Issue 111 – Is your CAR running properly?
ISO 9001:2015…
Is your CAR running properly?
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 110) we discussed the topic of “Is calibration ‘Not Applicable’ in a Service company?”, and now in this Newsletter we will discuss “Is your CAR running properly?”.
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
Is your CAR running properly? I hope the title of this Newsletter got your attention and maybe even made you curious as to what this had to do with ISO 9001… well I thought I’d use a play on words since of course I am referring to a CAR (Corrective Action Report or Request), which is probably the most commonly used form within a Quality Management System (QMS).
Clause 10.2 Nonconformity and Corrective Action, states the following: “When a nonconformity occurs, including any arising from complaints, the organization shall… etc…etc…etc“. The reason why a CAR form is even needed is due to the requirement contained within Clause 10.2.2 (b): “The organization shall retain documented information as evidence of… the results of any corrective action“. In my opinion, in the very middle of this whole Clause is where the most important statements are made, such as asking organizations to uncover the root causes of problems, taking actions to eliminate those causes, and finally to make sure that the actions taken are effective… in other words did the “fix” work, and will it continue to work in the future.
I am all about “process”, so normally I would expect a CAR to go through it’s various steps and then finish off by someone signing off stating that “the fix worked”. In order to know a “fix” has worked, and will continue to work in the future, then I usually expect to see some time pass by before the CAR is “closed out”, so that you have some evidence to prove that the “fix” worked. For example, if I had a certain product type that I produce, that had a problem the last time I ran it, then I would put a “fix” in place to stop that problem from re-occurring, and then wait until I ran that product type again, before I would really know whether my “fix” will work over and over again. This may not be how CARs in your organization are currently being “processed”, but it probably should be.
Typically, the last section on the CAR form is reserved for verifying that the action taken, was indeed effective… or not. This really should be the responsibility of the Manager/Supervisor directly connected with the process that caused the problem. That person should first go and verify that whatever action that was supposed to be taken, was actually taken. Secondly, that person should then decide how best to determine if the “fix’ was effective, including how much time should go by to accomplish this effectiveness check. If all goes well, then it should be signed off by that same Manager/Supervisor. It’s critically important to remember that the intent is to fix the problem once, and then be done with it… nothing worse than a wounded problem roaming around the company waiting to surprise a Customer.
The last person that needs to be included in the CAR chain of activities (process) is whoever has overall authority over the QMS (sometimes referred to as the Management Representative). This person should have the final say on whether the corrective action taken was in fact “effective”… AND that the Quality Management System (QMS) is not adversely affected by the “corrective actions” that were taken. Let me give you an actual example (from my auditor travels) of why this final “check” is important. During one of my audits I discovered that the organization had stopped performing any evaluations of their Suppliers/Vendors. After further discussion I was told that the year before, the Purchasing Manager had a CAR assigned to them regarding a poorly performing Vendor, and the Purchasing Manager decided that the easiest fix was to simply revise the Procedure so that Vendors no longer had to be evaluated on an annual basis. Anyone who understands Quality knows the acronym GIGO (garbage in, garbage out). The CAR in this situation was Closed, and life carried on… until a large Customer complained about getting “garbage” in their Order, caused by that same Vendor. This organization had no person in the CAR process to make that last “check” to safeguard the integrity of the QMS.
As a final comment, the fastest way to test whether your CAR is running properly, is to ask “Has this same problem occurred before?… If the answer is Yes, then your CAR process is likely broken.
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…
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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
Helping Business Professionals Reduce Risk and Remove Waste!