Eight Practices for Sustaining Quality Transformations

Many quality transformations fail to maintain momentum once the most pressing issues have been corrected

By Vikas Bhadoria, Jaidev Rajpal and Kartik Reddy, McKinsey & Company

Sustaining a quality transformation is an elusive goal for many pharmacos. Despite commitments to transition from firefighting to prevention, many quality transformations fail to maintain momentum once the most pressing issues have been corrected. All levels of the organization bear their share of responsibility for transformations that fizzle out.

In McKinsey’s experience, eight smart management practices form the basis for sustained quality transformations.

1. Building Senior Management Capabilities to Lead Quality
Well-informed senior managers serve as powerful role models. For example, at a large generics company, a business unit head routinely visits plants and conducts reviews and problem-solving sessions on the shop floor. He selects the top two or three issues for root cause analysis and resolution. This requires lifelong learning and perpetual education for top managers, who need to understand what best-in-class means for quality with regard to both processes and decision making. Benchmarks from pharma and other industries are an essential starting point.

2. Continually Raise Aspirations Along the Quality Journey
Metrics play a major role in motivating employees to focus on quality issues at all levels of the organization. Best-in-class companies do not rest on their success in a quality improvement program. They continually set higher and higher aspirations for key performance indicators (KPIs) as they make progress on the quality journey, to raise the performance bar and prevent a complacent mind-set from taking hold among employees. They also refine their KPIs, including leading performance indicators (such as shop-floor, line-clearance failures) and lagging ones (such as recalls due to product intermixing).

3. Establish Forums to Cascade Priorities Throughout the Organization
Setting priorities for a quality transformation at the company’s senior level is just the starting point. To effect and sustain meaningful changes, these priorities need to be systematically communicated to the quality function and the shop floor. Leading companies establish a system of meetings and review sessions, to cascade priorities from the corporate level to business units and down to the plant or site level. These forums also serve as conduits for feedback to senior management on what the quality priorities should be.

4. Engage Line Operators to Foster Ownership of Quality
Sustaining a quality transformation requires having line operators take ownership of quality issues. Many pharmacos will need to radically shift mind-sets on the line to accomplish this. Line operators typically regard quality personnel not only as the owners of quality but also as the “police” responsible for enforcing compliance. 

Although the quality function plays an essential role in a transformation, line operators must also be fully invested in the transformation’s success for the improvements to be sustained. Operator ownership also helps to overcome change fatigue. It allows line operators to maintain attention even after the transformation formally ends and prevents them from falling back into their previous mode of operations.

5. Build Line Operators’ Problem-Solving Capabilities
To apply their ownership of quality issues in practice, line operators need capabilities to identify and fix the root causes of quality deviations. Many organizations make the mistake of providing only classroom training or e-learning, without ensuring that the lessons are translated into new ways of working on the shop floor.

To build problem-solving capabilities on the shop floor effectively, leading organizations use a field-and-forum approach that includes classroom training and on-the-job coaching. They also provide line operators with the most effective tools for root-cause problem solving, such as the “5 Whys” and FMEA.

6. Audit 2.0: Create an Empowered Internal Audit Team
Internal audit teams can play a critical role in sustaining a quality transformation. They can be thought of as the organization’s “conscience keeper” through their independent oversight of quality performance. Although most pharmacos have internal audit teams, many fail to set up effective teams or make effective use of them. These teams are often understaffed. Further, senior management may not read or even notice their reports.  Best-in-class pharmacos ensure that internal audit teams have the tools and power to act as conscience keepers for a sustained transformation.

7. Tackle Significant Quality Issues Rapidly and Visibly
Efforts to sustain quality transformations can be derailed if major quality issues, such as product intermixing or foreign particles in products, are allowed to persist. Because these issues can sap energy and morale, organizations must address them head on.

To ensure that major issues do not distract resources from the overall transformation, leading companies form an empowered task force to comprehensively address the organization’s top two or three issues. Resolving these issues rapidly and visibly helps to build momentum for the larger transformation.

8. External Orientation: Scanning Other Companies/Industries for Best Practices
Leading pharmacos recognize the value of applying learnings from outside the organization to sustain quality transformations. They regularly engage external experts to raise the performance bar by building technical capabilities and providing benchmarks.

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