Next Level Audits

To continually improve a system, audits need to move beyond “are we following the process,” to a more incisive look at accuracy, efficiency, and effectiveness. Here are some suggestions for audit questions to ask and audit trails to follow, to help your QMS be a stronger and more accurate representation of your company’s processes.

Inputs and outputs: Where does information or material come from? What operations are performed? Where does it go next? In what form, or how organized? What records are kept, and how?

Accuracy - When was this procedure written? Do we still use these processes in the way they are described? Have we changed the technology or the steps? Was it a boilerplate procedure taken from some outside source? Could it be simplified, streamlined, or better customized? What in-process records are kept, and how? How do employees doing this procedure have access to the document? When they have questions on how to apply it, who do they ask?

Are new employees trained with this procedure as the guide? If not, and the training is both different and effective, should the procedure be changed to reflect the training? Or should training be modified to follow the procedure?

Is this process efficient the way it is being performed? Can we eliminate any extra steps/wasted time/effort/motions/distance? What would you eliminate if you could? How is the work area organized? Are all materials and tools at hand, easily moved, properly identified?

How are outputs organized, inspected or prepared for inspection? Can the same containers (eggcrate, boxes, flats, etc) easily move throughout production until final pack/ship, rather than being reorganized multiple times?

Do records to show the entire chain of events, from preparation to customer order to materials to processes to inspection/approval to shipping? Is the raw material traceable? Are the machines and tools used recorded so calibration/verification can be traced?

What does our Yield or OTD data show us about process effectiveness? What is the error rate using these steps and tools of this process? Are there common causes? Does this process flow smoothly into the next? How does this process contribute to the overall effectiveness of the company in providing processes or services to the customers?

All good audits seek 2 things: What’s working and Where can we improve? Recognize the teams efforts in both areas.