Supplier Quality

Snapshot

Challenge: A pharmaceutical CDMO faced pressing challenges in maintaining compliance with regulatory authorities and customers, particularly in the field of supplier quality.

Results:

• All critical suppliers evaluated, and QA agreements negotiated
• All commissioned complaints negotiated and professionally supported
• Supplier processes and templates updated, and personnel trained

This meant the customer personnel could work more efficiently, with correct data and reduction of scrap costs.

Customer introduction

The company is a leading biologics CDMO with sites in the EU and US, serving companies worldwide. They specialize in vehicles for cell and gene therapeutics, liquid filling and lyophilization.

Problem

For the CDMO, several long-standing issues had reached  Backlogs in QA Agreements (QAA) and supplier change notifications (SCNs) had been piling up. Resources were insufficient to handle the workload because essential employees were on parental leave without proper transfer of knowledge and replacement. Also, tasks were assigned to new procurement employees beyond their competency. There was a general lack of process efficiency due to a lack of standardization (e.g. longstanding open discussions on the same topic), low levels of automation, excessive paper documentation, and disorganized software applications. Cooperation between departments was low, hindering problem-solving and data sharing. Furthermore, there was poor compliance with processes and procedures, leading to several audit observations, product quality issues and elevated scrutiny by authorities.

Solution

StingOrg introduced a multi-faceted approach, including:

• Resource Allocation: Adding resources to manage the workload effectively.
• Process Optimization: Improving QA agreement templates, preparation, and communication with suppliers.
• Data Cleanup: Updating material databases, eliminating obsolete data, and improving material lists.
• Standardization: Establishing consistent processes for SCNs and QAAs.
• Training: Educating the team and suppliers on best practices.
• Moderation: Fostering cooperation between departments.

Two StingOrg consultants worked on this project, along with the CDMO Supplier quality and Procurement teams

Results

The following results were obtained:

• QA agreements created and complaint processes and templates improved and streamlined.
• Critical suppliers and their QA agreements were evaluated.
• All necessary QA agreements with international suppliers were prepared, negotiated, and signed.
• Backlogs were reduced, including substituting arrangements and training new employees.
• Quality awareness in procurement was raised.
• Significant improvement of compliance, reducing audit observations and product quality issues.

Conclusions

Through strategic collaboration with StingOrg, the CDMO transformed its supplier quality management practices. By standardizing processes, improving cooperation, and investing in resources, the company not only achieved compliance with regulatory and customer requirements but also enhanced operational efficiency. This case study underscores the importance of proactive quality management in the pharmaceutical industry and demonstrates how team efforts combined with an external viewpoint can yield tangible results.