I am part of out weekly design control meeting for our company’s new product, we have a meeting where we discuss how we can improve the batch records and we assign task based on a tracker that we constantly update. Most of our improvement come from the operators that work directly with the manufacturing of the product. Our main objective and risk management worked hand in hand as for GMP you need total risk management. For our design control our process had improvement to equipment and developments that would enhance the current process and new one.