Managing Ongoing Compliance to Standards when they are Changed

[gretzles]

Just wondering what tools people use for ensuring procedures remain compliant with the standard when they are changed. I've seen this done by having all elements of the standard referenced in the quality manual and procedures referencing the quality manual and then requiring the Quality Manager to approve all changes to these documents.

I'd like to use a less hierarchical system (ie wiki) for documentation and allow more freedom to make updates.

My current thinking is to have a page for every element of the standard and 'include' that on the relevant pages.

I'd like to hear how others have solved this. (Also, please direct me to where there might be other discussions about this in the forum)

thanks

 

[Pancho]

IMO, the included quotes from the standard would be clutter and get in the way of the valuable content of your procedures. Even references to the standard are superfluous to users of your documents.

Process owners should be familiar with the standard, and they should be ultimately responsible for the quality of their documents, their process, and its products. Applying the standard comes naturally after they have written the first version of your documents. If a user modifies a document in an undesirable manner, then the process owner can and should revert the change. And operators need not know what the standard says in order to consult the docs on how to do their jobs.

Omit information not directly relevant to the user of the procedure. However, if you are using a wiki, I would recommend that you do include in every page

1)
A main menu with links to to the main page for every one if your company processes.

2)
a navigation panel (secondary menu) that has an outline consisting of the hierarchy of links to every other document in the process to which that page belongs.

The above inclusions are relevant to users because they show how their work relates to other parts of your system. These navigation menus create a "very small world network" between your documents even if document authors omit contextual links. Such network is key to availability at points of use.

 

[gretzles]

Thanks Pancho

Keeping out the clutter is definitely part of the plan.

I might have to do a bit more work with the process owners in understanding the standard. I agree that they should be the ones that best understand the parts of the standard that apply to them.

I am still working on how to include those menus - I'm only a couple of days into my trial, but I can already see how useful they will be

 

[_Jens_]

Hi,
I think one useful tool would be to keep one list of relevant standards along with some meta-information, e.g., the organization issuing the standard, version, status (e.g. draft, released, effective, obsolete), effective date, product categories affected, whether it is binding/recommendation/etc, to which markets it pertains (US/EU/CN/JP/BR/...). The meta-Information would be useful for filtering. Such a list could be maintained by expert communities or a quality/regulatory intelligence group, or both. If a new or revised standard is issued then it is simply added to the list as a new document in "draft" status. All process owners/Q managers are regularly (e.g., monthly) informed about changes to the list and are responsible to check whether their processes / procedures are affected, and then have to update SOPs and work instructions for operations. Thus workers usually do not have to look up the original standards, but if, then they have a central place to look for. Also, you can always demonstrate q compliance to auditors.