Root cause investigation

In addition to incident reporting systems, root cause analysis techniques can be used to evaluate the causes of serious incidents where resources are usually available for in-depth investigations. A practical example of root cause investigation methods is provided in Chapter 7. 

The guidance for tliis element covers responsibilities and authorities, determination of the significance of a quality (ESH/PSM) related problem, root cause investigation, cause-and-effect analysis, preventive actions and additional controls, and change documentation. For ESH/PSM, this element might be interpreted as covering both potential hazards as well as actual problems. 

Improvement - Implement Corrective Action, Preventative Action (CAPA) procedures, incorporating root cause investigation... 

CHECKLISTS - Root cause investigation methods often include a set of integrated and comprehensive checklists (or accompanying reference documents) to ensure that common generic causes and issues are considered. 

Determining the causes is a necessary precursor to detailing findings, formulating recommendations, and implementing actions. This chapter presents two overall approaches to structured root cause investigation and develops a set of tools to identify root causes. 

Structured root cause methods recognize that incidents have multiple underlying causes. Structured root cause investigations attempt to identify and implement system changes that will eliminate recurrence not only... 

Plant data did not indicate a cause, other than bearing failure— repaired/replaced. A detailed root cause investigation had never been performed. When an investigation was conducted, the equipment was operable and detailed evidence from the last failure was lost during the repairs. 

Corrective actions PAT opens the door for new tools for root cause investigations and data collection in production Manufacturing Science provides the foundation for more effective approaches CGMP initiative objective f-5 Product is out of specification (OOS) or procedural deviations Crisis —immediate action needed Required by regulators... 

Warnings went unheeded - Findings indicated that most incidents were often preceded by a series of smaller accidents, near misses, or accident precursors. Operations and maintenance procedures must include analysis, root cause investigation, and corrective action. 

There may be more issues that warrant investigation, but this gives you the general idea of a root cause investigation. All anomalies, no matter how minor, are recorded and viewed as part of the process. The fact the truck was late for scheduled maintenance may or may not have caused the variation (accident), but you would never know if you did not look. 

Here is an example. At 4 30 pm on a simny afternoon a driver backs into a pole in a parking lot. The driver s stated reason was he lost track of it. The safety professional immediately assigns inattention by the driver as the cause of the variation. Upon root cause investigation the following is discovered ... 

So what did the root cause investigation turn up as contributing factors Which one(s) would you classify as the root In short, which one(s) started the entire chain of events that led to the variation also known as the unexpected output of the safety system Based on your findings, would you classify the variation as special or common If it is special, what actions should you take If it is common, what actions should you take ... 

The basic reason for investigating and reporting the causes of occurrences is to enable the identification of corrective actions adequate to prevent recurrence and thereby protect the health and safety of the pnblic the workers the equipment, machinery, and facility and the environment. Every root cause investigation and reporting process should include live phases. While there may be some overlap between phases, every effort shonld be made to keep them separate and distinct. The phases of a root cause analysis are... 

A range of tools are available for root cause investigations, ranging from simple questioning techniques such as 5 x Why , to sophisticated software packages. In well-run companies, information on accidents is distributed openly throughout the organization by hazard-alert and similar illustrated information reminders, in order to remind employees of risks and precautionary measures in the workplace. 

A system analogy is one way to portray the interaction between an engineering problem-solving process and its environment. Root cause investigation, in this... 

Root cause investigation (RCI) It is conducted in much greater depth than the CFA and goes substantially beyond the physical root of a problem to identify the human errors involved. It stops at the major human causes and does not involve management system deficiencies. RCIs are generally confined to a single operating unit. 

It is similar to root cause investigations conducted for injury and damage incidents. The problem statement is not usually set in stone in the initial stage of the project, as it can be redefined as new project specification limits are identified. Once baseline data is collected, the problem statement can be further defined. At this point the problem statement will shift from We do not know what we want to do to We know exactly what we want to do. At this stage a data-driven system begins to develop that will help understanding on how the selected process works. 

Ensure implementation of operational safety risk mitigation plans and reviews of progress against the plans at site and corporate level. Monitor implementation of proper corrective actions and ensure they are promptly completed following audits and after thorough root cause investigations of all incidents or potentially high consequence near misses. 

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