Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions
Congratulations! You’re being audited by the FDA! If you’re doing business within the United States, you may find your organization faced with an unannounced FDA audit. But unannounced doesn’t mean that you need to be unprepared or out of control. Let’s take a closer look at ways you can prepare yourself, your team, your site, your quality system, and even the FDA inspector for a successful audit.
“An audit is a unique opportunity for you to tell your story. In
essence, you are communicating and demonstrating how
you run your business within the framework of your Quality
Konyika Nealy, VP of QA & Validation, Pilgrim Quality Solutions
Prepare Yourself for Inspection
One of the best ways to prepare for your next FDA audit is to stay on top of your previous inspection results. You can be sure that an inspector will revisit prior observations and corrective actions during future inspections. It is especially important to complete any action plans associated with previous observations.
Your organization’s internal audit history is also a good source for anticipating vulnerabilities during an FDA audit. Prepare yourself by periodically reviewing internal processes for weak areas that the FDA may not have discovered in previous audits. Then take action to correct these areas so you can reduce your risk of future noncompliance.
Prepare Your Team
You may need to manage the audit, but you likely have a team in place to support you, or who may be called in to speak with the inspector. Your team needs to be prepared, and that comes down to training. Two key training areas that are important to review include your organization’s operating procedures for how the FDA inspection will be managed and expectations for how your team should behave throughout the audit.
The Inspection Management SOP
The FDA auditor has arrived. What happens next? Will there be a tour? Who will accompany the inspector? Is there a room where the audit should take place? Being prepared for details like these will set the tone for your audit. That’s why an inspection management plan (like all of your plans) should be created and documented. At a minimum, the Inspection Management SOP should document how you handle:
- Receiving inspectors at your site
- Information flow between executives, staff, and inspectors
- The roles of key individuals
- Key physical areas during the audit (audit room, war room, etc.)
- Conducting site tours
- Preparing daily summaries
- Planning and executing audit follow-up
This plan should be a part of your company’s general training requirements so that executives, audit team members, and other staff members who participate in the audit will understand their roles and expectations throughout the process.
Beyond your audit team, other staff members may be called in for an interview with the auditor. It is critical that all staff know how they should interact with the auditor during the interview. Here are some sample Do’s and Don’ts that can help clarify “audit etiquette” for your team:
- Do: Listen to questions carefully and ask for clarification when needed.
- Do: Answer completely, directly, and honestly.
- Do: Speak with authority.
- Do: Leave as soon as the interview is over.
- Don’t: Guess or speculate.
- Don’t: Volunteer more information than necessary to completely answer the question.
- Don’t: Make the auditor ask for information more than once or hope he will forget.
- Don’t: Argue or act unprofessionally.
Remember that you’re only as prepared as the rest of your team. So be sure to document your expectations and provide periodic training and updates to ensure your team is as prepared for an FDA audit as you are. Customer audits, mock audits, and your own internal audit program are additional opportunities to reinforce the activities and behavior that should take place during an FDA inspection and to correct any issues if needed.
Prepare Your Site
Managing your site is a critical element of maintaining a calm and controlled environment during an audit. If possible, designate a space separate from the audit room as your internal control room or “War Room.” The War Room is for your internal team only. It is the place where you can discuss the auditor’s requests, review audit data, and brief your staff members before they enter the audit room. Having a separate area to regroup can help each team member enter the audit room feeling (or at least appearing) calm and confident.
Prepare the Auditor/Inspector
As you work to prepare for FDA inspections, consider how to help the inspector prepare to work with you. One way is to compile a brief fact book about your organization. It can contain information that will be useful during the audit such as:
- Company Overview
- Organizational Chart
- Company Demographics (headcount, diagrams)
- SOP List
- Recent Field Actions
- Recent CAPAs and Complaints
This type of standard information demonstrates that you’re continually working to be ready for inspection and that you’re eager to showcase your quality system.
Prepare Your Quality System
Documents and records, employee training, CAPAs, complaints, and your internal audit program will all be subject to the auditor’s scrutiny. To be prepared for an audit, you will need to periodically review your quality system records for these areas. While you can’t be certain exactly what an auditor will ask, you can use the objectives and sample questions below to review your quality system the way an auditor will during an inspection.
Auditor Objectives: When inspecting document controls, the auditor will determine whether the document inventory is accurate, up-to-date, and periodically reviewed. This includes understanding if procedures are followed for document creation, identification, approval, revision, storage, retrieval, protection, and distribution.
- Is the SOP current? Has there been a periodic review?
- Is the SOP content clear and unambiguous?
- Is there an appropriate approval group?
- Are references, attachments, and forms cited?
- Are there any revisions to the SOP? Are these dated and approved? Is a reason given for these revisions?
Auditor Objectives: The auditor will determine employees’ understanding of the procedures that affect their work, as well as managers’ understanding of their quality objectives.
- How were you trained and/or qualified to perform your job?
- Are there training records that give evidence to this?
- Where are the training records located?
- What forms and/or records do you use while performing your job?
Internal Quality Audits
Auditor Objectives: The auditor will confirm that an internal audit program has been established and is being executed, and verify the qualification/inspection of critical suppliers.
- Please provide your audit schedule for the past year.
- Were all audits completed on time? Have all findings been corrected?
- How often do you audit your critical suppliers? Please provide the dates of previous audits.
Auditor Objectives: The auditor will verify that CAPA system procedures are defined and documented. The auditor will also determine if root cause analysis, trend analysis, and CAPA remediation are being carried out appropriately.
- Do you ever encounter issues with your product or process? If so, how do you handle them?
- What do you do when you find a nonconformity?
- How do you record a CAPA investigation?
- How do you determine if the CAPA was effective?
- Who has visibility into CAPA information?
Auditor Objectives: When examining your customer complaint process, the auditor determines potential problem areas in the manufacture or design of the device, or lot or batch specific issues. The auditor will also determine the rigor of your investigation process and verify your compliance with reporting requirements.
- Please provide a complete list of your complaint records.
- Do your procedures include the criteria and process for Medical Device Reporting?
- Was root cause determined? Does it match the lower-level CDRH codes?
General compliance and documentation within each of these areas should always be in place.
Stay Ready For Your Next FDA Audit
You can track many of the areas above in MS Excel or manually, but at some point you will need more power behind your quality processes to keep your system under control. This level of control is critical to understanding and demonstrating your quality system’s compliance.
Automated quality management software, such as our SmartSolve® solution, will standardize your quality processes and improve your visibility into higher-level results. SmartSolve gives you fast access to the reports you need to periodically review your quality system or to fulfill an FDA inspector’s request. This includes your SOP Master List, Employee Training History, CAPA and Complaint Counts and Aging, and more.
More and more FDA inspections are unannounced, so you must continually work to be prepared for your next audit. It’s important to consider whether you, your team, your site, and your quality system are ready to be audited at any given time. By considering each of these areas and putting a plan in place now, you will be prepared to succeed.
Prepare to Succeed: Stay Ready for Your Next FDA Audit
This e-book gives you actionable strategies to prepare yourself, your team, your site, your quality system and even the FDA inspector for a successful quality system audit. Plus, we’ll discuss how automating key quality processes will help you quickly demonstrate compliance.