1 Methodology This Quick Process Guide follows some of the principles laid by Richard Stup in his Standard Operating Procedures: A Writing Guide. 2 Process 2.1 Determine best option for process control Consider better alternatives to control risks associated with the process, including elimination, substitution and engineering control of the hazards. If administrative controls are determined to be the best option, then develop the respective SOP. 2.2 Determine critical inputs and outputs. During this phase, the critical features of the product are identified in conjunction with the relevant inputs to the process that need to be controlled to obtain the desired results. For instance, oven temperature and baking time when making bread. 2.3 Map the process List the steps in the process, including at least all the steps related to the control and monitoring of the critical variables identified above. 2.4 Chose best format for SOP document Use the following guide to pick best format of SOP:
2.5 Review and test Review the SOP draft for adequacy. Review team should include stakeholders such as the operators and “clients” downstream from the process. Consider the pertinence of review by product or process subject matter experts.
Test effectiveness with novice operators. 2.6 Deploy Release the SOP document and train stakeholders, including the operators, on the intent and content of the document.
I am developing a series of "quick guides" to assist with the definition of quality management processes. The quick guides are two-page documents, the first page contains the text that describe the process and the second page is a graphical (flow chart) description of the same. Send me an email at Luis.Suarez@tech-gopher.com if you want a copy of the two-page document.