As an executive at a pharmaceutical company, the pressure is on to maintain or grow profits. The pipeline looks promising; however your new drugs are a few years away from market. Your “blockbuster” is coming off patent next year. Meanwhile you look around your landscape and see that regulators seem to have stepped up enforcement and inspections. Over the recent years your company has outsourced most of your clinical trials. You have sold off a few of your manufacturing sites and find more than half of your products are made by contract manufacturers. The products you do make contain raw materials that come from someplace offshore. You ask yourself, “How do we assure quality while giving away control and ensuing limited visibility into the supply chain responsible for your products?” Your finance and purchasing department are looking to reduce costs. They are squeezing suppliers for better pricing and longer payment terms. They are shopping around for lower cost materials, lower cost service providers, and lower cost contract manufacturers. In a competitive environment, your suppliers are doing the same to their suppliers, and this pattern continues on down the line. Do you have fears that at some point in the supply chain a company may decide to cut one too many corners? That they may use an unproven or unsafe substitute? It has happened before, and it is bound to happen again.
At least you have automated your internal systems related to quality. You manage your supplier scorecard in your ERP system, deviations and CAPAs in a quality system, you have a product complaint system, and you manage change in at least five different automated systems that you know of. But is this enough?
While having multiple systems is an improvement, can you connect the dots if clues to a real problem are hidden in these multiple systems? Many proactive companies have taken the next step and consolidated their quality processes in an Enterprise Quality Management System that becomes a pillar system for their company. In one place, quality executives have visibility into the quality processes that may expose problems. These processes include internal and supplier auditing, deviation and incident management, laboratory issues and complaints. No matter the process that identifies the problem, the same process is still followed. You track and manage your investigations of the issue, risk assessment, root cause analysis and your resolution actions. In addition, you track any related preventive actions and change management that may be spawned by the CAPA plan.
Progressive companies include all three dimensions that challenge global quality: processes, business unit and geography. Besides the processes mentioned above, companies should also include how these processes are managed by different business units, including product development, manufacturing, suppliers, clinical and any other department that may affect the end product. The third dimension includes regions and geography. Bringing quality processes performed by all of your business units across the globe together gives you a system that provides full transparency across your organization and an easy way to trend and analyze potential quality issues.
Putting an Enterprise Quality Management System in place as a pillar system in your company provides you with confidence that your global processes are in control. You are assured that you are putting a safe product on the market and protecting your customers and your company reputation. Putting this enterprise quality management system in place also creates efficiencies in your organization which helps add to the savings that your management is looking for to increase shareholder value for your company.