You never forget the first time you experience the true cost of non-compliance.
For me, I’d just moved from the FDA to private industry. After four months on the job the FDA came in for an inspection. It didn’t go well.
We were hammered with a long list on our Form 483, followed by a warning letter. We scrambled to hire costly consultants and legal experts. The team spent countless overtime hours remediating processes and performing retrospective reviews on quality records. Some reviews led to product recalls, which were not only expensive but damaged our brand.
While all quality and operations professionals are familiar with the cost of quality, they may not realize the cost of non-compliance can be just as impactful on product quality and customer satisfaction.
Too often, I’ve seen the following compliance-related business areas neglected. When properly applied, these four best practices can put you on the path of consistent compliance.
1. Build robust quality processes early.
Bottom line, the creation of compliant, quality products requires a robust quality management system (QMS). Such systems increase efficiency and reduce errors, which means less time responding to crises, more time for improvements, and happier customers.
Fledgling companies just trying to get off the ground don't always recognize the benefits of investing in quality. Trust me, starting with a solid QMS will pay off in the long run.
A comprehensive QMS includes effective document control management, internal audit, CAPA, supplier and material control programs, and last but definitely not least, an effective training program. Within your QMS, here are a few bonus tips:
- Focus on proactive CAPA initiatives in addition to deviation and audit responses. Getting out ahead of potential issues will preserve company time, money, and reputation.
- Conduct regular internal audits. It is much easier and desirable to find your own issues and correct them than waiting for auditors or regulators to point them out to you.
2. Frequently reevaluate quality resources. At most companies, resources tend to coalesce around sales and marketing and manufacturing. Unless there’s been a major quality failure, quality is often taken for granted and rarely gets additional resources for improvements.
This attitude towards quality ignores the ever-expanding nature of quality regulations and requirements, especially if a company is entering a new market or engaging new suppliers. Without frequent reassessment of its resource needs, a once well-running quality department can quickly become overburdened. Do not run the risk of straining your quality department; after all, they are the company’s watchdog.
3. Make quality company culture, not a department. Great business leaders know that quality is everyone’s responsibility. All departments, whether obvious or not, have significant inputs and outputs in the QMS processes.
Fostering partnerships between quality managers and their peers across the business will engender continuous improvement and effective cross-discipline collaboration. I cannot emphasize this point enough.
4. Invest in continuous employee development. Quality, like any department, can fall into the “we’ve always done it that way” trap. It is key for quality leaders to preach and model that change is good and necessary.
The “c” in cGxPs is there for a reason; applying industry best standards requires employees who are aware of them and can implement them effectively. Experienced employees have critical tribal knowledge and maintain stability in a company. New employees bring in fresh eyes and new knowledge. Both are necessary for a company to grow and succeed.
Learn from my experience - don’t wait until you are faced with a quality issue to address the costs of non-compliance.
Invest early in an adequate quality management system. Create a company culture that puts quality and customers first. Empower, educate, and strengthen your workforce.
Sophia Finn has over 10 years of quality experience in regulated industries. She began her career with the FDA working in CBER’s vaccine lot release program and later moved to the FDA's office of regulatory affairs as a regulatory microbiologist. Additionally, Sophia has managed CAPA, complaints, audit, and deviation programs in the medical device industry. Sophia has a master of science in bioscience in regulatory affairs from Johns Hopkins University and is an ASQ Certified Quality Auditor.