CAPA (Corrective and Preventive Action) Support in India

The most frequent CAPA failure in India’s manufacturing environment, and the major reason behind the significant number of quality failure repetition rate, is the failure to dig deeper into the reasons for the problem to find the root cause rather than relying on superficial causes and attributing the problem to the first apparent reason. In case of a repetitive batch yield variance that is associated with inconsistency in the raw materials used, and without checking the cause behind the inability of the initial inspection process to spot the inconsistencies, identifying the supplier as a possible source of such issues, and designing the process in a way to tolerate such variances, then such an exercise would be considered a symptom association rather than a root cause analysis exercise. IMARC Engineering provides a structured multilayer root cause analysis where each and every identified cause is traced back to its ultimate root cause.

The criteria for CAPA documentations also vary from one regulatory body to another based on their requirements for manufacturing operations within India. The CAPA documentation must be made as per the criteria of CDSCO pharmaceutical GMPs which is CAPA documents that are made following the Schedule M and WHO-GMP documentation requirements. For CAPA documentations in manufacturing units regulated by the US FDA, the CAPA documentations are prepared as per the criteria set forth in the 21 CFR Part 820 and 21 CFR Part 211 guidelines. Similarly, for ISO 9001 and ISO 13485 certified manufacturing units, CAPA documentation follows the guidelines set forth in the nonconformity clause of ISO 9001 and ISO 13485 corrective action clause requirement respectively. Lastly, for food safety management systems in FSSAI regulated manufacturing facilities, CAPA documentations are made according to HACCP system documentation requirements.

Investigations into the causes of quality problems that may prove to be difficult will need to have inputs from production, QA, engineering, procurement, and management all working together, which in most Indian manufacturing companies are usually focused on their own priorities and may also have different perspectives on events that occurred. An unstructured CAPA investigation will lead to a partial root cause analysis, disputes on ownership of the correction process, and delayed implementation because there is no consensus on who did what wrong. IMARC Engineering can facilitate cross-functional CAPA investigations by applying structured investigation approaches where all parties involved agree on the sequence of events, organize the gathering of evidence across different disciplines, avoid placing blame on individuals by focusing on root causes, and set ownership and timelines for corrective actions.

CAPA programs that simply respond to quality events individually when they occur, without analysing quality data trends for systemic problems that signal weaknesses in processes before they lead to actual failures, function in an ongoing state of reactivity that continually lags behind quality failure trends. The trigger system developed by IMARC Engineering analyses quality trends in data from batch records, deviation reports, customer complaint files, supplier quality data, and internal audit results, detecting statistically significant adverse trends for which corrective actions must be taken prior to any product failure, regulatory finding, or customer quality problem event. This proactive strategy changes the nature of the CAPA system from one of reactive failure management to one of quality failure prevention.

CAPA reports which are closed after implementing corrective actions without validating that such actions have indeed been effective in preventing future recurrences meet the requirement of CAPA process documentation but fall short of fulfilling the aim of quality improvement. In their assessment of CAPA reports, inspectors look for evidence that effectiveness verification activities were planned during initial CAPA implementation; that such activities are performed according to the planned time; and that the finding of effectiveness verification activities is based on objective evidence rather than subjective opinions. IMARC Engineering prepares effectiveness verification programs when corrective actions are being developed; these specify criteria that indicate what constitutes effectiveness, the duration necessary to collect statistically valid evidence, and the means to collect evidence.

CAPA investigations conducted at the individual level that are effectively managed with the help of outside assistance do not foster the development of organisational capability needed for managing CAPA effectively without external assistance since the necessary organisational capability is located in the competencies of the outside team rather than within the knowledge, skills, and procedures of the internal quality organisation. IMARC Engineering designs its CAPA projects to simultaneously develop organisational capabilities and address existing quality problems through the development of CAPA SOPs based on the root cause analysis approach for addressing quality failures falling into particular categories relevant to the customer, training the quality and cross-functional teams on conducting CAPA investigations and reporting, implementing quality metrics and trend analysis tools for identifying quality problems and initiating CAPA projects, and conducting quality management reviews of CAPA performance.