Redefining Quality Audits for a Digital World

Quality audits help ensure effectiveness and compliance within the quality system. However, today’s digital world requires a different approach to quality management. It demands a digitalized internal audit system.

Embracing advanced technology will allow quality audits to be efficient, provide valuable insight, mitigate risk, increase productivity, provide reliable data, and reduce costs. 

This column will consider the benefits of taking a digital approach to quality audits. First, let’s start with some background on why we need internal audits.

Why Conduct Internal Audits

Internal audits are commonly referred to as “first-party audits” and are conducted by an organization to determine compliance with a set of requirements. An internal audit provides various benefits to an organization. By evaluating processes, systems, and products, a manufacturer can ensure operations are abiding by regulations and standard operating procedures (SOPs). When conducted regularly, audits allow manufacturers to monitor an organization’s strategies, goals, objectives, policies, and procedures.

Internal audits are more than a “checkbox.” If done properly, they can be the key to finding the value and improving outcomes. Correctly performed audits can enable organizations to see further and deeper into their business, by:

• Identifying quality issues and providing insight into efficiency and effectiveness 
• Enabling monitoring of procedures and processes at planned intervals
• Addressing product safety and effectiveness
• Ensuring compliance to internal, international, and industry standards and regulations as well as customer requirements
• Determining effectiveness of the implemented system in meeting specified objectives
• Exploring continuous improvement opportunities, revealing existing and emerging risk
• Providing feedback to top management

Barriers to Effective Audit Management

Barriers to achieving an effective internal audit system is not a new topic, but with digital transformation it allows companies an opportunity to redefine their audit management system, removing obstacles such as:

Ineffective Policies and Procedures: Ineffective policies and procedures that align business objectives with quality and operation not measuring the performance of the quality management system (QMS) to create the value in internal audits.

Poor Documentation Process: Documentation is key to providing transparency and maintaining a strong quality foundation, which is lost when organizations still perform manual internal audits using a paper-based documentation system and manual spreadsheets to capture the required data. The data is transcribed into other documents and formats, creating multiple opportunities for errors.

Poor documentation results in additional risk such as rework, incomplete audits, missed continuous improvement opportunities, reduced productivity, missed deadlines, and insufficient communication with stakeholders. 

Siloed Processes and Systems: Each audit may result in numerous findings and related corrective and preventive actions (CAPAs) that must be addressed and managed. When all elements of an audit program are manual or are not integrated with each other, critical information may not be transferred from one process to another in a timely manner. As a result, steps may be missed and required information not gathered. Lack of integration is inefficient and creates human error (due to manual transfer of data), which makes it difficult to close the loop and ensure CAPAs adequately address audit-related issues.

Automating the Internal Audit Process

A digital audit management solution process results in a method that is efficient, effective, and repeatable. The basic steps for an internal audit look like:

Planning: Proper planning results in an audit that flows efficiently and minimizes repeat visits that take time and effort without adding value. Digital audit management helps with planning processes that include assigning appropriate auditors to lead and assist with the auditing effort; specifying which processes and sub-processes will be audited, as well as the results from the previous audit; defining the audit’s scope, objectives, and agenda; determining which audit template to use for performing the audit; developing a chronology of the audit from start to finish; and determining the types of resources and documents needed from the process owner.

Scheduling: An automated audit system simplifies the process of scheduling audit dates, including automatic reminders to initiate and assign audits. Automated scheduling is particularly useful when multiple audits occur at the same time because it eliminates personnel conflicts.

Performing the Audit: Audit management systems can help the lead auditor manage the overall audit process, including gathering required data; recording audit findings and objective evidence for each question; issuing action items to address discrepancies; managing and communicating any changes to the audit plan; communicating progress to all stakeholders; and ensuring the schedule stays on track. Digital audit management systems let auditors electronically document audit results, whether they have internet connectivity or not. This allows auditors to document everything once (including all the classifications management needs for future tracking and trending).

Reporting: Once the appropriate criteria are evaluated, auditors can generate a formatted report that includes the written audit observations of good practices, and risks and problems identified. This report forms the basis of the discussion about audit results and findings. This solution provides reporting capabilities that also generate trends and metrics against data gathered across reports.

Action Items: The auditee must respond to audit nonconformities by their respective due dates. The response must include an investigation into the root cause, a proposed corrective action, and a completion date. An integrated CAPA management solution will effectively manage the CAPA process based on the criticality and the risk factor of the finding. In the case of supplier audits, the offline capabilities mentioned previously now allow auditors to email audit findings to the auditee. The auditee can respond electronically, which helps ensure the response fulfills expectations of the organization’s quality system.

Close-Out: An audit can be completed and closed out once all action items are addressed, effectiveness is measured, and signatures are completed. A final audit report can be generated to document the audit for inspection, or the audit management system can be used as the official system of record.

Changing How We Look at Internal Audits

Auditors continue to do things the way they always have yet business practices, mindsets, and compliance are always changing. Internal audits need to be adaptable, provide valuable results, and offer key data analytics. The key is to have a flexible mindset to allow them to embrace change and make the most of the technology at the organization’s disposal.

Ensuring the audit practice is aligned with the business’s needs improves overall communication between auditor and auditee.

Benefits of an Automated Audit Management System

With an automated audit management solution employing “flexible-yet-controlled” templates with integrated quality management and CAPA processes, life science organizations can benefit by mitigating risk, increasing productivity, and reducing costs—yielding improved product quality.

Mitigate Risk: Automating auditing processes helps ensure all necessary steps are completed in a timely fashion and no steps are missed. Such automation also minimizes possible human error from data re-entry. Using such an automated system, life science organizations minimize the risk the audit will be inaccurate and subject to FDA oversight. Successful audit programs identify the areas of highest risk within the enterprise and allow senior management to allocate resources appropriately.

Increase Audit Productivity: Automating processes eliminates time-consuming manual and non-value-added efforts, such as repeated phone calls and emails for scheduling, manual data consolidation for reports, paper-based approval cycles, spreadsheet population for tracking/ trending, etc. New technology also enables auditors to work in areas without internet access such as airplanes or hotel rooms. As a result, automation enhances productivity.

Reduce Costs: By saving resources and reducing cycle time, automated processes decrease the human capital required to perform the audit and the time needed to both conduct and rectify the findings.

Improve Product Quality: Closed-loop processes and comprehensive reporting improve the quality of audits to ensure they can better identify—and mitigate—risks in an organization’s operations. By improving the methods used in manufacturing processes, these organizations can ultimately improve product quality.

Increase Visibility: Automated audit solutions integrated with quality management systems readily allow access to a multitude of operational and quality metrics across the entire organization, which affords visibility to decision makers. This visibility results in quicker strategic and operational decision making, and streamlined processes and controls lead to better product quality and reduced waste across the entire value chain.

The Future of Audit Management Is Digital

Today’s organizations are moving from manual, disparate, and siloed audit management to centralized and automated audit management solutions that simplify internal audits. This enhances quality through use of historic durability and reliability data to review and adapt plans to predict future performance.

As a result, organizations will reap the benefits of greater efficiency due to real-time visibility, higher levels of productivity, and less operational risk, which ultimately leads to better product quality and efficiencies across the audit process, and greater value across the enterprise. 

---

Zillery A. Fortner is the product advisor, QA/RA Life Sciences, at Sparta Systems, a Honeywell company. She earned a bachelor’s degree in health science from South University. Fortner has 20 years of experience in the medical device arena related to quality assurance, regulatory affairs, and JACHO. She served 10 years in the military as a certified surgical technician. Fortner is an active member of ASQ and AAMI.