By Nancy Singer, President of Compliance-Alliance*, and Daniela Drago, Ph.D., Assistant Professor, Director Regulatory Affairs Program, George Washington University School of Medicine & Health Sciences** An effective way to learn about best practices for regulatory compliance is to ask the experts. To do this, Compliance-Alliance, with the assistance of George Washington School of Medicine and Health Sciences, recently sent out a survey. The purpose was to assess the influence of RA/QA professionals and get suggestions on how to create a culture of compliance.
Three hundred and eighty six employees in medical device companies responded. The breakdown included
- 45 senior executives (including CEOs),
- 165 regulatory officials,
- 124 quality officials, and
- 52 others (including personnel in manufacturing/operations sales, marketing, R&D, clinical, and legal)
Some of the results were disturbing. When asked how top management perceives the RA/QA function, over 25% viewed the function as either
- a necessary evil,
- a policeman who says no, or
- a deterrent to the company making its revenue goals.
When describing typical challenges for getting cooperation for regulatory compliance, employees cited
- Inadequate commitment from the CEO (17%)
- Inadequate commitment from senior executives (38%)
- Inadequate authority in the RA/QA function (38%)
Over one third of the respondents named marketing and sales as the departments that act as though they can ignore RA/QA recommendations with impunity. A substantial number suggested specific actions that RA/QA personnel could take to get cooperation. The suggestions are grouped into five categories.
1. Educate Management.
To help top management appreciate that the company’s business is highly regulated, RA/QA professionals should schedule educational sessions to explain:
- What the regulatory requirements are,
- How compliance with the requirements can cut costs and increase profits,
- What the consequences of noncompliance might be, and
- How the RA/QA professional can help.
During these sessions, RA/QA professionals should not use regulatory jargon or cite the requirements word for word. Rather, they should discuss the impact of the requirements on the company’s business.
2. Stress the Importance of Quality.
QA officials need to work with top management to develop a communication plan. The purpose is to educate employees that quality is everyone’s responsibility. When employees build quality into products through good design, they minimize the need for corrective actions. The operations department, rather than fixing quality failures, can spend its time making new products. Additionally, marketing and sales can stress the company’s standards for excellence as a benefit.
3. Provide RA/QA Professionals a Seat at the Table.
Government entities regulate the design, manufacturing, marketing, and sales of medical devices. To ensure compliance, RA/QA professionals should be included on teams that
- Create the initial product design,
- Select the raw material suppliers and subcontractors,
- Write the premarket submissions,
- Review marketing copy, and
- Educate the sales people about compliance.
When RA/QA professionals don’t participate in the initial meetings, company officials may miss critical requirements. Then company executives may find that they failed to consider the implications of a specific course of action. They soon learn that making mid-course corrections wastes valuable time and often incurs additional expenses.
4. Disseminate the Government’s Regulatory Actions Against Other Companies.
RA/QA professionals initially need to educate all departments about the sanctions that regulatory authorities can use against companies who fail to comply with government regulations. These include:
- Untitled letters,
- 483 observations,
- Warning letters,
- Criminal actions,
- Import detentions, and
- Withholding of regulatory approvals and government contracts.
When the government brings these actions, they publicize them. RA/QA officials should teach all personnel how to locate this information, and the need to bring it to management’s attention. If several departments discuss the government’s regulatory actions, management will have a greater appreciation of the significance of the information.
5. Encourage Accountability by Installing Electronic Systems.
Regulatory compliance is everyone’s responsibility. However, top management may put a higher priority on the tasks related to getting new products on the market, rather than taking corrective actions for marketed products. Companies that install enterprise quality system software are able to track the individuals responsible for specific corrective actions. They also can obtain reports when corrective actions have been completed. This information allows management to monitor and recognize those departments that maintain or improve the quality of the company’s products.
The RA/QA professional serves an important role in medical device firms. People in these professions need to be educators, ambassadors, negotiators, problem solvers, and, at times, enforcers. By acquiring the necessary skills and employing electronic systems, they can gain both the respect and support of top management and the employees in other departments.
*For information about Compliance-Alliance go to www.compliance-alliance.com
**For information about the Regulatory Affairs Program at George Washington University School of Medicine and Health Sciences program go to http://smhs.gwu.edu/crl/programs/regulatory-affairs