Every System Is Perfectly Capable of Giving the Results it Currently Gives

Every System Is Perfectly Capable of Giving the Results it Currently Gives 13

If results are disappointing, ask what in this system—or in systems connected to it—could be producing them.14 Stepping back can reveal interactions and operating conditions that a close examination of one component misses.

Single-loop learning adjusts actions within existing rules. Double-loop learning also questions the assumptions, goals, or rules behind those actions. Systems thinking can help with that second kind of inquiry.15

Julian Amey, former VP of Global Supply Chain at AstraZeneca, describes how stepping back helped resolve a manufacturing problem.

‘Years ago, I was involved in production planning in the US, working on secondment. This involved overseeing our own manufacturing facilities, as well as those of third parties who were doing contract manufacturing for us.

We had a successful product where the manufacture was sourced from a third party in the Midwest under a contract manufacturing arrangement. It was decided before I moved to the US that we would bring the manufacture in‐house to our own facility on the East Coast. We had all the product and manufacturing intellectual property, and the decision to shift production was regarded as low risk. The product involved a sponge impregnated with liquid antiseptic, glued to a plastic scrub brush, with a nail pick, wrapped in a laminated silver foil package that was glued and sealed, and then boxed.

We built a line for in‐house production, with equipment and layout like that used by the contract manufacturer. The plant performed successful commissioning trials, production trials and put material on stability testing. After building up some stocks and with everything considered “good to go,” we switched over to our own supply.

We started shipping the product, and initially, everything was fine. But as we shipped the product across the US, we began to get reports of problems from the shippers. For some reason, shipments to California and the states west of the Rockies seemed to result in leaks from the packaging. There also appeared to be a problem when the product was sent by air freight when under time constraints to supply a replacement product.

Clearly, we were not happy to find these new problems, never seen before, with an important product, so a team was commissioned to understand the root causes of what was going on and put in place corrective measures. They looked at various issues and made various changes: they went to a thicker, heavier grade foil, amended the pressure on the sealing rollers and changed the sealing lacquer.

But all these changes didn't have any significant impact: the packages continued to leak when shipped to the West Coast. One evening, the US VP for Production talked to me about the supply issue and expressed his concern that we seemed to be getting nowhere in resolving the problem. He was very frustrated because it was an experienced team involved in the root cause analysis, and they had been looking at this for weeks and weeks. Despite trying all the things they had suggested, none of them was properly addressing the problem. He said he was now thinking he would need to reengage the contract manufacturing firm.

Now, at that time, I was still relatively young and was still in very much a “learning mode,” so I asked a casual question: “Where is the contract manufacturer located, by the way?,” to which I was told the name of a town. “Where's that?” I asked. “In Utah,” came the reply. Although my knowledge of US geography was somewhat limited, I knew Utah was on the edge of the Rockies, so I next asked, “Do you know the altitude of the town?” I got a blank look, so we found an atlas, looked up the altitude and then did some quick calculations about air pressure.

And, then and there, we realised what the likely problem was. In Utah, the product was being packed at a high altitude, so it was almost like a vacuum pack effect. Whereas the production we had on the East Coast was close to sea level. The leaking problem was to do with expanding air in the antiseptic packs. It had nothing to do with any of the things the RCA team had been looking at – the solution to the problem involved, literally, thinking outside of the box. The RCA team had “zoomed in” on many of the details and technicalities they knew well but had not been able to step back.

In the end, we simply put a roller on the machine, which just compressed the foil package before it was sealed, removing the air, and subsequently, there were no more problems.

This is a good example of why you need a holistic, systemic approach to RCA, not just a narrow technical analysis. It made me realise how much even the best people can get “locked into a paradigm” that they don't realise they are trapped in. That team was focusing on the things they knew how to fix rather than beyond that.

It taught me how important it was to have a diversity of experiences and different ways of thinking when working on an important RCA investigation. Sometimes a non‐technical perspective can offer a new angle, a new insight. Henceforth, I was always keen that we had cross‐functional teams working on RCA investigations.'

The team had changed the packaging materials and sealing process without resolving the leaks. Asking where the product had previously been made exposed a difference in air pressure that those local fixes had missed.