Quality & Corrective Actions
Ensure compliance with a robust corrective action process.
A good day on the shop floor has everything running smoothly. No issues with machines, staff, or suppliers, and products are shipped on time and without defects. However, the typical manufacturing plant may not experience many of these days. More often it seems that equipment breaks down unexpectedly, operators require additional training, and suppliers are late with deliveries. It could also be a matter of a machine suddenly making out of tolerance parts, or an auditor uncovers some troubling information about your operating procedures. While these situations can be headache-inducing, they can also be helpful if handled well.
When opportunities for improvement come up, this is the true test of your processes. Quality depends on continuous improvement, and—though they can be stressful and unwanted—problems are a way of making the company and the team even better. This is all just theory, however, until an audit brings issues to light. That’s when corrective actions come into play.
Corrective actions (CARs) are a way to make the problem go away. In addition, they can also teach your company how to improve your manufacturing processes. In that way, they are at the heart of a continuous improvement program.
As ISO 9001:2015 made clear, the priority is to prevent problems, but if that fails, corrective action is the next best thing. Corrective action is defined as “action to eliminate the cause of a nonconformity and to prevent its recurrence,” according to ISO.
Though the ISO 9001:2015 version did make changes regarding corrective and preventive action, the requirements have not disappeared. Despite these changes, the theory behind them holds true. If it’s not possible to prevent a problem—always the ideal method—then at least the solution should address how to avoid it in the future.
As Jack West and Charles A. Cianfrani write in ASQ’s Quality Progress, “Correction and corrective action are still required in ISO 9001:2015 and are addressed in clauses 9 and 10. In simple terms, an organization is required to react to nonconformity and take action to control and correct it, and to deal with the consequences.”
A nonconformity, as stated by ISO, would be any failure to meet a requirement. This could be a requirement from a customer, regulatory body, ISO, or your organization. Audits, whether internal or external, will uncover these issues. Keep in mind that audits are there to improve an organization and lead the way to a better version of the company, so addressing any nonconformities is a necessary step on the road to improvement.
While the terminology has changed in the ISO 9001:2015 standard—preventive action is now known as risks and opportunities—the idea has not. Better to prevent than fix a problem, as Benjamin Franklin would say. It seems that “an ounce of prevention” applies to colonial era projects just as much as today’s nonconformities.
The process can be daunting, however. To answer your questions, it might help to look at some guidelines summarized by SGS. In “The Route to ISO 9001:2015,” SGS lays out what an organization should do regarding nonconformities and summarizes the requirements of clause 10.2 this way: “When a nonconformity occurs does the organization:
React to the nonconformity and take action to control and correct it; deal with the consequences?
Evaluate the need for action to eliminate the causes of the non-conformity so that it does not recur or occur elsewhere by: reviewing and analyzing the nonconformity; determining the causes of the nonconformity; determining if similar nonconformities exist or could potentially occur?
- Implement any action needed?
- Review the effectiveness of corrective action taken?
- Update risks and opportunities determined during planning?
- Make changes to the QMS?”
In addition, SGS says, companies should ask, “Are corrective actions appropriate to the effects of the nonconformities encountered? Is documented information retained as evidence of:
- The nature of the nonconformities and any subsequent actions taken?
- The results of any corrective action”
Getting the hang of this can be difficult. If you’ve asked yourself these questions and not been happy with the answers, perhaps a change of perspective is needed.
If you’re looking for more guidance, Mark Ames described some misunderstandings related to corrective action during an ASQ webcast. He notes that common sense should play a central role in corrective actions, though it often doesn’t. He notes that it is important not to overlook the needs of the customer, needs of the organization, identified and potential risks, regulatory requirements, and the cost/benefit tradeoffs.
Ultimately, corrective actions should be a satisfying way to get something out of a problem. Knowing that you won’t have to face the same issue again—or at least that’s the idea—should be a relief. To ensure that your corrective action process is robust, ISO requires organizations to review the effectiveness of actions taken. For example, this could take the form of a meeting or just a follow-up with those involved. Continual improvement takes work, and it also takes corrective action.