Most companies’ ability to deliver their products or services highly depends on consistent supplies of raw materials, components or services from suppliers.

It is not unusual in life science industry to have single source of polymer due to the requirements on supplier qualification, validation of processes, stability testing and product registration. It is very time consuming and costly to change critical raw materials and for primary packaging for medicinal products it can often take a couple of years. Change of critical raw materials for medial devices can as well be very time consuming and costly.

In 2015 EU polymer industry declared force majeure on more than 40 occasions in 4 months and there was a lot of concerns in the industry and focus on Supply Chain Contingency Plans.

The last years with more severe weather conditions has also left its imprints on the plans.

2020 is a very unusual year with Covid-19 pandemic and a comprehensive world lock-down, which also impact some companies’ ability to supply as in the example below

I guess that most companies have urgently to update their supply chain contingency plan with the risk for pandemic.

If you are lacking a good template and process for supply chain contingency plans and are interested in an online course, please let me know and I will thank you with a 25% discount on your first online training. Follow the link for more details: Online Courses by Borgensgaard Consulting

Quality management of suppliers can have a significant impact on your quality performance and compliance. One way to control suppliers, is to perform an onsite audit.

I have participated in more than 100 customer audits and it has been a mixed experience depending on the auditor’s competences. Most auditors were very well trained in the standards and regulatory requirements, but many of them had limited knowledge or experience with the manufacturing processes and the critical aspect of the components/products. I think it is pity that companies (pharmaceutical, medical device and suppliers) spend some much time and money on auditing without providing the auditors knowledge about product and processes, so that they ask the important and critical questions and make the observations which are most critical to quality performance and compliance.

It is not only beneficial to the “customers” but also to the “suppliers”. Some suppliers might think, it is better that auditors knows as little as possible. My experience is the opposite. Experienced auditors, who are familiar with the products and processes, can help suppliers to focus on further development of areas of importance and avoid critical issues and complaints. Suppliers, who are using the input from the auditors in a positive way, can use it as a driver for higher quality performance and customer satisfaction and achieve competitive advance.

I have a lot of experience and learning's from the past +25 years, that I plan to share by offering online courses. One subject on my list is audit of suppliers of primary plastic packaging for pharmaceuticals and plastic component for medical devices.

If you are interested in such an online course, please let me know and I will thank you with a 25% discount on your first online course.  Follow the link for more details: Online Courses by Borgensgaard Consulting