Dr. Simon’s whiteboard explanation this week showed how every subsystem (design controls, purchasing, risk management, training) is a process that is a part of a larger process. Each has inputs, outputs, and feedback loops that make it so that problems in one area can bleed into others. For example, if purchasing fails to vet a supplier properly, design controls and quality control will get that risk down the road.
This highlights why internal audits are so important, as they verify compliance and test how well all the subsystems are interacting. Audits often get a bad reputation, since people see them as compliance checks, but I think they can be powerful learning tools when looked at correctly.
The Basic Audit Model of standards + facts to audit results shows that context and interpretation matter. If the team sees audits as collaborative instead of a punishment, they can drive measurable improvements. How do you think companies can shift the culture so internal audits can be seen as opportunities for improvement instead of an inspection of your work? Additionally, do you think incorporating AI into audits can help shift this culture? AI before a human audit review could help both sides, as easily manageable problems can be fixed, and the human audit can focus on bigger issues.
Audits are something I do have experience with when I was managing a lot of communication equipment. I understand how PAINFUL they can really be, especially if poorly mismanaged from previous personnel, but really, if one is properly managing their equipment, documentation or whatever it may be, the process is a lot easier as well as informative. They're there for a reason and ensure that every system or subsystem stays in line and doesn't bite anyone later at the worst time. I believe that culture shift starts from the top down (as has been discussed before). Leadership should, of course, lead by example and ensure that there is transparency to what is being done. If they can also teach and guide to others as well, there can be a shift in how audits are seen ultimately.
In terms of incorporating AI, I think it could help make auditing easier, but I think it helps little in shifting the culture. I believe that has to come from leadership personally and it also is a bit more motivating seeing someone in charge also trudging through the sense processes that you would be going through as well. I think AI could help in standardizing the process easier though or even be used as a tool for preparation and training.
Obviously, AI is already being heavily researched and expanded on, with many companies finding way on how to seamlessly implement it into their system. AI can indeed help handle routine pats, like checking if training is up-to-date, finding documents or information relate to the company, or spotting a pattern in complaint or errors that interrupt production. That can give human auditors more time to focus on the bigger, more complicated problems that require judgment and experience. However, AI is still rough around the edges, and companies should be cautious on trusting software too much. At the end of the day, the final decision should be reviewed by a human, just in case the AI missed anything. What do you think is an acceptable range that companies should rely on AI during audits before it starts becoming too much of a risky endeavor?
I don’t have any experience with audits, but I like the idea of viewing audits as learning tools rather than check-ins that create more work. However, to shift this culture, leadership needs to promote transparency, not just compliance. This is where company culture becomes a big factor, because if a company is more obsessed with releasing their product rather than its quality, then as an employee who is simply looking to keep their job offering transparency on certain issues becomes harder to do. When it comes to leadership, I think that they have to prove that they do care about the company's mission statement and are serious about making products that reflect it. They also have to be able to show the people working under them that audits are an important part of that process, and one way they could start is by being a part of those audit meetings and discussions.
As for AI in audits, I think its best role is in pre-audit readiness, flagging documentation gaps, identifying trends in nonconformities, and standardizing checklists. As mentioned above, the use of AI would simply offer a standardization of the process and elimination of administrative work rather than helping to change company culture. Additionally, companies should be aware that while AI might make audits easier, their algorithms might not be able to grasp concepts like ethics and risk judgement, which are decisions that are better left to a human auditor.
I don't believe there really is a good way to frame an audit, as its now just another deadline you and your team must account for. While yes, teams should constantly keep things up to specification, however that's not the way it goes, especially for a team very interested in their work. The last thing I as an engineer want to think about is filling out paperwork for an audit to prove my methodology, and I wouldn't be surprised if many others shared my sentiment. While they're always extremely useful to learn and grow from, the nature of an audit is to be an afterthought which gives it the feeling of being a punishment. Many teams could attempt to grow and get ahead of the next audit, but that just takes time away from developing the next device.
