Medical Device Quality Control | Abaxis D

By: Marci Lynn Crane

A recent Forbes article1 was disturbing. Not in the “nightmare sense” of the word or even the “weird sense”. It was more like the “pitiable sense”.

Why?

Well, the article began on a positive note. Abaxis, a medical device company located in California, has recently been successful in developing, patenting and distributing a machine that can quickly diagnose blood tests----emphasis on the word “quickly”.

However David Whelen, the author of the Forbes article, goes on to describe a variety of set backs that made (or still make) the precious Abaxis victory taste more than remotely bitter.

Whelen describes the Abaxis set backs as follows:


  • “…one-third of its machines had defective components and were returned.”
  • “Salesmen had good leads but were distracted dealing with unhappy customers.”
  • “At Friday staff meetings executives yelled at one another.”
  • “In June Severson [An Abaxis decision maker] asked his head assembly guy to prove that the failure rate was slowing. Soon his letter of resignation was on Severson's desk.”


In essence, although the development of the blood device could truly be deemed a success the road that Abaxis took to get there would be considered less than worthy.

Unnecessary Failures
It’s probably true that learning from mistakes is a virtue but it’s probably also true that some mistakes are simply unnecessary. The Abaxis mistakes listed above are, in reality, avoidable. Some might question how they would be consciously averted. The answer, as in so many instances answers are bound to do, lies in the lap of information technology.

The Abaxis Problem and the Quality Control Software Solution
If Abaxis had employed compliant quality control software solutions their “pain and controversy” (as Whelen puts it) would most likely have been avoided or at least greatly ameliorated. How? Let’s take a look at the Abaxis set backs one at a time.

Set Back #1: “Machines had Defective Components”
This mistake is a common one for life science, medical device and technology companies alike. Ideally, it would be outstanding if defective components were no where to be found, but realistically that achievement would be very unlikely. However, the manner in which a company chooses to handle defective components can be controlled and the systems that life science or technology companies choose to handle their defective systems are definitely unequal in nature.

Quality Control Software Solution #1: CAPA, Change Control and Training Solutions
http://www.mastercontrol.com/company/"">MasterControl2, an http://www.mastercontrol.com/"">integrated quality control software suite provider, proffers the software solutions that would have made the categorical difference for Abaxis. Even just a select few of the MasterControl software solutions can manage and streamline documents, customer complaints processes, CAPA management, change control and employee training in an online, centralized location while simultaneously meeting regulatory and compliance standards set for many companies by the FDA, the ISO and/or the EMEA (European organization).

Not only is the MasterControl process more accurate it also works faster so that defects are quickly changed and unhappy customers are cajoled more effectively.

Set Back #2: “Distracted Dealing with Unhappy Customers”
Dealing with unhappy customers is also an inevitable process. It’s to be expected. Again however, the manner in which unhappy customers are dealt with can make all the difference in a company’s future reputation not only externally (in the minds of customers) but internally (within the minds of company employees). The overwhelming Abaxis customer complaints problem was unnecessary and could have been avoided for the benefit of the company’s internal and external affairs.

Quality Control Software Solution #2: A Customer Complaints Solutions
Abaxis could have avoided the overwhelming situation of dealing with so many unhappy customers if they had 1) managed their quality control and product testing via a centralized software system that tracks and manages quality documents/forms and 2) by investing in the MasterControl Customer Complaints solution which consistently routes customer complaints to the CAPA system where quality control employees are notified quickly of customer concerns. The CAPA solution can also be integrated with the MasterControl Documents solution (for the location of quality document errors) and can in addition be connected to the Change Control and Training solutions when changes need to occur.

Set Back #3: “Executives Yelled at One Another”
It’s no fun to work for a company where people act like barking dogs.

Quality Control Software Solution #3: Accountability Features
The MasterControl software suite can track, and record the changing versions of all types of documents or forms. Appropriate employees receive tasks and if those tasks remain uncompleted then it’s easy to see who is at fault. No yelling is required.

Set Back #4: “Letter of Resignation”
If employees don’t have loyalty it’s like working with a bunch of walking machines who take a lunch break.

Quality Control Software Solution #4: A Better Solution Overall
An organized environment where people know what they are supposed to do and where the right training is provided is an environment where employees can begin to let down their guard and start thinking like people again.

Your company doesn’t have to invest in MasterControl quality control software, but Abaxis most certainly would have benefited from it.

1 members.forbes.com/forbes/2007/1029/088.html
2 There may be other solutions that provide comparable solutions but this article will focus on the software features provided by MasterControl.

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