Auditing without a Procedure
How do you audit when there is no documented procedure to audit against?
With the documentation requirements giving the responsibility of determining what documents are needed for control of processes, it will become part of the auditor’s responsibility to determine if the necessary procedures and work instructions have been documented.
How can an auditor determine if a process is controlled if there is no procedure or work instruction?
As an auditor, you must evaluate if the process is being performed consistently, with consistent and acceptable results. An auditor can do this by asking several of the people performing the process questions. Ask the people the questions individually, so they do not influence one anothers’ answers. If the process is in control, the answers will be consistent. Some sample questions:
- Can you explain the steps to this process?
- What measuring and monitoring is required for this process?
- What are acceptable ranges for the equipment?
- What are the acceptance criteria for the product?
- What records do you need to complete for this process?
Ask enough people to give you a good idea of how much the process varies between each individual performing the process. If the answers vary, there should be a procedure. The need for a procedure will generally depend on the complexity of the process and the training of the people responsible for the process.