Whether it’s an internal review, a customer audit, or a regulatory inspection, QMS audits are a critical part of maintaining compliance in regulated industries like pharmaceuticals, biotechnology, and medical devices. By ensuring your team and system is prepared, you’ll be better able to reduce risk, avoid findings, and build trust with auditors.
Here’s a step-by-step checklist to help your organization get ready.
Step 1: Understand the Scope and Type of Audit
Before anything else, clarify:
- What type of audit is being conducted?
- Internal audit
- Supplier or customer audit
- Regulatory inspection (FDA, EMA, etc.)
- What is the scope?
- Specific processes (e.g., CAPA, document control)
- Entire quality system
- Targeted review of a product lifecycle
Knowing the scope will help focus preparation efforts and ensure relevant documents and teams are aligned.
Step 2: Review Past Audit Findings
Start by examining:
- Previous audit reports
- CAPAs (Corrective and Preventive Actions) from past findings
- Documentation showing closure of those CAPAs
Auditors often check that prior issues have been resolved. Be ready to show closure evidence, effectiveness checks, and updated procedures.
Step 3: Validate QMS Readiness
Ensure your QMS is functioning as intended:
- Check system validation: If using an electronic QMS (eQMS), ensure validation documentation is up to date.
- Verify workflows: Key quality processes (complaints, deviations, training, etc.) should follow defined procedures.
- Confirm audit trails: Systems must show traceability—who did what, when, and why.
Step 4: Organize Key Documentation
Prepare and organize these records in advance:
- Quality Manual and SOPs
- Training records and matrices
- Document control logs
- Internal audit schedules and reports
- Change control and risk assessments
- CAPA logs and trending reports
- Management review meeting minutes
- Supplier qualification files
- Equipment calibration and maintenance records
- Batch and production records (if applicable)
Use a checklist to ensure all documents are current, controlled, and accessible.
Step 5: Train Your Team
People are a major part of the audit process. Prepare by:
- Reviewing audit protocols with your team
- Reconfirming roles and responsibilities
- Coaching subject matter experts (SMEs) on how to respond
- Conducting mock audits or Q&A sessions
Ensure everyone understands how to answer clearly, refer to documented processes, and avoid speculation.
Step 6: Prepare the Audit Environment
Set up a controlled and professional audit environment:
- Designate an audit room and escort
- Provide access to read-only documents
- Have IT support available for eQMS access
- Prepare refreshments, badges, and workspace if on-site
Virtual audits may require special setup—test connections, screen sharing, and secure file access in advance.
Step 7: Assign Audit Roles
A successful audit depends on coordination. Assign roles such as:
- Audit Host: Leads the audit process and facilitates discussion
- Scribe: Takes notes, tracks requests, and records responses
- Document Retriever: Quickly accesses and shares requested documents
- SME Coordinator: Brings in the right personnel to answer detailed questions
Make sure everyone is aligned on how to communicate and escalate issues during the audit.
Step 8: Handle Auditor Requests Promptly
During the audit:
- Listen carefully to requests
- Clarify when needed
- Only provide what’s asked for—don’t overshare
- Use traceable documents with version control
- Track all auditor questions and document responses
Stay calm and factual. Don’t speculate or guess. It’s okay to say, “Let me confirm and get back to you.”
Step 9: Conduct a Post-Audit Review
Once the audit ends:
- Debrief internally to document what went well and what didn’t
- Record auditor observations or feedback
- Begin drafting responses if findings were issued
- Initiate CAPAs immediately if necessary
- Update procedures and training based on lessons learned
Audits are a learning opportunity—use the experience to strengthen your QMS.
Step 10: Maintain a State of Readiness
The best audit preparation is ongoing readiness. Build audit preparation into your quality culture:
- Conduct regular internal audits
- Track and trend quality metrics
- Periodically review and update SOPs
- Train new employees early and often
- Keep validation current as systems evolve
With the right QMS and a proactive approach, audits become a routine part of maintaining high standards, not a disruption.
Learn how to choose the right QMS for you with this guide.
