Risk-based inspection

The project "Non-Invasive Inspection within an Asset Risk Management Strategy" is another joint industry project, funded by EC-THERMIE, representing the current trend towards onstream (non-invasive) inspection in combination with risk-based inspection philosophies to establish component condition. In this project, industry and authorities participate aiming at a beneficial use of today s NDT without sacrificing on safety. 

In plant maintenance, the availability of quantitative and non-invasive screening NDT methods will reduce the time needed for shutdowns and increase the intervals between them. Modem NDT methods will become just as important a tool for Risk Based Inspection approaches and maintenance planning as operational parameters and degradation mechanisms already are. 

Risk-Based Inspection. Inspection programs developed using risk analysis methods are becoming increasingly popular (15,16) (see Hazard ANALYSIS AND RISK ASSESSMENT). In this approach, the frequency and type of in-service inspection (IS I) is determined by the probabiUstic risk assessment (PRA) of the inspection results. Here, the results might be a false acceptance of a part that will fail as well as the false rejection of a part that will not fail. Whether a plant or a consumer product, false acceptance of a defective part could lead to catastrophic failure and considerable cost. Also, the false rejection of parts may lead to unjustified, and sometimes exorbitant, costs of operation (2). Risk is defined as follows ... 

In the simplest terms, a fault-tree for risk analysis requires the following information probabiUty of detection of a particular anomaly for an NDE system, repair or replacement decision for an item judged defective, probabiUty of failure of the anomaly, cost of failure, cost of inspection, and cost of repair. Implementation of a risk-based inspection system should lead to an overall improvement in the inspection costs as well as in the safety in operation for a plant, component, or a system. Unless the database is well estabUshed, however, costs may fluctuate considerably. 

ASME Research Task Eorce on Risk-Based Inspection Guidelines, Risk-Based Inspection—Development of Guidelines, CRTD Vol. 20-1, The American Society of Mechanical Engineers, New York, 1991. 

The TGA uses a more refined system for setting inspection frequency, based on product type and on manufacturer type. The risk-management approach applied to licensing is... 

Strong Public Health Protection Information on pharmaceutical development studies in new drug applications is generally limited and varies from application to application. This creates an uncertain environment and curtails FDA reviewers ability to make risk-based decisions and inhibits their ability to recognize and assess how quality was built in. Risk communication between review and inspection staff is also inhibited. Appropriate pharmaceutical development information can improve public health by improving FDA s risk-based decisions and by facilitating continuous improvement. 

U.S. Department of Health and Human Services (2004), Risk-based method for prioritizing cGMP inspections of pharmaceutical manufacturing sites—A pilot risk ranking model, Food and Drug Administration, Rockville, MD. 

Some companies are now using Risk-Based Inspections (RBI), especially for the costly preparation efforts for internal inspections. RBI is a method that is gaining credibility and... 

Some companies are now using Risk-Based Inspections (RBI), especially for the costly preparation efforts for internal inspections. RBI is a method that is gaining credibility and popularity. Organizations calculate a proposed inspection frequency by considering the consequences of failure (as described previously) and the likelihood of failure based on the anticipated internal corrosion rates. The method employs a risk matrix. 

It is significant that the FDA has itself adopted a risk-based strategy for inspections in order to concentrate resonrces and effort where it provides the most benefit — a clear indication that this is a philosophy acceptable to it. 

Tischuk, John L. (2002). The Application of Risk Based Approaches to Inspection Planning. Tischuk Enterprises (UK). 

By 2004, the FDA intends to develop a more detailed model for cGMP inspections centered on the risk-based approach. 

The statutory guidance emphasises that the first duty of local authorities—to cause its area to be inspected. .. to identify contaminated land —is to be carried out in a risk-based way. The key stages are screening and assessment of risks . 

This guidance, issued in the fall of 2004, ° is essentially encouraging the industry to adopt new technologies (such as PAT) to control quality and introducing a risk-based approach to the science and to ensure the EDA s practices in reviews and inspections are based on state-of-the-art pharmaceutical science. It was defined elegantly by Janet Woodcock (FDA Commissioner, October 2005)... 

Visual and other non-intrusive examinations are an essential part of maintenance. This typically begins with an inspection plan that outlines the type and frequency of inspection. The anticipated damage mechanism and the probability determine the type of inspection. The frequency is determined by the consequences associated with the damage. The consequences and the probability together constitute the risk-based inspection (RBI) strategy. 

---