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 senior management bears ultimate responsibility for establishing, implementing, and resourcing all of the organization's systems. Therefore, they have direct accountability for brand integrity and increased risks arising from inefficient, ineffective, and unsafe systems. The management must balance multiple objectives including supplying a safe and effective product, maintaining profitability, sustaining regulatory compliance, and supporting continuous quality improvement. They have both the authority and the responsibility to ensure these objectives are met. A well-designed and implemented DM system that incorporates risk-management principals provides an indispensable tool to help managers fulfill their obligations.

One major biotechnology company recently reported a "...major improvement in the company's corrective and preventive action process that significantly reduced the company's perceived liability exposure and saved millions of dollars..." when they instituted a management review.12

In addition, active engagement of senior management is essential for the successful functioning of a DM system. Managers demonstrate their involvement by:
  • engaging staff routinely in interactive process design and assessment work.
  • encouraging open communication without fear of reprisal, listening to staff input, and soliciting feedback in the context of just culture.
  • supporting value-added training that enhances job knowledge and skills
  • monitoring systems performance through inquiries, review of status and progress reports, and reacting to critical information in a timely manner.
  • ensuring line staff participate in deviation investigations. Too often a manager or supervisor performs the deviation investigation and determines the root cause and corrective action without staff input despite the fact that staff may have daily involvement and extensive experience. The involvement of staff also encourages them to anticipate potential problems and communicate them to the appropriate manager.
  • Senior management is also responsible for exploiting the benefits offered from continually monitoring and analyzing the system's data output. This enables more informed decisions about the need for changes and timely actions to prevent serious and costly problems. The DM system will provide a mechanism for timely and effective escalation of quality issues to the appropriate management level. It feeds key information into the management review process and helps ensure continual compliance with regulatory requirements.


In summary, the DM system that integrates risk management throughout the process will help the organization discriminate between critical and noncritical issues and better manage the sometimes conflicting interests of business, regulatory, and customer requirements.

The design of deviation management should encompass key elements including timely reporting, assessing risk, taking necessary immediate containment actions, performing thorough investigations and RCA, completing appropriate CAPA, and monitoring the effectiveness of corrective actions. The DM system must also provide for deviation trending to predict performance changes and allow for preventive action, tracking and status reporting on a routine basis; and an escalation process to communicate critical issues to appropriate management.

Finally, the deviation management system with strong management support can be advantageous, not only to the staff (by providing a process that works for them), but also to the organization's bottom line by offering benefits such as reducing product rework and destruction, and time spent on failed corrective actions. Collectively, these help assure regulatory compliance and protection of the organization's brand.

Gail Bredehoeft is principal consultant and Judy O'Hara is senior consultant at Parexel Consulting, St. Lowell, MA 01851,


1. US Food and Drug Administration. Warning Letters. Available from: http://www.fda.gov/foi/warning.htm.

2. The Gold Sheet: Pharmaceutical & Biotechnology Quality Control. 2007;41(4):13–17.

3. US Food and Drug Administration. 483 Observations from 1/04 to 3/05. Available from: http://www.fda.gov/ora/frequent/483s/boston_sci_2005_var/watertown_ma.html.

4. Pharmaceutical Technology, December 2, 2006. In the Field Section: Table 1, Causes of Form 483 and Warning Letter Citations based on 818 FY 2006 Citations .

5. US Food and Drug Administration. Turbo Establishment Inspection Report.

6. International Conference on Harmonization. Q9, Quality Risk Management. Geneva, Switzerland; 2005.

7. The Gold Sheet: Pharmaceutical & Biotechnology Quality Control. 2008;42(1):14.

8. United States v. Barr Laboratories, 812 F. Supp. 458, 467–68 (D.N.J. 1993).

9. Brassar M, Ritter D. The Memory Jogger II, A Pocket Guide of Tools for Continuous Improvement and Effective Planning. 1st ed.

10. The Quality Toolbox, 2nd ed. ASQ Quality Press;2004:p.236–242.

11. Barr Labs, 812 F. Supp. at 468.

12. The Gold Sheet: Pharmaceutical & Biotechnology Quality Control. 2008;42(1):13.

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