Managing Non-Conformance: A Guide to Corrective and Preventive Action

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Corrective action entails the deliberate steps taken to investigate and correct reported non-conforming events. The aim of initiating corrective action is to establish the root cause of the non-conformance and remove it to ensure that it does not recur in future (Berte et al. 2007, pg. 10). For instance, an organization whose facilities are frequent targets of burglars may find it necessary to relocate to a more secure locality to ensure that such attacks do not recur. Preventive action involves action taken to correct weaknesses which have the potential of causing non-conformance.

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Preventive action is proactive and may not be taken on reported non-conformance (Berte et al. 2007, pg. 10). For instance, a new organization may consider locating its services in a secure locality to reduce chances of burglary attacks which are more likely to occur in less secure localities. Remedial action is taken to correct n existing non-conformance. Unlike corrective action, remedial action is taken not to provide a permanent solution but to resolve the immediate problem (Baldwin 2005, pg.

6).

Therefore, remedial action does not always remove the root of the non-conformance (Berte et al. 2007, pg. 10). For example, if water supply to a locality is disrupted, the city authorities may use bowsers to transport water to the locality before a permanent solution to the problem is found. Question 2 In a “just culture” environment, it is appreciated that no system is infallible and that not all non-conformance results from recklessness or incompetence on the part of the employees (Berte 2007, pg 6; Silverstein, 2003, pg. 1).

As such, non-conformance may not always precede disciplinary action on an employee.

A “just culture” environment also provides an atmosphere in which employees or users of a system are encouraged to pass information and report existing or potential non-conformances as early as possible. Open communication ensures that error reporting faces no impediments (Eurocontrol 2006, pg. 11). An important benefit of a “just culture” to a laboratory is that it provides opportunities for early corrective action following a non-conformance.

For instance, if technicians report promptly that they used faulty equipment which may have led to misinterpretation, action can be taken promptly to ensure that patients get the correct results and are treated properly. By allowing employees to pass information freely on the system, a “just culture” also ensures that a laboratory administration is informed on potential non-conformances, allowing it to take preventive action early enough. Question 3:

Non-conforming events can be detected through external sources or feedback from supppliers, clients/customers, and visitors. For instance, customer complaints or queries can help to identify an existing or potential problem. An advantage of external sources is that their feedback can help identify problems which those within the organization may have missed or considered trivial. The disadvantage is that many people may not give their feedback, meaning that the organization may not get the information it needs.

Auditing internal reports, processes and procedures also provides an important way of identifying errors. The advantage is that internal audits can be conducted as frequently as necessary as the information needed is available locally. A disadvantage is that the auditors may be restricted by organizational goals and faith. Consequently, they may be biased, and they may not identify what qualifies as weaknesses to the external sources.

External assessments entail the evaluation of an organization processes and procedures against externally-set standardsand conducted by external inspectors. The inspectors use established tools and procedures to conduct assessments and documents non-conforming events. A major advantage is that organizations are able to adjust to nationwide, regional or international standards of operations. A leading disadvantage is that external audits are costly and unaffordable for small and medium-sized ventures. Reference List. Baldwin, R. 2005.

Corrective Actions (CAPA) Guidelines. Minnesota: rmbi. Berte, L. , Arney, K. , Astion, M. , Hoffstadter, L. , Lim, B. , Schiffgens, J. , See, R. & Stevens, M. 2007. Management of Nonconforming Laboratory Events; Approved Guideline. Clinical and Laboratory Standards Institute, Vol. 27 No. 27. Eurocontrol 2006. Establishment of ‘Just Culture’ Principles in ATM Safety Data Reporting and Assessment. Brussels: Eurocontrol. Silverstein, M. 2003. An Approach to Medical Errors and Patient Safety in Laboratory Service: A White Paper. Atlanta.