Incident analysis personnel responsibilities

The personnel responsible for the collection and analysis of incident data vary in different organizations. One common practice is to assign the responsibility to an investigation team which includes the first line supervisor, a safety specialist and a plant worker or staff representative. Depending on the severity of an incident, other management or corporate level investigation teams may become involved. 

One approach is to mesh all investigation and root cause analysis activities under one management system for investigation. Such a system must address all four business drivers (1) process and personnel safety, (2) environmental responsibility, (3) quality, and (4) profitability. This approach works well since techniques used for data collection, causal factor analysis, and root cause analysis can be the same regardless of the type of incident. Many companies realize that root causes of a quality or reliability incident may become the root cause of a safety or process safety incident in the future and vice versa. 

Training and documentation. Responsibilities associated with PV and QA depend on the training of manufacturing personnel and the documentation of their activities. Such activities help to form the recognized quality standard that a pharmaceutical company builds for its products. These personnel are trained to carry out the standard procedures required by GMP documentation includes the write-up/revision of these procedures. Other records document how a batch of product is manufactured, whether unusual incidents or deviations occurred, the existence of reject notices, product complaints, and the investigation and analysis (as needed) of the above abnormalities. 

An incident creates a dynamic environment, the decisions made in the initial analysis and the corresponding responses are critical to a desirable outcome. The continued thoughtful consideration of the interdependencies between the hazards, location, equipment, personnel, and cascading effects will make for sound decision making and appropriate resource allocation. 

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