Quality is free -

I have never thought that a simple phrase spoken in a get together by my boss would have such a deep impact in my mind - "Quality is free"! Whenever, the corporates thinks for the implementation of quality initiatives, the only purpose is its strategic importance for encashing its value - in terms of credentials, reputation and also improvement in goods. However, what most corporates worries is the Cost of Quality - the phrase - 'Quality is free' is tremendous.
But is quality really free ?? If so then what it the Cost of Quality ? 

Well, I will say - it is free !!

A company needs technology for improvement in design, more better technology for mass production, cut cost, cut margins and it needs marketing efforts to proliferate its reach
Nevertheless, what is freely available in the efforts of perfection - are the innovative thoughts of systematic approach and logical methodologies. 

This is quality and it is free!!

FDA Proposes its Office in China

In what may be seen as a setback to India and the progress of its pharmaceutical industry as such, the US State department has announced to set up a full time permanent US FDA office in China. The opening of this office is although pending from the approval to be obtained from government of China.
In earlier news last year, the FDA was planning to open their office in one of the city in India preferably at Hyderabad. However, what conspired in the galleries is not known.
This is despite of the fact, that recent Baxter’s Heparin case where four people died was originally manufactured in China.
As more and more Indian companies are inching towards generic drugs multinationals, the FDA is tightening its noose over these companies while relaxing its standards towards Chinese drug manufacturers where from sources known that getting a GMP certificate takes only 7 days!!!
It is not known that whether it is economic pressures, technological issues or the diplomatic appeasement.

When fears go wrong...

It was the year 2005 when India adopted patent regeime. The worst fear which was projected was that of loosing India's strength over pharmaceutical development and manufacturing.
Much of that fear has already lost withn last 3 years. On the contarary, the MNCs operating in India from at least last 40 to 50 years have eroded their market captelisation.
The Pfizer, Novartis and Merck have all lost the glory of their past days operation in India. With nothing much to offer from their global new product basket, these companies continue to struggle over pricing issues.
To read the complete storey published in Economic Times, click here.

Integrated CAPA Approach, as a key model for Quality Systems

It was rather 5 years back, when the concpet of integrating all deficiencies capturing tools with a single investigative and managing tool - CAPA came into thought. Though I had conceptuliased this idea, but its writing it down only took this much of time! The idea is that -CAPA can be developed as a single logbook concept, wherein all the deficiencies are listed, investigated and reviewed. This is good approach of reducing these identified deficiencies as a part of achieving total quality. I am giving the abstract of this article whereas to read the complete article and understand the integrated CAPA approach, click here.

Synopsis

Resolving problems and attempting to identify and prevent potential problems is a typical activity for most businesses. There are many business solutions available which promises to provide in-depth understanding of process and systems and thereby reduces or prevent potential problems. CAPA is one of such comprehensive fundamental management tool that provides a simple step by step process for completing and documenting corrective or preventive actions. CAPA focuses on the systematic investigation of discrepancies (failures and/or deviations) in an attempt to prevent their reoccurrence.To ensure that corrective and preventive actions are effective, the systematic investigation of the failure incidence is pivotal in identifying the corrective and preventive actions undertaken. The integrated CAPA model thus becomes a functional link between the overall deficiencies on one side, and their investigations and immediate corrective and preventive measures on the other side. The tool when implemented must have a vision and can provide controls needed to consistently produce a product of accepted quality. Therefore combining both the vision and controls together makes a comprehensive methodology for improvement over a period of time. CAPA thus becomes a functional link between the deficiencies on one side, and their investigations and immediate corrective and preventive measures on the other side and a year-by-year approach of reducing these identified deficiencies as a part of achieving total quality.