Corrective Action Programs
Keep production running
FDA requirements for quality, validations, complaints and recalls set high standards for compliance. To meet the challenges of operating in a regulated environment, systematic, analytical processes cut through the complexity of compliance, helping teams to set priorities, troubleshoot issues effectively, complete well-documented investigations and implement effective CAPAs.
When advanced critical thinking processes are integrated into CAPA systems and software, teams not only improve compliance but ultimately reduce regulatory issues and their associated costs.
Integrate analytic thinking into processes, monitoring systems and software
An effective CAPA program begins with prioritizing relevant issues
Effectively clarifying deviations and prioritizing them allows investigators to assemble appropriate teams and apply appropriate methods to conduct effective and compliant investigations.
Training and facilitation can dramatically improve root cause analysis
Investigators capable of applying a systematic RCA process are better able to gather the data needed to find true cause efficiently, take effective action and establish effectiveness checks. This eliminates investing in expensive, unnecessary counter-measures and reduces recurring problems.
Eliminate distractions when the pressure to perform is high
A structured issue resolution process helps investigators focus and act rationally and constructively even in emergency situations. When risks or costs are high, following a structured analytic process helps investigators maintain momentum without distractions.
A common investigative approach prevents misunderstandings and builds confidence
A shared approach and language unites functions and eliminates the silos that can slow investigations. In addition, consistent documentation of the thinking behind compliance efforts provides clarity within the organization and for auditors.