by David R. Butcher
Marketing Communications, MasterControl
When an FDA investigator issues a Form 483 after inspecting your facility, the cited observations should be addressed in writing to the FDA within 15 days, even if the initial response will be preliminary. To prepare an appropriate response to the audit findings and get on the necessary path to mitigate and resolve the identified issues, you’ll want to focus on at least three key areas, according to ARC Experts President and CEO Walt Murray.
In the final installment of a three-part webinar series on FDA inspections, Murray, a consultant with more than 30 years of experience in quality management and regulatory affairs, recently explained how quality managers can successfully organize an internal response team, manage the corrective and preventive action (CAPA) process and ultimately provide a proper post-inspection FDA response.
1) Internal Organization
Define your response team’s specific responsibilities, from both a project management standpoint and an analysis standpoint. Who will be assigning tasks within the project, what will those tasks include and who will do them? You’ll need to establish a project team and project team leader, and then prepare a project plan to map out the response effort. A project plan should include what internal and external resources will be needed to complete the actions that will be taken.
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Murray recommends meeting with the resource team – typically made up of upper and middle management – which is there to ensure the appropriate criteria are being used in the decision making process. Those criteria would include the following:
- Who is involved;
- Project constraints;
- Team member constraints;
- Requirements to be applied and implemented;
- Regulatory stipulations; and
- Risks, which affect what and how much should be done.
Set expectations on the nature of the feedback, including how often feedback will occur and who will provide it. Determine what reporting will occur to give the FDA what it’s looking for, and gather that reporting in a timely manner. It can be helpful to prepare a one-page project management document, especially to meet a timeline of commitments. And of course, make sure the project plan is updated.
2) CAPA Management
Determine how you will manage the CAPA process. When opening corrective actions (or less significant correction actions), you must consider which resources to assign to which action items. It is important to understand who will manage the tasks. Developing a responsibility matrix will help clearly define and delineate responsibility and authority. These roles and responsibilities should be working the action items within either a correction, corrective or preventive action approach.
Important questions to ask and answer include the following:
- How will action items be assigned?
- Who will monitor the progress of the actions and their closure?
- Will there be one or several process owners?
Once the CAPAs are open, there must be true root cause analysis. You must think through actions that will need to be taken, in terms of cause-and-effect relationships. The actions should be coordinated in an integrated fashion and should be performed in a timely manner. Tasks should be assigned in a format that allows an active tracking mechanism and should tie into the original CAPA. Determine whether preventive actions are needed as a result of corrective actions being taken.
Ensure that all appropriate action items in each CAPA are completed and that only the appropriate people are reviewing and signing off on proposed FDA reports.
3) Proper Reporting
Internal reporting and management reporting are crucial to keeping CAPA owners, project leaders and management all in the loop. During the CAPA process, management should be given a secondary level of reporting beyond the project management level of continuous reporting. Reports for management review should be concise and occur at appropriate times during the project.
Providing updates to the FDA is not required but is strongly encouraged. As you respond aggressively to 483s with corrective actions, Murray recommends regularly providing the FDA with information about reporting and supporting documentation that could mitigate any further action from the FDA District Office. It is imperative that the FDA be aware of "timely actions, the nature of the information to be provided and how it will satisfy the infraction,” Murray says. Management must determine the information to provide to the FDA.
Generally, the content of the reporting to the FDA depends on a number of elements, including:
- How often the reporting will be done;
- What type of report format will be used;
- Whether you’re expecting an additional FDA warning letter;
- The risks relative to understanding the reporting mechanism; and
- Who should be signing off on the report.
It’s important that you keep the timelines promised to the FDA. Murray advises giving explanation of action items that may be taken beyond the schedule, but keeping the timeline for the reporting on that item.
Ultimately, providing proper responses to FDA findings requires establishing good project management, critical-thinking skills and showing the use of your system in addressing issues.
“Make sure your CAPA process as it relates to the inter-relationship of non-conforming conditions, deviations, suppliers, audits, etc. – make sure all of these things are interconnected and you can show how they work effectively together,” Murray says. “Overall, ensure the FDA gets a sense that you truly have integrated processes in a systematic approach.”
To delve deeper into what to expect when preparing and providing a post-inspection FDA response, watch the complimentary webinar Working on a Post-Inspection FDA Response.
David Butcher has been writing about business and technology trends in the industrial B2B space for more than a decade. Currently a marketing communications specialist at MasterControl, he previously served as editor of ThomasNet News’ Industry Market Trends and as assistant editor for Technology Marketing Corp.’s Customer Interaction Solutions. He holds a bachelor’s degree in journalism from the State University of New York, Purchase.