How do you Create SOPs for Multiple Authorities?

[Jen C]

Hello all,

I am working on updating my company's SOPs for event reporting and recalls. We deal mostly with the EU, but also with the US and Canada. I'm just curious about how other companies write these kinds of cross-authority SOPs. Do you write separate SOPs for each jurisdiction, or just one to cover all? And if the latter, do you treat each authority as a separate case, or attempt to come up with one overall process that applies to all jurisdictions?

Thanks for your feedback!
Jen

 

[insect warfare]

Re: Creating SOPs for multiple authorities - how do you do it?

Seems to me the most practical application is to document all the common aspects that apply to all authorities, and then start outlining the things that are specific to each authority, and hammer them out on paper. In the end, you should have a single working document with little to no duplication. My piece of advice to you would be not to get wrapped around the axle or "analysis-paralysis" could set in. And make sure it is consistent with your other documentation.

Keep it as simple as possible, but no simpler than that...

Brian

 

[yodon]

Re: Creating SOPs for multiple authorities - how do you do it?

I knew I had seen a flowchart posted in the Cove that covered reporting requirements (blewispunk, 2010). See: http://elsmar.com/Forums/attachment.php?attachmentid=11948

It covers EU, US, and Canada. As with any posting (esp. one 3 years old), take caution using it, things may have changed.

 

[sagai]

The most simple way to do so is to define a decision point from the process prospective and to provide the links to the corresponding web pages of the authorities.

 

[kgott]

Hello all,

I am working on updating my company's SOPs for event reporting and recalls. We deal mostly with the EU, but also with the US and Canada. I'm just curious about how other companies write these kinds of cross-authority SOPs. Do you write separate SOPs for each jurisdiction, or just one to cover all? And if the latter, do you treat each authority as a separate case, or attempt to come up with one overall process that applies to all jurisdictions?

Thanks for your feedback!
Jen

Sometimes they just have to be done.

We have clients who demand that in addition to legislative requirements, we also need to address all the requirements of OHSAS 18001 and AS4801 (Australian safety std) and the clients internal requirements at the same time. This causes us to have to address issues and make statements in our processes, that just do not apply to our work but we have to get a certain 'score' to be certain 'category' of supplier. We do this just to accommodate the requirements for a few international iconic mining and O&G clients.

It's a juggling act but by careful wording, one can navigate through the maze. I have found the key can lie in being somewhat 'generalistic' in the description of how the process works or on how we meet their standard.

Bear in mind too that SOPs when approved by clients, are subject to change as a result of changes in the way work is done and continuous improvement occurs.

Sometimes these are mere 'tick-the-box' exercises but sometimes auditors come to visit. We will be visited in October so that will be an interesting time for me.

 

[tehuff]

I have done it both ways (all-in-one or separate) and both methods have their merits. The front-end process at a general level is the same for all countries so put this in an SOP and then either a) create separate country-specific sections in this same document or b) point to separate country-specific SOPs. Either way, make it transparent so it is easy to explain to an auditor. I agree with Insect Warfare, don't spend too much time figuring out ALL the common points in the process. At the first major diversion in country requirements at a higher level, break it into country-specific sections or separate SOPs. There may be some redundant requirements across the countries at this point, but that's ok. It will be easier to manage in the end.

 

[benderspeck]

My experience is that some SOPs should be distinct for each country. Even though the process for reporting may be very similar, the auditors may not accept a "single process" for reporting to all countries. I broke out the procedure to deviate and be country specific just to make them happy.

 

[Jen C]

Thanks so much for all your feedback! It sounds like there isn't one standard way of doing this, which is kind of as I suspected. We are tending to write one procedure that has the general information up-front, then detailed info for each jurisdiction further down. It can make for long procedures though, so I can see where sometimes breaking it out into separate documents would be more appropriate.

Thanks again!

 

[insect warfare]

Glad we could help!!! Good luck, and let us know how it works out....

Brian