When something goes wrong in your process or product, simply fixing the issue on the surface might not be enough to prevent it from happening again. This is why corrective actions are important–they go beyond quick fixes and tackle the root cause of an issue.
Read on for a practical guide to corrective actions–what they are, the steps for implementing them, and an example plan so you’ll be able to apply them to your own organization. By making corrective actions a key part of your workflow, you can promote continuous improvement, putting you on the path to long-term success.
What is corrective action?
Corrective action is an aspect of quality management where you correct a task, process, product, or even an individual’s behavior when any of these factors produce errors or deviate from the original plan. It’s meant to fix issues that have already happened so they won’t repeat in the future.
It usually follows a structured process where you identify the issue, analyze the root cause, implement a solution, then monitor the results so they last over the long-term.
You’ll find corrective actions used more frequently in pharmaceuticals, medical devices, and food products. However, they are also used in other areas of manufacturing.
Under the latest ISO 9001:2015 standards, companies are advised to combine corrective actions with preventive actions, where you also aim to prevent problems from happening. These standards emphasize the importance of a risk-based approach throughout the process, leading to CAPA (Corrective and Preventive Action) reports.
How the corrective action process works
Here are five steps for implementing corrective actions that comply with ISO 9001:2015:
1. Determine whether the situation requires corrective action
Not every problem justifies corrective action. The purpose of a corrective action report is to identify and resolve problems that threaten a company’s QMS. Quality managers and their teams select an appropriate risk analysis technique to determine the severity of a QM non-conformity and decide whether corrective action is required. The most commonly used approaches are FMEA and HAZOP.
It is a good way to initiate risk management at the very beginning of the process. The level of risk and the impact that a problem will have on the organization, product or services are determined. Once a corrective action is deemed necessary, the quality team and process owners can work together and use an ISO 9001:2015 compliant corrective action report template to document the progress of their plan.
2. Conduct a root cause analysis
Root cause analysis is a methodical approach to identify the cause of systematic problems and to solve them. It is based on the assumption that problems are best solved by removing the root causes rather than just treating the apparent symptom. Root cause analysis is best used for problems that cannot be solved quickly, are repetitive and systematic.
ISO 9001:2015 strongly recommends that cross-functional team members and leaders be involved throughout the planning of corrective actions. Quality teams can promote this by using software to facilitate collaboration, even if they are located in different locations.
The 5 Why method and 8 Disciplines of Problem Solving (8D) are good techniques for root cause analysis. They help to jointly develop a good problem statement, identify the causes, and brainstorm on appropriate solutions to the problems to be solved.
3. Work as a team on the corrective action plan
Identifying causes and their effects helps to formulate the most appropriate corrective measures. A corrective action plan always includes two main actions: a “corrective” recommendation, the nonconformity identified, and the corrective action.
In addition to the non-compliance and the recommended corrective action, specific details should be provided, such as the implementation schedule, key persons, signatories, and costs. Once the plan for corrective action has been completed and reviewed, it can be distributed to key people to standardize the information.
4. Communicate and implement corrective actions
Increased commitment of managers helps to communicate the change and the reasons for implementing the corrective actions correctly. Notify key people about the QMS software and the assigned tasks. Provide a communication channel through which everyone can provide regular feedback during its implementation. All these factors are crucial to the plan’s success.
5. Carry out follow-up actions to ensure the effectiveness of the corrective action
IS0 9001:2015 insists that companies review the effectiveness of their corrective actions and update the level of risk and potential opportunities. After installation, process owners and the quality team should wait an appropriate period of time and perform follow-up audits.
Additional areas in the digital corrective action plan as a template are available to allow quality managers to enter comments during the review. Various functions of the QMS software can be used to document the results, such as attaching photos and notes to more clearly demonstrate the impact of the implemented corrective actions.
Example of a corrective action plan
To give you a better idea of how the corrective action process works, here’s a sample of a corrective action plan. If you need more help writing, try out our sample corrective action plan template for free.
Description of the problem: A pharmacist accidentally issued the incorrect medication with a similar sounding name to the wrong patient.
What actions will be taken to correct the problem? All pharmacist employees will receive additional supplemental training on how to prevent pharmaceutical errors that put patients at risk. This training will cover how to eradicate sound-alike errors in addition to providing strategies to combat other common pharmaceutical mistakes such as mislabeling, the dispensation of expired drugs, errors in compounding, etc.
Location where corrective action will take place: The training will take place in the staff lounge.
When will the correction take place? The training will take place on the third of October, 2019 at 3:30 pm.
Who will carry out the corrective action? Dr. David Jones.
How will the corrective action be implemented? Dr. David Jones will present a PowerPoint covering the prescribed training material. This remedial course will aim to requalify the pharmacist in their daily duties and tasks.
It’s important to note that some situations require more than one corrective action to be put in place to resolve the problem. Remember to start by answering the five Ws (who, what, where, why, when) to frame your corrective actions. In the end, you should have successfully completed a corrective action report.
To get you started, you can download these corrective action templates and adapt them to your workflow.
Reasons for corrective actions
The corrective action request process involves clear identification of a problem and thorough documentation of resources and steps to alleviate symptoms. However, the main goal is to find and resolve the root cause of the problem. Ideally, corrective action requests are made only for critical and recurring problems:
- Contractual nonconformances – Ensure that the communicated and expected deliverables have been provided. These can be tracked through the contractually established guidelines.
- Deficiencies in the first article – The first article should meet the design requirements and its functionality.
- Overall poor performance – Delivery delays or other problems occur, or the supplier demonstrates poor service in the fulfillment process.
- Health and safety hazards – When problems occur that endanger the health or safety of customers and the general public.
- Customer requests – In circumstances where a customer requests a change in form, fit, and function.
In a request for corrective action, outline the problem statement and its implications. Recommend completion of a factory acceptance test by the supplier to immediately correct the nonconformance and avoid costly production delays.
Making corrective action request forms
Requests for corrective action can seem bureaucratic and lengthy, but they offer numerous benefits:
- Corrective action request forms help with problem resolution.
- The corrective action request form assists in detailing the steps to be taken to resolve a particular issue.
- The request process brings transparency to corporate activities and strengthens the team and action relationships.
- Insights can be gained for future events and developments.
The downside of a corrective action request can be poor implementation. Then, corrective actions can become a bureaucratic burden when requests are made for even minor incidents. They also run the risk of focusing on the symptoms rather than the cause. Employees should be made aware of these pitfalls in order to get the most out of employing corrective action requests as a part of their job responsibilities.
Use an app and software for corrective action requests
Lumiform is a powerful app and desktop software that helps quality managers of both parties take immediate action to eliminate the cause of nonconformity. Also, it can help mitigate risks of product recalls and properly document corrective actions for ISO certification or compliance.
With Lumiform’s mobile app, you can easily submit corrective action requests via tablet or smartphone – online or offline. With the desktop software, you are able to track the progress of your corrective action request. This significantly reduces the risk of lost quality, documentation errors, and reputational damage. With Lumiform, quality managers can:
- Convert individual paper lists into digital corrective action request forms within minutes using the flexible form builder.
- Lumiform offers a variety of templates for a quick and secure digital start.
- Using the super intuitive mobile app, team applications are a breeze to complete and saves time.
- Bundle all test corrective action requests automatically in one report and send them immediately.
- Gain insights for future events and developments through extensive analysis.