What Are Corrective Action Request Forms?
A corrective action request is used to formally notify suppliers to request corrective action on a defective process or service. Corrective action is an aspect of quality management to correct a task, process, product, or even an individual’s behavior when any of these factors produce errors or deviate from the original plan.
Corrective action request forms can be viewed as improving relationships with a supplier to eliminate undesirable effects. Corrective action may apply to an entire contract if the results from materials and services deviate from the desired yield.
Corrective and preventive actions (CAPA) and ISO 9001:2015 used to be separate action plans each with its own requirements. Combined with a CAPA report, they outline the plans for how the existing problem can be solved immediately and how it can be avoided in the future. However, the latest ISO 9001:2015 standards make pre-defined procedures for preventive measures superfluous. Instead, they emphasize the importance of a risk-based approach throughout the process, rather than “preventive measures” being carried out and documented separately.
Corrective action and preventive action (CAPA) requests are used more frequently in pharmaceuticals, medical devices, and food products. However, they are also used in other areas of manufacturing.
In this Quality Manager’s Guide we describe in 5 steps how corrective actions that comply with ISO 9001:2015 can be implemented using compliance software.
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1. Step: 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. Step: 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. Step: Work as a Team on the Corrective Action Plan Using a Template
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 digital plan for corrective action has been completed and reviewed, it can be distributed to key people to standardize the information.
4. Step: Communication and Implementation of 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. Step: Carry Out Follow-up Actions to Ensure the Effectiveness of the Corrective Actionn
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.
5 Reasons for Corrective Action Requests
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.
The Benefits of 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 & 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.