While flipping through Pharmaceutical Manufacturing magazine at work, I found an article about what pharmaceutical companies are doing in order to improve quality. The author, Doug Bartholomew, gives reasons why he believes pharmaceutical manufacturing companies are resistant to making changes in the article, “Proactive Compliance: Putting the “P” in CAPA”. CAPA is short for corrective and preventive action, the different processes and systems that are used in the pharmaceutical manufacturing industry in order to ensure quality by providing basic guidelines on identifying, fixing, and preventing the problem in the future..
A lot of the topics that are covered in the article are related to what we have gone over in class. Continuous improvement is difficult for pharma manufacturing companies because of the regulations that are to assure quality. Just like it is time consuming and expensive to be certified, or registered, to meet one of the quality systems we have learned about in class, the same applies to the different quality standards that are set up in the pharmaceutical manufacturing industry. Pharma manufactures shy away from making changed to their processes because every little change that is made has to be re-certified.
Over the past decades, pharma manufacturing companies have started to realize the importance of continuous improvement. Bartholomew quotes K.R. Karu, who is the industry solutions director at the quality management and CAPA system distributer, Sparta Systems; on what the manufacturing companies need to do to ensure high quality levels. One of Karu’s suggestions was to consider Juran’s quality thinking of having quality already built in to the process. Since quality is already built into the process, companies only need to monitor the process. Through inspection manufacturers should be able to find or come up with possible problems, and make changes to prevent them from ever happening.
The definition on CAPA is not completely understood the some throughout the industry. Every company interprets the guidelines differently. Preventative measures would be easier to accomplish if there were more guidelines were more descriptive. In the article it says that the problem is the “preventative” measures have all come about because of a “corrective” actions. A pure example of a preventative measure that is given is the installation of “state of the art” production line equipment so the number of errors can be reduced. A corrective action would be to update, and/or repair, older equipment after a problem arises, in order to reduce the number of manufacturing errors. They are working on coming up with preventative measures that are truly preventative, making sure something that is unforeseen does not go wrong.
What are some ideas that you have that could improve the confusion between “corrective” verses “preventing” for CAPA?
The Chicago Department of Aviation announced that O’Hare International Airport will be implementing a new procedure in order to reduce the time that customers stand in the customs line. The new procedure is for U.S. passport holders who are returning to the United States on international flights, to improve their customer service experience with customs officials and decrease wait time in line. It is intended that by July 1st, in the midst of the travel season, customers will no longer fill out the paper customs declaration forms on the plane. Instead, after departing the plane, U.S. passport holders will be directed to a self-service kiosk. Once they are at the kiosk, the U.S. passport holder will scan his/her passport to start the claiming process, all before any interaction with a customs official. The customer is then issued a receipt from the machine, with the answers to questions they have answered at the kiosk, to give to the customs official for verification.
This new customs process is an adaption to keep customers satisfied by keeping lines short. The new procedure also includes a few of the five service dimensions that we have learned in class. O’Hare is demonstrating the second service dimension, responsiveness. Implementing the self-service kiosks is in response to the additional four international airlines that will be servicing out of O’Hare this summer. The Chicago Department of Aviation, allowing O’Hare to use the new self-service kiosk devices, is also showing empathy towards the customers. O’Hare and The Chicago Department of Aviation are considering and empathizing with customers by recognizing the stressfulness of standing in line for hours and waiting to complete the customs process upon re-entry into the county. The tangible service dimension is also considered in the new and, what is expected to be improved, paperless customs process. The whole process of communicating with the customs officials is being altered with this new equipment.
The system has been tested with the Canada Border Services Agency and has proved to be useful at the Vancouver International Airport over the past year. The successful trial in Vancouver encouraged The Chicago Department of Aviation to put the new self-service kiosk into action at O’Hare International Airport. This new technology is a breakthrough improvement. There has been little to no change to improve and expedite the re-entry in to the U.S. customs process in the recent past. This new change is much needed.
Personally, after first hand experiences of standing in the customs control line for hours, I am excited for the self-service kiosks to be put into action. For frequent fliers, once they learn the new technology, they will be flying through the line.
How do you feel about the self-service kiosks for the purpose of speeding up the process of re-entry into the United States? Do you think this will be helpful/beneficial to both travelers and customs officials? Do you foresee any problems that may arise from this change?