Quality documentation can be improved. Whether you use a simple word processing program such as Word to document your processes, or a more sophisticated documentation software program, organizing your material and
identifying the simplest way to meet your needs is the key to documentation success. Let’s reaffirm the purpose of work instructions:
Training. Instructions serve as a supplement to hands-on training; they are written to facilitate the training process.
Reference. Once people are trained, there might be a need to make quick reference to specific tasks.
Problem-Solving. Any identified corrective actions should use the supporting work instructions to assist the problem-solving process.
Continuous Improvement. A review of documentation on a defined basis helps ensure that what you have defined reflects the current process.
All documents within your quality system should be reviewed at some point. Not only is this a requirement of most standards, it just makes good sense. Whether you are developing a new system or just going through a review, the following four steps will help you as you go through the process of definition, review and simplicity.
1. Organize by Department. First, ensure that your system is divided into logical departments or locations. This makes locating information easy and keeps it applicable to that specific area. Doing this does not complicate a function with requirements outside of the responsibilities. Also, identify an organizational chart for the department. Then identify people by job titles (never names) on documentation.
2. Define Responsibilities & Authorities (R&A) for Personnel. Create a "Responsibilities & Authorities" document for each position. Then, define the responsibilities for each function (again,
Review each responsibility and determine if it lends itself to work instruction. Use the R&A as a mechanism for driving your training program. Do not identify responsibilities on every document. Repeating information is redundant and adds no value.
3. Simplify Work Instructions. Be sure there is only one sentence per action verb. Stay away from writing paragraphs. Nobody will read them, and they do not allow for easy reference.
Do not describe "why" things are done. The purpose of work instructions is to document "how." "Why" detail is best left for the training process. If you don’t know why you are doing things, you have
bigger issues to address.
Remember that work instructions are not written to the level of detail that could help someone off the street. They are the guiding instructions to facilitate the training process and then made available for reference.
Do not write interdepartmental work instructions. Nobody should write what another department should be doing. Only those responsible for the work should be involved with the definition of the instructions. If those responsible are involved, they will own the system.
Before you create a new document, ask yourself, "Can we modify our existing documentation?"
4. Improve Control. Avoid duplication. Documents that reside in multiple locations increase the possibility of confusion.
References in your systems should only refer laterally or up within your documentation structure, never down. The lower you go in the structure, the more volatile the modifications or revisions.
Don’t sign or initial quality system procedures or work instructions. Identify within the R&A document the function responsible for approval. Ask yourself, "How does a signature truly add value?"
Make documentation available electronically. Have the department’s Table of Contents on the desktop. Hyperlink from this table to each procedure. Consider the electronic version the "controlled" copy. Everything printed is considered to be uncontrolled (and identified as such in the footer).
This four-step process will help you improve, simplify and clarify your company’s system documentation. Remember, creation of the documentation is the easy part. The discipline to update and maintain this information is more difficult. That’s why it is crucial to make your system intuitive and simplistic. Keeping simplification and clarity as your vision will serve your company and your team well.