A successful corrective and preventative action (CAPA) process requires deviation investigations. They assist organizations in locating the primary reason of a deviation, dealing with it, and putting preventative measures in place. It’s not always easy to carry out efficient examinations of deviations, though. To make sure their CAPA process is actually effective; organizations need to be aware of a few frequent problems. This post will examine seven typical mistakes that might reduce the efficacy of deviation investigations and offer advice on how to prevent them. Organizations can promote continual improvement in their operations and raise the general caliber of their CAPA process by being aware of and taking action against these problems.
The accompanying segments recognize basic missteps organizations make while investigating deviation – and how organizations can reduce them.
1. Under utilization historical data for continuous improvement
The information curated over time long history of the organization through investigations contains a wealth of data, which can be utilized for simultaneous improvement, expanding productivity, and reducing the repetitions of errors. Monitoring investigation data will help in understanding types of incidents such as OOS, OOT and underlying its root causes in your organization. Based on the developed and curated data, we can classify the incidents/events and generate actionable insights.
2. Relying on human error as a root cause
Human error may be a root cause category, but it is neither specific root cause or it leads to reasonable actions. It is to be understood, the main reason is usually in other areas, such as methodology, training, condition, or instruments. It is imperative to find a valid, underlying root cause and to portray it in actionable terms to prevent repetitions, and drastically lessen the number of future human related mistakes.
3. Not getting to the probable root cause
There are numerous reasons, where root cause is not obvious. Few primary reasons could be lack of adequate time and resources, lack of proper training to investigators, lack of technical and knowledge skills sets.
Reasonable and scientifically proven RCA (root cause analysis) tool should be considered to understand the underlying reason. Further Root cause Analysis tools such as fish-bone analysis, 5-Why’s, Kepner-Tregoe or IS-IS NOT analysis can often tease out a challenging most probable root cause from an array of discordant facts.
4. Generating an cumbersome and un-specific investigation report
The investigation and its report should be clear, simple and can be easily followed up into actions. The report should be supported by supporting facts and scientific rationale, so that it can be used as a reference guide in near future.
5. Overlooking supporting factors for Errors
In the process of finding Root Cause analysis, supporting factors are often ignored. Supporting factors also require careful investigations and should be included in CAPAs. Utilization of 5-Whys tool is a valuable tool to recognize supporting factors from root causes.
6. In effective CAPAs implementation strategy
Even after implementation of CAPAs, errors or quality issues re-occur, it shows that Root Cause Analysis is not appropriate, execution mechanism is cumbersome. Therefore CAPAs efficiency should be monitored by Quality Assurance department and appropriate actions to be taken.
7. Lack of Human interaction by Investigators
Too many investigations fail to obtain information from the employees with the most relevant insight and information surrounding the event, interviews should be conducted as soon as possible after an event occurs. The essential details of interviews should be summarized in the investigation.
Now that you know this:- hopefully you are in position to answer the Assignment(s)
Do your QA department regularly monitor OOT/OOS/OOC/Incidents? Do they call for insights and discussions with QC/Analytical departments?
What percentages of incidents/OOS are attributed to human errors in CAPA? This percentage is increasing or decreasing year on year basis?
Do your QA/QC department completely use tools such as 5-whys to completely investigate root cause analysis? Do staff has sufficient experience to investigate Root cause analysis?
Do your QA/QC department sufficiently monitor CAPA efficiency? How they are measured?