GxP Lifeline Feature Article

How to Solve the Top Five Quality Audit Challenges


Practical Solutions to Common Audit Challenges Faced By Life Science Companies

When the American Red Cross was hit with a $4.2 million fine last year, it was the culmination of more than a decade of blood-safety violations that stemmed from a poor quality system. Among other things, the FDA found shortcomings in the areas of quality assurance and inventory management, and issues pertaining to donor screening and blood component manufacturing. This kind of systemic problem is just what quality audit is supposed to prevent.

Under GxP principles, quality audit should be conducted periodically as a tool for evaluating the effectiveness of the total quality system. It's not clear to what extent the Red Cross has been performing quality audits. But it’s fair to say that for most life science organizations, quality audits can be daunting. Here are some of the most common challenges pertaining to quality audit and some tips on solving them.

1. Inefficient System for Planning and Scheduling. For audit to be effective, it must be conducted on an on-going basis. And this can be difficult for companies that rely on a paper-based or a partially electronic system. Planning and scheduling would require multiple meetings or conference calls of auditors, auditees, and others involved. Follow-up work would entail uncoordinated phone calls, e-mail, and personal reminders. Scheduling of audit-related tasks would depend on someone remembering to send assignments at certain dates.

Solution: Automating the quality audit process would eliminate most of the legwork and manual tasks. Choose a system that automates task assignment, follow-up, escalation, review, and approval. A good system will provide forms that will track basic information critical during this stage, such as type of audit, date, description, objective, scope, audit area, and lead auditor. Agendas and checklists can be created well in advance with an automated system.

2. Lack of Secure, Centralized Repository. Most internal auditors are out in the field inspecting facilities. They might use paper forms and either paper or electronic spreadsheet to collect data. In a manual process, this would generate voluminous paperwork and/or electronic files that are stored separately by auditors. Come FDA inspection time, producing and gathering all audit-related documents would require a major effort.

Solution: Choose a Web-based system to give all authorized users easy access regardless of location. Auditors and process owners can add their input directly into the system, which will serve as a centralized repository for all audit documentation. A centralized repository will make search and retrieval easy.  Select a system that offers FDA-compliant security features covering such areas as user authentication, record retention, and audit trail. The system should allow you to limit access of every user based on the person’s role and system rights.

3. Poor Tracking. A key aspect of quality audit is making sure that findings are being addressed and problems are being resolved. Even when a company performs only a small number of audits annually, each audit typically results in numerous findings and related corrective/preventive actions (CAPAs). Under a manual system, tracking these findings and related documents, evaluating risks, verifying findings, and ensuring proper closure would mean combing through voluminous paperwork and a lot of legwork, both of which could result in delayed CAPA completion.

Solution: One of the biggest benefits of switching to an electronic system is that tracking will be done automatically. A robust system should provide forms for collecting and tracking data throughout the audit process. It should also track verification of the process owner’s response to the findings to ensure proper closure of each finding.

4. CAPA Not Integrated with Audit Process. One of the purposes of the audit process is to reveal issues that need to be addressed, typically through a separate CAPA process. So, companies that establish a quality audit process that is not integrated with the CAPA process seem to be missing the point. This is the case with most manual systems, which require more effort and constant vigilance to make sure that critical findings immediately move into CAPA. Granting that you are able somehow to do this manually, there is still the problem of overall monitoring. It is almost impossible to capture the big picture of the quality system under manual processes, making it harder for managers to be proactive. 

Solution: To optimize your quality audit process, integrate it with CAPA. This is best achieved with an automated system. A fully integrated system should connect the audit process not only with CAPA, but also with change control, training, and other quality processes, giving managers the ability to monitor the entire quality system.

5. Ineffective Analytics and Reporting System. It’s difficult to generate accurate and timely reports and trends using disparate tools, such as electronic spreadsheets, flowcharting software, and paper documents. Without an effective reporting tool, managers are unable to see the overall situation that audit findings may reveal.

Solution: Pick a system that provides advanced analytics and reporting capability, including customizable reports and online charting. Through the reports, managers get a real-time view of the audit process and can respond to issues immediately.


Read more about the quality audit process::

White Paper:

Quality Audit – A Tool for Continuous Improvement and Compliance

Tech Paper:
MasterControl Audit™



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