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Quality, Compliance, and Remediation

We help clients achieve significant and sustainable improvement in their quality performance, customer satisfaction, and regulatory compliance.

In a world of increasing complexity and regulation, quality is an often-untapped source of competitive advantage. Superior quality and flawless compliance can help companies dramatically reduce quality-related costs, improve their brand perception, and improve revenues.

What we do

We define quality as consistently meeting or exceeding customer expectations at every touchpoint. We help clients design and conduct quality transformations and remediation programs in a broad range of industries. For example, our expertise enables us to address the particular requirements of highly regulated industries such as pharmaceuticals or to address the complexities of advanced-manufacturing industries such as aerospace and automotive. Our transformation-based approach spans the complete value chain and product life cycle, from product development to sales and service.

  • Benchmarking. To help clients diagnose their quality performance qualitatively and quantitatively, we employ our proprietary benchmarking data to assess factors such as product quality, total costs of quality, resource efficiency, maturity of shop-floor and quality processes, and quality culture.
  • Developing quality and compliance strategies. Many companies take a short-term approach to address quality costs and imminent nonconformances. Instead, we help clients develop strategies that sustain quality excellence and compliance for the long term.
  • Optimizing the quality management system (QMS). Using our “house of quality” framework, we give clients the ability to assess and adjust their QMS for high performance along key parameters, including strategy, processes, organization, and capabilities.
  • Fostering a quality culture. In our experience, companies achieve quality excellence when every employee owns quality and stands personally accountable for customer satisfaction. Drawing on tools that help benchmark performance, we enable clients to build an end-to-end culture and capability-building program that endures.
  • Delivering compliance and remediation services. Within compliance and remediation, we are able to support a full suite of services using a pragmatic approach and functional experts with deep experience in regulatory requirements. These include helping clients respond quickly to crises and minimize negative impact, as well as identifying and correcting the root causes of quality failures using our proven diagnostic tools.

Examples of our work

Our quality and compliance work in the past 5 years has helped more than 150 clients around the globe. Examples include the following:

  • helping a leading European automotive original-equipment manufacturer with a holistic quality transformation, which reduced warranty costs by 25 percent and helped elevate customer-satisfaction rankings to top positions in key markets
  • working with a ship manufacturer in its quality transformation, increasing “right first time” inspections by 40 percent and reducing customer complaints at inspections by more than 25 percent
  • helping a top healthcare company accelerate a multisite quality remediation program that included revising over 800 procedures and retraining more than 5,000 employees, as well as reviewing and remediating thousands of records
  • diagnosing a leading aerospace company’s QMS and designing a transformation program to address costs of poor quality in excess of $1 billion
  • serving a leading medical-device company to develop and roll out best-practice and standardized procedures for its QMS, starting with the highest-risk areas, which resulted in significantly improved key metrics in complaint handling and response, as well as quality

Featured capabilities

We invest heavily in developing knowledge and tools to ensure client transformations succeed. These include the following:

  • POBOS Quality, a proprietary benchmarking capability for pharmaceutical, consumer-health, and medical-device companies providing insights in quality performance and risk, total quality cost, and drivers of quality based on more than 200 manufacturing sites from over 30 top pharmaceutical companies
  • QMS maturity diagnostic, an assessment of the 57 essentials of a great QMS in our framework—the house of quality—with benchmarks and survey results to allow objective comparisons of quality practices
  • Quality-culture benchmark survey, an assessment of the quality culture of a company based on an employee-level survey and linked to quality risk and performance, which provides insights along dimensions such as integrity, capabilities, governance, leadership, and mind-set, based on more than 10,000 responses
  • Quality-control lab-network benchmark, quantitative benchmarking of lab sizing, outsourcing, consolidation levels, technology adoption, and organization models, based on more than 15 organizations (a mix of large and midsize pharmaceutical and consumer health-related companies)
  • McKinsey Capability Center Network, clients can build capabilities in lean manufacturing, quality control, green operations and more at our global network of model factories.

FEATURED EXPERTS

David Keeling

Senior Partner, Chicago

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