When Quality Matters – CAPA Is More Than Just Compliance

By Michael Curran-Hays, Kepner-Tregoe

The leaders of successful companies know that quality management isn’t just doing the bare-minimum to comply with government regulations. Quality is the key to competitive advantage, profitability and customer satisfaction – the foundation of a successful business. Organizations that enhance their company culture with product and process quality also find their employees are happier, more productive and take pride in their work, leading to higher employee retention rates, fewer sick-days and greater levels of employee innovation.

CAPA – a balanced approach to quality

In the health-sciences industry, there is a quality tool called CAPAs, an acronym for “Corrective And Preventative Actions.” Outside the health-sciences industry, this term isn’t as well-known, but most industries have a similar concept that is part of their overall quality-management and/or problem-management processes. When an issue is encountered, CAPA provides two sets of responses – a corrective action to alleviate the immediate impact and a preventative action to reduce the risk of the issue happening again. By capturing and tracking both of these actions, a company can have greater confidence the issue is resolved completely.

In some industries, such as pharmaceuticals, government regulators require companies to have a structured set of processes for managing issues that could impact patient health and safety. That’s a good requirement, because if a company’s products are unsafe, then it is in consumers’ best interest the company does a thorough job of both correcting the problem and ensuring it doesn’t happen again. What about other industries where quality problems aren’t “life-or-death” situations or problems with services, systems, processes, etc. and other products don’t face the scrutiny of government regulation?

Achieving sustainable results

While it might seem that business leaders are only focused on the current quarterly financial performance or stock price (which is often the focus of the media), creating sustainable results is actually the challenge for company leaders. Competitive advantage, financial performance, profitability and employee retention aren’t short-term issues. Companies must find a way to sustain results during an extended period to be successful. Quality-management processes and tools, such as CAPA, can help a company sustain results by balancing near-term business continuity with long-term business success.

Consider a company in a service industry (perhaps, a call-center business) – customer support surveys, online reviews and issue escalations all provide management with indicators about the quality of service being provided and the company’s effectiveness serving customers’ needs. While a poor service experience isn’t likely to lead to death or injury, and government regulators aren’t likely to impose a fine for non-compliance, these issues do impact the future performance of the company. Dissatisfied customers can lead to the loss of future revenue, damage the company’s reputation or require costly remediation activities (to make the customer happy). Many of these impacts can be avoided by using CAPAs as part of the quality-management process.

Recognizing the root cause of the issue

The individual issue or service interaction is likely to reveal symptoms of underlying problems with processes, training, product quality, marketing expectations, etc. By capturing the issues and analyzing their root cause, companies can determine a means not just to address the single, isolated incident (making this customer happy), but also to fix the underlying problem, so it doesn’t impact other customers during the future. The reason CAPA is such a good technique for these situations is because just addressing the short-term issue (the corrective action) won’t solve the problem, it will just hide or make it easy to disregard the symptom. Likewise, failing to address the immediate impacts and telling the customer it will be resolved during the future (the preventative action) will only leave the customer more agitated and dissatisfied. A successful outcome requires addressing both the Corrective and Preventative actions.

Sustainable company performance starts with a culture of quality. Identifying which processes and techniques support and resolve issues quickly and completely when they occur. CAPAs can be a powerful tool in your quality tool box, not just to address regulatory-compliance issues, but also any other issue where quality matters to your company.

Read more about CAPAs (Corrective and Preventative Action)

Corrective and Preventative Actions Are Evolving: CAPAs for Continuous Improvement

Don’t wait for big trouble to review your CAPA process!

The impact of culture on CAPA effectiveness

Interested to find out about our CAPA workshop? Learn more….


Companies large and small use problem-solving processes from Kepner-Tregoe every day to help their staff members address all kinds of issues – from small tactical service requests to large-scale major incidents. Companies that use KT process understand its’ primary purpose is to help your employees do their jobs as effectively and efficiently as possible. When the process just works, your staff can focus on the business problems at hand.

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