Effective CAPA Program, a Valuable Tool in Quality Improvement Dharmi Trivedi

Effective CAPA Program, a Valuable Tool in Quality Improvement What is CAPA Why CAPA process is important Elements of Effective CAPA CAPA Process Other Industries Warning Letters related to deficient CAPA process Lessons Learned

Definition of CAPA Corrective action and Preventive action Corrective Action – Action taken to eliminate the causes of an Prevailing discrepancy to prevent recurrence Preventive Action – Action taken to eliminate the cause of a possible discrepancy or other adverse condition to prevent such an occurrence

What is CAPA Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action (21CFR ) The pharmaceutical company should have a system for implementing corrective actions and preventive actions resulting from the investigation of complaints, product rejections, non-conformances, recalls, deviations, audits, regulatory inspections and findings, and trends from process performance and product quality monitoring (ICH Q ) An effective CAPA program will decrease process variation and improve product quality

Why CAPA is so important CAPA is an essential element of quality system All control points flow through CAPA process CAPA should be a solution to the problem Without corrective action there is no meaning of investigation CAPA loop is not closed until it is proven effective

Elements of Effective CAPA Process Analyzing processes Investigating the cause Identifying the actions Verification and Validation of CAPA for its effectiveness Implementing the changes Communication Management review Documentation

CAPA Process Identification Investigation Analyzing/Root Cause Action Plan Loop is closed Follow up and check for effectiveness Evaluation

Case Study of an effective CAPA Customer complaints-Product carton has an illegible lot # and exp. date Problem- ribbon on the printer Short term CAPA – change the ribbon and 200% inspection at the end of packaging line Long term CAPA - Changed the printing technology that produce high quality codes and keeps the line running No illegible lot #/Exp. Date Check effectiveness -CAPA is working Loop is closed

Other industries Space shuttle crashed in 1986 Toyota recall in 2009 BP water oil spilled in gulf of Mexico in 2010

Other Industries (Cont’d) The 1986 Challenger Explosion The explosion of the Shuttle was caused by the hardware failure. (Source: Quality Management blog posted by A. Oagood).

Other Industries (Cont’d) In 2009 Toyota recall 9 Million Cars

Other industries (Cont’d) Toyota Recall “The purpose of the recall was to address quality assurance and quality control problems with a removable floor mat that could cause accelerators to get stuck and potentially lead to a crash”. (Source: Quality Management blog posted by A. Oagood ).

Other Industries (Cont’d) The 2010 BP Deepwater Rig Explosion

Other Industries (Cont’d) The 2010 BP Deepwater Rig Explosion “The quality management failure for this situation was weak cement around the well. Contractors failed to properly test the cement in order to save time and money. Technicians also incorrectly interpreted a fluid pressure test, and ignored warning signs”. (Source: Quality Management blog posted by A. Oagood).

Other Industries (Cont’d) Each of this company failed to follow quality standards These companies put more emphasized on Growth rather than Quality

Examples of Warning Letters(WL) Issued by FDA Failure of your CAPA procedure to address the analyses of quality data to identify existing and potential causes of nonconforming products and other quality problems, as required by 21 CFR (a)(1). For example, your CAPA procedure does not describe what quality data will be trended, how often this data will be trended and analyzed, and what statistical methodology will be employed to detect recurring quality problems.(Retrieved from: FDA website WL 2009)

Examples of WL (Cont’d) Failure to establish and maintain corrective and preventive action procedures that include requirements for ensuring the corrective and preventive action is effective, as required by 21 CFR (a)(4). Specifically, your firm failed to identify and document the verification of the effectiveness of the action taken for (b)(4) closed CAPAs.(Retrieved from: FDA website -WL-2014)

Examples of WL (Cont’d) Failure to establish and maintain adequate procedures for implementing corrective and preventive action (CAPA) and to document the activities and their results, as required by 21 CFR (a) and (b). For example, your firm failed to document all CAPA activities and results associated with the following: Monthly trend analysis of sources of quality data, such as complaints, product quality investigations, incoming inspection rejects, and audits, are not being conducted and documented, as described in your written CAPA procedures. Your firm acknowledged the monthly trend analysis was not being conducted and the analysis procedure was not implemented. (Retrieved from: FDA website -WL-2012)

Examples of WL (Cont’d) Failure to establish procedures for corrective and preventive action, as required by 21 CFR (a). For example, the procedure, “Corrective and Preventive Action (CAPA) Procedure” does not include requirements for (i) the analyzing of quality data to identify existing and potential causes of nonconforming product or other quality problems, and (ii) the verification and validation of corrective and preventive actions. (Retrieved from: FDA website -WL-2012)

Lesson Learned Follow quality standards Fix quality defects by investigation root cause of defects Action Plan Preventive action Check effectiveness of CAPAs

Effective CAPA Program, a Valuable Tool in Quality Improvement Questions?

Effective CAPA Program, a Valuable Tool in Quality Improvement Thank You