Elevating Operational Excellence in Pharma: From Manufacturing to Quality Assurance

Quality Assurance Benchmarking

The latest addition to the Operational Excellence (OPEX) benchmarking portfolio is the dedicated Quality Assurance (QA) benchmarking. The benchmarking allows a holistic performance and maturity assessment of QA systems and provides the foundation for a systematic improvement of QA processes.

The benchmarking was developed in 2022 in collaboration with leading pharmaceutical companies to ensure the relevance and applicability of the considered topic fields and questions asked. The benchmarking was finally launched in spring 2023.

The Quality Assurance Benchmarking Model

The Quality Assurance Benchmarking Model helps to structure all QA activities and allows a systematic alignment of the observed process fields. All 15 process fields are covered by a dedicated performance and maturity section in the questionnaire. In addition to 15 process fields of QA, there is a dedicated section of structural factors of the company to be benchmarked. This allows the definition of a comparable peer group and provides valuable background information.

QA Process Fields

In total, 15 QA process fields are analysed in the benchmarking. For each process field, a dedicated KPI set is being used for the performance assessment of the related processes. Furthermore, qualitative enabler questions are used to analyse the maturity of the processes and to capture successful practices. The QA process fields are divided into three main categories.

Value-stream related activities

This category encompasses six fields of activity, each linked to a specific phase in the value-creation process. Starting at supplier quality management, it subsequently includes Batch Record Review, Process Monitoring, as well as Deviation Handling. Lastly, in the market perspective it includes the creation processes of Stability studies, as well as Product Quality Reviews (PQRs).

Internal support processes

The internal support processes include seven process fields that support operations in the overall company. This includes i.e. the Quality Risk Management, the Training and Knowledge Management processes and systems, as well as the development and implementation of new Standard Operating Procedures (SOPs) in the Quality Management System (QMS) Design category.

Regulatory compliance

In order to take an external perspective on QA, regulatory compliance assesses the cooperation with regulatory agencies. This is done in a twofold way. Firstly, Inspections analyses the performance and maturity of the inspection handling processes. Secondly, Regulatory Affairs focuses on the generic relationship management and cooperation with regulatory agencies.

Personalized Comprehensive Report

Personalized Comprehensive Report

The personalized benchmarking report shows your relative performance compared to your peer-group and High Performer. The latter are those companies with the overall highest QA performance. A management summary will be provided that gives relevant insights on the performance and maturity in the various process fields. Heat maps show your relative performance for all KPIs compared to your peer-group median and High Performer. Furthermore, a detailed overview of structural factors of your site compared to peer-group will be provided. 

A sample report can be requested using the form at the bottom of this page.

Benefits of Your Participation

  • Assessment of OPEX Performance and Maturity of your QA System.
  • Fully flexible benchmarking process and personal assistance from the St.Gallen team.
  • Personalized peer-group from St.Gallen QA database.
  • Personalized benchmarking report showing your relative performance compared to your peer-group and High Performer.
  • Getting access to successful practices and practical insights from the latest St.Gallen QA research.


We are happy to conclude the benchmarking exercise with an optional on-site workshop. Conducting a workshop allows to discuss the benchmarking results in detail and derive improvement actions based on our extensive experience.

Data Security and Privacy

The benchmarking project will be conducted in accordance to the International Benchmarking Code of Conduct which ensures a correct attitude of all participants. The company data will be handled with utmost discretion and if applicable will be made anonymous. Company specific data is not to be used without prior approval of the respective company. The project initiators reserve to themselves to use the project results in summary and blinded for publications.

Get in touch

In case you are interested in participating in our QA Benchmarking, please do not hesitate to contact us.

Fabian Klinkner

Research Associate

Dufourstrasse 40a
Büro 24-0-241
9000 St Gallen

Jessica Rebecca Helbling

Research Associate

Büro 24-0-241
Dufourstrasse 40a
9000 St Gallen

Request a sample report

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