I Don't Want to See Your ISO 9001 Quality Manual

Well, okay, I do, but not right away. I mean, we hardly know each other yet. We build to that.

Here's how it often unfolds: a shop owner meets me at the front door and walks me to a conference room with coffee, maybe some doughnuts. On the table is a three-ring binder or stack of documents. The owner gestures as if inviting me to survey the land before me, the land of ISO 9001. I say thank you, but...

Let's Get It Started

Introductions, scope, schedule, criteria, sampling methods. All the usual stuff a good opening meeting should cover when following the guidance of ISO 19011. I try to keep it short and polite, because the real work of an effective internal audit isn't in the room with us.

This is where many ISO 9001 internal audits go wrong. The auditor stays seated, butt planted all too comfortably in the seat. The binder opens, pages are flipped. Two hours disappear into a document and records request list. By the time the auditor gets their free lunch, the shop has been "assessed" without the auditor setting foot in it. That's not how you figure out if a quality system works, that's how you figure out if someone is good at paperwork.

These Steel-Toed Shoes are Made for Walking

First, I always ask for a tour of the facility and the flow of materials through receiving, inventory, production, and over to shipping. The whole flow of work and materials, in the order it actually moves. Twenty or thirty minutes, pen in hand, ready to take notes and generate ideas for how to really be effective.

I'm not looking for nonconformities yet (but sometimes I find them anyway). I'm looking for the quality management system, because one surely exists regardless of the Quality Manual. I just want to see the shop run. Materials are moving, machines are running, and someone is deciding what is conforming and what is going in the scrap bin. Product is shipping and customers are coming back because the shop is doing something right.

The Map is not the Territory

After the walk, we return to the conference room and now I read the Quality Manual and relevant procedures. I am looking for controls that help to ensure quality while also conforming to ISO 9001. I want to see what the organization says it does.

• Where does a decision get made and who makes it and how?

• Where do inspections happen and why and what records are kept?

• How are materials identified and protected?

• What happens when there's a nonconformity or other issue?
  

Now I have two mental models of the same shop. One built with my own eyes on the floor, the other built by the shop in a set of procedures that describe how they work. Or do they?

Let's Begin Again

One of my favorite quotes is from T.S. Eliot:

"We shall not cease from exploration / And the end of all our exploring / Will be to arrive where we started / And know the place for the first time."

Now the real work of the audit begins and it starts right back where I came from, with fresh ideas of how to approach things to ensure the audit is effective and adds real value.

I head out to the floor again, but this time it's a different kind of walk. Slower, inquisitive, exploring, and looking into corners and cabinets, nooks and crannies. I talk to the operators and ask questions I couldn't have asked before, because I didn't really know what I was looking at or what was expected.

Sometimes the procedure describes a control that isn't happening on the shop floor. Sometimes the control is happening but nobody wrote it down. Sometimes the procedure describes a control that used to happen, right up until someone found a better way and nobody updated the procedure.

You can't see any of that from a conference room. The floor is where the magic happens. The procedures just try to capture it.

A colleague and I once half-jokingly suggested that maybe one sign of a good manufacturing internal audit is how many steps the auditor got in each day.

If your current internal auditor spent all day in the conference room, they didn't audit your quality management system. They audited your filing and recordkeeping. Congratulations? Need a highly effective internal audit? I could use the exercise. Use the Contact link at the top of this page to learn more about practical9001 and our internal audit services.