Writing our Standard Operating Procedures - Examples wanted

G

Ghenderson

#1
Good Evening,
We are a private supplement manufacturer and need to write our SOP's. Is there a helpful templates which will get us started with writing and developing the company's SOP manual. We need some help getting started.:frust:
 
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C

Chris Ford

#2
Re: Writing our Standard Operating Procedures

Good Evening,
We are a private supplement manufacturer and need to write our SOP's. Is there a helpful templates which will get us started with writing and developing the company's SOP manual. We need some help getting started.:frust:
I'm still feeling my way around this site, but there are several forums that include templates and discussions about implementing a quality system. They're broken down into standard-specific topics, so it's pretty easy to find what applies to you.

My suggestion would be to first step back and take a look at why you need a quality system in place. Decide which standard or standards you're going to conform to, then buy the standards. Go to a workshop on implementing that standard... they usually only take a couple or three days... even one day seminars can be helpful. It's really important to understand what you're doing and why you're doing it when you're implementing a quality system. A lot of people just start writing procedures because they're told that they have to in order to conform. They're missing the point.

You need to understand how your business works, and how a quality system can benefit it before you start implementing procedures... if you're going to implement a system that's effective, that is.

At any rate, which ever route you take, I'm sure you're going to find a lot of helpful hints here. I've been very impressed with what I've read here over the last couple of days.

Best of luck to you,
 
G

Ghenderson

#6
EXCELLENT!!!!

Thank you, your examples have made things much clearer. I was able to locate a website that has also been helpful which I will share. I'm not sure of this sites policies regarding posting a web link so I'll just explain how to find the website using your preferred search engine.

In your search string type in HACCP Based SOP's. That should bring you to several choices and the first couple sites listed will be the templates website.

I have yet to see a site as helpful as the HACCP site about SOP templates and I thought that others members here may know of similiar sites. I'm new to this site but have already found it as a wonderful resource. I hope that anyone who may have more SOP's templates specifically relating to Dietary Supplements writes to this post.

Thanks again,:agree:
GHenderson
 
J

Jeff W

#7
I'm in the same boat as you are. Writing SOPs for FDA DSHEA compliance with a dietary supplement/functional foods firm that is, ahem, a little behind in their documentation - but may actually be in better shape than most in this newly regulated industry. I will soon find out at the Supply Side West convention in Vegas.

I am extracting my SOP guidance directly from the FDA Final Rule in the CFR, and also from a GMP compliance webinar that was put on by AIBMR and is still posted on the Natural Products Insider website.

One of the explicit "requirements" of an SOP is that it be written in plain language to make it more useful for training of ALL staff, not just the manicured and brainy types. From what I have seen, almost all companies fail miserably in the creation of "common language" SOPs. The tone is generally pseudo-intellectual, legalistic, and dense. Very dense. it is stunning how many SOPs I have seen that cannot actually be understood, that leave out steps, that don't define their terms, that call the same thing by different names, and that seem to revel in obfuscation.

My theory is that the people writing SOPs have little insight into the important business function of a well-crafted SOP. But they do have a lot of experience sitting in front of computers. These SOPs are the specifications by which an organization functions, the standards it holds itself to.

Fewer elitist compliance wonks and more blue-collar geniuses - that would be really cool!

Geez - I guess I had a rant that needed to be released. Thanks for listening.
Jeff
 
J

JaneB

#8
I'm not sure of this sites policies regarding posting a web link so I'll just explain how to find the website using your preferred search engine.
It's fine to share a link to something you found useful.

The proviso would be against someone posting a weblink to their own site/trying to drive traffic to their website etc. under the pretence of being 'helpful'.
 
J

JaneB

#9
From what I have seen, almost all companies fail miserably in the creation of "common language" SOPs. The tone is generally pseudo-intellectual, legalistic, and dense. Very dense. it is stunning how many SOPs I have seen that cannot actually be understood, that leave out steps, that don't define their terms, that call the same thing by different names, and that seem to revel in obfuscation.

My theory is that the people writing SOPs have little insight into the important business function of a well-crafted SOP. But they do have a lot of experience sitting in front of computers. These SOPs are the specifications by which an organization functions, the standards it holds itself to.
I agree - clarity, brevity and user-friendliness are important.

While I agree some writers don't understand the importance, I also think that not enough value is given to good, clear writing. So often poor models proliferate, which means that other people think that's how things are or are supposed to be. They don't and they aren't.
 
B

brahmaiah

#10
I agree - clarity, brevity and user-friendliness are important.

While I agree some writers don't understand the importance, I also think that not enough value is given to good, clear writing. So often poor models proliferate, which means that other people think that's how things are or are supposed to be. They don't and they aren't.
I think there is no standard definition of an SOP.Some people call a procedure in a manual an SOP.Many think that an SOP is like a work instruction for an operator and it should be displayed in the work place.Can any one please define an SOP preferably with examples?
V.J.Brahmaiah
 
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