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