Learn about the meaning of corrective action, how to create a corrective action plan, and demonstrate a corrective action process that conforms with quality standards.
Published February 1st, 2021
Corrective action is a specific set of steps used in quality management to eliminate process discrepancies and prevent root cause recurrence. Corrective actions in the workplace usually mean systematic changes performed by assigned personnel to address work-related issues and improve business operations.
A corrective action plan is a detailed document that records exactly what should be done and what was actually done to rectify any non-conformance. It should be S.M.A.R.T. (Specific, Measurable, Attainable, Relevant, Timebound) and includes timeframes, costs, and signatories. Corrective action plans should be used when identified problems could negatively impact the quality management system (QMS) of an organization.
A corrective action plan is important because it serves as a proper documentation of the corrective actions an organization has taken. By developing a corrective action plan, quality managers, site supervisors, and team leaders can make sure that corrective actions are carried out and monitored effectively.
Creating a corrective action plan can seem to be a daunting task at first, and the persons responsible could benefit from ideas about where to begin. Generally, there are 3 different ways you and your team can try to start developing a corrective action plan:
One of the quickest ways to help you get started with your corrective action plan is by using a template. A corrective action plan template is a useful tool that enables teams to easily document a course of action for a non-conformity. Take note that utilizing a template can jumpstart the creation of a corrective action plan, and it still needs to be finalized and reviewed.
Another approach that can help you continue developing a corrective action plan is to go through corrective action identification activities. Training your teams to be able to correctly identify the need for a corrective action is a worthwhile endeavor that sets them up for success.
Here is a sample scenario from a US-based university research: “There has been a number of consent form irregularities seen with the study, including the use of incorrect versions and not re‐consenting with the updated version.” Collaborate with your team in determining the root cause and the elements that need to be considered when developing the corrective action plan, among other things.
Following the 4 Ws and 2Hs format can be helpful in crafting a more comprehensive corrective action plan. Consider asking these sample questions to facilitate a planning session with your team:
While corrective actions come in many forms, they usually reflect in a Corrective and Preventive Action Report Form and a Corrective Action Request Form. Here are a couple of examples of the two most common types of corrective actions:
Corrective Action Examples: Corrective and Preventive Action Report and Corrective Action Request
Corrective actions are implemented to identify, resolve, and prevent issues of quality non-conformity. In prior ISO 9001 standards, Corrective and Preventive Actions (also known as CAPA) were separate action plans that each had their own requirements. Summarized in a CAPA Report, they outline the plans on how to fix the existing problem immediately and how to prevent it in the future.
However, the latest ISO 9001 standards (ISO 9001:2015 Clause 10.2) eliminated the need for predefined procedures for preventive actions. Instead, it emphasized the importance of having a risk-based approach throughout the process, rather than “preventive actions” being done and documented separately.
In this simplified guide for quality managers, we present 5 steps on how to implement corrective actions that are compliant with ISO 9001:2015, with the help of a compliance software.
Not every issue warrants a corrective action. The purpose of issuing a corrective action plan is to identify and resolve problems that are systemic, something that endangers a company’s Quality Management System software.
Quality managers and their teams can choose an appropriate risk analysis technique to determine the severity of a non-conformity and decide if a corrective action is needed. The most frequently used approaches are FMEA and HAZOP. This is a good way to inculcate risk management right at the start of the process and help qualify the level of risk and impact an issue brings to the organization, product, and/or services.
Once a corrective action is deemed necessary, the quality team and process owners can collaborate and use an ISO 9001:2015 – compliant corrective action report template to document their plan’s progress.
Root-cause analysis (RCA) is a methodical approach in analyzing a problem and identifying the root causes to solve counterproductive issues or events. It is based on the belief that issues are best solved by eliminating the root cause/s, as opposed to merely addressing the apparent symptom. RCA is best used for issues that cannot be resolved quickly, are repetitive, and systemic.
ISO 9001:2015 highly recommends engaging cross-functional team members and leaders throughout the planning of corrective actions. Quality teams can encourage this by using a compliance software to facilitate collaboration, even when they’re in different locations.
The 5 Whys and/or 8 Disciplines of Problem-Solving (8D) approaches are good root-cause analysis techniques that can help them work together on crafting a good problem statement, identifying the root cause/s, and brainstorming on appropriate solutions to address non-conformance.
Identifying the root causes and their effect can help formulate the most appropriate corrective action/s. In a corrective action plan, there are two key actions: a “correction” recommendation to immediately eliminate a detected non-conformity and the corrective action itself.
Apart from the details about the non-conformity and the recommended corrective action, specific details should also be provided, such as implementation timeline, key people and signatories, and costs. Once finalized and reviewed, the digital corrective action plan can be shared to key people to standardize information.
Enhance leadership involvement and encourage them to communicate the change and the rationale behind it. Notify key people via the QMS software about their assigned tasks. Provide a communication channel where anyone can give regular feedback while the corrective action is being implemented. These all factor in and determine the success of a corrective action plan’s implementation.
IS0 9001:2015 requires organizations to review the effectiveness of corrective actions and update risk levels and possible opportunities. After the implementation, the process owners and quality team should wait a suitable amount of time and conduct follow-up reviews.
Additional fields in the digital corrective action plan are available so quality managers can input comments during the review. To document results, they can use QMS software features, such as attaching photos and notes, to provide clearer evidence on the effects of the implemented corrective action.
To implement corrective action plans that are compliant with ISO 9001:2015, quality managers can use a collaborative compliance software like iAuditor by SafetyCulture to manage their implementation — from root-cause analysis to review of effectiveness of corrective action plans.
Keeping track of corrective actions can be challenging and time-consuming, especially when paperwork can either easily get lost or hidden in filing cabinets. Try using the iAuditor corrective action software to help implement, document, and monitor risk-based corrective actions.
Corrective Action Software: Monitoring Corrective Actions using iAuditor
One look into iAuditor’s actions analytics, you can view to do, in progress, completed, and even can’t do actions efficiently. Date ranges are easily customizable, so you can look back and track your progress with ease. Corrective actions can also be viewed according to priority level and more. Strengthen your quality management system today—Book a demo or Sign-up for free!
Use this risk-based Corrective Action Report template to document plans on how to eliminate non-conformities and its root cause/s.
Failure Modes and Effects Analysis is a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service.
A HAZOP is a sequenced and methodical study of a process that seeks to identify problems that may represent risks to personnel or equipment.
Use this 5 whys template to resolve the root cause of a problem so that your business teams can avoid encountering them again.
This template is used to document a comprehensive root-cause analysis based on the 8 Disciplines of Problem-Solving, previously known as the Team-Oriented Problem-Solving.
Use and customize this template to check your organization’s Quality Management System compliance to ISO 9001:2015 standards.
SafetyCulture Staff Writer
Dirk is a contributing writer for SafetyCulture who has 3+ years of experience being a Safety Officer in an international airline. Over the course of his tenure, he worked on projects involving training management, ramp safety inspections, quality & safety certification audits, and safety promotion programs. Further, he is interested in maximizing the power of technology to help make the world a better place.
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