Corrective preventive action

Upon identification of the processes required to support the enterprise, the next step is to define exactly what is in and out of scope for each process. Mapping all the processes and their inter relationship with other processes will determine if any gaps or duplication exists in the system. Duplication may be warranted or eliminated. Gaps between processes require remediation. For example, a nonconformance process should have direct linkage into a corrective action process. A well-operating nonconformance process without an active, integrated corrective/ preventive action process will yield little benefit to the organization and efforts expended on the nonconformance process will be nominal in their overall positive business impact. 

How CM will be periodically assessed by LA, including readiness for FDA inspection, corrective/preventive action expectations... 

No corrective/preventative action taken to prevent software errors due to the buildup of temporary files in computers used to control [computer system], [FDA 483, 2001]... 

Table 6.2 (column 4) and Table 6.3 (column 9) allow for vaUdalion that independence is properly evidenced or that any corrective/preventative action is satisfactorily accomplished. 

ID Component in zone External failure mode(s) Intrinsic hazards Systemic vulnerabilities Effect on the aircraft Corrective/preventative action and/or mitigations... 

Determining corrective preventive actions Using all available resources Closing the loop... 

Corrective/preventive actions Eliminate root causes Eliminate underlying causes Eliminate the hazard Construct a barrier Institute new procedures Train employees... 

Monitoring and measurement Non-conformance and corrective and preventive action Records... 

The standard requires the corrective and preventive action procedures to be followed in addressing design failures. 

Preventive action cannot be taken on a failure that has occurred (see ISO 8402) except on other future designs. What is intended is that remedial action is taken to correct the design fault and corrective action taken to prevent the same failure arising again either in the same design or in other designs. 

Returning to the standard, this clause also only addresses the correction and prevention of nonconformities, i.e. departures from the specified requirements. It does not address the correction of defects, of inconsistencies, of errors, or in fact any deviations from your internal specifications or requirements. As explained in Part 2 Chapter 13, if we apply the definition of nonconformity literally, a departure from a requirement that is not included in the Specified Requirements is not a nonconformity and hence the standard is not requiring corrective action for such deviations. Clearly this was not the intention of the requirement because preventing the recurrence of any problem is a sensible course of action to take, providing it is economical. Economics is, however, the crux of the matter. If you include every requirement in the Specified Requirements , you not only overcomplicate the nonconformity controls but the corrective and preventive action controls as well. 

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. 

Figure 14.1 Ciause reiationships with the corrective and preventive action eiement...

The standard requires the supplier to establish, document, and maintain documented procedures for implementing corrective and preventive action. 

As the source of nonconformities are so varied it may not be practical to have a single corrective or preventive action procedure. It may be more practical to embody corrective action provisions in the following procedures ... 

The standard only requires a procedure for implementing corrective and preventive action and not for determining it, although the requirements of clauses 4.14.2 and 4.14.3 do require the actions to be determined - presumably before being implemented ... 

Assessing the degree of corrective and preventive action necessary (4.14.1.1)... 

The standard requires that any corrective or preventive action taken to eliminate the causes of actual or potential nonconformities is to a degree appropriate to the magnitude of problems and commensurate with the risks encountered. 

The action taken during process monitoring (see Part 2 Chapter 9) can be considered preventive action when corrections are made to the process ahead of occurring nonconformities. Hence Statistical Process Control is a technique which serves nonconformity prevention as well as detection. 

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