Quality Audit Preparation: Best Practices to Remember

A Senior Director of Quality at a leading medical device manufacturing company was grappling with the following challenges:

• The teams were scrambling to prepare documents at the last minute for external audits.
• The quality and manufacturing teams had to work overnight prior to the visit of an ISO 13485 auditor the following day.
• Different manufacturing locations were following disparate quality approaches.
• Access to real-time data was a major challenge.
• Lack of proper document management slowed down the quality management process.

The quality leader said: “The writing was on the wall. We had to overhaul our entire QMS, but the first steps were to transform document management and audit management processes.”

Without proper documentation and easy access to data, it was becoming impossible to streamline QMS workflows. They also realized that internal audits had to be done, to identify gaps and transform the end-to-end quality management lifecycle.

The company, which was rapidly growing and listed on NASDAQ, decided to take its quality management function to the next level and decided to implement ComplianceQuest to streamline its quality processes. This was in 2019. Now, over the last four years, the company has implemented the following solutions from ComplianceQuest:

• Document Management
• CAPA
• Audits
• Nonconformance
• Risk Management
• Supplier Management
• Inspection Management
• Training
• Change Handling
• Equipment Management

Recently, we went back to the quality director, and here’s what he had to say:

“According to our lead ISO 13485 auditor, ‘ComplianceQuest knows the compliance world, they know quality, and their package is one of the most professional, strongest EQMS tools that exists.’”

We narrate this story here for a simple reason: It all started because the quality team was burning the midnight oil to prepare for an external audit the next day. The chaos that day was a trigger that led to a massive transformation. Today, the company is able to push the boundaries of quality excellence - thanks to having a data and metric-driven approach, with the power of a next-generation, automated EQMS Solution.

In this blog, we focus on what it takes to be audit-ready, and key best practices to follow when it comes to quality audit preparation.

Quality Audit Preparation - Best Practices to Remember

In today's competitive market, the significance of quality audits cannot be overstated - they are pivotal for maintaining standards, improving quality performance, driving quality excellence, and ensuring compliance. Here’s how quality teams can prepare to ensure the audit management process is effective and efficient.

Review Previous Audits: Start with introspection. Analyze past audits to address corrective actions comprehensively. Pinpoint patterns and recurring issues that need extra attention. Make sure this processis data-driven and objective. Document findings carefully.

Know Your Weaknesses through Internal Audits: Be your own critic. Audit your Quality Management System (QMS) rigorously before facing an external audit. This proactive step can help you identify and mitigate gaps that might otherwise go unnoticed.

Take the time to Know Your Auditor: Each auditor has a unique focus and style. They may also have specific goals or objectives about why they are doing an audit. Familiarize yourself with their methods and what they prioritize - and align your preparation accordingly.

Organize Documentation Efficiently: Well-organized QMS documentation is the backbone of a successful audit. Ensure everything is up-to-date, accessible, and logically structured to facilitate easy retrieval of information.

Train Your Staff and Conduct Mock Interviews: Knowledgeable employees are your best allies during an audit. Train them about the audit process, clarify their roles, and conduct mock interviews to build confidence.

Perform Process Walkthroughs: An on-the-ground review of your processes can reveal a lot about your operational compliance and record-keeping. Take the time to physically walk through key processes.

Assess Top Risks: Identifying high-risk areas within your QMS allows you to focus and prioritize your efforts on strengthening controls and oversight mechanisms.

Verify Preventive Actions: Make sure that all the strategies and systems in place to prevent nonconformities are functioning as intended.

Clean-Up Facilities: First impressions are important. Ensure that work areas are not only compliant but also orderly and safe to project a positive image during site tours.

Confirm Schedule: Ensure that you have adequate staffing and that all key employees are available throughout the audit period.

Communicate Status: Keep your leadership in the loop regarding audit readiness. This transparency ensures that you can quickly mobilize support from management when needed.

Cultivate Audit Readiness in Your Culture: Finally, make audit preparedness a core aspect of your quality culture. This encourages continuous improvement and keeps everyone audit-ready at all times.

By following these strategies, your organization can approach quality audits with confidence and turn them into opportunities for enhancement rather than mere compliance checks.

Remember, an effective audit is not just about passing a test—it's about continuous improvement and setting higher standards for your organization. To know more, visit: www.compliancequest.com/online-demo