Focus on the information, not specific documents
by Mikel E. Janitz
The phrase "control of documents" is simple, but it's one tough element of ISO 9000 to design, document, implement and maintain. To simplify this element, you need to ask, "How do you define and control information?"
First, identify the information or documents you want to control, and point them out to those directly associated with your quality management system. The documents should include those procedures, work instructions, forms and product specific information that directly affect production and the product.
To understand how to control documents, you must understand the systems that support them. Those systems should include a master list, unique identification, revision status or level, reviewer, approver, issuance or distribution, removal of obsolete documents and notification of change. Whatever system or sequence you choose, it must be effective and flexible.
Most people tend to get hung up on the document's intended use, title or purpose by trying to define it as a training document, reference document, training aid or quality alert. What's in a name? A lot. Some think if you don't label a document as a work instruction, procedure or policy, it doesn't have to be controlled. That couldn't be further from the truth. Change is difficult, and changing someone's mind to control a document he or she feels does not need to be controlled is not easy.
People need to learn the document's content is more important than its intent. Documents contain information that needs to be accurate, timely and generated by the appropriate authority. No matter what you call the document, the information it contains is what requires control.
It is difficult for some people to understand a document needs to be controlled when they call it a training document or a reference only document. But once you demonstrate the information is the important aspect, people will stop focusing on titles and start seeing the value in controlling the information.
The best way to manage and control information is electronically. We have reached the age of the paperless office and shop floor. First, let's look at the front side of document control--how to generate the information:
- Assign responsibility for creating the information.
- Control access to where the information is generated and maintained.
- Minimize the number of people who create, modify and approve information.
- Allow the information to be easily accessible by all who need it.
- Ensure the information is clearly understood and legible.
- Train the users on how to access and verify the information.
- Provide an index.
Now let's look at the users' side:
- Train the authors and users on system requirements.
- Provide for multiple access points (input/output).
- Allow information to be created from multiple locations.
- Allow access to the information from users' personal computers or a common computer.
- Print copies if necessary.
- Validate hard copy information before use.
- Require readers to provide feedback to the author for updates.
- Identify updated information with an electronic flag.
Positive retrieval or removal of obsolete documents is now a moot point. Allow the information to be printed, but watermark it to indicate the information is not controlled in hard copy form. Remember you don't control uncontrolled documents. Second, and arguably most important, train the reader to verify the hard copy and dispose of obsolete hard copies.
Control Information, Not Distribution
Look at the fundamentals again. Allow your organization to focus on information in general, not on documents and their hard copies. Create a system that crosses department boundaries and supports everyone's needs.
Some things to consider include:
- Creating and maintaining information electronically using the file name and path as the title.
- Making the author the person who creates, reviews, approves and revises information.
- Adding a date to the document to indicate status or revision level.
- Requiring the user to verify information, therefore placing the burden of disposing of hard copies on the user.
Don't forget to define the responsibility of the electronic system infrastructure, too. Once you get the definition in place and understood by the participants, they can begin minimizing and consolidating information. This will lead to fewer steps and improve the bottom line. That's what it's all about.
MIKEL E. JANITZ is quality manager of supplier development and engines at Mercury Marine-MerCruiser in Stillwater, OK. He earned a master's degree in engineering and technology management at Oklahoma State University. Janitz is an ASQ member and a certified quality systems lead auditor.