J
JayJay
Hi everyone,
Background on me: I come from a medium-sized med device manufacturer which was ISO 9000 & 13485 certified, CE marked, and FDA QSR compliant with more than 50 employees. <--- Hell on me
Background on current company: I am now at a very small company (only 6 people) which is almost fully automated for our internal processes - we outsource all of our manufacturing and have an awesome design team - ALL 6 OF US! Anyway, we all participate everywhere in the company, as most 6 person companies do... We don't plan to grow much more (maybe an additional 2-3 positions over the next 3 years) - and we are considering 13485 certification over the next couple of years. <--Love it
Problem / Question: I am trying to decide for FDA QSR S820.20 (mgmt responsibility) if a simple organization chart with titles is sufficient for structure, authority, responsibility, etc. Seeing as how we only have 6 people: 1 president, 3 VPs, and 2 managers, our responsibilities fluctuate and shift depending on whose available. What I am used to doing is :
1. defining a need for a position and its responsibilities
2. finding someone to fill that position
3. associating 1&2 on an org chart
(What we're doing is more like having each person fill 7 or 8 positions.)
What I am afraid of though (I am dealing with FDA afterall) is that if I do 1-3, we will get dinged on something that was filled under someone else's responsibilities and/or authority - overkill
I am also afraid that if I leave it up to a simple org chart that it won't "include provisions for responsibility, authority, and resources". - deficient
Any recommendations on how to find a happy medium?
Any links on the site I missed?
Any input would be GREATLY appreciated!
Thanks,
JayJay
Background on me: I come from a medium-sized med device manufacturer which was ISO 9000 & 13485 certified, CE marked, and FDA QSR compliant with more than 50 employees. <--- Hell on me
Background on current company: I am now at a very small company (only 6 people) which is almost fully automated for our internal processes - we outsource all of our manufacturing and have an awesome design team - ALL 6 OF US! Anyway, we all participate everywhere in the company, as most 6 person companies do... We don't plan to grow much more (maybe an additional 2-3 positions over the next 3 years) - and we are considering 13485 certification over the next couple of years. <--Love it
Problem / Question: I am trying to decide for FDA QSR S820.20 (mgmt responsibility) if a simple organization chart with titles is sufficient for structure, authority, responsibility, etc. Seeing as how we only have 6 people: 1 president, 3 VPs, and 2 managers, our responsibilities fluctuate and shift depending on whose available. What I am used to doing is :
1. defining a need for a position and its responsibilities
2. finding someone to fill that position
3. associating 1&2 on an org chart
(What we're doing is more like having each person fill 7 or 8 positions.)
What I am afraid of though (I am dealing with FDA afterall) is that if I do 1-3, we will get dinged on something that was filled under someone else's responsibilities and/or authority - overkill
I am also afraid that if I leave it up to a simple org chart that it won't "include provisions for responsibility, authority, and resources". - deficient
Any recommendations on how to find a happy medium?
Any links on the site I missed?
Any input would be GREATLY appreciated!
Thanks,
JayJay
