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CAPA systems help organizations improve

Increased market pressures, the latest regulatory requirements and internal improvement initiatives are leading companies to evolve and optimize their corrective action and improvement processes. Quality Management System compliance requires organizations to capture all issues and to track these through to completion. ISO 14000, AS 9100, ISO 9001 and ISO/TS 16949 (sections 8.5.2 and 8.5.3) all require that a Corrective Action and Preventive Action system (or CAPA system) is maintained.

How to deploy a corrective/preventive action process

In any organization, when opportunities for improvement, deviations, non-conformances, or complaints occur, the Corrective Action and Preventive Action process needs to be initiated to control and fix the problem. A typical CAPA workflow looks like this:

Compliant CAPA process

Robust CAPA processes help ensure compliance

ISO QMS/BMS standards state that a CAPA process should be defined and operated. The CAPA process should provide the following basic functionality:

8.5.2 Corrective action

The organization shall take action to eliminate the cause of nonconformities in order to prevent their recurrence.

Corrective actions shall be appropriate to the effects of the nonconformities encountered.

A documented procedure shall be established to define requirements for

  1. reviewing nonconformities (including customer complaints),
  2. determining the causes of nonconformities,
  3. evaluating the need for action to ensure that nonconformities do not reoccur,
  4. determining and implementing action needed,
  5. records the results of actions taken (see 4.2.4), and
  6. reviewing corrective action taken.
8.5.3 Preventive action

The organization shall determine action to eliminate causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems.

A documented procedure shall be established to define requirements for

  1. determining potential nonconformities and their causes,
  2. evaluating the need for action to prevent occurrence of nonconformities,
  3. determining and implementing action needed,
  4. records of results of action taken (see 4.2.4), and
  5. reviewing preventive action taken.

Features of a world class CAPA system

The CAPA process can be managed manually (via paper forms) or through the use of specialized software. A typical commercial CAPA software product will offer the following features:

  • A web interface, allowing all stakeholders to access the system (supplies, customers, external sites)
  • An intuitive workflow, requiring little or no training
  • Audit trails, history and tracking
  • The ability to measure organizational improvement
  • Visual KPIs
  • Corrective Action Report generation
  • Automated stakeholder updates
  • Be available to all employees

A good CAPA process will drive improvement

The adoption of CAPA system is important to today's commercial industries. It enables businesses to compete through their rate of improvement. When a business improves faster than its competition then it should ultimately grow its market share. CAPA Manager from Adaptive BMS provides the ideal CAPA solution for your organization.

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