If you are interested in the IEC 60601 Series of Standards for Medical Electrical Equipment (MEE) and Medical Electrical Systems (MES), this is the group that will allow you to share your experiences, ask questions and discuss your opinions. This is a platform for 60601 experts, and those that want to learn more, to discuss topics related to this large set of standards related to MEE & MES including 7 Collateral Standards (and counting) and over 60+ Particular Standards. In addition to these Particular Standards, there are many other standards that apply to MEE & MES. 

This series of standards is very important in the medical device regulatory world as the IEC 60601 series of standards are the “Gold” standard for national regulatory agencies such as the FDA, Health Canada, The EU Medical Device Directives (MDD & AIMDD), the Japanese Ministry of Health, Labour & Welfare (MHLW), and many other national regulators. Most countries adopt these standards into their national standards mostly without modification but on occasion national deviations are needed to meet the national electrical code among many other issues. 

This group is here to discuss a wide range of topics related to the IEC 60601 series of standards, the regulatory impact of these standards (such as the differences in 3rd ed. vs 2nd ed. of IEC 60601-1 & country specific regulatory impacts), the changes continually happening in this field (i.e. 3rd ed. of IEC 60601-1, IEC 60601-1, 3rd ed. + Amendment 1, etc.), what are the regulatory requirements for specific countries as they evolve (like in the Middle East & Asia), and many more topics within the medical device world are also up for play.

The group is run by Leo Eisner of Eisner Safety Consultants, an expert in the IEC 60601 series of standards, and the group is owned by IEC.  Please come and join us in this new adventure and see what you can bring to this new group and/or learn from your group members.

* NOTE:  The IEC is the owner of this LinkedIn sub-group under their main umbrella IEC LinkedIn Group.  Leo Eisner is the manager of the group and if you have any questions with regard to the IEC 60601 series of standards on Medical Electrical Equipment Sub-Group please contact Leo.

Robert Packard, who is one of the managers of the LinkedIn Group “Medical Devices: QA/RA”, wrote recently on a subject that many companies struggle with.  What really is the difference between Root Cause, “Systemic” Root Cause, Preventative Action, and Corrective Action and he also touches on SCARs (Supplier Corrective Action).

Read on to see what Robert has to say.  Note, you may need to join LinkedIn to see this discussion. Thx Rob for sharing!

For those of you that couldn’t read the group discussion I have been given permission to repost the discussion item below.  But you may want to join the LinkedIn group as there was some really good discussion (some agreement and disagreement but all very civilized as we are all very much professionals and respect each others valuable perspectives).  So, thx to all involved in this discussion and let’s thx Rob again for his insight and generosity to share his knowledge in this field.  Thx Rob!

Discussion posted in the LinkedIn Group: Medical Devices: the subgroup on QA/RA

Root Cause vs. Systemic Root Cause?? Help me!

Yesterday I was reading an article by Christine Park ( http://bit.ly/CheckBoxCAPA ) and the article reminded me of a supplier corrective action request (SCAR) form that I once received. The SCAR form asked me to identify the “specific root cause” and the “systemic root cause”. I tried Google but that was useless (this was quite a while ago), so I tried calling the customer and asking for clarification.

Here’s a story to explain the difference:

My mother-in-law had a condo in New Jersey and my family was visiting one summer. It was a really hot day and the AC stopped working. We called the complex maintenance number, and the repairperson arrived minutes later. After a few minutes, he said that he had identified the problem and he would have it fixed in about an hour. He suggested that we might want to find a cool place to relax while he worked. When returned, there was a note explaining what he had done.
1. thawed the ice build-up in the system,
2. recharged the system with refrigerant, and
3. tightened connections to stop leaking of refrigerant.

If you worked in maintenance and you had to write a CAPA plan for the broken AC, the investigation of root cause would state that you inspected the system and found a build-up of ice caused by a low refrigerant level. The “specific root cause” is loose connections—resulting in leakage of the refrigerant. Thawing the system and recharging it are corrections, while tightening the connections is a corrective action.

Some people make the mistake of saying that the “root cause” is low refrigerant. Therefore, they mistakenly refer to recharging of the system as “corrective action” and tightening the connections as “preventive action.”

Tightening of the connections is not a preventive action, because it doesn’t address the “systemic root cause”. The systemic problem with the system is that there is no preventive maintenance being performed on the AC system. The “system” is not really the AC system. The AC system is a process within the larger system. In order to “dig deeper” as Christine says, you need to look outside the immediate process for the parts of the Management System that are supposed to prevent these problems. The lack of preventive maintenance by the complex allowed the connections to become loose. Therefore, implementing a preventive maintenance schedule for the AC systems throughout the complex is a preventive action that addresses the systemic root cause.

I’m more of a purist in my use of the terms “corrective action” and “preventive action”, and I would refer to implementing a preventive maintenance schedule as a long-term, corrective action.

Does your company make this distinction?

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Cheers!
Rob Packard