Global Quality — Improving Quality, Reducing Compliance Issues
A global medical device and pharmaceutical company with nearly 20 manufacturing plants worldwide
was experiencing a rise in the number of quality and compliance issues despite spending more money and
increasing headcount in its quality department. Although competitors were facing similar issues, the company
wanted to dramatically improve its compliance levels, while keeping its cost of quality under control.
Challenge
A.T. Kearney was engaged to work with the Global Head of Quality to assess the effectiveness and efficiency of the company’s global quality function.
Approach
Our team conducted an in-depth assessment of the practices and performance of the quality function, both at the corporate and site level. The 10-week assessment identified:
- Overly complex quality systems that required high volumes of testing and retesting of products
- Redundant and inconsistent quality assurance layers (at the site and corporate levels)
- Corrective versus preventive actions
- The most stringent policies applied across all products—many times beyond individual product requirements
- Disaggregated and inconsistent quality metrics
Results
We developed a plan to help the company reduce major quality issues by 40 percent and costs by 15 to 20 percent.
The plan consisted of the following:
- Simplify and standardize policies, documentation, non-conformance investigations
- Leverage electronic documentation and records to reduce paper and improve accessibility to better information
- Exploit global technology platforms and processes to improve efficiency
- Centralize or share resources in areas such as supplier quality and document management
- Increase control over key compliance processes such as change management and supplier quality
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