Deviation Investigations-7-Common Pitfalls to be understood for effective CAPA?

Deviation Investigations-7-Common Pitfalls to be understood for effective CAPA?

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.

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