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Camstar's

Corrective and Preventive Action (CAPA) Management System fundamentally changes the way that quality incidents are detected, investigated, corrected and ultimately prevented. Historically, CAPA effectiveness has been limited due to the isolation of the process and a lack of available data to support true root cause analysis and preventive action.

Camstar's next generation CAPA Management solution helps you move from a reactive process to a proactive, predictive and preventive approach supported by early warning indicators, intelligent root cause analysis and global enforcement to truly eliminate defects and prevent recurrence throughout your enterprise and value chain.

Built on Camstar's Enterprise Platform, Camstar's CAPA Managementsolution helps you to effectively respond to a quality issue or event and gives you immediate access to the contextual data from raw materials, components, suppliers, equipment, production, and field use to quickly contain affected materials and isolate possible root causes for investigation. With access to the right information, you can implement and enforce the appropriate preventive actions to ensure non-recurrence and substantially decrease the cost of poor quality.

Camstar's CAPA Management transforms your ability to translate customer complaints and production issues back into product and process design to fully close the loop and allow you to eliminate risk, exposure to recall and brand issues, and ensure customer satisfaction. Core capabilities include:

 

  • Corrective Actions (CAR) – identify, isolate and eliminate the cause of an existing nonconformity, noncompliance, defect or other undesirable issue in order to prevent reoccurrence.
  • Supplier Corrective Actions (SCAR) - identify and collaborate with suppliers who are determined to be the cause of a quality issue.
  • Preventive Actions (PAR) – prevent rather than respond to a nonconformance by assuring that revised processes affecting the design and production of a product are documented, followed and approved.
  • Risk Analysis – prioritize and escalate CAPAs based on the level of threat that the issue represents, enable fast containment of serious quality problems, fully understand the impact of an ECO resulting from a corrective action or preventive action .
  • Investigations - perform more accurate root cause analysis by providing critical data from Quality, Manufacturing and other core systems required to perform investigations
  • Failure Mode Effects Analysis (FMEA) – monitor and identify when a threshold has been exceeded and an adverse trend might be developing, enabling manufacturers to take steps to control emerging risks.
  • Enforcement – automatically enforce corrective and preventive actions across the global sites through the powerful Manufacturing Execution capabilities available in Camstar's Closed-loop Quality Execution Platform.
  • Effectivity Analysis – set-up review verifications to ensure that corrective and preventive actions have been truly effective in eliminating quality issues.
Camstar's CAPA Management is an integral component of the Camstar Enterprise Platform.
Click here to learn more about the capabilities of Camstar CAPA Management.


 

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Beyond Compliance: Turn FDA Initiatives into Impetus for Higher Product Quality, Growth and Profitability

Speaker: Mark Lincoln, Terumo Cardiovascular Systems
February 16, 2012
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