In the year since the bottom fell out of the economy, I have seen many clients, large and small, struggle to maintain regulatory compliance. At the same time, FDA’s budget has increased, it is hiring additional resources, has a new commissioner and soon a new director at CDRH, and is promulgating new regulations and guidance documents such as the recent draft guidance, “Presenting Risk Information in Prescription Drugs and Medical Device Promotion.”
About a year ago, a small client of mine was forced to lay off workers including the QA manager. The company recently brought me in to conduct an internal audit. The results showed that most functions traditionally performed by QA were no longer being carried out, and that other employees were not following most of the standard operating procedures (SOPs). Fortunately, no safety or other critical issues were uncovered, and the company was able to initiate corrective actions prior to an FDA inspection or client audit.
In these times of scarce resources and increasing regulatory scrutiny, management often needs to make difficult decisions regarding what gets accomplished and when. Here are some things to consider when making these decisions.
• Do not eliminate internal audit/assessment activities or management reviews. Corrective actions cannot be prioritized if management does not know what the issues are.
• Take a risk-based approach in everything you do and allocate resources accordingly. Potential product/patient/user safety issues should always be acted on first. Document the decisions you make.
• When workforce reductions are necessary, ensure that the critical functions of the positions eliminated are formally transferred to others. Do not assume this will automatically take place. Do ensure that SOPs and job descriptions are updated accordingly, and that individuals are appropriately trained.
• When appropriate, use outside resources such as contractors, consultants, and service providers to help fill gaps. Having a well-defined scope of what you want them to accomplish will help you to find the best resources, monitor progress, and keep costs in check.
The bottom line is that management needs to continue to keep regulatory compliance at the forefront. Corrective actions mandated by FDA are almost always more stringent and costly than those voluntarily initiated internally.
John Hoffman has almost 30 years’ global experience and expertise in medical device, pharmaceutical, and IVD quality assurance and regulatory affairs. He is proficient in all FDA regulations, ISO 13485, medical device and diagnostics directives, sterilization, product safety and liability, and client satisfaction. He has dealt with a variety of devices and companies and is well-versed in all types of device and GxP software. Hoffman maintains a strong working relationship with FDA as well as standards and industry associations. For more information about QMR LLC, see the company’s listing in the online Consultants Directory or go to the company’s Web site, http://www.qmr-llc.com.