Operational Excellence Improves Quality and Compliance

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Equipment and Processing Report

Equipment and Processing Report, Equipment and Processing Report-11-20-2013, Volume 0, Issue 0

An operational-excellence initiative increased collaboration between operations and quality personnel to address human-error-caused deviations.

Life-sciences companies face more pressure than ever to reduce costs and increase efficiency. In response, many companies have embarked on operational excellence programs. When these programs are carefully planned and executed, they can significantly improve how companies work by reducing waste, streamlining processes, increasing productivity, and assuring an uninterrupted supply of products to customers. In addition to increased efficiency and cost reduction, there is a third leg to the stool: quality and compliance benefits. With carefully designed, executed, and sustainable operational excellence programs—and with improved quality and compliance targeted as one of the goals from the outset—companies can ensure they reap the full benefits of operational excellence.

Operational excellence programs may be narrowly focused on specific processes and functions or broader in scope to encompass an entire site or multiple sites. Consider a vaccine manufacturer that faced recurring compliance problems in two key manufacturing operations. To address the problems, the organization undertook an operational excellence initiative focused on reducing human-error-caused deviations and increasing right-first-time performance in batch records. The ultimate goal was not simply to make the processes compliant, but to create sustainable improvement by training all stakeholders, not just a targeted few; increasing collaboration and partnership between operations and quality; and creating a continuing quality assurance (QA) presence on the shop floor. The absence of a QA presence coupled with the perception by shop floor personnel that QA auditors were adversaries who simply policed production were principal underlying causes of the compliance problems faced by the company. Through an extensive coaching and mentoring effort, QA personnel came to see themselves not solely as auditors (which they have to be), but as partners with the operations staff, there to help assure quality and compliance, but also to help address issues and provide guidance to help up-skill shop floor personnel in their understanding and performance of cGMP/compliance.

To tackle human-error-caused deviations, the deviation management process was redesigned to bring it into line with current FDA expectations and industry best practices, and to assure that the people closest to the observation of issues were involved in the process. Instead of handing off deviation management to another department, as was done previously, the operations group took over responsibility for managing alerts and deviations in real time on the shop floor while the trail was still warm. Deviations could then be investigated in a matter of hours-not weeks-and closed faster in a scientifically sound and compliant manner. Deviation reports were made the responsibility of a single investigator with specific analytical and investigation reporting skills. The reports were then designed to connect the event and its root cause to the corrective and preventive action, helping make recurring deviations rare.

In a parallel effort, batch records were simplified and optimized, as were a number of critical standard operating procedures, which were so difficult to follow that they each generated errors, deviations, and waste. Working together, the quality and operations groups were then able to dramatically improve the rate of right-first-time documentation. The quality function created new roles designed to partner with operations and deliver quality and compliance in real time, in-process, on the shop floor. A quality coordinator was assigned to the area with sole responsibility for compliance. Compliance specialists were created to rotate through the operations area and to spend 80% of their time on the shop floor to provide real-time, in-process batch record documentation review and mentor operations personnel on compliance issues and decision-making when deviations occurred.


Ian L. Uydess, PhD, is a managing consultant at Tunnell Consulting, and Robert E. Spector is principal at Tunnell Consulting.

This article was excerpted from "Operational Excellence: More Than Just Process Improvement," published in the October 2013 issue of BioPharm International.