Nancy Singer for Sparta Systems

Preventing recalls is the ultimate goal for medical device companies, but that’s easier said than done. The manufacturer must establish and enforce quality processes and controls within the company and also when using suppliers. The Food and Drug Association (FDA) is required to monitor a company’s performance to ensure they are producing high quality products and protecting the public health. To establish FDA’s mission, Congress passed the Federal Food, Drug, and Cosmetic Act. The law holds top management accountable if their firm fails to produce safe and effective products.

Whitepaper: Prevent Quality System Deficiencies by Conducting Effective Internal Audits

The FDA Regulations, 21 CFR 820.22, require that medical device companies conduct quality audits to determine the effectiveness of their quality system. In Form FDA 483 observations, FDA investigators have cited companies for failing to:

• Establish quality audit procedures,
• Provide adequate resources for internal audits,
• Conduct quality audits at sufficient intervals, and
• Have independent auditors conduct the audit.

There are some steps that a company can take to avoid 483 observations and prevent recalls all together. Properly implementing a quality management system is a big part to achieve that success along with providing the experienced personnel to staff the audit process.

Preparation
To establish procedures for quality audits, companies should read the section of the Quality System Regulation on Quality Audits, 21 CFR 820.22 and the relevant sections of the Preamble to the Quality System Regulation, which explains FDA’s response to public comments and questions about provisions in the regulation.

Additionally, companies should look at the HIMA (currently AdvaMed) ‘Points to Consider When Preparing for an FDA Inspection under the QSIT Management Controls Subsystem.’ They should also refer to guidelines on auditing by the Global Harmonization Task Force Study Group 4 (SG4).

In their procedures, companies should state that they will conduct audits at specified pre-defined intervals to ensure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system.

Resources
When providing adequate resources for audits, companies need to ensure that the personnel assigned to conduct audits have the appropriate background, training, and experience. They need to be familiar with FDA’s regulations, the relevant standards, and the company’s auditing procedures. They also should be familiar with the company’s products, the quality policy and manufacturing processes.

Objectivity of the Auditors
The Quality System Regulation requires that audits be conducted by an individual who does not have “direct responsibility for the matters being audited.” Additionally, a report of each audit must be reviewed by the management having responsibility for the matter audited. FDA takes this provision seriously. During an inspection, an FDA investigator will sometimes ask to see an organization chart to ensure that an internal auditor’s duties are outside the scope of the activities that he/she is auditing.

Using In-House vs. Outside Auditors
Some companies use in-house personnel to conduct their audits while others use a consulting firm or a former FDA investigator. Among the advantages of using in-house personnel are 1) the in-house personnel have a better understanding of the product and processes, and 2) companies don’t have to pay for the audit. A disadvantage is that in-house personnel are familiar with the processes and may skip over the need to document each activity. Additionally, they may have political concerns about evaluating the efforts of their colleagues.

Advantages of using outside auditors include the ability of the auditors to be more critical because they may have seen better ways of performing tasks at other companies. Additionally, they can be frank, as the people who are being audited are not their co-workers. If a former FDA investigator is used, that individual will have to good understanding of how FDA officials will approach an inspection. The disadvantages are the cost and the lack of familiarity with the company’s products and processes.

Characterizing Audit Findings
Many firms characterize audit findings as major, minor, and an opportunity for improvement. Another way to characterize findings is the need for correction, the need for corrective action (existing systemic nonconformance), or the need for preventive action (potential nonconformance).

Reporting Audit Findings
Some companies have their auditors write unstructured narrative reports, while others have them fill out a form. If a company has an electronic system, the auditor can easily fill in predetermined fields and then support the findings with a detailed narrative. An electronic system allows the audit report to be prepared quickly and the auditor can efficiently compare the current audit findings with findings from previous audits.

Importance of Audit Findings
To ensure that company employees take audit findings seriously, executive management needs to communicate the importance of internal audits. They should educate employees as to why internal audits are done and the role that unbiased audits play in regulatory compliance and product quality. To ensure that employees take appropriate corrective action as a result of the audit, many firms include audit follow-up as an evaluation criteria for performance review and bonuses.

Management Reviews
Since management with executive responsibility will be held accountable for the success or failure of the quality system, the results of quality audits should be an agenda item during management review meetings. The management representative or other staff should describe the type of findings, the root cause for the findings and the corrections, corrective actions, and preventive actions that will be taken.

Protecting Internal Audit Findings
When FDA wrote the Quality System Regulation, FDA officials wanted internal audits to uncover problems within the company’s quality system. To encourage companies to be candid in their audit findings, the Quality System Regulation, 21 CFR 820.180 (c), exempts internal audits findings from the documents that companies are required to provide to FDA during an inspection.
To take advantage of this exemption, companies should prepare a separate cover sheet that they can show separate from their audit report to provide to an FDA investigator.

The cover sheet should contain:
• The name of the person who performed the audit,
• The date the audit was conducted, and
• The items covered by the audit (the audit agenda).

Conclusion
Companies with robust quality systems understand that internal audits play a key role in ensuring that the company is complying with the government’s regulatory requirements and is producing safe and effective products. By dedicating adequate resources to the program, companies are more likely to find and correct process and product problems early in the production cycle and enhance their ability to produce quality products.

Whitepaper: Prevent Quality System Deficiencies by Conducting Effective Internal Audits

About the author: Nancy Singer founded Compliance-Alliance, LLC to specialize in the professional development for those employed in the medical device industry. Previously she served as AdvaMed’s Special Counsel for FDA compliance and enforcement matters. In her role as Special Counsel, Nancy was a member of the working group that conceived and validated the procedures for the Quality System Inspection Technique (QSIT). She served as the industry spokesperson on the educational programs that taught QSIT to representatives of FDA and the medical device industry. While working on QSIT, Nancy received Vice President Gore’s Reinventing Government Hammer Award and the FDA Commissioner’s Special Citation. Nancy began her career as an attorney with the United States Department of Justice where she did litigation for the Food and Drug Administration. Subsequently she was a partner at the law firm of Kleinfeld, Kaplan and Becker.