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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 Part820.100 refers to analysis of data sources to identify existing and potential causes ofnonconforming product and other quality problems. 820.90 requires an investigation ofnonconforming product and 820.198 requires an investigation of complaints.

In all cases, the activities associated with the analysis and investigation, and theirresults, must be documented.

Tips on avoiding scope creepTo avoid scope creep, first know when scope creep is likely to happen and thenrecognize when it does happen and take action. If manager knows that there is a scopecreep and that it is affecting the project, he must take necessary corrective andpreventive actions to stop the creep from further affecting the project. When scopecreep exists, this situation can be identified by analyzing the scheduled variance for thetasks. By performing root cause analysis on them, potential scope creep can beidentified.

Contribut ing cause vs. root causeWould the problem have occurred if the cause had not been present? If no, then it is aroot cause. If yes, then it is a contributing cause. Will the problem reoccur as the resultof 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 tosimilar events? If no, then it is a root cause. If yes, then it is a contributing cause. Aneffective 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 investigationRequirements for documenting the corrective and preventive actions activities requiredby the process should be clearly spelled out in a written procedure or correspondingform. Such documentation includes: identification of the actual or potential non-

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