ISO 9001:2015 – Newsletter – Issue 96


 

 

Issue 96 – Root Cause or Root Canal, which is worse?

 

ISO 9001:2015…

Root Cause or Root Canal, which is worse?

 

I appreciate receiving emails with questions and/or comments from readers of this Newsletter… please continue to do so since it provides me with direction on where to aim the content of these publications.  In my last Newsletter (ISO 9001:2015 Newsletter Issue 95) we discussed the topic of  “Any upside to remote auditing?”, and now in this Newsletter we will discuss “Root Cause or Root Canal, which is worse?”.

 

The ISO 9001:2015 Element numbering…

Element 4 – Context of the organization
Element 5 – Leadership
Element 6 – Planning
Element 7 – Support
Element 8 – Operation
Element 9 – Performance evaluation
Element 10 – Improvement

 

Root Cause or Root Canal, which is worse?… Based on my anecdotal evidence it would appear that people would prefer to get a root canal rather than perform basic root cause analysis.  Most people are aware of the 5-Why approach (asking “Why?” something has occurred, 5 times until you drill down past the symptoms) however many fail to get past the first Why.  It doesn’t help that most of the CAR’s that I have reviewed have been completed long after the event was addressed, so there isn’t much energy left to fill out all of the sections of the CAR form.  This makes me wonder how people knew what to “fix” when they weren’t clear on what really caused the problem in the first place.  This is likely why the same problems often flare back up days or weeks or months later… because we never actually eliminated ALL of the underlying causes.

This brings up my second point… rarely does a problem of any sizeable magnitude, have only one root cause.  Typically immediate corrective action is taken which might address one of the causes of the problem… but other “root causes” are probably still lurking out there waiting to re-ignite the fire.  So how do you know if you’ve eliminated all of the root causes?  One way is to make sure to “check for effectiveness”, which by the way is a “shall” requirement in Clause 10.2.1 [d] of the ISO 9001:2015 Standard.  One of my Clients found a clever way of using this “check point” within their CAR process… their policy was that no CARs can be closed in less than 90 days… the idea being that it stops the “quick fixes”, and ensures that enough time has gone by to see if that same problem crops up again (which means all root causes were not eliminated).

 

What if root causes cannot be removed or minimized?… In some cases, the root cause behind the problem is inherent in the Process, or in the Equipment, or in the Inputs to the Process… You may have product problems that occur because of the nature of the product or process itself.  There may be no solution available (perhaps it is experienced industry-wide), or the solution may be too expensive to implement based on thin profit margins, or it is a downside of the old equipment/technology which is all you can afford.  Whatever the reason, you should still respond to Customer Complaints by identifying the “known” root causes and then advise them that you will do your best to mitigate recurrence of these problems but that it will likely re-occur.  The Customer will then need to decide if they can tolerate having these product problems within their process.  By the way, in these instances where the product or service problem is inherent within the process, then the “check for effectiveness” is “not applicable” since no actions were taken to eliminate the root causes.

 

Be sure to watch for our next Newsletter issue where I will be answering some of the questions that I get from Readers of my Newsletters about how to implement the requirements of ISO 9001:2015 in a specific and practical way, that will also help improve business performance…

 

To view all of our past Newsletters or to sign up to receive them… click here

 

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Need Help?

ISO 9001:2015 Internal Audit Outsourcing (we can do it for you OR with you!)

For cost effectiveness, the Internal Audit function can be outsourced to an external experienced auditor on a periodic basis. This will provide an independent and objective assessment to management, of where process issues may exist, along with identifying opportunities for improvement.  It will also provide the evidence needed to satisfy the Internal Audit requirements in the ISO Standards.  We have used two different approaches with this service: a) We conduct the entire audit ourselves, or b) We act as the lead auditor, and along with your Team of internal auditors, we complete the entire audit together.  This latter approach allows your people to receive guidance and direction from an experienced lead auditor while at the same time maintaining significant involvement in the internal audit process.

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Internal Process Auditor Training for ISO 9001:2015

The two (2) day Internal Process Auditing for ISO 9001:2015 Training Session is focused on a process approach to auditing with the objective being not only to assess conformance of the quality management system, but also to uncover process improvements during an audit. This goes hand in hand with the process auditing requirements found within ISO 19011 and the process approach covered in ISO 9001:2015, which promotes continual process improvement throughout this Standard. An enhanced checklist is developed, and there will be workshops throughout, to reinforce learning, as well as a live, practice audit. If you are looking to meet the ISO 9001:2015 internal audit requirements and to “raise the bar” for your internal audit program then this is the course you should consider.

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Until next time…

Tim Renaud

www.isosupport.com

Helping Business Professionals Reduce Risk and Remove Waste!