This is “not” the way

Never just take someone’s word for it.  I’ve seen so many times that someone says (this does include auditors…) something that they just assumed was required, because that’s just always been the way they have done it.  Then you ask them to point it out in the regulations or the standards where it is called out.  They normally don’t like it when they can’t find what they are looking for…

So don’t just do your quality and regulatory work and follow the crowd. Don’t be afraid to ask why we are doing something, and if what the team is doing makes sense.  You might just find out that these are not the “requirements” you are looking for.