Internal Audits & Annual Physicals: Is Ignorance Really Bliss?
What Do Your Annual Internal Audit and Annual Physical Have in Common?
They both roll around once a year, and both are typically dreaded. Your annual internal audit and annual physical examination are both important, and have more in common than you may think.
Annual Internal Audit
The internal audit process is critical to medical device companies to ensure that their Quality System is effective and compliant for the size and scope of their company.
Annual Physical Exam
An annual physical exam is a yearly visit to your primary care physician to make sure that your overall health is okay, and that you don’t have any medical conditions that you are unaware of.
The internal audit program at your company should be carefully designed to find areas that need improvement, and to catch any potential nonconformities internally: It’s far better to identify any issues or gaps in your QMS during an internal audit than during an FDA or ISO audit. Similarly, your annual physical examination is focused on preventive care to attempt to circumvent any potential health issues before they become serious.
Reasons for Avoidance/Disdain
1. People believe that their current status is adequate
Companies often believe their current processes are effective because they have “always been done this way”, and it has seemingly always been effective. In terms of health, many people believe they are generally healthy, and do not need an annual check-up.
2. People have had negative experiences in the past
Internal Audits can be intimidating and stressful when findings arise, leading to a negative association with the audit process. This can also happen when a patient feels unheard or rushed at a physician’s appointment.
3. People fear that the outcome can only be negative
People often take the approach that “ignorance is bliss”. In a QMS, if an audit is not performed, no issues can be identified. Likewise, in the healthcare setting, if you never get checked, you don’t have to worry about getting bad news- until something REALLY goes wrong.
4. People are already overwhelmed with the tasks at hand; “I don’t have time for this!”
Internal Audits take an abundance of resources and time away from an already busy day-to-day. Plus, the results often cause additional work to update any findings that may be identified during the audit. Similarly, people are so busy with their day to day lives and balancing everything that waiting in a doctor’s office for an extended period may not feel worth it.
While RookQS cannot provide you with your annual physical exam, you can Look to Rook to aid in conducting and supporting your annual internal audit. RookQS has a team of 12 certified quality auditors (CQAs) for a variety of regulations, including FDA 21 CFR 820, ISO 13485:2016, MDSAP, and CE Mark under MDR.
Note: This article does not constitute medical advice. We are quality and regulatory consultants, not medical professionals, and are not suggesting the appropriate cadence for your healthcare screenings.