The 5 Rules of Standards Collection Management.
- Define those standards you must have in your collection.
- Define a method for keeping your standards current.
- Define a method for insuring that staff only uses the correct copies.
- Have a method for accessing other standards of interest.
- Define a method for knowing about other standards of interest for potential evaluation.
Rule 1:
Define those standards you must have in your collection.
In setting up a centralized, managed standards collection, the first task is to define what documents must be controlled.
There are a number of sources for you to use in order to determine what standards are (or should be) used by your organization.
Standards that are called out in customer contracts have legal implications for your organization. You should review all contracts to determine if any standards are being referenced in them. If so, a decision needs to be made if the standards will be purchased for the processing of the order, to be kept with the back-up paperwork for the contract, or if you will maintain a collection of these standards in case the usage may be recurring. These types of referenced documents may require special handling later in our processes. Also note: your customer may provide you with drawings or other specifications to adhere to in fulfilling a customer contract. These drawings may reference other external standards. These referenced documents need to be identified and reviewed for proper handling. Standards can be called out in your own internal product specifications. Such standards need to be identified not only by document but also for applicable revision level. For these documents, you may want to monitor not only the standard that is referenced, but also those team members in your organization responsible for the internal specification. Later in our processes, we may want to be able to easily communicate document changes to these folks. During the identification process, customers will send us requests on letterhead for a copy of their confidential information regarding the documents they've purchased in the past. Because we keep a list of every document we've sold to each customer location, and the name of the person using the document, this listing can be invaluable during the discovery phase. Also, you may also have specific technologies that you need to monitor. For example, if you are in the medical device manufacturing business, you may have a manufacturing facility that needs to be current with clean room technologies. You will want to identify any standards that are called out in company procedures, or that are the basis for company protocols. Again, you will want to have specific contacts within the organization who will do the actual monitoring of the document content to insure your company is using legally defensible technologies in it's products and processes. Lastly, you may have specific regulatory or region specific information you need to keep on hand. Some examples are the Medical Device Directive, which is a European regulatory document. You will want to familiarize yourself with the parts of the world in which you sell product or would like to sell product, and define those legislative bodies that will have an impact on your business. Misjudging the seriousness of the legal environment in which we do business can have catastrophic results in worse case scenarios.
Rule 2:
Define a method for keeping your standards current.
Once you have identified those specifications, standards, regulations, etc. that have a legal bearing on your business, you need to figure out how to maintain your collection in "current" condition. There are really two steps to this process.
First, you need to find out if those documents you already have on hand are correct. You may choose to go to the source organization for each document and query them as to the document's validity. Or you may choose a "library" organization to review your list for you.
Should you choose to use an external firm to audit your collection, you need to give your audit company a complete list of the documents you actually have. Include any dates, revision level information, and so on for each item. Some items will be 100% current, some partially current, and some may be at the wrong revision level or obsolete altogether. Your audit should show which items are good, which need partial upgrading, which are replaced and which are withdrawn without replacement.
Once you have a confirmed document set to work with, the next order of business is keeping it in good shape! You can again go to each of the source organizations on some kind of scheduled basis in order to review your document status. For some source organizations, you may even find that they have an email notification service. However, if you have an extensive number of documents or your proposed schedule is too time consuming, you may prefer to have a "library" firm handle this aspect of your collection management.
Some benefits of using a third party for this task are that the large standards distributors get standards documents and standards information from a wide range of standards providers on a daily basis. This means that when a document they're monitoring for you gets changed, they're likely to know right away. Also, depending on the level of service you get from your service, they may be able to notify you within 24 hours of the change to your documentation. This fast notification service is something that customers have been demanding for a long time.
If you have standards in your collection that are included because of contractual activity, you may find that not all documents are always in use. One level of service we offer is postcard service, and for our customers in this situation, we find that they often staple the postcard to the actual modified document without purchasing the upgrade. Then, the next time someone in the organization needs to use the document for a new contract, the postcard alerts them to the fact that the document on the shelf is out-of-date in some way.
The other thing you may find is that you may want to integrate the process of collection definition (the discovery phase) and data conformance (the audit phase). We did this in an on-going project with NASA. In order to manage the use of standards in all the NASA projects, we are part of an effort to create a list of NASA-approved standards. In this effort, NASA has set up a system to handle the input of standards that are used on a project-by-project basis. The information is forwarded to Document Center, where we verify the status of each standard that is used in each NASA project. Then, we continue to monitor each of the standards that make it onto the list.
Here's one example of the results of the NASA project: "Unfortunately, ignoring revisions to standards is equivalent to ignoring experience with the standard, and ignoring experience is not good engineering practice. A pilot survey of one major program subsystem found only 124 standards (out of a total of 552) were still current; half of the documents were uncontrolled, and the remaining documents were either cancelled or inactive, although some had replacements. The program had no standards related problems, but the guidance wasn't current best practice, and the risk was there. Corrective action was taken."
Rule 3:
Define a method for insuring that staff only uses the correct copies.
Once you've got your collection defined and have a way to insure that it stays current and in conformance with your legal requirements, you need to find a way to confirm that staff is using the correct documents as required. This is a tricky task, as engineers love to have copies of frequently accessed standards in binders and desk drawers.
However, there are a number of ways to ensure that your employees are using the controlled collection. And that's good, since that's why you've got the controlled collection in the first place!
For smaller companies, a print collection in a central location often times is quite acceptable. We've seen small standards collections in binders on shelves, in file cabinets, and in shelved folders. As long as you know that when a standard is required, the staff member needing the information is going to access the data from your controlled set, you're fine.
However, as organizations grow larger or become more familiar and comfortable with technology, the use of electronic files is another great way to solve this issue. However, there are still issues of copyright compliance and licensing restrictions that surround the use of electronic copies of copyright standards. So please be careful to obey the law if you would like to institute a networked collection.
Currently, there are a wide variety of ways that source organizations are making their documents available. Some are only providing them in paper. Some are providing them in CD Rom format as well, with such restrictions as no printing capability, no networking rights, and so on. Sometimes you can get CD Rom copies with a 1 to 5 user license, and so on. Other times, standards are available as pdf copies, usually with a license agreement that restricts the purchaser to use the pdf file to print one paper copy only and retain the pdf file on one computer only for the use of one person.
We are starting to sign agreements that allow us to extend the license for a pdf purchase for multiple users, with pricing on a sliding scale. But not all organizations are comfortable with this. Some of the associations that hold copyrights are important titles may sell multiple user rights only for standards in a subscription bundle, by ICS code for example.
So, setting up a custom electronic standards library at this stage is still a bit of a challenge. However, in the long run, the use of technology in this way should provide standards users with the true confidence needed for company-wide compliance with the approved set of standards and regulations.
Rule 4:
Have a method for accessing other standards of interest.
Sometimes staff is going to need to review or use standards that are not necessary for company-wide control In order to prevent the inadvertent use of non-controlled copies of the managed list, it is advisable to have a secure method for placing orders for documents. Remember, we need to prevent the use of controlled standards outside of our managed environment. And yet we need to allow for the use of not-controlled standards on an as- needed basis.
Our customers sometimes have all standards orders pass through the hands of the document control function. Or, they may force all orders through the approved list process, with automatic order availability if the document does not appear on the approved list.
The use of a vendor with an aggregated catalog can make the ordering process a lot easier than using individual sources, and can allow you to have your vendor support your procurement policies. Or, sometimes association memberships come with publication benefits you can use for primary distribution.
In any event, you must make a plan for how your staff will procure non- approved standards so that you will know that they are in compliance with your controlled set at all times. If employees are able to order at will outside your process, sooner or later a non-controlled copy of an essential document will make its way into your system.
Rule 5:
Define a method for knowing about other standards of interest for potential evaluation.
Our last issue is how to keep staff up-to-date with industry trends and to make sure that you're not missing important information because it didn't make it onto your original audit process.
At the end of this presentation, we'll review important sources of information for the medical device industry. One option is to review those resources on a regular basis. Sometimes they have "what's new" pages that are updated on a regular basis. Or they make have email alerts that will let you know everything that is changing for specific time periods.
At our company, we integrate information on committee activities, draft releases, and released documents by technology classification and release reports on a quarterly basis. Some areas we cover in these reports include quality, clean room technology, medical device technology, and so on.
Other ways to get similar information is in industry magazines and newsletters, although we don't have any specific titles to suggest.
There are constant changes in the medical device sector due to the impact of the EU and FDA. Keeping up with the new standards can be a challenge for any organization, but essential to assuring that one's products are in conformance with current requirements.
Appendix:
Sources of Medical Device Information:
Quality - American Society for Quality
Medical Devices - AAMI, the Association for the Advancement of the Medical Instrumentation
FDA - Food and Drug Administration, CDRH - Center for Devices and Radiological Health
EU - Medical Device Directive and resulting EN standards
ISO - the International Organization for Standards
IEC - the International Electrotechnical Commission