Having looked at a blog entry by the Westgards, which is always interesting, here are my thoughts.
Regarding IQCP, they say it’s mostly been a “waste of time”, an exercise of paperwork to justify current practices, with very little change occurring in QC practices.
This is no surprise to me – here’s why.
There are two ways to reduce errors.
FMEA (or similar programs) reduces the likelihood of rare but severe errors.
FRACAS (or similar programs) reduces the error rate of actual errors, some of which may be severe.
Here are the challenges with FMEA
- It takes time and personnel. There’s no way around this. If sufficient time is not provided with all of the relevant personnel present, the results will suffer. When the Joint Commission required every hospital to perform at least one FMEA per year, people complained that performing a FMEA took too much time.
- Management must be committed. (I was asked to facilitate a FMEA for a company – the meetings were scheduled during lunch. I asked why and was told they had more important things to do). Management wasn’t committed. The only reason this group was doing the FMEA was to satisfy a requirement.
- FMEA requires a facilitator. The purpose of FMEA is to challenge the ways things are done. Often, this means challenging people in the room (e.g., who have put systems in place or manage the ways things are done). This can create an adversarial situation where subordinates will not speak up. Without a good facilitator, results will suffer.
- The guidance to perform a FMEA (such as EP23) is not very good. Example: Failure mode is a short sample. The mitigation is to have someone examine each tube to ensure the sample volume is adequate. The group moves on to the next failure mode. The problem is that the mitigation is not new – it’s existing laboratory practice. Thus, as the Westgards say – all that has happened is the existing process has been documented. That is not FMEA. (A FMEA would enumerate the many ways that someone examining each sample could fail to detect the short sample).
- Pareto charts are absent in the guidance. But real FMEAs require Pareto charts.
- I have seen reports where people say their error rate has been reduced after they conducted a FMEA. But there are no error rates in a FMEA (errors rates are in a FRACAS). So this means no FMEA was carried out.
- And how anyone could say they have conducted a FMEA and conclude that it is ok to run QC monthly.
Here are the challenges with FRACAS
- FRACAS requires a process where errors are counted in a structured way (severity and frequency) and reports issued on a periodic basis. This requires knowledge and commitment.
- FRACAS also requires periodic meetings to review errors whereby problems are assigned to corrective action teams. Again, this requires knowledge and commitment.
- Absence of a Pareto chart is a flag that something is missing (no severity classification, for example).
- People don’t like to see their error rates.
- FRACAS requires a realistic (error rate) goal.
There are FRACAS success stories:
Dr. Peter Pronovost performed a FRACAS type approach on placing central lines and dropped the infection rate from 10% to 0 by the use of checklists.
In the 70s, the use of a FRACAS type approach reduced the error rate in anesthesiology instruments.
And FMEA failures
A Mexican teenager came to the US for a heart lung transplant. The donated organs were not checked to see if they were the right type. The patient died.