Why audit CAPA
One of my favourite professional activities has always been preventing or resolving problems and learning from them. I’ve also noticed that it’s something that organizations frequently struggle with.
CAPA (Corrective and Preventive Action) is essential to quality and food safety. However, more than simply implementing a CAPA procedure is required. Organizations must ensure that their CAPA process achieves its objectives effectively and efficiently. One method is to audit the CAPA process regularly.
Organizations benefit from CAPA audits in several ways. It allows them to identify areas where the process isn’t working correctly and make the necessary changes. It ensures the organization’s CAPA process complies with all applicable standards and regulations. It assists organizations in determining the effectiveness of their CAPA process and, last but not least, promotes organizational improvement.
What to audit in CAPA
Here are seven key areas to address, but this is by no means an exhaustive list:
1. The CAPA system must be clearly defined and documented. As a result, the audit should evaluate the system’s documentation, tracking, and reporting capabilities.
2. As a critical component of CAPA, the audit should assess the strength of the RCA (Root Cause Analysis) process, including the tools and methodologies used.
3. The audit should examine the monitoring and verification activities.
4. The audit should evaluate the effectiveness of corrective and preventive actions. The actions should be appropriate to address the problem’s root cause and prevent future occurrences.
5. The audit should determine the adequacy and completeness of CAPA documentation. All necessary information about the issue, RCA, and corrective and preventive actions should be included in the documentation.
6. The audit should review the CAPA training provided to employees. All employees involved in the CAPA process should receive training on their respective roles and responsibilities.
7. The audit should evaluate whether or not the organization is learning from CAPA’s implementation. Learning from successes and failures is critical.
The most common pitfalls in CAPA auditing
When auditing CAPA, organizations should be aware of some potential pitfalls. One of the most common pitfalls of CAPA auditing is its limited audit scope. If the audit does not cover all aspects of the CAPA process, such as root cause analysis and effectiveness verification, it may not provide a complete picture.
A second point to consider is the auditor’s competence. If the auditor performing the CAPA audit is unfamiliar with the CAPA process, they may be unable to identify all problems or may overlook critical ones. Audits may thus be ineffective or incomplete as a result.
Finally, one of the primary goals of CAPA auditing is to ensure that corrective actions are effective. The audit goal is not achieved if the auditor does not verify the effectiveness of corrective actions.
The link to Culture
Auditing CAPA is essential to maintaining a quality and food safety culture. Organizations can demonstrate their commitment to continuous improvement while promoting transparency, accountability, and team member engagement by ensuring that corrective and preventive actions are practical and implemented promptly.
Auditing culture is not an easy task. The auditors are expected to gather hard evidence to drive a conclusion on a soft topic. But it is possible. The management of some essential programs like CAPA will provide many helpful hints in determining the maturity of the operation. Here are some questions to be answered:
• Who is in charge of running the CAPA program?
• How do they define and hold themselves accountable?
• Is the organization encouraging a culture of learning from mistakes and sharing them with a broader audience?
• What methods are used to identify, discuss, and address risks and root causes?
There is much value in auditing CAPA
Auditors should dedicate enough time to it and prepare well to perform an in-depth assessment.
It is worth the investment.
By Marc Cwikowski
April 24, 2023