Operational Excellence

We strive to empower your organisation on its journey towards Operational Excellence. Our work bases on three pillars:

  • Research conducted on FDA research grants, e.g. within their Quality Metrics Initiative
  • Benchmarking pharmaceutical, OTC and personal care manufacturing as well as Quality Control Lab operations
  • Individual projects for industry that combine applied research and data analytics with consulting expertise.

Find more details on all of these and examples of research and consulting projects below.

In addition to the above, we offer different formats for knowledge exchange and are happy to share our insights. Please find an outline of these formats in the "Exchange" section.

Benchmarking

OPEX Manufacturing Benchmarking
OPEX Manufacturing Benchmarking

Our original OPEX manufacturing benchmarking for the pharmaceutical industry was established in 2004 and is a success story since then. We have the world's largest independent database of this kind, which enables us to deliver precise and insightful comparisons.

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Quality Control Lab Benchmarking

Quality Control Lab Benchmarking

In 2016 we launched the QC Lab benchmarking to represent more of the value chain and to support industry in their trending "Lean Labs" initiatives. It follows the same, proven approach of a holistic representation of maturity and performance. Currently, we already have a dataset of more than 140 QC labs available and therefore are able to draw meaningful conclusions.

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In a joint effort with the Personal Care Products Council (PCPC), we ramp up similar programs for OTC and personal care product manufacturers. Get involved to spearhead this excellence initiative! 
PLEASE CONTACT MARK GROTHKOPP.

Quality Assurance Benchmarking

Quality Assurance Benchmarking

The latest addition to our benchmarking portfolio is the Quality Assurance (QA) Benchmarking. It was developed during the last few years in collaboration with leading pharmaceutical companies and was finally launched in Spring 2023. It is the first benchmarking that allows to systematically assess the performance and maturity of QA related processes in a holistic sense.

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FDA Quality Metrics Research

FDA Quality Metrics Research

Our team was commenced work on a FDA research grant to investigate Quality Metrics in 2016. Since then we developed a model reflecting all relevant aspects of the research frame. We analysed different interrelations and links to regulatory outcomes. 

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Conferences

Conferences

Our conference "Elevating Operational Excellence in Pharma: From Manufacturing to Quality Assurance" is a one day event in which we present insights on leading and sustaining Operational Excellence. We combine research results, case studies and joint discussions to create a full day that is ideal to get you or your colleagues up to speed on Operational Excellence or to refresh your knowledge with new updates. 

This year, we are happy to announce we are back in Dublin for an exclusive event. 
MORE INFORMATION

Exchange Groups

The "OPERATIONAL EXCELLENCE RESEARCH GROUP" consists of six to ten companies that come together for four two-day meetings per year (2 x Europe, 2 x North America). The goal is to combine detailed research result with input presentations from our participants and a focus on expert discussions. It gives you room for in-depth knowledge exchange across organisations. The meetings typically have guiding topics such as Production System, Digitalisation, Performance Measurment, Quality Culture, Quality Metrics and Lean Labs. We take care of organising, moderating and facilitating the events.

Due to the high interest in excellence initiatives around QC labs and to share insights from the lab benchmarking, we inaugurated the QC Lab Operational Excellence EXCHANGE PLATFORM (QCEX) in 2018. There are three two-day meetings annually. For the initial round, we geographically limited meeting locations to Europe. Key topics of the 2022 meetings were Capability Buidling, Data Trending and Digitzation & Automation among others. The topics for next year will be defined at the beginning of eaach meeting series together with the participants.

To expand our activities in the area of Production Systems further across different industries, we established the PRODUCTION SYSTEMS PLATFORM (PSP) in 2023. This platform operates as a think tank that provides an environment to discuss, develop and shape the future of Production Systems as well as to share successful practices. Enabled by presentations, workshops and in-depth discussions between the participating companies, the platform brings together Production Systems experts in four one-day meetings per year, to exchange and engage in the topic.

Projects

Team

Mark Grothkopp

Dr.

Project Leader

ITEM-HSG
Büro 24-0-238
Dufourstrasse 40a
9000 St. Gallen

Matteo Bernasconi

M.A. HSG

Research Associate

ITEM-HSG
Büro 24-0-238
Dufourstrasse 40a
9000 St Gallen

Lorenzo Pirrone

Research Associate

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

Fabian Klinkner

Research Associate

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

Jessica Rebecca Helbling

Research Associate

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

OPEX Newsletter

Our newsletter occasionally provides you with information about upcoming projects and conferences - subscribe to stay updated on the latest research!

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