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zbw2 replied to the topic Discussion Topic: The cost of Quality in the forum Quality Control and Quality Assurance 7 years, 6 months ago
For everyday tasks, “its too much work” is never a good reason not to do a particular task. the same applies to QA/QC systems. while these systems can be quite onerous to maintain, I think most people would rather good quality over expedited delivery or lowered cost. From a business standpoint, especially a startup, low cost and quality are priority, therefore, spending the time and money on the front end is worth the headache and potential multi-million dollar lawsuit or recall.
Samsung SDI is a good example of a company that would have benefited from better QA/QC systems. The recall following the exploding Note 7s caused Samsung to lose 26 billion in market value. after the recall Samsung ran an extensive marketing campaign illustrating the revamp of their QA system to regain public trust in the brand. It was bad enough that the burning phones destroyed users’ property and damaged lungs from smoke inhalation.
the stakes are raised when considering FDA regulated medical devices.
Just a few days ago, sept 28,2017, Sorin Group Italia issued a recall on defective Implantable cardioverter defibrillators. this is only 2 years after recalling contaminated heart valves. from 2014- “the valves released have been sterilised using a recognised process but Corynebacterium was not included in the validation study and therefore Sorin Group Italia has assessed that there is a risk that the finished product is contaminated”. the sept 28th recall, which was ultimately blamed on faulty software design, may have been avoided with more stringent QA Systems. what if one more set of eyes at $60k+ would have noticed the software’s error. This is their third recall on a class 2 device in three years. I think its safe to say proper QA is worth the headache.https://www.engadget.com/2016/09/13/samsung-loses-26-billion-market-value/
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158442
https://www.lexology.com/library/detail.aspx?g=e8770c90-f9e3-4e4e-abc3-2c614e833e08
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?start_search=1&event_id=&productdescriptiontxt=&productcode=&IVDProducts=&rootCauseText=&recallstatus=¢erclassificationtypetext=&recallnumber=&postdatefrom=&postdateto=&productshortreasontxt=&firmlegalnam=Sorin%20Group%20Italia&PMA_510K_Num=&pnumber=&knumber=&PAGENUM=100