Reader Responds: 'Vendor Audits Are A Waste'
By Rob Wright, Chief Editor, Life Science Leader
Follow Me On Twitter @RfwrightLSL
By Rob Wright
In the February issue, I wrote an article entitled, “Buttoning Down the Pharma Supply Chain.” It must have a touched a nerve with one reader. As I was leaving the office for the weekend, I got an email from subscriber Thom Davis. Thom wrote,
“Can you send me a link to the proposed guidance document to which you are referring. I wish to comment to FDA about it. The ’misplaced’ emphasis that FDA (and many quality consultants) place on vendor audits is just a symptom of ignorance. While FDA and many biotech companies do send their quality auditors 'hither and yon' verifying things at contractors physical sites, much (not all admittedly) is an extremely expensive wasted effort. I know this because I performed 300+ contract audits over my career and can tell you that fewer than 1% resulted in a finding that made me believe the product supplied may make my employers product questionable. Was that worth the >$1,500,000 dollars that it cost the vendors and my employers?”
I provided Thom with “a link,” but not “the link.” I informed him that the FDA’s fast track I wrote about was originally announced in the summer of 2010. As it has not been formalized, the official commenting period has yet to begin. Apparently, fast track means not faster than eight months, and counting. Thom replied with additional insights,
“Short answer, there is little 'bang for your buck' in doing vendor audits. When you add to that the fact that very few 'auditors' have ASQ-CQA or better audit training/credentials, you see it will be another waste of resources that should be better put into other methods of verifying the product or service supplied actually meets your needs. It will just drive up the already too-high drug costs with no effect. Examples of what should be done instead of periodic vendor audits include:
- post receiving test of materials,
- verification by alternate laboratory that CofAs (certificates of analysis) are accurate;
- document reviews of supplied documents from vendors.
The issues I see in life sciences are that the industry is “new” to quality management. It should take lessons from the U.S. Nuclear program — what life sciences is struggling with now is 20 years outdated from state-of-the-art.”
I asked Thom if he minded my sharing his thoughts. Have questions for him? He welcomes your feedback. Here is his email - tpdavis@yahoo.com.