Risk-based Corrective Actions

The corrective action requirements fail to stipulate when corrective action should be taken except to say that they shall be to a degree appropriate to the risks encountered. There is no compulsion for the supplier to correct nonconformities before repeat production or shipment of subsequent product. However, immediate correction is not always practical. You should base the timing of your corrective action on the severity of the nonconformities. All nonconformities are costly to the business, but correction also adds to the cost and should be matched to the benefits it will accrue (see later under Risks). Any action taken to eliminate a nonconformity before the customer receives the product or service could be considered a preventive action. By this definition, final inspection is a preventive action because it should prevent the supply of nonconforming product to the customer. However, an error becomes a nonconformity when detected at any acceptance stage in the process, as indicated in clause 4.12 of the standard. Therefore an action taken to eliminate a potential nonconformity prior to an acceptance stage is a preventive action. This rules out any inspection stages as being preventive action measures - they are detection measures only. 

The standard does not require you to take corrective action on every nonconformity or prevent every potential nonconformity. Here it is suggested that the decision to act should be based on the magnitude of the problem and the risks encountered. It is therefore implying that you only need act on the vital few. In fact this is good practice anyway, but to find that vital few you need to collect and analyze most of the data in the first place. Having made your proposals you should then conduct a risk analysis as part of the solution. Before managers will take action, they need to know ... 

Site assessment activities are focused on collecting only tliat iiifomiatioii that is necessary to make risk-based corrective action decisions... 

Risk-based decision making and risk-based corrective action arc decision making processes for assessing and responding to a health hazard. The processes take into account effects on human healdi and the enviroiunent, inasmuch as chemical releases vaiy greatly in terms of complexity, physical and chemical characteristics, and in the risk that they may pose. Risk-based corrective action (RBCA) was initially designed by the American Society for Testing and Materials (ASTM) to assess petroleum releases, but tlie process may be tailored for use with any hazard. 

Petroleum hydrocarbons are commonly found in environmental contaminants, although they are not usually classified as hazardous waste. However, soil and groundwater contamination by petroleum hydrocarbon has spurred various analytical and site remediation developments (e.g., risk-based corrective actions). 

ASTM. 1995. Risk-Based Corrective Action Guidance. American Society for Testing and Materials, West Conshohocken, PA. 

Process owners must be capable to evaluate and interpret the effect of nonconformances and planned deviations on their systems. Process owners can evaluate the need and lead efforts for corrective or preventive action, ensuring adequate corrections and improvements are implemented. An effective QMS ensures deviations from approved processes are owned and adequately investigated by the process owner s and ultimately approved by their quality assurance counterpart. The knowledge of these events is the basis and foundation for the process owners to make a risk-based evaluation on whether or not process changes are required, documentation or training require modification, or continuous improvement efforts are warranted. 

See also Carcinogen Classification Schemes Dose-Response Relationship Exposure Assessment Exposure Criteria Hazard Identification Risk Assessment, Ecological Risk Based Corrective Action (RBCA) Risk Characterization Risk Communication Risk Management Uncertainty Analysis. 

RBCA and the use of risk-based decision-making to establish health-protective remedial measures and controls at a site is a process that is producing health-protective and cost-effective corrective action sites. RBCA is used to decide the level of corrective action necessary at a site to protect human health and the environment, site-specific remediation goals (RBSLs or SSTLs), and the concentrations of constituents that can remain at the site because they will not impact human health and the environment. For sites already undergoing remediation, the RBSLs or SSTLs can be used to determine when the site no longer poses a threat to human health and the environment. Therefore, RBCA is useful both for newly discovered releases as well as for old releases that may have treatment systems with constituent concentrations reaching asymptotic levels. 

Risk Based Corrective Action (RBCA), Pages 733-736, Shawn L. Sager SummaryPlus Full Text + Links PDF (64 K)... 

Risk Based Corrective Action Process Flow Chart... 

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