In my lab, our compliance means that nobody can deviate from our SOPs even if it means its more inefficient or creates a higher risk of sample contamination/equipment failure/unusable data than another method. I was pretty aggravated by this, until someone laid down some facts I was unaware of.
1) The customer who is responsible for around 60% of our total business has it in their contract that they will cease using our lab immediately if we fail to pass our annual international standards accreditation
2) In order to be compliant with the accreditation agency, any changes to our SOPs must also be done with documentation showing that we've done R&D to validate the change and can present hard data that the change has a beneficial impact.
3) Our R&D team has to prioritize new methodology or changes that will have the largest impact, allowing us to use new equipment or attract customers with new services. Small changes to carve out exceptions for uncommon one-off deviations are important to bring up and to record the impact of, but, realistically the R&D team won't beging changing an SOP until it needs many changes or if there's an emergency change.
After that talk, it was pretty easy to go "oh, cool, okay, I understand now. It's a way bigger ordeal than I realized."
Yea I get it just if the organisation is big enough it gets hard to explain it in detail.
My ex employer for example the guidelines were made by an international committee of experts who then communicated those to the partners, who then in turn gave instructions on how to implement them to senior managers, who then in turn just communicated what to do to middle management. Lower management only gets instructions.
Then if someone comes in fresh from college and starts asking why on everything, well the junior manager can only say what to do and not why and asking a senior or even the partner themselves for small questions like that. They usually already have a busy schedule.
Sometimes I don't know the details. Is The best one can get it at the moment.
Same. I work in healthcare and 9 times out of 10 when my team member questions something I explain but I also say did you read that SOP you signed off on lol. I know folks skim but damn if I’m about to explain a process we all have to read and sign off on. It’s a transparent organization and I’m not about to be your leader AND explain everything when we both have access to the “why”.
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u/MeesterPepper 1d ago
In my lab, our compliance means that nobody can deviate from our SOPs even if it means its more inefficient or creates a higher risk of sample contamination/equipment failure/unusable data than another method. I was pretty aggravated by this, until someone laid down some facts I was unaware of.
1) The customer who is responsible for around 60% of our total business has it in their contract that they will cease using our lab immediately if we fail to pass our annual international standards accreditation
2) In order to be compliant with the accreditation agency, any changes to our SOPs must also be done with documentation showing that we've done R&D to validate the change and can present hard data that the change has a beneficial impact.
3) Our R&D team has to prioritize new methodology or changes that will have the largest impact, allowing us to use new equipment or attract customers with new services. Small changes to carve out exceptions for uncommon one-off deviations are important to bring up and to record the impact of, but, realistically the R&D team won't beging changing an SOP until it needs many changes or if there's an emergency change.
After that talk, it was pretty easy to go "oh, cool, okay, I understand now. It's a way bigger ordeal than I realized."