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Article 12 part 1

Read Time 5 Minutes

In Part 10 of this series on Innovation and R&D, I talked about the Design of Experiments for New Product Development. In Part 11, I touched upon Statistical Process Control.

Why Testing and Statistical Methods?

In this article, I will talk about Testing and Statistical Methods in R&D for quality improvement. Why so much emphasis on Statistical Methods? Because every measurement has an error and we need to make sound decisions in presence of these errors (uncertainty). Statistical thinking provides us with a solid science to help us improve quality and productivity, predictively.

In chemical Industry when we talk about Testing we typically talk about Testing Methods for yield, conversion, purity, impurities; we also talk about sophisticated testing methods such as GC, GPC, LC, IR, NMR, AA, UV, etc. etc. 

However, in R&D we seldom talk about Testing for Quality, Quality Control Charts, QC Sampling Plans, etc.

We need to. 

As R&D Scientists, we need to be Technology Visionaries/Czars and ensure that not only we provide a good recipe and process to Manufacturing for productivity and quality but also provide PokaYoke – mistake proofing, a full proof method for delivering the same performance, batch to batch, lot to lot, day in and day out, month after month, and year after year.

Taguchi: Quality(lack of) is Loss to Society

 Dr. Genichi Taguchi provides a very broad measure of quality - Quality (cost of) is Loss to Society.  If you see waste, you see loss to society! More importantly, if you see waste, you also see an opportunity for quality improvement, an opportunity for contribution to society.

As a simplistic example of Taguchi thinking, Dr. Deming used to quote a relationship between a Japanese Tire Producer and its customer, an Auto Maker. For billing and payment purposes, the Auto Maker asked the Tire Producer, “How should they be paid?” The Tire Producer said, “Just count the number of cars you produced and multiply that by five (four plus a spare). Pay us for the tires sold.” No weekly/monthly exact counts of shipments, No exact weekly billing and payments; use just estimates. No inventory management, no audit trails. Lower cost for the Tire Producer, lower cost for the Auto Maker. A win-win for both the customer and the supplier.

Dr. Taguchi cited another example: Disposable paper napkins for use in bathrooms. A Japanese paper mill studied the problem; they found that if they make thinner paper napkins, consumers use several napkins to dry their hands. If they make the napkin slightly thicker, only one napkin will suffice for drying hands. They should charge a higher cost for each napkin, make slightly higher profit, but reduce total costs for the users. This will result in less paper waste, less trash, less recycle, less pollution. Loss to society is reduced. Everyone wins.

Quality Failure can be Costly

Here is a recent example.  “How Tap Water Became Toxic, in Flint, Michigan” CNN News January, 2016.  The City of Flint in Michigan is bankrupt. The State Governor, appointed a Czar, a City Manager, to make all decisions for Flint to save money. The City Manager decided that instead of using water supplied by City of Detroit, from Lake Huron, Flint should use cheaper Flint River water.  Citizens complained, to no avail. Now 60,000 residents are affected with water with 40% of the samples with 5 ppb or higher lead content. The River water is so acidic, lead plumbing in older city pipes started dissolving. All the older city pipes may have to be replaced. Young kids may have to be monitored for years for brain damage. All citizens are now being supplied, bottled water for cooking. “A 2011 study on the Flint River found it would have to be treated with an anti-corrosive agent for it to be considered as a safe source for drinking water. Adding that agent would have cost about $100 a day, and experts say 90% of the problems with Flint’s water would have been avoided.” [ref. 1]

Quality Problems in Indian Pharma Industry

Indian pharma industry is replete with quality problems. A few years ago Indian pharma giant Ranbaxy was fined US $500 Million dollars by US FDA. [ref. 2] The Bloomberg article Indian Labs Deleted Drug Test Results[ref. 3] cites Sun Pharma and a dozen other Indian pharma companies. Specific plants have been banned from export to U. S. [see also ref. 4 and 5]


Here are some interesting data from Bloomberg[ref. 3]:

  • India is the second-largest drug exporter to the U.S.
  • The top 10 Indian pharma companies generate $15 billion in annual sales
  • The U.S. doesn’t require tests of imported drugs as they cross the border. The FDA relies on factories themselves to conduct quality tests and report accurate results, only performing its own studies if it gets enough complaints about a medicine
  • FDA has 12 staff members in India to police about 600 FDA-registered Indian factories  
  • This year, the FDA had conducted 97 inspections of drug manufacturers
  • FDA Commissioner pledged to increase the FDA’s personnel in India from 12 to 19
  • India’s national drug regulator, the Central Drugs Standard Control Organisation, has 400 staff, aided by about 1,500 additional state regulators. India plans to raise the total number to 10,000 to 12,000 in the next three to five years
  • 12 companies with plants in India are on the US FDA banned list

To be Continued ...

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