CAPA : NEW APPROACH

The manufacturers who are using Corrective and Preventive Action plans must have a clear idea of the intended yield, the focus of the data to be collected. 21 CFR Part 820.100 refers to analysis of data sources to identify existing and potential causes of nonconforming product and other quality problems. 820.90 requires an investigation of nonconforming product and 820.198 requires an investigation of complaints.

In all cases, the activities associated with the analysis and investigation, and their results, must be documented. Tips on avoiding scope creep To avoid scope creep, first know when scope creep is likely to happen and then recognize when it does happen and take action. If manager knows that there is a scope creep and that it is affecting the project, he must take necessary corrective and preventive actions to stop the creep from further affecting the project. When scope creep exists, this situation can be identified by analyzing the scheduled variance for the tasks. By performing root cause analysis on them, potential scope creep can be identified. Contributing cause vs. root cause Would the problem have occurred if the cause had not been present? If no, then it is a root cause. If yes, then it is a contributing cause. Will the problem reoccur as the result of the same cause if the cause is corrected or prevented? If no, then it is a root cause. If yes, then it is a contributing cause. Will correction or prevention of the cause lead to similar events? If no, then it is a root cause. If yes, then it is a contributing cause. An effective root-cause investigation must:

Identify the problems, failures, or nonconformities; Analyzes the causes of failures; Include a thorough failure investigation; and Document the investigation, follow-up and conclusions.

Documenting the investigation Requirements for documenting the corrective and preventive actions activities required by the process should be clearly spelled out in a written procedure or corresponding form. Such documentation includes: identification of the actual or potential non-

conform mance, a rec cord of the investigatio the CAP action pl on, PA lan, implem mentation and follow-up activities, and conclusions. ,

Monitoring the in nvestigatio proces on ss A system can be es m stablished t ensure actions taken are consistent with t to the nonconf formity type and that t degree of actions t e the taken is pro oportionate to the e significance of the nonconform and the potential impacts an risks. It i also mity nd is nt t is stigation ma lead to m ay more than o solution. one importan to note that analysi and inves The ratio onale for ch hoosing one solution o e over anothe should be documented. er e SMART CAPA Pla T ans A smart CAPA plan should spe ecifically be a series of actions to correct and prevent t e f d the findings of the insp pection. It s should be o owned and tracked b someone in the d by e y. ems should be clear and discrete with a spe d e ecific person named as the n s company Action ite responsi ible party it completio Each ite should h ts on. em have a due date. In se evere cases a s, summar or periodic progress report of t CAPA m be sent to the hea agency to ry s the may t alth show go faith an progress ood nd s.