Documents and Their Control
Last month’s column addressed the notion that developing controlled processes is key to an effective quality management system (QMS). It should follow that a well-developed system needs careful documentation to provide a basis for controls.
Often we hear that unnecessary or too-restrictive documentation is created. Efficient and effective documentation is:
• Complete. The processes need to be adequately described so that the documentation can be useful in training, auditing, and operations.
• Useful. The form and content need to be so clearly stated that the average employee with a question can refer to the applicable document for the answer.
• Easily accessed and found. Documents will not be used frequently unless they are structured, filed, and indexed in a user-friendly manner.
• Simple. This is a tough one. It’s easy to make complicated documents to cover simple topics. Simple is generally better. Visual is generally better. Remember the old phrase, “a picture is worth a thousand words”? When it comes to documenting production and delivery processes, it’s often true that a digital photograph says more than is possible to write down. A digital camera is often worth more than any tool other than your computer.
• Online with liberal hyperlinks. I know, lots of us older guys like to read paper. So what? Most workers are very comfortable with finding and using documents in a web-based environment.
Documentation must be limited to that needed to operate the QMS efficiently and effectively. Yes, limited. Certainly you need a quality policy, objectives, a quality manual, and the few specific procedures required by ISO 9001. That is really very little documentation. Of course, if you must comply with one of the sector-specific QMS standards, such as ISO/TS 16949, more documents may be required. But ISO 9001, subclause 4.2.1, includes the notion that the organization has “… documents needed by the organization to ensure the effective planning, operation, and control of its processes….” This is where organizations often fail.
Instead of limiting themselves to documents that meet the test of “needed to ensure effective planning, operation, and control of its processes,” some organizations document everything. That’s a big mistake. Why? The simple answer is that creating more documentation than you need causes complexity and, ultimately, complexity causes problems. The important point to remember is that the type and extent of such documentation is up to the organization. This apparent freedom comes at a price, however. It means that you have a responsibility to make competent decisions on what documentation is needed and how to create it.
Documentation developed with these ideas in mind may be a great contribution to achieving a system that has efficient and effective controls. On the other hand, poorly structured, ill-prepared documentation will often result in loss of system control.
What about control of the documents that we generate? ISO 9001, subclause 4.2.3, requires that the organization define in a documented procedure the controls needed:
“a) to approve documents for adequacy prior to issue,
b) to review and update as necessary and reapprove documents,
c) to ensure that changes and the current revision status of documents are identified,
d) to ensure that relevant versions of applicable documents are available at points of use,
e) to ensure that documents remain legible and readily identifiable,
f) to ensure that documents of external origin are identified and their distribution controlled, and
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.”
Necessary documents should be treated as important to the business and be subjected to rigorous, reasonable controls. Too many documents in the system make controls complex.
Good documentation is the basis for disseminating understanding of the QMS and its requirements throughout the organization, and that understanding is a basis for achieving control of processes and auditing effectiveness. Too many documents, or complex documents with complicated controls, are detrimental to effectiveness. The quality professional can help the organization select the right document set to suit its needs and to make certain that important documents are controlled.
John E. (Jack) West is a consultant, business advisor, and author with more than 30 years of experience in a wide variety of industries. From 1997 through 2005 he was chair of the U.S. TAG to ISO/TC 176 and lead delegate for the United States to the International Organization for Standardization committee responsible for the ISO 9000 series of quality management standards. He remains active in TC 176 and is chair of the ASQ Standards Group.
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