Compliance issues can be a nuisance to resolve. Save yourself the headache, and avoid these common problems altogether.
There’s an adage that says, “If it Isn’t documented, it didn’t happen.” Compliance auditors believe that proof lies in the documentation. The proof of a firm’s compliance is substantiated by its records. Verbal confirmations are inadequate, but a procedure, supported by records that prove that it was followed is incontrovertible in an audit – if consistency is present. Documents need to be consistent to each other, with contemporaneously-documented dates, times and information to assure data integrity. Inconsistent documentation, results in inconsistency across an organization, which can cause inconsistently performing processes and, eventually products have the potential to endanger lives. Just do it right – and document it right – the first time, and you will see compliance improve.
Decisions involving quality and compliance need to be questioned by someone free from conflicts-of-interest, so an ethics-centered quality department is essential for compliance success. Sticky situations come up, and they always will. A quality department will help an organization make product decisions, by weighing the pros and cons in an unbiased manner, and bringing to light the risks, while helping to identify the mitigations needed to assure patient safety. Because quality ultimately reports to the CEO, the CEO should hire someone who can be relied upon to have an unwavering commitment to making ethical decisions, even in the most difficult situations. Strong technical and risk-management acumen is essential to the Head Quality role. This is someone the CEO can trust unconditionally to resolve the thorny issues, so the CEO can focus on the other responsibilities of running a company.
It is better to avoid the thorny issues altogether than to deal with them. The key cost avoidance (and headache avoidance) task is to understand whether a process really works. Generally, risk assessment will break a process into steps that can be individually analyzed. The analysis will show how each step could fail, and what might be done to eliminate the risk. Such a detailed analysis may reveal surprises about the process, which can be proactively mitigated, before the organization experiences any serious issues. Be sure to document your risk assessment for posterity, and have QA approval on it, per 1 and 2 above.
Risk Assessment is a mental exercise, and educated guesses cannot anticipate all future mistakes. In the compliance world, the process of mistake correction is called CAPA (Corrective Action/Preventive Action). To err is human, but instead of wasting energy laying blame, learn from mistakes and investigate the problem for the information it can reveal. Compliant companies differentiate themselves with awesome information management. When a mistake happens, use the information, then collect more data to not only fix the problem, but to prevent its recurrence. Then go further by looking for other places vulnerable to the same problem. As a final capstone, go back after some time has passed and determine whether the solution truly fixed the problem. How awesome is that?
Following procedures, mitigating risks, and having a high Say/Do ratio is essential to compliance. A quality management system (QMS) should be built in such a way that process flow ensures that the necessary tasks are done, by prioritizing tasks so they can be properly completed. (It goes without saying that adequate staffing is essential to completing tasks consistently and on time.)
Remember, there is nothing worse to an auditor than a repeat finding. Find a way to get the job done. Poor follow-through destroys trust, with both regulators and customers, and is just bad business.
In summary, get your documentation right the first time, have strong quality oversight, do thorough risk analysis so you can be proactive and mitigate issues, don’t repeat your mistakes, and always do what you say you will. You got this.
Enjoying this blog? Learn More.
SOP Management as a Compliance Tool in FDA and ISO EnvironmentsDownload Now