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Kathleen Hodges is the vice president of quality at BASi
An effective CAPA plan provides a mechanism for responding to the unexpected.
The term corrective and preventive action (CAPA) is traditionally associated with good manufacturing practices (GMP) and ISO, and some would argue it has no relevance in its good laboratory practices (GLP) counterpart. Regardless of the working environment, however, the ability to monitor and establish control over processes is an essential element of any quality program. A structured approach to identifying and addressing nonconformance can provide performance data necessary to successfully integrate improvements into the system. Although managing deviations is a requirement, CAPA is a quality system that makes good business sense for any organization.
Three types of events will typically result in the need for a CAPA solution plan: an anomalous result, an external finding, or a deviation from a written procedure. The anomalous result, which is known as an out-of-specification or out-of-trend result, falls outside of normal method behavior or manufacturing specifications. Anomalous results can stem from poor system suitability, equipment maintenance, or the improper preparation of samples or standards, or may be indicative of an unknown matrix effect. A thorough investigation will usually pinpoint an assignable cause or reason for the inconsistent result. There are instances where the assignable cause may not be discovered, however, and it is in these circumstances where a follow up CAPA program can prove useful.
The external finding is generated as a result of an audit or complaint. The solution to these findings can fall into two categories. Short-term corrective actions are immediately apparent, such as a documentation error or safety violation. Long-term corrective actions may require extensive effort or cost, or may be multi-layered. Without the periodic review built into an established CAPA program, these long-term actions may fall between the cracks and never come to fruition.
Finally, a deviation is generally the result of human error, but is nonetheless crucial for identifying weaknesses. Corrective action may or may not be appropriate in the case of a deviation, but the preventive actions can help limit the recurrences seen over an extended period of time and may even result in stronger support mechanisms such as training.
The characteristics of these events do not necessarily lend themselves to an easy investigation or root cause determination. In some instances, such as an anomalous result, an investigation is straightforward and determines if the result is true or the by-product of a failure in some part of the testing system. Depending on the nature of the external finding, an investigation and root cause determination may not be needed in the traditional sense, but rather used to rule out causal factors.
Having an established CAPA program can help track the follow-up actions needed to close out an observation with a customer or regulatory agency and effectively demonstrate control over the quality of the systems. Also important is trending to identify repeat occurrences, which can be handled by a CAPA solution plan. The trending can point to systemic issues, such as procedural clarity, and exhibit a proactive approach toward risk management and continuous improvement.
There are four main elements of a CAPA program that will demonstrate control over the procedures and processes that make up the working environment: documentation, investigation, CAPA, and measurement. These elements often are in place informally, but without adequate follow-through they will be ineffective in demonstrating the systemic control desired.
An appropriate level of documentation must take place immediately following discovery or occurrence of the event. Quality and management will need to characterize the type of events anticipated and determine a suitable course of action. This also may be the point in the process where customers, sponsors, or study directors are notified of the event. Notification will depend largely on contractual obligations or protocol directions or the discretion of management.
This documentation will help recreate any variables that may affect the outcome of the investigation. Documentation also enables personnel down the line in the investigation or measurement phases to accurately gauge the risk associated with the event or effectiveness of the implemented actions. With risk assessment, management can determine the level of resources to be allotted for the investigation and CAPAs.
The Investigation Phase
The investigation phase is the most fluid of the CAPA process, and the amount of work effort should be commensurate with the risk associated with the event. The primary focus of the investigation should be a determination of a root cause, and there should be concrete evidence of active searching. Documentation during the investigation phase should demonstrate the development and testing of theories, but procedures should be in place to limit or control the amount of secondary testing and outline decision-making guidelines. The appearance of testing-into-compliance must be avoided.
The investigation, while determining the root cause, should also look for deficiencies in records, audits, and reports. These may be indicative of a broader problem that continually contributes to an event. For instance, a routine freezer alarm may be attributed to a door being left open too long. However, the trending data provided by a structured CAPA program may indicate other issues are at play. An investigation should review that the maintenance records are up to date and completed according to pre-set standards. If a routine maintenance item has been overlooked, there may be larger issues at stake than just the door being left open. The investigation may need to ascertain if the preventive maintenance schedule is adequate, if poor documentation skills are at fault, or if the vendor is not providing appropriate support and service.
Corrective and Preventative Actions
After the investigation has identified a root cause for the event, the investigators and management should focus on identifying the appropriate corrective actions needed to resolve the immediate issue and preventive actions aimed at reducing or eliminating recurrence. CAPAs should be assigned a responsible owner and given a definite timeline for completion.
CAPAs may be fairly straightforward, but in some instances, determining an appropriate action may be difficult. An anomalous result is either shown to be true or replaced with data that are proven accurate. In the case of an external finding, a written procedure may not contain all the elements needed, and the root cause points to a subject matter expert being left out of the collaboration steps. This item is corrected by revising the document. Depending on how the document management system is controlled, ensuring all appropriate collaborators take part in the revision is more easily said than done. In the end, preventive actions may simply be a system of checks and balances aimed at eliminating as many of the variables as possible.
Trending is Key
Of the four elements of a CAPA system, measurement or trending may be the most important. To combat the ever-changing kaleidoscope of personnel, documents, instruments, and equipment, maintaining a CAPA system will permit a consistent and unbiased look at how an organization is managing the procedures and processes that make up its operations. Periodic review of open and closed CAPAs may reveal previously unknown contributing causes to the occurrence of events.
Trending events according to factors such as personnel, department, instrument, or type of event can assist in better allocation of resources for training, maintenance, or continuous improvement.
By keeping the CAPA system up-to-date with the events, responsible personnel, and target dates for completion, an organization can build in an accountability strategy that keeps customers satisfied that their concerns or problems are being addressed. An effective CAPA system can demonstrate control, mitigate risk, and reduce costs, which are strong indicators of an organization's focus and commitment to quality.
Kathleen Hodges is the vice president of quality at BASi, West Lafayette, IN, 765.497.5877, firstname.lastname@example.org