Root cause change analysis

The change management process should also ensure that a root cause analysis has been conducted to make sure the real problem has been identified and corrected. For example, if a pump seal fails it could simply be replaced with an identical seal. However, it may have failed because it was left in service beyond its natural life and the real failure was in the preventative maintenance program that should have replaced it earlier. 

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. 

Once the causal factors have been identified, the factors are analyzed using a root cause analysis tool, such as 5-AVhys or predefined trees. See Chapter 9 for a more detailed discussion of Barrier Analysis (sometimes called hazard-barrier-target analysis or HBTA) and Change Analysis (also referred to as Change Evaluation/Analysis or CE/A). In essence, these tools act as a filter to limit the number of factors, which are subjected to further analysis to determine root causes. 

Causal factor identification is relatively easy to learn and apply to simple incidents. For more complex incidents with complicated timelines, one or more causal factors can easily be overlooked, however, which inevitably will result in failure to identify their root causes. There are a number of tools, such as Barrier Analysis, Change Analysis, and Fault Tree Analysis, that can assist with bridging gaps in data and the identification of causal factors. Each of these tools has merits that can assist the investigator in understanding what happened and how it happened. 

The first three of the above problems are particularly relevant for near miss reporting, because it requires why information to backtrack the root causes any selection bias in terms of actual consequences must be changed into one in terms of potential consequences and finally safety management must switch from ad hoc analysis of anecdotes to structural analysis of patterns of causes. 

Set timetable for improvement 2. Create multidisciplinary team to address the issue 3. Review the literature and/or published standards 4. Define quality indicators 5. Analyze baseline data 6. Review current practices 7. Perform root cause analysis 8. Create action plan for change... 

It can be anticipated that XMCT wfll see widespread use in probing the internal structure of solid pharmaceuticals. Recent examples in tablets have included studies of compaction process conditions (157), the mapping of tablet density and porosity (146,158), changes in structure on hydration (159) (Fig. 6), and the detection of internal fractures (160). XMCT also has the potential to provide a powerful tool for process optimization and root cause analysis in formulation development. 

Thorough and effective analyses of workplace incidents are critical components of a comprehensive safety management system. Yet, many incident analysis processes (i.e., accident investigations) fall short. They frequently fail to identify and resolve the real root causes of injuries, process incidents and near misses. Because the true root causes of incidents are within the system, the system must change to prevent the incident from happening again. 

Corrective actions address the root cause and may be as simple as recalibration of an instrument or as complex as procedural or organizational changes. Depending on this complexity, reports on corrective actions may require more detailed cause analysis and extended risk assessment. Actions that require multiple steps are compiled in action lists, which may be predefined for problems that are straightforward to handle. 

The first consideration in defect analysis is whether the part has been handled after removal from service. Handling can alter the appearance or contaminate it to the point that either failure analysis could not be conducted or the root cause could not be determined. Surface analysis techniques are sensitive to handling and cannot distinguish between the changes caused by the failure and contamination. The best practice is to minimize handling the part and keep track of the history of the part. There are certain steps that frequently have to be taken such as decontamination of parts that have been in contact with corrosive, toxic, or flammable chemicals. A log should be considered to keep track of what has been done to the part, which may help explain any unforeseen consequences of part handling. 

Failure analysis is another key role of the lab to study warranty returns and identify root causes of problems. There are many new industry and customer-specific test methods that must be applied. Many lab managers indicate they never do the same test twice in a month, but have to adapt to changing needs. Software plays a big role in the ability of the lab to quickly change over test methods and data analysis. These... 

Lagging indicators by themselves do not provide much explicit guidance to management as to what needs to be done to keep improving safety. The events themselves have to be analyzed using some type of root cause analysis. Also, lagging indicators tend to react quite slowly to system changes. 

If it is agreed that a system change is needed, then management may decide to conduct a root cause analysis of the problem or opportunity under consideration. Otherwise, there is a danger that the final solution will focus on the symptoms rather than the real cause of the problem. Hence the problem may recur. 

In the example, analysis may demonstrate that the frequent occurrence of a high level in T-101 may have nothing to do with the operation of the tank itself. Other causes include the unsteady operation in either Units 100 or 200 that create fluctuations of the flow of RM-12 into or out of T-101. In turn, these problems could have other causes. For example, fluctuations in the flow through Unit 200 may be traced to problems with the steam supply system. Eventually, the analysis will identify a root cause, and may also show that resolving one of these other issues would be far more effective than changing T-101 instrumentation. 

Once the core management team has signed off on the proposed change, the MOC flows to a project team whose task is to decide on what actual change is most appropriate. The project team can use a root cause analysis to help them determine the best solution to the problem that has been identified. 

Having satisfied themselves that there is a need for a system change, the reviewers should analyze all aspects of the proposed change to make sure that it is thoroughly understood. They may choose to carry out a root cause analysis. 

At this level, the root cause analysis needs to address the supervisors primary responsibilities, which are to make sure that the immediate situation is brought safely under control, and to make short-term changes that prevent the immediate recurrence of this or similar events. 

One problem to watch for during root cause analysis is that of fixation. Fixation can be a serious problem when conducting a root cause analysis because people tend to view potential hazards in light of their own experiences and opinions. During discussions people tend to take up a particular point of view, and then obstinately defend it, even when they are proven to be wrong. They develop pride of ownership in their opinions. In other words, people tend to pick on one or two events, or perceived causes of events, and will not change their mind from that point forward. In the literal sense of the word, they are prejudiced, because they prejudge events and the causes of events. 

Carroll, J.S., Rudolph, J.W. and Hatakenaka, S. 2002. Lessons learned from nonmedical industries Root cause analysis as culture change at a chemical plant Quality and Safety in Health Care, 11(3), 266-9. 

At the conclusion of the root cause analysis session, underlying causes of the event were summarized. Finally, participants suggested changes that could be made in systems and processes that would reduce the risk of similar adverse events occurring in the future. Methods for monitoring the efficacy of these changes were developed by the participants, and the results of the intervention were subsequently monitored. 

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