Auditing in Medical Device Organizations: Why an Effective Audit Management Program is Essential

Why Audits?

Between 2018 and 2022, 13,623 medical devices were recalled. In the last year, recall events in the medical device industry increased by 8.8% resulting in a cost of $83.3 million according to the National Institute of Health.i

Audits are valuable tools for evaluating a company’s ongoing conformance and performance which help promote continuous process improvement in the medical device industry and help them avoid recall events. Specifically, within the medical device industry, audit requirements are embedded within the quality management systems (QMS) and regulations such as those set forth by regulators like the U.S. Food and Drug Administration (FDA). The organization shall conduct internal audits at planned intervals to determine whether the quality management system conforms to the requirements of ISO (International Standards Organization) and FDA requirements.ii

An audit program is the organizational structure, commitment, and documented methods used to plan and perform audits. Operational effectiveness of the audit program depends on clearly defined objectives for a well-managed audit program. A well-managed medical device audit program must:

• Establish internally who will plan and perform audits.

• Standardize and improve its current performance.

• Produce audit results that are meaningful.

• Verify compliance.

• Promote continual process improvement.

3 Benefits of An Effective Audit Program

Effective audit programs bring three key benefits:

1. They identify risks.

2. They improve inefficiencies.

3. They provide cost savings.

How to Improve the Effectiveness of the Auditing Function

To improve the effectiveness of a current auditing function at your organization it is important to:

1. Establish goals for the audit program and report progress top management.

2. Re-engineer the audit process to identify bottlenecks and redundancies.

3. Identify new value-added services, such as software programs.

4. Set-up a skills training program: Train and certify internal stakeholders.

5. Implement audit management software: Invest in a proven audit software solution such as MasterControl.

Supplier Audits

A supplier audit is performed by businesses to ensure that the external supplier meets the organization's quality standards. In a supplier audit, the auditor inspects if the supplier is adhering to the industry regulations and medical device QMS and practices such as health and safety measures and correct manufacturing processes.

Monitoring a supplier’s performance requires constant assessment of product quality, cost, and compliance. Why is this important for medical device manufacturers?

1. It minimizes risk.

2. It strengthens relationships.

3. It upholds compliance.

4. It sustains a safe supply chain.

Supplier management is the practice of selecting, evaluating, qualifying, and monitoring suppliers. For medical device companies selling their products in the U.S. market or the European Union (EU), supplier quality management is a core requirement as per regulatory requirements. We also need to understand that medical device supplier quality management is not just a regulatory requirement, but a crucial business practice. Companies operating in the medical device industry need to ensure that the suppliers chosen are up to industry standards.

3 Keys to Eliminating Risk

Three important areas are important for eliminating risk for medical device companies:

1. Having an Approved Supplier List (ASL).

2. Having procedures in place for selecting and evaluating suppliers.

3. Monitoring the performance of the approved suppliers.

Testing for control of the process by using the Plan, Do, Check, Act (PDCA) technique can reveal fundamental flaws and mitigate risk.

Internal Audits

Internal audits for medical device manufacturers are audits of a company’s quality management system processes to assess the extent to which the company is meeting the requirements and adherence to ISO 13485:2016 standards (medical device QMS). This is important to ensure the safety of the medical devices both domestically and internationally, specifically for the EU, and to sell the device internationally.

Process Audits

These medical device audits are commonly used on manufacturing assembly lines and often in conjunction with Kaizen events. They are conducted to determine if established practices – procedures, work instructions, and policies – are being effectively implemented and to verify that controls are adequate, suitable, and effective.

Organizational Context

The audit program can also be linked to executive leadership responsibility for strategic plans and deliverables. This can enhance continuous improvement in medical device manufacturing. These objectives can be created to establish audit schedules, audit training, and the implementation of an audit program (see chart below).

Team Effort

Medical device audits are a collaborative effort between both internal and external shareholders, and everyone can contribute for a positive outcome. As W. Edwards Deming said, “Quality is everyone’s responsibility.”

References:

1.  “Characterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study,” Mooghali M, Ross JS, Kadakia KT, Dhruva SS, Med Devices (Auckl), 2023 May 19;16:111-122. doi: 10.2147/MDER.S412802. PMID: 37229515; PMCID: PMC10204764.

2. ISO 13485:2016 Section 8.2, 8.2.4, Section 4, 4.1.2 (b), Section 4, 4.1.3 (d), Section 5.6, 5.6.2 (d) ISO 19011:2018 21 CFR Part 820.22 (FDA)ISO 14971:2019 (Risk). MDSAP.