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CAPA Program is a process that identifies a problem and solves it. It also determines root causes and takes corrective action to prevent them.
A CAPA Program helps businesses by enabling them to address issues immediately and prevent their recurrence in the long term. It helps integrate reactive and proactive approaches to issues and facilitates continuous improvement of the quality management program. It can also help improve the productivity and performance of the company across the board.
Issues can arise at any time, even in the most smooth operations, due to various factors - human error, supplier issues, environmental factors, and even the political climate. Therefore, businesses need to implement a Corrective Action Preventative Action program (CAPA Program) to help them address and correct problems before they become irreparable or cause further damage. A CAPA program is good for businesses for the following reasons:
Though corrective action and preventive action are spoken of together and are interrelated, they are not the same. Corrective action happens after an issue has erupted. Mitigative measures are implemented in preventive action to prevent the issue or minimize the damage.
Whenever there is a deviation from within the quality management system, CAPA helps to identify it. The four sources of information for CAPA include:
However, it must be noted that CAPA is a very intensive program and not necessary every time an issue has been reported. It is necessary to assess the issue’s intensity, frequency, and impact and see whether it needs a root cause analysis and further action. Following taking immediate action to diffuse the situation and contain the extent of the damage, the problem must be defined, and the need for CAPA assessed.
Nikki Willett, CSO/VP of Industry Solutions at ComplianceQuest, pointed out a few years ago in her article ‘It’s Raining CAPAs’…
In 2010, the Food and Drug Administration noted that insufficient corrective and preventive action procedures topped the list of most…
The CAPA plan must be fool-proof to ensure compliance while correcting a problem and prevent its future recurrence. For the…
According to the U.S. Food and Drug Administration, corrective and preventive action is to collect and analyze information, identify and investigate product and quality problems, and take corrective and preventive action to avoid recurrence. It is a component of risk management where issues are resolved, potential issues are identified, and control measures are put in place to mitigate them. A CAPA program helps with
The need to acquiesce with the applicable regulations is the most common reason and benefit of a CAPA management system. Organizations can reduce nonconformances and ensure product quality and performance by implementing a CAPA program.
Reducing nonconformances in products and processes reduces the risk of recalls and warning letters. The workplace becomes safer, and asset performance improves. This leads to lower reworks and repairs costs, and even warranty expenses can be minimized.
CAPA is implemented after understanding the root cause of the issue and is implemented for situations that warrant specific action. These actions typically address design and engineering issues, which leads to greater operational efficiency.
On implementing the CAPA program, it must be monitored constantly to ensure it meets the goals. In case of any issues, it needs to be corrected to achieve the desired outcomes. This helps with the constant improvement of the quality management system.
The concept of CAPA was initially introduced by the Food and Drug Administration in 2006 as part of the Quality Systems Guidance. This formed the basis for the ICH Guideline Q10 and has also been incorporated in the EU GMP Guide, which provides guidelines for CAPA programs for the pharmaceutical industry.
CAPA programs comprise a subsystem housed in your overall quality management system and must adhere to requirements outlined by FDA 21 CFR 820.100, ISO 9001:2015, and ISO 13485:2016.
ISO 13485 is a general quality management system standard, forming the foundation for variations such as ISO 13485, which specifically addresses the medical device industry.
Corrective Action and Preventive Action are addressed in two clauses:
8.5.2 Corrective Action The root cause of any nonconformance must be removed to prevent recurring issues. All necessary corrective actions must be taken at the earliest and should be proportionate to the impact of the nonconformance. All procedures followed must be documented. The corrective action must be monitored and tracked to ensure no adverse impact and that the objectives are achieved. The records must be maintained and easily accessible.
8.5.3 Preventive Action Identifying potential nonconformities will help organizations prevent their occurrence. This requires identifying risks and implementing controls proportionate to the effects of the possible issues. This also needs to be documented, the process verified, and the effectiveness of control measures evaluated to ensure the issue is resolved. The record of the measures taken must also be maintained and easily accessible.
FDA 21 CFR Part 820: This provides guidelines to medical device companies on manufacturing and selling products in the United States. Often, medical device companies align their practices to ISO 13485 and FDA 21 CFR Part 820.
Food and Drug Administration requires the CAPA process to be captured, reviewed, approved, controlled, and retrieved. This also requires reviewing and verifying the actions to ensure their effectiveness in meeting the objectives, and the process must be documented.
Trend analysis is an important requirement of the FDA. This requires businesses to have access to accurate, complete, and holistic data to capture trends and identify recurring issues.
Failure investigation is another important requirement for determining the root cause before a corrective action is recommended. Design controls play a crucial role in CAPA to detect nonconformities early and reduce the effort needed to correct product or process issues.
All relevant information regarding the issues and the actions taken must be shared for management review and all stakeholders on a need-to-know basis.
To know more, read : https://www.compliancequest.com/bloglet/capa-iso-13485/
To ensure the accuracy of the reports and the insights drawn, businesses need access to quality data regarding product and quality issues. The data should be holistic and include information from all acceptance activities, services, returned product records, and complaints.
CAPA must be implemented when the same problem recurs. A one-time occurrence may need some action but not root cause analysis and corrective action, preventive action, except in case of an injury. Some sources to identify the problem are nonconformance, customer feedback, testing failure, etc. This is an indication of there being a systemic issue that needs to be rectified.
The Implementation of CAPA requires a planned and strategic approach. This is enabled by the organization’s CAPA program that sets up a framework, equips employees with the relevant skills, and automates the process in case an issue is identified.
Having a CAPA program and familiarizing the team with it is essential to be effective and implemented like clockwork.
Data-Driven CAPA:
The first key element is collecting, storing, and processing data to help businesses identify existing and potential issues and trends. Automating it can help quality leaders by alerting them to potential issues. It is also essential for root cause analysis and monitoring the effectiveness of CAPA after its implementation. The CAPA workflow must be automated with integration with other enterprise software, such as ERP, CRM, and SCM, to provide a holistic view of processes.
Issue Identification:
Early detection of issues, even before they can become one by identifying potential risks, can help prevent or contain the issue’s impact. Therefore, employees must be trained to spot the issues and equipped with tools to report them.
Investigating Issue:
An issue may have an obvious trigger, but the root may spread deeper, and there may be multiple other causes for it. It is important to determine and solve the root causes for the issue to be resolved effectively. 5 Whys and Fishbone diagrams are two of the popular root cause analysis methodologies.
Planning Corrective Action:
Corrective action may require doing multiple things and involving multiple teams. Therefore, a corrective action plan must be defined, outlining the steps needed to correct the issue. These steps must also be recorded.
Assessing Risk:
Regulations require businesses to take a risk-based approach to quality management. Putting in a CAPA system facilitates this as the preventive action report generates potential risk.
Reporting:
Reporting is a critical regulatory requirement of CAPA and is facilitated by good CAPA software. A standardized template enables employees to report CAPA-related activities such as identifying complaints, describing defects, the action taken, its resolution, people involved, when it is expected to be implemented, and so on. This is also a source of insights into trends and identifies potential risks.
CAPA Process Automation:
Automating CAPA implementation will enable better communication and collaboration, tracking and monitoring progress, gathering data for further analysis, and course correction. An integrated, cloud-based solution will help all employees understand the roles and responsibilities, the implications, the changes required, and the action plan. This clarity will help improve the process of CAPA implementation and its outcomes.
Tracking and Measuring:
To ensure the CAPA program delivers as expected, it must be monitored and tracked. The impact must be communicated to the relevant teams, and any course corrections must be done in case of gaps.
Find out more about ComplianceQuest CAPA management software : https://www.compliancequest.com/capa-management-software/
Businesses must report the corrective and preventive actions taken to minimize non-conformances. The report needs to be systematic and organized, from having a unique CAPA number that will enable tracking from start to post-implementation tracking and monitoring.
The next step in reporting CAPA is to describe the issue in detail, including all relevant information such as the time and the site where the issue occurred, in which product, and who was affected.
The third step is to describe the root cause analysis undertaken to identify the core causes of the issue and the corrective and preventive actions taken to resolve the issue and prevent its recurrence.
The report must also include all relevant dates, such as when the issue was reported, when the corrective and preventive actions were taken, and the people responsible for the action.
For The Art of Effective CAPA Writing - Dos and Don’ts https://www.compliancequest.com/whitepaper/dos-and-donts-in-capa-writing/
We went live with CQ just a few weeks ago and it works great! We received excellent training and after some playing around and getting used to it we found that it is really easy to use. So far we have implemented Document and Training Management as well as CAPA and both have everything we need right out of the box. After years of cumbersome spreadsheets and databases CQ is a blessing. It makes document management quick and easy… and it’s a pleasure to use.
Helen Cary,Document Control Specialist
CAPA report has the following benefits:
The best practices for writing a CAPA report include:
A complete CAPA form should typically include:
Five Steps Corrective and Prevention Action (CAPA) Reporting Template
Checklist | July 12th, 2021
MDSAP Quality Management System (QMS) Assessment Checklist (Part 4): Nonconformity, Corrective Actions and More
Checklist | April 6th, 2022
Field Safety Corrective Action (FSCA) For Medtech Companies
Checklist | October 4th, 2021
Identification, Assessment, Investigation, Analysis, Action Plan, Implementation, and Tracking are the key stages of Corrective and Preventive Action Program.
The Corrective and Preventive Action report is initiated when a nonconformance is spotted or when there is a customer complaint. It should be written for issues that have an impact and when CAPA becomes essential.
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