8 replies to this topic

[telizabeth]

Hi, I am the single member of our company's newly established quality department. We manufacture products under a GMP certificate from BSI. I have made several recommendations to upper management on a number of topics and a lot of times, they either disagree or take no action. I want to protect myself by having them sign a document saying my recommendation was overruled and/or won't be considered. Basically something to say, I noticed this/this needs to be fixed but I can't do anything about it because Senior Management says no or won't give me the necessary resources to handle it. Is there a name for this type of document or a general type of procedure to follow when one finds them self in positions like this?

[TimG]

What would the goal of that be?

Are you trying to keep a record to show them that their push back is standing in the way of pushing quality forward? ( I am strongly resisting the urge to say WELCOME TO QUALITY, but I just said it...)

If you have a CAPA program, the open actions without completed solutions could work to track this. You could have a monthly 'CAPA review' and have them all sign off that they've reviewed the non-compliance's, possibly even a section "X position has determined no action toward correction will occur at this time," but that's going to get you some push-back most likely.

 

Are you trying to cover your butt in case something bad happens and there are possible legal repercussions?

If so, it would be similar to what I advised in this thread: https://www.ifsqn.co...ch-appreciated/

Check it out, see if that helps. Mainly you're going to want to CYA with a journal and keep email's where you bring your concerns to the attention of upper management.

[The Food Scientist]

I mean you can do that and put "pending" as a comment next to the status so it seems like it is pending by management (maybe they'll change their mind?).

 

..OR you can run and find yourself a better job where all your reccomendations are valued? (I know I got tired of the pending with no action, so I ran!) 

 

Goodluck!

Edited by The Food Scientist, 29 July 2020 - 04:17 PM.

[telizabeth]

Thanks for your replies. I am admittedly new to this world and am learning as I go. I agree a CAPA report would be the best way to have these topics documented. Thankfully I'm not in as bad a place as NotWithoutIntegrity but I do understand the importance of CYA and want to be prepared if an auditor asks me why something is the way it is- I want evidence to prove I've brought it up/attempted to remedy it but the decision is out of my hands.

[Setanta]

Thanks for your replies. I am admittedly new to this world and am learning as I go. I agree a CAPA report would be the best way to have these topics documented. Thankfully I'm not in as bad a place as NotWithoutIntegrity but I do understand the importance of CYA and want to be prepared if an auditor asks me why something is the way it is- I want evidence to prove I've brought it up/attempted to remedy it but the decision is out of my hands.

 

Hopefully there is someone on your team that knows this work needs to happen and can help you get the little things done. If you can show incremental progress, it is still progress

[TimG]

Thanks for your replies. I am admittedly new to this world and am learning as I go. I agree a CAPA report would be the best way to have these topics documented. Thankfully I'm not in as bad a place as NotWithoutIntegrity but I do understand the importance of CYA and want to be prepared if an auditor asks me why something is the way it is- I want evidence to prove I've brought it up/attempted to remedy it but the decision is out of my hands.

 

An older wiser person once told me that a quality/food safety persons #1 job in a food/drug plant is to try our best not to ship something out that could hurt someone.

2 big areas of your job are going to be: 

1. Absolutely never compromising when you feel a food safety risk is imminent (and banging your drum as loud as possible until it's resolved)
2. Pushing for improvements to quality, efficiency, etc and having the patience and understanding in the knowledge they won't always be a priority

Knowing where the line is drawn between the 2 is going to come with experience and asking others who are more experienced, like on this message board.

[SQFconsultant]

I don't want to really make a joke here - but if you do this and want senior management to sign off on it I would suggest you call it your resignation and beforehand go and look for job.

 

That is the way it will be seen.

 

In place of that having a robust intenal auditing program where you document the items needing attention, assign for followup, making senior management aware each time - you want to get peoples attention to take action, show that  you have to continue to roll over these items everytime you do an inspection/doc audit and very soon  you will get action - or a major slap at audit time.

 

I have found in my consulting business that the you can take a company from zero to 100 by having a great internal auditing program - it might take some time for it to sink into their heads - but it will make a very big difference.

Edited by SQFconsultant, 29 July 2020 - 06:51 PM.

[telizabeth]

I don't want to really make a joke here - but if you do this and want senior management to sign off on it I would suggest you call it your resignation and beforehand go and look for job.

 

That is the way it will be seen.

 

In place of that having a robust intenal auditing program where you document the items needing attention, assign for followup, making senior management aware each time - you want to get peoples attention to take action, show that  you have to continue to roll over these items everytime you do an inspection/doc audit and very soon  you will get action - or a major slap at audit time.

 

I have found in my consulting business that the you can take a company from zero to 100 by having a great internal auditing program - it might take some time for it to sink into their heads - but it will make a very big difference.

 

Appreciate the advice on including these items in my monthly internal audits month after month-- this is what I've been doing and probably all the documentation I need come audit time to show my due diligence. Hopefully upper management will hear me eventually or get tired of seeing those same items on my reports and fix them!

[Hoosiersmoker]

It's called an email. I learned this from OSHA training. Cite the item that needs to be addressed with your recommendations. If and when you get a reply stating they will not agree to the recommendation, you have your rejection, in writing with their signature. If there is no reply, resend. New date, shows persistence. Send these with a Delivery and Read Receipt.

 

Also agree with above: You would do well to spiff up your resume too because it seems the program to them is all for looks. If there's little to no support from upper management the system is doomed to mediocrity at best.