Saturday, September 09, 2006

Another Example of Poor Quality: This One Comes Close to Home

I have talked about NASA's poor quality and how their quest to improve is no different than what most of us work on everyday as Quality professionals.

In today's newspaper, I found another organization called out for its poor quality: The American Red Cross.

First, let me define the SIPOC model. The model is a component of the six sigma tool used to plan projects.
S=Suppliers
I=Inputs
P=Process
O=Outputs
C=Customers.

The Red Cross scenario clearly fits the model:
S=Blood donors
I=Procedures and quality control for blood donation, Blood from donors, etc.
P=Receiving and distributing donated blood
O=Donated blood
C=Recipients of donated blood

Recently, the Food and Drug Administration (FDA) fined the Red Cross $4.2 million for poor quality control of its blood supply. The penalty was the largest blood related fine (ever) levied by the FDA. (It should be noted that testing of several suspect units of blood revealed no contamination)

The article doesn't say what failed in Red Cross' quality system. The reporter mentions that over the years, the FDA has fined Red Cross $9.9 million over its quality control practices. Wow!

$9.9 million dollar fines for a poor quality system. Can you imagine if the big three punished its suppliers this way for poor quality? We would not have an automotive industry. (or maybe failing suppliers would get their act together)

Red Cross management issued a statement assuring their commitment to improve (link below). We'll see. www.redcross.org

Let's watch the news and Red Cross' website to see what they do to improve their quality system.

2 comments:

Anonymous said...

Stephen,
Great post. I work for a small community blood bank in PA and have followed this story.

The link below leads to a PDF of a specific list of violations. It's kinda scary.

http://www.fda.gov/ora/frequent/letters/1000123507_ARC/consent_decree_100023507.pdf

But that doesn't mean people should stop donating blood. People should find out who supplies their local hospital. After all the Red Cross supplies less than half of the nation's blood. The other half seems to be doing ok.

Stephen said...

Thanks for the comment.

I agree that people should not stop donating blood but this problem could certainly lead to that.

It is imperative that Red Cross' management address this issue and fix the quality system as quickly as possibly. When they do, the press should do its part to inform the public.

The key is Red Cross' management. They set the policies, procedures, and instructions. They manage the resources. They must get to the root cause of this problem and eliminate it.

The cynic in me says the management either won't do it or can't do it since this is not the first time the FDA has fined the Red Cross. So, money does not get their attention.

Let's hope for the best.