Quality Progress - July 2016 - 63

ONE GOOD IDEA BY JOHN CARPENTER AND SALLY MCCOLLUM Dealing With Deviation Bringing the SBAR method to manufacturing DEVIATIONS ARE an expected part of rubric, each step of the SBAR format, nected at time of discovery. Staff was manufacturing.1 Regardless of the prod- along with a fictional example, is de- re-educated on maintenance process. The uct being made, deviations will occur scribed as follows: associated SOP was modified to require and must be routinely documented and investigated.2 For many organizations, it is an ongo- Situation: Summarize the deviation event in one to three sentences. For example, "Freezer temperature log dual sign-off on all steps in the maintenance process. Freezer will be restocked with normal supply." ing challenge to ensure that employees for equipment 1234 revealed a 12-hour gap At our organization, we began imple- are consistently reporting these inci- in the recording between May 4, 2016, and menting SBAR by training employees in a dents. While there are myriad mecha- May 5, 2016." classroom format as well as with written nisms available to document deviation investigation processes, there's one concept frequently used in hospital settings Background: State the policy or procedure that is relevant to the deviation. For example, "As per standard operat- assignments. The training resulted in a more detailed and streamlined documentation across deviations and authors. Standardized formatting also led to that can be applied to the manufacturing ing procedure (SOP) all equipment must industry. be continuously temperature-monitored a more efficient review of deviation oc- for excursions and data assessed weekly curances because information was more for impact." easily located within individual reports. The situation, background, assessment and recommendation (SBAR) method, Assessment: Describe in sequential The SBAR method allows all roles in- more recently to clinical healthcare format pertinent details discovered during volved in a process to easily incorporate a processes, is a standardized, clear and the event investigation. thorough technique of conducting, evalu- derived from the U.S. Navy and applied concise method to capture and report For example, "The quality department ating and documenting an investigation information.3 While not typically used in performed a routine review of tempera- and also helps determine the impact of current good manufacturing practices ture logs on May 5, 2016, and found a gap the deviation, while promoting efficiency (cGMP) settings, incorporating this in the recording between May 4, 2016, and in the process. QP format in our cGMP environment has May 5, 2016. promoted a focused uniformity and ef- During the investigation, the reviewer ficiency within documentation, investiga- discovered that the temperature monitor- tion and approval that is reproducible ing sensor was disconnected from the across deviations and authors. port. Review of the maintenance logs The SBAR technique guides the author indicated that the freezer underwent through four steps to document the routine maintenance on May 4, 2016. investigation in a standardized, stream- Maintenance steps include disconnect lined approach, while compartmental- sensor, clean immediate area and recon- izing deviation details into important and nect sensor. distinctive sections. This is in contrast to The involved staff recalled discon- an unguided, free-text approach, where necting the sensor and cleaning the area, event details can vary by author and may but not performing the reconnection. All be overlooked during documentation and contents of the freezer were discarded at investigation. Cumulatively, the SBAR the time of investigation." elements guide the author to synthesize Recommendation: State what actions corrective and preventive actions where will occur or have already occurred as applicable. next steps to prevent event recurrence. To gain a better understanding of this 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. For example, "The sensor was recon- July 2016 * QP 63

Table of Contents for the Digital Edition of Quality Progress - July 2016

Up Front
LogOn
Expert Answers
Keeping Current
Mr. Pareto Head
A Quick Study
Clear Pathway
Pulling It All Together
Dead or Alive
Innovation Imperative
Measure for Measure
Quality in the First Person
Career Corner
Standards Outlook
ASQ's Continuing Education and Profesional Development Directory
QP Toolbox
QP Reviews
One Good Idea
Back to Basics

Quality Progress - July 2016

http://www.nxtbook.com/naylor/ASQM/ASQM0719
http://www.nxtbook.com/naylor/ASQM/ASQM0619
http://www.nxtbook.com/naylor/ASQM/ASQM0519
http://www.nxtbook.com/naylor/ASQM/ASQM0419
http://www.nxtbook.com/naylor/ASQM/ASQM0319
http://www.nxtbook.com/naylor/ASQM/ASQM0219
http://www.nxtbook.com/naylor/ASQM/ASQM0119
http://www.nxtbook.com/naylor/ASQM/ASQM1218
http://www.nxtbook.com/naylor/ASQM/ASQM1118
http://www.nxtbook.com/naylor/ASQM/ASQM1018
http://www.nxtbook.com/naylor/ASQM/ASQM0918
http://www.nxtbook.com/naylor/ASQM/ASQM0818
http://www.nxtbook.com/naylor/ASQM/ASQM0718
http://www.nxtbook.com/naylor/ASQM/ASQM0618
http://www.nxtbook.com/naylor/ASQM/ASQM0518
http://www.nxtbook.com/naylor/ASQM/ASQM0418
http://www.nxtbook.com/naylor/ASQM/ASQM0318
http://www.nxtbook.com/naylor/ASQM/ASQM0218
http://www.nxtbook.com/naylor/ASQM/ASQM0118
http://www.nxtbook.com/naylor/ASQM/ASQM1217
http://www.nxtbook.com/naylor/ASQM/ASQM1117
http://www.nxtbook.com/naylor/ASQM/ASQM1017
http://www.nxtbook.com/naylor/ASQM/ASQM0917
http://www.nxtbook.com/naylor/ASQM/ASQM0817
http://www.nxtbook.com/naylor/ASQM/ASQM0717
http://www.nxtbook.com/naylor/ASQM/ASQM0617
http://www.nxtbook.com/naylor/ASQM/ASQM0517
http://www.nxtbook.com/naylor/ASQM/ASQM0417
http://www.nxtbook.com/naylor/ASQM/ASQC12518
http://www.nxtbook.com/naylor/ASQM/ASQM0317
http://www.nxtbook.com/naylor/ASQM/ASQM0217
http://www.nxtbook.com/naylor/ASQM/ASQM0117
http://www.nxtbook.com/naylor/ASQM/ASQM1216
http://www.nxtbook.com/naylor/ASQM/ASQM1116
http://www.nxtbook.com/naylor/ASQM/ASQM1016
http://www.nxtbook.com/naylor/ASQM/ASAC0016
http://www.nxtbook.com/naylor/ASQM/ASQM0916
http://www.nxtbook.com/naylor/ASQM/ASQA0016
http://www.nxtbook.com/naylor/ASQM/ASQM0816
http://www.nxtbook.com/naylor/ASQM/ASQM0716
http://www.nxtbook.com/naylor/ASQM/ASQM0616
http://www.nxtbook.com/naylor/ASQM/ASQM0516
http://www.nxtbook.com/naylor/ASQM/ASQM0416
http://www.nxtbook.com/naylor/ASQM/ASQM0316
http://www.nxtbook.com/naylor/ASQM/ASQM0216
http://www.nxtbook.com/naylor/ASQM/ASQM0116
http://www.nxtbook.com/naylor/ASQM/ASQM1215
http://www.nxtbook.com/naylor/ASQM/ASQM1115
http://www.nxtbook.com/naylor/ASQM/ASQM1015
http://www.nxtbook.com/naylor/ASQM/ASQM0915
http://www.nxtbook.com/naylor/ASQM/ASQM0815
http://www.nxtbook.com/naylor/ASQM/ASQM0715
http://www.nxtbook.com/naylor/ASQM/ASQM0615
http://www.nxtbook.com/naylor/ASQM/ASQM0515
http://www.nxtbook.com/naylor/ASQM/ASQM0315
http://www.nxtbook.com/naylor/ASQM/ASQM0215
http://www.nxtbook.com/naylor/ASQM/ASQM0115
http://www.nxtbook.com/naylor/ASQM/ASQM1214
http://www.nxtbook.com/naylor/ASQM/ASQM1114
http://www.nxtbook.com/naylor/ASQM/ASQM1014
http://www.nxtbook.com/naylor/ASQM/ASQM0914
http://www.nxtbook.com/naylor/ASQM/ASQM0814
http://www.nxtbook.com/naylor/ASQM/ASQM0714
http://www.nxtbook.com/naylor/ASQM/ASQM0614
http://www.nxtbook.com/naylor/ASQM/ASQM0514
http://www.nxtbook.com/naylor/ASQM/ASQM0414
http://www.nxtbook.com/naylor/ASQM/ASQM0314
http://www.nxtbook.com/naylor/ASQM/ASQM0214
http://www.nxtbook.com/naylor/ASQM/ASQM0114
http://www.nxtbook.com/naylor/ASQM/ASQM1213
http://www.nxtbook.com/naylor/ASQM/ASQM1113
http://www.nxtbook.com/naylor/ASQM/ASQM1013
http://www.nxtbook.com/naylor/ASQM/ASQM0913
http://www.nxtbook.com/naylor/ASQM/ASQM0813
http://www.nxtbook.com/naylor/ASQM/ASQM0713
http://www.nxtbook.com/naylor/ASQM/ASQM0613
http://www.nxtbook.com/naylor/ASQM/ASQM0513
http://www.nxtbook.com/naylor/ASQM/ASQM0413
http://www.nxtbook.com/naylor/ASQM/ASQM0313
http://www.nxtbook.com/nxtbooks/naylor/ASQM0213
http://www.nxtbook.com/nxtbooks/naylor/ASQM0113
http://www.nxtbook.com/nxtbooks/naylor/ASQM1212
http://www.nxtbook.com/nxtbooks/naylor/ASQM1112
http://www.nxtbook.com/nxtbooks/naylor/ASQM1012
http://www.nxtbook.com/nxtbooks/naylor/ASQM0912
http://www.nxtbookMEDIA.com