A Risk-Based Approach to Deviation Management - Follow a risk-based approach to maintain a state of control. - BioPharm International


A Risk-Based Approach to Deviation Management
Follow a risk-based approach to maintain a state of control.

BioPharm International
Volume 22, Issue 4

The benefits derived from a well thought out corrective action based on in-depth root cause analysis are multiple and include the following:

  • prevention of deviations from recurring and prevention of potential deviations from occurring
  • reduction in recalls and market withdrawals
  • reduced safety and regulatory risk
  • increased customer satisfaction resulting from consistently produced quality products
  • redeployment of resources from fixing problems to other projects and commitments
  • increased employee satisfaction (reduced frustration) in resolving problems in an efficient, effective manner
  • cost savings from a decrease in discarded or reworked products.


Monitoring the performance of the organization's quality system is essential for continuous improvement and the functionality of the DM system plays an important role in this process. Useful information may be obtained in a variety of ways including monitoring the process outcomes (e.g., effectiveness of CAPA); trending deviations; and establishing performance measures to ensure system objectives are met (e.g., timeliness of investigations and completion of corrective actions).

In some circumstances, it may be necessary or desirable to monitor the effectiveness of CAPA. Generally, this need is based on the criticality of the deviation and the magnitude of the corrective action taken (i.e., time, money, or resources consumed). Methods for checking effectiveness may include:
  • reviewing the DM tracking system to determine whether the expected decrease or elimination of like deviations has occurred
  • using the internal auditing program to determine whether the problem has been eliminated
  • examining relevant documentation during annual product review to determine whether corrective action has effectively addressed the problem
  • looking for unanticipated adverse consequences resulting from a change.

The method and schedule for performing effectiveness monitoring should be determined at the time corrective action is developed. Typically, effectiveness is confirmed within three to six months postimplementation.

Deviation trending is an important way to monitor the overall performance of operations and identify potential systems-based problems. It should be performed on a routine basis (e.g., monthly or bimonthly). A useful way of trending involves categorizing deviations based on root cause. Root causes may be classified by function or by quality system and sub-system. Deviations also can be categorized by process or product line. Trend reports must be reviewed and analyzed by the management and the quality unit to identify the existence of significant trends and determine the need for action to address adverse trends.

Performance measurements for the DM system should be established and monitored on a routine basis to ensure the system is performing as designed and meets expectations. Select the elements that are most critical or appear to be problematic and design metrics around these. Useful metrics do not need to be overly complex and the number should not exceed three or four. Limiting the number of metrics is more likely to result in useful data that will aid in identifying potential problems and trends, i.e., too many measuring points equals too much information equals loss of focus. Examples of performance measures are:

  • number of times CAPA plans fail to correct the deviation (note: this is often an indicator of how well RCA is performed)
  • number (or percent) of times established timeframes for completing a deviation investigation are not met
  • number (or percent) of times target dates of CAPA are not met
  • number of times status reports are not created and circulated.


The primary role of the quality unit in deviation management is collection and analysis of quality data and providing independent oversight. The quality unit staff are involved in assuring that each key step is performed appropriately from discovery and reporting through corrective action completion and effectiveness verification. The quality unit assures that investigators have explored all aspects of the problem, assessed the potential risk, and used the appropriate investigative techniques. Through their independence, the quality unit has direct, uncompromised access to senior managers to communicate critical quality information. They possess the ability to balance the conflicting interests that threaten to undermine the DM system. Often, the quality unit fulfills the role of system administrator or system owner. Some of the tasks the quality unit performs include:

  • initial review of deviations after discovery for evaluation of criticality
  • review and approval of investigation report
  • preside over material review board for product disposition problems
  • review and approval of CAPA plans
  • Monitoring and ensuring that DM timelines are met
  • Trending deviations
  • Generate and issue DM status reports
  • Expedite communication to senior management about hazardous deviations
  • Provide training on the DM system to all staff.

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