Initialisation of a quality offensive to reduce quality-related costs

Analysis and the creation of transparency regarding overall quality-related costs in value-added and non-value-added processes at a manufacturer in the medical technology and pharmaceutical industry.

One of the significant challenges in initialising quality offensives with the aim of reducing quality-related costs is the continuous analysis of the weak points of the process. To do so, it is imperative to have transparency relating to the current Q-costs situation in the value-added and non-value-added processes of the individual company.


  • Increasing customer requirements and rising quality demands from the market.
  • Substantial increase in the costs of non-conformity (complaint costs, goodwill costs).
  • A lack of transparency regarding the overall quality-related costs in value-added and non-value-added processes.
  • The lack of an “outward-looking view” with relation to the subject of quality and reliability (in terms of product and process).
  • Insufficient transparency regarding optimisation requirements (overall picture of the required actions, including recommendations for actions).

Specific assignment

  • Creation of transparency for quality-related costs.
  • Independent evaluation of quality management and the Q-relevant processes using “KBC Q-Scan” (top-down Q-analysis).
  • Identification of procedural causes of selected error patterns of medical technology products (relocalising product issues).
  • Deduction and initialisation of short, middle, and long-term recommendations for optimisation.

KBC approach

In carrying out the “KBS Q-Scan”, we used a structured, interview-based questionnaire to identify from the top-down, individual weak points in the value-added and non-value-added processes.

At the same time, using a bottom-up relocalisation in the case of specific technical product issues, we were able – with the help of root cause pharmaceutical engineering that was specially tailored to our client – to quickly detect the corresponding weak points in the process. We then compared these weak areas with the results of the top-down analysis, in the process grouping and prioritising them. In the next step, targeted process improvement recommendations were derived from these results, with the aim of permanently solving the product issues. Finally, we evaluated the recommended actions with a view to their costs and the potential benefits for quality-related costs in the future and prepared the finding for management in a manner which was transparent and oriented to the business case.

Realisation of potential

Together with our client we were able to analyse the actions required and develop process optimisation measures. By means of optimisation project that were focused on content, and evaluated and agreed upon using business cases, the quality work in our client’s key procedural areas were able to be sustainably improved and product issues prophylactically avoided. The processes and methods already tried and tested by KBC for initialising measures in other initiatives were thus able to be successfully implemented for a quality offensive in the medical technology and pharmaceutical industry.