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If you are wondering whether your organization could benefit from formal Root Cause Analysis (RCA) and Corrective Action training, read below to see if any of these issues are present in your day to day operations. RCA and Corrective Actions are some of the most useful tools for continual improvement.
Here’s why you should make them part of your company’s (and all employees’) improvement tool belt.
1. High Number of NCRs in Your Company
It’s true that the number of NCRs will depend on the volume of operations a specific company has, therefore making the “number” of NCRs a relative figure. However, if you know you have a high number of NCRs, the issue may be that you are not performing good Root Cause Analysis (RCA) and Corrective Action.
When you issue an NCR, you are doing it in order to track and quantify the nonconformances, defects, or issues causing your production or service operations to lag. But the story should not end there. The biggest benefit of tracking NCRs is the ability to see how the performance of your operations is changing from week to week, month to month, from product to product, etc. Tracking allows you to use that information to select which issues you want to concentrate on, in order to perform Corrective Action and subsequently RCA.
Is the number of NCRs in your company high? You may want to tabulate your NCR data weekly and select which issues to focus on and do an RCA. By doing a thorough RCA and Corrective Action on the critical few, you can start a concerted effort to drive down the level of NCRs. Remember: tracking for the sake of tracking – with no clear process to drive this number down – is a clear indication that you are not following up with Corrective Action as needed.
2. The Same Mistakes Keep Happening Over and Over
If Corrective Actions span from similar sources or mistakes, there is a very good chance they are not being addressed appropriately to begin with. This may mean that the RCA conducted for any particular issue:
- is flawed
- is not thorough enough
- is not getting to the actual root cause
- or, the actions implemented do not address the root causes identified
I frequently say “Make new mistakes, not the same mistakes”, as repeating the same mistakes will be a good indication that the RCA conducted on the initial mistake was not robust enough to prevent the same problem from happening again.
3. Nonconformities from Your Internal or External Audit Cannot Be Closed
Conducting a well-rounded Corrective Action is not just about finding the root causes of a problem. It also entails identifying the actions to address the very root causes identified, and of course being able to document all of these in a coherent manner. Often, the responses cannot be understood, or they do not represent the truth because they are being “sugar coated.”
From the moment you write the problem statement, you need to keep in mind that it should make sense to people that were present in the audit, as well as those who were not. It should also make sense now, as well as 6 months later when the issue is no longer fresh in our minds. Above all, write the truth.
I cannot recall how many times I have read a Corrective Action and RCA, and then followed up with the person who wrote it only to get a totally different explanation. The answer is always “I didn’t think I needed to include that.” This is always an immediate red flag that employees are not properly trained in RCA techniques. That’s why at Mireaux all of our Turnkey Consulting projects make RCA training a mandatory step.
4. Minor Nonconformities from Your Internal or External Audit Keep Getting Elevated to Majors
Another scenario to consider:
- A minor nonconformity from an audit is accepted.
- The problem happens again.
- The minor nonconformity is elevated to a major one upon verification at a subsequent audit.
In the case described above, there is a high probability your root causes or actions were flawed, not carried out as planned, or poorly implemented. If an Auditor sees that the problem happened again (unless due to totally different circumstances) the Auditor expects that with proper RCA and Corrective Action, a problem should not happen again. So if it does, then your minor nonconformity gets elevated to a major nonconformity.
5. Your ISO or API Certification Gets Revoked
If your company’s ISO or API certification gets pulled or revoked for issues other than financial, you may have serious RCA and Corrective Action shortcomings. To get to this stage, it means that you were issued nonconformities that were either not answered, answered poorly, or repeated during the audit follow up. And this cycle would have had to repeat for a few months for the Registrar or API to finally decide to go this extreme route.
If you were part of this process, then you know whether your corrective actions were rejected, or whether the problems resurfaced during follow up audits thus making the RCA not valid. However, if you were not part of this process, and you have no idea why you lost the certificate, be aware that some Management Representatives may hide all of these from Top Management with the believe that it will eventually resolve itself. If you find yourself with this dilemma, please understand this type of issue will not resolve itself. In fact these issues will not be resolved until you conduct thorough RCA to get to the bottom of all issues, while accepting that you may need to overhaul many of your processes.
Bonus for API Certification Holders
6. You Engage in a Never-ending Electronic Fistfight with API Regarding Nonconformities
If you are in the middle of a back and forth with API’s assigned Audit Reviewer, and findings are not getting closed, STOP! Put the mouse down, and take a deep breath. A shotgun approach will not work with API.
Review of API responses are conducted by employees who are well trained in RCA techniques and Corrective Action principles – but who were not present in the audit. Your RCA and Corrective Action responses and supporting material must be robust enough to withstand this process. If you think the issues will resolve themselves and the auditor will eventually get tired and just accept your responses, you are wrong.
Go back to the basics, assemble your team of all appropriate stakeholders and use formal RCA techniques such as The 5 Whys to find the root causes of the problem. Enlist the same stakeholders to implement various action items to address the root causes found. Once all actions have been implemented and verified, submit your responses to API in an organized fashion.
Running into any of the issues described in this article is a clear sign that there are problems with the way Root Cause Analysis is conducted and Corrective Actions are implemented at your company. The most effective way to get your continual improvement program back on track is to provide training on these topics. Mireaux Management Solutions offers a 1-day training course on Root Cause Analysis and Corrective Action, available in Public Training or On-Site at your company. Contact us at (713) 589-4680 for more information.