Written procedures determining tasks that require

To determine which procedures must be written for a given job, you must first determine the tasks performed in that job. Although there are many different ways to identify tasks (refer to Appendix C, How to Determim Tasks That Require Written Procedures), most of these methods have six common steps ... 

HOW TO DETERMINE THE TASKS THAT REQUIRE WRITTEN PROCEDURES... 

Following risk assessment, the next step is to draft a formal validation plan. This is a written plan that includes all the specific validation procedures, installation tasks, acceptance testing, documentation requirements, reviews and verification tasks that need to be followed for proper system validation. The plan should also define individual responsibilities for these tasks and include an expected timeline. The plan should be designed around the URS and take into account the risk assessment determinations performed earlier. 

Evaluate each task to determine if the task will require a written procedure. Factors that determine if a task requires a written procedure can be the frequency, criticality, and complexity of performing the task. Other factors can include regulatory requirements such as the OSHA 1910.119 Process Safety Management Rule procedure requirements. For example, starting a simple pump may not require a written procedure because it is a very simple task that people are trained to do from memory. However, starting a compUcated pump with many auxiliary systems or a pump that is critical to safety may require a written procedme to ensure the pump is always started correctly. 

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