You’re responsible for documentation for your organization. And you want to make sure your Standards Collection can meet the requirements of your regulatory and/or quality management programs. Developing a Compliant Standards Collection takes work, but once put into place your company will benefit throughout the organization.
The first step in setting up a compliant standards collection is to identify any and all standards used within the company. You’ll need to find them, sort them into controlled and uncontrolled classifications, identify them by number and revision level (date), and link them to products, divisions, and/or personnel.
Where can you find standards within your organization? Many companies have relied on paper format collections over the years. So there may be a central repository of documents that will provide you with your baseline collection. But be aware! There may be “rogue” copies floating around within your company as well.
To find these “strays” you may be able to do a physical inventory of standards stored at employees desks and on their computers. But if your company is larger, you may need to enlist the assistance of all staff members. They’ll need to self identify and surrender any copies of standards they possess. Staff members can also be helpful in connecting various standards to regular processes and products of the company.
Why ask how a standard applies to your business processes? You are going to need to make a distinction between those documents you use in the course of your business and those that have been obtained for “one-off” requirements. Documents that you need because they are referenced in your procedures or are required by law or regulation are going to be “controlled.” You’ll be monitoring them closely from here on out.
Uncontrolled documents are those purchased for other purposes, like evaluation of a technology, product development that did not get implemented, and so on. And sometimes staff members have standards at their desks that they do not want to surrender. You should mark these copies as “uncontrolled” so that users are responsible to check the status of the documents themselves.
Now we need to take the first steps in setting up a method for monitoring and retaining our controlled document set. At the same time, we’ll develop a protocol for letting people know when a document is uncontrolled. Why? An uncontrolled document may be out-of-date because it is not part of the set you’re keeping track of on a regular basis.
It’s most important to know that your controlled documents are current (the most recent revision). So you’ll need to take an inventory and compare what you have to what’s correct.
Here, Document Center Inc. can assist you with our Standards Audit service. For a small fee, we take the list of documents you have (including the dates on the cover of each) and compare them to our database of standards. When your Audit is complete, you’ll get a list of the revisions you’ll need in order to get your core list of standards into compliant condition.
It is also helpful at this point to connect the standards you’re controlling to the places in your organization and your documentation where they are actually used. Then as your standards are updated in the future, you’ll be able to notify the folks that use them of the changes. This is essential for gap analysis and for compliance with quality and regulatory requirements.
It can be a daunting process to collect, categorize, and assess your documents. But it is an essential first step in developing a compliant standards collection. Starting off on the right foot reaps dividends later on down the road.
Next time we’ll discuss how you can procure the items you need to get your collection up-to-date and how you can provide access to your standards to the appropriate personnel.
Meanwhile, if you need help in managing your standards collection, contact Document Center Inc. We’re on the web at www.document-center.com. Or you can get in touch with our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’ve been working with standards since 1982 and have a variety of programs that can assist in every phase of your collection management process. Make us your Standards Experts!
