Product Safety Case Studies
John McBain and James Balassone
All employees are expected to act according to their organization's Code of Ethics or Conduct, based upon the values of the organization.
Furthermore, product safety engineers are asked to:
(a) Determine "safety" of products
(b) Obtain various non-governmental agency certifications for products
(c) Confirm that products comply with government regulations
(d) Examine and test products according to various standards
They are required to do this using the minimum time, money, and number of product samples - usually at the end of the product development process, when changes are more difficult and everyone wants to ship products.
Some agencies authorize companies to test products, provide the data to the agency, and ship the product bearing the agency mark. The company's capability has been evaluated by the agency and a contract signed to allow this.
A new high-end computer is ready to ship - except for one test that you will not complete for another three weeks. The probability of failure is low - and even if the test fails, corrections can be made and sent out later to customers. Marketing is VERY anxious to ship because the end of the fiscal quarter is next week.
Should you put on the agency mark and ship while finishing the test?
Your boss tells you that this has occurred before; the company shipped the product, and there was no problem. He also says that if you do not want to sign off, then he will do so.
What should you do?
Products were shipped before this test was completed - but it happened when you were on a business trip. The production manager apologizes, but doesn't want to take any action.
What should you do?
The company records-retention policy instructs employees to discard development records and test results for products five years after End of Life is declared. This policy is in compliance with local legal requirements.
Because of the press of work you have not disposed of some old records, and they are a couple of years over the limit for the company policy. You finally get time to clean out your files, but you receive a legal request for any information about the old product that is involved in an injury case. Your records may or may not be applicable to the case.
Should you destroy the records?
You have just discovered that a country in the Far East has new regulations that apply to your product. The requirement is to submit a report and get a file number to apply to your product - after the government department has given its OK. However, you know from industry contacts that there is no enforcement of the law at this time.
Should you delay shipping products until they are compliant or take other action?
Products have been held at customs in this country, and you ask a local agent to investigate. Later you hear the products were released without any changes and without certification.
Should you look further into this event? Why or why not?
You make the identical product at two factories, but only one is authorized to apply a certain certification mark. Unfortunately, the wrong factory shipped the product to the country that requires the certification mark. Returning the product and shipping out the identical product with a different mark on the label would be very expensive and time-consuming, and your customer would be very unhappy.
What are your options?
Your company's product uses some supplementary circuit protection in larger units. While visiting the factory for another reason, you tour the production line and notice that the protectors are different from the ones you originally evaluated. They seem to have the same ratings, but you suspect they may not be suitable as a substitute.
This product is not your responsibility, and you would have to do some research to figure out if there is a problem.
What course(s) of action should you take to investigate the potential problem?
The production line supervisor tells you the substitution has been approved by the factory safety engineer, but you are positive these protectors are not suitable.
What should or could you do?
The latest edition of the standard that applies to your products now has three pages of "safety" markings and warnings specified. So many warnings about very unlikely situations greatly reduce the impact of warnings that might prevent dangerous events. You have actually surveyed customers and found that to be true.
Should you reduce the warning labels to only to the important ones or just follow the standards of the certification agencies?
Your marketing department wants you to color-coordinate and reduce in size the warning labels. The new version still would comply with the standard, but it would not stand out on the machine.
Should you resist the change?
The factory has a lot of old inventory with silk-screened markings that do not comply with the new requirements, although they did comply with the previous edition. To change them would cost thousands of dollars.
Should you let the company use up the old stock, although it is technically not in compliance?
John McBain is program coordinator for the Institute of Electrical and Electronics Engineers, Silicon Valley Chapter. James Balassone is executive-in-residence at the Markkula Center for Applied Ethics at Santa Clara University.
Jan 1, 2000
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