Product Safety Incidents
We currently have a good process for collecting information from product safety incidents in the field. We are now trying to develop a matrix which lists which individuals in our organization should be involved. This involvement should depend on the severity of the incident. Types of incidences would include Reportable Injury, Property Loss, Instrument Damage, Product Recall, Upgrades in the field less than a specified amount, Upgrades in the field greater than a specified mount,, Customer Notification, etc. Is there anyone willing to share a matrix or provide suggestions/format on how the notification process is done in his/her organization? All responses are appreciated. Regards Joe Martin Compliance Engineering Applied Biosystems marti...@appliedbiosystems.com --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@mediaone.net For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: http://www.rcic.com/ click on Virtual Conference Hall,
Re: Safety Incidents
I'd like to add to George's great post. Having done this type of reporting only once long ago with another company far away, thank God, I reduced it as much as possible to a typical UL type standard: construction and performance, with some additional info. Did the incident involve the construction of the product? example: shearing surfaces, too heavy, Did the incident involve the performance of the product? examples: overvoltage/current/temp Did the incident involve a single or multiple failure of the product? example: wire insulation wearing away, windings shorting together, or, contacts welding on a rely which caused an overcurrent condition which caused In order for the product to do it's intended job, does the product require the end user to be handling the product while the job is being done? Y/N examples: hand drill, drill press ... Did the incident occur with intervention from the end user? Was the end user performing - normal operating procedures, routine maintenance, an emergency shut down ... Regards, Doug McKean - Original Message - From: wo...@sensormatic.com To: emc-p...@majordomo.ieee.org Sent: Thursday, April 19, 2001 7:19 AM Subject: Safety Incidents My company has a standard process for the reporting and follow up of alleged safety incidents concerning our products. We are now attempting to create a standard format for the final report to ensure that all of the necessary aspects of the investigation are complete and adequately documented from both an engineering and legal aspect. Is there anyone out there that would share with us any information they have in this regard? Or, can you point me in the right direction to find the information? --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@mediaone.net For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: http://www.rcic.com/ click on Virtual Conference Hall, --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@mediaone.net For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: http://www.rcic.com/ click on Virtual Conference Hall,
Re: Safety Incidents
Hello Richard, If you need details re the Recall aspect, visit the Safety Link www.safetylink.com and using your browser's Find in Page tool, search for the term recall handbook. This will take you to a link to CPSC's handbook on this subject. Searching on the term recall will yield a link to another site addressing product liability. Regards, Art Michael * * * * * * * * * * * * * * * * * * * * * * * International Product Safety Bookshop * * Check out our current offerings! * * http://www.safetylink.com/bookshop.html * * * * Now offering Chinese Product Safety* * Compliance, by William Kelley * * * * Another service of the Safety Link* * www.safetylink.com * * * * * * * * * * * * * * * * * * * * * * * On Thu, 19 Apr 2001 wo...@sensormatic.com wrote: My company has a standard process for the reporting and follow up of alleged safety incidents concerning our products. We are now attempting to create a standard format for the final report to ensure that all of the necessary aspects of the investigation are complete and adequately documented from both an engineering and legal aspect. Is there anyone out there that would share with us any information they have in this regard? Or, can you point me in the right direction to find the information? --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@mediaone.net For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: http://www.rcic.com/ click on Virtual Conference Hall, --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@mediaone.net For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: http://www.rcic.com/ click on Virtual Conference Hall,
RE: Safety Incidents
Very good ideas, George, and we have implemented most of these in our information gathering phase. We are not clear as to what is necessary and sufficient information for the final report, especially when someone is claiming injury or property damage and no fault is found. I just posted in another e-mail some ASTM standards that a list member passed on to me. They hold some promise of being helpful and we plan to investigate them. Richard Woods -- From: geor...@lexmark.com [SMTP:geor...@lexmark.com] Sent: Friday, April 20, 2001 9:17 AM To: wo...@sensormatic.com Cc: emc-p...@majordomo.ieee.org Subject: Safety Incidents You have raised a very important question that many of us must deal with in some way. I note you have received no replies via the listserver. I know of no documented legal requirements for the incident investigation process, although OHSA, CPSC, and others may have documented requirements for notification (external reporting) in the event of a pervasive product safety defect that could result in injury or property damage. Luckily, I have no reason to find out the details of these. Your question seems directed more at the reporting and documentation processes than the investigative process. However, it is the latter process that determines the data and information that would necessary in the event of a notification/reporting action. I have an incident investigation process that I use, but there is no one right method. First of all, the engineering aspect generally follows the same methods used to analyze any engineering problem, viz. (1) what evidence or data is available, (2) what are the symptoms of the problem, (3) what are the possible causes, (4) what is the most likely cause, (5) is the likely cause internal or external to the product, etc. My process is fairly simple, based on common sense, and includes the following: - Date, time, and location of the incident - Names and contact info for owner, operator, witness, etc. - Speak with any actual witness(es) of the incident - What did the witness(es) see, hear, smell, touch, etc.? - What was the perceived risk; shock, fire, sharp edges,? - Did any injury or property damage occur? - Does the incident resemble prior incidents for which we know the cause? - Initial assessment of severity of the incident based on initial data. - Does initial assessment warrant a stop-ship pending conclusions? - Are there any photographs or official reports of the incident? (e.g. fire dept., insurance investigator, medical, etc.) - Where is the unit located at this time? - Do we need to see the unit? - If so, can the unit be shipped to us? - If the unit cannot be shipped to us, do we need to go to the unit? - What external factors are pertinent; i.e. other ITE, UPSs, thunderstorms, outlet strips, nearby open flames or heaters, gross misuse, ..? - What is the service history of this unit? - Examine the unit. - What, if any, damage is visible? - What other clues are visible, e.g. arcing, overheated component, etc...? - What portions of the unit are operable, and which are not? - What are the final conclusions as to the cause and whether a hazard did or did not exist? - If appropriate, inform the customer of the findings. - If a hazard was exposed, was it due to a random event or to a product design and/or manufacturing defect? - What, if any, actions should be taken to avoid a similar occurance? - Do the probabilty and severity of the incident warrant notification (external reporting) and/or recall actions? Final note: In general, I have found that most reported incidents did not result in a hazard and were not caused by product or manufacturing defects. For example, smoke and/or odors from a failing component will often be perceived as a fire. Shocks from simple electrostatic discharge (ESD) may be viewed as a serious shock threat. The above are my personal views based on 38 years of engineering experience. George Alspaugh woods%sensormatic@interlock.lexmark.com on 04/19/2001 10:19:32 AM Please respond to woods%sensormatic@interlock.lexmark.com To: emc-pstc%majordomo.ieee@interlock.lexmark.com cc:(bcc: George Alspaugh/Lex/Lexmark) Subject: Safety Incidents My company has a standard process for the reporting and follow up of alleged safety incidents concerning our products. We are now attempting to create
RE: Safety Incidents
Stig, we put together a reporting process and that is working well and we have been generating reports. But we have asked ourselves what information is necessary and sufficient for the report. We based our process on information in the following books. Willie Hammer, Product Safety Management and Engineering, 2nd Edition; 1993; ISBN 0-939874-90-3; American Society of Safety Engineers catalog order No. 4342 Paul Hill, Managing Product Safety Activities; Paul W. Hill Assoc. Boca Raton, Florida; 1993 In response to my posting, I received the following information. There are a lot of good books on the subject that you might find on Amazon.Com, but here are some ASTM standards on Technical Aspects of Products Liability Litigation, by Committee E-40. They cover: ASTM E620 Reporting Opinions of Technical Experts ASTM E678 Evaluation of Technical Data ASTM E860 Examining and Testing Items That Are Or May Become Involved In Products Liability Litigation ASTM E1020 Reporting Incidents ASTM E1138 Technical Aspects of Products Liability Litigation, Standard Terminology of ASTM E1188 Collection and Preservation of Information and Physical Items by a Technical Investigator. The newest versions can probably be ordered from ASTMs website. Richard Woods -- From: Stig Jorgensen [SMTP:jorgen...@skyskan.com] Sent: Friday, April 20, 2001 9:21 AM To: wo...@sensormatic.com Subject: RE: Safety Incidents Hi, Woods. I am very interested in what is out there on the subject. We have a simple, all too simple, questioner. It looks like that a two step process may be the way to go. First a basic report and then a very complete report for serious incidents. I recognize the legal consequential implications in the long-term even for an innocent event. Do we need a harmonized FORM? Stig jorgen...@skyskan.com --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@mediaone.net For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: http://www.rcic.com/ click on Virtual Conference Hall,
Safety Incidents
You have raised a very important question that many of us must deal with in some way. I note you have received no replies via the listserver. I know of no documented legal requirements for the incident investigation process, although OHSA, CPSC, and others may have documented requirements for notification (external reporting) in the event of a pervasive product safety defect that could result in injury or property damage. Luckily, I have no reason to find out the details of these. Your question seems directed more at the reporting and documentation processes than the investigative process. However, it is the latter process that determines the data and information that would necessary in the event of a notification/reporting action. I have an incident investigation process that I use, but there is no one right method. First of all, the engineering aspect generally follows the same methods used to analyze any engineering problem, viz. (1) what evidence or data is available, (2) what are the symptoms of the problem, (3) what are the possible causes, (4) what is the most likely cause, (5) is the likely cause internal or external to the product, etc. My process is fairly simple, based on common sense, and includes the following: - Date, time, and location of the incident - Names and contact info for owner, operator, witness, etc. - Speak with any actual witness(es) of the incident - What did the witness(es) see, hear, smell, touch, etc.? - What was the perceived risk; shock, fire, sharp edges,? - Did any injury or property damage occur? - Does the incident resemble prior incidents for which we know the cause? - Initial assessment of severity of the incident based on initial data. - Does initial assessment warrant a stop-ship pending conclusions? - Are there any photographs or official reports of the incident? (e.g. fire dept., insurance investigator, medical, etc.) - Where is the unit located at this time? - Do we need to see the unit? - If so, can the unit be shipped to us? - If the unit cannot be shipped to us, do we need to go to the unit? - What external factors are pertinent; i.e. other ITE, UPSs, thunderstorms, outlet strips, nearby open flames or heaters, gross misuse, .? - What is the service history of this unit? - Examine the unit. - What, if any, damage is visible? - What other clues are visible, e.g. arcing, overheated component, etc...? - What portions of the unit are operable, and which are not? - What are the final conclusions as to the cause and whether a hazard did or did not exist? - If appropriate, inform the customer of the findings. - If a hazard was exposed, was it due to a random event or to a product design and/or manufacturing defect? - What, if any, actions should be taken to avoid a similar occurance? - Do the probabilty and severity of the incident warrant notification (external reporting) and/or recall actions? Final note: In general, I have found that most reported incidents did not result in a hazard and were not caused by product or manufacturing defects. For example, smoke and/or odors from a failing component will often be perceived as a fire. Shocks from simple electrostatic discharge (ESD) may be viewed as a serious shock threat. The above are my personal views based on 38 years of engineering experience. George Alspaugh woods%sensormatic@interlock.lexmark.com on 04/19/2001 10:19:32 AM Please respond to woods%sensormatic@interlock.lexmark.com To: emc-pstc%majordomo.ieee@interlock.lexmark.com cc:(bcc: George Alspaugh/Lex/Lexmark) Subject: Safety Incidents My company has a standard process for the reporting and follow up of alleged safety incidents concerning our products. We are now attempting to create a standard format for the final report to ensure that all of the necessary aspects of the investigation are complete and adequately documented from both an engineering and legal aspect. Is there anyone out there that would share with us any information they have in this regard? Or, can you point me in the right direction to find the information? --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@mediaone.net For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: http://www.rcic.com/ click on Virtual Conference Hall,
Safety Incidents
My company has a standard process for the reporting and follow up of alleged safety incidents concerning our products. We are now attempting to create a standard format for the final report to ensure that all of the necessary aspects of the investigation are complete and adequately documented from both an engineering and legal aspect. Is there anyone out there that would share with us any information they have in this regard? Or, can you point me in the right direction to find the information? --- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson:pstc_ad...@garretson.org Dave Healddavehe...@mediaone.net For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: http://www.rcic.com/ click on Virtual Conference Hall,
