IA Catchwords- Series- 4

 

Corrective actions are not identified

This applies to product, process and system related NCR's. Corrective actions are evolved/identified based on data collection during processing and internal auditing, periodically analyzed, identifying root causes of the problems and prioritizing them to identify corrective actions. While disposition actions addresses the immediate redressal/attending to the NCR for prevention of the specific product/process/system to go out of control, corrective actions are to be identified to eliminate the root cause and to prevent recurrence. There are many opinions on this issue. One is that for every product/process NCR, there shall be a Corrective action. Another point is that many problems may occur randomly, which may not repeat and hence such problems may not need Corrective actions. However, in the case of system related issues, for every observed NCR one may not be able to implement corrections, but Corrective action is to be identified and initiated. In the case of Customer complaints, many customers demand corrective actions for every NCR/Observation observed by them. Obviously, it needs to be addressed. Please remember that for every NCR, be it product, or process or system, there are 3 levels of addressing them- correction, Corrective Action and Preventive Action. Never gets confused between Corrective and preventive actions. While Corrective Actions prevent recurrence of problems, Preventive Actions prevent Occurrence of problems.

 

Customer complaints are not closed

Customer complaints are always causes for concern. It is imperative that these are complaints are properly recorded, irrespective of their nature. No filtering is recommended. A centralized system of recording is recommended to ensure customer focus. This recording shall ensure availability of complete details- both technical and systemic. The system shall have mechanisms for immediate redressal, including replacement, if any, and their closure to the satisfaction of the customer. The closure details shall be available along with the complaint details. Closure could be one of correction or of corrective action or both. A clear definition of the closure mechanism shall be established and documented. Closures shall be evidenced for all the recorded complaints. If it involves, the reporting the corrective actions to the customer, the same shall be evidenced. Closure shall include verification of effectiveness of the corrective actions taken by checking the elimination of the nature of the complaint. Closure actions shall include complete investigation, analysis and objective evidence of changes in the system. The absence of any one of the above would mean that the complaint is not closed.

 

Data is not being captured

Data and Measurements are the backbones of any QMS. Data capturing is essential for sustenance and improvement of the processes. Data may be available, but if not captured, the process performance cannot be measured. If one wants to know the status of any process, data capture is essential. There are many methods of data capture. It could be recorded either in soft or in hard copy. It could be automatic or manual. It could be in analog or in digital form. It could be elaboration of process parameters, performance details, personnel data, machine capabilities, specifications of products/ raw materials, delivery data, etc., In short, data capturing provides a complete snap shot of the processes. It could be vital/essential/desirable for the operations of the business. It could include both business and operational processes. If either the data captured is inadequate or ineffective, then it is necessary to review the process for improvement.