July 03, 2008

Sony's Quality Blunder

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The Sony brand has been built painstankingly over the years over Quality more than anything else. It seems that even reputable world class companies such as Sony, are not immune to huge quality fiascos as the following article published today illustrates.

"Sony Pulls Update Following PS3 Firmware Fiasco
By Walaika Haskins
TechNewsWorld
07/03/08 11:29 AM PT

The PlayStation 3 firmware 2.40 update that Sony rolled out earlier this week included features like new XrossMediaBar functions, a new Trophies system and, in a few cases, complete system meltdown. Hours after Sony made the firmware available, users started complaining about a range of problems, and Sony has pulled the update in order to investigate.

Sony's (NYSE: SNE) 2.40 firmware update for the PlayStation 3 video game console ran into problems less than an hour after the company made it available for download "
Read here the full article
:http://www.technewsworld.com/story/Sony-Pulls-Update-Following-PS3-Firmware-Fiasco-63690.html
Acoording to analysts the firmware flop has embarased Sony.

"To release an update like that and then have to pull it because it was turning people's PS3s into PS paperweights is an embarrassment. This is a pretty big black eye for them. You can be sure before this update gets released again into the wild Sony's going to really go over it with a very fine-toothed comb to make sure this circumstance doesn't happen again," said analyst Michael Gartenberg in an interview to TechsNewsWorld.

Sony should have used that fine-toothed comb before rushing the version out the door on their website.

The lesson to be learned by Sony, and every vendor in this day and age, is that we live in the age of the Internet. Nowadays, when things go wrong, they are not isolated problems, known to the vendor and a few of its customers who have run into those specific problem. Everyone knows about them, and the perception may be worse than reality.
One flop and millions of marketing and advertising $$ go down the drain.
When will companies learn that quality is no longer a "nice to have" option they can do without or sacrifice it to the TTM (Time To Market) Moloch?

October 15, 2007

Risk Management for medical devices

While no medical device is entirely free of risk, what's the best way to minimize it?
By complying with ISO 14971:2007, the international standard in device risk management, and by developing a solid risk management plan. But understanding the recently expanded ISO and effectively implementing it is not the same thing.
The three biggest additions to the newest version of ISO 14971 are: six new terms, better integration with ISO 13485 and the addition of Annex (J)
For detailed guidance on how to :
• apply risk management in a straightforward easy manner
• ensure compliance with the FDA's QSR and the EU's Medical Device Directives ,
adhering to ISO 14971:2007

Contact: willyg@tqas.co.il
View Willy Grunfeld's profile on LinkedIn

October 04, 2007

What are the key management principles of the ISO 9000 standards and most performance excellence models?

ISO 9000 standards and performance excellence models are based on management principles that reflect the fundamental ideas of a good management. This section lists the principles of each key methodology and provides hyperlinks to their websites for further explanation.

The principles of the standards and performance excellence models are as follows:

ISO 9001 and ISO 9004 - Quality management principles:
 Customer focus
 Leadership
 Involvement of people
 Process approach
 System approach to management
 Continual improvement
 Factual approach to decision making
 Mutually beneficial supplier relationships

Malcolm Baldrige National Quality Award - Core values and concepts:

 Visionary leadership
 Customer-driven excellence
 Organizational and personal learning
 Valuing employees and partners
 Agility
 Focus on the future
 Managing for innovation
 Management by fact
 Social responsibility
 Focus on results and creating value
 Systems perspective

European Foundation for Quality Management - Fundamental concepts of excellence:

 Results orientation
 Customer focus
 Leadership and constancy of purpose
 Management by processes and facts
 People development and involvement
 Continuous learning, innovation and improvement
 Partnership development
 Corporate social responsibility


Deming Application Prize – TQM Principles:

 Distinctive performance improvement through the application of TQM
o Challenging and customer-oriented business objectives and strategies under management leadership,
o Proper implementation of TQM to achieve the business objectives, and
o Outstanding results obtained for the business objectives.
 TQM understanding and enthusiasm
o Aiming at long-term success through benefits to customers and other interested parties
o Managing the organization putting 'quality' in its core,
o Top management leadership, vision, strategies, and policies
o Participation of all the organization’s members based on human resource development
o Developing and applying effective quality management methods
o Improving and transforming organization's constitution for sustainable success