, Robert Cohn, to help them form The Dalkon Corp. Because The Dalkon Corp had no sales force, they decided to sell the product to another company. That company was AH Robins,…
The U.S. Naval Ship Repair Facility and Japan Regional Maintenance Center (SRF/JRMC), Yokosuka detachment has thousands of gallons of oil routinely drained from ships coming into dry dock. Special teams have to be on standby and ready at any given time to remedy a spill. Shop X-99 consists of 65 members, 28 of which are…
In 2006, Singapore’s Housing and Development Board wanted to improve work processes and better support it’s own mission. They enlisted the help of Accessway V2 Innovation & Quality Circle to help. Accessway V2 used the Lotus Blossom Technique to identify problems and solutions. They decided the problem with the most potential solutions would be the…
This week's episode is the third and final in a series with API the American Petroleum Institute. We had the pleasure of speaking with David Miller, PE, F.ASCE Senior Director, Standards Development | Global Industry Services about the latest edition of the API Spec Q2 management system standard for Oil & Gas Service providers. If…