by Steven Severt
Producing nonconforming product is costly. Your organization has paid for labor to produce the nonconforming product and expended available equipment time and resources only to have to scrap or rework the product. There’s also the cost of additional labor to make the product again. Plus, nonconforming products that find their way to customers can cause a host of unpleasant issues.
Despite the costs and risks, the production and rework of nonconforming product seems to be something that many managers are ready to accept. “These defects are inherent in my process,” they might say. These are followed with the dreaded, “There’s nothing that I can do.”
There’s always something that can be done about nonconforming products, but only if the organization is committed to continual improvement using root cause analysis and corrective and preventive actions.
ISO 9001:2015 highlights the need for organizations to dive into their problems to discover the root cause of nonconformities in clause 10.2. It requires the organization do the following when dealing with nonconformities, including those arising from complaints:
- React to the nonconformity by taking action to control it and deal with the consequences.
- Analyze the nonconformity to determine root cause and whether similar nonconformities exist or could potentially occur.
- Implement corrective actions and review the effectiveness of actions taken.
- Update risks and opportunities identified during quality planning.
- Make changes to the quality management system, as necessary.
The first step when a problem arises is to contain the problem to protect your downstream processes or customers from being further affected by nonconforming product. After the problem is contained, it must be analyzed to understand root cause(s) so that it/they can be corrected and to update quality planning documentation to reflect the new failure modes. Once this is done, the actions are implemented in similar processes and products to ensure that these failure modes cannot occur elsewhere.
This is a typical problem-solving process. Here are three typical roadblocks organizations face in their approach to nonconformities that rob them of the opportunity to improve.
The deny-deflect-dispute mindset is a common one; it’s the organization’s failure to take responsibility for the nonconformity that was created. If a customer or downstream process reports that you’ve sent them non-conforming product, this is the immediate urge to respond with something like, “This couldn’t have happened in my process. It’s impossible. Perhaps the defect was created in your process.” In the case of a customer complaint, this is often characterized by an urge to dispute the issue before investigating the problem.
Of course, the defect may have been created in the downstream process or at the customer’s location, but the root cause analysis didn’t bring the person reacting in that way to that conclusion. It was an immediate defense mechanism and something that will rob the organization of the opportunity to improve a process that may be creating nonconforming product. It will also likely damage the relationship with customers and downstream process owners.
Blame the supplier
If your product includes components that are purchased from a supplier, a similar defense mechanism manifests in an immediate reaction to blame a supplier for problems when they arise. If you experience problems in an assembly process in which supplied components are used, you might assume that the supplied components are to blame. You might demand reaction or cost recovery from the supplier before doing your due diligence to determine if the supplier has provided you with nonconforming material. It’s possible that your own components or assembly process are to blame. Perhaps the problem stems from a combination of the supplied components and your own processes.
Similarly, perhaps you find that the supplied component is creating problems. Perhaps a defect from a supplied component passed through your assembly process and on to your customer, who then experienced a failure and reported it to you. Is this also not your responsibility? Can you really wash your hands of it? Did you not have a responsibility to impart adequate controls on your supplier? Why did you allow it to leave your facility? It seems to be a natural reaction to throw up your hands and say, “That’s their problem.” But, if you are sending non-conforming material to your customer, it is very much your problem. Not acknowledging these truths will rob your organization of the opportunity to improve supplier relationships and internal controls for products that incorporate supplied components.
Blame the operator
The last on the list is a classic: the innate desire to blame the hourly worker for nonconformities that arise. It becomes so easy to say, “The operator didn’t do his job; that is why I have nonconforming product at my customer location.” Like the other items on this list, this is management’s inability to take responsibility. It’s rarely the hourly worker’s fault. Nearly every hourly employee wants to come to work and make quality products—not intentionally make defective material or send it out the door. They are working within a system that allows for them to make or ship nonconforming material.
Before you blame the operator, take a second to reflect on the system that you’ve built for them. Ask yourself these questions:
- Is the process statistically capable?
- Was the expectation clear?
- Did I give them the tools, the training, and the resources to meet the expectation?
If you can answer yes to all the above, then perhaps you have a rogue among your ranks that is sabotaging your operation. But if you can answer no at any point, you have not given them an adequate system to always deliver quality products to downstream processes or to your customers. And, if this reflection is honest, you will always be able to answer no. Improve your system.
Note that all these items are a failure of management to take responsibility for failures and truly understand root causes so that they can be eliminated. It’s the easy route, but you will never improve. Your processes will continue to produce nonconformities. Your customers and downstream operations will continue to receive subpar products. You will continue to incur unnecessary costs.
If you want your organization to be committed to improvement, you need to understand the necessity of root cause analysis and effective corrective action. This begins with the mindset of taking responsibility.
About the author
Steven Severt, who writes for isoTracker—a nonconformance and quality management software vendor—is a quality management professional with nearly two decades of experience in the automotive and medical device industries. He has extensive experience launching and supporting manufacturing processes to supply automotive OEMs as well as developing, supporting, and auditing quality management systems that adhere to the requirements of ISO 9001, IATF 16949, ISO 13485, and 21 CFR 820.