How to structure work instructions in the ISO 9001 QMS
Knowing when to write work instructions and what to put into them are often struggles that hinder people from implementing a quality management system (QMS). Since ISO 9001 does not specify how you must structure your documentation, this decision is largely left up to you, but there are some best practices that can be taken into account when creating your work instructions.
Do you even need work instructions?
I have said this many times, but it bears repeating: it is not always necessary or even wise to create documentation on everything. I was watching a webcast presentation from Mark Ames recently, where he demonstrated how people often get it wrong when deciding what to document. Looking at three processes that have low, medium, and high complexity and risk, people tend to think that the higher the complexity and risk, the more need there is for documented procedures. This turns out to be the opposite. The examples given were:
- Low complexity: baking a cake where every box of cake mix has the recipe printed on it.
- Medium complexity: driving a car where there are no procedures, but instead rules and training.
- High complexity: brain surgery where you would not want to hear your doctor ask for the procedure as you were going under anesthetic, but instead want a highly trained individual who can think through any problems rather than looking to a manual.
So, really ask yourself if you need to write down the procedure you are documenting, or if you would be better with a trained operator who can think and react to problems. If you do indeed decide it is best to write down your work instructions, the first step is in researching what you need to say to direct the work of your employees.
Research what information you need to relay
In the article 7 steps in writing policies and procedures for ISO 9001, I talked about the steps used for policies and procedures to define the information to document, get approval for the document, and train relevant employees. These seven steps helped to make sure that you gathered the appropriate information for your document and made sure it was aligned with the other documentation of your QMS.
For work instructions, these steps to gather this information to put in the document are valid, but there are a few more things to consider during this process:
- What level of information are you documenting? This is one of the first and most important questions to answer. How much detail do you really need to give? For example, if you have a good form that is easy to fill in because you can determine what information needs to go where, then you don’t need to have work instructions to tell people how to fill in the form. However, if the information is hard to find in your computer system, then more detailed work instructions explaining how to find the required information might be helpful. You need to determine what level of detail will make your work instructions useful for your employees.
- What do you need to do to make the work instructions understandable? This seems like a straightforward question, but it is often not thought through fully. What language do your work instructions need to be in for your employees: French, English, Spanish, or another language? Do you need to have work instructions that are bilingual?
- Should you use flowcharts or another graphical representation? This can be one way to help make your work instructions understandable. Many people find a flowchart easy to follow, but will all your employees find this to be enough information – or do you need more? Do your employees need training to understand flowcharts or whatever graphical representation you are using?
Find the right structure that works for your organization and people
There is no “right” structure for work instructions; there is only a best fit for the people in your organization. Once you have found the structure that works for you, make sure that everyone understands how to use it and equally importantly, why you have chosen these work instructions to document.
One last thing to ensure is that people know how to suggest improvements and changes in work instructions. One of the risks of documented work instructions is that they can hamper improvements if people are afraid to change the documentation; and, to get the best out of your QMS, you want to make improving easy. After all, improvement is one of the main reasons to have a QMS in the first place.
To find out what documentation is required by ISO 9001 and what is commonly used, see this white paper on Mandatory Documentation Required by ISO 9001:2008.