Welcome to week 1 of RA/QA Clarity! The next 4 weeks will have a focus on Internal Audits. Internal Audits are the biggest area of confusion and stress for everyone managing a quality system. Throughout the thousands of companies we have worked with, the question we hear repeated is always:
How am I supposed to schedule my internal audits? The regulations require that they only be conducted. What is meant by this vague statement?
Both the FDA QSR (Quality System Regulation) and ISO13485 are purposely vague on the quality audit requirements. I know this is not the response you are looking for! But keep in mind that various companies, from tongue depressors to mechanical heart implants, all have to follow the same regulations. There are a multitude of companies that have their own interpretation and need for internal quality audits. Therefore, the regulations cannot be too specific, it would not work for everyone.
This vagueness works in your favor! The expectation is that each company will take the regulations and apply it to their business practices. There is no “right” way to do internal quality audits.
That being said, when we go into companies to assist with their quality system, one of the first things analyzed is internal quality audits. This is because this is a section notorious for being over written within the system. Many managers simply ask me:
I have inherited this quality system and do not know how to streamline it. I just cannot keep up with this procedure!
Remember above, where we discussed the vagueness of the regulations? This is where it becomes a benefit. Since there is no specific requirement, you can easily establish the minimum – CONDUCT QUALITY AUDITS. Period. Its that simple.
What does this simplicity mean in terms of how the regulations are interpreted by government bodies?
Government bodies performing inspections (FDA) or audits (ISO13485) all have been trained on what to look for and how to write companies up on non-conformities. They interpret the internal quality audit regulations on the following points:
- Is there a procedure discussing internal quality audits?
- Are internal quality audits conducted per the procedure?
- Are internal quality audits conducted once a year at a minimum?
- Do individuals audit their own work?
- Are corrective actions taken based upon internal quality audit findings?
#3 is the focus of this blog post. Look at that! Only once a year? And that does not mean you can do one on December 31 and the next on January 1! Please make sure they are about 12 months apart.
There is no requirement or expectation to have them quarterly, or to group departments together, or to have some crazy system to perform an internal quality audit every month.
Simplify the internal quality audit process and do it one time a year. You can do it in one day for small virtual companies, or over a full week for large companies that span several locations. Doing it this way will serve several important points:
- Keep the company focused on the process and not the inconvenience.
- Give the ability for everyone to have it on their schedule and prepare adequately.
- Allow for easier scheduling with Executive Management to review the findings.
- Not be a burden on your RA/QA task list by getting it done and having the ability to move onto other quality system management tasks.
- Most important – Meet the regulations.
WEEK 1 ACTION ITEM – Take an honest, hard look at your internal quality audit procedure and schedule. Make the changes to simplify and clarify. Follow the schedule and know that you are meeting the regulations while simplifying your system and at the same time cleaning up your RA/QA task list.
Have any questions about the process? Join us in the 52 Weeks to RA/QA Clarity Facebook group! Post your questions any time. We look forward to continuing the conversation.