Recent postings in the WSJ blog and elsewhere have asked the troubling question: Does Lean Manufacturing, by definition, lead to quality control problems? Click here for an interesting read. (For something that doesn't require registration, click here.)

Maybe a cookie cutter approach to Lean can do this, but not Lean as I've heard it described so often and so intelligently--in which risk mitigation is a priority, and where ensuring alternative sources for key materials/components "just in case" is part of the planning process. (Although in areas such as use of disposable bioprocessing equipment, there are some troubling long-term questions....how interchangeable are the equipment options being offered by different vendors? Could an overreliance on disposables potentially create more QC problems for biotech down the line?)

But it is somewhat difficult to have great  faith in the Lean concept when you hear no less than Toyota's CEO apologize for the devastating recalls affecting its company's major product lines. Major QC problems from a company whose name has, over the years, become synonymous with product quality? Is it a matter of hubris, asked a columnist in today's Washington Post (click here to read). Now Toyota is just as bad as the rest of the automotive industry....

In the pharma world, could J&J, in the news recently for OTC product recalls, be following a similar path? The company has led the drug industry in Lean Six Sigma and operational excellence for decades. But, on a much broader scale, how well is the drug industry handling QC? Drug recalls are trending up, in the U.S. and Europe, as recent U.K. statistics also made clear.  And manufacturing issues are often to blame.

Forget about fear of FDA. How deeply ingrained is attention to QC and consumer safety in pharma's corporate philosophies? What impact are ongoing, radical corporate downsizings having? Is outsourcing always the best approach? After all, it's not as if lean CMO's haven't landed in hot water over quality and FDA compliance issues.

Finally, on a mundane level, every day and in every lab and manufacturing facility, are the right data being recorded and transmitted to the right people at the right time? As Emil Ciurczak asked recently, "have we become lazy and stupid?" After all, he says, everything required for FDA compliance (and thus, QC) was taught in freshman chemistry, when the "lab notebook" concept was introduced. One individual failing to follow the rules can lead to botched root cause analyses, recalls, and even consent decrees.

Is an industry's attention to QC only as strong as its weakest link? Like the lab tech who admitted to an FDA inspector that she took everything down in pencil first?

OK,it's February, the groundhog reportedly saw his shadow, and I'm in a bad mood. For an Andy Rooney style rant, read on.

AMS