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