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Showing posts from June, 2021

The European Commission Blue Guide to the Implementation of EU Product Rules - Expected Updates

  The EU Blue Guide on the implementation of the EU product rules have become one of the main reference documents that explains how to implement the applicable EU legislation based on the New Approach, or New Legislative Framework. This document is invaluable to consultants like me. The current version is the 2016 revision, which is becoming outdated in some aspects. A lot of what is contained in the 2016 version will remain valid, but it is necessary to take account of the changes in legislation introduced by the Lisbon Treaty that came into force on 2009/12/01 with regard to legal references and terminology applicable to EU related documents, procedures, etc. This was the main reason for the publishing of the 2016 version of the Blue Guide, which was built on the 2000 version, but which included new chapters, e.g. the obligations of economic operators, etc. There were also some revised chapters, e.g. those on standardization and market surveillance. But things have changed in the...

Executive Management and Quality

Executive management is the highest level of management in the organization. In smaller companies it may be the owner, or an appointed factory manager, and so on. In large organizations it could be the top level of management, or the board of directors. In small companies the line between executive and middle management is often not clear, e.g. the owner is also the general manager, the production manager, the quality manager, and so on. He or she is often responsible for all the activities of the company, including the quality function. In larger organizations we often find an appointed quality manager, who may also have other functions or positions at the same time. In corporates we may find corporate, divisional and factory quality managers, as the case may be. In ISO 9001:2015 we find that there is no longer a requirement for an appointed management quality representative. Executive or top management as a team is accountable and responsible for the quality of products and servi...

Quality Organization: How do we organize for quality in our organizations?

  Sources Juran’s Quality Control Handbook, 4 th edition, by J M Juran and Frank M Gryna Human activities always had to meet multiple needs, including our natural need for quality and even perfection. Customers have always demanded quality. Quality was often the privilege of the rich, and the poor had to make do with what they got. But the reason for this was that often the poor manufactured for themselves or purchase from whoever was willing to sell to them at prices that they could afford, while the rich could make use of the services of skilled artisans. But quality standards were there from the earliest times. Imagine if there were no quality standards when the pyramids were built! In the old days quality was the responsibility of the craftsmen who worked in the villages. Consumerism was not yet a thing, and production volumes were low. Trade was mostly localized. This all changed during the industrial revolution. Factories appeared, machines for production purposes ...

Building Quality Leadership - Being the leaders in our market sector as a result of our quality products and services

  ISO 9001 has a lot to say about leadership, but today I would like to address another form of leadership, leadership in quality, and being the market leaders in the market sector that your company is active in. Traditionally we have always assumed that good quality products and services will give the company a larger share of the market. This is a valid assumption, but there are other factors that also need to be considered, as we have seen in my previous blog “Quality and the Bottom-line”. It is especially true for companies who take the time to find out what it is that really give them the advantage over others, which is part of the company’s context evaluation. If a company gets it “right” when they first hit the market with a specific product or service, they quickly build a reputation for supplying quality products or services. The biggest challenge is to maintain this reputation. Competitors are always looking for ways to get a bigger share of the market, meaning that no ...

Quality and the Bottom-Line

  So much has been said about the need to implement a quality management system, and in most cases in accordance with the requirements of ISO 9001:2015, the current version of the standard. What not much is explicitly being said about is how quality actually affects the bottom line of the company, there where it really matters, in terms of Rands and Cents. Apart from often being quite an expensive effort to implement and maintain such a system, how does quality per se affect the economics of the company? Quality affects the economics of the company in two ways: The effect on cost: If we define quality as freedom from defects, what could be termed as a "higher" degree of quality (in other words, less defects), should lower the operational costs. The effect on income: We define income as all income into the company for the purpose of this discussion. It includes sales and all other forms of income, and refers to gross income, not profit. Because quality products and serv...