QMS Documentation: Don’t Get Trapped by Your Words

Conditional words or phrases can keep you from painting yourself into a corner

Sometimes interpreting ISO 9001 or API Q1/API Q2 requirements seems to force us to agree to things we won’t be able to do, or to sustain for more than a few months, let alone days. So how do we write our policies and procedures to explain our approach while avoiding being boxed in by our own words?

There are a handful of words or phrases you can use, as necessary, when you don’t want your procedures to be overly proscriptive. Call these “conditional” words or phrases (some might call it “hedging”). These words, when inserted into your procedures, may help you comply with the requirements of quality management system standards without backing yourself into a corner.

Leave maneuvering room in procedures or work instructions

Here are some useful words to include in your procedures or work instructions:

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Comments

Using Conditional Words and Phrases

I must say I disagree with Ms. Boudreaux on the use of conditional words in process documentation. I have been in Quality for fourteen years, mostly as an ISO auditor. In my experience these are words and phrases that should be avoided. Whenever I see “as applicable”, “deemed appropriate” or “when required”, the next question I have is, “Where is it documented what is applicable/appropriate/required?” Unless those things are defined it is a very weak process. And typically, if you ask 10 different people to know this without it being defined, you will most likely get 10 different answers. Respectfully, Rhonda Case

A disagreement with the disagreement

People can be trained (or may otherwise be competent) to know what is "appropriate" when the words "as appropriate" are used in a procedure. There is no requirement for every possible appropriate action to be documented. The standard does't require cookie-cutter management. If management does, then okay, but only if they say so. Use of the phrase "as appropriate" is often a legitimate authorization for competent personnel to think for themselves and make decisions they have been authorized to make. There are plenty of cases where "as appropriate" is appropriate.

Bingo

You got it. Competency is the word. Thank you for your comments.

use at your own discretion

Rhonda thank you for your comments. I understand your point and that's what I said in the article "Use at your own risk". The idea is to provide discretion, but that is up to you. Competent people can be given sufficient leverage to make certain decisions. People without any skills or experience, would probably not do well with this open-ended instructions. In that case, the more detail, specific and concise instructions you give, the better you will be. So competency dictates the level of control you place on your procedures.

Five pages - Words !

The Bee Gees, Words, lyrics: " ... this world has lost its glory ... let's start a brand new story ... talk in everlasting words ... it's only words, and words are all I have".