Size of Quality Department

[Zero_yield]

BTW simultaneously we will be implementing an ERP system with electronic batch records which will affect a lot of processes and documentation.... which will make life doubly interesting I'm sure!

We switched ERP systems in 2020, and I think that was probably more impactful to our Manufacturing than anything else that happened in 2020 (the start of COVID included). Just for a little preview of what's coming your way lol

 

[KarenA01]

If you choose to use a consultant just make sure they('ve)
1 - done more than take a whiz-bang training course,
2 - are not just good at playing buzz-word bingo
3 - have more than a flashy business card
4 - got some solid references they will absolutely share
5 - aren't just giving you a cut & paste hack job

I've seen some great stuff out there and I've seen some absolutely horrible stuff as well

I'm pretty sure all of that is the case...

The Principle of the company we are using (he was also our 9001 consultant), as I previously mentioned, represents the US on a number of international ISO standard commitees and has a Lot of credentials....

in addition he was initially recommended to me by a family friend who is now retired but spent his most of his career as quality engineer (his MS is Chemical Engineering and MS is Engineering management). My friend knew that consultant for a number of years I think though ASQ. That consultant impressed everyone here.

It will be a different person this time because the guy we used last time is not the 13485 expert in his company... but we do trust them.

5 - aren't just giving you a cut & paste hack job

For the SOPs, as I said we are not starting from scratch and so have a starting point.

-Karen