(Post updated on 24 Jan 2013 for those that couldn’t access the LinkedIn Group, refer to 3rd paragraph below)
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