This is a re-run from April 2011 and is one of our most appreciated and widely read blogs.
Maria Andersson, who is responsible for the Supplier Management System, explains how this is performed at Rechon.
How do you maintain control of your suppliers at Rechon?
“The Supplier Management System at Rechon includes all suppliers that may have an impact on the quality of the products. It could be a supplier delivering gloves used in the Class A area, a service contractor performing calibration, a contract lab or an exipient or API supplier. For different categories of suppliers we have different requirements, of course, and different levels of control. However, the general rule for all suppliers in the system is that we have them listed, they are classified to risk levels, a change of supplier is handled in the Change Control system and a yearly evaluation of all suppliers is performed. Different groups, consisting of people from different departments at Rechon meet several times per year to evaluate and improve routines and the control of the supplied materials and services.”
How have you implemented risk analysis in your Supplier Management System?
“Risk management has been introduced to the Supplier Management System stepwise. We have systematically gone through all suppliers, or in some areas, categories of suppliers. We listed possible risks, existing risk reducing actions, evaluated the potential risk for product and patient, and classified them in the risk levels low, medium and high. After that new risk reducing actions were implemented for both materials and suppliers.
When new suppliers are introduced a risk assessment is performed and the supplier is classified. The risk classifications are then re-evaluated regularly to see if anything has occurred that will have an impact on the risk for the patient or the product.”
What have you gained from your work with Supplier Management?
“The main benefit from the risk assessment sessions, I would say, is the awareness and knowledge sharing that naturally comes when people from different areas meet and discuss about their different experiences with the suppliers and the supplied material or service. When you go through risks related to the suppliers you also find other related routines where improvements can be made.
We went from a system with a specified audit frequency depending on the category of the material or service supplied, to an audit frequency based on the level of risk for the specific material or service in question. After the risk assessments, some suppliers were found to fit in a category where the audit frequency or surveillance of the supplier’s quality system could be reduced and others where it had to be increased.
After the implementation of the risk based Supplier Management System we consider us to be in control and we have a much better knowledge of our suppliers!“