4.5 Document and Data Control 4.5.1 General

The supplier shall establish and maintain documented procedures to control all documents and data that relate to the requirements of this American National Standard including, to the extent possible, documents of external origin such as standards and customer drawings.

This is the standard requirement: "establish and maintain documented procedures" to control anything at all to do with the quality of the product. In my book, that's just about everything. After all, if something has nothing to do with the quality of our products, why are we doing it? The information needed to do the job definitely affects the quality of our products.

4.5.2 Document and Data Approval and Issue

The documents and data shall be reviewed and approved [...] prior to issue. [...]

This control shall ensure that:

1. the pertinent issues of appropriate documents are available at all locations where operations essential to the effective functioning of the quality system are performed.
2. b) invalid and/or obsolete documents are promptly removed [...].
3. [...]

This is really quite simple. Assemble the necessary information, make sure that it is correct, get it to the people who need it, and make sure that it is kept up to date. This is easy to understand. This is motherhood and apple pie. No one is going to disagree with this. So why do so many organizations have difficulty accomplishing this?

One reason may be that accomplishing this is considered to be trivial. When asked, most people would say: "Of course we do that. Of course we get everyone the documents they need. Of course we keep them up to date." My response to these assertions would be to ask them to prove it. If they can prove it to an uninterested observer, they have satisfied the ISO 9001 requirements for document and data control. If they just hand-wave, they are only fooling themselves.

Let's follow the steps in order.

1. Assemble the necessary information. This is an on-going effort but the bulk of this should be accomplished during the contract review and planning phase of the project. A list of this information should be kept along with some way to note the current revision.

2. Review the information. Make sure this information is as correct and up-to-date as possible before anyone starts using it. If some document is changed, it is crucial to make sure that previous versions are eliminated.

3. Distribute the information. Get it to the people who need it. Who needs what should be determined during the planning phase of the project. Or, get everything to everybody on the project. Make sure you either keep a list of who-has-what or have some other mechanism to see that updates replace all previous versions of a document.

4. Have an update mechanism. When changes are made, you must have a means of disseminating the update. It only takes one person using an out-of-date document to cause a whole lot of problems and rework. That's why you keep a list of who-has-what or use some other mechanism to replace all out of date versions. This is the most important aspect of a document control system: ensuring that an updated document replaces all copies of an out of date document.

Knowledge is the key ingredient of quality.

Aguayo, Dr. Deming: The American Who Taught the Japanese About Quality, Fireside, 1991.