Pulling Back the Curtain: Cause Analysis and Corrective Actions

Cause analysis and corrective actions are critical aspects of both ISO 9001 and ISO 17025 compliance, as well as numerous other certifications and accreditations.

The requirements for these processes are painted with a broad brush, allowing organizations to design their own strategy to track and implement changes. Qualtrax offers its users the opportunity to automate these processes and build customized workflows to ensure that you cover all the bases, regardless of which method or methods your organization uses to administer and track your cause analysis and corrective actions.

So what are those bases anyway? What’s the difference between a correction and a corrective action, and what is the best method for conducting a cause analysis? Thanks for asking! We recently hosted a webinar with Melanie Ross from ANAB to answer these and other questions around this challenging topic. You can watch the webinar in its entirety here. This blog is intended to hit the high points and illuminate some of the big-picture take-aways.

To start off, there are benefits to both correction and corrective action. The difference is that a corrective action treats the cause of a nonconformity, while a correction often just treats the symptoms of a nonconformity. After you determine your cause in cause analysis, you must take comprehensive actions in order to eliminate the nonconformity. Corrections are individual actions to address individual issues.

It is important to note that the latest editions of both ISO 9001:2015 and ISO 17025:2017 moved away from the term “root cause analysis,” and now simply address “cause analysis” instead. This change reflects the idea that nonconformities rarely have one distinct cause, and limiting the analysis to one cause could limit the effectiveness of the correction and corrective actions.

Effective cause analysis is the key to determining actions that yield long-lasting results. This is why it is so important to perform effective cause analysis: so that the nonconformity does not recur or occur elsewhere in the organization’s management system or operations.

Corrective actions need to respond appropriately to the effects of the nonconformities encountered. If you’re making donuts, for example, and you discover that your current process is putting sprinkles on jelly donuts (clearly a nonconformity!), changing your jelly recipe is not an appropriate corrective action to remedy the situation. Once the corrective action has been taken, effectiveness of the action must be reviewed. If the effectiveness of the actions taken is not evaluated, it cannot be determined that the cause was eliminated and the problem corrected. In other words, once you’ve corrected the process to add a sugar coating rather than sprinkles to your jelly donuts, you need to observe that the process is working before you can determine that the corrective action was successful.

Cause analysis is the determination of a potential problem’s underlying cause or causes. It is the process of identifying all causes that have or may have resulted in an undesirable condition, situation, nonconformity or failure. It is an analytical technique used to determine the basic underlying reason that causes a variance, defect or risk.

Some of the most common cause analysis techniques include the Ishikawa Diagram (fishbone diagram), Five Whys, Failure Mode and Effects Analysis, and Pareto Charting. While each method is effective, Five Whys is probably the most common technique used in general settings.

Techniques can also be combined during the cause analysis process. For example, once an Ishikawa Diagram has been developed, Five Whys can be used to further examine the cause for each category.

If this whole process seems overwhelming and you’re tempted to start breathing into a brown paper bag, just know that Qualtrax is here to help. Our Best-in-Class workflow set includes a cause analysis workflow that comes standard and is ready to use right off the bat. This workflow allows you to automate the entire process, ensuring that you don’t skip a step and that every little detail is documented.

Better yet, you can customize any workflow – including our Best-in-Class set – to meet the needs of your organization. If your team wanted to use the Five Whys method, for example, you can easily build that functionality into your process, guaranteeing consistency in your process and providing a failsafe way to ensure that your team always follows the process to the appropriate conclusion without taking any shortcuts.

Let’s take a quick look at the four primary methods for performing a cause analysis:

ISHIKAWA/FISHBONE

The Ishikawa or Fishbone Diagram (also known as a cause and effect diagram) is a diagram showing causes of a particular situation. The bones of the diagram are labeled with categories for grouping causes. Details of the causes are added to the bones. The categories can vary depending on the context of the organization and the nature of the nonconformity. Common categories are 6 M’s, 4 S’s or 8 P’s (see diagram). Once the bones are filled in, causes are identified and corrective actions can be determined and implemented. If further analysis is needed for the causes, you can use the 5 whys method to dig deeper for effective corrective action planning.

FIVE WHYS

Five whys is a simple tool used by organizations to determine causes of nonconformities. The first response is usually a symptom of the nonconformity rather than the cause or causes. You will continue asking why until you get a real cause that can have correction or corrective action implemented to eliminate that cause or causes. Sometimes you may get to a cause before asking why five times. Other times you may need to ask why several times and on several branches to identify additional causes.

FAILURE MODE AND EFFECTS ANALYSIS (FMEA)

In FMEA, you list out all of the typical failures and rank them for severity, probability of occurrence and probability of detection. Those scores are multiplied together to get the risk preference number (RPN). Failure modes with higher RPNs would be addressed first, while lower RPN scores would be acceptable risks. This is similar to risk analysis and risk-based thinking when we look at probability of occurrence and likelihood.

PARETO CHARTING

In Pareto charting, the causal factors are tallied per event in the form of a bar chart. The contribution from the top 20 percent of the causal factors create 80 percent of the nonconformities. Addressing the top causal factors with correction and corrective action will eliminate nonconformities related to these factors. Once the top 20 percent of causal factors are addressed, you can then move down to the next level of causal factors and continue to address them until nonconformities don’t occur or recur.

Keep in mind that regardless of the method you employ, the corrective action process is ongoing. Nonconformity occurs or could occur at any time and the laboratory needs to control and correct it. Your assessor will be checking to ensure that you reacted to the nonconformity and addressed the consequences, as well as evaluated the need for action to eliminate causes.

You will also be expected to implement those actions and review effectiveness, as well as update the risks and opportunities defined during planning. You need to implement actions into the management system, such as updating documentation and providing training. You need to retain records. You must continue to do this as nonconformities occur or could occur within the system.

It may feel like you need a special team dedicated to handling all this responsibility, but in reality, Qualtrax is uniquely positioned to provide all the support you need. As soon as you open the corrective action workflow, a series of steps is put in motion to take you through the entire ordeal, requiring you to fill in the necessary information, automatically routing tasks to the next appropriate party and documenting every step to ensure your CAR is compliant and will stand up to the scrutiny of your assessor.

These are just four methods for cause analysis, but there are many more ways to perform the task and arrive at the cause or causes of a nonconformity. The analysis method chosen should be based on the context of your organization and the specific nonconformity being addressed. A one-size-fits-all approach isn’t effective in ensuring all nonconformities are controlled and corrected and consequences addressed. You need to select the analysis or analyses that suit your organization and the specific nonconformity at hand.

Effective cause analysis will ensure that nonconformity does not recur or occur elsewhere in the management system. This saves time and money for your organization by solving a problem only once. Incorporating risks and opportunities into the corrective action process further improves the management system. Qualtrax can provide the confidence to ensure that you perform these tasks appropriately and have the documentation to prove it.