Quality management systems are built on the premise of continuous improvement. Corrective and preventive action (CAPA) programs are part of improvement efforts, along with auditing, data analysis and reviews. Even though many companies lump corrective and preventive action systems together, these entities are meant to address problems at different stages for effective quality management.
Namely, corrective actions address problems that have already occurred; while preventive actions are designed to prevent problems. Although the focus is different, both actions are necessary and hold plenty of value such that problems or potential problems are identified, investigated and resolved.
Reactive Problem Solving with Corrective Actions
Corrective action programs provide an organized way to problem solving. The end goal is to fix an issue so that it doesn’t come back. In quality systems, the mainstay of corrective actions is a root cause analysis, a method for getting to the real reason for a non-conformance or deviance from a standard mode of operation. Once the root cause is pinpointed, timely actions are taken to prevent the problem from happening again with adequate follow-up and solution verification.
The need for a corrective action is typically identified through inspections, audits, process failures or employee input. However, the deal is that the problem has already occurred, and the response is reactionary.
Proactive Problem Solving with Preventive Actions
On the other hand, preventive actions are implemented prior to the occurrence of a non-conformance or deviance. Preventive action programs are proactive tools tied to quality system elements that involve monitoring and assessing system and process effectiveness. Being proactive means staying on top of process inputs, outputs, and other data that signal trends and abnormalities and acting on them before they become issues.
Organizations typically identify preventive action opportunities during management reviews or other meetings where quality or quality system data is reviewed for would-be problems. Sometimes, changes in contractual or regulatory requirements dictate the need for preventive actions. Once potential issues are identified, preventive actions can be determined, implemented and evaluated for effectiveness.
CAPA Illustrations
The examples below further illustrate the difference between corrective and preventive actions.
Corrective Action
A quality technician is routinely checking base plates pulled from a final assembly area for inspection. She discovers that the plates have an off center locating hole. This means that parts will not seat properly, affecting the quality of final product assemblies. The problem has already occurred, but a full investigation is needed to determine why. The technician promptly submits a corrective action request and then segregates defective parts to prevent use. The following day, a cross-sectional team works to find the root cause of the problem and viable solutions that will make certain quality parts are made in future production runs. In this scenario, an existing problem was detected, and corrective actions were initiated to resolve it.
Preventive Action
In a management review meeting, the quality manager presents evidence of an adverse trend taking place regarding the valuation of customer service. The information came by way of customer responses to satisfaction surveys and focus group meetings. In order to head off a potential problem, the management team assigns responsible parties to investigate causes for the downward trend and implement actions that will turn things around. The team analyzes the data using statistical methods and identifies the reason behind the slide in consumer confidence. A customer service problem was averted due to the launch of successful preventive actions.
Documenting the Difference
Most CAPA software systems require a documented procedure for how organizations choose to deal with corrective and preventive actions. One way to keep these actions focused as intended is to create separate procedures for problem solving (corrective action) and problem prevention (preventive action).
For corrective action programs, be sure documented procedures spell out:
- How non-conformances within the quality system are identified
- How corrective actions are initiated
- Acceptable methods for discovering root causes
- How to determine and implement solutions
- How to follow-up and evaluate solution effectiveness
- How to document and record corrective actions from start to finish
For preventive action programs, the procedures are similar, but also make sure the documentation includes guidance on:
- How to identify potential nonconformities and trends within the quality system using available data
- How and when to take action to prevent a problem or non-conformance from developing
- How to document and record preventive actions and solution follow-up
Managing CAPA Changes
Whether corrective or preventive actions are taken, it is important to remember that implemented actions can cause established systems and procedures to change. This may mean changes to operational procedures, work instructions, employee training protocols or any other impacted quality system elements. Careful change management is needed to effectively integrate and get the word out about newly required or modified practices.
Well-designed quality management systems continually improve over time with effective corrective and preventive action programs. Even though corrective actions are reactive, and preventive actions are proactive, both are valuable to continuous improvement. Organizations can realize a decrease in issues like product defects, customer complaints, customer returns or product recalls when high functioning corrective and preventive action systems are deployed and maintained.