Response to case study scenario 1
My decision is not to ignore the problem. At first I would go to my supervisor’s superiors. These superiors could be either the management of safety testing, quality management or technical director. I would raise my concerns regarding the potential risk posed, not only to the client but also to the company.
My concerns are:
The specific part of the unit causing the power consumption failure is unclear, this is the problem. The fire risk could be caused by the following or combination of failures
• Component – Non conforming to standards/design
• Design - Non conforming to standards i.e. PCB track width/separation.
• Materials used – Non conforming to standards design/production.
The company is producing a product with a batch failure rate of 1.5%, which I consider high, when in the industry you would normally expect a low failure rate for every million units not hundreds. If we produce a million units I would expect 15,000 units to fail using this percentage rate.
Financially, the cost to rectify is unknown as the cause of the problem is unknown and clients would expect a refund for defective goods, while also causing damage to the company reputation and potentially fighting litigation.
Legally the company can be held responsible for any damage caused by the defective product and have a responsibility making the product safe and that the necessary parties and authorities are informed about the risks. This is the purpose of General Product Safety Directive (GPSD) 2001/95/EC [1].
If the company is accredited to ISO 9000 [2], I would expect the top management to take action as it is their role “to promote the quality policy and quality objectives throughout the organization to increase awareness, motivation and involvement;”
If the management do not take action, then I would have to contact an authority which oversees our ISO 9000 accreditation and inform them that the company is not complying with the ISO 9000 standard. I would consider contacting the USB-IF (Universal Serial Bus Implementers Forum) as the company may no longer be in compliance of the USB specifications which could be a factor in the risk posed.
I would expect the company to recall the units which are linked to the test batch immediately. This will have to come from senior management as I have no authority over the situation.
Ethically it is my duty to raise my concerns as these risks pose a threat to life and property of others, of which the company is liable, the company quality policies are not being adhered to and also leave the company open to litigation.
From my own personal experience, having an electrical device fail which causes a fire or what can be interpreted as a fire, can cause distress, people will consider themselves lucky if present at the time of an incident but would start to think of the consequences if not there. It is unacceptable and ethically wrong to cause such distress.
[1] General Product Safety Directive (GPSD) 2001/95/EC
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32001L0095:EN:HTML
[2] BS EN ISO 9000:2005 Quality Management Systems
