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.
Corrective action is a measure implemented to address a gap in performance, compliance, or process effectiveness. It involves identifying and correcting the root cause of an issue to prevent its recurrence. Corrective actions are commonly used in various fields such as quality management, safety protocols, regulatory compliance, and process improvement.
A corrective action plan is a documented strategy that outlines steps to address issues and gaps in business operations. Typically used in quality management, it helps identify and resolve processes that could negatively impact the business and interfere with reaching company goals. The corrective action plan should be S.M.A.R.T. (Specific, Measurable, Attainable, Relevant, Timebound) and include timeframes, costs, and signatories.
A corrective action plan is a documented, S.M.A.R.T. strategy designed to identify, resolve, and prevent issues in business operations, focusing on root causes to ensure problems do not recur.
Corrective actions aim to improve performance, compliance, safety, and operational efficiency while enhancing employee engagement and customer satisfaction.
The implementation process includes determining the need, conducting root cause analysis, team planning, communication, and follow-up reviews to ensure effectiveness, aligned with ISO 9001:2015 standards.
Corrective action is a structured approach designed to identify, resolve, and prevent issues within an organization, ultimately aiming to improve performance, safety, and compliance. Its importance spans several key areas:
Performance and Behavior Improvement: Corrective action helps set clear standards for employees, providing guidance and warning of consequences for noncompliance, but its primary goal is to facilitate improvement rather than punish.
Problem Resolution and Prevention: By focusing on root causes rather than symptoms, corrective actions ensure that problems are addressed effectively and do not recur. This leads to lasting solutions and continuous improvement in business processes and outcomes.
Operational Efficiency: Corrective actions streamline processes by eliminating unnecessary steps and optimizing resources, which results in cost savings and increased productivity.
Compliance and Risk Management: Implementing corrective actions helps organizations meet regulatory requirements and mitigate risks, protecting the company from legal penalties and reputational damage.
Employee Engagement and Safety: Addressing issues promptly demonstrates a commitment to employee well-being, which boosts morale and engagement. In safety-sensitive environments, corrective actions are critical for identifying and mitigating hazards, fostering a culture of safety and continuous improvement.
Customer Satisfaction and Trust: Systematic problem-solving through corrective actions improves product and service quality, leading to higher customer satisfaction and trust in the brand.
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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:
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. Collaborate with your team in determining the root cause and the elements that need to be considered when developing the corrective action plan and implementing corrective action management, 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:
What should be done to correct the issue?
Who should be responsible for implementing these corrective actions?
When and how often should the corrective actions be carried out?
Where should the corrective action documentation take place?
How can we make sure that these corrective actions prevent recurrence?
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.
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, Corrective Action Request, and 8D Report
Here’s an example of corrective action (following the 4Ws and 2Hs).
Briefly describe the problem |
Reports of IV line errors have risen by 7% since the previous quarter. |
What will be done? (Action steps, description) |
In-house seminars will be held to retrain hospital personnel on safe and proper preparation of IV lines, pre-insertion guidelines, labelling of IV lines, placement, monitoring, as well as complete and proper documentation. |
Why will it be done? (Justification, reason) |
The seminars will serve to clarify SOPs regarding the preparation, utility, and monitoring of IV lines. It is also intended to reinforce our standards to improve safety and lower rates of preventable errors. |
Where will it be done? (Location, area) |
Providence Conference Room |
When will it be done? (Time, dates, deadlines) |
7 seminars will be held for 30 minutes each to cover all shifts and personnel without adversely affecting staffing: July 19 July 20 |
Who will do it? (Who’s responsible?) |
Doctor Barnes for July 19 (9am,11am,3pm) |
How will it be done? (Method, process) |
Doctor Barnes, Doctor Sparrow, and Doctor Maye will convene and create a 30-minute presentation on the proper proper preparation of IV lines, pre-insertion guidelines, labelling of IV lines, placement, and monitoring to be presented at intervals stated above. |
How much? (What will it cost to do/make?) |
No extra expenses. |
Here are a few other corrective action examples that specifically deals with workplace safety and business security:
Providing equipment upgrades
Implementing safety training
Conducting regular and random safety audits
Updating work processes
Revisiting safety protocols and guidelines
Based on the given corrective action examples, here are some tips on how to create corrective action reports and the most basic information that should be captured by the reports:
Determine and record the issue or non-conformance that prompted the need for corrective action.
Taking pointers from creating a corrective action plan, capture the details of the corrective action to be taken to rectify the non-conformance.
Submit the corrective action report to the intended recipients and keep a record for future reference and follow through.
While both intend to address non-conformance, there are some differences between corrective and preventive action.
Corrective Action | Preventive Action |
Considered the “reactive” way of addressing non-conformance | “Proactive” way of addressing non-conformance |
Corrects a non-conformance that already happened | Aims to keep a non-conformance from happening in the first place |
Both corrective action and preventive action intend to avoid the re/occurrence of non-conformance |
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 Mitti (by SafetyCulture) to manage their implementation — from root-cause analysis to review of effectiveness of corrective action plans.
Mitti (by SafetyCulture) is an effective tool for implementing corrective actions. Conduct paperless and discreet observation checks using digital checklists on any device. Capture photo evidence of classroom settings and teaching practices to document issues and improvements. All observation data is securely stored in the cloud, with instant reports that can be shared with relevant stakeholders to support timely corrective action and ongoing compliance.
Customize effortlessly: Tailor templates with specific needs by incorporating custom logic into digital checklists
Empower your team: Invite your team members to utilize and explore the platform, enabling them to experience its capabilities
Never miss an audit: Schedule inspections that notify all relevant personnel to ensure that no check-ins are overlooked
Keep everyone informed: Generate comprehensive reports that are easily shareable with leaders, team members, and other relevant stakeholders
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