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

Several techniques that support comprehensive root cause analysis include:

  • Brainstorming: an interactive group-thinking process to identify all possible causes. The exercise can be structured or unstructured. This is a process carried on without criticism or judgment that stimulates thinking and generates many enhanced ideas. 9
  • Cause and effect or fishbone diagrams: 9 a technique which expands the scope of thinking beyond a single type of cause and also allows the focus to be centered on the core of the issue and not the history or personal opinions. This process prompts the problem solvers to consider the five basic components of a process (people, procedures, materials, equipment, and facilities or environment) as possible sources of root causes.
  • Failure mode and effects analysis (FMEA): 10 a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service. Failures are prioritized according to how serious their consequences are, how frequently they occur, and how easily they can be detected. The purpose of the FMEA is to take actions to eliminate or reduce failures, starting with the highest priority ones.
  • Five why matrices: a process that has been determined to uncover the real root cause by asking "why" five times. This expands the depth of thinking beyond the first thought or impression.

The root cause of a deviation can usually be attributed to a defect in the system design (e.g., inadequate procedures, materials, equipment, facilities, or unqualified personnel), system implementation, or individual performance.

In circumstances where multiple potential root causes have been identified, investigators should narrow the list from possible causes to most probable cause(s). They can use various analytical tools and techniques such as voting on the more probable causes based on objective evidence, rather than gut feeling.

Figure 1
Generally, industry practice dictates that deviation investigation and root cause determination are completed within 30 days of discovery of the deviation. In fact, in the U.S. v. Barr Laboratories case, the Court declared that “…all failure investigations must be performed promptly, within thirty business days of the problem's occurrence, and recorded in written investigation or failure reports”.11 If this is not possible, justification for the delay should be documented in the investigation report along with the date of expected completion. The deviation investigation process is shown in Figure 1.


After the determination of root cause(s), corrective actions can be determined. To narrow the field of possible corrective actions and select the best solution, the following techniques can be used:

  • Matrix diagram: 9 a method in which the team selects the best of alternatives of the solutions and rates them.
  • Force field analysis: 9 a method of weighing the pros and cons of change to identify the forces and factors that support or work against the problem.
  • Affinity diagram: 9 a method for sorting multiple ideas into categories.

To be effective, corrective action(s) must address the root cause. In fact, a strong correlation or linkage should be evident throughout the deviation report from one section to the next, i.e., the description should relate to the investigation, which should relate to the cause and that should relate to the corrective action, and so on. In some circumstances, the identified root cause may require several corrective actions. In these cases, the corrective actions may be implemented consecutively, rather than simultaneously, to determine the impact of any single action on the cause. Consideration should be given to the severity and frequency of the occurrence, demands on resources, and priority of the deliverables.

The team that is involved in determining and implementing the best solution(s) should be one that has the authority and responsibility to make it happen. If the team determining the action to be taken lacks the authority, even the most logical or rational corrective action may not be implemented or implemented incorrectly because the time, money, and resources were not authorized.

Corrective and preventive action (CAPA) plans require that individual tasks and deliverables, timelines, roles, and responsibilities be documented. This provides a mechanism for tracking completion of all activities associated with the action plan. Progress reports should be sent to the affected department managers and the quality unit on a timely basis to ensure that timelines are met and any problems are addressed in a timely manner. If timelines cannot be met, justification for the delay should be documented and forwarded to the quality unit for review and concurrence. Senior management must be informed of corrective actions that have passed their target dates. Timely notification enables the management to deploy resources where needed.

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