Your CAPA process is the most important process in your Quality System for two reasons. First, CAPA is the tool you use to fix quality problems. Second, your CAPA process is guaranteed to be an area of interest for your next FDA inspector.
If CAPA is so important, why do companies still have inefficient CAPA processes?
When auditors review a CAPA process, some start by reading the procedure. When the FDA writes a 483 observation about CAPA processes, the wording begins with “Procedures for corrective and preventive action have not been adequately established. Specifically…”. The approach of auditors and inspectors seems to suggest that your procedure is the key to an effective CAPA process, but your procedures are not the reason for the success or failure of processes.
Processes are effective when the management of the processes is effective. If a CAPA falls behind schedule, writing a justification for an extension is a process “solution.” A natural solution is managing the process better. Management needs to monitor the progress of CAPAs regularly, prioritize resources to ensure that CAPAs are completed on time, and make decisions on which actions should be taken to prevent the recurrence of quality problems. Therefore, you need to spend more time developing a method of managing CAPAs than you spend developing the CAPA process itself.
What is an A3 Report?
An A3 report is a tool that is ideally suited for managing CAPAs. “A3” refers to the size of the paper used (i.e., – approximately 11”x17”). An A3 report is a one-sided, single piece of paper used to build consensus among company management when making an important decision. The initial draft of the A3 report is distributed to each affected department to ensure that all possible inputs to a quality problem are received. By encouraging 360-degree feedback for a proposed solution to a quality problem, you will ensure that the CAPA you develop addresses the issue altogether.
In addition to encouraging 360-degree feedback, an A3 report includes an analysis of the problem, identification of the cause, proposed actions that require management decision, a section for documenting actions taken, and a follow-up section for management to review at specific milestones during the implementation plan. Including all of this information in one-page forces CAPA owners to summarize information for management, and the standardized format makes it easier for managers to locate the information they want.
Here’s how these sections would be used for managing CAPAs.
Analysis of the Problem
This section is identical to the section of a traditional CAPA record, where the investigation of the problem is documented. This is where tools such as 5 Why analysis, Pareto charts, and Fishbone Diagrams would be used to illustrate the analysis of the problem. This section may change a great deal during the 360-degree review of the A3 report.
Root Cause or Potential Cause
In this section, there should be a concise statement of the root cause for corrective action plans or the potential cause(s) for preventive action plans. During the initial review of the A3 report, management may ask the person or team assigned to the CAPA to investigate the problem in greater depth or investigate other possible sources of information if the analysis appears to be inadequate. Management should also ensure that the causes are within the company’s control to correct or prevent. Identifying a cause that is outside the company’s control is just placing blame.
Proposed Actions
This section is similar to a typical CAPA plan, but the section includes the reason(s) why the proposed actions are recommended. The reasons why actions are proposed are important during the process of management reviewing the initial A3 report and approving the recommended actions. The best practice is to phrase the reasons in terms of quantitative results that will be achieved because this will provide a framework for metrics during follow-up by management.
Actions Taken
This section of the A3 report is updated throughout the implementation of the project. By comparing this section with proposed actions, management can monitor the status of each task included in the CAPA plan.
Follow-up
This section of the A3 report identifies how management will monitor the implementation of actions and when. The initial A3 report identifies what management will be monitoring, how it will be monitored, and at what milestones. Ideally, the monitoring includes quantitative metrics demonstrating the CAPA’s effectiveness. During the implementation of the CAPA plan, actual metrics will be recorded in this section, and any adjustments that management makes are recorded here.
If you want to learn more about A3 reports, you can learn more from Daniel Matthews at http://bit.ly/A3Workbook.
You can also learn more about improving your CAPA process by attending one of the workshops on CAPA: September 9 in Orlando or October 3 in San Diego. Each workshop is one day, and early bird pricing is $249 per day if you register before August 1.