The author, an experienced trainer, shares six secrets for how to write a procedure and improves its effectiveness.
During a CAPA course I taught earlier today, one of the attendees asked if I have a course on “How to Write Better Procedures.” Unfortunately, the only material I could offer was material from a course I taught on “Training the Trainer.” That training course focused on visual communication. There are several books related to Lean Manufacturing that explain indepth how to use visual communication to replace text (i.e., – “a picture says a thousand words”). During my ride home, however, I thought of a few other ideas that might help anyone that is in the process of writing or re-writing a procedure.
1. Develop a standardized format for procedures. If you have a procedure for writing procedures, ensure you allow the flexibility to deviate from the standardized format. The Standard does require that procedures have a “mandatory” format. Referring to the standardized formatting as “suggested formatting” will avoid unnecessary nonconformities.
2. Avoid making unnecessary references to other external standards. If you are writing a procedure on risk management—it makes sense to reference ISO 14971. It does not make sense to reference all the other risk analysis standards, unless you are specifically using them to perform risk analysis. Included in this category would be references to other regulatory requirements, such as 21 CFR 820 or Part 1 of the Canadian MDR. Companies can claim compliance with other requirements in the Quality Manual instead. What should be referenced in a document is any related procedures or forms.
3. Avoid including the revision of a Standard. This is just another opportunity for unnecessary nonconformities. If you don’t specify the revision, then an auditor can only assume that the most current revision of the Standard is implied. If changes to a Standard are minor, no changes to a procedure may be warranted and a revision to the procedure can be avoided—assuming that the revision of the Standard is not specified. Some argue that you should include the revision and update the reference to document that the procedure was reviewed to determine if changes were warranted. This is unnecessary. A review of procedures, where the decision is made for “no change,” can easily be documented in the Management Review under the category of “New and Revised Regulatory Requirements.”
4. Indicate the process owner and training requirements associated with each procedure. By doing this, it is easier to define who is responsible for reviewing and revising procedures—as well as who is assigned CAPAs if there are findings related to the process in question.
For the training requirements, the process owner should specify who needs to be trained on the process. Why? They know the procedure best. If there is a “grey area,” this should be resolved with the department manager for the job function in question. In addition, retraining requirements should be specified. By this, I mean that it is a good idea to indicate if retraining is required when a procedure has been revised. If the revision is minor, training should only be required for people that have not been trained to a previous revision.
5. Adopt the Plan-Do-Check-Act (PDCA) model for the structure of procedures. For the “Plan” portion, the procedure should explain how to prepare to do something. This planning activity can apply to anything from planning to perform an audit to planning to inspect incoming raw materials. The “Do” portion is what most people refer to as the “Procedure” section. The “Check” portion of the procedure is a great place to specify the monitoring and measurement requirements for the process (see Section 8.1 of the Standard). Finally, the “Act” portion of the procedure should indicate what to do when target metrics are not met. For example, what should be done when an alert limit is reached? What should be done when an action limit is reached?
6. Include revision history. It’s extremely helpful to know which Engineering Change Order (ECO) approved the document revision, why the changes were made, the nature of changes, whether there is a related corrective action and when the change was made.