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cGMP Compliance Magnifies Business Results, Part 2

Effective monitoring and reporting can compare planned performance with actual performance, as well as precisely specify the nature of deviations, including their identity, location, timing and magnitude.

By JOHN AGER, Consultant & Master Trainer, Kepner-Tregoe Inc.

JOHN AGERThis is part two of a two-part piece. Part one can be found here.

Issue Investigation

A good investigation leads to true cause. When people in your organization conduct investigations:

  1. How often do they get to true cause?
  2. How much time is spent gathering relevant data vs. documenting speculations?
  3. How well do their investigations explain the logic used to determine cause?

Problem analysis is finding the root cause of deviations, and investigating the cause or causes of failure. When something goes wrong, the question is, why? Problem analysis provides a powerful logic for understanding the root cause of performance deviations. Corrective action that drives business value rests upon a foundation comprised of an effective, systematic logic for finding root cause.

Investigation Approved

Approvals should be based on clear criteria and support the performance system. When people in your organization present investigations for approval:

  1. How many review cycles are required for approval?
  2. What information is provided to investigators to help them improve their investigations?
  3. How are people encouraged to complete thorough investigations?

Kepner-Tregoe’s approach to managing performance is based on the experiences of effective leaders who know that setting clear expectations for performance — and then helping employees achieve that performance — are the keys to sustaining a competitive advantage. The approach centers on a five-component model (situation, performer, response, consequences and feedback) that has been consistently re-validated since its inception and provides a practical, useful framework for understanding human performance.

CAPA Selection

A good CAPA is the best-balanced CAPA chosen to meet the detailed needs of the specific non-conformance. When people in your organization recommend CAPAs:

  1. How often do CAPAs provide actions to remove true cause?
  2. How often do CAPAs recommend actions to prevent re-occurrence?
  3. How often do the recommendations address any risk associated with the CAPA?

Decision analysis is selecting the best solution for the deviation by making choices between alternative corrective actions. It is also concerned with selecting the action that best meets agreed performance objectives, while managing the risks attendant to any change. Alternative actions may be known, or a new solution must sometimes be created. Senior management is often involved in sanctioning the actions that are adopted.

CAPA Implementation

There are two important aspects to implementation: prioritization and scope management by the leadership team, and then effective implantation by the project team.

When people in your organization implement CAPAs:

  1. How well/often are CAPAs delivered on time, on cost and on performance?
  2. How often do CAPAs overlap?
  3. How often does scope change?

Project management utilizes resources wisely to implement value-added change. A good plan provides objectives that decision-makers can use to prioritize changes and identify overlapping changes.

Potential Problem Analysis is avoiding risks inherent in the solution and anticipating risks that may arise from implementing a corrective action and planning appropriate action before they become reality.

CAPA Approved

As with investigation approvals, CAPA approvals should be based on clear criteria and support the performance system. When investigations and CAPAs are closed:

  1. How well is efficacy confirmed?
  2. How well is ongoing monitoring established?
  3. How well are the efforts of team members appropriately acknowledged to encourage people to complete thorough investigations and implement appropriate CAPAs?

With acceptable standards in place, monitoring and reporting can compare planned performance with actual performance. Effective monitoring and reporting precisely specifies the nature of deviations, including their identity, location, timing and magnitude. In addition, information about distinctions between successful and unsuccessful production operations must be effectively documented. The critical objective is identifying, on a short interval basis, all meaningful deviations between planned and actual performance.

To read part one of this two-part series, please click here. What’s your take? Please feel free to comment below! For more information, please visit