2 answers
Candace
Student
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For the mechanical engineer, what does the team do when a product is recalled because there is a design flaw?
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2 answers
Sarah Williams
Electrical Engineer
52
Answers
Jacksonville, Florida
Updated
Sarah’s Answer
If you work in a regulated industry (which is most of them), your company will be required to have a process for this. How robust the process is can vary.
I work for a medical device company. We track where all of our devices are sold and who all our customers are. For certain implanted devices, we also sometimes track patients. If a recall happens, we can trace specific devices to the right customer/patient and notify them to return their device. This is similar to the auto industry, as well as others.
Usually, executing recalls is led by the Quality or Regulatory function of a company. Engineers work in these functions, and part of their job may be to help assess the safety impact of different situations and establish the scope of a recall when necessary.
I work for a medical device company. We track where all of our devices are sold and who all our customers are. For certain implanted devices, we also sometimes track patients. If a recall happens, we can trace specific devices to the right customer/patient and notify them to return their device. This is similar to the auto industry, as well as others.
Usually, executing recalls is led by the Quality or Regulatory function of a company. Engineers work in these functions, and part of their job may be to help assess the safety impact of different situations and establish the scope of a recall when necessary.
Glenn A
Mechanical Engineering Manager @ Belkin
149
Answers
Irvine, California
Updated
Glenn’s Answer
Sarah gives great answers. I have worked in Medical and Consumer electronics, and all from a product development standpoint. Although medical is regulated, good consumer electronic companies do a similar approach. Recall involves a lot of steps. I will answer from a ME design perspective.
Engineering may be involved in site visits to review the failure and gather information from the people closest to the failure.Engineering can be involved in assessing the impact to the end user (or patient for medical products)
Engineering is involved in a root cause analysis. (what failed, why did it fail, why was this missed during the development process, etc)
Engineering is involved with a corrective action plan. (How do we handle product in the field, how do we handle product in the factory, what is the long term design and manufacturing solution.
In medical, there is usually a CAPA (Corrective and Preventative Action) the engineers may be involved in changing the design process to insure that this does not occur again.
Sometimes it is a manufacturing defect, where engineering is involved with working with the supplier to correct their processes.
Engineering may be involved in site visits to review the failure and gather information from the people closest to the failure.Engineering can be involved in assessing the impact to the end user (or patient for medical products)
Engineering is involved in a root cause analysis. (what failed, why did it fail, why was this missed during the development process, etc)
Engineering is involved with a corrective action plan. (How do we handle product in the field, how do we handle product in the factory, what is the long term design and manufacturing solution.
In medical, there is usually a CAPA (Corrective and Preventative Action) the engineers may be involved in changing the design process to insure that this does not occur again.
Sometimes it is a manufacturing defect, where engineering is involved with working with the supplier to correct their processes.