2019

ONE GOOD IDEA

Dealing With Deviation

Bringing the SBAR method to manufacturing

by John Carpenter and Sally McCollum

Deviations are an expected part of manufacturing.1 Regardless of the product being made, deviations will occur and must be routinely documented and investigated.2

For many organizations, it is an ongoing challenge to ensure that employees are consistently reporting these incidents. While there are myriad mechanisms available to document deviation investigation processes, there’s one concept frequently used in hospital settings that can be applied to the manufacturing industry.

The situation, background, assessment and recommendation (SBAR) method, derived from the U.S. Navy and applied more recently to clinical healthcare processes, is a standardized, clear and concise method to capture and report information.3 While not typically used in current good manufacturing practices (cGMP) settings, incorporating this format in our cGMP environment has promoted a focused uniformity and efficiency within documentation, investigation and approval that is reproducible across deviations and authors.

The SBAR technique guides the author through four steps to document the investigation in a standardized, streamlined approach, while compartmentalizing deviation details into important and distinctive sections. This is in contrast to an unguided, free-text approach, where event details can vary by author and may be overlooked during documentation and investigation. Cumulatively, the SBAR elements guide the author to synthesize corrective and preventive actions where applicable.

To gain a better understanding of this rubric, each step of the SBAR format, along with a fictional example, is described as follows:

Situation: Summarize the deviation event in one to three sentences.

For example, "Freezer temperature log for equipment 1234 revealed a 12-hour gap in the recording between May 4, 2016, and May 5, 2016."

Background: State the policy or procedure that is relevant to the deviation.

For example, "As per standard operating procedure (SOP) all equipment must be continuously temperature-monitored for excursions and data assessed weekly for impact."

Assessment: Describe in sequential format pertinent details discovered during the event investigation.

For example, "The quality department performed a routine review of temperature logs on May 5, 2016, and found a gap in the recording between May 4, 2016, and May 5, 2016.

During the investigation, the reviewer discovered that the temperature monitoring sensor was disconnected from the port. Review of the maintenance logs indicated that the freezer underwent routine maintenance on May 4, 2016. Maintenance steps include disconnect sensor, clean immediate area and reconnect sensor.

The involved staff recalled disconnecting the sensor and cleaning the area, but not performing the reconnection. All contents of the freezer were discarded at the time of investigation."

Recommendation: State what actions will occur or have already occurred as next steps to prevent event recurrence.

For example, "The sensor was reconnected at time of discovery. Staff was re-educated on maintenance process. The associated SOP was modified to require dual sign-off on all steps in the maintenance process. Freezer will be restocked with normal supply."

At our organization, we began implementing SBAR by training employees in a classroom format as well as with written assignments. The training resulted in a more detailed and streamlined documentation across deviations and authors.

Standardized formatting also led to a more efficient review of deviation occurances because information was more easily located within individual reports.

The SBAR method allows all roles involved in a process to easily incorporate a thorough technique of conducting, evaluating and documenting an investigation and also helps determine the impact of the deviation, while promoting efficiency in the process.


References

  1. David Elder and Peter Smith, "Regulation and Compliance: Deviation Investigations," Pharmaceutical Technology, Vol. 36, No. 4, 2012, pp. 22-22.
  2. "Written Procedures; deviations," Code of Federal Regulations, Title 21, Section 211.100.
  3. J. Compton, K. Copeland, S. Flanders, C. Cassity, M. Spetman, Y. Xiao and D. Kennerly, "Implementing SBAR Across a Large Multihospital Health System," Joint Commission Journal on Quality and Patient Safety, Vol. 38, No. 6, 2012, pp. 261-268.

John Carpenter is a quality assurance manager at Duke University’s Translational Research Institute in Durham, NC. He holds a master’s degree in biotechnology from American University in Washington, D.C. Carpenter is an ASQ member and ASQ-certified quality auditor.


Sally McCollum is a project coordinator at Duke University’s Translational Research Institute in Durham, NC. She holds a doctorate in pharmacy from Campbell University in Buies Creek, NC.



good informative article / methodology
to prevent / reduce quality problems

Aylin N. Minikus
ASQ CQPA, CQE, CQA


--Aylin N. Minikus, 12-10-2018

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