The Importance Of Business Continuity And Recovery Strategies

Business continuity planning (BCP) is put into action by companies to prevent disruptions in operations. In the area of pharmaceutical and biotech manufacturing, it is extremely critical that raw materials are received in a timely manner to prevent disruptions in manufacturing, and potentially preventing life saving treatments from getting into the hands of those who need it. However, manufacturing provides challenges to accurately complete business continuity planning. The evaluations must include all facets of the supply chain, from suppliers of raw materials to components used to create the end product; a supplier's disasters can become a customer's disasters.

Historically, manufacturers approached business continuity planning by using the requirements set by their suppliers, typically based on worst-case scenarios. Planning for the worst-case scenario can result in tying up millions of dollars for inventory that may never be needed. Increasing financially-based pressures on cash flow, has evolved this methodology in recent years. The approach being applied today involves evaluation and ranking of risks which may occur, and planning for those which are the most likely.

Improving a company's risk management strategy and strengthening their response to threats and disasters does not have to be overwhelming.1 If managed properly, a business continuity plan can give a company a flexible and focused framework for addressing various risks simultaneously and one that involves all critical business units in the design and execution of the plan.

Millipore has developed and implemented plans designed to anticipate and minimize interruption to key business processes, production facilities and distribution sites. Each center of excellence has implemented these policies and procedures, to ensure the health, safety and welfare of employees and ensure the continuity of supply to customers.

The approach toward potential risks and applicable continuity and recovery operations is product specific. Plans are created which document the continuity strategies, providing details on equipment, facilities, and resources needed for recovery of operations. Millipore's business continuity risk assessment process includes the review of over 90 separate risks covering technology, business process, man-made, and environmental events.

To meet emerging customer needs for a secure supply of product, Millipore maintains an active business continuity program centered on three elements: Production Reliability, Risk Assessment and Mitigation, and Crisis Management. Implementation of these principals is critical for existing products, but must also be considered for products in development as well.

Production Reliability
Millipore's BCP strategy is built into new products being developed, in addition to those already sold to customers. Reviews and assessments in the design stage help ensure that the manufacturing process for a product is robust and repeatable, and the raw materials supply is stable and reliable, often through the qualification of dual raw materials sources. This is in addition to the evaluation of products which are currently manufactured.

Risk Assessment and Mitigation
Leveraging the results of a thorough risk/vulnerability assessment, risk mitigation measures are implemented to reduce the likelihood or impact of an interruption. Each plant and key supplier undergoes a thorough risk assessment; the corrective actions identified from these assessments are tracked to resolution in a formal corrective action system.

Crisis Management
In the event that a disaster does occur, it is critical to implement a framework which includes site-based teams and procedures. This framework codifes the process for responding to disasters and business interruption. The goal is to minimize recovery times should an event occur. The entire supply chain, not just manufacturing, is reviewed to ensure the recovery time objectives are obtainable. Each plant has a specific Crisis Management Plan and trained crisis management and emergency response teams. These plans and teams are exercised on an annual basis to ensure the highest state of readiness and appropriateness of emergency recovery time objectives.

An example -- Millistak+ Pod Business Continuity Plan
Launched in 2005, the Millistak+ Pod filter format leveraged the success of Millistak+ depth filter media into an easy to use, self-contained format for the clarification of cell culture fluids. Given the rapid adoption of the format in critical manufacturing environments such as biotech, a thorough BCP evaluation was completed in June 2007.

Based upon the 90-point risk evaluation, all identified mitigation measures were entered into the corrective actions system. Included in this evaluation was a study of potential bottleneck points in the manufacturing process and plans established to increase capacity as the demand for Millitak+ Pod filters increases. Some operations were duplicated, dual sourcing of raw materials qualified where possible, and secondary manufacturing for specific operations established. Based upon the risk assessments completed, recovery time objectives were established and Millipore inventories set at appropriate levels to ensure adequate supply of product.

It is important to note that these measures serve as the basis upon which to develop risk mitigation plans with Millistak+ Pod filter users. The final component of any strategy is the development of a business continuity plan for specific products in conjunction with the customer. Depending upon their evaluation of the criticality of the product in the manufacturing process, one definition for customers could be the establishment of appropriate inventory levels based upon recovery time objectives as established in the risk mitigation survey. This can be handled in several ways including:

• Full risk mitigation inventory held for a specific customer and part number
• Standing orders
• Safety stock programs
• Some combination of the options above

All of the above options must be thoroughly evaluated and discussed with the customer to understand forecasted demand and how that demand will change depending on where the product is in the development pipeline. For example, full risk mitigation inventory held at 25 Millistak+ Pod filters per month has a much lower impact on cash flow versus demand of 2000 Millistak+ Pod filters per month.

Conclusions
Business continuity planning comes down to partnerships—Millipore has established risk mitigation plans, but in the end, this is only one part of a complete Business Continuity Plan. Manufacturers and suppliers must work together in a partnership to establish plans which are efficient and cost effective for both parties. This partnership includes a thorough understanding of

• Reliability of the production process
• Thorough understanding of the risks and their likelihood to occur
• Establishment of obtainable recovery time objectives should a crisis occur
• Thorough understanding of a customer's definition of risk mitigation planning

With these actions completed in partnership between the manufacturer and the customer, disruptions to critical manufacturing processes can be minimized in a manner which is efficient and cost effective for everyone.

SOURCE: Millipore