The maintenance of regulatory compliance relies on audits. What frequent problems arise during internal or external audits of a QMS and how can companies prepare to avoid these pitfalls?
During audits of a Quality Management System (QMS), common issues that pop up include incomplete documentation, non-conformities with procedures, and missing or outdated training records. Companies often face challenges with risk management or ineffective corrective actions as well. To avoid these pitfalls, it's important to keep documents up to date, conduct regular internal audits to catch problems early, and ensure employees are properly trained with records to prove it. A good risk management process and making sure corrective actions are actually working can go a long way in preparing for a smoother audit.
From what I've read, one of the most common issues during QMS audits is weak traceability, especially when companies can't clearly connect design changes or complaints back to something they documented. Studies point out frequent findings in supplier management, such as missing evaluations or incomplete material records, which can cause problems. To prepare, companies should perform routine checks, internally, to make sure documentation stays up to date. I saw that they recommend "mock audits" to help reams practice and identify weak spots before doing an external or supplier audit. I believe this also goes around with having routine internal audits to make sure the QMS is working well.
Challenges during auditing can appear in the investigator’s audit report especially when they are QMS deficiencies. Negar and Natalie provided examples of frequent problems that can arise. As a result, the company needs to respond back with a plan to correct the issues and then execute the plan. The auditor will perform a follow-up in order to confirm that the plan was implemented and their findings were resolved. If there are significant violations, then the FDA will issue a warning letter in which the company can try to resolve their compliance violations. The FDA can also recall products if they find evidence of public health risk. However, the company’s operations depend on the severity of the violations and their ability to remove the products. Audit findings can emphasize the effects of poor management commitment, human factors, money, and the QC & release process. For example, there is a history of drug companies charged for distributing adulterated or misbranded drugs. The quality and management teams approved components that failed testing and attempted to cover or omit data in their documentation.
Adding on with a specific example of incomplete documentation missing which leads to a failed audit is the lack of "assumed" process in the documentation. In cases where employees work at a company for a fair amount of time, they begin to learn how certain processes should be done, and it becomes second nature. In the documentation process, specifics of how a task was performed can be missing because some employees may regard it as too obvious to include. Compounded across many procedures, training records, and documents, audits can become trouble for companies. Educating employees on the importance of listing all the steps in a certain procedure is critical for long-term audit preparedness. When an auditor looks at a QMS, they base their conclusions on whether the processes are properly documented in the QMS, not if the employees know what they are doing. Inconsistencies in a QMS due to "assumed" processes are important and should no be overlooked.
