Ever since the first non-conformance was written, we’ve been looking for ways to find the cause, do a corrective action and bid farewell to the profit sucking problem. It’s been a problem closing out non-conformances since I’ve been associated with ISO – 1992. All the studies of ‘Top non-conformances’ from Registrars showed closeouts as the #2 problem in 1996 (document control was #1 – QMI study). Twenty years later in a BSI analysis of 250,000 audits over a 3 year period showed that nothing much had changed despite the incredible advances in software and automation. Document control is still #1, non-conformance close-outs are still #2 and issues related to Internal Audits are in the third spot. These studies are what guided the design of our cloud-based platform, by the way.
As for the ‘WIIFM?’ let’s start with this ‘cost of quality’ calculation that some organizations use. Here’s what I see most of them missing when they add up the cost of an error:
- Taking the phone call and sending it on to the right person
- Documenting the non-conformance
- Back and forth with the customer and documentation
- Initial exploration and documentation
- Root cause analysis and documentation
- Revisions to Documentation, processes, measurements, testing, purchasing, design, repackaging…
- First attempt at corrective action and documentation
- Second attempt at corrective action and documentation…revisions…and documentation!
- Retesting…new Inspection and Test Plan…and documentation!
- Shipping…and documentation…
- Did I mention ‘documentation’?!?
And so it goes – so many hidden costs that never make it to the profit line. Not only that, everyone involved can’t do their ‘real’ work generating revenue, either.
Speaking of profit, here’s a mathematical fact about profit: If you’re operating at a 2% net profit, look how much extra revenue you need if you make a $1,000 error:
$50,000 x 2% = $1,000
So you need an extra 50,000 in revenue to make up for a $1,000 mistake. That’s a lot of burgers!
The last thing I see often that indicates a weak Root Cause Analysis is the cause being identified as, ‘operator error’. Yes, it can happen but the research data confirms that operator error is the actual cause about 6% of the time. This means that 94% of the time, it’s either infrastructure, work environment or the process that let the operator make the error. Something to think about!
Finally, the steps you take in the corrective action phase will have a better chance of working if you use the process approach and risk-based thinking as you go. Follow the flow of work so you can anticipate what could go wrong downstream from the spot you’re making the change. Be sure to look upstream as well to see if there’s anything you need to do before the work flows to the newly minted process.
I thought it might be helpful to put the spotlight on some tools that you may want to take a look at to help your RCA. If you can fix a weakness that’s causing non-conformances and costing you $, the time invested will be well worth it. This list is not complete, but I see it as a good starting point for the next Root Cause Journey you might embark on:
- Ishikawa Fishbone – tried and true since the mid 1960s. Easy to use and VERY effective.
- Affinity Diagram – same methodology as Ishikawa, but you discover the categories from the brainstorming ideas
- Pareto charts can point to a weakness
- Scatter diagrams can reveal the source of a problem.
To be more proactive, you may want to consider Failure Mode and Effects Analysis (FMEA). A well done FMEA will also give you a good starting point if something runs amiss. Some organizations do DFMEA for the design function and PFMEA for process design/redesign. Works great for continual improvement projects, too.
Root Cause Analysis is one of the best investments an organization can make in itself. Preventing a problem from recurring is like taking a wheelbarrow of money to the bank!
We have easy-to-use Root Cause Analysis tools built into our Cloud-based Management System platform for managing your risks. We’d be happy to spend 10 or 15 minutes with you to see if it’s a fit…